chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 14Jun2022 and dose administered on 15-Jul-2022; Administered a Moderna Covid-19 vaccine two days after 30 day expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a Moderna Covid-19 vaccine two days after 30 day expiration) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14Jun2022 and dose administered on 15-Jul-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a Moderna Covid-19 vaccine two days after 30 day expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14Jun2022 and dose administered on 15-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a Moderna Covid-19 vaccine two days after 30 day expiration) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 14Jun2022 and dose administered on 15-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was initially stored in the refrigerator on 14-Jun-2022. Vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jul-2022 and was administered on 14-Jul-2022; Dose administered >12(US)/24(CA) hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12(US)/24(CA) hours post puncture) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jul-2022 and was administered on 14-Jul-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12(US)/24(CA) hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jul-2022 and was administered on 14-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered >12(US)/24(CA) hours post puncture) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jul-2022 and was administered on 14-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The vial was initially stored in the refrigerator on 11-Jul-2022.  The date and time of vial was first punctured on 13-Jul-2022 at 9:30 EST.  The vial was stored post puncture in Refrigerator.  The vial did not undergo any temperature excursion.  The patient received the Moderna Covid-19 vaccine booster dose and no side effects have been reported yet.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis
Clinical narrative: long lasting side effects from the Moderna vaccine related to joint inflammation; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (long lasting side effects from the Moderna vaccine related to joint inflammation) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (long lasting side effects from the Moderna vaccine related to joint inflammation). At the time of the report, ARTHRITIS (long lasting side effects from the Moderna vaccine related to joint inflammation) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported.  Company Comment: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced unexpected, non-serious AESI arthritis, after receiving a dose of mRNA-1273.  There is very limited information in this case; it was only reported that the patient had long lasting side effects from vaccination related to joint inflammation.  Clinical course, diagnostic evaluation, concomitant medications, and treatment details were not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no reported medical history, who experienced unexpected, non-serious AESI arthritis, after receiving a dose of mRNA-1273.  There is very limited information in this case; it was only reported that the patient had long lasting side effects from vaccination related to joint inflammation.  Clinical course, diagnostic evaluation, concomitant medications, and treatment details were not reported.  The outcome was unknown.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Sex: U
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  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. This patient had not reported any symptoms or side effects. The vial does not undergo any temperature excursions. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2022: Follow-up received includes No new information. On 15-Jul-2022: Follow-up received includes No new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with an open vial from 13-Jul-2022 that was not discarded; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with an open vial from 13-Jul-2022 that was not discarded) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 vaccination.     Concurrent medical conditions included Specific allergy (drug) (Sulfa Drugs).    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with an open vial from 13-Jul-2022 that was not discarded). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with an open vial from 13-Jul-2022 that was not discarded) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient received the Moderna COVID-19 vaccine booster dose (unknown which booster dose it was) and no side effects had been reported. The reporter had no information on patient's past vaccination history. The events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized).  The vial was initially stored in the refrigerator on 11-Jul-2022. The vial was first punctured on 13-Jul-2022. The vial stored in refrigerator post puncture and the vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius= 46 degree to 77 degree Fahrenheit) was seconds (long enough to draw a vial) and it was reported that the vial did not exposed to room temperature for more than 24 hours.  No treatment information was provided by the reporter.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered 2 days after beyond use date; Vaccine administered 2 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date) and PRODUCT STORAGE ERROR (Vaccine administered 2 days after beyond use date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination.     Patient had been never diagnosed or tested positive for Covid-19. Non acute illness at the time of vaccination and upto one month before. No other vaccines given on the same day as moderna covid-19 vaccine. No other vaccines received within one month prior to any dose of moderna covid-19 vaccine.  Concurrent medical conditions included Asthma. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) and AZELASTINE for Asthma.    On 28-Jun-2022 at 8:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Jun-2022 at 8:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered 2 days after beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date) and PRODUCT STORAGE ERROR (Vaccine administered 2 days after beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patients had reported no side effects. Number of doses or vails were reported as 7. The vial was initially stored in the refrigerator on 26-May-2022. The vial did not undergo any temperature excursion. Treatment details were not reported by the reporter.
