chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine and reports they put it in the refrigerator and it was only good for 30 days but it has been 60 day and were administered to patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine and reports they put it in the refrigerator and it was only good for 30 days but it has been 60 day and were administered to patients.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine and reports they put it in the refrigerator and it was only good for 30 days but it has been 60 day and were administered to patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine and reports they put it in the refrigerator and it was only good for 30 days but it has been 60 day and were administered to patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator:29NOV2021 Date of administration: 17-DEC-21 -1 vial, 28-DEC-21 -1 vial, 14-JAN-22- 2 vial, 28-JAN-22- 2 vial.  No concomitant medications were reported. No treatment medications were reported. -   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2022: Follow up received contains non-significant information. On 03-Feb-2022: Follow up received and contains non significant information (reporter added)
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: now is in the hospital with Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (now is in the hospital with Covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (had Pfizer as his primary series). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Cancer.    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 COVID-19 (now is in the hospital with Covid-19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (now is in the hospital with Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: results not provided Results not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.  Patient never had any antibodies after booster vaccine.  Company comment: This spontaneous case concerns a male patient of unknown age with relevant medical history of cancer and with interchange of vaccine products (Tozinameran, pfizer biontech covid-19 vaccine), who experienced serious unexpected AESI event of COVID 19 unspecified days after receiving mRNA-1273 vaccine. It was reported that the patient did not develop any antibodies after vaccination and is now hospitalized with COVID 19. Medical history of cancer and the current pandemic situation of COVID 19 could be risk factors for the event. At the time of reporting the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with relevant medical history of cancer and with interchange of vaccine products (Tozinameran, pfizer biontech covid-19 vaccine), who experienced serious unexpected AESI event of COVID 19 unspecified days after receiving mRNA-1273 vaccine. It was reported that the patient did not develop any antibodies after vaccination and is now hospitalized with COVID 19. Medical history of cancer and the current pandemic situation of COVID 19 could be risk factors for the event. At the time of reporting the outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Systemic lupus erythematosus
Clinical narrative: SLE flare (severe recurrent arthritis); SLE flare (severe recurrent arthritis); This literature-non-study case was reported in a literature article and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (severe recurrent arthritis)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  Evaluation of immune response and disease status in Systemic Lupus Erythematosus patients following SARSCoV-2 vaccination. Arthritis Rheumatol;74(2):284     Concurrent medical conditions included Systemic lupus erythematosus.   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 SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (severe recurrent arthritis)) (seriousness criterion medically significant) and ARTHRITIS (SLE flare (severe recurrent arthritis)). At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (severe recurrent arthritis)) and ARTHRITIS (SLE flare (severe recurrent arthritis)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SYSTEMIC LUPUS ERYTHEMATOSUS (SLE flare (severe recurrent arthritis)) and ARTHRITIS (SLE flare (severe recurrent arthritis)) to be related.    Concomitant and treatment were not reported.  Company comment: This literature non-study case with limited information on patient with medical history of Systemic lupus erythematosus, experienced the unexpected serious AESI event Systemic lupus erythematosus on an unknown data after second dose of mRNA-1273 which taken on an unknown date. It was reported that the patient had an SLE flare and recurrent arthritis. At the time of reporting the outcome was unknown. The patient's medical history of Systemic lupus erythematosus remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.   This case was linked to MOD-2022-475935 (Patient Link).; Sender's Comments: This literature non-study case with limited information on patient with medical history of Systemic lupus erythematosus, experienced the unexpected serious AESI event Systemic lupus erythematosus on an unknown data after second dose of mRNA-1273 which taken on an unknown date. It was reported that the patient had an SLE flare and recurrent arthritis. At the time of reporting the outcome was unknown. The patient's medical history of Systemic lupus erythematosus remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE (TRIUMEQ) for HIV disease.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days). On 02-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to 26 patients from 5 vials stored in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.  HCP stated they administered Moderna COVD-19 Vaccine to 26 patients from 5 vials that where stored in the fridge for more than 30 days.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site abscess, Vaccination site discolouration, Vaccination site pain, Vaccination site reaction
