chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: 1 person got heart attack; 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 MYOCARDIAL INFARCTION (1 person got heart attack) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (1 person got heart attack) (seriousness criteria medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (1 person got heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.  Company comment: This case concerns a patient of unknown age and gender with no relevant medical history who experienced serious unexpected event of MI on unknown date after receiving a dose of the Mooderna Covid 19 vaccine on unknown date.Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.   This case was linked to MOD-2021-332598 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history who experienced serious unexpected event of MI on unknown date after receiving a dose of the Mooderna Covid 19 vaccine on unknown date.Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: 1 person died after regular shots; 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 DEATH (1 person died after regular shots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were provided by the reporter.  No treatment information details was provided by the reporter.  It was reported that one person died after regular shots and reporter thinks it was moderna vaccine but was not sure about it.  This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the expected fatal event of Death, with no cause of death provided. The event occurred at an unknown date after a dose of Spikevax (unknown dose). The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-332581 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the expected fatal event of Death, with no cause of death provided. The event occurred at an unknown date after a dose of Spikevax (unknown dose). The rechallenge was not applicable due to the fatal outcome. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 74.0
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 74-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 10-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-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.   Vaccine was administered after 15 days of first puncture of vial. No concomitant medication information was provided. No treatment medication were provided.  Company Comment: This is a case of expired product administered for this 74-year-old patient, unknown gender, with no medical history reported, with no associated adverse event reported at this time. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-337432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up information includes no new information , but the dose number updated to 2 and therapy onset updated and .relevant information added in inarrative.; Sender's Comments: This is a case of expired product administered for this 74-year-old patient, unknown gender, with no medical history reported, with no associated adverse event reported at this time. The rechallenge is not applicable. Patient received both doses expired. The benefit-risk relationship of Moderna COVID-19 Vaccine  is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Pain, Pain in extremity, Pruritus
Clinical narrative: Pain in arm; Burning sensation; Skin warm; feeling kinda painful.; sleepy; itchy; developed a rash on the right arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), BURNING SENSATION (Burning sensation), SKIN WARM (Skin warm), PAIN (feeling kinda painful.) and SOMNOLENCE (sleepy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), BURNING SENSATION (Burning sensation), SKIN WARM (Skin warm), PAIN (feeling kinda painful.), SOMNOLENCE (sleepy), PRURITUS (itchy), RASH (developed a rash on the right arm) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), BURNING SENSATION (Burning sensation), SKIN WARM (Skin warm), PAIN (feeling kinda painful.), SOMNOLENCE (sleepy), PRURITUS (itchy), RASH (developed a rash on the right arm) and FATIGUE (tiredness) outcome was unknown.            No concomitant medication listed. Ice pack, Tylenol, and lotion after the second dose. The patient developed a rash on the right arm on the second day and was feeling tired, sleepy, and said that it was hot like the first one, the rash was hot too, still have it. It was itchy yesterday, and it was going away now, the whole rash.   This case was linked to MOD-2021-332471 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin warm, Somnolence
Clinical narrative: Pain in arm; Burning sensation; Skin warm; feeling kinda painful.; sleepy; itchy; developed a rash on the right arm; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), BURNING SENSATION (Burning sensation), SKIN WARM (Skin warm), PAIN (feeling kinda painful.) and SOMNOLENCE (sleepy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), BURNING SENSATION (Burning sensation), SKIN WARM (Skin warm), PAIN (feeling kinda painful.), SOMNOLENCE (sleepy), PRURITUS (itchy), RASH (developed a rash on the right arm) and FATIGUE (tiredness). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm), BURNING SENSATION (Burning sensation), SKIN WARM (Skin warm), PAIN (feeling kinda painful.), SOMNOLENCE (sleepy), PRURITUS (itchy), RASH (developed a rash on the right arm) and FATIGUE (tiredness) outcome was unknown.            No concomitant medication listed. Ice pack, Tylenol, and lotion after the second dose. The patient developed a rash on the right arm on the second day and was feeling tired, sleepy, and said that it was hot like the first one, the rash was hot too, still have it. It was itchy yesterday, and it was going away now, the whole rash.   This case was linked to MOD-2021-332471 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID (VIT C), THIAMINE (VITAMIN B1 [THIAMINE]), COLECALCIFEROL (VIT D3), FOLIC ACID and MAGNESIUM for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication also include 2 medicine for intestine. No treatment medications were provided.  Patient mentioned he was experiencing flu like symptoms may be because of change of weather.  As the company fired all the employees because of lack of work patient didn't receive the 2nd dose of the Moderna COVID19 vaccine
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after 2 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial) in an 89-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 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 2 days of puncturing the vial) 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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received on 29-sep-2021 and has non significant information
