chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna vaccine) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B12A) for COVID-19 vaccination.     Concurrent medical conditions included Obstructive sleep apnea syndrome since 15-Dec-2019, Atrial fibrillation since 07-Feb-2019 and Vitamin B12 deficiency since 13-May-2019. Concomitant products included APIXABAN (ELIQUIS) from 12-Jul-2021 to an unknown date and FLECAINIDE from 05-Jul-2019 to an unknown date for Atrial fibrillation, VITAMIN B12 NOS from 13-Jun-2019 to an unknown date for Vitamin B12 deficiency.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna vaccine). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up document received on 01-Oct-2021 included Patient's race, historical condition, dosage information and concomitants.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling hot, Pain, Pain in extremity, Rash
Clinical narrative: arm was just hurting for at least 2 days; broke out  with a rash; burning rash like hot rash; feeling hot; feeling kinda painful.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was just hurting for at least 2 days), RASH (broke out  with a rash), BURNING SENSATION (burning rash like hot rash), FEELING HOT (feeling hot) and PAIN (feeling kinda painful.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was just hurting for at least 2 days), RASH (broke out  with a rash), BURNING SENSATION (burning rash like hot rash), FEELING HOT (feeling hot) and PAIN (feeling kinda painful.). At the time of the report, PAIN IN EXTREMITY (arm was just hurting for at least 2 days), RASH (broke out  with a rash), BURNING SENSATION (burning rash like hot rash), FEELING HOT (feeling hot) and PAIN (feeling kinda painful.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided by reporter. No Treatment medications were provided by reporter.   This case was linked to MOD-2021-332641 (Patient Link).
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided. The vaccine was administered after 4 days from  time from first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contain no new significant information,but the event onset and therapy onset date added and  vaccine was administered after 4 days from  time from first puncture was missed and added in narrative
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient has been administrated suspect product  after six day of the first puncture the vial.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains NNI
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered 8 days after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 8 days after first puncture) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 8 days after first puncture). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 8 days after first puncture) had resolved. Not Provided      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 provided.   This case was linked to MOD-2021-333898.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: follow up contains No new information
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered 21 days after 1st punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered 21 days after 1st punctured) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 21 days after 1st punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered 21 days after 1st punctured) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation received on 29-Sep-2021 contain Non significant information.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Someone on job site tested positive for Covid this past Saturday; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Someone on job site tested positive for Covid this past Saturday) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced COVID-19 (Someone on job site tested positive for Covid this past Saturday). At the time of the report, COVID-19 (Someone on job site tested positive for Covid this past Saturday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.; Sender's Comments: This case concerns a patient of unknown age and gender with no details on previous relevant medical history, who experienced the event of COVID. It is unknown if the patient was vaccinated with Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine) prior to the event, thus the case is considered non valid.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise, Pyrexia
Clinical narrative: Feeling lousy; Not been feeling well; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling lousy), MALAISE (Not been feeling well) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 006B21A and 042B21-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VORTIOXETINE HYDROBROMIDE (TRINTELLIX), LEVOTHYROXINE SODIUM (SYNTHROID), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), BREXPIPRAZOLE (REXULTI), BUSPIRONE HYDROCHLORIDE (BUSPAR), TRAZODONE, METOPROLOL, CLONAZEPAM (KLONOPIN) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced FEELING ABNORMAL (Feeling lousy), MALAISE (Not been feeling well) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Feeling lousy), MALAISE (Not been feeling well) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment was not specified.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.            No Concomitant medications were reported.  Vial used post 2 days after the time from first puncture.  No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up contains No New Information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Chills, Diarrhoea, Nausea
