chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product  was not provided by the reporter.  No treatment information was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Left ventricular hypertrophy, Palpitations, Vaccination site pain
Clinical narrative: felt kind of confused; arm soreness but it was no issue; left ventricle of her heart become enlarged; had palpitations ever since; This spontaneous case was reported by a consumer and describes the occurrence of LEFT VENTRICULAR HYPERTROPHY (left ventricle of her heart become enlarged) and PALPITATIONS (had palpitations ever since) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CEFALEXIN (CEFALIN [CEFALEXIN]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), SALBUTAMOL SULFATE (VENTOLIN ACCUHALER), LOSARTAN, VENLAFAXINE, PANTOPRAZOLE, HYDROCODONE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), IRON (IRON ORAL) and PRAVASTATIN for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm soreness but it was no issue). On 19-Mar-2021, the patient experienced CONFUSIONAL STATE (felt kind of confused). In 2021, the patient experienced LEFT VENTRICULAR HYPERTROPHY (left ventricle of her heart become enlarged) (seriousness criterion medically significant) and PALPITATIONS (had palpitations ever since) (seriousness criterion medically significant). At the time of the report, LEFT VENTRICULAR HYPERTROPHY (left ventricle of her heart become enlarged), PALPITATIONS (had palpitations ever since), CONFUSIONAL STATE (felt kind of confused) and VACCINATION SITE PAIN (arm soreness but it was no issue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient stated about medical history that several years ago had a heart stress test done but she can't remember anything about it. Laboratory investigations included EKG and stress tests done but results were not mentioned. Treatment information was not provided.   This case was linked to MOD-2021-371800, MOD-2021-371801 (Patient Link).; Sender's Comments: This case concerns a 64-year-old, female patient with no relevant medical history, who experienced the unexpected event of Left Ventricular Hypertrophy. The event occurred approximately 1 month (exact date not specified) after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered dose past the manufacture expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered dose past the manufacture expiry date (2nd dose that was expired when administered on 15Oct2021 Lot#050E21A  Exp 13Oct2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date (2nd dose that was expired when administered on 15Oct2021 Lot#050E21A  Exp 13Oct2021)) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date (2nd dose that was expired when administered on 15Oct2021 Lot#050E21A  Exp 13Oct2021)). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the manufacture expiry date (2nd dose that was expired when administered on 15Oct2021 Lot#050E21A  Exp 13Oct2021)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided. 9 patients were administered dose past the manufacture expiry date along with patient. 3 doses administered on 15-Oct-2021 and 6 doses administered on 22-Oct-2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given a dose from an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vaccine was administered in the deltoid region . Initial expiration date was  09Oct2021 and  was extended to 27Oct2021. Concomitant medication use was unknown Treatment information was unknown
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Splitting headache; Nausea; Redness and swelling on left arm at injection site.  It looks like a red knot.; Redness and swelling on left arm at injection site.  It looks like a red knot.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness and swelling on left arm at injection site.  It looks like a red knot.), HEADACHE (Splitting headache), NAUSEA (Nausea) and VACCINATION SITE SWELLING (Redness and swelling on left arm at injection site.  It looks like a red knot.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness and swelling on left arm at injection site.  It looks like a red knot.) and VACCINATION SITE SWELLING (Redness and swelling on left arm at injection site.  It looks like a red knot.). On 02-Nov-2021, the patient experienced HEADACHE (Splitting headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Redness and swelling on left arm at injection site.  It looks like a red knot.), HEADACHE (Splitting headache), NAUSEA (Nausea) and VACCINATION SITE SWELLING (Redness and swelling on left arm at injection site.  It looks like a red knot.) outcome was unknown.            Concomitant medications were not provided.  Treatment information included Nausea relief.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Dysphonia, Ear discomfort, Ear infection, Ear inflammation
Clinical narrative: Horse voice after 2nd shot; Lump under the left arm pit after 2nd shot; Left ear infection after 2nd shot; Can not hear on the left ear after 2nd shot; Inner left ear is getting large after 2nd shot; Inner left ear is getting more inflamed after 2nd shot; Inflammation under the left arm pit after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Horse voice after 2nd shot), INFLAMMATION (Inflammation under the left arm pit after 2nd shot), AXILLARY MASS (Lump under the left arm pit after 2nd shot), EAR INFECTION (Left ear infection after 2nd shot) and HYPOACUSIS (Can not hear on the left ear after 2nd shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced INFLAMMATION (Inflammation under the left arm pit after 2nd shot), AXILLARY MASS (Lump under the left arm pit after 2nd shot), EAR INFECTION (Left ear infection after 2nd shot), HYPOACUSIS (Can not hear on the left ear after 2nd shot), EAR DISCOMFORT (Inner left ear is getting large after 2nd shot) and EAR INFLAMMATION (Inner left ear is getting more inflamed after 2nd shot). On 02-Nov-2021, the patient experienced DYSPHONIA (Horse voice after 2nd shot). At the time of the report, DYSPHONIA (Horse voice after 2nd shot), INFLAMMATION (Inflammation under the left arm pit after 2nd shot), AXILLARY MASS (Lump under the left arm pit after 2nd shot), EAR INFECTION (Left ear infection after 2nd shot), HYPOACUSIS (Can not hear on the left ear after 2nd shot), EAR DISCOMFORT (Inner left ear is getting large after 2nd shot) and EAR INFLAMMATION (Inner left ear is getting more inflamed after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information was provided. No treatment medication were provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, SARS-CoV-2 test, Vaccination site lymphadenopathy
