chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: currently sits at 63 days since receiving first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (currently sits at 63 days since receiving first dose) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (currently sits at 63 days since receiving first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (currently sits at 63 days since receiving first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant Follow up
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (vaccination site pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of 1 dosage form. On 30-Apr-2021, VACCINATION SITE PAIN (vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; Fever; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills) and PYREXIA (Fever) 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 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced CHILLS (chills) and PYREXIA (Fever). At the time of the report, CHILLS (chills) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: non significant followup
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Influenza, Myalgia, Pyrexia
Clinical narrative: Fast heartbeat; Body aches; Headache; Fever/high temperature; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Fast heartbeat), MYALGIA (Body aches), PYREXIA (Fever/high temperature) and HEADACHE (Headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (Fever/high temperature). On 18-May-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). On an unknown date, the patient experienced HEART RATE INCREASED (Fast heartbeat). The patient was treated with OSELTAMIVIR at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 14-May-2021, PYREXIA (Fever/high temperature) outcome was unknown. On 22-May-2021, MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown. At the time of the report, HEART RATE INCREASED (Fast heartbeat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Influenza: (Negative) negative. On 20-May-2021, SARS-CoV-2 test: (Negative) negative.         No concomitant medications were not provided.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow up appended for Document Attachment
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fast heartbeat; Body aches; Headache; Fever/high temperature; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Fast heartbeat), MYALGIA (Body aches), PYREXIA (Fever/high temperature) and HEADACHE (Headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PYREXIA (Fever/high temperature). On 18-May-2021, the patient experienced MYALGIA (Body aches) and HEADACHE (Headache). On an unknown date, the patient experienced HEART RATE INCREASED (Fast heartbeat). The patient was treated with OSELTAMIVIR at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 14-May-2021, PYREXIA (Fever/high temperature) outcome was unknown. On 22-May-2021, MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown. At the time of the report, HEART RATE INCREASED (Fast heartbeat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Influenza: (Negative) negative. On 20-May-2021, SARS-CoV-2 test: (Negative) negative.         No concomitant medications were not provided.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant Follow up appended for Document Attachment
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: feeling more pain/achiness; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (feeling more pain/achiness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (feeling more pain/achiness). At the time of the report, ARTHRALGIA (feeling more pain/achiness) outcome was unknown.            Patient had a physical therapy on 25-May-2021  No concomitant medications were not reported. No treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Followup received on 26-MAY-2021 and No new information
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Getting COVID After the Vaccine; 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 COVID-19 (Getting COVID After the Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history 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 COVID-19 (Getting COVID After the Vaccine). At the time of the report, COVID-19 (Getting COVID After the Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. No treatment was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up is added. No new information was reported. On 29-May-2021: No new information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were not provided. No treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: I have left and right side lower back pain; 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 BACK PAIN (I have left and right side lower back pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced BACK PAIN (I have left and right side lower back pain). At the time of the report, BACK PAIN (I have left and right side lower back pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: stomach pain; 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 ABDOMINAL PAIN (stomach pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 ABDOMINAL PAIN (stomach pain). At the time of the report, ABDOMINAL PAIN (stomach pain) outcome was unknown. Not Provided          No concomitant medication included.  No treatment medication included.  Action taken with mRNA-1273 Moderna COVID-19 Vaccine was not applicable   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up Received on 25-May-2021, No new information
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Swelling in the joints; Pain in joints; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in the joints) and ARTHRALGIA (Pain in joints) in a 120-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0128AZIA and 043B2IA) for COVID-19 vaccination.     Concomitant products included FINASTERIDE, ARIPIPRAZOLE (ABILIFY) and SERTRALINE for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced JOINT SWELLING (Swelling in the joints) and ARTHRALGIA (Pain in joints). The patient was treated with IBUPROFEN for Joint pain, at a dose of 1 dosage form. At the time of the report, JOINT SWELLING (Swelling in the joints) and ARTHRALGIA (Pain in joints) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity
Clinical narrative: torax painful, inexplicable sintoms; right arm pain from intercostal inside of esternon; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021 and was forwarded to Moderna on 25-May-2021.    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 CHEST PAIN (torax painful, inexplicable sintoms) and MYALGIA (right arm pain from intercostal inside of esternon) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHEST PAIN (torax painful, inexplicable sintoms) and MYALGIA (right arm pain from intercostal inside of esternon). At the time of the report, CHEST PAIN (torax painful, inexplicable sintoms) and MYALGIA (right arm pain from intercostal inside of esternon) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up accepted on 27-05-21
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose 46 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose 46 days ago) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 46 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose 46 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment and concomitant medication reported.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Influenza like illness, Nasal congestion
Clinical narrative: rash quarter size by site of injection; headache; flu like symptoms; a lot of phlegm; coughing and congestion; coughing and congestion; feeling fatigue; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PRODUCTIVE COUGH (a lot of phlegm), COUGH (coughing and congestion), NASAL CONGESTION (coughing and congestion) and FATIGUE (feeling fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PRODUCTIVE COUGH (a lot of phlegm), COUGH (coughing and congestion), NASAL CONGESTION (coughing and congestion), FATIGUE (feeling fatigue), PYREXIA (low grade fever) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE RASH (rash quarter size by site of injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PRODUCTIVE COUGH (a lot of phlegm), COUGH (coughing and congestion), NASAL CONGESTION (coughing and congestion), FATIGUE (feeling fatigue), PYREXIA (low grade fever), VACCINATION SITE RASH (rash quarter size by site of injection) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were not reported. Treatment medication like TYLENOL was included.
