chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential subpotent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential subpotent dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19.     On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential subpotent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential subpotent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor frezer documentation following a freezer changeover/ Potential subpotent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    No concomitant medications information was reported. Reporter stated that a site that administers the Moderna COVID-19 vaccine did not monitor the freezer temperatures where the Moderna vaccine is stored. The site had a data logger, but it was not set up to record. The HCP stated there is no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site.Therefore, it was unknown if a freezer temperature excursion actually occurred. There were no adverse events. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover was reported. The event did not cause the patient to seek medical care. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Live follow-up: Quality complaint no. only added.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis. No Medical History information was reported. On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.) outcome was unknown. Not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). No concomitant medications information was reported. Reporter stated that a site that administers the Moderna COVID-19 vaccine did not monitor the freezer temperatures where the Moderna vaccine is stored. The site had a data logger, but it was not set up to record. The HCP stated there is no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. Therefore, it was unknown if a freezer temperature excursion actually occurred. There were no adverse events. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover was reported. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Quality complaint no. added.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product measured potency issue, Product temperature excursion issue
Clinical narrative: Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Potential subpotent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     It was unknown patient had ever been diagnosed with or tested positive for COVID-19.     On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT MEASURED POTENCY ISSUE (Potential subpotent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    Concomitant medications details were not reported by the reporter.  It was reported that vaccines were stored, there was no monitoring of the freezer temperature, and those vaccines was administered to patients. Vaccination site has a data logger, but it was not set up to record.  The HCP stated that there was no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site.  There was no adverse event, only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.  Treatment details were not reported by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Follow up received and Quality Complaint number added.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose; Sore throat; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jun-2022, the patient experienced RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, RHINORRHOEA (Runny nose) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported.  It was reported that the patient woke up in the morning with a runny nose and a sore throat. The patient wanted help with getting an examination at rite aid. Patient was told to call to get tested for COVID. It was unknown whether the patient took Moderna COVID19 Vaccines.  No treatment medications was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster; 1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster) and EXPIRED PRODUCT ADMINISTERED (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster) and EXPIRED PRODUCT ADMINISTERED (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster). At the time of the report, PRODUCT STORAGE ERROR (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster) and EXPIRED PRODUCT ADMINISTERED (1 vial of Moderna vaccine was opened on Friday ,The vial was used on Monday for a COVID booster for a COVID booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. 1 vial of Moderna vaccine was opened on Friday and placed in the vaccine refrigerator (temperature between 37-43 F). The vial was used on Monday for a COVID booster after remaining in the vaccine refrigerator over the weekend.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza virus test, SARS-CoV-2 test
Clinical narrative: Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not reported.  It was reported that patient might had cold virus. The caller stated that they were all sick as they had the flu and had lot of problems in the family.  Treatment medication was unknown.   This case was linked to MOD-2022-596889, MOD-2022-597292, MOD-2022-596527 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza, Influenza virus test, SARS-CoV-2 test positive
Clinical narrative: Sick; She stated that they had flu; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick) and INFLUENZA (She stated that they had flu) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick) and INFLUENZA (She stated that they had flu). At the time of the report, ILLNESS (Sick) and INFLUENZA (She stated that they had flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test positive: negative (Negative) Negative.         No concomitant information was reported. It was stated that patient had had lot of problems in the family and and said that the grandson may had brought the cold viruses home. No treatment information was provided.   This case was linked to MOD-2022-596889, MOD-2022-596523, MOD-2022-597292 (Patient Link).   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Polymerase chain reaction, Sluggishness
Clinical narrative: Started feeling sluggish 4 days after 2nd booster; Body aches started 4 days after 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (Started feeling sluggish 4 days after 2nd booster) and MYALGIA (Body aches started 4 days after 2nd booster) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Exposed to COVID Virus more than 2 weeks prior to 2nd booster vaccine. Negative PCR more than 2 weeks prior to 2nd booster vaccine.).   On 24-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2022, the patient experienced SLUGGISHNESS (Started feeling sluggish 4 days after 2nd booster) and MYALGIA (Body aches started 4 days after 2nd booster). At the time of the report, SLUGGISHNESS (Started feeling sluggish 4 days after 2nd booster) and MYALGIA (Body aches started 4 days after 2nd booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: negative Negative.         No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-596502 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial stored >12 hours post puncture; vaccine has now been expired because it was after 12 hours, Dose administered >12(US) hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine has now been expired because it was after 12 hours, Dose administered >12(US) hours post puncture) and PRODUCT STORAGE ERROR (Vial stored >12 hours post puncture) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jun-2022 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2022 at 9:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine has now been expired because it was after 12 hours, Dose administered >12(US) hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored >12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine has now been expired because it was after 12 hours, Dose administered >12(US) hours post puncture) and PRODUCT STORAGE ERROR (Vial stored >12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that it was the patient's second booster dose. No concomitant medications was reported. No treatment medications was reported.  The vial was initially stored in the refrigerator on 22-Jun-2022. The vial was first punctured on 22-Jun-2022 7:45 AM. The vial was stored in fridge post puncture. The vial does not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celcius= 46 to 77 degree Fahrenheit ) was 2 minutes.
