chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Mobility decreased, Nausea, Pollakiuria
Clinical narrative: Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient never had COVID-19 test or diagnosis and did not took other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient's concurrent medical condition includes Blood pressure.  The patient's past medical history included Mitral valve replacement (15 years ago). Concurrent medical conditions included Drug allergy (Beta blockers (some)), Diabetes, Cholesterosis, Heart disorder and Glaucoma. Concomitant products included WARFARIN SODIUM (JANTOVEN) for Anticoagulant therapy, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for Blood pressure management, METOPROLOL SUCCINATE for Cardiac disorder, SIMVASTATIN for Cholesterosis, GLIMEPIRIDE for Diabetes, LATANOPROST and BRIMONIDINE for Glaucoma.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Jan-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On 27-Jan-2021, DIZZINESS (Dizziness) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient stated that AE did not cause patient to seek medical care and patient did not experienced similar events in the past. Patient also stated that due to a mitral valve issue that was diagnosed about 15 years ago she was put on blood thinners once she had the surgery for the mechanical heart valve. Recent status was reported as Stable. Due to this issue, her doctors have categorized her as a high risk patient. She had an increased chance of getting serious infections for even smaller infections like sinus.  No treatment medication information was provided.   This case was linked to MOD-2022-540353, MOD-2022-540288 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (frequent urination), MOBILITY DECREASED (if she was on the floor, she could not pull herself up), HEADACHE (headaches with the 2nd one, headache got worse if she moved her head up and down), NAUSEA (nausea) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included Mitral valve replacement (15 years ago). Concurrent medical conditions included Drug allergy (Some Beta blockers). Concomitant products included WARFARIN SODIUM (JANTOVEN) for Anticoagulant therapy, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for Blood pressure, SIMVASTATIN for Cholesterol, GLIMEPIRIDE for Diabetes, LATANOPROST and BRIMONIDINE for Glaucoma, METOPROLOL SUCCINATE for Heart disorder. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Jan-2021, the patient experienced HEADACHE (headaches with the 2nd one, headache got worse if she moved her head up and down). On an unknown date, the patient experienced POLLAKIURIA (frequent urination), MOBILITY DECREASED (if she was on the floor, she could not pull herself up), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, POLLAKIURIA (frequent urination), MOBILITY DECREASED (if she was on the floor, she could not pull herself up), HEADACHE (headaches with the 2nd one, headache got worse if she moved her head up and down), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had a history of mechanical heart valve due to a mitral valve issue that was diagnosed about 15 years ago and she was put on blood thinners once she had the surgery for the mechanical heart valve. Due to this issue, her doctors have categorized her as a high-risk patient. She has an increased chance of getting serious infections for even smaller infections like sinus. She says that it becomes a life and death situation for her. No recent changes in the mitral valve replacement were observed and condition was stable. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. All the dose 2 events didn't cause patient to seek medical care. Patient not tested positive for COVID-19. This case was linked to MOD-2022-540353, MOD-2022-540133, MOD-2022-540507 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Delirium, Headache, Nausea, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (frequent urination), MOBILITY DECREASED (if she was on the floor, she could not pull herself up), HEADACHE (headaches with the 2nd one, headache got worse if she moved her head up and down), NAUSEA (nausea) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included Mitral valve replacement (15 years ago). Concurrent medical conditions included Drug allergy (Some Beta blockers). Concomitant products included WARFARIN SODIUM (JANTOVEN) for Anticoagulant therapy, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for Blood pressure, SIMVASTATIN for Cholesterol, GLIMEPIRIDE for Diabetes, LATANOPROST and BRIMONIDINE for Glaucoma, METOPROLOL SUCCINATE for Heart disorder. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Jan-2021, the patient experienced HEADACHE (headaches with the 2nd one, headache got worse if she moved her head up and down). On an unknown date, the patient experienced POLLAKIURIA (frequent urination), MOBILITY DECREASED (if she was on the floor, she could not pull herself up), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, POLLAKIURIA (frequent urination), MOBILITY DECREASED (if she was on the floor, she could not pull herself up), HEADACHE (headaches with the 2nd one, headache got worse if she moved her head up and down), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had a history of mechanical heart valve due to a mitral valve issue that was diagnosed about 15 years ago and she was put on blood thinners once she had the surgery for the mechanical heart valve. Due to this issue, her doctors have categorized her as a high-risk patient. She has an increased chance of getting serious infections for even smaller infections like sinus. She says that it becomes a life and death situation for her. No recent changes in the mitral valve replacement were observed and condition was stable. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. All the dose 2 events didn't cause patient to seek medical care. Patient not tested positive for COVID-19. This case was linked to MOD-2022-540353, MOD-2022-540133, MOD-2022-540507 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Mobility decreased, Nausea, Pollakiuria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (frequent urination), MOBILITY DECREASED (if she was on the floor, she could not pull herself up), HEADACHE (headaches with the 2nd one, headache got worse if she moved her head up and down), NAUSEA (nausea) and FATIGUE (fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included Mitral valve replacement (15 years ago). Concurrent medical conditions included Drug allergy (Some Beta blockers). Concomitant products included WARFARIN SODIUM (JANTOVEN) for Anticoagulant therapy, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for Blood pressure, SIMVASTATIN for Cholesterol, GLIMEPIRIDE for Diabetes, LATANOPROST and BRIMONIDINE for Glaucoma, METOPROLOL SUCCINATE for Heart disorder. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 23-Jan-2021, the patient experienced HEADACHE (headaches with the 2nd one, headache got worse if she moved her head up and down). On an unknown date, the patient experienced POLLAKIURIA (frequent urination), MOBILITY DECREASED (if she was on the floor, she could not pull herself up), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, POLLAKIURIA (frequent urination), MOBILITY DECREASED (if she was on the floor, she could not pull herself up), HEADACHE (headaches with the 2nd one, headache got worse if she moved her head up and down), NAUSEA (nausea) and FATIGUE (fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had a history of mechanical heart valve due to a mitral valve issue that was diagnosed about 15 years ago and she was put on blood thinners once she had the surgery for the mechanical heart valve. Due to this issue, her doctors have categorized her as a high-risk patient. She has an increased chance of getting serious infections for even smaller infections like sinus. She says that it becomes a life and death situation for her. No recent changes in the mitral valve replacement were observed and condition was stable. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. All the dose 2 events didn't cause patient to seek medical care. Patient not tested positive for COVID-19. This case was linked to MOD-2022-540353, MOD-2022-540133, MOD-2022-540507 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, SARS-CoV-2 antibody test
Clinical narrative: Last august before the first booster came out, the caller got the 3rd full shot and was not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Last august before the first booster came out, the caller got the 3rd full shot and was not immunocompromised) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023D21A, 046B21A and 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Last august before the first booster came out, the caller got the 3rd full shot and was not immunocompromised). At the time of the report, EXTRA DOSE ADMINISTERED (Last august before the first booster came out, the caller got the 3rd full shot and was not immunocompromised) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: high (High) Levels were soaring.         No concomitant medications were reported. No treatment medications were reported.  Patient stated that she was not immunocompromised and was administered with full shot and thought it was a booster at that time and did not know that it was not out yet.
