chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: was not able to get the 2nd dose on time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (was not able to get the 2nd dose on time) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (was not able to get the 2nd dose on time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (was not able to get the 2nd dose on time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given by reporter. No treatment medication was given by reporter.  It was reported that the vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 89-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Pyrexia, Sensitive skin, Vaccination complication
Clinical narrative: feels cold; skin feels sensitive; described experiencing something that sounded like "super hydrated" and other symptom "twice"; temperature; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feels cold), SENSITIVE SKIN (skin feels sensitive), VACCINATION COMPLICATION (described experiencing something that sounded like "super hydrated" and other symptom "twice") and PYREXIA (temperature) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 050E214) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-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 FEELING COLD (feels cold), SENSITIVE SKIN (skin feels sensitive), VACCINATION COMPLICATION (described experiencing something that sounded like "super hydrated" and other symptom "twice") and PYREXIA (temperature). At the time of the report, FEELING COLD (feels cold), SENSITIVE SKIN (skin feels sensitive), VACCINATION COMPLICATION (described experiencing something that sounded like "super hydrated" and other symptom "twice") and PYREXIA (temperature) outcome was unknown.            No concomitant medication was provided.  Patient reported  side effects from the second dose of the Moderna COVID-19 vaccine. He described experiencing something that sounded like super hydrated and other symptom twice ,  he just said that before he got the vaccines he felt great. He also said he had temperature, feels cold and his skin feels sensitive.  No treatment information was provided. Patient took the vaccine from Pharmacy.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Storage condition at the time of the excursion: refrigerated storage, Excursion duration: 72 hours post expiration date; Received expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Storage condition at the time of the excursion: refrigerated storage, Excursion duration: 72 hours post expiration date) and EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Storage condition at the time of the excursion: refrigerated storage, Excursion duration: 72 hours post expiration date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Storage condition at the time of the excursion: refrigerated storage, Excursion duration: 72 hours post expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitants and Treatment medication were reported. Excursion duration: 72 hours post expiration date. Vials were unpunctured but after punctured used within 12 hours.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired for a few days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired for a few days after first shot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Pulmonary embolism. Concurrent medical conditions included Arthritis.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced FATIGUE (Tired for a few days after first shot). In January 2021, FATIGUE (Tired for a few days after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.   This case was linked to MOD-2021-351022, MOD-2021-351023 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep for 2 days), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift left arm for 2 days) and VACCINATION SITE PAIN (Left arm hurt extremely bad for 2 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary embolism and Arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced INSOMNIA (could not sleep for 2 days), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift left arm for 2 days) and VACCINATION SITE PAIN (Left arm hurt extremely bad for 2 days). In February 2021, INSOMNIA (could not sleep for 2 days), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not lift left arm for 2 days) and VACCINATION SITE PAIN (Left arm hurt extremely bad for 2 days) had resolved.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-351016, MOD-2021-351023 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Diarrhoea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea after the 3rd shot), BACK PAIN ("Middle and Lower back killing me" after the 3rd shot), PYREXIA (Fever (Unknown Fahrenheit) after the 3rd shot) and ARTHRALGIA (Joints hurt after the 3rd shot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pulmonary embolism and Arthritis.    On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced DIARRHEA (Diarrhea after the 3rd shot), BACK PAIN ("Middle and Lower back killing me" after the 3rd shot), PYREXIA (Fever (Unknown Fahrenheit) after the 3rd shot) and ARTHRALGIA (Joints hurt after the 3rd shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 13-Oct-2021, DIARRHEA (Diarrhea after the 3rd shot), BACK PAIN ("Middle and Lower back killing me" after the 3rd shot), PYREXIA (Fever (Unknown Fahrenheit) after the 3rd shot) and ARTHRALGIA (Joints hurt after the 3rd shot) had resolved.            No concomitant medication is reported   This case was linked to MOD-2021-351022, MOD-2021-351016 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.  No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-351209 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.  It was unknown if the doses are first, second or third doses for the patients.   The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Vaccination site pain
