chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Illness, Nausea
Clinical narrative: weakness/I'm getting weaker; Don't have any appetite, and I'm already thin. can't afford to lose any weight; those days I'm pretty sick. I'm bin bed constantly; nausea in my stomach; "Like I feel tired"/ I'm bin bed constantly; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness/I'm getting weaker), DECREASED APPETITE (Don't have any appetite, and I'm already thin. can't afford to lose any weight), ILLNESS (those days I'm pretty sick. I'm bin bed constantly), NAUSEA (nausea in my stomach) and FATIGUE ("Like I feel tired"/ I'm bin bed constantly) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness/I'm getting weaker), DECREASED APPETITE (Don't have any appetite, and I'm already thin. can't afford to lose any weight), ILLNESS (those days I'm pretty sick. I'm bin bed constantly), NAUSEA (nausea in my stomach) and FATIGUE ("Like I feel tired"/ I'm bin bed constantly). At the time of the report, ASTHENIA (weakness/I'm getting weaker), DECREASED APPETITE (Don't have any appetite, and I'm already thin. can't afford to lose any weight), ILLNESS (those days I'm pretty sick. I'm bin bed constantly), NAUSEA (nausea in my stomach) and FATIGUE ("Like I feel tired"/ I'm bin bed constantly) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Non significant follow up.NNI.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: The injection site is swelling; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (The injection site is swelling ) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (The injection site is swelling ) and PYREXIA (Fever). At the time of the report, VACCINATION SITE SWELLING (The injection site is swelling ) and PYREXIA (Fever) outcome was unknown.        No relevant concomitant medication was reported. The treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips
Clinical narrative: Lips were chapped in 2 days after receiving 1st dose/Lips were scaly.; This spontaneous case was reported by a consumer and describes the occurrence of CHAPPED LIPS (Lips were chapped in 2 days after receiving 1st dose/Lips were scaly.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 021B21A) for COVID-19 vaccination.     No medical history was provided.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced CHAPPED LIPS (Lips were chapped in 2 days after receiving 1st dose/Lips were scaly.). The patient was treated with XIPAMIDE (AQUAPHOR [XIPAMIDE]) for Chapped lips, at a dose of 1 UNK. At the time of the report, CHAPPED LIPS (Lips were chapped in 2 days after receiving 1st dose/Lips were scaly.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product used included blood pressure medicine.  Treatment medication included Aquaphor, Lip balm, stayed hydrated.  On 01-Mar-2021 the patient's lips were chapped and were scaly after first dose on 27-Feb-2021.  And it still continues after 2nd dose which was on 27-Mar-2021.
Sex: U
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: light sensitivity; 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 PHOTOPHOBIA (light sensitivity) 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 PHOTOPHOBIA (light sensitivity). At the time of the report, PHOTOPHOBIA (light sensitivity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underaged patient received vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underaged patient received vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underaged patient received vaccine). On 15-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underaged patient received vaccine) 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.   Concomitant drug was not reported. Treatment medication was not reported.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Chills, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: Low grade fever; Had no taste or smell; Did not feel great; Headache; Body Aches; Fever of 100; Chills; Run down like the flu; Congestion; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), FEELING ABNORMAL (Did not feel great), ANOSMIA (Had no taste or smell) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 09-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), HEADACHE (Headache), MYALGIA (Body Aches), PYREXIA (Fever of 100) and CHILLS (Chills). On 10-Jul-2021, the patient experienced FEELING ABNORMAL (Did not feel great). On 13-Jul-2021, the patient experienced ANOSMIA (Had no taste or smell). On 19-Jul-2021, the patient experienced PYREXIA (Low grade fever). On 12-Jul-2021, CHILLS (Chills) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), FEELING ABNORMAL (Did not feel great), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown and PYREXIA (Fever of 100) and PYREXIA (Low grade fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-260133 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, Vaccination site pain
