chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 2:47 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the Reporter. No Treatment Information were provided by the Reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 3:47 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 03-Nov-2021 at 1:47 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drugs were reported.  Patient allergic to medications, food and other product was unknown at the time of reporting. It was unknown that the patient had ever been diagnosed or tested positive for COVID-19.  The vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight. Excursion duration was reported as 1 month and on 19NOV2021 vials went from the super cold freezer to the refrigerator. At the time of reporting, 70 vials were still in ultra cold freezer and 8 vials were stored in refrigerator. No vaccine state changes were noticed and the vaccine was never refrozen. Number of vials/doses 78 vials were impacted. No previous temperature excursions were noticed.  No treatment drugs were reported.   This case was linked to MOD-2021-402935.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator included 14Jan2022.  The administration of vaccine included 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022. The vial did not undergo any temperature excursions. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-492833 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported Pharmacist reported that they gave 26 doses after the 30-day use by date. Pharmacist would like to know if those doses were viable or not. Number of doses/vials: 26 Date the vial was initially stored in the refrigerator : 14Jan2022  Date(s) of administration of vaccine: 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.Vial did not undergo any temperature excursions.  No treatment information was reported. .
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist reported that they gave 26 doses after the 30-day use by date. Pharmacist would like to know if those doses were viable or not. Number of doses/vials: 26 Date the vial was initially stored in the refrigerator : 14Jan2022  Date(s) of administration of vaccine: 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.Vial did not undergo any temperature excursions. No concomitant products were reported. No treatment information was reported. .
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) 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, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported. Number of doses/vials: 26 Date the vial was initially stored in the refrigerator: 14Jan2022. Dates of administration of vaccine reported as 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator on 14Jan2022. Reporter stated that vial does not undergo any temperature excursions. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: 14Jan2022 Dates of administration of vaccine: 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022. No concomitant and treatment medication details
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Patient felt achy; Pain in left arm; Patient felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm), PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Hypertension (Started at the age of 25), Asthma (started at the age of 30), Hypothyroidism (started 6 years ago), Sulfonamide allergy and Hypersensitivity (Sulfites, even in food). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, CHLORTALIDONE (CHLORTHALIDONE) for Diuretic therapy, LEVOTHYROXINE for Hypothyroidism, POTASSIUM and SALMETEROL XINAFOATE (SEREVENT) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm). In January 2021, the patient experienced FATIGUE (Patient felt a little tired). In January 2022, the patient experienced PAIN (Patient felt achy). On 11-Jan-2021, PAIN IN EXTREMITY (Pain in left arm) had resolved. At the time of the report, PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient height was reported as 5'3.  On 21Feb2022 she visited her dentist, and he noticed large swollen lymph nodes under her neck, it was bilateral. Dentist prescribed antibiotics because maybe this was due to an infection, but recommended to visit her physician to find out what could be the real cause. On 22Feb2022 patient visited to a massage therapist, and she told her there was also swollen lymph nodes on the armpit.   This case was linked to MOD-2022-493593 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Patient felt achy; Pain in left arm; Patient felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm), PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Hypertension (Started at the age of 25), Asthma (started at the age of 30), Hypothyroidism (started 6 years ago), Sulfonamide allergy and Hypersensitivity (Sulfites, even in food). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, CHLORTALIDONE (CHLORTHALIDONE) for Diuretic therapy, LEVOTHYROXINE for Hypothyroidism, POTASSIUM and SALMETEROL XINAFOATE (SEREVENT) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm). In January 2021, the patient experienced FATIGUE (Patient felt a little tired). In January 2022, the patient experienced PAIN (Patient felt achy). On 11-Jan-2021, PAIN IN EXTREMITY (Pain in left arm) had resolved. At the time of the report, PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient height was reported as 5'3.  On 21Feb2022 she visited her dentist, and he noticed large swollen lymph nodes under her neck, it was bilateral. Dentist prescribed antibiotics because maybe this was due to an infection, but recommended to visit her physician to find out what could be the real cause. On 22Feb2022 patient visited to a massage therapist, and she told her there was also swollen lymph nodes on the armpit.   