Clinical narrative: sore arm; After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed.; After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), BEDRIDDEN (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed.) and FATIGUE (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Thyroid disorder, Bladder pain, Heart disorder, Lipid metabolism disorder, Type 2 diabetes mellitus, Asthma and Allergy (Patient has medical allergies.). Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (DUONEB) for Asthma, AMITRIPTYLINE for Bladder pain, ATENOLOL and AMLODIPINE for Blood pressure fluctuation, LOSARTAN for Blood pressure measurement, CLOPIDOGREL BISULFATE (PLAVIX) for Coagulation disorder, ISOSORBIDE MONONITRATE for Heart disorder, FENOFIBRATE for Lipid metabolism disorder, LEVOTHYROXINE for Thyroid disorder, METFORMIN for Type 2 diabetes mellitus.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore arm), BEDRIDDEN (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed.) and FATIGUE (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed). On 11-Sep-2021, FATIGUE (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) had not resolved and BEDRIDDEN (After 1st dose of the vaccine consumer had sore arm, fatigue, and stayed in bed.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-351102 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a expired vaccine) 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 EXPIRED PRODUCT ADMINISTERED (patient received a expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were stored in the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.   This case was linked to MOD-2021-350918, MOD-2021-350921, MOD-2021-350925, MOD-2021-350929, MOD-2021-350930, MOD-2021-350935, MOD-2021-350936, MOD-2021-350939, MOD-2021-350941, MOD-2021-350944, MOD-2021-350947, MOD-2021-350959, MOD-2021-350972, MOD-2021-350996, MOD-2021-350998, MOD-2021-351000, MOD-2021-351002, MOD-2021-351003, MOD-2021-351018, MOD-2021-351020, MOD-2021-351021, MOD-2021-351025, MOD-2021-351030, MOD-2021-351035, MOD-2021-351038, MOD-2021-351040, MOD-2021-351042, MOD-2021-351048, MOD-2021-351049, MOD-2021-351050, MOD-2021-351053, MOD-2021-351062, MOD-2021-351071, MOD-2021-351076, MOD-2021-351094, MOD-2021-351111, MOD-2021-351123, MOD-2021-351144, MOD-2021-351146, MOD-2021-351153, MOD-2021-351155, MOD-2021-351180, MOD-2021-351190, MOD-2021-351194, MOD-2021-351198, MOD-2021-351201, MOD-2021-351209, MOD-2021-351213, MOD-2021-351214, MOD-2021-351220, MOD-2021-351222, MOD-2021-351224, MOD-2021-351544, MOD-2021-351623, MOD-2021-351627, MOD-2021-351642, MOD-2021-351643, MOD-2021-351646, MOD-2021-351651, MOD-2021-351652, MOD-2021-351653, MOD-2021-351658, MOD-2021-351663, MOD-2021-351665, MOD-2021-351696, MOD-2021-351699, MOD-2021-351713, MOD-2021-351718, MOD-2021-351724, MOD-2021-351732, MOD-2021-351733, MOD-2021-351747, MOD-2021-351753, MOD-2021-351761, MOD-2021-351768, MOD-2021-351774, MOD-2021-351776, MOD-2021-351790, MOD-2021-351794, MOD-2021-351797, MOD-2021-351828, MOD-2021-351833, MOD-2021-351838, MOD-2021-351848, MOD-2021-351861, MOD-2021-351867, MOD-2021-351877, MOD-2021-351890, MOD-2021-351905, MOD-2021-351914, MOD-2021-351936 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 to 5 patients received shot past 30-day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 30-day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) 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 (4 to 5 patients received shot past 30-day use by date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 to 5 patients received shot past 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 reported.  No Treatment was reported by reporter.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication use was reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Extra dose administered, Product temperature excursion issue
Clinical narrative: Dose administered after 12 hours of vial puncture.; Dose administered after being more than 24 hours at room temperature; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) and EXTRA DOSE ADMINISTERED (Extra dose administered) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021 at 10:40 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) and EXTRA DOSE ADMINISTERED (Extra dose administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 12 hours of vial puncture.), PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after being more than 24 hours at room temperature) and EXTRA DOSE ADMINISTERED (Extra dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was not given.  Reporter stated that Caller assumes the patient is immunocompromised but didn't confirm it.   This case was linked to MOD-2021-351411 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 78-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Pain in upper left arm that progressed to her elbow then down to her hand; Redness in upper left arm that progressed to her elbow then down to her hand; Swelling in upper left arm that progressed to her elbow then down to her hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in upper left arm that progressed to her elbow then down to her hand), VACCINATION SITE ERYTHEMA (Redness in upper left arm that progressed to her elbow then down to her hand) and VACCINATION SITE SWELLING (Swelling in upper left arm that progressed to her elbow then down to her hand) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in upper left arm that progressed to her elbow then down to her hand), VACCINATION SITE ERYTHEMA (Redness in upper left arm that progressed to her elbow then down to her hand) and VACCINATION SITE SWELLING (Swelling in upper left arm that progressed to her elbow then down to her hand). At the time of the report, PAIN IN EXTREMITY (Pain in upper left arm that progressed to her elbow then down to her hand), VACCINATION SITE ERYTHEMA (Redness in upper left arm that progressed to her elbow then down to her hand) and VACCINATION SITE SWELLING (Swelling in upper left arm that progressed to her elbow then down to her hand) had not resolved.            No concomitant medications were reported. Treatment medication included over the counter pain medicine. Reporter stated that in six months, after her 2nd dose her arm hadn't gotten better, it got worse. Patient saw her primary doctor and couple of specialists. They do not know what is wrong.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis
Clinical narrative: After 1st dose, she had cellulitis in injected arm couple days after injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (After 1st dose, she had cellulitis in injected arm couple days after injection) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In February 2021, the patient experienced VACCINATION SITE CELLULITIS (After 1st dose, she had cellulitis in injected arm couple days after injection). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and MELOXICAM for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CELLULITIS (After 1st dose, she had cellulitis in injected arm couple days after injection) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication include allergy medication and supplements. Treatment medication include X-ray, MRI, followed up  with rheumatoid arthritis specialist.   This case was linked to MOD-2021-351175 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Oct-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: numbness; tingling; 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 HYPOAESTHESIA (numbness) and PARAESTHESIA (tingling) 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 HYPOAESTHESIA (numbness) and PARAESTHESIA (tingling). At the time of the report, HYPOAESTHESIA (numbness) and PARAESTHESIA (tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD21-152452 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Feeling abnormal, Myalgia, Pain in extremity
Clinical narrative: every bone of the body was hurting; the arm hurt pretty much all day; slept all day; started not to feel good; muscle ache everywhere; 99°F fever; all the joints hurt bad/hurt real bad on the joints; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (every bone of the body was hurting), PAIN IN EXTREMITY (the arm hurt pretty much all day), SOMNOLENCE (slept all day), FEELING ABNORMAL (started not to feel good) and MYALGIA (muscle ache everywhere) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052F21A, 007M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BONE PAIN (every bone of the body was hurting), PAIN IN EXTREMITY (the arm hurt pretty much all day), SOMNOLENCE (slept all day), FEELING ABNORMAL (started not to feel good), MYALGIA (muscle ache everywhere), PYREXIA (99°F fever) and ARTHRALGIA (all the joints hurt bad/hurt real bad on the joints). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency. At the time of the report, BONE PAIN (every bone of the body was hurting), PAIN IN EXTREMITY (the arm hurt pretty much all day), SOMNOLENCE (slept all day), FEELING ABNORMAL (started not to feel good), MYALGIA (muscle ache everywhere), PYREXIA (99°F fever) and ARTHRALGIA (all the joints hurt bad/hurt real bad on the joints) had resolved.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: every bone of the body was hurting; the arm hurt pretty much all day; slept all day; started not to feel good; muscle ache everywhere; 99°F fever; all the joints hurt bad/hurt real bad on the joints; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (every bone of the body was hurting), PAIN IN EXTREMITY (the arm hurt pretty much all day), SOMNOLENCE (slept all day), FEELING ABNORMAL (started not to feel good) and MYALGIA (muscle ache everywhere) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052F21A, 007M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced BONE PAIN (every bone of the body was hurting), PAIN IN EXTREMITY (the arm hurt pretty much all day), SOMNOLENCE (slept all day), FEELING ABNORMAL (started not to feel good), MYALGIA (muscle ache everywhere), PYREXIA (99°F fever) and ARTHRALGIA (all the joints hurt bad/hurt real bad on the joints). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency. At the time of the report, BONE PAIN (every bone of the body was hurting), PAIN IN EXTREMITY (the arm hurt pretty much all day), SOMNOLENCE (slept all day), FEELING ABNORMAL (started not to feel good), MYALGIA (muscle ache everywhere), PYREXIA (99°F fever) and ARTHRALGIA (all the joints hurt bad/hurt real bad on the joints) had resolved.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache after the second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-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 HEADACHE (Headache after the second dose). At the time of the report, HEADACHE (Headache after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Adverse reactions reported after the first dose of Moderna Covid-19 vaccine.  Concomitant medication use was unknown Treatment information was unknown
