chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of libido
Clinical narrative: loss of sexual desire; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF LIBIDO (loss of sexual desire) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced LOSS OF LIBIDO (loss of sexual desire). At the time of the report, LOSS OF LIBIDO (loss of sexual desire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not reported
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Illness, Malaise, Pain in extremity
Clinical narrative: Both arms hurt for almost a week; Didn't feel good for about 4 days; Both in bed for 2 days/couldn't get out of bed; Got sick/felt sick for 4 days.; Fever of 102/My fever was 100.7; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn't feel good for about 4 days), BEDRIDDEN (Both in bed for 2 days/couldn't get out of bed), ILLNESS (Got sick/felt sick for 4 days.) and PYREXIA (Fever of 102/My fever was 100.7) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she and her husband both had COVID a year ago.) in 2020.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn't feel good for about 4 days), BEDRIDDEN (Both in bed for 2 days/couldn't get out of bed), ILLNESS (Got sick/felt sick for 4 days.), PYREXIA (Fever of 102/My fever was 100.7) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Fever, at an unspecified dose and frequency. In August 2021, PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn't feel good for about 4 days) and ILLNESS (Got sick/felt sick for 4 days.) had resolved. At the time of the report, BEDRIDDEN (Both in bed for 2 days/couldn't get out of bed), PYREXIA (Fever of 102/My fever was 100.7) and VOMITING (Vomited) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 102 (High) fever and 100.7 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication  was not provided.  Caller stated that  the second dose is coming up on this Saturday.   This case was linked to MOD-2021-301975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received on 02-sep-2021 contains significant information( as reported of fever updated)
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Both arms hurt for almost a week; Didn't feel good for about 4 days; Both in bed for 2 days/couldn't get out of bed; Got sick/felt sick for 4 days.; Fever of 102/My fever was 100.7; Vomited; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn't feel good for about 4 days), BEDRIDDEN (Both in bed for 2 days/couldn't get out of bed), ILLNESS (Got sick/felt sick for 4 days.) and PYREXIA (Fever of 102/My fever was 100.7) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (she and her husband both had COVID a year ago.) in 2020.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn't feel good for about 4 days), BEDRIDDEN (Both in bed for 2 days/couldn't get out of bed), ILLNESS (Got sick/felt sick for 4 days.), PYREXIA (Fever of 102/My fever was 100.7) and VOMITING (Vomited). The patient was treated with PARACETAMOL (TYLENOL) in August 2021 for Fever, at an unspecified dose and frequency. In August 2021, PAIN IN EXTREMITY (Both arms hurt for almost a week), MALAISE (Didn't feel good for about 4 days) and ILLNESS (Got sick/felt sick for 4 days.) had resolved. At the time of the report, BEDRIDDEN (Both in bed for 2 days/couldn't get out of bed), PYREXIA (Fever of 102/My fever was 100.7) and VOMITING (Vomited) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: 102 (High) fever and 100.7 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication  was not provided.  Caller stated that  the second dose is coming up on this Saturday.   This case was linked to MOD-2021-301975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received on 02-sep-2021 contains significant information( as reported of fever updated)
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash after my 2nd injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash after my 2nd injection) 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 RASH (rash after my 2nd injection). At the time of the report, RASH (rash after my 2nd injection) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Herpes zoster, Tenderness
Clinical narrative: Shingles on the left side of their face; Cyst on the left side of their neck; Cyst was big and tender and ended up being removed; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (Shingles on the left side of their face), CYST (Cyst on the left side of their neck) and TENDERNESS (Cyst was big and tender and ended up being removed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), CELECOXIB (CELEXA [CELECOXIB]), WARFARIN SODIUM (COUMADIN), OMEPRAZOLE and LEVOTHYROXINE for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HERPES ZOSTER (Shingles on the left side of their face), CYST (Cyst on the left side of their neck) and TENDERNESS (Cyst was big and tender and ended up being removed). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency and Surgery for Cyst. In 2021, CYST (Cyst on the left side of their neck) and TENDERNESS (Cyst was big and tender and ended up being removed) had resolved. At the time of the report, HERPES ZOSTER (Shingles on the left side of their face) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The consumer stated that she had shingles on the left side of their face and a cyst on the left side of their neck, starting a couple of weeks after the first dose. The consumer stated that the cyst was big and tender and ended up being removed. The  provider seemed worried about the caller having spiked proteins.     This case was linked to MOD-2021-302081 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Little reaction at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Little reaction at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Thyroid condition for about 40 years ) and Addison's disease (Addison's disease for about 20 years). Concomitant products included PREDNISONE, FLUDROCORTISONE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 12-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 VACCINATION SITE REACTION (Little reaction at the injection site). At the time of the report, VACCINATION SITE REACTION (Little reaction at the injection site) 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.   Treatment information was not provided.   This case was linked to MOD-2021-301960 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccine symptoms second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine symptoms 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.   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 VACCINATION COMPLICATION (Vaccine symptoms second dose). At the time of the report, VACCINATION COMPLICATION (Vaccine symptoms second dose) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vials used that were more than 30 days in refrigerator administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials used that were more than 30 days in refrigerator administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials used that were more than 30 days in refrigerator administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials used that were more than 30 days in refrigerator administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was reported by reporter.  Crosslinked to MOD21-136212, MOD21-136213, MOD21-136214, MOD21-136215, MOD21-136216, MOD21-136217, MOD21-136218