Clinical narrative: Unresponsive abscess on Injection Site 1 month after booster; Sore with black dot on Injection Site 1 month after booster; Sore with black dot on Injection Site 1 month after booster; Giant hole on Injection Site 1 month after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Giant hole on Injection Site 1 month after booster), VACCINATION SITE ABSCESS (Unresponsive abscess on Injection Site 1 month after booster), VACCINATION SITE DISCOLOURATION (Sore with black dot on Injection Site 1 month after booster) and VACCINATION SITE PAIN (Sore with black dot on Injection Site 1 month after booster) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 028L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Giant hole on Injection Site 1 month after booster). On 29-Jan-2022, the patient experienced VACCINATION SITE ABSCESS (Unresponsive abscess on Injection Site 1 month after booster). 29-Jan-2022, the patient experienced VACCINATION SITE DISCOLOURATION (Sore with black dot on Injection Site 1 month after booster) and VACCINATION SITE PAIN (Sore with black dot on Injection Site 1 month after booster). At the time of the report, VACCINATION SITE REACTION (Giant hole on Injection Site 1 month after booster), VACCINATION SITE ABSCESS (Unresponsive abscess on Injection Site 1 month after booster), VACCINATION SITE DISCOLOURATION (Sore with black dot on Injection Site 1 month after booster) and VACCINATION SITE PAIN (Sore with black dot on Injection Site 1 month after booster) had not resolved.            No concomitant medication was provided Treatment included Antibiotic and Steroids which did not improve her arm. Patient reported that she had unresponsive Injection Site abscess to Antibiotics  and steroids after booster on 29-Jan-2022   This case was linked to MOD-2022-477081 (Patient Link).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Incorrect dose administered
Clinical narrative: Receiving the 3rd dose instead of booster; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Receiving the 3rd dose instead of booster) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 040A12A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Quintuple coronary bypass (17 year ago had a quintuple bi-pass.). Concurrent medical conditions included Blood pressure abnormal and Heart rate abnormal. Concomitant products included WARFARIN for Anticoagulant therapy, METOPROLOL for Blood pressure management, LOSARTAN for Heart rate abnormal, ATORVASTATIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 30-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT DOSE ADMINISTERED (Receiving the 3rd dose instead of booster). At the time of the report, INCORRECT DOSE ADMINISTERED (Receiving the 3rd dose instead of booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antibody test: 4.9 4.9. On an unknown date, Antibody test: 19.9 19.9.         It was reported that patient was not getting the antibody level he was expecting. It was stated that patient did not have any immunocompromise and not taking any immunosuppressive medications. It was reported that patient Initial titer was 4.9 in September which was exponentially lower than anyone after having the first two doses. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2022: Follow up received and contains No New Information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Patient felt a little bit of flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Patient felt a little bit of flu) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PNEUMOCOCCAL VACCINE (2 weeks before the infusion). Past adverse reactions to the above products included No adverse event with PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Multiple sclerosis since 1990, Immunocompromised, Allergy to antibiotic (Augmentin), Allergy to antibiotic (Bactrim) and Seasonal allergy. Concomitant products included BACLOFEN for Multiple sclerosis.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced INFLUENZA (Patient felt a little bit of flu). On 28-Mar-2021, INFLUENZA (Patient felt a little bit of flu) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not seek any medical care for the AE. and did not experienced the similar events in the past. Patient never had COVID test positive. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-477957, MOD-2022-477958 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose administered out of schedule: 3rd dose administered 9 months after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered out of schedule: 3rd dose administered 9 months after 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 068G21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Multiple sclerosis since 1990, Allergy to antibiotic (Augmentin), Drug allergy (Bactrim) and Seasonal allergy. Concomitant products included BACLOFEN and OCRELIZUMAB (OCREVUS) from 20-Oct-2021 to an unknown date for Multiple sclerosis.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered out of schedule: 3rd dose administered 9 months after 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose administered out of schedule: 3rd dose administered 9 months after 2nd dose) outcome was unknown.            Other vaccines given within 1 month prior to Moderna COVID-19 vaccine  was unspecified pneumonia vaccine 2 weeks before the infusion. Multiple sclerosis was worsening and hence, she got Ocrevus infusions on 20Oct2021.  No treatment details were provided.   This case was linked to MOD-2022-477957, MOD-2022-477945 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: I had severe pain that started in my left shoulder, then into my left neck for 5 days; I had severe pain that started in my left shoulder, then into my left neck for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (I had severe pain that started in my left shoulder, then into my left neck for 5 days) and NECK PAIN (I had severe pain that started in my left shoulder, then into my left neck for 5 days) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Environmental allergy, Food allergy (sea food), Asthma and Hypertension.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, the patient experienced ARTHRALGIA (I had severe pain that started in my left shoulder, then into my left neck for 5 days) and NECK PAIN (I had severe pain that started in my left shoulder, then into my left neck for 5 days). At the time of the report, ARTHRALGIA (I had severe pain that started in my left shoulder, then into my left neck for 5 days) and NECK PAIN (I had severe pain that started in my left shoulder, then into my left neck for 5 days) had resolved.            No concomitant medication were provided No treatment details were provided
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Impaired driving ability, Mental fatigue, Migraine
Clinical narrative: sometimes feels like she's having a mental episode like she would space out like she was in a whole other world; migraines, describes the migraines in December not at a 10, but at a 20,; dizziness; nausea; fatigue; body aches; she couldn't drive; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (she couldn't drive), MENTAL FATIGUE (sometimes feels like she's having a mental episode like she would space out like she was in a whole other world), MIGRAINE (migraines, describes the migraines in December not at a 10, but at a 20,), DIZZINESS (dizziness) and NAUSEA (nausea) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 004C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced IMPAIRED DRIVING ABILITY (she couldn't drive), MIGRAINE (migraines, describes the migraines in December not at a 10, but at a 20,), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches). On an unknown date, the patient experienced MENTAL FATIGUE (sometimes feels like she's having a mental episode like she would space out like she was in a whole other world). The patient was treated with BUTALBITAL;CAFFEINE;PARACETAMOL for Migraine, at an unspecified dose and frequency. In December 2021, FATIGUE (fatigue) and MYALGIA (body aches) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (she couldn't drive), MENTAL FATIGUE (sometimes feels like she's having a mental episode like she would space out like she was in a whole other world), DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown and MIGRAINE (migraines, describes the migraines in December not at a 10, but at a 20,) was resolving.            It was reported that the patient had migraines were bad to the point where she had to lay down.  She described the migraines in Dec not at a 10, but at a 20.  In Jan she was on unspecified medication from her primary care physician that brought the migraine level down to 5 to 7.  She had seen a new doctor who prescribed a new medicine called Butalbital-Acetaminophen-Caffeine that kept the migraines down at a 1 or 2.   No concomitant medications were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: sometimes feels like she's having a mental episode like she would space out like she was in a whole other world; migraines, describes the migraines in December not at a 10, but at a 20,; dizziness; nausea; fatigue; body aches; she couldn't drive; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (she couldn't drive), MENTAL FATIGUE (sometimes feels like she's having a mental episode like she would space out like she was in a whole other world), MIGRAINE (migraines, describes the migraines in December not at a 10, but at a 20,), DIZZINESS (dizziness) and NAUSEA (nausea) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 004C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced IMPAIRED DRIVING ABILITY (she couldn't drive), MIGRAINE (migraines, describes the migraines in December not at a 10, but at a 20,), DIZZINESS (dizziness), NAUSEA (nausea), FATIGUE (fatigue) and MYALGIA (body aches). On an unknown date, the patient experienced MENTAL FATIGUE (sometimes feels like she's having a mental episode like she would space out like she was in a whole other world). The patient was treated with BUTALBITAL;CAFFEINE;PARACETAMOL for Migraine, at an unspecified dose and frequency. In December 2021, FATIGUE (fatigue) and MYALGIA (body aches) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (she couldn't drive), MENTAL FATIGUE (sometimes feels like she's having a mental episode like she would space out like she was in a whole other world), DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown and MIGRAINE (migraines, describes the migraines in December not at a 10, but at a 20,) was resolving.            