chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The date of refrigeration of the dose was 07-May-2021.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Felt a little chill; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Felt a little chill) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced CHILLS (Felt a little chill). At the time of the report, CHILLS (Felt a little chill) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was reported.  Patient had no any side effects at all after the second dose.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Lot 026C21A with expiration of 24Oct21 was given on 25Oct21; 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 (Lot 026C21A with expiration of 24Oct21 was given on 25Oct21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Lot 026C21A with expiration of 24Oct21 was given on 25Oct21). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Lot 026C21A with expiration of 24Oct21 was given on 25Oct21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported.  Moderna Lot: 026C21A with expiration of 24Oct21 was given on 25Oct21 to six patients. Vials were stored in ultra cold freezer (-20 C) until they were taken out on 16Oct21 and placed in a refrigerator (4 C) where they were thawed and kept until the vial was punctured at 8 am on 25Oct21 . Doses were administered between the hours of 8am - 10am until realization of expiration and quarantine of vials. One dose was a series dose (0.5 ml) and five doses were booster doses (0.25 ml). No adverse events were witnessed for any of the patients.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: Follow received on 27Oct2021 contains additional information on route of administration and dose number and event details.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Diarrhoea, Headache, Pyrexia
Clinical narrative: his spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), DIARRHEA (diarrhea), COVID-19 (tested positive for COVID-19), PYREXIA (fever) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced AGEUSIA (loss of taste), DIARRHEA (diarrhea), COVID-19 (tested positive for COVID-19), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, AGEUSIA (loss of taste), DIARRHEA (diarrhea), COVID-19 (tested positive for COVID-19), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test: positive (Positive) Positive on Rapid test and negative (Negative) Negative on Non-Rapid test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. This case concerns a 61-year-old female patient with no relevant medical history who experienced non serious unexpected events of special interest ageusia and COVID-19. The events occurred unspecified time after the first dose of Covid19 Moderna. Reportedly, after the first dose of Covid19 Moderna, the patient experienced diarhroea, headache, loss of taste and pyrexia and was tested positive for COVID-19 with rapid test. Afterwards, on a non-rapid test, the patient was negative for COVID-19. Rechallenge was not applicable due to nature of the event of COVID-19 and since the event outcome was unknown and there are no details regarding the second dose. Therefore, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report; Sender's Comments: This case concerns a 61-year-old female patient with no relevant medical history who experienced non serious unexpected events of special interest ageusia and COVID-19. The events occurred unspecified time after the first dose of Covid19 Moderna. Reportedly, after the first dose of Covid19 Moderna, the patient experienced diarhroea, headache, loss of taste and pyrexia and was tested positive for COVID-19 with rapid test. Afterwards, on a non-rapid test, the patient was negative for COVID-19. Rechallenge was not applicable due to nature of the event of COVID-19 and since the event outcome was unknown and there are no details regarding the second dose. Therefore, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: his spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), DIARRHEA (diarrhea), COVID-19 (tested positive for COVID-19), PYREXIA (fever) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced AGEUSIA (loss of taste), DIARRHEA (diarrhea), COVID-19 (tested positive for COVID-19), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, AGEUSIA (loss of taste), DIARRHEA (diarrhea), COVID-19 (tested positive for COVID-19), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test: positive (Positive) Positive on Rapid test and negative (Negative) Negative on Non-Rapid test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. This case concerns a 61-year-old female patient with no relevant medical history who experienced non serious unexpected events of special interest ageusia and COVID-19. The events occurred unspecified time after the first dose of Covid19 Moderna. Reportedly, after the first dose of Covid19 Moderna, the patient experienced diarhroea, headache, loss of taste and pyrexia and was tested positive for COVID-19 with rapid test. Afterwards, on a non-rapid test, the patient was negative for COVID-19. Rechallenge was not applicable due to nature of the event of COVID-19 and since the event outcome was unknown and there are no details regarding the second dose. Therefore, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report; Sender's Comments: This case concerns a 61-year-old female patient with no relevant medical history who experienced non serious unexpected events of special interest ageusia and COVID-19. The events occurred unspecified time after the first dose of Covid19 Moderna. Reportedly, after the first dose of Covid19 Moderna, the patient experienced diarhroea, headache, loss of taste and pyrexia and was tested positive for COVID-19 with rapid test. Afterwards, on a non-rapid test, the patient was negative for COVID-19. Rechallenge was not applicable due to nature of the event of COVID-19 and since the event outcome was unknown and there are no details regarding the second dose. Therefore, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Treatment information was not provided. Vaccine refrigeration date was 07-May-2021.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Date of refrigeration was  on 07-May-2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Paraesthesia, Pyrexia, Vaccination complication