Age: 1.92
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspepsia, Vomiting
Clinical narrative: digestive issues; Diarrhea; Vomiting; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSPEPSIA (digestive issues), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) in a 1-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     The patient had no known allergies. The patient never had COVID positive test or diagnosis.  The patient's past medical history included Ear operation (Ear tube surgeries) in March 2022. Concurrent medical conditions included Asthma. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma.    On 25-Jun-2022 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jun-2022, the patient experienced DYSPEPSIA (digestive issues). 28-Jun-2022, the patient experienced DIARRHOEA (Diarrhea) and VOMITING (Vomiting). On 28-Jun-2022, DYSPEPSIA (digestive issues), DIARRHOEA (Diarrhea) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient received first dose on 25-Jun-2022 around 9 am. On 28-Jun-2022 around 9 patient had digestive issues, diarrhea and vomiting reactions and those reactions were short lived lasting from 9 am until noon. Patient had not experienced similar events in the past. The adverse events did not cause patients to seek medical care. As a treatment patient received Bland diet.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received expired Booster dose about 20 hours post puncture; Received expired Booster dose about 20 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture) and PRODUCT STORAGE ERROR (Received expired Booster dose about 20 hours post puncture) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received expired Booster dose about 20 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture) and PRODUCT STORAGE ERROR (Received expired Booster dose about 20 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. It was reported that number of doses/vials was 1 vial / 2 doses. On 02-JUN-2022 the vial was initially stored in the refrigerator. On 23JUN2022 at 1:14PM the vial was first punctured. Vial did not undergone any temperature excursions. Post punctured the vial was stored in the refrigerator approximately for under 20 hours. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-596592.
Age: 68.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination site discomfort, Vaccination site mass
Clinical narrative: I got the vaccine and noticed that on my arm it was a little wart; I just woke up and my arm, I had to wrap up my arm like I just had a shot,; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (I got the vaccine and noticed that on my arm it was a little wart) and VACCINATION SITE DISCOMFORT (I just woke up and my arm, I had to wrap up my arm like I just had a shot,) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 045A21A and 046L21A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Heart transplant. Concurrent medical conditions included Blood pressure abnormal (Blood pressure Taking Lisinopril.). Concomitant products included LISINOPRIL for Blood pressure abnormal, SIROLIMUS (RAPAMUNE), CICLOSPORIN (NEORAL) and PREDNISONE for Heart transplant rejection.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 08-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (I got the vaccine and noticed that on my arm it was a little wart) and VACCINATION SITE DISCOMFORT (I just woke up and my arm, I had to wrap up my arm like I just had a shot,). At the time of the report, VACCINATION SITE MASS (I got the vaccine and noticed that on my arm it was a little wart) and VACCINATION SITE DISCOMFORT (I just woke up and my arm, I had to wrap up my arm like I just had a shot,) outcome was unknown.            No treatment medication was reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Patient received potentially affected vials that was stored in freezer with no DDL monitoring; Patient received potentially affected vials that was stored in freezer with no DDL monitoring; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  There was no change in the state of the vaccines, no temperature excursion history (the temperatures of the freezer remained consistently within range and was recorded in a log) and received them from shipment in frozen and remained frozen when in the freezer. Vial was thawed when patient came for vaccination. Storage condition was frozen. The lot numbers supposedly affected were 022J21A, 083J21A and 059M21A. Maximum/minimum temperatures were not recorded; only morning and evening temperatures were recorded. The excursion in question was from 8-Feb-2022 to 20-May-2022 and affected only 6 patients within that time frame. The vials were moved to the refrigerator to be thawed for vaccinations on 8-Feb-2022, 21-Feb-2022, 31-Mar-2022, 2-May-2022 and 20-May-2022. The vials were stored in a fridge/freezer combo unit which are completely separate compartments with completely different temperature.  No treatment medication was reported by reporter.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored about 20 hours post puncture; Received expired Booster dose about 20 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was stored about 20 hours post puncture) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2022 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored about 20 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired Booster dose about 20 hours post puncture) and PRODUCT STORAGE ERROR (Vial was stored about 20 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Number of doses/vials: 1 vial / 2 doses. The vial was initially stored in the refrigerator on 02-JUN-2022. The vial was first punctured on 23-JUN-2022 at 1:14PM. The vial was stored in Refrigerator post puncture. The vial does not undergone any temperature excursions. Post punctured the vial was stored in the refrigerator approximately for under 20 hours. The vial exposed to room temperature for >24 hours: Less than 24 hours.  