Clinical narrative: Horse voice after 2nd shot; Lump under the left arm pit after 2nd shot; Left ear infection after 2nd shot; Can not hear on the left ear after 2nd shot; Inner left ear is getting large after 2nd shot; Inner left ear is getting more inflamed after 2nd shot; Inflammation under the left arm pit after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (Horse voice after 2nd shot), INFLAMMATION (Inflammation under the left arm pit after 2nd shot), AXILLARY MASS (Lump under the left arm pit after 2nd shot), EAR INFECTION (Left ear infection after 2nd shot) and HYPOACUSIS (Can not hear on the left ear after 2nd shot) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced INFLAMMATION (Inflammation under the left arm pit after 2nd shot), AXILLARY MASS (Lump under the left arm pit after 2nd shot), EAR INFECTION (Left ear infection after 2nd shot), HYPOACUSIS (Can not hear on the left ear after 2nd shot), EAR DISCOMFORT (Inner left ear is getting large after 2nd shot) and EAR INFLAMMATION (Inner left ear is getting more inflamed after 2nd shot). On 02-Nov-2021, the patient experienced DYSPHONIA (Horse voice after 2nd shot). At the time of the report, DYSPHONIA (Horse voice after 2nd shot), INFLAMMATION (Inflammation under the left arm pit after 2nd shot), AXILLARY MASS (Lump under the left arm pit after 2nd shot), EAR INFECTION (Left ear infection after 2nd shot), HYPOACUSIS (Can not hear on the left ear after 2nd shot), EAR DISCOMFORT (Inner left ear is getting large after 2nd shot) and EAR INFLAMMATION (Inner left ear is getting more inflamed after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication information was provided. No treatment medication were provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 2nd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis, Vaccination complication
Clinical narrative: similar malaise; slight inflamed lymph node under their left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (similar malaise) and LYMPHADENITIS (slight inflamed lymph node under their left arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 048A21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (similar malaise) and LYMPHADENITIS (slight inflamed lymph node under their left arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (similar malaise) and LYMPHADENITIS (slight inflamed lymph node under their left arm) outcome was unknown.            No concomitant medications reported. The day after the booster dose, the patient had similar malaise which occurred after the second shot and took 1 aspirin and then noticed a slight inflamed lymph node under their left arm.   This case was linked to MOD-2021-371873 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain
Clinical narrative: shooting pain up my buttocks; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (shooting pain up my buttocks) 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-Nov-2021, the patient received third 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (shooting pain up my buttocks). At the time of the report, MUSCULOSKELETAL PAIN (shooting pain up my buttocks) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: second dose missed; fever; chills; headache; body aches; fatigue; swollen lymph nodes of left underarm; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body aches), FATIGUE (fatigue), LYMPHADENOPATHY (swollen lymph nodes of left underarm) and PRODUCT DOSE OMISSION ISSUE (second dose missed). At the time of the report, PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body aches), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen lymph nodes of left underarm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose missed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient was supposed to get the 2nd dose 24Oct2021 and did not go.  patient stated that  she had fever, chills, headache, body aches and fatigue for about 48 hours after 1st dose and for a week had swollen lymph nodes of left underarm.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia
Clinical narrative: second dose missed; fever; chills; headache; body aches; fatigue; swollen lymph nodes of left underarm; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body aches) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body aches), FATIGUE (fatigue), LYMPHADENOPATHY (swollen lymph nodes of left underarm) and PRODUCT DOSE OMISSION ISSUE (second dose missed). At the time of the report, PYREXIA (fever), CHILLS (chills), HEADACHE (headache), MYALGIA (body aches), FATIGUE (fatigue) and LYMPHADENOPATHY (swollen lymph nodes of left underarm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (second dose missed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient was supposed to get the 2nd dose 24Oct2021 and did not go.  patient stated that  she had fever, chills, headache, body aches and fatigue for about 48 hours after 1st dose and for a week had swollen lymph nodes of left underarm.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired for about one day after his first vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired for about one day after his first vaccination.) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Felt tired for about one day after his first vaccination.). At the time of the report, FATIGUE (Felt tired for about one day after his first vaccination.) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications was reported. Treatment information was not provided.   