chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: arm is quite swollen still/after the second dose had similar or some problems but faded quickly; redness / after the second dose had similar or some problems but faded quickly; itchy / after the second dose had similar or some problems but faded quickly; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is quite swollen still/after the second dose had similar or some problems but faded quickly), ERYTHEMA (redness / after the second dose had similar or some problems but faded quickly) and PRURITUS (itchy / after the second dose had similar or some problems but faded quickly) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-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 PERIPHERAL SWELLING (arm is quite swollen still/after the second dose had similar or some problems but faded quickly), ERYTHEMA (redness / after the second dose had similar or some problems but faded quickly) and PRURITUS (itchy / after the second dose had similar or some problems but faded quickly). At the time of the report, PERIPHERAL SWELLING (arm is quite swollen still/after the second dose had similar or some problems but faded quickly), ERYTHEMA (redness / after the second dose had similar or some problems but faded quickly) and PRURITUS (itchy / after the second dose had similar or some problems but faded quickly) had resolved.            No concomitant medications  were provided. No treatment medications  were provided.  The arm looked like the size of a huge egg.   This case was linked to MOD-2021-391831 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: report a side effect/ did have side effects with these two; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report a side effect/ did have side effects with these two) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS and Thyroid disorder NOS. Concomitant products included LEVOCETIRIZINE for Allergy NOS, MULTIVITAMIN [VITAMINS NOS] for Elderly, LEVOTHYROXINE SODIUM for Thyroid disorder NOS.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report a side effect/ did have side effects with these two). At the time of the report, VACCINATION COMPLICATION (report a side effect/ did have side effects with these two) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-391830, MOD-2021-391838 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Tiredness; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and MYALGIA (Soreness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension, Chronic kidney disease and Arthritis. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), ACETYLSALICYLIC ACID (ASPIRIN LOW), METFORMIN, ATENOLOL, LISINOPRIL, MAGNESIUM OXIDE, AMLODIPINE, ATORVASTATIN and CLONIDINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness) and MYALGIA (Soreness). At the time of the report, FATIGUE (Tiredness) and MYALGIA (Soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-391840 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 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 nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided    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 information was provided by the reporter.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date; 108 doses given instead of 120; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and ACCIDENTAL OVERDOSE (108 doses given instead of 120) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and ACCIDENTAL OVERDOSE (108 doses given instead of 120). In 2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and ACCIDENTAL OVERDOSE (108 doses given instead of 120) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Number of doses/vials: 108 doses Date the vial was initially stored in the refrigerator: 16Sep2021 Date(s) of administration of vaccine: 18Oct2021-2Nov2021  No concomitant and treatment medication was reported
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 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 nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported. On 29-Oct-2021, fourteen doses were administered. Date the vial was initially stored in the refrigerator is 16-Sep-2021. The vials did not undergo any temperature excursions.   This case was linked to MOD-2021-011631, MOD-2021-378412, MOD-2021-391847, MOD-2021-391849, MOD-2021-391850, MOD-2021-391851, MOD-2021-391852, MOD-2021-391853, MOD-2021-391854, MOD-2021-391856, MOD-2021-391857 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 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 nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). In 2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) had resolved. Not Provided      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. Number of doses or vials were 108 doses. Date the vial was initially stored in the refrigerator on 16-Sep-2021. Date(s) of administration of vaccine was from 18-Oct-2021 to 02-Nov-2021.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Muscle 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 MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) outcome was unknown.        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 reported by reporter No treatment medications provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of efficacy; breakthrough COVID; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (breakthrough COVID) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, the patient experienced DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (breakthrough COVID). At the time of the report, DRUG INEFFECTIVE (Lack of efficacy) and COVID-19 (breakthrough COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.         