chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 031L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 02-Jan-2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Patient received 3 Moderna COVID-19 vaccine: Shot 1: First Primary monovalent dose on 27-Jan-2021 (Lot# 031L20A & Exp. Date: unknown). Shot 2: 2nd Primary monovalent dose on 24-Feb-21 (Lot# 023M20A & Exp. Date: unknown). Shot 3: First Monovalent Booster dose on 04-Nov-2021 (Lot# 07F21A & Exp. Date unknown). No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow up: Added start date of event covid-19 and updated its outcome. Added details of all vaccination of Moderna vaccine. Updated narrative.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 07F21A, 023M20A and 031L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication and treatment provided
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator: October 24, 2022; No adverse event; 14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 05-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (14 patients administered bivalent Moderna covid-19 vaccines after 30-day beyond use date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: October 24, 2022).    No concomitant medications were reported.   14 patients administered bivalent Moderna covid-19 vaccines after 30 day beyond use date. No patients have been administered monovalent vaccine after the beyond use date. Doses were administered from 08-Dec-2022 to 10-Jan-2023.  Date the vial was initially stored in the refrigerator was 24-Oct-2022.  Vial did not undergo any temperature excursions.  No treatment medication was provided.  This case pertain to 13th of 14 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-703586 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jan-2023: Live Significant Follow up received included patient demographics and narrative updated. On 24-Jan-2023: Live follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703586:Master case - 1st adult
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest, Schizophrenia
Clinical narrative: schizophrenia; cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of SCHIZOPHRENIA (schizophrenia) and CARDIAC ARREST (cardiac arrest) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE and COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In August 2022, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SCHIZOPHRENIA (schizophrenia) (seriousness criterion medically significant). The patient died in August 2022. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, SCHIZOPHRENIA (schizophrenia) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. It was reported that, patient died of a cardiac arrest ,on the streets, some time in Aug 2022. No treatment medication information was reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a male patient (age not specified), with no medical history reported, who experienced the unexpected Fatal serious (medically significant) event of Cardiac Arrest and unexpected serious (medically significant) event of Schizophrenia. Latency cannot be properly assessed, since vaccination date was not disclosed; however, the events occurred in the context of a dose (reported as initial booster) of mRNA-1273. It was reported that in August 2022, the patient experienced CARDIAC ARREST and the patient died in August 2022, on the streets. The reported cause of death was Cardiac arrest. The exact course of events which led to the fatal outcome was not disclosed. It was unknown if an autopsy was performed. At the time of death, outcome of schizophrenia was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704425:Child case; Reported Cause(s) of Death: cardiac arrest
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiomegaly, Chest X-ray, Electrocardiogram, Erythema
Clinical narrative: redness of the face; flushing of the face; high blood pressure; Heart enlarged on the right side.; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness of the face), FLUSHING (flushing of the face), HYPERTENSION (high blood pressure) and CARDIOMEGALY (Heart enlarged on the right side.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 026B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 ERYTHEMA (redness of the face), FLUSHING (flushing of the face), HYPERTENSION (high blood pressure) and CARDIOMEGALY (Heart enlarged on the right side.). At the time of the report, ERYTHEMA (redness of the face), FLUSHING (flushing of the face), HYPERTENSION (high blood pressure) and CARDIOMEGALY (Heart enlarged on the right side.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 183/103 mmHg high blood pressure. On an unknown date, Chest X-ray: The EKG, and Chest X-Ray were normal. On an unknown date, Electrocardiogram: The EKG, and Chest X-Ray were normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non-significant follow up- Narrative updated
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hypertension
Clinical narrative: redness of the face; flushing of the face; high blood pressure; Heart enlarged on the right side.; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness of the face), FLUSHING (flushing of the face), HYPERTENSION (high blood pressure) and CARDIOMEGALY (Heart enlarged on the right side.) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 026B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 ERYTHEMA (redness of the face), FLUSHING (flushing of the face), HYPERTENSION (high blood pressure) and CARDIOMEGALY (Heart enlarged on the right side.). At the time of the report, ERYTHEMA (redness of the face), FLUSHING (flushing of the face), HYPERTENSION (high blood pressure) and CARDIOMEGALY (Heart enlarged on the right side.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 183/103 mmHg high blood pressure. On an unknown date, Chest X-ray: The EKG, and Chest X-Ray were normal. On an unknown date, Electrocardiogram: The EKG, and Chest X-Ray were normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non-significant follow up- Narrative updated
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022; No adverse event; 4 patients were administered with doses BUD on 23Jan2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023), PRODUCT STORAGE ERROR (4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023), PRODUCT STORAGE ERROR (4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23Jan2023) and PRODUCT STORAGE ERROR (4 patients were administered with doses BUD on 23Jan2023. Vaccines were stored in the fridge since 21Dec2022).    No concomitant medications were reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administered a patient a Moderna Covid bivalent booster as the 3rd Covid vaccine/the facility was checking inventory and thinks they may have given the dose from a pediatric vial; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered a patient a Moderna Covid bivalent booster as the 3rd Covid vaccine/the facility was checking inventory and thinks they may have given the dose from a pediatric vial) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 018C22A) for COVID-19 prophylaxis.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (administered a patient a Moderna Covid bivalent booster as the 3rd Covid vaccine/the facility was checking inventory and thinks they may have given the dose from a pediatric vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered a patient a Moderna Covid bivalent booster as the 3rd Covid vaccine/the facility was checking inventory and thinks they may have given the dose from a pediatric vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (administered a patient a Moderna Covid bivalent booster as the 3rd Covid vaccine/the facility was checking inventory and thinks they may have given the dose from a pediatric vial).    No concomitant and treatment were provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines were stored in the fridge on 21-Dec-2022 and administered on 23-Jan-2023; No Adverse Event; 4 patients were administered with doses BUD on 23-Jan-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23-Jan-2023), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 21-Dec-2022 and administered on 23-Jan-2023) and NO ADVERSE EVENT (No Adverse Event) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     Patient had no known relevant medical history/conditions, allergy, concomitant diseases and risk factor. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 23-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23-Jan-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 21-Dec-2022 and administered on 23-Jan-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23-Jan-2023), PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 21-Dec-2022 and administered on 23-Jan-2023) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 patients were administered with doses BUD on 23-Jan-2023) and PRODUCT STORAGE ERROR (Vaccines were stored in the fridge on 21-Dec-2022 and administered on 23-Jan-2023).    Concomitant medication was not provided.   The dose administered was Initial Booster.  Vaccines were stored in the fridge since 21-Dec-2022.  Treatment information was not provided.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Dysuria, Influenza, Lethargy, Myalgia, Pyrexia