Clinical narrative: very aggressive immune response; was like a little spot of poison ivy; tingly sensation; rash at the injection site; injection site was a little itchy; It was raised and was the size of a 50 cent piece; injection site was red; Has a little fever; very tired; not really much soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (was like a little spot of poison ivy), VACCINATION COMPLICATION (very aggressive immune response), PAIN IN EXTREMITY (not really much soreness in the arm), PARAESTHESIA (tingly sensation) and VACCINATION SITE RASH (rash at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PAIN IN EXTREMITY (not really much soreness in the arm), PYREXIA (Has a little fever) and FATIGUE (very tired). On 30-Sep-2021, the patient experienced VACCINATION SITE REACTION (was like a little spot of poison ivy), PARAESTHESIA (tingly sensation), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (injection site was a little itchy), VACCINATION SITE SWELLING (It was raised and was the size of a 50 cent piece) and VACCINATION SITE ERYTHEMA (injection site was red). On an unknown date, the patient experienced VACCINATION COMPLICATION (very aggressive immune response). The patient was treated with ARNICA MONTANA (topical) for Adverse event, at an unspecified dose and frequency. On 05-Oct-2021, VACCINATION SITE ERYTHEMA (injection site was red) had resolved. At the time of the report, VACCINATION SITE REACTION (was like a little spot of poison ivy), VACCINATION COMPLICATION (very aggressive immune response), PAIN IN EXTREMITY (not really much soreness in the arm), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (injection site was a little itchy), VACCINATION SITE SWELLING (It was raised and was the size of a 50 cent piece), PYREXIA (Has a little fever) and FATIGUE (very tired) outcome was unknown and PARAESTHESIA (tingly sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  Treatment included Arnica cream and other lotions which made the adverse events worse. Ice helped in relieving the symptoms.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: very aggressive immune response; was like a little spot of poison ivy; tingly sensation; rash at the injection site; injection site was a little itchy; It was raised and was the size of a 50 cent piece; injection site was red; Has a little fever; very tired; not really much soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (was like a little spot of poison ivy), VACCINATION COMPLICATION (very aggressive immune response), PAIN IN EXTREMITY (not really much soreness in the arm), PARAESTHESIA (tingly sensation) and VACCINATION SITE RASH (rash at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PAIN IN EXTREMITY (not really much soreness in the arm), PYREXIA (Has a little fever) and FATIGUE (very tired). On 30-Sep-2021, the patient experienced VACCINATION SITE REACTION (was like a little spot of poison ivy), PARAESTHESIA (tingly sensation), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (injection site was a little itchy), VACCINATION SITE SWELLING (It was raised and was the size of a 50 cent piece) and VACCINATION SITE ERYTHEMA (injection site was red). On an unknown date, the patient experienced VACCINATION COMPLICATION (very aggressive immune response). The patient was treated with ARNICA MONTANA (topical) for Adverse event, at an unspecified dose and frequency. On 05-Oct-2021, VACCINATION SITE ERYTHEMA (injection site was red) had resolved. At the time of the report, VACCINATION SITE REACTION (was like a little spot of poison ivy), VACCINATION COMPLICATION (very aggressive immune response), PAIN IN EXTREMITY (not really much soreness in the arm), VACCINATION SITE RASH (rash at the injection site), VACCINATION SITE PRURITUS (injection site was a little itchy), VACCINATION SITE SWELLING (It was raised and was the size of a 50 cent piece), PYREXIA (Has a little fever) and FATIGUE (very tired) outcome was unknown and PARAESTHESIA (tingly sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  Treatment included Arnica cream and other lotions which made the adverse events worse. Ice helped in relieving the symptoms.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information were provided. No treatment medication were provided. Vaccine was refrigerated on 07-May-2021.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved.        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.  Date of refrigeration was reported as 07-May-2021.   This case was linked to MOD-2021-363226, MOD-2021-363032 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 20-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. No treatment information was provided.   This case was linked to MOD-2021-364227 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Feeling hot, Influenza like illness, Tinnitus
