chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: M
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 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 09-Nov-2021, 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.On 08-Nov-2021, the vial was initially stored in the refrigerator.It was stated that, there were 36 doses per vials and the vial did not undergo any temperature excursions. No concomitant medications were reported.  No treatment information was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and medication information provided.  No treatment information provided   Reporter did not allow further contact
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment information was provided. Date the vial was initially stored in the refrigerator 08-Nov-2021.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose) 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 was reported
Age: 25.0
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 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 09-Nov-2021, 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 concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was reported by reporter.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporterNo treatment medications provided by the reporter.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) 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 was reported .  On 08-Nov-2021, the vial was initially stored in the refrigerator. It was stated that, there were 36 doses per vials and the vial did not undergo any temperature excursions.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) 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.   Concomitant medication details were not provided. Treatment details were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications are provided.No treatment medications are provided. Did the vial undergo any temperature excursions? No.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Chills; fever; Fatigue; muscle pain; pain in the arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), PYREXIA (fever), FATIGUE (Fatigue) and MYALGIA (muscle pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HEADACHE (Headache), CHILLS (Chills), PYREXIA (fever), FATIGUE (Fatigue), MYALGIA (muscle pain) and VACCINATION SITE PAIN (pain in the arm of injection site). At the time of the report, HEADACHE (Headache), CHILLS (Chills), PYREXIA (fever), FATIGUE (Fatigue), MYALGIA (muscle pain) and VACCINATION SITE PAIN (pain in the arm of injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; Chills; fever; Fatigue; muscle pain; pain in the arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), PYREXIA (fever), FATIGUE (Fatigue) and MYALGIA (muscle pain) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HEADACHE (Headache), CHILLS (Chills), PYREXIA (fever), FATIGUE (Fatigue), MYALGIA (muscle pain) and VACCINATION SITE PAIN (pain in the arm of injection site). At the time of the report, HEADACHE (Headache), CHILLS (Chills), PYREXIA (fever), FATIGUE (Fatigue), MYALGIA (muscle pain) and VACCINATION SITE PAIN (pain in the arm of injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Fatigue; General pain at site of injection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at site of injection) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) 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 FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at site of injection). At the time of the report, FATIGUE (Fatigue) and VACCINATION SITE PAIN (General pain at site of injection) 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 were provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment details were reported. No concomitant medications were reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications and treatment information were not provided by reporter.The expired vaccine was administered to 37 patients( unknown amount of patients both males and females). On 08-Nov-2021, the vial was initially stored in the refrigerator. The vial didn't undergo temperature excursion.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Influenza like illness, Myalgia
Clinical narrative: sick; flu like symptoms; fever; chills; tiredness; soreness; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. 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 ILLNESS (sick), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness), MYALGIA (soreness) and NAUSEA (nauseas). At the time of the report, ILLNESS (sick), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness), MYALGIA (soreness) and NAUSEA (nauseas) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Non-Significant Follow up-Snapshot Document attached, Reporter contact details updated
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: sick; flu like symptoms; fever; chills; tiredness; soreness; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills) and FATIGUE (tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. 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 ILLNESS (sick), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness), MYALGIA (soreness) and NAUSEA (nauseas). At the time of the report, ILLNESS (sick), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), CHILLS (chills), FATIGUE (tiredness), MYALGIA (soreness) and NAUSEA (nauseas) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Non-Significant Follow up-Snapshot Document attached, Reporter contact details updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 9 patients were vaccinated from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients were vaccinated from an expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported.On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients were vaccinated from an expired vial). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (9 patients were vaccinated from an expired vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.The nurse called back saying that she had more information to provide. The vial was actually opened over 48 hours ago.The vial was punctured and left at room temperature on 08Nov2021 at 1:54 PM.Date the vial was initially stored in the refrigerator: 07Nov2021 or 08Nov2021.Total amount of time the vial was exposed to room temperature range: 62 hours.No concomitant medications were reported.No treatment medications were provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: A little hive on his lip; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (A little hive on his lip) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), FLUOXETINE HYDROCHLORIDE (PROZAC), LEVOTHYROXINE SODIUM (SYNTHROID), PROPRANOLOL HYDROCHLORIDE (INDERAL), GABAPENTIN, ATORVASTATIN CALCIUM (LIPITOR), LAMOTRIGINE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced URTICARIA (A little hive on his lip). At the time of the report, URTICARIA (A little hive on his lip) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication reported.   This case was linked to MOD-2021-377174 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Inappropriate schedule of product administration, Nausea, Pyrexia
Clinical narrative: really sick; temperature; Redness; nauseated; bad headache; 2nd dose administered on 1 March; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness ), ILLNESS (really sick), PYREXIA (temperature), NAUSEA (nauseated) and HEADACHE (bad headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Tachycardia (with heart rate of 202 BPM that lasted roughly for 5-10 minutes (occurred after the administration f first dose).).Concomitant products included DEXLANSOPRAZOLE (DEXILANT), VITAMIN B [VITAMIN B NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 1 March). On 02-Mar-2021, the patient experienced ERYTHEMA (Redness ), ILLNESS (really sick), PYREXIA (temperature), NAUSEA (nauseated) and HEADACHE (bad headache). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 1 March) had resolved. On 02-Mar-2021, ERYTHEMA (Redness ), ILLNESS (really sick), PYREXIA (temperature) and NAUSEA (nauseated) had resolved. At the time of the report, HEADACHE (bad headache) outcome was unknown. Treatment medications were not provided. Patient was scheduled to receive the booster vaccine on Sunday. This case was linked to MOD-2021-029272 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: really sick; temperature; Redness; nauseated; bad headache; 2nd dose administered on 1 March; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness ), ILLNESS (really sick), PYREXIA (temperature), NAUSEA (nauseated) and HEADACHE (bad headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Tachycardia (with heart rate of 202 BPM that lasted roughly for 5-10 minutes (occurred after the administration f first dose).).Concomitant products included DEXLANSOPRAZOLE (DEXILANT), VITAMIN B [VITAMIN B NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 1 March). On 02-Mar-2021, the patient experienced ERYTHEMA (Redness ), ILLNESS (really sick), PYREXIA (temperature), NAUSEA (nauseated) and HEADACHE (bad headache). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered on 1 March) had resolved. On 02-Mar-2021, ERYTHEMA (Redness ), ILLNESS (really sick), PYREXIA (temperature) and NAUSEA (nauseated) had resolved. At the time of the report, HEADACHE (bad headache) outcome was unknown. Treatment medications were not provided. Patient was scheduled to receive the booster vaccine on Sunday. This case was linked to MOD-2021-029272 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Pyrexia, Vaccination complication
Clinical narrative: after the second dose had some side effects; after the second dose had fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (after the second dose had some side effects) and PYREXIA (after the second dose had fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation. Concomitant products included LOSARTAN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (after the second dose had some side effects) and PYREXIA (after the second dose had fever). At the time of the report, VACCINATION COMPLICATION (after the second dose had some side effects) and PYREXIA (after the second dose had fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.         No treatment medications were reported. Patient's concomitant medication includes Atrial fibrillation medication 50Mg 2xDay.   This case was linked to MOD-2021-383416 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO) for Coagulation disorder, MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain) and CHILLS (Chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle pain) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-382995 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; 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 PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 12-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication information was reported.No Treatment medications were provided. There was an excursion from their freezer on 01Oct2021.This case was linked to -MODERNATX, INC.-MOD-2021-387730, -MODERNATX, INC.-MOD-2021-387762 (E2B Linked Report). This case was linked to MOD-2021-383439, MOD-2021-387536, MOD-2021-387782, MOD-2021-387795, MOD-2021-387929 (Patient Link); Sender's Comments: -MODERNATX, INC.-MOD-2021-387762:MASTER FILE. US-MODERNATX, INC.-MOD-2021-387730:MASTER FILE.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Excursion from the freezer/administered to 118 patients(08Nov2021- 14 given); 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(08Nov2021- 14 given)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) 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 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(08Nov2021- 14 given)). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer/administered to 118 patients(08Nov2021- 14 given)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-383410, MOD-2021-383422, MOD-2021-383426 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Vaccination site pain