Age: 77.0
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 77-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 25-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Jun-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 was reported No treatment medication was reported It was reported that the patient took the vaccine after 7 days from first puncture. Reporter had stated that they were looking for a decision as to whether these doses can be counted or if the provider needs to contact the patients for re-administration of the doses.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant FU added.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Paraesthesia
Clinical narrative: tingling in my hands, my face and my feet/  started like in chin area and spread; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in my hands, my face and my feet/  started like in chin area and spread), CHILLS (Chills) and MYALGIA (Body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). On 16-Sep-2021, the patient experienced PARAESTHESIA (tingling in my hands, my face and my feet/ started like in chin area and spread). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 12-Sep-2021, CHILLS (Chills) and MYALGIA (Body aches) had resolved. At the time of the report, PARAESTHESIA (tingling in my hands, my face and my feet/ started like in chin area and spread) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
Age: 83.0
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 83-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 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-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 medication information provided by the reporter. No treatment information provided. Time from first puncture-14 days   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: follow up document document contains non significant information; Sender's Comments: This report refers to a case of Expired vaccine used for mRNA-1273, Lot# 006C21A with no associated AEs. Causality for this medication error is not applicable.
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 55-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 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-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.   Concomitant medication information was not reported.  It was reported that, first dose of vaccine was administered after 1 days from first puncture.  Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non significant follow up
Age: 81.0
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 81-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 01-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Jul-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 was provided by the reporter. Vaccine was administered 21 days after first puncture of vial No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received on 28-Sep-2021. Non-significant follow up.
Age: 82.0
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 90-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 08-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-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) (Unknown), the reporter did not provide any causality assessments.   After 29 days of puncturing the vial, dose was administered No concomitants were reported by reporter No treatment medications were reported by reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received on 29-Sep-2021 contains non significant information.
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. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Jul-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 products were reported. no treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information included no new information.
Age: 54.0
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 54-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 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-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.   The Patient took Vaccine after 15 days the vial was first thawed and punctured. No concomitant information was reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received on contain no significant information.
Age: 37.0
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 37-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 05-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non significant follow up
Age: 76.0
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 76-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 concomitants medications was reported.  No treatments medications was reported.  It was reported that vaccine was administered 9 days from first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received  contains no new information, but action taken updated to not applicable because the only event in the case is medication error.
Age: 70.0
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 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). On 06-Jul-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 was reported.  It was reported that, first dose of vaccine was administered after 11 days from first puncture.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received on 29-sep-2021 contains no new information
Age: 67.0
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 67-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 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Aug-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 medication was given.  First vaccine was administered after 8 days from first puncture.  No treatment medication was given.   This case was linked to MOD-2021-333899 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information received contains no new information.
Age: 72.0
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 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-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. 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 medications were provided.  The vaccine was administered after 21 days of first puncture.  The Moderna vaccine was used as though it had preservative, just like flu multi-dose vials.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Includes no new information.