No treatment medications was reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Patient received potentially affected vials that was stored in freezer with no DDL monitoring; Patient received potentially affected vials that was stored in freezer with no DDL monitoring; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  There was no change in the state of the vaccines, no temperature excursion history (the temperatures of the freezer remained consistently within range and was recorded in a log) and received them from shipment in frozen and remained frozen when in the freezer. Vial was thawed when patient came for vaccination. Storage condition was frozen. The lot numbers supposedly affected were 022J21A, 083J21A and 059M21A. Maximum/minimum temperatures were not recorded; only morning and evening temperatures were recorded. The excursion in question was from 8-Feb-2022 to 20-May-2022 and affected only 6 patients within that time frame. The vials were moved to the refrigerator to be thawed for vaccinations on 8-Feb-2022, 21-Feb-2022, 31-Mar-2022, 2-May-2022 and 20-May-2022. The vials were stored in a fridge/freezer combo unit which are completely separate compartments with completely different temperature. Vials were not stored in approved freezer with a digital data logger.  No treatment medication was reported by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 6 patients vaccinated from vials stored in freezer no DDL temp monitoring; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer no DDL temp monitoring) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer no DDL temp monitoring). At the time of the report, PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer no DDL temp monitoring) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were given.  Reporter stated the pharmacy hasn't been using a data digital logger to monitor the freezer temperatures that the Moderna COVID-19 vaccine is stored in. The HCP reported 6 patients have received vaccination since February 2022 from these potentially affected vials that were originally stored in the freezer with no DDL monitoring. It was reported that to their knowledge, there has been no temperature excursion and the temperatures of the freezer remained consistently within range. They keep a written temperature log. It was reported that there is no current and previous temperature excursion. The storage condition at the time was frozen storage. The lot numbers supposedly affected were 022J21A, 083J21A, and 059M21A. Maximum or minimum temperatures were not recorded but only morning and evening temperatures were recorded. The excursion in question was from 8 Feb 2022 to 20 May 2022 and affected only 6 patients within that time frame. The vials were moved to the refrigerator to be thawed for vaccinations on 8 Feb 2022, 21 Feb 2022, 31 Mar 2022, 2 May 2022, and 20 May 2022.  No treatment information were given.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Patient received potentially affected vials that was stored in freezer with no DDL monitoring; Patient received potentially affected vials that was stored in freezer with no DDL monitoring; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) and PRODUCT STORAGE ERROR (Patient received potentially affected vials that was stored in freezer with no DDL monitoring) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  There was no change in the state of the vaccines, no temperature excursion history (the temperatures of the freezer remained consistently within range and was recorded in a log) and received them from shipment in frozen and remained frozen when in the freezer. Vial was thawed when patient came for vaccination. Storage condition was frozen. The lot numbers supposedly affected were 022J21A, 083J21A and 059M21A. Maximum/minimum temperatures were not recorded; only morning and evening temperatures were recorded. The excursion in question was from 8-Feb-2022 to 20-May-2022 and affected only 6 patients within that time frame. The vials were moved to the refrigerator to be thawed for vaccinations on 8-Feb-2022, 21-Feb-2022, 31-Mar-2022, 2-May-2022 and 20-May-2022. The vials were stored in a fridge/freezer combo unit which are completely separate compartments with completely different temperature.  No treatment medication was reported by reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Other time she had a gout flair was around a week or so before receiving the second Moderna booster dose; This spontaneous case was reported by a patient and describes the occurrence of GOUT (Other time she had a gout flair was around a week or so before receiving the second Moderna booster dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 prophylaxis.     Patient had never got COVID+ test or diagnosis in the past.  Previously administered products included for COVID-19 vaccination: Pfizer (1st primary series dose) on 13-Apr-2021 and Pfizer (2nd primary series dose) on 04-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (Codeine (rash)), Asthma (Started 30 years ago and still has rare occurrences. No recent change in status such as improvement or worsening reported), Blood pressure high (Started from more than 10 years ago. No recent change in status such as improvement or worsening reported), Atrial fibrillation (Started more than 10 years ago. No recent change in status such as improvement or worsening reported) and Hashimoto's thyroiditis (Started more than 10 years ago. No recent change in status such as improvement or worsening reported).  On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In 2022, the patient experienced GOUT (Other time she had a gout flair was around a week or so before receiving the second Moderna booster dose). At the time of the report, GOUT (Other time she had a gout flair was around a week or so before receiving the second Moderna booster dose) outcome was unknown.     Concomitant medications included unknown medication for high blood pressure and thyroid.  Dosage text was reported as first booster dose.  It was reported that the only other time patient had a gout flair was around a week or so before receiving the second Moderna booster dose.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Treatment information was not provided.   This case was linked to MOD-2022-596614 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Gout, Osteoarthritis, Pain, X-ray