Clinical narrative: Low grade fever; Had no taste or smell; Did not feel great; Headache; Body Aches; Fever of 100; Chills; Run down like the flu; Congestion; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), FEELING ABNORMAL (Did not feel great), ANOSMIA (Had no taste or smell) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 09-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), HEADACHE (Headache), MYALGIA (Body Aches), PYREXIA (Fever of 100) and CHILLS (Chills). On 10-Jul-2021, the patient experienced FEELING ABNORMAL (Did not feel great). On 13-Jul-2021, the patient experienced ANOSMIA (Had no taste or smell). On 19-Jul-2021, the patient experienced PYREXIA (Low grade fever). On 12-Jul-2021, CHILLS (Chills) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), FEELING ABNORMAL (Did not feel great), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown and PYREXIA (Fever of 100) and PYREXIA (Low grade fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-260133 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Headache
Clinical narrative: Low grade fever; Had no taste or smell; Did not feel great; Headache; Body Aches; Fever of 100; Chills; Run down like the flu; Congestion; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), FEELING ABNORMAL (Did not feel great), ANOSMIA (Had no taste or smell) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 09-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), HEADACHE (Headache), MYALGIA (Body Aches), PYREXIA (Fever of 100) and CHILLS (Chills). On 10-Jul-2021, the patient experienced FEELING ABNORMAL (Did not feel great). On 13-Jul-2021, the patient experienced ANOSMIA (Had no taste or smell). On 19-Jul-2021, the patient experienced PYREXIA (Low grade fever). On 12-Jul-2021, CHILLS (Chills) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), FEELING ABNORMAL (Did not feel great), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown and PYREXIA (Fever of 100) and PYREXIA (Low grade fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-260133 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza, Malaise, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Low grade fever; Had no taste or smell; Did not feel great; Headache; Body Aches; Fever of 100; Chills; Run down like the flu; Congestion; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), FEELING ABNORMAL (Did not feel great), ANOSMIA (Had no taste or smell) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 09-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), HEADACHE (Headache), MYALGIA (Body Aches), PYREXIA (Fever of 100) and CHILLS (Chills). On 10-Jul-2021, the patient experienced FEELING ABNORMAL (Did not feel great). On 13-Jul-2021, the patient experienced ANOSMIA (Had no taste or smell). On 19-Jul-2021, the patient experienced PYREXIA (Low grade fever). On 12-Jul-2021, CHILLS (Chills) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Run down like the flu), NASAL CONGESTION (Congestion), FEELING ABNORMAL (Did not feel great), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches) and VACCINATION SITE PAIN (Arm was sore) outcome was unknown and PYREXIA (Fever of 100) and PYREXIA (Low grade fever) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-260133 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Chills, Feeling abnormal, Headache, Influenza like illness
Clinical narrative: Run down like the flu; Congestion; Did not feel great; Had no taste or smell; Had no taste or smell; Headache; Body Aches; Fever of 100; Chills; joint pain; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), AGEUSIA (Had no taste or smell) and ANOSMIA (Had no taste or smell) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04021A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history and concomitant drug information was provided by reporter.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), AGEUSIA (Had no taste or smell), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches), PYREXIA (Fever of 100), CHILLS (Chills) and ARTHRALGIA (joint pain). At the time of the report, INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches) and ARTHRALGIA (joint pain) had not resolved, AGEUSIA (Had no taste or smell) was resolving and PYREXIA (Fever of 100) and CHILLS (Chills) had resolved.            No medical history and concomitant drug information was provided by reporter.  No treatment medication was provided by reporter.   This case was linked to MOD-2021-260110 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, Vaccination site pain
Clinical narrative: Run down like the flu; Congestion; Did not feel great; Had no taste or smell; Had no taste or smell; Headache; Body Aches; Fever of 100; Chills; joint pain; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), AGEUSIA (Had no taste or smell) and ANOSMIA (Had no taste or smell) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04021A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history and concomitant drug information was provided by reporter.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), AGEUSIA (Had no taste or smell), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches), PYREXIA (Fever of 100), CHILLS (Chills) and ARTHRALGIA (joint pain). At the time of the report, INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches) and ARTHRALGIA (joint pain) had not resolved, AGEUSIA (Had no taste or smell) was resolving and PYREXIA (Fever of 100) and CHILLS (Chills) had resolved.            No medical history and concomitant drug information was provided by reporter.  No treatment medication was provided by reporter.   This case was linked to MOD-2021-260110 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Headache
