chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: needle and the hub got detached, and some liquid leak; needle and the hub got detached, and some liquid leak; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (needle and the hub got detached, and some liquid leak) and UNDERDOSE (needle and the hub got detached, and some liquid leak) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 045B21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, the patient experienced DEVICE CONNECTION ISSUE (needle and the hub got detached, and some liquid leak) and UNDERDOSE (needle and the hub got detached, and some liquid leak). On 18-Nov-2021, DEVICE CONNECTION ISSUE (needle and the hub got detached, and some liquid leak) and UNDERDOSE (needle and the hub got detached, and some liquid leak) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old received Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna vaccine) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna vaccine). On 19-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported. A 12-year-old patient received the first dose of Moderna COVID-19 vaccine on 19NOV2021 (Lot# 939904 & Exp. Date: 24MAR2022 ) instead of Pfizer.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Vaccination site pain
Clinical narrative: Upset stomach; I had tenderness in injection site arm; Tiredness/Fatigue; Headache.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), VACCINATION SITE PAIN (I had tenderness in injection site arm), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headache.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. URV12F1A, 029120A and 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), VACCINATION SITE PAIN (I had tenderness in injection site arm), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headache.). At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), VACCINATION SITE PAIN (I had tenderness in injection site arm), FATIGUE (Tiredness/Fatigue) and HEADACHE (Headache.) had not resolved.            No Concomitant product use was reported. No treatment information was provided.  The patient reported that they experienced tenderness in injection site arm, tiredness, fatigue, upset stomach and headache. Reportedly, the symptoms were ongoing.   This case was linked to MOD-2021-016567 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MIRTAZAPINE (REMERON) for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.  The vaccine was punctured and left at room temperature for about 24 hours. The reporter was not aware that the patient is experiencing any symptoms, and no treatment was given
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: Sore arm; Just little bit of chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and CHILLS (Just little bit of chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm) and CHILLS (Just little bit of chills). At the time of the report, VACCINATION SITE PAIN (Sore arm) and CHILLS (Just little bit of chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 HEADACHE (headache) 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 HEADACHE (headache). At the time of the report, HEADACHE (headache) 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.   No concomitant medication details was provided. No treatment medication details was provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received more than 35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days after 1st dose) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days after 1st dose). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 35 days after 1st dose) had resolved.            No concomitant medications reported by reporter No treatment medications provided by the reporter.   The patient wants to get an appointment for the booster dose.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light headed/Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed/Dizziness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, VITAMIN B [VITAMIN B NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Light headed/Dizziness). On 03-Mar-2021, DIZZINESS (Light headed/Dizziness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.  Patient said that it wasn't too bad.  This case concerns a 64 year old female. with relevant medical history of hypertension, who experienced Non-serious , unexpected event of Dizziness which occurred on the same day after vaccination with the first dose of mRNA -1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is negative since this event  had resolved and did no recur after the 2nd and 3rd dose as narrated in the source document. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   This case was linked to MOD-2021-392024, MOD-2021-392034 (Patient Link).; Sender's Comments: This case concerns a 64 year old female. with relevant medical history of hypertension, who experienced Non-serious , unexpected event of Dizziness which occurred on the same day after vaccination with the first dose of mRNA -1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is negative since this event  had resolved and did no recur after the 2nd and 3rd dose as narrated in the source document. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: that after the second one she was sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (that after the second one she was sleepy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013a21a and 030m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 SOMNOLENCE (that after the second one she was sleepy). At the time of the report, SOMNOLENCE (that after the second one she was sleepy) outcome was unknown.            Concomitant products included blood pressure medicine for an unknown indication. Treatment medications were not provided.   This case was linked to MOD-2021-391994 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: itched; rash all over stomach/it was bad; rash all over stomach and legs/it was bad; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itched), RASH (rash all over stomach/it was bad) and RASH (rash all over stomach and legs/it was bad) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 031M20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced RASH PRURITIC (itched), RASH (rash all over stomach/it was bad) and RASH (rash all over stomach and legs/it was bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (itched), RASH (rash all over stomach/it was bad) and RASH (rash all over stomach and legs/it was bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the rash was not painful.