It was reported that the patient had migraines were bad to the point where she had to lay down.  She described the migraines in Dec not at a 10, but at a 20.  In Jan she was on unspecified medication from her primary care physician that brought the migraine level down to 5 to 7.  She had seen a new doctor who prescribed a new medicine called Butalbital-Acetaminophen-Caffeine that kept the migraines down at a 1 or 2.   No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: felt lousy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt lousy) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt lousy). At the time of the report, FEELING ABNORMAL (felt lousy) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Sweating at night; This spontaneous case was reported by a nurse and describes the occurrence of NIGHT SWEATS (Sweating at night) 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 NIGHT SWEATS (Sweating at night). At the time of the report, NIGHT SWEATS (Sweating at night) 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.   No concomitant and treatment medication were reported.   This case was linked to MOD-2022-478534 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: sweating at night worse since the booster dose; This spontaneous case was reported by a nurse and describes the occurrence of HYPERHIDROSIS (sweating at night worse since the booster 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 HYPERHIDROSIS (sweating at night worse since the booster dose). At the time of the report, HYPERHIDROSIS (sweating at night worse since the booster dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.  Patient reported sweating at night since the first dose that got worse since the booster dose.   This case was linked to MOD-2022-478513 (Patient Link).   Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Scratch, Vaccination site pruritus
Clinical narrative: Scratchy feeling; Feeling an itch in the site of injection\Itchy site of injection; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scratchy feeling) and VACCINATION SITE PRURITUS (Feeling an itch in the site of injection\Itchy site of injection) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 immunisation.     Has patient had COVID + test on Feb2021.  The patient's past medical history included COVID-19 in February 2021.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced SCRATCH (Scratchy feeling) and VACCINATION SITE PRURITUS (Feeling an itch in the site of injection\Itchy site of injection). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SCRATCH (Scratchy feeling) and VACCINATION SITE PRURITUS (Feeling an itch in the site of injection\Itchy site of injection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient was not on any concomitant medication and had no allergies. The patient had no history of acute or chronic illness at the time of vaccination.  It was reported that the itchy feeling at the site of injection and scratchy feeling was not fully subsisted since the first dose of the vaccine. The patient also stated that it got worse when she received the second dose.   This case was linked to MOD-2022-478879, MOD-2022-478868 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, SARS-CoV-2 test, Scratch, Vaccination site pruritus
Clinical narrative: Whole body its itchy; got worse when she received the second dose and the booster dose; Itchy site of injection; itch gotten worse after getting the 2nd and booster doses; Scratch until skin is marked; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scratch until skin is marked), PRURITUS (Whole body its itchy), CONDITION AGGRAVATED (got worse when she received the second dose and the booster dose) and VACCINATION SITE PRURITUS (Itchy site of injection; itch gotten worse after getting the 2nd and booster doses) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced SCRATCH (Scratch until skin is marked). On 29-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy site of injection; itch gotten worse after getting the 2nd and booster doses). On an unknown date, the patient experienced PRURITUS (Whole body its itchy) and CONDITION AGGRAVATED (got worse when she received the second dose and the booster dose). At the time of the report, SCRATCH (Scratch until skin is marked) and VACCINATION SITE PRURITUS (Itchy site of injection; itch gotten worse after getting the 2nd and booster doses) outcome was unknown and PRURITUS (Whole body its itchy) and CONDITION AGGRAVATED (got worse when she received the second dose and the booster dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive Positive.         No Concomitant medications were reported.   This case was linked to MOD-2022-478698, MOD-2022-478879 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-1 test, Scratch, Vaccination site pruritus