Clinical narrative: Right foot gout flair; Pain was "pretty intense"; Couldn't walk for 3 to 4 days; Osteoarthritis; This spontaneous case was reported by a patient and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis), GOUT (Right foot gout flair), PAIN (Pain was "pretty intense") and GAIT DISTURBANCE (Couldn't walk for 3 to 4 days) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (1st primary series dose) on 13-Apr-2021 and Pfizer (2nd primary series dose) on 04-May-2021; for Drug use for unknown indication: Codeine. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer; and Rash with Codeine. Concurrent medical conditions included Drug allergy (Codeine (rash)), Asthma (30 years ago, No recent change in status such as improvement or worsening.) since 1992, Blood pressure high (Start Date: More than 10 years ago, No recent change in status such as improvement or worsening.), Atrial fibrillation (Start Date: More than 10 years ago, No recent change in status such as improvement or worsening.) and Hashimoto's thyroiditis (Start Date: More than 10 years ago, No recent change in status such as improvement or worsening.).    On 12-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In June 2022, the patient experienced OSTEOARTHRITIS (Osteoarthritis). On 17-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GOUT (Right foot gout flair), PAIN (Pain was "pretty intense") and GAIT DISTURBANCE (Couldn't walk for 3 to 4 days). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency and DICLOFENAC at an unspecified dose and frequency. At the time of the report, OSTEOARTHRITIS (Osteoarthritis) had not resolved and GOUT (Right foot gout flair), PAIN (Pain was "pretty intense") and GAIT DISTURBANCE (Couldn't walk for 3 to 4 days) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: results not provided Results not provided.         Concomitant medications included unknown "high blood pressure" medication, unknown "thyroid" medication. The patient experienced a right foot gout flair on 17Jun2022 that lasted for 3 to 4 days. Patient stated the pain was "pretty intense" and she couldn't walk for 3 to 4 days. The patient went to see her primary care physician and had an X-Ray performed. Patient stated her doctor believed it may be gout and also osteoarthritis. Additional tests in the future are to be performed to diagnose gout definitively. Patient was prescribed Celebrex and diclofenac for treatment. Patient reported on 29Jun2022 her right foot was "pretty normal". Patient stated all symptoms have improved.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered
Clinical narrative: COVID-19; received a vaccine that was past the use by date by two days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine that was past the use by date by two days) and COVID-19 (COVID-19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 010A21A and 032L20A) for COVID-19 vaccination.     She had no allergies to medications, food and other products. No medical history relating to mentioned adverse event was reported. She did not had any acute or chronic illnesses at the time of vaccination. She did not received any other manufacturer vaccine one month prior of receiving Moderna Covid-19 vaccine.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine that was past the use by date by two days). On 01-Jan-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine that was past the use by date by two days) outcome was unknown and COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, COVID-19: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication details were reported.  Patient did not seek medical care (office visit, urgent care, ER or hospitalization) for adverse event.  Company comment- This spontaneous case concerns a 41-year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 (with a positive SARS-CoV-2 test) that occurred 25 days after receiving the third dose of mRNA-1273 Vaccine.  Expired product administered was also reported in the case. No further information was provided. Outcome of the events was recovered at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 41-year-old female patient with no reported medical history, who experienced the unexpected non-serious AESI COVID-19 (with a positive SARS-CoV-2 test) that occurred 25 days after receiving the third dose of mRNA-1273 Vaccine.  Expired product administered was also reported in the case. No further information was provided. Outcome of the events was recovered at the time of this report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection/infusion for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 18-May-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: positive (Positive) Patient experienced COVID-19.         No concomitant drug reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality of HUMIRA, for the event(s) of COVID-19 was not provided and Possible for Pfizer Biontech COVID-19 vaccine.  No treatment information was provided by the reporter.  Company Comment: This spontaneous case concerns a 29 year-old male patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after a booster dose of mRNA-1273 vaccine administration. Patient was previously vaccinated with a dose of Comirnaty (Interchange of vaccine products). No treatment medication were reported. The diagnosis of COVID-19 was supported by a positive SARS-CoV-2 test. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 29 year-old male patient, with no relevant medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred unknown days after a booster dose of mRNA-1273 vaccine administration. Patient was previously vaccinated with a dose of Comirnaty (Interchange of vaccine products). No treatment medication were reported. The diagnosis of COVID-19 was supported by a positive SARS-CoV-2 test. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.