chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included ALENDRONATE SODIUM for Osteoporosis.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medications were reported.  Patient took second dose on 25 FEB 2021 in right arm with batch no. 0BL20A.   This case was linked to MOD-2021-354424 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) 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. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-354394.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received dose from vial past the 30-day use by date/vial was initially stored in the refrigerator on 13-Sep-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from vial past the 30-day use by date/vial was initially stored in the refrigerator on 13-Sep-2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from vial past the 30-day use by date/vial was initially stored in the refrigerator on 13-Sep-2021). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from vial past the 30-day use by date/vial was initially stored in the refrigerator on 13-Sep-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 5 First dose-67 patients received doses beyond the use date (30 days on refrigeration); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (5 First dose-67 patients received doses beyond the use date (30 days on refrigeration)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (5 First dose-67 patients received doses beyond the use date (30 days on refrigeration)). At the time of the report, PRODUCT STORAGE ERROR (5 First dose-67 patients received doses beyond the use date (30 days on refrigeration)) had resolved. Not Provided      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. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-354434, MOD-2021-354436 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: friends who has received the Moderna COVID 19 vaccine and had side effects days later; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (friends who has received the Moderna COVID 19 vaccine and had side effects days later) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    No Medical History information was reported.    On 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 VACCINATION COMPLICATION (friends who has received the Moderna COVID 19 vaccine and had side effects days later). At the time of the report, VACCINATION COMPLICATION (friends who has received the Moderna COVID 19 vaccine and had side effects days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided. Reporter stated that he had friends who have received the Moderna COVID 19 vaccine and had side effects days later. They all had it at different days. No further information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased activity, Illness
Clinical narrative: Couldn't function after second dose but was within the normal limits; Second dose made me ill; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED ACTIVITY (Couldn't function after second dose but was within the normal limits) and ILLNESS (Second dose made me ill) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0BL20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included ALENDRONATE SODIUM for Osteoporosis.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED ACTIVITY (Couldn't function after second dose but was within the normal limits) and ILLNESS (Second dose made me ill). At the time of the report, DECREASED ACTIVITY (Couldn't function after second dose but was within the normal limits) and ILLNESS (Second dose made me ill) outcome was unknown.            No treatment medicines were reported.  Patient stated she hesitant to take the booster.   This case was linked to MOD-2021-354399 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Palpitations, Somnolence
Clinical narrative: Palpations of the Heart; Sleepy; Headache until to date; Chills; Nausea, no vomiting; Soreness of Upper Left Arm where the Shot was given; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), CHILLS (Chills) and NAUSEA (Nausea, no vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), CHILLS (Chills), NAUSEA (Nausea, no vomiting) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given). At the time of the report, PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), CHILLS (Chills), NAUSEA (Nausea, no vomiting) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given) outcome was unknown and HEADACHE (Headache until to date) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant and Treatment medication were reported.  The patient had two shots of the Moderna Vaccine of which during the same night and awoke to reaction.   This case was linked to MOD-2021-354466 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Palpations of the Heart; Sleepy; Headache until to date; Chills; Nausea, no vomiting; Soreness of Upper Left Arm where the Shot was given; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), CHILLS (Chills) and NAUSEA (Nausea, no vomiting) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), CHILLS (Chills), NAUSEA (Nausea, no vomiting) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given). At the time of the report, PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), CHILLS (Chills), NAUSEA (Nausea, no vomiting) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given) outcome was unknown and HEADACHE (Headache until to date) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant and Treatment medication were reported.  The patient had two shots of the Moderna Vaccine of which during the same night and awoke to reaction.   This case was linked to MOD-2021-354466 (Patient Link).