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow up was received on 22-NOV-2021: No new information.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) outcome was unknown.            No concomitant medications was reported. No treatment medications was reported.; Sender's Comments: This case concerns a 77 year old patient with unknown gender  with no reported medical history , who experienced Non-serious unexpected event of Illness which occurred on an unknown date after vaccination with the 3rd dose ( booster dose )  of mRNA-1273  vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge is not applicable since the event was reported after the 3rd dose ( Booster dose ) , no additional doses will be given and also the outcome of the event is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm ) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm ). On 27-Feb-2021, PAIN IN EXTREMITY (sore arm ) 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.   concomitant medication includes blood pressure, cholesterol and antireflects. No treatment information provided. This is a spontaneous case concerning a 66-year-old, male patient with no relevant medical history, who experienced the unexpected, non serious event of pain in extremity. The event pain in extremity occurred the same day with the first dose of mRNA-1273 vaccine administration. The rechallenge was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-392066, MOD-2021-392099 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 66-year-old, male patient with no relevant medical history, who experienced the unexpected, non serious event of pain in extremity. The event pain in extremity occurred the same day with the first dose of mRNA-1273 vaccine administration. The rechallenge was positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness
Clinical narrative: light flu-like symptoms; achy joints; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (light flu-like symptoms), ARTHRALGIA (achy joints) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (light flu-like symptoms), ARTHRALGIA (achy joints) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (light flu-like symptoms), ARTHRALGIA (achy joints) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-392056, MOD-2021-392086 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness
Clinical narrative: Light flu-like symptoms; Achy joints; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Light flu-like symptoms), ARTHRALGIA (Achy joints) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Light flu-like symptoms), ARTHRALGIA (Achy joints) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Light flu-like symptoms), ARTHRALGIA (Achy joints) and CHILLS (Chills) outcome was unknown.       No relevant concomitant medications was reported. Treatment information was not provided.  This case was linked to MOD-2021-392085, MOD-2021-392056 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Have some past expiration administrations that have surfaced; 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 (Have some past expiration administrations that have surfaced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Have some past expiration administrations that have surfaced). On 29-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Have some past expiration administrations that have surfaced) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was happened 6 months ago and reported that  not sure of the exact date it was pulled from the freezer.  No concomitant products were reported. No treatment drugs were reported.  Company comment- This is a case of Expired Product Administered concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: Follow up received included non significant information.; Sender's Comments: This is a case of Expired Product Administered concerning a patient of an unknown age and gender with no relevant medical history, who experienced no other associated adverse events. The event occurred the same day after receiving an undisclosed dose number of mRNA-1273 Vaccine. The rechallenge was not applicable since no dose number was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 18-Nov-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 and medication information provided.  No treatment information provided This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report   This case was linked to MOD-2021-392126 (Patient Link).; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 30-Apr-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 drug were reported. This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-392126 (Patient Link).; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-May-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 product use was reported. No treatment information was provided. Vaccine administration date was on 18 Nov 2021. Assessment use by date  was 28 Apr 2021. Days post expiry was 14 Company comment- This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some past expiration administrations that have surfaced (The vaccine was expired on 28-APR-2021, and was administered on 07-MAY-2021); 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 (We have some past expiration administrations that have surfaced (The vaccine was expired on 28-APR-2021, and was administered on 07-MAY-2021)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced (The vaccine was expired on 28-APR-2021, and was administered on 07-MAY-2021)). On 07-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced (The vaccine was expired on 28-APR-2021, and was administered on 07-MAY-2021)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided. The assessment use date was 28 Apr 2021. Days post expiry was 9.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: have some past expiration administrations that have surfaced; 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 (have some past expiration administrations that have surfaced) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (have some past expiration administrations that have surfaced). On 02-May-2021, EXPIRED PRODUCT ADMINISTERED (have some past expiration administrations that have surfaced) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-392091, MOD-2021-392110, MOD-2021-392115, MOD-2021-392117, MOD-2021-392129 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some past expiration administrations that have surfaced; 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 (We have some past expiration administrations that have surfaced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). On 08-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) 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.   