chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a 1st dose of the Moderna Covid-19 Vaccine from an expired vial (8-Feb-2022); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a 1st dose of the Moderna Covid-19 Vaccine from an expired vial (8-Feb-2022)) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a 1st dose of the Moderna Covid-19 Vaccine from an expired vial (8-Feb-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a 1st dose of the Moderna Covid-19 Vaccine from an expired vial (8-Feb-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 reported.  The reporter stated that their clinic administered a 1st dose of the Moderna Covid-19 Vaccine from an expired vial (08-Feb-2022) to a patient on 10-Feb-2022. The date the vial was initially stored in the refrigerator was 10-Feb-2022. It was also reported that the vial didn't undergo any temperature excursions.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication reported.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range.   Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Significant Follow up received: contains updated outcome of the event of product storage error and narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   A pharmacy administered doses of the Moderna vaccine 1 day after the published expiration date. Approximately 30 doses were administered from 2 vials as a combination of primary and booster doses. The pharmacist did not describe any symptoms after these individuals received the vaccine, however he has not followed up with these individuals.  On 10-FEB-2022 MOD-2022-479841 became invalid as it was confirmed that there is no specific patient who received the Moderna COVID-19 vaccine. Therefore, this case will be logically deleted from safety data base
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F). In November 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved. At the time of the report, PRODUCT STORAGE ERROR (stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication reported.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The vaccine was administered after been frozen at 23 degrees Fahrenheit since receipt.  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   This case was linked to MOD-2022-474544 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Significant Follow up received, contains updated narrative.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: Immunocompromised patient may have received half a dose; Four months since the patient received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient may have received half a dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since the patient received the second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   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. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient may have received half a dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since the patient received the second dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient may have received half a dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Four months since the patient received the second dose) outcome was unknown.            No concomitant products were reported.   No treatment information was reported.   This case was linked to MOD-2021-132127 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported  It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from 24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt.  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: On 10-Feb-2022: Follow-up received contain significant information outcome of the event of product storage error and narrative updated.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided Excursion duration: From 09Nov2021 to current date.There are total of 10 15-dose vials were impacted. The HCP mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. Anatomical location was reported as Deltoid muscle Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow up document contains updated the event verbatim and I narrative supplement.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt..  The patient did not experience any adverse events after receiving vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.  No treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow-up received as additional information to initial version and  I-narrative supplement updated.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree Fahrenheit; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree Fahrenheit) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree Fahrenheit). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt.  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.  No treatment drugs were reported.   This case was linked to MOD-2022-474599, MOD-2022-479993, MOD-2022-479969 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow-up received contain significant information: narrative and date of vaccination were updated.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment drugs were reported It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt..  The patient did not experience any adverse events after receiving vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow-up received as additional information to initial version and  I-narrative supplement updated.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; Expired Vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-474599 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow Up received on 10-FEB-2022 Contains Significant information: Updated Outcome of the events
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided.  It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt.  The patient did not experienced any adverse events after receiving the vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Updated narrative.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication information was given.  It was reported that 10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree Fahrenheit  to 24.7 degree Fahrenheit. HCP mentioned that they always had the freezer between this range. All doses were injected IM in deltoid muscle. It was reported that the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt, and they have not had any adverse events. Moderna has stated vaccine could continued to be used until expiration.  Storage condition at the time of the excursion was frozen storage. Maximum temperatures reached, as applicable  was Maximum of 24.7 degree Fahrenheit. Excursion duration was from 09Nov2021 to current date (vials have not been moved from freezer). Currently vials were stored in freezer. Visual inspection noting any vaccine state change was visually inspected frozen (never been thawed). Proposed desired Use by Date (date of vaccination clinic, patient appointments, etc. that HCP would like vaccine administered from the vials in question) was unknown. Number of vials/doses impacted were 10 15-dose vials. Pertinent details like whether the vial(s) were punctured, any previous excursions with the impacted vial(s) include no other excursions. Two vials were used. Doses were administered on 23Nov2021 and 27Nov2021     Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow up received contains information on product storage error and added to I narrative supplement.