Age: 70.0
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 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 (Expired vaccine used). On 13-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 concomitants were provided. No treatment was provided. The vaccine was administered after 11 days from  time from first puncture.   This case was linked to MOD-2021-333942 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up contains no new information, but initial version missed to capture therapy onset and event onset date, batch number corrected and added.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pyrexia
Clinical narrative: slept for 24 hours; Ran a high fever that night; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for 24 hours) and PYREXIA (Ran a high fever that night) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced HYPERSOMNIA (slept for 24 hours) and PYREXIA (Ran a high fever that night). On 12-Mar-2021, PYREXIA (Ran a high fever that night) had resolved. On 13-Mar-2021, HYPERSOMNIA (slept for 24 hours) had resolved.            Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: This case concerns an 88-year-old female patient with no relevant medical history reported who experienced non serious unexpected events of hypersomnia and expected pyrexia. The events occurred within 24 hours from  the second dose of Spikevax. Rechallenge was not applicable since the events occurred after the second dose. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report
Age: 52.0
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 (used expired vaccine) in a 52-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 Sep 13, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 13, 2021, patient administered expired product (used expired vaccine). On Sep 13, 2021, administered expired product  (used expired vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. The vaccine was administered after 3 days from time from first puncture. Most recent follow-up information incorporated: On Sep 28, 2021: Follow-up received contained relevant information. The vaccine was administered after 3 days from time from first puncture added in narrative.
Age: 54.0
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 54-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 13-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-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 by the reporter.  Treatment information was not provided. It was reported that the patient took the vaccine on 13Sep2021 after 6 days from first puncture.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received on 29 Sep 2021 contains no new information.
Age: 38.0
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 38-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 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 medication were reported No treatment medication were reported. The vaccine was administered after 4 days from  time from first puncture.   This case was linked to MOD-2021-332638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up received contains no new information , but initial version the vaccine was administered after 4 days from  time from first puncture was missed and added in inarrative
Age: 29.0
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 29-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 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 medication was provided. No treatment medication was provided. The vaccine was administered after 4 days from  time from first puncture.   This case was linked to MOD-2021-332638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up contains no new information , but the vaccine was administered after 4 days from  time from first puncture was missed and added in narrative
Age: 73.0
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 73-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 09-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Jul-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 information was reported. No treatment medications were provided. Time from first puncture was 14 days.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow was received, contains no new information.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after 5 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 5 days of puncturing the vial) in a 47-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 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 5 days of puncturing the vial). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 5 days of puncturing the vial) 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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains non significant Information.
Age: 54.0
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 54-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 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Jul-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. No treatment details were provided. Time from first puncture was 3 days. The Moderna vaccine was used as though it had preservative, just like flu multi-dose vials.   This case was linked to MOD-2021-333941 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains no significant information
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 30-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Jul-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.   Concomitant product information was not provided. Treatment information was not provided. Vaccine was administered after 8 days from first punctured of vial.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: follow up received on 2-Sep-2021 contains non-significant information
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used-17 days after puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-17 days after puncture) in an 83-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 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-17 days after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-17 days after puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported Vial was punctured 17 days before administration.  Reporter was looking for a decision as to whether those doses could be counted or if the provider needed to contact the patients for re-administration of the doses.   This case was linked to MOD-2021-333897 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: follow up received contain no significant information
Age: 45.0
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 (used expired vaccine) in a 45-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 21, 2021, patient administered expired product (used expired vaccine). On Jul 21, 2021, administered expired product (used expired vaccine) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-337434 (patient link). Most recent follow-up information incorporated: On Sep 28, 2021: Follow-up received contained non-significant information.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered 24 hrs after 1st punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 hrs after 1st punctured) in a 27-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 26-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 hrs after 1st punctured). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 24 hrs after 1st punctured) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up document received contains No New Information
Age: 59.0
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 59-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 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-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. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  The vaccine was administered after 26 days of first puncture.  The Moderna vaccine was used as though it had preservative, just like flu multi-dose vials.   This case was linked to MOD-2021-337435 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Possible NNI.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered 2 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 2 days after 1st punctured) in a 60-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 27-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered 2 days after 1st punctured). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered 2 days after 1st punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine was administered after 2 days of first puncture of vial No concomitant medication was provided Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up contains  NNI
Age: 85.0
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 an 85-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 (Vaccine was administered as if it had a preservative). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered as if it had a preservative) had resolved. Not Provided      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 information not provided. Vaccine was administered 2 days after first puncture of vial. Treatment information not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant FU added.