Clinical narrative: Itchy site of injection; itch gotten worse after getting the 2nd and booster doses; scratchy feeling/ got worse when she received the second dose and the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy site of injection; itch gotten worse after getting the 2nd and booster doses) and SCRATCH (scratchy feeling/ got worse when she received the second dose and the booster dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy site of injection; itch gotten worse after getting the 2nd and booster doses) and SCRATCH (scratchy feeling/ got worse when she received the second dose and the booster dose). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchy site of injection; itch gotten worse after getting the 2nd and booster doses) and SCRATCH (scratchy feeling/ got worse when she received the second dose and the booster dose) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-1 test: positive (Positive) Positive.         Patient stated that she was on concomitant medication.  Patient started feeling an itch in the site of injection and scratchy feeling had not fully subsisted since she got the first dose of the vaccine. Patient stated that it got worse when she received the second dose and the booster dose on 07Jan2022. The patient stated that she never had symptom with any other vaccine before she received the Moderna covid19 vaccine.  Patient had no past history elating to mentioned AE and both Acute and Chronic illnesses at the time of Vaccination.  Treatment medication was not provided by the reported.   This case was linked to MOD-2022-478698, MOD-2022-478868 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Dry mouth, Lip pain, Loss of personal independence in daily activities
Clinical narrative: I lost my taste / I can only taste sweet and sour; Sore throat; weird tongue sensation; a lot of pain in my upper tips; mouth very dry; I am loosing energy; I can not work; loose of mouth; lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I lost my taste / I can only taste sweet and sour), OROPHARYNGEAL PAIN (Sore throat), TONGUE DISCOMFORT (weird tongue sensation), LIP PAIN (a lot of pain in my upper tips) and DRY MOUTH (mouth very dry) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B, 016C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced AGEUSIA (I lost my taste / I can only taste sweet and sour), OROPHARYNGEAL PAIN (Sore throat), TONGUE DISCOMFORT (weird tongue sensation), LIP PAIN (a lot of pain in my upper tips), DRY MOUTH (mouth very dry), ASTHENIA (I am loosing energy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can not work), ORAL DISCOMFORT (loose of mouth) and PAIN (lot of pain). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency. At the time of the report, AGEUSIA (I lost my taste / I can only taste sweet and sour), OROPHARYNGEAL PAIN (Sore throat), TONGUE DISCOMFORT (weird tongue sensation), LIP PAIN (a lot of pain in my upper tips), DRY MOUTH (mouth very dry), ASTHENIA (I am loosing energy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can not work), ORAL DISCOMFORT (loose of mouth) and PAIN (lot of pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took mucus relief and nasal spray as treatment medication.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Oral discomfort, Oropharyngeal pain, Pain, SARS-CoV-2 test, Tongue discomfort
Clinical narrative: I lost my taste / I can only taste sweet and sour; Sore throat; weird tongue sensation; a lot of pain in my upper tips; mouth very dry; I am loosing energy; I can not work; loose of mouth; lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I lost my taste / I can only taste sweet and sour), OROPHARYNGEAL PAIN (Sore throat), TONGUE DISCOMFORT (weird tongue sensation), LIP PAIN (a lot of pain in my upper tips) and DRY MOUTH (mouth very dry) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B, 016C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced AGEUSIA (I lost my taste / I can only taste sweet and sour), OROPHARYNGEAL PAIN (Sore throat), TONGUE DISCOMFORT (weird tongue sensation), LIP PAIN (a lot of pain in my upper tips), DRY MOUTH (mouth very dry), ASTHENIA (I am loosing energy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can not work), ORAL DISCOMFORT (loose of mouth) and PAIN (lot of pain). The patient was treated with AMOXICILLIN for Adverse event, at an unspecified dose and frequency. At the time of the report, AGEUSIA (I lost my taste / I can only taste sweet and sour), OROPHARYNGEAL PAIN (Sore throat), TONGUE DISCOMFORT (weird tongue sensation), LIP PAIN (a lot of pain in my upper tips), DRY MOUTH (mouth very dry), ASTHENIA (I am loosing energy), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can not work), ORAL DISCOMFORT (loose of mouth) and PAIN (lot of pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took mucus relief and nasal spray as treatment medication.