This case was linked to MOD-2022-493593 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Bilateral large swollen lymph nodes under the neck and in the armpit; Patient felt a little tired; experience pain in left arm during 5 days after injection; Patient felt achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experience pain in left arm during 5 days after injection), PAIN (Patient felt achy), LYMPHADENOPATHY (Bilateral large swollen lymph nodes under the neck and in the armpit) and FATIGUE (Patient felt a little tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 012M20A and 012L20A) for COVID-19 vaccination.   Concurrent medical conditions included Hypothyroidism (Started 6 years ago), Asthma (Started at age of 30), Allergy to chemicals, Food allergy, Penicillin allergy, Sulfonamide allergy and Hypertension (Started at age of 25). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, CHLORTHALIDONE for Diuretic therapy, LEVOTHYROXINE for Hypothyroidism, POTASSIUM and SALMETEROL XINAFOATE (SEREVENT) for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced PAIN IN EXTREMITY (experience pain in left arm during 5 days after injection), PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired). On 21-Feb-2022, the patient experienced LYMPHADENOPATHY (Bilateral large swollen lymph nodes under the neck and in the armpit). On 28-Aug-2021, PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired) had resolved. On 01-Sep-2021, PAIN IN EXTREMITY (experience pain in left arm during 5 days after injection) had resolved. At the time of the report, LYMPHADENOPATHY (Bilateral large swollen lymph nodes under the neck and in the armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Four weeks after booster dose, she got flu shot. No treatment was given for immediate symptoms after vaccination. Dentist prescribed antibiotics for swollen lymph nodes, because it could be due to an infection, but he was not sure.  On 21-Feb-2022 she visited her dentist, and he noticed large swollen lymph nodes under her neck, it was bilateral. Dentist prescribed antibiotics because maybe this was due to an infection, but recommended to visit her physician to find out what could be the real cause. On 22-Feb-2022 patient visited to a massage therapist, and she told her there was also swollen lymph nodes on the armpit.   This case was linked to MOD-2022-493593 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Bilateral large swollen lymph nodes under the neck and in the armpit; Patient felt a little tired; experience pain in left arm during 5 days after injection; Patient felt achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experience pain in left arm during 5 days after injection), PAIN (Patient felt achy), LYMPHADENOPATHY (Bilateral large swollen lymph nodes under the neck and in the armpit) and FATIGUE (Patient felt a little tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906, 012M20A and 012L20A) for COVID-19 vaccination.   Concurrent medical conditions included Hypothyroidism (Started 6 years ago), Asthma (Started at age of 30), Allergy to chemicals, Food allergy, Penicillin allergy, Sulfonamide allergy and Hypertension (Started at age of 25). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, CHLORTHALIDONE for Diuretic therapy, LEVOTHYROXINE for Hypothyroidism, POTASSIUM and SALMETEROL XINAFOATE (SEREVENT) for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced PAIN IN EXTREMITY (experience pain in left arm during 5 days after injection), PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired). On 21-Feb-2022, the patient experienced LYMPHADENOPATHY (Bilateral large swollen lymph nodes under the neck and in the armpit). On 28-Aug-2021, PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired) had resolved. On 01-Sep-2021, PAIN IN EXTREMITY (experience pain in left arm during 5 days after injection) had resolved. At the time of the report, LYMPHADENOPATHY (Bilateral large swollen lymph nodes under the neck and in the armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Four weeks after booster dose, she got flu shot. No treatment was given for immediate symptoms after vaccination. Dentist prescribed antibiotics for swollen lymph nodes, because it could be due to an infection, but he was not sure.  On 21-Feb-2022 she visited her dentist, and he noticed large swollen lymph nodes under her neck, it was bilateral. Dentist prescribed antibiotics because maybe this was due to an infection, but recommended to visit her physician to find out what could be the real cause. On 22-Feb-2022 patient visited to a massage therapist, and she told her there was also swollen lymph nodes on the armpit.   This case was linked to MOD-2022-493593 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:33 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 2:33 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications on use were not provided.  Patients were given doses from vials that were stored in an ultracold freezer which is colder than they should have been. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion. The vials moved from freezer to refrigerator on 03 Nov 2021. The maximum and minimum reached temperatures was negative 82 degrees Fahrenheit. The vials were returned to the freezer or refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursion issues had happened.  No treatment information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity
Clinical narrative: Pain in left arm; Patient felt achy; Patient felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm), PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Allergy to chemicals (Sulfites, even in food), Hypertension (started at age of 25), Asthma (started at age of 30) and Hypothyroidism (started 6 years ago). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) for Asthma, CHLORTALIDONE (CHLORTHALIDONE) for Diuretic therapy, LEVOTHYROXINE for Hypothyroidism, POTASSIUM and SALMETEROL XINAFOATE (SEREVENT) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm), PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired). On 05-Feb-2021, PAIN (Patient felt achy) and FATIGUE (Patient felt a little tired) had resolved. On 09-Feb-2021, PAIN IN EXTREMITY (Pain in left arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had not taken COVID test. No treatment was given for immediate symptoms after vaccination.   This case was linked to MOD-2022-493586, MOD-2022-493598 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 3:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion and minimum reached temperatures was negative 82 degrees Fahrenheit.The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19 Nov 2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer or refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator.No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 4:39 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 4:39 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient was given a dose from a vial that was stored in an ultracold freezer which was colder than they should have been.  No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 3:20 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Nov-2021 at 3:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   It was reported that the vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight and 280 patients received Moderna Covid 19 stored at minus 82 degrees Farenheight.  The patient allergies were reported as unknown. It was also unknown if the patient was diagnosed with or tested positive for COVID-19.  The treatment information was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter called to report they gave 26 doses after the 30-day use by date. It was reported that the vial was initially stored in the refrigerator on 14 Jan 2022. The dates of vaccine administration were 14 Feb 2022, 15 Feb 2022, 16 Feb 2022, 18 Feb 2022, 21 Feb 2022.  No treatment medication was reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 3:58 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021 at 3:58 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.  No treatment medications were provided.  Total 280 patients received Moderna  COVID-19 stored at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator 14Jan2022. The vaccine was administered on 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.  No treatment medication information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the 30-day use by date) 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. Patient took booster dose. On 14-Jan-2022 the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medication was reported by reporter.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (administered past the 30-day use-by-date) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 042J21A) for COVID-19 immunization. No medical history reported. February 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. February 2022, patient administered expired product (administered past the 30-day use-by-date). At the time of the report, administered expired product (administered past the 30-day use-by-date) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reportedly, 26 doses given after the 30-day use-by-date. It was reported the vial was initially stored in the refrigerator on Jan 14, 2022. The dates of vaccine administration were Feb 14, 2022; Feb 15, 2022; Feb 16, 2022; Feb 18, 2022 and Feb 21, 2022.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) 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, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist called because they gave 26 doses after the 30-day use by date. Pharmacist would like to know if those doses were viable or not.  Dose administered after 30-day Use by Date or after manufacturer date of expiry  Total number of doses/vials was 26.  On 14-Jan-2022, the vial was initially stored in the refrigerator.   Date(s) of administration of vaccine on 14-Feb-2022, 15-Feb-2022, 16-Feb-2022, 18-Feb-2022 and 21-Feb-2022.  vial did not undergo any temperature excursions.  No treatment drug were reported.   No concomitant medication were reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: doses administered past the 30-day use by date; Dose administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) and PRODUCT STORAGE ERROR (doses administered past the 30-day use by date) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) and PRODUCT STORAGE ERROR (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was initially stored in the refrigerator on 14-Jan-2022. The administration of vaccines were 14-Feb-2022, 15-Feb-2022, 16-Feb-2022, 18-Feb-2022, 21-Feb-2022. No concomitant medications were reported. The vial had not undergone any temperature excursions. No treatment medications were reported.   This case was linked to MOD-2022-492833 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported Pharmacist reported that they gave 26 doses after the 30-day use by date. Pharmacist would like to know if those doses were viable or not. Number of doses/vials: 26 Date the vial was initially stored in the refrigerator : 14Jan2022  Date(s) of administration of vaccine: 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.Vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past the 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications details were reported. Pharmacist reported that they gave 26 doses after the 30-day use by date. Pharmacist would like to know if those doses were viable or not. Number of doses/vials: 26 Date the vial was initially stored in the refrigerator : 14Jan2022  Date(s) of administration of vaccine: 14Feb2022, 15Feb2022, 16Feb2022, 18Feb2022, 21Feb2022.Vial did not undergo any temperature excursions.   No treatment information details were reported.