chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Nurse administered inadvertent sub-cutaneous injection; A spontaneous report  was received from a pharmacist concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the nurse administered inadvertent subcutaneous injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot number 037K20A) on 28 Dec 2020 subcutaneously for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the pharmacist called and stated that the nurse administered an inadvertent subcutaneous Moderna vaccine injection to a patient. The patient did not experience any adverse reactions. The pharmacist also wanted to know the efficacy and if there was any data about this route of administration.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, the nurse administered inadvertent subcutaneous injection was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 037K20A. There were no reported AEs associated with this case of incorrect route of product administration.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 73-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but  discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 025J20-2A. There were no reported AEs associated with this case of Product storage error.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 55-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # 025J20-2A. There were no reported adverse event associated with this case of product storage error.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from vial which had been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 38-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine administered from vial which has been punctured for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine administered from vial which had been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 (Lot number: 026L20A). There were no reported AEs associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 59-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an undisclosed date, the County Health Department received the vaccine and stored the product at 38.2 degrees Fahrenheit.  On 24 Dec 2020, the health care provider received the vaccine and stored the material at -20 degrees Celsius.  The thawing procedure was followed prior to administration.  On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, Exp. date: 25 Feb 2021) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273. There were no reported AEs associated with this case of product storage error.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 60-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 60 year old, male patient.  The patient's medical history is not provided.  The event occurred on 28 Dec 2020, when the patient was given the first dose of the mRNA-1273 (Lot: 025J20-2A) . This report refers to a case of storage error where refrozen mRNA-1273  has been administered to the patient.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from vial which has been punctured for more than 6 hours; A spontaneous report was received from a nurse  concerning a 44-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine administered from vial which has been punctured for more than 6 hours.   The patient's medical history not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, vaccine administered from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 44 year old, female patient. The patient's medical history is not provided. The patient experienced an unexpected event of vaccine administered from vial which has been punctured for more than 6 hours.  The event occurred on 30 Dec 2020 during administration of the first dose of mRNA-1273 (Lot number: 026L20A).  There were no reported adverse events. The sponsor considered the event as not related to mRNA-1273.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 42-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273. There were no reported AEs associated with this case of product storage error.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from vial which has been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 44-years old, female patient who received Moderna's Covid-10 vaccine (mRNA-1273) and experienced vaccine administered from vial which has been punctured for more than 6 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) in the right deltoid intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, vaccine administered from vial which has been punctured for more than 6 hours, was resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, lot # 026L20A. There were no reported AEs associated with this case of expired product administered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered vaccine that was not stored in recommended teperature; A spontaneous report was received from a nurse concerning a 41-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # 025J20-2A. There were no reported AEs associated with this case of product storage error.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product leakage
Clinical narrative: Some leakage from the hub of the side of needle; May not have received a full dose of the vaccine; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 Vaccine and who might not have received a full dose of the vaccine when there was some leakage from the hub side of the needle.  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On 31-Dec-2020 the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. A physician reported that some leakage was observed from the hub of the side of a needle when the dose of vaccine was administered.  The patient may not have received a full dose.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, might not have received a full dose of the vaccine when there was some leakage from the hub side of the needle, was resolved on 31 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect route of product leakage and incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product leakage and incorrect dose administered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse, concerning a  69-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 69 year old, female patient.  The patient's medical history is not provided.  The event occurred on 28 Dec 2020, when the patient was given the first dose of the mRNA-1273 (Lot: 025J20-2A) . This report refers to a case of storage error where refrozen mRNA-1273  had been administered to the patient.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from vial which has been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 57-year-old female patient who received Moderna's COVID-19 Vaccine and experienced vaccine administered from vial which has been punctured for more than 6 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) for prophylaxis of COVID-19 infection in the left deltoid.   