No relevant concomitant medications were reported. No treatment information was provided.  Company Comment: This case concerns a 73 year old female , with no medical history reported , who experienced Non-serious , Unexpected , AESI event of Covid 19 and Drug ineffective which occurred 6 months and  27 days after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be administered and also the outcome of the events was unknown. The age of the patient can be considered as confounder for this case ( elderly people are vulnerable to Covid 19 infection and its complications because to the altered immune response). The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 73 year old female , with no medical history reported , who experienced Non-serious , Unexpected , AESI event of Covid 19 and Drug ineffective which occurred 6 months and  27 days after vaccination with the 2nd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case is not applicable since the events occurred after the 2nd dose and no additional doses will be administered and also the outcome of the events was unknown. The age of the patient can be considered as confounder for this case ( elderly people are vulnerable to Covid 19 infection and its complications because to the altered immune response). The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Having trouble getting dressed; ache / cant use my shoulder; muscle has been very very sore; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Having trouble getting dressed), ARTHRALGIA (ache / cant use my shoulder) and MYALGIA (muscle has been very very sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Having trouble getting dressed), ARTHRALGIA (ache / cant use my shoulder) and MYALGIA (muscle has been very very sore). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Having trouble getting dressed) outcome was unknown and ARTHRALGIA (ache / cant use my shoulder) and MYALGIA (muscle has been very very sore) had not resolved.            No concomitant medication information was provided by the reporter.  No treatment information was  provided.; Sender's Comments: Non-serious Case
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: injection site is hard; He had chills; injection site is red; injection site is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site is hard), CHILLS (He had chills), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PAIN (injection site is sore) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (injection site is hard), CHILLS (He had chills), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PAIN (injection site is sore). At the time of the report, VACCINATION SITE INDURATION (injection site is hard), CHILLS (He had chills), VACCINATION SITE ERYTHEMA (injection site is red) and VACCINATION SITE PAIN (injection site is sore) had not resolved.            Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lip pain
Clinical narrative: Cold sore on lip; This spontaneous case was reported by a consumer and describes the occurrence of LIP PAIN (Cold sore on lip) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027O21A, 012M20A and 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LIP PAIN (Cold sore on lip). The patient was treated with LYSINE at an unspecified dose and frequency. At the time of the report, LIP PAIN (Cold sore on lip) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-392147, MOD-2021-391952 (Patient Link).; Sender's Comments: Non-serious Case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 21-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.  This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 6 patients received expired moderna vaccine booster doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired moderna vaccine booster doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired moderna vaccine booster doses). On 07-Nov-2021, EXPIRED PRODUCT ADMINISTERED (6 patients received expired moderna vaccine booster doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported, Date the vial was initially stored in the refrigerator: 07-Nov-2021.  No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: error resulting in administration of expired vaccine; Expired vaccine used; 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 PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Oct-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: error resulting in administration of expired vaccine; Expired vaccine used; 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 PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  No Treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error resulting in administration of expired vaccine; 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 (Error resulting in administration of expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired vaccine). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Error resulting in administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: error resulting in administration of expired vaccine; Expired vaccine used; 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 PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Sep-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; 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 (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product administration error
Clinical narrative: error resulting in administration of expired vaccine; Expired vaccine used; 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 PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Oct-2021, PRODUCT ADMINISTRATION ERROR (error resulting in administration of expired vaccine) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.    This case was linked to MOD-2021-363223 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Patient details was added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Vaccination complication