This case was linked to MOD-2021-372255 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received vaccine past published expiry date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received vaccine past published expiry date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received vaccine past published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patients received vaccine past published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that the affected vial was moved from freezer to the refrigerator on 28-Sep-2021.  Treatment information was not provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that she does not know which dosage it was, if it was 0.5/0.25ML or 50/100mcg, stated it was the one from the booster dose. Reporter stated that she did not have information about the first or second dose of the patients, but she knows that they were all Moderna patients.They all received the Moderna Covid19 Vaccine as first and second dose. No concomitant products were reported. No treatment information was reported by the reporter.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.  No Concomitant medication was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired moderna vaccine mistakenly administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired moderna vaccine mistakenly administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided No treatment medications were provided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Was given the 2nd dose of the Moderna COVID 19 vaccine 15 days after receiving the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was given the 2nd dose of the Moderna COVID 19 vaccine 15 days after receiving the 1st 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was given the 2nd dose of the Moderna COVID 19 vaccine 15 days after receiving the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was given the 2nd dose of the Moderna COVID 19 vaccine 15 days after receiving the 1st dose) had resolved.            No concomitant medications were provided by reporter. No treatment medications were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 3rd dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired 3rd dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: syringes stored at room temperature all day; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (syringes stored at room temperature all day) 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 PRODUCT STORAGE ERROR (syringes stored at room temperature all day). At the time of the report, PRODUCT STORAGE ERROR (syringes stored at room temperature all day) had resolved.            No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Light headache; Light fever; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Light headache) and PYREXIA (Light 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Light headache) and PYREXIA (Light fever). At the time of the report, HEADACHE (Light headache) and PYREXIA (Light fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.  It was reported that the patient had reaction only after her 1st dose. The reaction lasted only less than 12 hours.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered dose past the manufacture expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered dose past the manufacture expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  The vial had not undergo any temperature excursions.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Sore arm after first shot; Very low fever after first shot; Headache after first shot; Fatigue after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after first shot), PYREXIA (Very low fever after first shot), HEADACHE (Headache after first shot) and FATIGUE (Fatigue after first shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm after first shot), PYREXIA (Very low fever after first shot), HEADACHE (Headache after first shot) and FATIGUE (Fatigue after first shot). On 15-Feb-2021, PAIN IN EXTREMITY (Sore arm after first shot), PYREXIA (Very low fever after first shot), HEADACHE (Headache after first shot) and FATIGUE (Fatigue after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-372412, MOD-2021-372413 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: a booster dose (0.25 mL) to a patient that should have received a full dose (0.5 mL); This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (a booster dose (0.25 mL) to a patient that should have received a full dose (0.5 mL)) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A. and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-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 ACCIDENTAL UNDERDOSE (a booster dose (0.25 mL) to a patient that should have received a full dose (0.5 mL)). At the time of the report, ACCIDENTAL UNDERDOSE (a booster dose (0.25 mL) to a patient that should have received a full dose (0.5 mL)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  HCP said that they gave a booster dose (0.25 mL) to a patient that should have received a full dose (0.5 mL). This was patient's second dose. Patient doesn't have any underlying medical conditions.  This is a case of Accidental underdose for this 65-year-old female with no relevant medical history reported. It was reported that the patient received a second dose of 0.25 ml on 02-Nov-2021. No adverse events were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a case of Accidental underdose for this 65-year-old female with no relevant medical history reported. It was reported that the patient received a second dose of 0.25 ml on 02-Nov-2021. No adverse events were reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Bone swelling
Clinical narrative: Painful swelling on collarbone; developed painful swelling on collarbone; This spontaneous case was reported by a consumer and describes the occurrence of BONE SWELLING (Painful swelling on collarbone) and BONE PAIN (developed painful swelling on collarbone) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Oct-2021, the patient received third 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced BONE SWELLING (Painful swelling on collarbone) and BONE PAIN (developed painful swelling on collarbone). At the time of the report, BONE SWELLING (Painful swelling on collarbone) and BONE PAIN (developed painful swelling on collarbone) had not resolved.            No concomitant medication reported. No treatment medication reported.  Patient developed painful swelling on collarbone which was still there (left side - same side as the injected arm).   Patient was wondering if this could be a blood clot. It was confirmed all three doses were Moderna COVID-19 vaccine