Clinical narrative: diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months; stomach cramps; minor nausea; chills within 24 to 30 hours of vaccine; felt very weak within 24 to 30 hours of vaccine; low grade fever within 24 to 30 hours of vaccine; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (felt very weak within 24 to 30 hours of vaccine), DIARRHOEA (diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months), ABDOMINAL PAIN UPPER (stomach cramps), NAUSEA (minor nausea) and CHILLS (chills within 24 to 30 hours of vaccine) in a 73-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.    Co-suspect product included non-company product LOPERAMIDE for an unknown indication.    Concurrent medical conditions included Irritable bowel syndrome and Arthritis.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LOPERAMIDE (unknown route) 2 mg. On 20-Feb-2020, the patient experienced PYREXIA (low grade fever within 24 to 30 hours of vaccine). On 20-Feb-2021, the patient experienced ASTHENIA (felt very weak within 24 to 30 hours of vaccine) and CHILLS (chills within 24 to 30 hours of vaccine). On 21-Feb-2021, the patient experienced DIARRHOEA (diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months), ABDOMINAL PAIN UPPER (stomach cramps) and NAUSEA (minor nausea). At the time of the report, ASTHENIA (felt very weak within 24 to 30 hours of vaccine), DIARRHOEA (diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months), ABDOMINAL PAIN UPPER (stomach cramps), NAUSEA (minor nausea), CHILLS (chills within 24 to 30 hours of vaccine) and PYREXIA (low grade fever within 24 to 30 hours of vaccine) was resolving.        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 medication was reported by the reporter.    This case was linked to MOD-2021-333465 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months; stomach cramps; minor nausea; chills within 24 to 30 hours of vaccine; felt very weak within 24 to 30 hours of vaccine; low grade fever within 24 to 30 hours of vaccine; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (felt very weak within 24 to 30 hours of vaccine), DIARRHOEA (diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months), ABDOMINAL PAIN UPPER (stomach cramps), NAUSEA (minor nausea) and CHILLS (chills within 24 to 30 hours of vaccine) in a 73-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.    Co-suspect product included non-company product LOPERAMIDE for an unknown indication.    Concurrent medical conditions included Irritable bowel syndrome and Arthritis.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LOPERAMIDE (unknown route) 2 mg. On 20-Feb-2020, the patient experienced PYREXIA (low grade fever within 24 to 30 hours of vaccine). On 20-Feb-2021, the patient experienced ASTHENIA (felt very weak within 24 to 30 hours of vaccine) and CHILLS (chills within 24 to 30 hours of vaccine). On 21-Feb-2021, the patient experienced DIARRHOEA (diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months), ABDOMINAL PAIN UPPER (stomach cramps) and NAUSEA (minor nausea). At the time of the report, ASTHENIA (felt very weak within 24 to 30 hours of vaccine), DIARRHOEA (diarrhea started after that/distinct prolonged/protracted episodes of diarrhea for about 2 months), ABDOMINAL PAIN UPPER (stomach cramps), NAUSEA (minor nausea), CHILLS (chills within 24 to 30 hours of vaccine) and PYREXIA (low grade fever within 24 to 30 hours of vaccine) was resolving.        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 medication was reported by the reporter.    This case was linked to MOD-2021-333465 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle soreness like flu shot; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (Muscle soreness like flu shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN HCTZ), MONTELUKAST SODIUM (SINGULAIR), NIACIN and POTASSIUM for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MYALGIA (Muscle soreness like flu shot). The patient was treated with PARACETAMOL (TYLENOL) for Prophylactic, at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle soreness like flu shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-333431.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose/Had vaccine that expired on 22Sep2021 and was administered on 23Sep2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired on 22Sep2021 and was administered on 23Sep2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired on 22Sep2021 and was administered on 23Sep2021). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired on 22Sep2021 and was administered on 23Sep2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID 19 vaccine was admitted to patients after 27.5 hours at room temperature.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID 19 vaccine was admitted to patients after 27.5 hours at room temperature.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-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 (Moderna COVID 19 vaccine was admitted to patients after 27.5 hours at room temperature.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID 19 vaccine was admitted to patients after 27.5 hours at room temperature.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. B36A214) for COVID-19 vaccination.     The patient's past medical history included Lymphoma (non-Hodgkin's) in October 2020 and COVID-19 in November 2020. Concomitant products included RITUXIMAB (RITUXAN) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-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 CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: positive (Positive) Tested positive.         No treatment medications were reported. Patient did Covid test 2 weeks ago and it was negative.   This case was linked to MOD-2021-333559 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Musculoskeletal pain
Clinical narrative: Lower right upper buttocks pain; dull pain in my back located on the right side by my upper buttock and waist; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL PAIN (Lower right upper buttocks pain) and BACK PAIN (dull pain in my back located on the right side by my upper buttock and waist) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 1979, Drug allergy (sulfa drugs) and Drug allergy (some antibiotics). Concomitant products included SALMETEROL XINAFOATE (SEREVENT) from 1979 to an unknown date and CICLESONIDE (ALVESCO) from 1979 to an unknown date for Asthma.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced MUSCULOSKELETAL PAIN (Lower right upper buttocks pain). In May 2021, the patient experienced BACK PAIN (dull pain in my back located on the right side by my upper buttock and waist). At the time of the report, MUSCULOSKELETAL PAIN (Lower right upper buttocks pain) and BACK PAIN (dull pain in my back located on the right side by my upper buttock and waist) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-333574 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up information received on 30-SEP-2021 included no new information. On 01-Oct-2021: Follow information received on 01-OCT-2021 Patient demographics, medical history, concomitant medications and vaccination facility information was updated.