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Patients administered with vaccines that have undergone temperature excursion; 40 patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) and EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) and EXPIRED PRODUCT ADMINISTERED (40 patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No patients have reported any adverse events to date. It was reported that on 28 -Jan-2022 temp range: positive 34.7F to positive 41.2F; on 30-Jan-2022 temp range: positive 34.7F to positive 41.2F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range:positive 35.2F to positive 41.7F for 12 hours. The vial was thawed on 28 Jan 2022.  No treatment medication were reported.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient administered with vaccines that have undergone temperature excursion; Patient administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccines that have undergone temperature excursion) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccines that have undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Storage condition at the time of the excursion was reported as refrigerator. Maximum or minimum temperatures reached on 28-Jan-2022 temperature range positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit, on 30-Jan-2022 temperature range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit which occurred approximately for 48 hours, on 31-Jan-2022 temperature range was positive 34.7 degree Fahrenheit to positive 41.2 degree Fahrenheit for 12 hours and on 04-Feb-2022 temperature range was positive 35.2 degree Fahrenheit to positive 41.7 degree Fahrenheit for 12 hours.   It was patient's booster dose. Reporter stated that the vial was stored in refrigerator at the time of excursion. Vial was thawed on 28-Jan-2022.  The patient did not experienced any adverse event.  No treatment information was reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used) 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. The vial was first punctured on 13 Apr 2022 at 8.53 AM. Date the vial was initially stored in the refrigerator: 04-Apr-2022. The vial was stored in refrigerated post puncture. The vial did not undergo any temperature excursions . The vial stored post puncture was refrigerated. Total amount of time the vial was exposed to room temperature range was less than 15 minutes. Patient did not complain of any other adverse reactions. No treatment information was provided by the reporter.   This case was linked to MOD-2022-540270.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 Patients who received Moderna Covid-19 vaccine 12 hours after the vial had first been used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. Patient did not complain of any other adverse reactions. No treatment were reported.   This case was linked to MOD-2022-540270 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Nurse had popped a vial of Moderna Covid-19 yesterday on 13 Apr 2022 and doses were administered from the vial greater than 12 hours later; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse had popped a vial of Moderna Covid-19 yesterday on 13 Apr 2022 and doses were administered from the vial greater than 12 hours later) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J212A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022 at 2:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse had popped a vial of Moderna Covid-19 yesterday on 13 Apr 2022 and doses were administered from the vial greater than 12 hours later). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse had popped a vial of Moderna Covid-19 yesterday on 13 Apr 2022 and doses were administered from the vial greater than 12 hours later) 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 was on  04 Apr 2022. The vial was first punctured on 13 Apr 2022 at 8.53 AM and the vial was stored in refrigerated post puncture. The vial did not undergo any temperature excursions.Total amount of time the vial was exposed to room temperature range was less than 15 minutes. It was reported that the patient received first booster dose Moderna Covid-19 vaccine 12 hours after the vial had first been used. No adverse reactions known of to the primary series of the Moderna Covid-19 vaccine. Patient did not complain of any other adverse reactions. No treatment information was reported.   This case was linked to MOD-2022-540183, MOD-2022-540269, MOD-2022-540268 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site swelling
Clinical narrative: redness; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site) outcome was unknown. No concomitant medications were reported. The patient received the second booster dose of Moderna vaccine on 13-Apr-2022.  The patient reported that the patient could feel the area when the patient touches it.  No treatment information was provided.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product temperature excursion issue
Clinical narrative: Patients administered with vaccines that have undergone temperature excursion; First dose administered on 29-Sep-22 and second dose administered on 31-Jan-22; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 29-Sep-22 and second dose administered on 31-Jan-22) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Jan-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 29-Sep-22 and second dose administered on 31-Jan-22). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered on 29-Sep-22 and second dose administered on 31-Jan-22) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Products were reported. Maximum or minimum temperatures reached inside the refrigerator:- on 28-Jan-2022 temp range: positive 34.7F to positive 41.2F; on 30-Jan-2022 temp range: positive 34.7F to positive 41.2F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range: positive 35.2F to positive 41.7F for 12 hours. Vials Thawed on 28-JAN-2022 Patient have reported any adverse events to date No Treatment information was reported.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients administered with vaccines that have undergone temperature excursion; Patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients administered with vaccines that have undergone temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No patient had reported any adverse events to date. Vaccine was thawed on 28-Jan-2022.  It was reported maximum or minimum temperatures reached as applicable on 28-Jan-2022 temperature (temp) range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours.  