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, Vaccination site rash
Clinical narrative: rash quarter size by site of injection; headache; flu like symptoms; a lot of phlegm; coughing and congestion; coughing and congestion; feeling fatigue; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PRODUCTIVE COUGH (a lot of phlegm), COUGH (coughing and congestion), NASAL CONGESTION (coughing and congestion) and FATIGUE (feeling fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PRODUCTIVE COUGH (a lot of phlegm), COUGH (coughing and congestion), NASAL CONGESTION (coughing and congestion), FATIGUE (feeling fatigue), PYREXIA (low grade fever) and HEADACHE (headache). On an unknown date, the patient experienced VACCINATION SITE RASH (rash quarter size by site of injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PRODUCTIVE COUGH (a lot of phlegm), COUGH (coughing and congestion), NASAL CONGESTION (coughing and congestion), FATIGUE (feeling fatigue), PYREXIA (low grade fever), VACCINATION SITE RASH (rash quarter size by site of injection) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were not reported. Treatment medication like TYLENOL was included.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Acute sinusitis, Illness, Upper respiratory tract infection
Clinical narrative: Upper Respiratory Infection; full blown sick; Acute Sinusitis; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), ILLNESS (full blown sick) and ACUTE SINUSITIS (Acute Sinusitis) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), ILLNESS (full blown sick) and ACUTE SINUSITIS (Acute Sinusitis). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), ILLNESS (full blown sick) and ACUTE SINUSITIS (Acute Sinusitis) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medication include Antibiotic.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (terrible pain) 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 mRNA-1273 (batch no. Unknown) for COVID-19 vaccine.    No Medical History information was reported.   [an_susp_product_dose_history_s] On an unknown date, the patient experienced PAIN (terrible pain).   At the time of the report, PAIN (terrible pain) outcome was unknown. Not Provided    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes:  On 25-May-2021: non-significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Prolonged heavy periods; 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 HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods). At the time of the report, HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pain in extremity
Clinical narrative: Headache; muscle ache; sore arm; nausea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 23-May-2021, the patient experienced NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills). On 25-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache) and HEADACHE (Headache) outcome was unknown.            No Concomitants included. No Treatment mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received; Reporter's Comments: N/A; Sender's Comments: N/A
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; muscle ache; sore arm; nausea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and MYALGIA (muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 23-May-2021, the patient experienced NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills). On 25-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and MYALGIA (muscle ache). On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills), MYALGIA (muscle ache) and HEADACHE (Headache) outcome was unknown.            No Concomitants included. No Treatment mentioned.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received; Reporter's Comments: N/A; Sender's Comments: N/A
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Mucosal inflammation, Nasal congestion, Rhinorrhoea
Clinical narrative: coughing; stuffy and runny nose; stuffy and runny nose; Increase in their mucosity and in the thickness of the mucosity; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of COUGH (coughing), RHINORRHOEA (stuffy and runny nose), NASAL CONGESTION (stuffy and runny nose) and MUCOSAL INFLAMMATION (Increase in their mucosity and in the thickness of the mucosity) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included GLIMEPIRIDE, LISINOPRIL and NIFEDIPINE for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced COUGH (coughing), RHINORRHOEA (stuffy and runny nose), NASAL CONGESTION (stuffy and runny nose) and MUCOSAL INFLAMMATION (Increase in their mucosity and in the thickness of the mucosity). At the time of the report, COUGH (coughing), RHINORRHOEA (stuffy and runny nose), NASAL CONGESTION (stuffy and runny nose) and MUCOSAL INFLAMMATION (Increase in their mucosity and in the thickness of the mucosity) outcome was unknown. Not Provided      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.   jalumex 1000 mg  is included in concomitant medication claripine, pediatric benadryl  as treatment medication
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Induration, Rash
Clinical narrative: bruises in leg; It is firm to touch; Rash; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruises in leg), INDURATION (It is firm to touch) and RASH (Rash) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruises in leg), INDURATION (It is firm to touch) and RASH (Rash). At the time of the report, CONTUSION (bruises in leg), INDURATION (It is firm to touch) and RASH (Rash) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. No concomitant and treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Report contain no new information.