Clinical narrative: So cold; Feel overly warm; Severe chills, not every night /both times were very severe; Flu-like symptoms; A buzz that goes in and out of my head, like a tiny vibration.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (A buzz that goes in and out of my head, like a tiny vibration.), INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING COLD (So cold), FEELING HOT (Feel overly warm) and CHILLS (Severe chills, not every night /both times were very severe) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 017C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (A buzz that goes in and out of my head, like a tiny vibration.). On 01-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On an unknown date, the patient experienced FEELING COLD (So cold), FEELING HOT (Feel overly warm) and CHILLS (Severe chills, not every night /both times were very severe). At the time of the report, TINNITUS (A buzz that goes in and out of my head, like a tiny vibration.), INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING COLD (So cold), FEELING HOT (Feel overly warm) and CHILLS (Severe chills, not every night /both times were very severe) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.  It was reported that patient patient's doctor ran some tests and the results were negative. Further stated that chills were minor sometimes and very very severe other times, started getting these after she got her shots. Patent had very severe chills on 11-Oct-2021 and 23-Oct-2021.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved.        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.  Date of refrigeration was 07-May-2021   This case was linked to MOD-2021-364267 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of vaccine include 7th May 2021 No concomitant medication information were provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of vaccine was 19-Aug-2021.  No concomitant medication information was provided. No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The patient received dose from vial beyond 30-day use by date; The patient received dose from vial beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) and PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (The patient received dose from vial beyond 30-day use by date) had resolved. At the time of the report, PRODUCT STORAGE ERROR (The patient received dose from vial beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided. Date of refrigeration was mentioned as 7 May 2021.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was 07-05-2021 No relevant concomitant medications were reported. No treatment medication was  reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was 07-may-2021. No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-363032 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-364296 (Patient Link).
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Influenza, Pyrexia
Clinical narrative: Not feeling good; Flu; Wanting to lay down; Slight temperature; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling good), INFLUENZA (Flu), FATIGUE (Wanting to lay down) and PYREXIA (Slight temperature) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Not feeling good), INFLUENZA (Flu), FATIGUE (Wanting to lay down) and PYREXIA (Slight temperature). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Not feeling good), INFLUENZA (Flu), FATIGUE (Wanting to lay down) and PYREXIA (Slight temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) Slight temperature.         Patient reported that he was on blood pressure medication before receiving the vaccination. Patient reported he experienced little bit of reaction which was not severe.   This case was linked to MOD-2021-367526 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains no new information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) 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.    Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) 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-2021-364288 (Patient Link).
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 34-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Date of refrigeration was on 7-may-2021. Concomitant medication use was unknown. Treatment information was unknown
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30 day use by date) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 13, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 13, 2021, patient administered expired product (318 patients received dose from vials beyond 30 day use by date). On Jul 13, 2021, administered expired product (318 patients received dose from vials beyond 30 day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment informations were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination complication
Clinical narrative: very low-grade fever; having side effects; pain is really bothering her; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having side effects), PAIN (pain is really bothering her) and PYREXIA (very low-grade fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Osteoporosis (broken bones in her foot for osteoporosis).    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (having side effects) and PAIN (pain is really bothering her). On 25-Oct-2021, the patient experienced PYREXIA (very low-grade fever). At the time of the report, VACCINATION COMPLICATION (having side effects) and PAIN (pain is really bothering her) had not resolved and PYREXIA (very low-grade fever) outcome was unknown.            No treatment medications were provided by the reporter.  Patient reported that usually takes ibuprofen for arthritis. Patient had broken bones in her foot for osteoporosis and the pain was really bothering her.   This case was linked to MOD-2021-364277 (Patient Link).   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 04-Aug-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) 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 were reported. No treatment medications were reported. It was reported that date of refrigeration was 5/7/2021.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were provided by the reporter. No treatment information were provided. Refrigeration date were reported as 07-May-2021.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration of vaccine was 07-May-2021. No concomitant product reported by reporter. No treatment medication reported by reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 22-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        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.   This case was linked to MOD-2021-364365 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration was reported as 7 May 2021.  No Concomitant medication was reported.  No treatment medications were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-365189 (Patient Link).