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered past the 30 day use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30 day use) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30 day use). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30 day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered from a vial that was greater than 12 hours post puncture at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was greater than 12 hours post puncture at room temperature) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was greater than 12 hours post puncture at room temperature). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered from a vial that was greater than 12 hours post puncture at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. Th e reporter stated that the patient experienced no side effects after the vaccination.   This case was linked to MOD21-152960, MOD21-152979, MOD21-152980, MOD-2021-354372, MOD-2021-354517 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients received second dose beyond the use date (30 days on refrigeration); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received second dose beyond the use date (30 days on refrigeration)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 EXPIRED PRODUCT ADMINISTERED (10 patients received second dose beyond the use date (30 days on refrigeration)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 patients received second dose beyond the use date (30 days on refrigeration)) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment information was not provided.   This case was linked to MOD-2021-354415, MOD-2021-354436.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 52 patients received third dose beyond the use date (30 days on refrigeration); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (52 patients received third dose beyond the use date (30 days on refrigeration)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) 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 EXPIRED PRODUCT ADMINISTERED (52 patients received third dose beyond the use date (30 days on refrigeration)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (52 patients received third dose beyond the use date (30 days on refrigeration)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-354415, MOD-2021-354434 (Patient Link).
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received Moderna vaccine at Regulatory Authority.  No concomitant medications were provided. No treatment medication were provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Off label use, Somnolence, Vaccination site erythema, Vaccination site pain
Clinical narrative: Painful for the shot; bright red, Some Redness; left arm swollen, left arm was swollen above shoulder almost down to elbow; groggy; felt like she had been drugged, terrible reaction to third shot.; Caller reports she is not immunocompromised, Patient states "I got my booster shot"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Painful for the shot), VACCINATION SITE ERYTHEMA (bright red, Some Redness), VACCINATION SITE SWELLING (left arm swollen, left arm was swollen above shoulder almost down to elbow), SOMNOLENCE (groggy) and FEELING ABNORMAL (felt like she had been drugged, terrible reaction to third shot.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 042L20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) and CALCIUM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced SOMNOLENCE (groggy), FEELING ABNORMAL (felt like she had been drugged, terrible reaction to third shot.) and OFF LABEL USE (Caller reports she is not immunocompromised, Patient states "I got my booster shot"). On 13-Oct-2021, the patient experienced VACCINATION SITE PAIN (Painful for the shot), VACCINATION SITE ERYTHEMA (bright red, Some Redness) and VACCINATION SITE SWELLING (left arm swollen, left arm was swollen above shoulder almost down to elbow). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. On 12-Oct-2021, OFF LABEL USE (Caller reports she is not immunocompromised, Patient states "I got my booster shot") had resolved. At the time of the report, VACCINATION SITE PAIN (Painful for the shot) and VACCINATION SITE SWELLING (left arm swollen, left arm was swollen above shoulder almost down to elbow) was resolving and VACCINATION SITE ERYTHEMA (bright red, Some Redness), SOMNOLENCE (groggy) and FEELING ABNORMAL (felt like she had been drugged, terrible reaction to third shot.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant include : B - shot 1/month, crill oil , organic collagen.  Treatment include : Treatment Aleve in morning and night for a knee that was acting up for about three weeks (that started before shot).   This case was linked to MOD-2021-354658, MOD-2021-354665 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Painful for the shot; bright red, Some Redness; left arm swollen, left arm was swollen above shoulder almost down to elbow; groggy; felt like she had been drugged, terrible reaction to third shot.; Caller reports she is not immunocompromised, Patient states "I got my booster shot"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Painful for the shot), VACCINATION SITE ERYTHEMA (bright red, Some Redness), VACCINATION SITE SWELLING (left arm swollen, left arm was swollen above shoulder almost down to elbow), SOMNOLENCE (groggy) and FEELING ABNORMAL (felt like she had been drugged, terrible reaction to third shot.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 042L20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE, VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]) and CALCIUM for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced SOMNOLENCE (groggy), FEELING ABNORMAL (felt like she had been drugged, terrible reaction to third shot.) and OFF LABEL USE (Caller reports she is not immunocompromised, Patient states "I got my booster shot"). On 13-Oct-2021, the patient experienced VACCINATION SITE PAIN (Painful for the shot), VACCINATION SITE ERYTHEMA (bright red, Some Redness) and VACCINATION SITE SWELLING (left arm swollen, left arm was swollen above shoulder almost down to elbow). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. On 12-Oct-2021, OFF LABEL USE (Caller reports she is not immunocompromised, Patient states "I got my booster shot") had resolved. At the time of the report, VACCINATION SITE PAIN (Painful for the shot) and VACCINATION SITE SWELLING (left arm swollen, left arm was swollen above shoulder almost down to elbow) was resolving and VACCINATION SITE ERYTHEMA (bright red, Some Redness), SOMNOLENCE (groggy) and FEELING ABNORMAL (felt like she had been drugged, terrible reaction to third shot.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant include : B - shot 1/month, crill oil , organic collagen.  Treatment include : Treatment Aleve in morning and night for a knee that was acting up for about three weeks (that started before shot).   This case was linked to MOD-2021-354658, MOD-2021-354665 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses were administered from syringes and left at room temperature for 24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered from syringes and left at room temperature for 24 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered from syringes and left at room temperature for 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered from syringes and left at room temperature for 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Health care professional  states patients had received doses of  vaccine and  did not had information for the patients at that time, number of doses/vials: around 100 doses were administered /from 14 dose vials, not sure how many vials were affected.the vial was initially stored in the refrigerator: HCP did not have the exact information but stated vials were stored frozen and move to the refrigerator conditions daily.   The doses were draw up from the vial all at once (emptying the vial) and the syringes were left at room temperature and used for up to 24 hours. The vial doesn't undergo any temperature excursions . Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F). Syringes were exposed to room temperature for up to 24hours Concomitant medication use was unknown  Treatment information was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nausea
Clinical narrative: Felt like she had the flu; Felt nauseous; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like she had the flu) and NAUSEA (Felt nauseous) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like she had the flu) and NAUSEA (Felt nauseous). At the time of the report, INFLUENZA LIKE ILLNESS (Felt like she had the flu) and NAUSEA (Felt nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment  medications were reported.   This case was linked to MOD-2021-354622 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered past the 30-day use be date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use be date) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use be date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use be date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site joint pain
Clinical narrative: Patient received vaccine on shoulder and experienced simillar aggrevation of pain on that shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT PAIN (Patient received vaccine on shoulder and experienced simillar aggrevation of pain on that shoulder) in a 62-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 VACCINATION SITE JOINT PAIN (Patient received vaccine on shoulder and experienced simillar aggrevation of pain on that shoulder). At the time of the report, VACCINATION SITE JOINT PAIN (Patient received vaccine on shoulder and experienced simillar aggrevation of pain on that shoulder) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter  The anatomical location of vaccine was shoulder   This case was linked to MOD-2021-354390 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: chronic arthritis got better, chronic headache got better, chronic arthritis continued to get better; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (chronic arthritis got better, chronic headache got better, chronic arthritis continued to get better) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (chronic arthritis) and Headache (chronic headache).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 19-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (chronic arthritis got better, chronic headache got better, chronic arthritis continued to get better). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (chronic arthritis got better, chronic headache got better, chronic arthritis continued to get better) outcome was unknown.            No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.  It was reported that the patients chronic headache and chronic arthritis continued to get better on  19-MAR-2021.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: follow-up received contain patient demographics that is patient initial has been updated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine beyond MFG Exp. Date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided  The reporter stated that only Lot # 001C21A was used to inject 7 people beyond the manufacturer expiration date on 13 & 14th OCT2021 (Lot# 001C21A & MFG Exp. Date: 12OCT2021). The reporter stated that she does not think that any were pregnant because of their age. The reporter also stated that she thinks that it was the second dose for all recipients but was not sure.   This case was linked to MOD-2021-354610 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination complication
Clinical narrative: AE additional patient information provided/adverse events; 5 doses were administered expired yesterday 14Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021) and VACCINATION COMPLICATION (AE additional patient information provided/adverse events) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021). On an unknown date, the patient experienced VACCINATION COMPLICATION (AE additional patient information provided/adverse events). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021) had resolved. At the time of the report, VACCINATION COMPLICATION (AE additional patient information provided/adverse events) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-354310 (Patient Link).