On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine administered from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020; Reporter's Comments: This case concerns a 57-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), reporting Expired product administered without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered to 17 year old; A spontaneous report was received from a healthcare facility staff member concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, administered vaccine to a 17 year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the healthcare staff member reported the Moderna COVID vaccine was given to a 17 year old patient.  No symptoms or treatments have been reported by the provider.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, gave vaccine to a 17 year old, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a 17 year old patient.  The patient's medical history is not provided.  The event occurred on 29 Dec 2020 during administration of the first dose of the mRNA-1273. This report refers to a case of medication error where mRNA-1273  has been administered to the patient of inappropriate age.  There were no reported adverse  reaction associated with this case.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from vial which has been punctured for more than 6 hours; A spontaneous report was received from a nurse for a 64-year-old male patient who received Moderna's COVID-19 Vaccine and experienced vaccine administered from vial which has been punctured for more than 6 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) for prophylaxis of COVID-19 infection in the left deltoid.   On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided..   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine administered from vial which has been punctured for more than 6 hours, was recovered/resolved on 30 Dec 2020.; Reporter's Comments: This case concerns the 64-year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial, which had been punctured for more than 6 hours. On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. Reported event is unlisted for COVID-19 Vaccine (mRNA-1273) and causality assessment was assessed as not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Product administered at inappropriate site
Clinical narrative: Redness in the injection spot; Injection spot not the right place; A spontaneous report was received from a nurse concerning a 31-years old female patient, who was also a physician, who received the Moderna COVID-19 Vaccine (mRNA-1273) and experienced product administered at inappropriate injection site and injection site erythema.  The patient's medical history was not provided. No relevant concomitant medications were provided.   The patient received her first of two planned doses of mRNA-1273 vaccine (batch number 039K20-2A) on 28 Dec 2020 intramuscularly in the left arm for prophylaxis of COVID-19 infection and experienced product administered at inappropriate injection site when the shot was given below her deltoid.  On 29 Dec 2020, the patient noticed redness at the injection site.  Treatment information was provided.  Action taken in response to the events were not reported.  The outcome of the event, injection site erythema, was not resolved. The outcome of the event, product administered at inappropriate injection site, was resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 31 year-old female, who experienced a non-serious expected event of injection site erythema and product administered at inappropriate site. The event of injection site erythema occurred 1 day after first dose of mRNA-1273, lot # 039K20-2A. No treatment was administered for injection site erythema. Based on the current available information and temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. There was no reported AE associated with the case of product administered at inappropriate site.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273. There were no reported AEs associated with this case of product storage error.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 63-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020. .; Reporter's Comments: This report refers to a case of administered a vaccine that has been refrozen for mRNA-1273, lot # 025J20-2A. There were no reported adverse events associated with this case of administered a vaccine that has been refrozen.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 42-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273. There were no reported AEs associated with this case of product storage error.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 47-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273. There were no reported AEs associated with this case of product storage error.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273. There were no reported AEs associated with this case of product storage error.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered vaccine to 17 year old; A spontaneous report was received from a nurse concerning a 17 year old, female, patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, administered vaccine to a 17 year old.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The nurse reported the Moderna COVID vaccine was given to a 17 year old patient on an unknown date. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine to a 17 year old, was considered resolved.; Reporter's Comments: This case concerns a 17-year-old  female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: While administering the vaccine "quite a bit" leaked out; A spontaneous report was received from a pharmacist, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and while administering the vaccine "quite a bit" leaked out.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the reporter stated that a vaccine administrator did not attach the needle to the syringe and while administering the vaccine "quite a bit" leaked out and some was administered. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The events, while administering the vaccine "quite a bit" leaked out, was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna COVID-19 vaccine was administered to a 14 year old girl; A spontaneous report was received from a consumer concerning a 14-yeasr-old female patient who received Moderna's COVID-19 Vaccine and experienced the event, inappropriate age at vaccine administration.  The patient's medical history and concomitant product use were not provided/unknown by the reporter.  