Clinical narrative: Run down like the flu; Congestion; Did not feel great; Had no taste or smell; Had no taste or smell; Headache; Body Aches; Fever of 100; Chills; joint pain; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), AGEUSIA (Had no taste or smell) and ANOSMIA (Had no taste or smell) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04021A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history and concomitant drug information was provided by reporter.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), AGEUSIA (Had no taste or smell), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches), PYREXIA (Fever of 100), CHILLS (Chills) and ARTHRALGIA (joint pain). At the time of the report, INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches) and ARTHRALGIA (joint pain) had not resolved, AGEUSIA (Had no taste or smell) was resolving and PYREXIA (Fever of 100) and CHILLS (Chills) had resolved.            No medical history and concomitant drug information was provided by reporter.  No treatment medication was provided by reporter.   This case was linked to MOD-2021-260110 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza, Malaise, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: Run down like the flu; Congestion; Did not feel great; Had no taste or smell; Had no taste or smell; Headache; Body Aches; Fever of 100; Chills; joint pain; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), AGEUSIA (Had no taste or smell) and ANOSMIA (Had no taste or smell) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04021A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history and concomitant drug information was provided by reporter.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), AGEUSIA (Had no taste or smell), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches), PYREXIA (Fever of 100), CHILLS (Chills) and ARTHRALGIA (joint pain). At the time of the report, INFLUENZA (Run down like the flu), NASAL CONGESTION (Congestion), MALAISE (Did not feel great), ANOSMIA (Had no taste or smell), HEADACHE (Headache), MYALGIA (Body Aches) and ARTHRALGIA (joint pain) had not resolved, AGEUSIA (Had no taste or smell) was resolving and PYREXIA (Fever of 100) and CHILLS (Chills) had resolved.            No medical history and concomitant drug information was provided by reporter.  No treatment medication was provided by reporter.   This case was linked to MOD-2021-260110 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: noticing changes on her skin slowly/psoriasis went away/psoriasis almost entirely gone following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (noticing changes on her skin slowly/psoriasis went away/psoriasis almost entirely gone following vaccination) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002G21A and 011M20A) for COVID-19 vaccination.     The patient's past medical history included Psoriasis.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, 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 experienced THERAPEUTIC RESPONSE UNEXPECTED (noticing changes on her skin slowly/psoriasis went away/psoriasis almost entirely gone following vaccination). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (noticing changes on her skin slowly/psoriasis went away/psoriasis almost entirely gone following vaccination) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received  contains updated patient demographics, event outcome was updated to recovered. On 16-Sep-2021: Follow up include Non significant information
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster
Clinical narrative: very bad case of Shingles; very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (very bad case of Shingles) and HEADACHE (very bad headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concomitant products included TETRYZOLINE HYDROCHLORIDE (EYE DROPS [TETRYZOLINE HYDROCHLORIDE]) for Glaucoma NOS.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (very bad case of Shingles) and HEADACHE (very bad headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 4 times a day for 10 days. At the time of the report, HERPES ZOSTER (very bad case of Shingles) and HEADACHE (very bad headache) 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.   Treatment with Advil 4 times a day for 10 days was reported by the patient.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Vaccination site swelling
Clinical narrative: Arm pit became swollen; Arm pit became painful when she moved her arm; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Arm pit became swollen), AXILLARY PAIN (Arm pit became painful when she moved her arm) and VACCINATION SITE SWELLING (Injection site was swollen) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced LYMPHADENOPATHY (Arm pit became swollen), AXILLARY PAIN (Arm pit became painful when she moved her arm) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, LYMPHADENOPATHY (Arm pit became swollen), AXILLARY PAIN (Arm pit became painful when she moved her arm) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling in the right side of face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the right side of face) 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 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling in the right side of face). At the time of the report, PARAESTHESIA (Tingling in the right side of face) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided. The patient reported that she thinks she got her first dose of vaccine in the first week of April.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray, Chest discomfort, Illness, Nasopharyngitis