Age: 84.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 84-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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. Reporter states that Time from first puncture was 4 days   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received  on 29-sep-2021 and contains non significant information
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 17-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information was received include no new information.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used-11 days after opening; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-11 days after opening) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-11 days after opening). On 06-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-11 days after opening) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter Vial was punctured 11 days before administration.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information was received include no new information.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered as if it had a preservative) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered as if it had a preservative). On 07-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered as if it had a preservative) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given. Time from first puncture was 21 days.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains no new information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety
Clinical narrative: heighten anxiety/uncontrollable anxiety; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (heighten anxiety/uncontrollable anxiety) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (heighten anxiety/uncontrollable anxiety). At the time of the report, ANXIETY (heighten anxiety/uncontrollable anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17-year-old received vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17-year-old received vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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.   This case was linked to MOD-2021-332638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant follow up appended.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: 2nd dose of Moderna given after expriation of 9/25/201 per health system.; patient's 2nd had undergone a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose of Moderna given after expriation of 9/25/201 per health system.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient's 2nd had undergone a temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included CELECOXIB, ESTRADIOL, FOLIC ACID, HYDROXYCHLOROQUINE, AMITRIPTYLINE, IPRATROPIUM, METHOTREXATE, OMEPRAZOLE, PHENTERMINE, MACROGOL 3350 (MIRALAX) and PROGESTERONE (PROMETRIUM [PROGESTERONE]) for an unknown indication.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose of Moderna given after expriation of 9/25/201 per health system.) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient's 2nd had undergone a temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose of Moderna given after expriation of 9/25/201 per health system.) outcome was unknown and PRODUCT TEMPERATURE EXCURSION ISSUE (patient's 2nd had undergone a temperature excursion) had resolved.        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. dose 1 start date 30-08-2021 and route intramuscular right deltoid batch number 038b21A   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Significant follow up received Dose 1 details added in I narrative , concomitant medications, event  and Allergy added.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant follow-up received on 28 Sep 2021
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided. No treatment was provided.   This case was linked to MOD-2021-333886 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant follow-up the time of vial administered is changed from initial document.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided. No concomitant medication was reported. It was reported that, dose of vaccine was administered after 9 days from first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant follow-up
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (expired vaccine used) in a 69-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006C21A) for COVID-19 vaccination. No medical history reported. On Aug 20, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 20, 2021, the patient red product (expired vaccine used). On Aug 20, 2021, administered expired product (expired vaccine used) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Most recent follow-up information incorporated: On Sep 28, 2021: Follow-up received included no new information.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine administered 9 days after 1st punctured. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up appended on 29-sep-2021 and contains non significant information
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine used; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up received Non-significant.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (vaccine administered as if it had a preservative) in a 71-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine) (batch/lot# 006C21A) for COVID-19 immunization. No medical history reported. On Aug 20, 2021, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 20, 2021, patient administered expired product (vaccine administered as if it had a preservative). On Aug 20, 2021, administered expired product (vaccine administered as if it had a preservative) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Most recent follow-up information incorporated: On Sep 28, 2021: Follow-up received contained non-significant information.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: provider realized that they had been treating Moderna vaccine as though it had preservative/ the vaccine was administered 11 days after initial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (provider realized that they had been treating Moderna vaccine as though it had preservative/ the vaccine was administered 11 days after initial puncture) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (provider realized that they had been treating Moderna vaccine as though it had preservative/ the vaccine was administered 11 days after initial puncture). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (provider realized that they had been treating Moderna vaccine as though it had preservative/ the vaccine was administered 11 days after initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.   No treatment information was provided.   Reportedly, a provider realized that they had been treating Moderna vaccine as though it had preservative. A preliminary spreadsheet (with the affected doses administered, with the lot numbers and time from vial opening) was sent.   The patient in question received the vaccine  that was punctured 11 days earlier.   This case was linked to MOD-2021-332796, MOD-2021-332638.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information was received include no new information.; Sender's Comments: This is a case of Expired product administered (Expired vaccine used) for this 54-year-old patient of an unknown gender. Reportedly, the patient received the vaccine that was punctured 11 days before administration which is considered to be Expired product administered. No adverse events were reported at this moment. The rechallenge is not applicable. The company causality is also assessed as not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered as if it had a preservative) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered as if it had a preservative). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered as if it had a preservative) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vaccine was administered after 11 days of first puncture of vial. No concomitant medication information was provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information received on 28 Sep 2021 contains non significant information.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non significant follow up received includes no new information