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Received a half dose booster instead of a 3rd full dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received a half dose booster instead of a 3rd full dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Radiation therapy (For an unknown condition).   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Received a half dose booster instead of a 3rd full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Received a half dose booster instead of a 3rd full dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant use were reported No treatment were reported.  The patient called the vaccination provider to ask if patient got a half dose or full dose and said that patient should have gotten the full dose since the patient was undergoing radiation.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 15 year old received first dose of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received first dose of Moderna) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy and Peanut allergy. Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for an unknown indication.    On 07-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Feb-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received first dose of Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old received first dose of Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. The nurse accidentally gave a 0.5 ml dose of Moderna to a 15-year-old male patient. Patient had no reactions. Patient had never tested positive for COVID-19. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site lymphadenopathy
Clinical narrative: received the vaccine she got red and swollen lymph nodes; received the vaccine she got red and swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (received the vaccine she got red and swollen lymph nodes) and VACCINATION SITE LYMPHADENOPATHY (received the vaccine she got red and swollen lymph nodes) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (received the vaccine she got red and swollen lymph nodes) and VACCINATION SITE LYMPHADENOPATHY (received the vaccine she got red and swollen lymph nodes). At the time of the report, VACCINATION SITE ERYTHEMA (received the vaccine she got red and swollen lymph nodes) and VACCINATION SITE LYMPHADENOPATHY (received the vaccine she got red and swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.   Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: she has been loosing her memory/she started to loosing her memory/something that I done in the past I don't remember what it was/all I remember is that my family said that I am loosing my memory; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (she has been loosing her memory/she started to loosing her memory/something that I done in the past I don't remember what it was/all I remember is that my family said that I am loosing my memory) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS, METOPROLOL, ATORVASTATIN and AMLODIPINE for an unknown indication.    In September 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 AMNESIA (she has been loosing her memory/she started to loosing her memory/something that I done in the past I don't remember what it was/all I remember is that my family said that I am loosing my memory). At the time of the report, AMNESIA (she has been loosing her memory/she started to loosing her memory/something that I done in the past I don't remember what it was/all I remember is that my family said that I am loosing my memory) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include Dishol. The patient said their age, but did not match with the date of birth provided by the husband, it differs by one year. No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine was administered greater than 12 hours post first vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine was administered greater than 12 hours post first vial puncture) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine was administered greater than 12 hours post first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine was administered greater than 12 hours post first vial puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date and time vial was first punctured: 08Feb2022 at 9:32am in vaccination room with an average room temp of 74 degrees F. No concomitant medication were reported. No treatment information were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Malaise
Clinical narrative: Not feeling well; she had swelling under her right arm pit; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well), LYMPHADENOPATHY (she had swelling under her right arm pit) and FATIGUE (Tired) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F1IA) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In October 2021, the patient experienced MALAISE (Not feeling well), LYMPHADENOPATHY (she had swelling under her right arm pit) and FATIGUE (Tired). At the time of the report, MALAISE (Not feeling well), LYMPHADENOPATHY (she had swelling under her right arm pit) and FATIGUE (Tired) had not resolved.            Concomitant medications details were not reported by the reporter.  Treatment details was not reported by the reporter.