Sex: U
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: face has bumps; 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 SKIN MASS (face has bumps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (face has bumps). At the time of the report, SKIN MASS (face has bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow up appended
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Tooth disorder
Clinical narrative: her tooth got bad; active infection; This spontaneous case was reported by a consumer and describes the occurrence of TOOTH DISORDER (her tooth got bad) and INFECTION (active infection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014c21a and 048b21a) for COVID-19 vaccination.     No medical history was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-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 TOOTH DISORDER (her tooth got bad) and INFECTION (active infection). The patient was treated with AMOXICILLIN at an unspecified dose and frequency. At the time of the report, TOOTH DISORDER (her tooth got bad) and INFECTION (active infection) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; 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 URTICARIA (Hives) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. no Concomitant products were provided. no treatment medications were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: rash / spots in round circles; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash / spots in round circles) and VACCINATION SITE PAIN (sore arm) in an 83-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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash / spots in round circles) and VACCINATION SITE PAIN (sore arm). At the time of the report, RASH (rash / spots in round circles) and VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Sex: U
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; 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 URINARY TRACT INFECTION (Urinary tract infection) 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, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown. Not Provided          Patient received second dose of Moderna vaccine and wanted to know if it can cause Urinary Tract Infection in women.  No concomitant medications were reported. No treatment was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral disorder, Chills, Diarrhoea, Dysgeusia, Fatigue
Clinical narrative: really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant; a weird taste in my mouth; brain stuff; Legs Hurt; Legs Swollen; Diarrhea; Vaccination site pain; Body pain Increased; Fatigue Increased; Headache a weird different kind of headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs Hurt), PERIPHERAL SWELLING (Legs Swollen), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Body pain Increased) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fatigue and Pain.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body pain Increased), FATIGUE (Fatigue Increased), HEADACHE (Headache a weird different kind of headache), CHILLS (chills) and NAUSEA (nausea). On 09-May-2021, the patient experienced PAIN IN EXTREMITY (Legs Hurt) and PERIPHERAL SWELLING (Legs Swollen). On an unknown date, the patient experienced MUSCLE SPASMS (really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant), DYSGEUSIA (a weird taste in my mouth) and CEREBRAL DISORDER (brain stuff). On 09-May-2021, DIARRHOEA (Diarrhea) had resolved. On 25-May-2021, PAIN IN EXTREMITY (Legs Hurt), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body pain Increased), FATIGUE (Fatigue Increased), HEADACHE (Headache a weird different kind of headache), CHILLS (chills) and NAUSEA (nausea) had resolved, PERIPHERAL SWELLING (Legs Swollen) had not resolved. At the time of the report, MUSCLE SPASMS (really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant) had not resolved and DYSGEUSIA (a weird taste in my mouth) and CEREBRAL DISORDER (brain stuff) 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 medication provided by the reporter no treatment information reported by the reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information added. On 22-Jul-2021: Follow-up  information received contains significant information - Updated  lab test information :patient received an Echo and Ultrasound of her legs On 10-MAY-2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Myalgia, Nausea, Pain in extremity
Clinical narrative: really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant; a weird taste in my mouth; brain stuff; Legs Hurt; Legs Swollen; Diarrhea; Vaccination site pain; Body pain Increased; Fatigue Increased; Headache a weird different kind of headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs Hurt), PERIPHERAL SWELLING (Legs Swollen), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Body pain Increased) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fatigue and Pain.