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered 1st dose of Moderna COVID-19 vaccine to 14 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna COVID-19 vaccine to 14 year old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna COVID-19 vaccine to 14 year old). On 30-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered 1st dose of Moderna COVID-19 vaccine to 14 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site movement impairment
Clinical narrative: you lift up your arm and you go, oh ok.; soreness/ very mild soreness; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (you lift up your arm and you go, oh ok.) and MYALGIA (soreness/ very mild soreness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Exposure to fungus (had previously been exposed to black mold.). Concurrent medical conditions included Type 2 diabetes mellitus (Type 2 Diabetes on medication.) and Asthma.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (you lift up your arm and you go, oh ok.) and MYALGIA (soreness/ very mild soreness). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (you lift up your arm and you go, oh ok.) and MYALGIA (soreness/ very mild soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-302002, MOD-2021-302003 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: he had the same symptoms as me/he said it was worse than the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (he had the same symptoms as me/he said it was worse than the 2nd dose) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (he had the same symptoms as me/he said it was worse than the 2nd dose). At the time of the report, VACCINATION COMPLICATION (he had the same symptoms as me/he said it was worse than the 2nd dose) outcome was unknown.            The concomitant history was not reported. The treatment history was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received first dose on February but did not get second one; 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 (received first dose on February but did not get second one) 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 February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received first dose on February but did not get second one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received first dose on February but did not get second one) had resolved.            Concomitant medications were not reported. Treatment medications were not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Chills, Feeling abnormal, Illness
Clinical narrative: both in bed for 2 days; didn't feel good for about 4 days; couldn't get out of bed; felt sick for 4 days; fever of 107; chills; both arms hurt for almost a week; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn't feel good for about 4 days), MOBILITY DECREASED (couldn't get out of bed), ILLNESS (felt sick for 4 days) and PYREXIA (fever of 107) in a 71-year-old male patient 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 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn't feel good for about 4 days), MOBILITY DECREASED (couldn't get out of bed), ILLNESS (felt sick for 4 days), PYREXIA (fever of 107), CHILLS (chills) and PAIN IN EXTREMITY (both arms hurt for almost a week). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn't feel good for about 4 days) and ILLNESS (felt sick for 4 days) had resolved and MOBILITY DECREASED (couldn't get out of bed), PYREXIA (fever of 107), CHILLS (chills) and PAIN IN EXTREMITY (both arms hurt for almost a week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) fever of 100.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was tested positive for COVID-19 a year ago  Concomitant product was not provided by the reporter   This case was linked to MOD-2021-301937 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Additional information included lab data and new event.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: both in bed for 2 days; didn't feel good for about 4 days; couldn't get out of bed; felt sick for 4 days; fever of 107; chills; both arms hurt for almost a week; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn't feel good for about 4 days), MOBILITY DECREASED (couldn't get out of bed), ILLNESS (felt sick for 4 days) and PYREXIA (fever of 107) in a 71-year-old male patient 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 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn't feel good for about 4 days), MOBILITY DECREASED (couldn't get out of bed), ILLNESS (felt sick for 4 days), PYREXIA (fever of 107), CHILLS (chills) and PAIN IN EXTREMITY (both arms hurt for almost a week). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (both in bed for 2 days), FEELING ABNORMAL (didn't feel good for about 4 days) and ILLNESS (felt sick for 4 days) had resolved and MOBILITY DECREASED (couldn't get out of bed), PYREXIA (fever of 107), CHILLS (chills) and PAIN IN EXTREMITY (both arms hurt for almost a week) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.2 (High) fever of 100.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was tested positive for COVID-19 a year ago  Concomitant product was not provided by the reporter   This case was linked to MOD-2021-301937 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Additional information included lab data and new event.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Depression, Fatigue, Myalgia, Somnolence
Clinical narrative: Severe depression; Had no appetite; Slept most the day; Felt very fatigued; Mild soreness in the same right arm; This spontaneous case was reported by a pharmacist and describes the occurrence of DEPRESSION (Severe depression), DECREASED APPETITE (Had no appetite), SOMNOLENCE (Slept most the day), FATIGUE (Felt very fatigued) and MYALGIA (Mild soreness in the same right arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient's past medical history included Exposure to mold (Exposed to black mold) and Solid organ transplant. Concurrent medical conditions included Type 2 diabetes mellitus (Type 2 diabetes on medication) and Asthma.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced DEPRESSION (Severe depression), DECREASED APPETITE (Had no appetite), SOMNOLENCE (Slept most the day), FATIGUE (Felt very fatigued) and MYALGIA (Mild soreness in the same right arm). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse drug reaction, at a dose of 1500 mg. At the time of the report, DEPRESSION (Severe depression), DECREASED APPETITE (Had no appetite), SOMNOLENCE (Slept most the day), FATIGUE (Felt very fatigued) and MYALGIA (Mild soreness in the same right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.    This case was linked to MOD-2021-302002, MOD-2021-301965 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite
Clinical narrative: People lost their appetite within  24 hours; 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 DECREASED APPETITE (people lost their appetite within  24 hours) 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) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (people lost their appetite within  24 hours). At the time of the report, DECREASED APPETITE (people lost their appetite within  24 hours) 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.   No  Concomitant medications were provided.  No Treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis, Pyrexia
Clinical narrative: Freezing cold; Low grade fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Freezing cold), PYREXIA (Low grade fever) and HEADACHE (Headache) 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 NASOPHARYNGITIS (Freezing cold), PYREXIA (Low grade fever) and HEADACHE (Headache). At the time of the report, NASOPHARYNGITIS (Freezing cold), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Feb 2,2021 my wife had 1 shot of Moderna vaccine. She did not get the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Feb 2,2021 my wife had 1 shot of Moderna vaccine. She did not get the second shot) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Feb 2,2021 my wife had 1 shot of Moderna vaccine. She did not get the second shot). In 2021, PRODUCT DOSE OMISSION ISSUE (Feb 2,2021 my wife had 1 shot of Moderna vaccine. She did not get the second shot) had resolved.            Concomitant and treatment drugs were not provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines) 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 MIGRAINE (migraines). At the time of the report, MIGRAINE (migraines) had not resolved.            Patient had last dose of the Moderna vaccine 2 months ago. No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: second shot is given 2 months after the first; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot is given 2 months after the first) and PRODUCT DOSE OMISSION ISSUE (Missed 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.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot is given 2 months after the first) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot is given 2 months after the first) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.            No concomitant medications were provided. No treatment information were provided.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Heart rate
Clinical narrative: Chest pains, Occasional stabbing chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains, Occasional stabbing chest) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 3:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021 at 8:00 AM, the patient experienced CHEST PAIN (Chest pains, Occasional stabbing chest). At the time of the report, CHEST PAIN (Chest pains, Occasional stabbing chest) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Elevated 90-130 bpm..         Since June 2021, Patient experienced sharp stabbing chest pain in the left side upper chest which radiated through left shoulder and down left arm. when this happened, heart rate was elevated from  90-130 bpm..  Patient experienced at very random times and was not a constant issue, when it happened it lasts for 20 mins to hours.  Concomitant medications were not provided.  Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Significant information included Reporter details ,Patient demographics, Suspect Product details  and Event information and narrative was updated accordingly.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I had itching where I had calcifications removed from my breast; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (I had itching where I had calcifications removed from my breast) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast calcifications (calcifications removed from my breast).    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 PRURITUS (I had itching where I had calcifications removed from my breast). At the time of the report, PRURITUS (I had itching where I had calcifications removed from my breast) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.   This case was linked to MOD-2021-302098 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Epigastric pain; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Epigastric pain) and DIARRHOEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Epigastric pain) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Epigastric pain) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided    Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Vaccination site erythema, Vaccination site rash
Clinical narrative: Stripe of redness/looks like a stripe of redness, like a burn; It is a rash, but not raised; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), VACCINATION SITE ERYTHEMA (Stripe of redness/looks like a stripe of redness, like a burn) and VACCINATION SITE RASH (It is a rash, but not raised) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced LETHARGY (lethargic) and VACCINATION SITE RASH (It is a rash, but not raised). On 29-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (Stripe of redness/looks like a stripe of redness, like a burn). At the time of the report, LETHARGY (lethargic), VACCINATION SITE ERYTHEMA (Stripe of redness/looks like a stripe of redness, like a burn) and VACCINATION SITE RASH (It is a rash, but not raised) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not on any blood thinner. They are on daily medication, one medication they have been on for 20 years, and the other they have been on for 5 years. Patient declined to mention names of the Concomitant medication.  Treatment information was not provided.  The stripe of redness is about 2 inches by 3 inches, like a burn. It appeared below where the syringe was inserted.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Illness, Presyncope
