chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; body ache; nausea; fatigue; head ache; high fever of 103 to 104 Degrees Farenheight; This spontaneous case was reported by a physician and describes the occurrence of NAUSEA (nausea), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (fatigue), PAIN (body ache) and HEADACHE (head ache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced NAUSEA (nausea), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (fatigue), PAIN (body ache), HEADACHE (head ache) and PYREXIA (high fever of 103 to 104 Degrees Farenheight). On 20-Mar-2021, NAUSEA (nausea), INFLUENZA LIKE ILLNESS (flu like symptoms), FATIGUE (fatigue), PAIN (body ache), HEADACHE (head ache) and PYREXIA (high fever of 103 to 104 Degrees Farenheight) 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills for 24 hours felt like COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills for 24 hours felt like COVID-19) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 7Feb2021) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 19-Dec-2020, Chills (From Covid-19) on 19-Dec-2020 and Fatigue (From Covid-19) on 19-Dec-2020.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced CHILLS (chills for 24 hours felt like COVID-19). On 18-Feb-2021, CHILLS (chills for 24 hours felt like COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hypersomnia, Injection site pain
Clinical narrative: slept for about 36 hours with brief periods of being awake; aching joints; headaches; exhaustion; pain in the arm (left) where the injection was given; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA, ARTHRALGIA, FATIGUE, INJECTION SITE PAIN (pain in the arm (left) where the injection was given) and HEADACHE in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE and INJECTION SITE PAIN (pain in the arm (left) where the injection was given). On an unknown date, the patient experienced HYPERSOMNIA, ARTHRALGIA, and HEADACHE. At the time of the report, HYPERSOMNIA and INJECTION SITE PAIN (pain in the arm (left) where the injection was given) outcome was unknown and ARTHRALGIA, FATIGUE, and HEADACHE had not resolved.            No concomitant medication was provided.  No treatment medication was provided.  Action taken in response to mRNA-1273 was considered to be not applicable.   This case was linked to MOD-2021-068138.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore arm) and FATIGUE (Tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 09-Feb-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 INJECTION SITE PAIN (Sore arm) and FATIGUE (Tired). At the time of the report, INJECTION SITE PAIN (Sore arm) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-068118 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm; headaches; chills; pain in arm at injection site; nausea and vomiting to the point of only vomiting green bile like stuff; nausea and vomiting to the point of only vomiting green bile like stuff; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (headaches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm at injection site) and NAUSEA (nausea and vomiting to the point of only vomiting green bile like stuff) in a female 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 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (headaches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm at injection site), NAUSEA (nausea and vomiting to the point of only vomiting green bile like stuff) and VOMITING (nausea and vomiting to the point of only vomiting green bile like stuff). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (headaches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm at injection site), NAUSEA (nausea and vomiting to the point of only vomiting green bile like stuff) and VOMITING (nausea and vomiting to the point of only vomiting green bile like stuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: TCR received on 7-JUL-2021 - mailing address provided.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sore arm; headaches; chills; pain in arm at injection site; nausea and vomiting to the point of only vomiting green bile like stuff; nausea and vomiting to the point of only vomiting green bile like stuff; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (headaches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm at injection site) and NAUSEA (nausea and vomiting to the point of only vomiting green bile like stuff) in a female 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 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (headaches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm at injection site), NAUSEA (nausea and vomiting to the point of only vomiting green bile like stuff) and VOMITING (nausea and vomiting to the point of only vomiting green bile like stuff). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (headaches), CHILLS (chills), VACCINATION SITE PAIN (pain in arm at injection site), NAUSEA (nausea and vomiting to the point of only vomiting green bile like stuff) and VOMITING (nausea and vomiting to the point of only vomiting green bile like stuff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: TCR received on 7-JUL-2021 - mailing address provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Diarrhea; Stomach Cramps; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach Cramps) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach Cramps). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach Cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was reported No treatment information was provided
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia
Clinical narrative: numbness of the right side of the face and neck; numbness of the right side of the shoulder; numbness of the right side of the arm; Fatigue in all over her body; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness of the right side of the face and neck), HYPOAESTHESIA (numbness of the right side of the shoulder), HYPOAESTHESIA (numbness of the right side of the arm) and FATIGUE (Fatigue in all over her body) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 immunisation.     The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN for Pain management, AMOXICILLIN for Renal failure, PARACETAMOL (TYLENOL).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HYPOAESTHESIA (numbness of the right side of the face and neck), HYPOAESTHESIA (numbness of the right side of the shoulder), HYPOAESTHESIA (numbness of the right side of the arm) and FATIGUE (Fatigue in all over her body). At the time of the report, HYPOAESTHESIA (numbness of the right side of the face and neck), HYPOAESTHESIA (numbness of the right side of the shoulder), HYPOAESTHESIA (numbness of the right side of the arm) and FATIGUE (Fatigue in all over her body) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Received the 1st of Moderna vaccine under 18 years of age; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st of Moderna vaccine under 18 years of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant product use was not provided by the reporter.   On 05-Feb-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 05-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st of Moderna vaccine under 18 years of age). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received the 1st of Moderna vaccine under 18 years of age) outcome was unknown.      Action taken with mRNA-1273 in response to the event was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-068225 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068225:Same reporter
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Headache, Nausea
Clinical narrative: Red (covid) arm; Feels weak; Low-grade fever (100 F); Headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red (covid) arm), ASTHENIA (Feels weak), PYREXIA (Low-grade fever (100 F)), HEADACHE (Headache) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced ERYTHEMA (Red (covid) arm), ASTHENIA (Feels weak), PYREXIA (Low-grade fever (100 F)), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, ERYTHEMA (Red (covid) arm), ASTHENIA (Feels weak), PYREXIA (Low-grade fever (100 F)), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. Not Provided          No concomitant medications were provided.  Treatment for the event included paracetamol (Tylenol)  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Red (covid) arm; Feels weak; Low-grade fever (100 F); Headache; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red (covid) arm), ASTHENIA (Feels weak), PYREXIA (Low-grade fever (100 F)), HEADACHE (Headache) and CHILLS (Chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced ERYTHEMA (Red (covid) arm), ASTHENIA (Feels weak), PYREXIA (Low-grade fever (100 F)), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, ERYTHEMA (Red (covid) arm), ASTHENIA (Feels weak), PYREXIA (Low-grade fever (100 F)), HEADACHE (Headache), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown. Not Provided          No concomitant medications were provided.  Treatment for the event included paracetamol (Tylenol)  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Influenza like illness
Clinical narrative: horrible cough; dry cough; dry throat ache; feels congested like if i had the flu; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (dry throat ache), COUGH (horrible cough), COUGH (dry cough) and INFLUENZA LIKE ILLNESS (feels congested like if i had the flu) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 immunization.  The patient's past medical history included Blood pressure, Cholesterol and Thyroid disorder.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Apr-2021, the patient experienced DRY THROAT (dry throat ache). On 04-Apr-2021, the patient experienced COUGH (horrible cough), COUGH (dry cough) and INFLUENZA LIKE ILLNESS (feels congested like if i had the flu). At the time of the report, DRY THROAT (dry throat ache), COUGH (horrible cough), COUGH (dry cough) and INFLUENZA LIKE ILLNESS (feels congested like if i had the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Hangover, Pain in extremity
Clinical narrative: sore arm; felt hungover for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HANGOVER (felt hungover for 24 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and HANGOVER (felt hungover for 24 hours). At the time of the report, PAIN IN EXTREMITY (sore arm) and HANGOVER (felt hungover for 24 hours) outcome was unknown. Not Provided          The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable    Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes in the left arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2012, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in the left arm). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No treatment was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vomiting
Clinical narrative: headache; fatigue; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (fatigue) and VOMITING (vomiting) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and VOMITING (vomiting). At the time of the report, HEADACHE (headache), FATIGUE (fatigue) and VOMITING (vomiting) outcome was unknown. Not Provided          No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVILMED) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Body Aches). At the time of the report, HEADACHE (Headache) and MYALGIA (Body Aches) outcome was unknown. Not Provided
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19
Clinical narrative: Diagnosed with covid after the 1st dose, asymptomatic; This spontaneous case was reported by a pharmacist and describes the occurrence of ASYMPTOMATIC COVID-19 (Diagnosed with covid after the 1st dose, asymptomatic) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asymptomatic COVID-19.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ASYMPTOMATIC COVID-19 (Diagnosed with covid after the 1st dose, asymptomatic). At the time of the report, ASYMPTOMATIC COVID-19 (Diagnosed with covid after the 1st dose, asymptomatic) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient subsequently was diagnosed with COVID after the 1st dose however the patient was asymptomatic but had a little bit of the virus ( viral load). Since then, the patient has now tested negative but never received the 2nd dose of Moderna COVID vaccine as he was advised by the doctors to wait 90 days after being diagnosed with COVID initially.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Disturbance in attention