Clinical narrative: Sore arm; I was sick / Never been as sick; Covid-19 infection; I was due to get 2nd vaccine about 5 days ago; It had all moved to the top of my chest; I had a pretty bad Cold; Wheezing really bad; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (It had all moved to the top of my chest), NASOPHARYNGITIS (I had a pretty bad Cold), WHEEZING (Wheezing really bad), PAIN IN EXTREMITY (Sore arm) and ILLNESS (I was sick / Never been as sick) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced CHEST DISCOMFORT (It had all moved to the top of my chest), NASOPHARYNGITIS (I had a pretty bad Cold), WHEEZING (Wheezing really bad), ILLNESS (I was sick / Never been as sick), COVID-19 (Covid-19 infection) and PRODUCT DOSE OMISSION ISSUE (I was due to get 2nd vaccine about 5 days ago). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with VITAMINS NOS at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (It had all moved to the top of my chest), NASOPHARYNGITIS (I had a pretty bad Cold), WHEEZING (Wheezing really bad), PAIN IN EXTREMITY (Sore arm) and COVID-19 (Covid-19 infection) outcome was unknown, ILLNESS (I was sick / Never been as sick) was resolving and PRODUCT DOSE OMISSION ISSUE (I was due to get 2nd vaccine about 5 days ago) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Chest X-ray: normal (normal) normal. In July 2021, SARS-CoV-2 test: positive (Positive) COVID-19 test positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. Treatment information included steroid shot, antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received: No New Information.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue, SARS-CoV-2 test, Wheezing
Clinical narrative: Sore arm; I was sick / Never been as sick; Covid-19 infection; I was due to get 2nd vaccine about 5 days ago; It had all moved to the top of my chest; I had a pretty bad Cold; Wheezing really bad; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (It had all moved to the top of my chest), NASOPHARYNGITIS (I had a pretty bad Cold), WHEEZING (Wheezing really bad), PAIN IN EXTREMITY (Sore arm) and ILLNESS (I was sick / Never been as sick) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced CHEST DISCOMFORT (It had all moved to the top of my chest), NASOPHARYNGITIS (I had a pretty bad Cold), WHEEZING (Wheezing really bad), ILLNESS (I was sick / Never been as sick), COVID-19 (Covid-19 infection) and PRODUCT DOSE OMISSION ISSUE (I was due to get 2nd vaccine about 5 days ago). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with VITAMINS NOS at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (It had all moved to the top of my chest), NASOPHARYNGITIS (I had a pretty bad Cold), WHEEZING (Wheezing really bad), PAIN IN EXTREMITY (Sore arm) and COVID-19 (Covid-19 infection) outcome was unknown, ILLNESS (I was sick / Never been as sick) was resolving and PRODUCT DOSE OMISSION ISSUE (I was due to get 2nd vaccine about 5 days ago) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Chest X-ray: normal (normal) normal. In July 2021, SARS-CoV-2 test: positive (Positive) COVID-19 test positive..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. Treatment information included steroid shot, antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up received: No New Information.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Used; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Used) 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.   Concomitant product use not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain
Clinical narrative: reports of knots in the underarm area w pain; reports of knots in the underarm area w pain; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (reports of knots in the underarm area w pain) and AXILLARY PAIN (reports of knots in the underarm area w pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY MASS (reports of knots in the underarm area w pain) and AXILLARY PAIN (reports of knots in the underarm area w pain). At the time of the report, AXILLARY MASS (reports of knots in the underarm area w pain) and AXILLARY PAIN (reports of knots in the underarm area w pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Rash