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.  It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials out of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  The reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt..  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow-up received contain significant information outcome of the event of product storage error and narrative updated.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that 10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3°F to 24.7°F.  HCP mentioned that they always had the freezer between this range. Two vials were used to administered HCP's office employees. All doses were injected IM in deltoid muscle. Lot #033F21A. Exp. Date 08Apr2022.  Upon follow up it was reported that vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt and did not had any adverse events.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  Further it was reported that vaccine could be used until expiration date.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-474544 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow up received contains Significant information-updated narrative
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  10 vials of 15 doses each were stored in a freezer which temperature range was at all times from 24.3 degree F to 24.7 degree F. All doses were injected IM in deltoid muscle.  Administration date: 23 Nov 2021 and 27 Nov2021.  The reporter stated that While the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt, they have not had any adverse events. Moderna has stated vaccine could continued to be used until expiration.   No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow up document received on 10-Feb-2022 contains significant information, Confirmed that Not experienced any Adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product storage error, Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion), PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion), PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion), PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported  No treatments were reported It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  In follow-up the reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt..  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow up received updated narrative
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Little soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little soreness in arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy, Milk allergy and Penicillin allergy. Concomitant products included ROSUVASTATIN and PAROXETINE for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little soreness in arm). At the time of the report, PAIN IN EXTREMITY (Little soreness in arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication reported also included vitamins and minerals.  Patient took second shot (lot 004M20A) on 20-Feb-2021 and the Moderna booster (lot 058F21A) on 30-Nov-2021.  Patient stated that first dose was really low, like a normal shot.  No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Secretion discharge, Vaccination site pain, Vaginal discharge
Clinical narrative: Vaginal discharge,clay discharge,discharge very dark color; suddenly felt like a gush,like the ones you have when you're in your period; clay mucus discharge, sticky, no odor; some pain in the left arm, the side that the vaccine was administrated; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL DISCHARGE (Vaginal discharge,clay discharge,discharge very dark color), FEELING ABNORMAL (suddenly felt like a gush,like the ones you have when you're in your period), SECRETION DISCHARGE (clay mucus discharge, sticky, no odor) and VACCINATION SITE PAIN (some pain in the left arm, the side that the vaccine was administrated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007021-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2022, the patient experienced VAGINAL DISCHARGE (Vaginal discharge,clay discharge,discharge very dark color), FEELING ABNORMAL (suddenly felt like a gush,like the ones you have when you're in your period), SECRETION DISCHARGE (clay mucus discharge, sticky, no odor) and VACCINATION SITE PAIN (some pain in the left arm, the side that the vaccine was administrated). At the time of the report, VAGINAL DISCHARGE (Vaginal discharge,clay discharge,discharge very dark color), FEELING ABNORMAL (suddenly felt like a gush,like the ones you have when you're in your period), SECRETION DISCHARGE (clay mucus discharge, sticky, no odor) and VACCINATION SITE PAIN (some pain in the left arm, the side that the vaccine was administrated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment medication were provided.  It was reported that Patient was not sure about the Lot number since it was hand written and not sure it was a 0 between 7 and 2. Patient states Patient trying to read it, not seeing anything and seeing about menstrual period. Patient wanna know if that's one of the side effects it goes now. Patient mention that suddenly felt like a gush, like the ones you have when you're in your period, and went to look and find some clay mucus discharge, sticky, no odor. And this happened twice. Also patient state that has a perfect good health and not taking any Medication. AE related to 1dose.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immune system disorder, Inappropriate schedule of product administration, Psoriasis
Clinical narrative: all kind of disease because my immune system not working after the vaccines; Psoriasis; 1st dose date 5Feb2021, 2nd dose date 13Mar2021; Headache; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (all kind of disease because my immune system not working after the vaccines), PSORIASIS (Psoriasis), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose date 5Feb2021, 2nd dose date 13Mar2021) and HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 052B21A and 037C21A) for COVID-19 vaccination.     Concomitant products included GLIBENCLAMIDE (GLYBURIDE) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (all kind of disease because my immune system not working after the vaccines), PSORIASIS (Psoriasis), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose date 5Feb2021, 2nd dose date 13Mar2021) and HEADACHE (Headache). The patient was treated with METHOTREXATE for Psoriasis, at an unspecified dose and frequency; FOLIC ACID for Psoriasis, at an unspecified dose and frequency; TRIAMCINOLONE for Psoriasis, at an unspecified dose and frequency and HYDROXYZINE for Psoriasis, at an unspecified dose and frequency. At the time of the report, IMMUNE SYSTEM DISORDER (all kind of disease because my immune system not working after the vaccines), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose date 5Feb2021, 2nd dose date 13Mar2021) and HEADACHE (Headache) outcome was unknown and PSORIASIS (Psoriasis) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient height mentioned as 5.5 feet.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2022: Significant Follow Up- Corrective treatment added