No treatment information was reported.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates; temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No medical history information was reported.  Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 Vaccine on 01-May-2021 and Pfizer COVID-19 Vaccine on 22-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 Vaccine and Pfizer COVID-19 Vaccine.    On 31-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccine inside the refrigerator on four dates) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that they had temperature excursions involving 4 Moderna COVID-19 vaccines inside the refrigerator on 28-Jan2022 to 30-Jan-2022, 31-Jan-2022 and 04-Feb-2022. The impacted vaccines were administered to the patients.  Storage condition at the time of the excursion was refrigerator. Maximum or minimum temperatures reached and excursion duration were on 28-Jan-2022 temp range: positive 34.7 Fahrenheit (F) to positive 41.2 F; on 30-Jan-2022 temp range: positive 34.7 F to positive 41.2 F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7 F to positive 41.2 F for 12 hours and on 04-Feb-2022 temp range: positive 35.2 F to positive 41.7 F for 12 hours. Date the vials were moved from freezer to refrigerator were not available. As per the reporter the vaccines were thawed on 28-Jan-2022 because they were in the refrigerator.  The patient did not report any adverse events.  No treatment information was provided by the reporter.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates; temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) and POOR QUALITY PRODUCT ADMINISTERED (temperature excursions involving Moderna COVID-19 vaccines inside the refrigerator on four dates) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that they had temperature excursions involving 4 Moderna COVID-19 vaccines inside the refrigerator on 28-Jan2022 to 30-Jan-2022, 31-Jan-2022 and 04-Feb-2022. The impacted vaccines were administered to the patients.  Storage condition at the time of the excursion was refrigerator. Maximum or minimum temperatures reached and excursion duration were on 28-Jan-2022 temp range: positive 34.7 Fahrenheit (F) to positive 41.2 F; on 30-Jan-2022 temp range: positive 34.7 F to positive 41.2 F which occurred approximately for 48 hours; on 31-Jan-2022 temp range: positive 34.7 F to positive 41.2 F for 12 hours and on 04-Feb-2022 temp range: positive 35.2 F to positive 41.7 F for 12 hours. Date the vials were moved from freezer to refrigerator were not available. As per the reporter the vaccines were thawed on 28-Jan-2022 because they were in the refrigerator.  The patient did not report any adverse events.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Gait inability
Clinical narrative: he couldn't eat; he couldn't eat or walk to open the door for his mother; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (he couldn't eat) and GAIT INABILITY (he couldn't eat or walk to open the door for his mother) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEEDING DISORDER (he couldn't eat) and GAIT INABILITY (he couldn't eat or walk to open the door for his mother). At the time of the report, FEEDING DISORDER (he couldn't eat) and GAIT INABILITY (he couldn't eat or walk to open the door for his mother) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-540133, MOD-2022-540288, MOD-2022-540353 (Patient Link).
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients administered with vaccines that have undergone temperature excursion; patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) in a 32-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.   No patients have reported any adverse events to date. Vaccines were thawed on 28-Jan-2022. It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours.  Total 40 number of vials/doses impacted. Treatment medications were not reported   This case was linked to MOD-2022-539812 (Patient Link).
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 40 patients administered vaccines that have undergone temperature excursion; Patient was administered with vaccines that had undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (40 patients administered vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that had undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  On 30-Jan-2022, the patient received the booster dose of Moderna COVID-19 Vaccine   Vaccines were thawed on 28-Jan-2022.  It was reported Maximum or minimum temperatures reached as on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours.  It was reported that the patient did not experience any adverse event.  No treatment medications were provided.   This case was linked to MOD-2022-539812 (Patient Link).
Age: 48.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patients administered with vaccines that have undergone temperature excursion; patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Janssen (Dose-1) on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with Janssen.    On 04-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. No patients have reported any adverse events to date. Vaccines were thawed on 28-Jan-2022. It was reported Maximum or minimum temperatures reached as applicable (specify temp is in C or F) on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours. Treatment medications were not reported.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: patients administered with vaccines that have undergone temperature excursion; patients administered with vaccines that have undergone temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and EXPIRED PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients administered with vaccines that have undergone temperature excursion) and EXPIRED PRODUCT ADMINISTERED (patients administered with vaccines that have undergone temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vial was stored in refrigerator at the time of excursion. Vial was thawed on 28-Jan-2022.  It was reported Maximum or minimum temperatures reached as on 28-Jan-2022 temp range positive 34.7F to positive 41.2F, on 30-Jan-2022 temp range positive 34.7F to positive 41.2F which occurred for 48 hours; on 31-Jan-2022 temp range positive 34.7F to positive 41.2F for 12 hours and on 04-Feb-2022 temp range positive 35.2F to positive 41.7F for 12 hours.  It was reported that the patient did not experience any adverse event.  Treatment medications were not reported.