Clinical narrative: left arm swollen on the wrist area,could not strech her arm; soreness at the injection site, could not lay down on that side; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (left arm swollen on the wrist area,could not strech her arm) and VACCINATION SITE PAIN (soreness at the injection site, could not lay down on that side) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 004M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   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 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness at the injection site, could not lay down on that side). On 10-Nov-2021, the patient experienced JOINT SWELLING (left arm swollen on the wrist area,could not strech her arm). On 07-Nov-2021, VACCINATION SITE PAIN (soreness at the injection site, could not lay down on that side) had resolved. At the time of the report, JOINT SWELLING (left arm swollen on the wrist area,could not strech her arm) outcome was unknown.            No Concomitant medications were provided  No treatment medications were provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy
Clinical narrative: patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (patient is pregnant) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Jan-2022. On 24-Mar-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (patient is pregnant). On 24-Mar-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (patient is pregnant) had resolved.            No concomitant and treatment medication were provided The patient's last menstruation date was 26-Apr-2021. Company Comment: This case concerns a 29 year-old, female patient with no relevant medical history, with Maternal exposure before pregnancy and no associated adverse events reported. The patient received first dose of mRNA-1273 vaccine on 24 march and second dose on 21 april and her last menstrual period was reported on 26 april 2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 29 year-old, female patient with no relevant medical history, with Maternal exposure before pregnancy and no associated adverse events reported. The patient received first dose of mRNA-1273 vaccine on 24 march and second dose on 21 april and her last menstrual period was reported on 26 april 2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Expired product administered, Pyrexia
Clinical narrative: Extreme fever blisters under her nose  after booster; Fever after booster; Chills after booster; RPh told her expired  booster shot was administered to her; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Extreme fever blisters under her nose  after booster), PYREXIA (Fever after booster), CHILLS (Chills after booster) and EXPIRED PRODUCT ADMINISTERED (RPh told her expired  booster shot was administered to her) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-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 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced PYREXIA (Fever after booster), CHILLS (Chills after booster) and EXPIRED PRODUCT ADMINISTERED (RPh told her expired  booster shot was administered to her). On 31-Oct-2021, the patient experienced BLISTER (Extreme fever blisters under her nose  after booster). On 30-Oct-2021, EXPIRED PRODUCT ADMINISTERED (RPh told her expired  booster shot was administered to her) had resolved. On 01-Nov-2021, PYREXIA (Fever after booster) and CHILLS (Chills after booster) had resolved. At the time of the report, BLISTER (Extreme fever blisters under her nose  after booster) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient after the booster vaccine had a fever, and chills for a couple of days and also had extreme fever blisters under their nose on Sunday 31-Oct-2021. The blisters were still going on and a week after booster vaccination the Pharmacist called the patient and informed them that they received an expired vaccine and asked to go into the pharmacy to receive another shot.  The patient was reluctant to receive another shot because of the side effects that the patient had and did not received the repeated booster shot. The patient also reported that they had not seen a doctor yet.  Lot number of the first dose was provided as not legible.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vial refrigerated more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial refrigerated more than 30 days) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vial refrigerated more than 30 days). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vial refrigerated more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Facility administered 1 patient expired dose of the Moderna Vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Facility administered 1 patient expired dose of the Moderna Vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. No Medical History information was reported.On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Facility administered 1 patient expired dose of the Moderna Vaccine). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Facility administered 1 patient expired dose of the Moderna Vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.No Concomitant product use was reported. No treatment information was provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Facility administered 2 patients expired doses of the Moderna Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Facility administered 2 patients expired doses of the Moderna Vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. No Medical History information was reported.On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Facility administered 2 patients expired doses of the Moderna Vaccine). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Facility administered 2 patients expired doses of the Moderna Vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.Concomitant medication information was not provided by the reporter.Treatment information was not provided by the reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Second vaccine had some side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Second vaccine had some side effects) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (Second vaccine had some side effects). At the time of the report, VACCINATION COMPLICATION (Second vaccine had some side effects) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.   This case was linked to MOD-2021-383898 (Patient Link).