Age: 33.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: having similar side effect to her own; Injection arm hurts reported on blog; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having similar side effect to her own) and VACCINATION SITE PAIN (Injection arm hurts reported on blog) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (having similar side effect to her own) and VACCINATION SITE PAIN (Injection arm hurts reported on blog). At the time of the report, VACCINATION COMPLICATION (having similar side effect to her own) and VACCINATION SITE PAIN (Injection arm hurts reported on blog) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication listed.   No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 31.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30-day use by date) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: I'm just sitting here trying to check on my own vitals; This spontaneous case was reported by a consumer and describes the occurrence of VITAL SIGNS MEASUREMENT (I'm just sitting here trying to check on my own vitals) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VITAL SIGNS MEASUREMENT (I'm just sitting here trying to check on my own vitals). At the time of the report, VITAL SIGNS MEASUREMENT (I'm just sitting here trying to check on my own vitals) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: normal (normal) Result : patient tried to check on its vitals.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information provided. Patient went to a hospital a lot.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Type 2 diabetes mellitus
Clinical narrative: Type II diabetes mellitus; Sever tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TYPE 2 DIABETES MELLITUS (Type II diabetes mellitus) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 TYPE 2 DIABETES MELLITUS (Type II diabetes mellitus) (seriousness criterion medically significant) and TINNITUS (Sever tinnitus). At the time of the report, TYPE 2 DIABETES MELLITUS (Type II diabetes mellitus) and TINNITUS (Sever tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant product usage were not reported by the reporter. No treatment details were added.  This case concerns a 42-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of type 2 diabetes mellitus. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 42-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of type 2 diabetes mellitus. The event occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: anyone who has received the first Moderna shot and second shot mistakenly was given Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (anyone who has received the first Moderna shot and second shot mistakenly was given Pfizer) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (anyone who has received the first Moderna shot and second shot mistakenly was given Pfizer). On 15-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (anyone who has received the first Moderna shot and second shot mistakenly was given Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.  This patient received the second shot with Pfizer vaccine by accident on 15-OCT-2021 Lot FF8839.   The patient was fine and she does not have any side effects.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Additional information received and patient demographics were updated
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site erythema
Clinical narrative: Sharp electric pain that goes some inches up her right leg; Sharp electric pain in her right ankle; In the injection site she has a red stripe (not rounded as usually you would get from a shot), it is a 2 inch by 5 inch oblong red stripe; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sharp electric pain that goes some inches up her right leg), ARTHRALGIA (Sharp electric pain in her right ankle) and VACCINATION SITE ERYTHEMA (In the injection site she has a red stripe (not rounded as usually you would get from a shot), it is a 2 inch by 5 inch oblong red stripe) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 027A21A and 019821A) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosus. Concomitant products included PREDNISONE for Systemic lupus erythematosus.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE ERYTHEMA (In the injection site she has a red stripe (not rounded as usually you would get from a shot), it is a 2 inch by 5 inch oblong red stripe). On 15-Oct-2021 at 4:00 AM, the patient experienced PAIN IN EXTREMITY (Sharp electric pain that goes some inches up her right leg) and ARTHRALGIA (Sharp electric pain in her right ankle). At the time of the report, PAIN IN EXTREMITY (Sharp electric pain that goes some inches up her right leg), ARTHRALGIA (Sharp electric pain in her right ankle) and VACCINATION SITE ERYTHEMA (In the injection site she has a red stripe (not rounded as usually you would get from a shot), it is a 2 inch by 5 inch oblong red stripe) outcome was unknown.            Treatment medication was not provided by the reporter.  The patient did not experience any adverse events after first and second dose.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pruritus, Vaccination site pain
Clinical narrative: Right arm started to itch; Pain around the injection site; Feel sick; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Right arm started to itch), ILLNESS (Feel sick), FATIGUE (Tired) and VACCINATION SITE PAIN (Pain around the injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Urinary tract disorder NOS. Concomitant products included LOSARTAN for Blood pressure abnormal, METHOCARBAMOL for Muscle relaxant, FAMOTIDINE for Stomach discomfort, OXYBUTYNIN for Urinary tract disorder NOS, ALBUTEROL [SALBUTAMOL] and OXYCODONE HYDROCHLORIDE (OXYCODON) for an unknown indication.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced ILLNESS (Feel sick) and FATIGUE (Tired). On 15-Oct-2021, the patient experienced PRURITUS (Right arm started to itch) and VACCINATION SITE PAIN (Pain around the injection site). On 15-Oct-2021, ILLNESS (Feel sick) and FATIGUE (Tired) had resolved. At the time of the report, PRURITUS (Right arm started to itch) and VACCINATION SITE PAIN (Pain around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications were not provided.  Concomitant medication included Albuterol which was used as a bronchodilator and Oxycodon which was used as an analgesic.  Patient did not was fine for first few days.