Clinical narrative: experiencing diarrhea; possible rash sensation on her arms; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (experiencing diarrhea) and RASH (possible rash sensation on her arms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jul-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 DIARRHOEA (experiencing diarrhea) and RASH (possible rash sensation on her arms). On 19-Jul-2021, DIARRHOEA (experiencing diarrhea) and RASH (possible rash sensation on her arms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: significant follow up received: Reporter's Email Id, Phone Number is reported. Patient's height and weight is reported. Event outcome is reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Administered to  patient; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to  patient) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to  patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to  patient) 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.   Nurse is calling to report that they have 80 doses of the Moderna COVID-19 Vaccine. Lot No:  053C21A  & MFG Date: 04/09/2021  sitting in the refrigerator since 07JUN2021.  2 doses were administered, 32 days after storage in the refrigerator began Administered on 09JUL2021.  Caller has limited information regarding the patients:  She states that It was their First Doses. A 77-year-old and A 22-year-old  non-pregnant individual were vaccinated with expired vaccine, 2 days past refrigeration expiration date.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Moderna vaccine 1st dose, Pfizer 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine 1st dose, Pfizer 2nd dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Prophylaxis.    No medical history was provided by the reporter.    On 17-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine 1st dose, Pfizer 2nd dose). On 17-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna vaccine 1st dose, Pfizer 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provider by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Didn't receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose) 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 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: weakness; aches and pains; fever 101-103; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MYALGIA (aches and pains), PYREXIA (fever 101-103) and FATIGUE (fatigue) 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 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), MYALGIA (aches and pains), PYREXIA (fever 101-103) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), MYALGIA (aches and pains), PYREXIA (fever 101-103) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101-103 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided  Treatment information was not provided
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Vaccination site swelling
Clinical narrative: Left arm pit became painful; injection site was swollen; Left arm pit is swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Left arm pit is swollen), AXILLARY PAIN (Left arm pit became painful) and VACCINATION SITE SWELLING (injection site was swollen) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced LYMPHADENOPATHY (Left arm pit is swollen) and VACCINATION SITE SWELLING (injection site was swollen). On an unknown date, the patient experienced AXILLARY PAIN (Left arm pit became painful). At the time of the report, LYMPHADENOPATHY (Left arm pit is swollen), AXILLARY PAIN (Left arm pit became painful) and VACCINATION SITE SWELLING (injection site was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I received my first Moderna vaccine the first week of May, I haven't been able to get the second dose until now; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I received my first Moderna vaccine the first week of May, I haven't been able to get the second dose until now) 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 May 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 (I received my first Moderna vaccine the first week of May, I haven't been able to get the second dose until now). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I received my first Moderna vaccine the first week of May, I haven't been able to get the second dose until now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information reported. No treatment medication information reported.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of inappropriate schedule of product administration (more than 2-month interval between both doses of Moderna COVID-19 vaccine) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 051C21A) for COVID-19  immunization. No medical history reported. On May 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jul 19, 2021, patient experienced inappropriate schedule of product administration (more than 2-month interval between both doses of Moderna COVID-19 vaccine). At the time of the report, inappropriate schedule of product administration (more than 2-month interval between both doses of Moderna COVID-19 vaccine): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache ever since however not severe; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache ever since however not severe) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01D021A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced HEADACHE (Headache ever since however not severe). At the time of the report, HEADACHE (Headache ever since however not severe) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not received a Second Dose, 3.5 months after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received a Second Dose, 3.5 months after the first 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 19-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received a Second Dose, 3.5 months after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received a Second Dose, 3.5 months after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.