Clinical narrative: expired vials were used to provide 38 doses; Sore arm; some identified common side effects after the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses), PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). In November 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) had resolved. In November 2021, PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (some identified common side effects after the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No vial went any temperature excursions.  On 12-Nov-2021, all vaccines were administered within 2 hours.  Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. Till 19-Nov-2021, there were no adverse reactions to the vaccine.  As of 19 Nov 2021, there were no adverse reactions to the vaccine reported by the list below. We spoke with some that received the vaccine during these dates and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Nov-2021: The additional information included suspect administration date. On 19-Nov-2021: Follow-up information included about patients details On 19-Nov-2021: Significant FU appended (Second reporter Information was updated)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Vaccination complication
Clinical narrative: Expired vials were used to provide 38 doses of the Moderna Covid-19 Vaccine; Sore arm; Some identified common side effects after the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses of the Moderna Covid-19 Vaccine), PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (Some identified common side effects after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses of the Moderna Covid-19 Vaccine). In November 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (Some identified common side effects after the vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses of the Moderna Covid-19 Vaccine) had resolved. In November 2021, PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (Some identified common side effects after the vaccine) 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 provided Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non significant follow up received on 19-nov-2021 and new reporter information added
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 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) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported. Reported some that received the vaccine during dates given and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non Significant Follow Up Appended and Second reporter Information is updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator: thawed & given on same date, never stored in refrigerator No concomitant medications were provided. No treatment medications were provided Reported some that received the vaccine during dates given and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow Up received and a new reporter Information added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vials were used to provide 38 doses; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses) 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.  It was reported some that received the vaccine during dates given and some identified common side effects after the vaccine (ex: sore arm, etc.) and only lasted for a few hours but no more than 24 hours for 1st dose, 2nd dose and Booster.Reporter stated that no excursion had occurred and the Moderna vials were taken out of the freezer. It was also reported that on 11-Nov-2021 all vaccines were administered within 1 hour.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non Significant FU appended with Second reporter Information updated in case.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Felt a bit crappy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Felt a bit crappy) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION COMPLICATION (Felt a bit crappy). At the time of the report, VACCINATION COMPLICATION (Felt a bit crappy) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-390811 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: seem to get fairly mild breakthrough cases of Covid; seem to get fairly mild breakthrough cases of Covid; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), dose 2 via an unspecified route of administration on 05Feb2021 (Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Lot number was not reported) as DOSE 1, SINGLE both for covid-19 immunization. Medical history included tendency to get a fair amount of inflammation. The patient's concomitant medications were not reported. It was reported that seem to get fairly mild breakthrough cases of covid (drug ineffective and suspected covid-19) on an unspecified date in 2021. It was reported that patient seem to get fairly mild breakthrough cases of Covid somewhat often and had a tendency to get a fair amount of inflammation. Patient isolated a lot to avoid Covid. The outcome of the event suspected covid-19 was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Urticaria