Sex: F
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 female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Nov-2021 at 10:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient had no known drug allergies.  It was reported that patient had experienced no side effects when vaccine was administered and no side effects reported or noticed afterwards.  The vaccine was moved from freezer to refrigerator the day of administration.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2022: Follow up received patient demographic, product information. On 17-Jul-2022: Non-significant follow up received- Narrative updated.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was first punctured: 13Jul2022 at 9:30 EST/Dose administered more then12/24 hours.; Dose administered more than 12/24 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12/24 hours post puncture) and PRODUCT STORAGE ERROR (vial was first punctured: 13Jul2022 at 9:30 EST/Dose administered more then12/24 hours.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12/24 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was first punctured: 13Jul2022 at 9:30 EST/Dose administered more then12/24 hours.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered more than 12/24 hours post puncture) and PRODUCT STORAGE ERROR (vial was first punctured: 13Jul2022 at 9:30 EST/Dose administered more then12/24 hours.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was unknown if patient diagnose with/ tested positive for Covid-19 ever.  It was unknown if patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  It was unknown AE cause patient to seek medical care (office visit, Urgent care, ER, hospitalized).  The vial was initially stored in the refrigerator on 11 Jul 2022. Date and time vial was first punctured was 13 Jul 2022 at 9:30 EST.  The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): Seconds (long enough to draw a vial).  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2022-608992, MODERNATX, INC.-MOD-2022-608988, MODERNATX, INC.-MOD-2022-608999 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-608992:Patient 2 (Same reporter) MODERNATX, INC.-MOD-2022-608988:Patient 1 (Same reporter) MODERNATX, INC.-MOD-2022-608999:Patient 4 (Same reporter)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccinated with an open vial from 13-Jul-2022 that was not discarded; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with an open vial from 13-Jul-2022 that was not discarded) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Bactrim), Drug allergy (Hydrochlorothiazide) and Sulfonamide allergy (Sulfa Drugs).    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with an open vial from 13-Jul-2022 that was not discarded). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with an open vial from 13-Jul-2022 that was not discarded) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient date of birth was mentioned.  The patient received the Moderna COVID-19 vaccine booster dose (unknown which booster dose it was) and no side effects had been reported. The reporter had no information on patient's past vaccination history. The events did not cause the patient to seek medical care (office visit, Urgent care, ER, hospitalized).  The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator  26May2022; Vaccine administered 3 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 vaccination.     The patient had never diagnosed or tested positive for COVID-19. It was reported that patient had no acute illness at the time of vaccination and up to one month before. No chronic or long standing health conditions were reported.     On 29-Jun-2022 at 11:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator  26May2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  No other vaccines were given to patient when Moderna vaccine was administered. No other vaccines were received within one month prior to any dose of Moderna Covid-19 vaccine.  On 26-May-2022 vial was initially moved to refrigerator. The vial did not undergone any temperature excursion.  No treatment medication information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-601207 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-601207:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 26-May-2022 and administered on 29-Jun-2022; Vaccine administered 3 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 29-Jun-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022 at 10:30 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 29-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 3 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 29-Jun-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had never been diagnosed with or tested positive for COVID 19. Acute illness at the time of vaccination and up to one month before was reported as none. No concomitant medications were reported. The number of doses or vails were reported as 7. The vial was initially stored in the refrigerator on 26-May-2022. The vial had not undergone any temperature excursion. The patient had reported no side effects. Treatment details were not reported by the reporter.   This case was linked to MOD-2022-601207 (E2B Linked Report).; Sender's Comments:  MOD-2022-601207:Master case
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored beyond its expiry date; Gave a vaccine that expired 06July2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a vaccine that expired 06July2022) and PRODUCT STORAGE ERROR (Vaccine was stored beyond its expiry date) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Jul-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave a vaccine that expired 06July2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored beyond its expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave a vaccine that expired 06July2022) and PRODUCT STORAGE ERROR (Vaccine was stored beyond its expiry date) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. The vial was initially stored in the refrigerator on 22-Jun-2022. The vial does not undergone any temperature excursions. No treatment medications was reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was first punctured on 14-JUL-2022 at 12:09 pm and administered on 15-JUL-2022 at 11:15 am; 1 patient that was administered a Moderna Covid-19 more than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 patient that was administered a Moderna Covid-19 more than 12 hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-JUL-2022 at 12:09 pm and administered on 15-JUL-2022 at 11:15 am) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B22A) for COVID-19 vaccination.     No allergies were reported. No medical history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination.  Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Dose 0.3ml) on 24-Apr-2021, Pfizer (2nd dose, Dose 0.3ml) on 24-Apr-2021, Pfizer (3rd dose and Dose 0.3ml) on 09-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 15-Jul-2022 at 11:15 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022 at 11:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 patient that was administered a Moderna Covid-19 more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 14-JUL-2022 at 12:09 pm and administered on 15-JUL-2022 at 11:15 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 patient that was administered a Moderna Covid-19 more than 12(US) hours post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-JUL-2022 at 12:09 pm and administered on 15-JUL-2022 at 11:15 am) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. It was reported that number of dose/vials is 1 dose. On 11-JUL-2022 vial was initially stored in the refrigerator. Vial did not undergone any temperature excursions. Post puncture vial was stored in room temperature for about 23 hours. No side effects from patient have been reported yet. Treatment medication was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received Moderna Covid-19 vaccine that was first placed in the Pharmacies refrigerator more than 30 days ago.  35 days to be exact; Beyond use date of the vaccine was 8JUL2022, and the date that the vaccine was administered was 13Jul2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Beyond use date of the vaccine was 8JUL2022, and the date that the vaccine was administered was 13Jul2022) and PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine that was first placed in the Pharmacies refrigerator more than 30 days ago.  35 days to be exact) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Beyond use date of the vaccine was 8JUL2022, and the date that the vaccine was administered was 13Jul2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine that was first placed in the Pharmacies refrigerator more than 30 days ago.  35 days to be exact). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Beyond use date of the vaccine was 8JUL2022, and the date that the vaccine was administered was 13Jul2022) and PRODUCT STORAGE ERROR (Patient received Moderna Covid-19 vaccine that was first placed in the Pharmacies refrigerator more than 30 days ago.  35 days to be exact) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  Manufacturer expiration date of the vaccine was reported as 11-Nov-2022. The vial didn't undergo any temperature excursions.  No treatment drugs were reported   Reporter did not allow further contact
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose was administered on 18-Feb-2021 and second dose was administered on 03-Mar-2021; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 18-Feb-2021 and second dose was administered on 03-Mar-2021) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 700632007 and 7006320005) for COVID-19 vaccination.     Concurrent medical conditions included Milk allergy, Food allergy (Corn) and Eosinophilic esophagitis.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 18-Feb-2021 and second dose was administered on 03-Mar-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 18-Feb-2021 and second dose was administered on 03-Mar-2021) outcome was unknown.            Concomitant medications included unspecified medication for eosinophilic esophagitis.  It was reported that patient was part of the clinical trials of the Moderna COVID-19 vaccine and received the second booster dose.  No treatment medication was reported   This case was linked to MOD-2022-609215 (Patient Link).
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patients received first dose 0.25ml  from Red Cap adult vial; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patients received first dose 0.25ml  from Red Cap adult vial) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 15-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patients received first dose 0.25ml  from Red Cap adult vial). At the time of the report, INCORRECT DOSE ADMINISTERED (Patients received first dose 0.25ml  from Red Cap adult vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  The patient received Moderna COVID-19 vaccine from a vial with red cap and a label with light blue border.  No Treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-609133 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-609133:CMOD22-03372- crosslink (2 year 11 months old patient), Same reporter
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Extra booster administered; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra booster administered) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Coronary artery disease, Congestive heart failure, Hypothyroidism, Dementia, COPD and Drug allergy (Allergy to simvastatin).    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 EXTRA DOSE ADMINISTERED (Extra booster administered). At the time of the report, EXTRA DOSE ADMINISTERED (Extra booster administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No prior vaccine allergy reaction reported. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received a booster dose of 0.25ml from the booster dose only vial presentation with the middle set of  number of 275 instead of the recommended dosage of 0.5ml; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received a booster dose of 0.25ml from the booster dose only vial presentation with the middle set of  number of 275 instead of the recommended dosage of 0.5ml) 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 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jul-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received a booster dose of 0.25ml from the booster dose only vial presentation with the middle set of NDC number of 275 instead of the recommended dosage of 0.5ml). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received a booster dose of 0.25ml from the booster dose only vial presentation with the middle set of number of 275 instead of the recommended dosage of 0.5ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days beyond use date) and PRODUCT STORAGE ERROR (Vaccine administered 2 days after beyond use date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for an unknown indication. On 28-Jun-2022 at 8:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Jun-2022 at 8:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered 2 days after beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days beyond use date) and PRODUCT STORAGE ERROR (Vaccine administered 2 days after beyond use date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient born with twins. Number of doses/vials was reported as 7. On 26-May-2022, the vial was initially stored in the refrigerator. Vaccine was administered from 26-Jun-2022 to 4-Jul-2022. Vial did not undergo any temperature excursions. No treatment drug were reported.