On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (lot number either 025J20-219 or 025J20-214) intramuscularly for prophylaxis of COVID-19 infection, and the vaccine was administered to a 14-years old patient.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, inappropriate age at vaccine administration, was resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 14-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 025J20-219/4), reporting Product administration to patient of inappropriate age without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some of it leaked out and was enough to get her shirt wet, maybe she got 1/3 of the dose; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced incomplete dose administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an undisclosed date, the patient received her first of two planned doses of mRNA-1273 (Lot number not provided) intramuscularly for prophylaxis of COVID-19 infection.  Enough product leaked out to get her shirt wet. The pharmacist reported that the patient received maybe one-third of the dose.   Treatment for the event was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, incomplete dose administered, was considered resolved.   Action taken with mRNA-1273 in response to the events was not provided.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect dose administered without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Received vaccine below the deltoid in the bicep muscle; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and received the vaccine below the deltoid in the bicep muscle.   The patient's medical history was not provided. No relevant concomitant medications were reported.     On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patient reported that she typically received vaccines in her deltoid muscle but received the mRNA-1273 vaccine below the deltoid, in the bicep muscle. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, received vaccine below the deltoid in the bicep muscle, was considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered at inappropriate site without any associated adverse events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 53-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case 53-year-old, female administered a vaccine that has been refrozen for mRNA-1273, lot # 025J20-2A. There were no reported adverse events associated with this case of administered a vaccine that has been refrozen.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 65-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 025J20-2A. There were no reported AEs associated with this case of Product storage error.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 49-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 49 year old, female patient.  The patient's medical history is not provided.  The event occurred on 28 Dec 2020, when the patient was given the first dose of the mRNA-1273 (Lot: 025J20-2A) . This report refers to a case of storage error where refrozen mRNA-1273  had been administered to the patient.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 75-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of  a 75-year-old, male patient who  was administered a vaccine that has been refrozen for mRNA-1273, lot # 025J20-2A. There were no reported adverse events associated with this case of administered a vaccine that has been refrozen.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered a vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 58-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 58 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   This report refers to a case of product storage error for mRNA-1273, lot # 025J20-2A.  There were no reported AEs associated with this case of product storage error.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 22-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 22 year old, female patient.  The patient's medical history is not provided.  The event occurred on 28 Dec 2020, when the patient was given the first dose of the mRNA-1273 (Lot: 025J20-2A). This report refers to a case of storage error where refrozen mRNA-1273 has been administered to the patient.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 33-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of a 33-year-old, female patient who was administered a vaccine that has been refrozen for mRNA-1273, lot # 025J20-2A. There were no reported adverse events associated with this case of administered a vaccine that has been refrozen.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from vial which had been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 36-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) from a vial which had been punctured for more than 6 hours.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administered vaccine from vial which has been punctured for more than 6 hours, was considered resolved on 30 Dec 2020.; Reporter's Comments: This case concerns a 36-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), reporting vaccine administered from a vial which has been punctured for more than 6 hours without any associated adverse events.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product leakage
Clinical narrative: Gave the patient a vaccine and it leaked out; syringe leak/product leak; A spontaneous report was received from a pharmacist concerning a male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced vaccine leaked out down his arm while being administered.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   During the vaccine administration, the vaccine leaked out down the patient's arm.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine leaked out down his arm while being administered, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a male patient.  The patient's medical history is not provided.  The patient experienced the unexpected event of vaccine leaked out down his arm during the administration of the first dose of the mRNA-1273 (Lot 011J20A) on 29 Dec2020. This report refers to a case of Product administration error for mRNA-1273, lot # 011J20A.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received a partial dose; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received a partial dose.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 04 Jan 2021, during vaccine administration, the patient received a partial dose. The nurse reported the syringe was not fully attached to the hub and there was leakage. The patient received a partial dose, but how much she received was unknown. No treatment information provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, received a partial dose, was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of incorrect dose administered.