This case was linked to MOD-2021-392126 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  Vaccine was administered 19 days after it was expired.  This spontaneous case reports expired product administered  in a patient of an unknown age and gender who received mRNA-1273. No  associated adverse events were reported. on 17 May -2021 patient received a dose of mRNA-1273  19 days after expired  (batch 028A21A)The benefit-risk relationship of mRNA-1273  is not affected by this report.; Sender's Comments: This spontaneous case reports expired product administered  in a patient of an unknown age and gender who received mRNA-1273. No  associated adverse events were reported. on 17 May -2021 patient received a dose of mRNA-1273  19 days after expired  (batch 028A21A)The benefit-risk relationship of mRNA-1273  is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some past expiration administrations that have surfaced; 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 (We have some past expiration administrations that have surfaced) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). On 13-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The days of post expiry is reported to be 15 days. It is also reported that the event occurred 6 months ago from the date of e-mail receipt (18-Nov-2021).  No concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some past expiration administrations that have surfaced; 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 (We have some past expiration administrations that have surfaced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). On 05-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) 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.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-May-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 informations were reported.  No Treatment informations were reported.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Increased heart rate from shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (Increased heart rate from shot) 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 HEART RATE INCREASED (Increased heart rate from shot). At the time of the report, HEART RATE INCREASED (Increased heart rate from shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Increased heart rate.     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 medication were reported. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-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.   No concomitant medication was provided.            No treatment information was provided. This is a spontaneous case that reports EXPIRED PRODUCT ADMINISTERED to a patient of  unknown age and gender who received mRNA-1273 ( (batch no. 029A21A) on 17 -Jul-2021. There was not any associated adverse event reported. The benefit-risk relationship of mRNA-1273  is not affected by this report.; Sender's Comments: This is a spontaneous case that reports EXPIRED PRODUCT ADMINISTERED to a patient of  unknown age and gender who received mRNA-1273 ( (batch no. 029A21A) on 17 -Jul-2021. There was not any associated adverse event reported. The benefit-risk relationship of mRNA-1273  is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some past expiration administrations that have surfaced; 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 (We have some past expiration administrations that have surfaced) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced). On 22-May-2021, EXPIRED PRODUCT ADMINISTERED (We have some past expiration administrations that have surfaced) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Pulmonary imaging procedure abnormal
Clinical narrative: Pulmonary imaging procedure abnormal; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY IMAGING PROCEDURE ABNORMAL (Pulmonary imaging procedure abnormal) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 039A21A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included Smoker (11 years ago).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY IMAGING PROCEDURE ABNORMAL (Pulmonary imaging procedure abnormal). At the time of the report, PULMONARY IMAGING PROCEDURE ABNORMAL (Pulmonary imaging procedure abnormal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, Computerised tomogram: abnormal (abnormal) Results were not concerning but were kind of abnormality.         No concomitant medications were reported. No treatment information was reported.  Patient stated that the nurse informed lung CT was not concerning then but it has kind of abnormality.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 Vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 Vaccine). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired Moderna COVID-19 Vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-363223 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received included patient demographics, vaccine information
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 patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-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.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Significant FU appended (Second reporter Information is updated)
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  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-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.   Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Significant FU appended contains Second reporter Information is updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Vaccination complication
Clinical narrative: expired vials were used to provide 38 doses; Sore arm; some identified common side effects after the vaccine (ex: sore arm, etc.); This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.)) and EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). In November 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.)). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) had resolved. In November 2021, PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine (ex: sore arm, etc.)) 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.  No vial went any temperature excursions.  On 12-Nov-2021, all vaccines were administered within 2 hours.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: The additional information included suspect administration date. On 19-Nov-2021: Non-Significant Follow Up Appended : Second reporter Information was updated On 19-Nov-2021: Significant FU appended (Second reporter Information was updated)