Clinical narrative: really strong allergic reaction; Rash; almost like hives; This is a spontaneous report from a Pfizer sponsored program via a contactable Other HCP. A 66-year-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included lot allergies and thyroid condition. The patient's concomitant medications were not reported. The patient historical vaccine included received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization and she was fine with the first dose. On an unspecified date, the patient experienced really strong allergic reaction, rash for three weeks almost like hives. The outcome of the events was unknown.  Additional information: She stated caller was a HCP and caller wanted to know if a patient has bursitis in her elbow was it safe for her to receive the Pfizer COVID vaccine? Caller stated to her that she was a medical social worker (LCSW). Caller stated that she works in hospitals and with doctors and a patient was not getting a clear answer from her doctor and doctor would not call us so she was trying to get information for the patient. The caller stated her sister had the Pfizer COVID vaccine and did fine with the first dose but after the second dose she had a really strong allergic reaction where she had a rash for three weeks almost like hives. Caller states her sister reported this reaction to DSU already. Caller also stated that her sister has a lot allergies and a thyroid condition. Caller did not provide any other details for her sister. Informed caller that Pfizer cannot provide medical advice or treatment recommendations for individuals patients that it will be up to the HCP to provide recommendations based off patient's medical history as they will have access to their information. Caller enquired if it was common to have a rash for three weeks after the second dose and according to PI Section Adverse Reactions in Post Authorization Experience Rash is listed as a side effect that has been reported. Informed caller that PI does not state the duration that the rash can last.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.  Follow-up (19Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Amylase, Body temperature, COVID-19, Cell marker, Investigation
Clinical narrative: This is a literature report from the Regulatory Authority, 2021, vol 32; pp 842 entitled Utilization of donor-derived cell-free DNA and total cell-free DNA to inform treatment decisions in a pancreas transplant recipient with COVID-19 infection and active rejection.   A 51-year-old female received a deceased donor pancreas transplant in Aug2020. The patient was maintained on a triple immunosuppressive (IS) therapy regime, had stable amylase and lipase levels and no episodes of rejection. Six months later, the patient received the first dose of a COVID-19 vaccine, and the second dose three weeks later. The patients spouse was diagnosed with COVID-19 and soon after, the patient had elevated pancreatic enzymes, 156 and 199 (prior labs 67 and 27) and presented with elevated temperature (100.4 F.), cough, fatigue, loss of taste, diarrhea, myalgias and rhinorrhea. The patient was determined to have COVID-19 with a severity score of 2. IS was reduced and monoclonal ab therapy was initiated. dd-cfDNA fraction was 1.38%, indicated high-risk for AR, with corresponding total cfDNA elevated 10.2 multiples of the median (MoM). The patient was treated with Methylprednisolone 500 mg with a PO Prednisone tail. Three weeks later, the patient was negative for COVID-19 and IS was resumed. The dd-cfDNA fraction at this time was 1.59%, and total cfDNA decreased to 1.1 MoM. Subsequent weekly Prospera tests indicated dd-cfDNA fractions of 1.03%, 0.54%, and 0.81% with total cfDNA levels of 1.4 MoM, 1.3 MoM, and 0.94 MoM. Measurement of dd-cfDNA can guide IS management in pancreas transplant recipients with COVID-19 undergoing AR. Viral infections and anti-rejection therapies can influence total cfDNA. Thus, continued monitoring of both total and DD cfDNA are needed to identify a true response to therapy.; Sender's Comments: Based on the available information, a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 to the reported events COVID-19 and vaccination failure cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lipase, Pancreatic enzymes, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a literature report from the Regulatory Authority, 2021, vol 32; pp 842 entitled Utilization of donor-derived cell-free DNA and total cell-free DNA to inform treatment decisions in a pancreas transplant recipient with COVID-19 infection and active rejection.   A 51-year-old female received a deceased donor pancreas transplant in Aug2020. The patient was maintained on a triple immunosuppressive (IS) therapy regime, had stable amylase and lipase levels and no episodes of rejection. Six months later, the patient received the first dose of a COVID-19 vaccine, and the second dose three weeks later. The patients spouse was diagnosed with COVID-19 and soon after, the patient had elevated pancreatic enzymes, 156 and 199 (prior labs 67 and 27) and presented with elevated temperature (100.4 F.), cough, fatigue, loss of taste, diarrhea, myalgias and rhinorrhea. The patient was determined to have COVID-19 with a severity score of 2. IS was reduced and monoclonal ab therapy was initiated. dd-cfDNA fraction was 1.38%, indicated high-risk for AR, with corresponding total cfDNA elevated 10.2 multiples of the median (MoM). The patient was treated with Methylprednisolone 500 mg with a PO Prednisone tail. Three weeks later, the patient was negative for COVID-19 and IS was resumed. The dd-cfDNA fraction at this time was 1.59%, and total cfDNA decreased to 1.1 MoM. Subsequent weekly Prospera tests indicated dd-cfDNA fractions of 1.03%, 0.54%, and 0.81% with total cfDNA levels of 1.4 MoM, 1.3 MoM, and 0.94 MoM. Measurement of dd-cfDNA can guide IS management in pancreas transplant recipients with COVID-19 undergoing AR. Viral infections and anti-rejection therapies can influence total cfDNA. Thus, continued monitoring of both total and DD cfDNA are needed to identify a true response to therapy.; Sender's Comments: Based on the available information, a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 to the reported events COVID-19 and vaccination failure cannot be excluded.