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: my blood clot was caused by the Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (my blood clot was caused by the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (my blood clot was caused by the Moderna vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (my blood clot was caused by the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  Company Comment:  This is a spontaneous case reported by a consumer of unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of thrombosis (AESI). It is reported that the event occurred after the administration of the dose of mRNA-1273 vaccine. No further information was disclosure. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer of unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of thrombosis (AESI). It is reported that the event occurred after the administration of the dose of mRNA-1273 vaccine. No further information was disclosure. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051B22A, 031(M or H)21A, 003B21A and 031A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had not resolved.            It was reported that patient is not on any medications for any health conditions and patient has not taken any medication for the dizziness. It was reported that they have been feeling like this for the past 2 days.   This case was linked to MOD-2022-609216, MOD-2022-609219 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: In May of this year, I  tested positive for Covid-19.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (In May of this year, I  tested positive for Covid-19.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (In May of this year, I  tested positive for Covid-19.). At the time of the report, COVID-19 (In May of this year, I  tested positive for Covid-19.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: (Positive) Positive.     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.  Dosage text was reported as first booster dose.  Unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine.    Treatment information was not provided.  Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious COVID-19  after receiving the 1st booster dose of mRNA-1273 vaccine. The exact onset date of event and vaccination date were not reported. Patient had 1st booster dose about 6 months ago and reported that in May this year (2022) COVID test was positive. Clinical course and treatment details were not reported. The outcome of event was reported as recovered. There was no information provided regarding the first 2 doses of vaccination.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious COVID-19  after receiving the 1st booster dose of mRNA-1273 vaccine. The exact onset date of event and vaccination date were not reported. Patient had 1st booster dose about 6 months ago and reported that in May this year (2022) COVID test was positive. Clinical course and treatment details were not reported. The outcome of event was reported as recovered. There was no information provided regarding the first 2 doses of vaccination.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental overdose, Chills, Fatigue, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose; person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine; Sored arm; Chills; Fever; Body is tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Body is tired) and ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR45048, 7006320005, 7006320010 and 7008121001) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2.5 milliliter. On 14-Jul-2022, the patient experienced ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine). In July 2022, the patient experienced PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Body is tired). At the time of the report, PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Body is tired) had not resolved and ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine) outcome was unknown.            Patient did not had any allergy. Patient and her 3 children accidentally received doses of 2,5 ml of the Moderna Covid 19 vaccine. No concomitant medication were reported by the reporter. Treatment medication included painkiller for symptoms.   This case was linked to MOD-2022-609068 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose; person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine; Sored arm; Chills; Fever; Body is tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Body is tired) and ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR45048, 7006320005, 7006320010 and 7008121001) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2.5 milliliter. On 14-Jul-2022, the patient experienced ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine). In July 2022, the patient experienced PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Body is tired). At the time of the report, PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Body is tired) had not resolved and ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine) outcome was unknown.            Patient did not had any allergy. Patient and her 3 children accidentally received doses of 2,5 ml of the Moderna Covid 19 vaccine. No concomitant medication were reported by the reporter. Treatment medication included painkiller for symptoms.   This case was linked to MOD-2022-609068 (Patient Link).
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose; person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine; Sored arm; Chills; Fever; Body is tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever), FATIGUE (Body is tired) and ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR45048, 7006320005, 7006320010 and 7008121001) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2.5 milliliter. On 14-Jul-2022, the patient experienced ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine). In July 2022, the patient experienced PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Body is tired). At the time of the report, PAIN IN EXTREMITY (Sored arm), CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Body is tired) had not resolved and ACCIDENTAL OVERDOSE (Received 2,5 ml of the Moderna Covid 19 vaccine as a booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (person younger than 50 years old received a second booster of the Moderna Covid 19 vaccine) outcome was unknown.            Patient did not had any allergy. Patient and her 3 children accidentally received doses of 2,5 ml of the Moderna Covid 19 vaccine. No concomitant medication were reported by the reporter. Treatment medication included painkiller for symptoms.   This case was linked to MOD-2022-609068 (Patient Link).