Clinical narrative: Loss of memory; Loss of focus.; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Loss of memory) and DISTURBANCE IN ATTENTION (Loss of focus.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AMNESIA (Loss of memory) and DISTURBANCE IN ATTENTION (Loss of focus.). At the time of the report, AMNESIA (Loss of memory) and DISTURBANCE IN ATTENTION (Loss of focus.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Non-Significant Follow up added- reporter mail id
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling sickly.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sickly.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced MALAISE (feeling sickly.). At the time of the report, MALAISE (feeling sickly.) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Uterine pain
Clinical narrative: especially knee and hip area; Pain and pressure in area of uterine fibroids; Pain in whole left side of body; This spontaneous case was reported by a consumer and describes the occurrence of UTERINE PAIN (Pain and pressure in area of uterine fibroids), PAIN (Pain in whole left side of body) and ARTHRALGIA (especially knee and hip area) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Uterine fibroids.    On 26-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 UTERINE PAIN (Pain and pressure in area of uterine fibroids), PAIN (Pain in whole left side of body) and ARTHRALGIA (especially knee and hip area). The patient was treated with IBUPROFEN (ADVIL 12HOUR) at an unspecified dose and frequency. At the time of the report, UTERINE PAIN (Pain and pressure in area of uterine fibroids), PAIN (Pain in whole left side of body) and ARTHRALGIA (especially knee and hip area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional information received on 19th  MAY 2021 contains no new information
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Chills; Headache; Body aches; Tired; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and FATIGUE (Tired) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PYREXIA (Fever). On 05-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and FATIGUE (Tired). At the time of the report, PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), MYALGIA (Body aches) and FATIGUE (Tired) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information received on 18 May 2021 Outcome of the events changed from unknown to recovering
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Urinary incontinence
Clinical narrative: is going to the toilet so many times; urinary incontinence; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (is going to the toilet so many times) and URINARY INCONTINENCE (urinary incontinence) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concurrent medical conditions included Gout.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced POLLAKIURIA (is going to the toilet so many times) and URINARY INCONTINENCE (urinary incontinence). At the time of the report, POLLAKIURIA (is going to the toilet so many times) and URINARY INCONTINENCE (urinary incontinence) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information provided included unknown medication for Gout.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: Severe swollen right legs; Another swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING and SWELLING in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The patient's past medical history included Peripheral swelling in October 2020 and Osteoarthritis flare up (Treatment provided was prednisone) in January 2021. Previously administered products included for an unreported indication: CORTISONE (Patient received Cortisone injection in the knee) on 01-Feb-2021. Concurrent medical conditions included Baker's cyst, Pseudogout and Chondrocalcinosis.     On 11-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 PERIPHERAL SWELLING and SWELLING. The patient was treated with TYLENOL at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING and SWELLING outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment for the event included prednisone. The patient was concerned whether the rheumatologist prescribe her prednisone for the for her swollen legs. The patient reported that the swollen right leg had nothing to do with the Moderna vaccine. The patient had this problem back in October November December of 2020.The patient have osteoarthritis, bakers cyst, pseudogout, chondrocalcinosis. The patient reported that her leg swells up and gets inflamed. The patient was on prednisone at the time of report because of another swelling.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Live follow up received on 18-May-2021: Added relevant medical history. On an unknown date, patient took 2nd dose of vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Pain in extremity, Pyrexia
Clinical narrative: achiness; sore arm; felt so bad; fever; felt tired that lasted all day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt so bad), PYREXIA (fever) and FATIGUE (felt tired that lasted all day) 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 COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PAIN (achiness), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt so bad), PYREXIA (fever) and FATIGUE (felt tired that lasted all day). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN (achiness), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt so bad), PYREXIA (fever) and FATIGUE (felt tired that lasted all day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: form received. Event outcome updated where patient stated that she is fine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: she was told to wait for 90 days to get the 2nd dose; covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she was told to wait for 90 days to get the 2nd dose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: MONOCLONAL ANTIBODIES (Had monoclonal infusion.) on 31-Jan-2021. Concomitant products included BUDESONIDE, BUDESONIDE and UMECLIDINIUM for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 26-Jan-2021, the patient experienced COVID-19 (covid-19). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she was told to wait for 90 days to get the 2nd dose). At the time of the report, COVID-19 (covid-19) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she was told to wait for 90 days to get the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient under 18 years of age, got vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age, got vaccine) in a 17-year-old female patient 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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age, got vaccine). On 10-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient under 18 years of age, got vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: allergic reaction to the vaccine; rash on their neck, chest and shoulder. It was more severe on the left side, then, slowly spread to their whole body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (allergic reaction to the vaccine) and RASH (rash on their neck, chest and shoulder. It was more severe on the left side, then, slowly spread to their whole body) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included SUMATRIPTAN for Migraine, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ALBUTEROL [SALBUTAMOL], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and IBUPROFEN for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash on their neck, chest and shoulder. It was more severe on the left side, then, slowly spread to their whole body). On 02-Apr-2021, the patient experienced HYPERSENSITIVITY (allergic reaction to the vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and HYDROXYZINE on 06-Apr-2021 at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergic reaction to the vaccine) and RASH (rash on their neck, chest and shoulder. It was more severe on the left side, then, slowly spread to their whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication also included steroid shot.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Malaise, Nasopharyngitis, Pain
Clinical narrative: moderate body aches; heaviness as if I'm getting over something; doesn't feel well; really really cold; heaviness; severe body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (heaviness), PAIN (severe body aches), NASOPHARYNGITIS (really really cold), MALAISE (doesn't feel well) and PAIN (moderate body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced DISCOMFORT (heaviness) and PAIN (severe body aches). On 01-Apr-2021, the patient experienced NASOPHARYNGITIS (really really cold). On 06-Apr-2021, the patient experienced MALAISE (doesn't feel well). On an unknown date, the patient experienced PAIN (moderate body aches) and DISCOMFORT (heaviness as if I'm getting over something). On 31-Mar-2021, DISCOMFORT (heaviness) and PAIN (severe body aches) outcome was unknown. On 01-Apr-2021, NASOPHARYNGITIS (really really cold) outcome was unknown. At the time of the report, MALAISE (doesn't feel well), PAIN (moderate body aches) and DISCOMFORT (heaviness as if I'm getting over something) 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Pain in extremity
Clinical narrative: chills on left side of face; soreness on left side of chest; soreness on eft hand; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills on left side of face), CHEST PAIN (soreness on left side of chest) and PAIN IN EXTREMITY (soreness on eft hand) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced CHILLS (chills on left side of face), CHEST PAIN (soreness on left side of chest) and PAIN IN EXTREMITY (soreness on eft hand). At the time of the report, CHILLS (chills on left side of face), CHEST PAIN (soreness on left side of chest) and PAIN IN EXTREMITY (soreness on eft hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: A rash on the arm of the size of the palm of the hand that is itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (A rash on the arm of the size of the palm of the hand that is itchy) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RASH PRURITIC (A rash on the arm of the size of the palm of the hand that is itchy). At the time of the report, RASH PRURITIC (A rash on the arm of the size of the palm of the hand that is itchy) outcome was unknown. 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. This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (A rash on the arm of the size of the palm of the hand that is itchy) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced RASH PRURITIC (A rash on the arm of the size of the palm of the hand that is itchy). The patient was treated with MOMETASONE for Rash, at a dose of 0.1 percent. At the time of the report, RASH PRURITIC (A rash on the arm of the size of the palm of the hand that is itchy) outcome was unknown. 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigued in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 013A21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 10, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced fatigued. At the time of the report, fatigued outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Reporter did not allow further contact.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue, Underdose
Clinical narrative: some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly; administering only half of the dose; some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (administering only half of the dose), UNDERDOSE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly) and DEVICE CONNECTION ISSUE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced ACCIDENTAL UNDERDOSE (administering only half of the dose) and UNDERDOSE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly). On 19-Feb-2021, ACCIDENTAL UNDERDOSE (administering only half of the dose) and UNDERDOSE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly) outcome was unknown. At the time of the report, DEVICE CONNECTION ISSUE (some of the dose spilled/leaked out either due to a defective needle or the syringe was not attached properly) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm; Itchy; Red; Bumped; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Bumped) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Bumped). The patient was treated with Wound care (Ice therapy) for Vaccination site warmth; Wound care (Ice therapy) for Vaccination site pruritus; Wound care (Ice therapy) for Vaccination site erythema and Wound care (Ice therapy) for Vaccination site swelling. At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Bumped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. Patient done ice therapy which made the itchiness better