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue
Clinical narrative: Back was achy; Tired/Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back was achy) and FATIGUE (Tired/Fatigued) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02/A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (Back was achy) and FATIGUE (Tired/Fatigued). On 13-Mar-2021, BACK PAIN (Back was achy) and FATIGUE (Tired/Fatigued) had resolved.            No relevant concomitant medications were reported.  Treatment information include exercise.   This case was linked to MOD-2021-372106, MOD-2021-372416 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pain in extremity
Clinical narrative: Arm hurt/Both arms hurt/ her calves were also achy; She didn't sleep well last night; In the night woke up with aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt/Both arms hurt/ her calves were also achy), INSOMNIA (She didn't sleep well last night) and MYALGIA (In the night woke up with aches and pains) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02/A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt/Both arms hurt/ her calves were also achy), INSOMNIA (She didn't sleep well last night) and MYALGIA (In the night woke up with aches and pains). At the time of the report, PAIN IN EXTREMITY (Arm hurt/Both arms hurt/ her calves were also achy), INSOMNIA (She didn't sleep well last night) and MYALGIA (In the night woke up with aches and pains) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  This case concerns a 71 year-old female patient with no reported medical history who experienced the unexpected non-serious events of pain in extremity, insomnia, and myalgia. The events pain in extremity and myalgia occurred approximately the same day after the third dose of Moderna COVID-19 Vaccine, and the event insomnia occurred on an unknown date. The rechallenge was not applicable as no additional dosing will be administered.  The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report   This case was linked to MOD-2021-372414, MOD-2021-372106 (Patient Link).; Sender's Comments: This case concerns a 71 year-old female patient with no reported medical history who experienced the unexpected non-serious events of pain in extremity, insomnia, and myalgia. The events pain in extremity and myalgia occurred approximately the same day after the third dose of Moderna COVID-19 Vaccine, and the event insomnia occurred on an unknown date. The rechallenge was not applicable as no additional dosing will be administered.  The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Pyrexia
Clinical narrative: your voice with the phone conversation is hurting my ear and the upper part of my head; Banging headache,mostly on half of my face and my eye your /voice with the phone conversation is hurting my ear and the upper part of my head; Feverish, fever; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (your voice with the phone conversation is hurting my ear and the upper part of my head), PYREXIA (Feverish, fever) and HEADACHE (Banging headache,mostly on half of my face and my eye your /voice with the phone conversation is hurting my ear and the upper part of my head) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 01-Nov-2021, the patient experienced PYREXIA (Feverish, fever). On 02-Nov-2021, the patient experienced EAR PAIN (your voice with the phone conversation is hurting my ear and the upper part of my head) and HEADACHE (Banging headache,mostly on half of my face and my eye your /voice with the phone conversation is hurting my ear and the upper part of my head). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pyrexia, at a dose of 1 dosage form. At the time of the report, EAR PAIN (your voice with the phone conversation is hurting my ear and the upper part of my head), PYREXIA (Feverish, fever) and HEADACHE (Banging headache,mostly on half of my face and my eye your /voice with the phone conversation is hurting my ear and the upper part of my head) outcome was unknown.            No concomitant medications were reported. She is wondering if it would be ok to take an Excedrin instead of another Tylenol
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: On the inside of his elbow on both arms he has a red spot; red spot itches; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (On the inside of his elbow on both arms he has a red spot) and RASH PRURITIC (red spot itches) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced RASH ERYTHEMATOUS (On the inside of his elbow on both arms he has a red spot) and RASH PRURITIC (red spot itches). At the time of the report, RASH ERYTHEMATOUS (On the inside of his elbow on both arms he has a red spot) and RASH PRURITIC (red spot itches) outcome was unknown.            no concomitant drugs were reported. no treatment drugs were reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain in extremity
Clinical narrative: Mild feeling cold after second shot; Left arm ached a little after second shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Mild feeling cold after second shot) and PAIN IN EXTREMITY (Left arm ached a little after second shot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Shoulder discomfort (Left Shoulder problem prior vaccination.).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced FEELING COLD (Mild feeling cold after second shot) and PAIN IN EXTREMITY (Left arm ached a little after second shot). At the time of the report, FEELING COLD (Mild feeling cold after second shot) and PAIN IN EXTREMITY (Left arm ached a little after second shot) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-372539 (Patient Link).