Clinical narrative: Felt really sick; About to faint; Lost her taste; Lost her smell; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt really sick), PRESYNCOPE (About to faint), AGEUSIA (Lost her taste) and ANOSMIA (Lost her smell) 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.    In August 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ILLNESS (Felt really sick), PRESYNCOPE (About to faint), AGEUSIA (Lost her taste) and ANOSMIA (Lost her smell). At the time of the report, ILLNESS (Felt really sick), PRESYNCOPE (About to faint), AGEUSIA (Lost her taste) and ANOSMIA (Lost her smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A lot of cases were patients received the 2nd dose late; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A lot of cases were patients received the 2nd dose late) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A lot of cases were patients received the 2nd dose late). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A lot of cases were patients received the 2nd dose late) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.  HCP stated that they were seeing a lot of cases were patients received the 2nd dose late and wanted to know if they had to report all of them.   This case was linked to MOD-2021-225625, MOD-2021-246765 (E2B Linked Report).; Sender's Comments:  MOD-2021-225625:Same reporter MOD-2021-246765:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Vaccination complication
Clinical narrative: Tonight, I am still having side effects; Shortness of breath; what feels like an anxiety attack; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Tonight, I am still having side effects), DYSPNOEA (Shortness of breath) and ANXIETY (what feels like an anxiety attack) 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 VACCINATION COMPLICATION (Tonight, I am still having side effects), DYSPNOEA (Shortness of breath) and ANXIETY (what feels like an anxiety attack). At the time of the report, VACCINATION COMPLICATION (Tonight, I am still having side effects), DYSPNOEA (Shortness of breath) and ANXIETY (what feels like an anxiety attack) outcome was unknown.            No relevant concomitant medications were reported.  Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Can I get mi second dosis after 3 months/Second dose after two months; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Can I get mi second dosis after 3 months/Second dose after two months) 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 PRODUCT DOSE OMISSION ISSUE (Can I get mi second dosis after 3 months/Second dose after two months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Can I get mi second dosis after 3 months/Second dose after two months) had resolved.            No concomitant medication was provided.  No treatment medication was provided.  Patient asked can patient get second dosis after 3 months/second dose after two months.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Red spots; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red spots) 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) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red spots). At the time of the report, ERYTHEMA (Red spots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna Covid-19 vaccine administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to a patient) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to a patient). On 25-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Additional information received on 03 Sep 2021 contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: pulse is 118; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse is 118) 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 HEART RATE INCREASED (pulse is 118). At the time of the report, HEART RATE INCREASED (pulse is 118) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 118 (High) Pulse is 118.         Relevant concomitant medications were not reported by reporter. Treatment information was not reported by reporter.   Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Vaccination complication
Clinical narrative: Regular symptoms; A little redness in her arm with swelling which became bigger with time; A little redness in her arm with swelling which became bigger with time; Soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), ERYTHEMA (A little redness in her arm with swelling which became bigger with time), PERIPHERAL SWELLING (A little redness in her arm with swelling which became bigger with time) and VACCINATION COMPLICATION (Regular symptoms) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022b21a) for COVID-19 vaccination.     No Medical History information was reported.  On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced VACCINATION COMPLICATION (Regular symptoms). On 21-Aug-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm). On 28-Aug-2021, the patient experienced ERYTHEMA (A little redness in her arm with swelling which became bigger with time) and PERIPHERAL SWELLING (A little redness in her arm with swelling which became bigger with time). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), ERYTHEMA (A little redness in her arm with swelling which became bigger with time), PERIPHERAL SWELLING (A little redness in her arm with swelling which became bigger with time) and VACCINATION COMPLICATION (Regular symptoms) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant product use was provided by the reporter.   No treatment medications were reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numness in her legs and arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numness in her legs and arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numness in her legs and arm). At the time of the report, HYPOAESTHESIA (numness in her legs and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 13 doses administered out of possibly expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered out of possibly expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered out of possibly expired vial). On 20-Aug-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered out of possibly expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment history was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose administered >42 days after the first dose/received the first dose of Moderna 6 months ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose administered >42 days after the first dose/received the first dose of Moderna 6 months ago) 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 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose administered >42 days after the first dose/received the first dose of Moderna 6 months ago). In 2021, PRODUCT DOSE OMISSION ISSUE (Second dose administered >42 days after the first dose/received the first dose of Moderna 6 months ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information was not provided.  The patient was scheduled for the second dose on 30-AUG-2021.