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body pain Increased), FATIGUE (Fatigue Increased), HEADACHE (Headache a weird different kind of headache), CHILLS (chills) and NAUSEA (nausea). On 09-May-2021, the patient experienced PAIN IN EXTREMITY (Legs Hurt) and PERIPHERAL SWELLING (Legs Swollen). On an unknown date, the patient experienced MUSCLE SPASMS (really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant), DYSGEUSIA (a weird taste in my mouth) and CEREBRAL DISORDER (brain stuff). On 09-May-2021, DIARRHOEA (Diarrhea) had resolved. On 25-May-2021, PAIN IN EXTREMITY (Legs Hurt), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body pain Increased), FATIGUE (Fatigue Increased), HEADACHE (Headache a weird different kind of headache), CHILLS (chills) and NAUSEA (nausea) had resolved, PERIPHERAL SWELLING (Legs Swollen) had not resolved. At the time of the report, MUSCLE SPASMS (really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant) had not resolved and DYSGEUSIA (a weird taste in my mouth) and CEREBRAL DISORDER (brain stuff) 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 medication provided by the reporter no treatment information reported by the reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information added. On 22-Jul-2021: Follow-up  information received contains significant information - Updated  lab test information :patient received an Echo and Ultrasound of her legs On 10-MAY-2021.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant; a weird taste in my mouth; brain stuff; Legs Hurt; Legs Swollen; Diarrhea; Vaccination site pain; Body pain Increased; Fatigue Increased; Headache a weird different kind of headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs Hurt), PERIPHERAL SWELLING (Legs Swollen), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain) and MYALGIA (Body pain Increased) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fatigue and Pain.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body pain Increased), FATIGUE (Fatigue Increased), HEADACHE (Headache a weird different kind of headache), CHILLS (chills) and NAUSEA (nausea). On 09-May-2021, the patient experienced PAIN IN EXTREMITY (Legs Hurt) and PERIPHERAL SWELLING (Legs Swollen). On an unknown date, the patient experienced MUSCLE SPASMS (really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant), DYSGEUSIA (a weird taste in my mouth) and CEREBRAL DISORDER (brain stuff). On 09-May-2021, DIARRHOEA (Diarrhea) had resolved. On 25-May-2021, PAIN IN EXTREMITY (Legs Hurt), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Body pain Increased), FATIGUE (Fatigue Increased), HEADACHE (Headache a weird different kind of headache), CHILLS (chills) and NAUSEA (nausea) had resolved, PERIPHERAL SWELLING (Legs Swollen) had not resolved. At the time of the report, MUSCLE SPASMS (really intense bad Charlie horses for ages/  Charlie horses are now very slight and not constant) had not resolved and DYSGEUSIA (a weird taste in my mouth) and CEREBRAL DISORDER (brain stuff) 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 medication provided by the reporter no treatment information reported by the reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information added. On 22-Jul-2021: Follow-up  information received contains significant information - Updated  lab test information :patient received an Echo and Ultrasound of her legs On 10-MAY-2021.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site reaction
Clinical narrative: A lump that formed under the skin after the vaccination; Magnet was sticking to my arm at vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A lump that formed under the skin after the vaccination) and VACCINATION SITE REACTION (Magnet was sticking to my arm at vaccination site) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-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 VACCINATION SITE MASS (A lump that formed under the skin after the vaccination) and VACCINATION SITE REACTION (Magnet was sticking to my arm at vaccination site). At the time of the report, VACCINATION SITE MASS (A lump that formed under the skin after the vaccination) had resolved and VACCINATION SITE REACTION (Magnet was sticking to my arm at vaccination site) outcome was unknown.            Concomitant medications includes supplements.   No treatment medication were reported.  Patient had reported that a magnet was sticking to his arm at vaccination site. This report was false, which indicates to him  that no one actually wants to take reported incidents seriously.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received on 24-Jul-2021, new event vaccination site reaction was added.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Erythema
Clinical narrative: toes are all red; toes are on fire; 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 ERYTHEMA (toes are all red) and BURNING SENSATION (toes are on fire) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (toes are all red) and BURNING SENSATION (toes are on fire). At the time of the report, ERYTHEMA (toes are all red) and BURNING SENSATION (toes are on fire) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non-significant follow-up received, No new information
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Vaccination site pain
Clinical narrative: nurse stated that wasn't sure how much of the dose enter the armnot sure if sufficient dose went inside the arm; A little bit of soreness; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (nurse stated that wasn't sure how much of the dose enter the armnot sure if sufficient dose went inside the arm) and VACCINATION SITE PAIN (A little bit of soreness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS for an unknown indication.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced ACCIDENTAL UNDERDOSE (nurse stated that wasn't sure how much of the dose enter the armnot sure if sufficient dose went inside the arm) and VACCINATION SITE PAIN (A little bit of soreness). On 22-May-2021, ACCIDENTAL UNDERDOSE (nurse stated that wasn't sure how much of the dose enter the armnot sure if sufficient dose went inside the arm) had resolved. At the time of the report, VACCINATION SITE PAIN (A little bit of soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications includes medication for blood pressure.