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Her right wrist and big toe are swollen./ Her index finger and right hand are always swollen /Her left thumb is almost swollen with constant pain.; Her left thumb is almost swollen with constant pain.; After 2nd dose, immediately she had rash all over her body that would come and go for about 6 weeks; She started with joint pain.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Her right wrist and big toe are swollen./ Her index finger and right hand are always swollen /Her left thumb is almost swollen with constant pain.), PAIN IN EXTREMITY (Her left thumb is almost swollen with constant pain.), RASH (After 2nd dose, immediately she had rash all over her body that would come and go for about 6 weeks) and ARTHRALGIA (She started with joint pain.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PERIPHERAL SWELLING (Her right wrist and big toe are swollen./ Her index finger and right hand are always swollen /Her left thumb is almost swollen with constant pain.), PAIN IN EXTREMITY (Her left thumb is almost swollen with constant pain.), RASH (After 2nd dose, immediately she had rash all over her body that would come and go for about 6 weeks) and ARTHRALGIA (She started with joint pain.). The patient was treated with NAPROXEN SODIUM (ALEVE) for Rheumatoid arthritis, at an unspecified dose and frequency; IBUPROFEN for Rheumatoid arthritis, at an unspecified dose and frequency and MELOXICAM for Rheumatoid arthritis, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Her right wrist and big toe are swollen./ Her index finger and right hand are always swollen /Her left thumb is almost swollen with constant pain.) and PAIN IN EXTREMITY (Her left thumb is almost swollen with constant pain.) had not resolved, RASH (After 2nd dose, immediately she had rash all over her body that would come and go for about 6 weeks) was resolving and ARTHRALGIA (She started with joint pain.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional concomitant- Supplements , Allergy Medicine. Patient treated with X-ray & MRI   This case was linked to MOD-2021-351143 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave a moderna vaccine that expired on 9/28 today; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a moderna vaccine that expired on 9/28 today) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B20A) 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 (Gave a moderna vaccine that expired on 9/28 today). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Gave a moderna vaccine that expired on 9/28 today) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient was observed for side effects for 35 minutes following administration.  No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Patient age and gender added, suspect drug administration date, batch number updated.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site paraesthesia
Clinical narrative: numbness in left arm/ gets very numb while driving/ left foot also gets numb/ numbness weaker in left arm; tingling in left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in left arm/ gets very numb while driving/ left foot also gets numb/ numbness weaker in left arm) and INJECTION SITE PARAESTHESIA (tingling in left arm) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 022C21A) for COVID-19 vaccination.     The Medical history was not reported by the reporter.  Concomitant products included IRBESARTAN and BUPROPION for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-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 HYPOAESTHESIA (numbness in left arm/ gets very numb while driving/ left foot also gets numb/ numbness weaker in left arm) and INJECTION SITE PARAESTHESIA (tingling in left arm). At the time of the report, HYPOAESTHESIA (numbness in left arm/ gets very numb while driving/ left foot also gets numb/ numbness weaker in left arm) and INJECTION SITE PARAESTHESIA (tingling in left arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: Fatigue; Joint pain; 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 FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) 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 FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and medication information was reported. The patient experienced fatigue and joint pain the first day after the shot, and that it lasted for about 2 days.   This case was linked to MOD-2021-351195, MOD-2021-351195 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: Tingles in her left arm,tingling is spreading It has moved to her left shoulder, between neck & shoulder, and down her left side to her waist. It's also in her left shoulder blade and is now moving down her left leg.tingling is constant; severe pain comes in waves; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingles in her left arm,tingling is spreading It has moved to her left shoulder, between neck & shoulder, and down her left side to her waist. It's also in her left shoulder blade and is now moving down her left leg.tingling is constant) and PAIN (severe pain comes in waves) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jun-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 PARAESTHESIA (Tingles in her left arm,tingling is spreading It has moved to her left shoulder, between neck & shoulder, and down her left side to her waist. It's also in her left shoulder blade and is now moving down her left leg.tingling is constant) and PAIN (severe pain comes in waves). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and GABAPENTIN (NEURONTIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingles in her left arm,tingling is spreading It has moved to her left shoulder, between neck & shoulder, and down her left side to her waist. It's also in her left shoulder blade and is now moving down her left leg.tingling is constant) and PAIN (severe pain comes in waves) had not resolved.            Patient has been scheduled for an EMG & is going to see a neurologist.   Concomitant medications were not reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-351265.