Clinical narrative: flu; lethargic; following the administration was similar to prior experiences -- lethargic and arm was sore; flare-up /body aches; flare-up /fever; flare-up /extreme pain upon urination; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches) and PYREXIA (flare-up /fever) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lethargic and Pain in arm. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    On 14-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination). At the time of the report, INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination) to be related.    Following the administration of the bivalent booster, the patient had flare-up speculation related to vaccine. The patient had flu shot for those over 65 at the same time. The day following the administration, the patient was lethargic with arm soreness. The first flare up was after three weeks later, when was feeling of coming down with flu shot. The patient had body aches, fever, lethargy and extreme pain upon urination. With the exception of the urination pain, all other symptoms disappeared within a few hours. The pain lasted for almost a week and subsided slowly over that period of time. After two weeks later, the patient had same experience. The information was unknown whether the patient experienced any additional symptoms.  The concomitant medication was not reported. The treatment medication was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Vaccination site pain
Clinical narrative: flu; lethargic; following the administration was similar to prior experiences -- lethargic and arm was sore; flare-up /body aches; flare-up /fever; flare-up /extreme pain upon urination; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches) and PYREXIA (flare-up /fever) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lethargic and Pain in arm. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    On 14-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination). At the time of the report, INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination) to be related.    Following the administration of the bivalent booster, the patient had flare-up speculation related to vaccine. The patient had flu shot for those over 65 at the same time. The day following the administration, the patient was lethargic with arm soreness. The first flare up was after three weeks later, when was feeling of coming down with flu shot. The patient had body aches, fever, lethargy and extreme pain upon urination. With the exception of the urination pain, all other symptoms disappeared within a few hours. The pain lasted for almost a week and subsided slowly over that period of time. After two weeks later, the patient had same experience. The information was unknown whether the patient experienced any additional symptoms.  The concomitant medication was not reported. The treatment medication was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Bone pain, Burning sensation, Dysuria, Fatigue, Flushing
Clinical narrative: flu; lethargic; following the administration was similar to prior experiences -- lethargic and arm was sore; flare-up /body aches; flare-up /fever; flare-up /extreme pain upon urination; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches) and PYREXIA (flare-up /fever) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lethargic and Pain in arm. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    On 14-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination). At the time of the report, INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination) to be related.    Following the administration of the bivalent booster, the patient had flare-up speculation related to vaccine. The patient had flu shot for those over 65 at the same time. The day following the administration, the patient was lethargic with arm soreness. The first flare up was after three weeks later, when was feeling of coming down with flu shot. The patient had body aches, fever, lethargy and extreme pain upon urination. With the exception of the urination pain, all other symptoms disappeared within a few hours. The pain lasted for almost a week and subsided slowly over that period of time. After two weeks later, the patient had same experience. The information was unknown whether the patient experienced any additional symptoms.  The concomitant medication was not reported. The treatment medication was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Illness, Influenza, Lethargy, Myalgia, Pyrexia
Clinical narrative: flu; lethargic; following the administration was similar to prior experiences -- lethargic and arm was sore; flare-up /body aches; flare-up /fever; flare-up /extreme pain upon urination; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches) and PYREXIA (flare-up /fever) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lethargic and Pain in arm. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    On 14-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination). At the time of the report, INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination) to be related.    Following the administration of the bivalent booster, the patient had flare-up speculation related to vaccine. The patient had flu shot for those over 65 at the same time. The day following the administration, the patient was lethargic with arm soreness. The first flare up was after three weeks later, when was feeling of coming down with flu shot. The patient had body aches, fever, lethargy and extreme pain upon urination. With the exception of the urination pain, all other symptoms disappeared within a few hours. The pain lasted for almost a week and subsided slowly over that period of time. After two weeks later, the patient had same experience. The information was unknown whether the patient experienced any additional symptoms.  The concomitant medication was not reported. The treatment medication was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: flu; lethargic; following the administration was similar to prior experiences -- lethargic and arm was sore; flare-up /body aches; flare-up /fever; flare-up /extreme pain upon urination; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches) and PYREXIA (flare-up /fever) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lethargic and Pain in arm. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot.    On 14-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination). At the time of the report, INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered INFLUENZA (flu), LETHARGY (lethargic), VACCINATION SITE PAIN (following the administration was similar to prior experiences -- lethargic and arm was sore), MYALGIA (flare-up /body aches), PYREXIA (flare-up /fever) and DYSURIA (flare-up /extreme pain upon urination) to be related.    Following the administration of the bivalent booster, the patient had flare-up speculation related to vaccine. The patient had flu shot for those over 65 at the same time. The day following the administration, the patient was lethargic with arm soreness. The first flare up was after three weeks later, when was feeling of coming down with flu shot. The patient had body aches, fever, lethargy and extreme pain upon urination. With the exception of the urination pain, all other symptoms disappeared within a few hours. The pain lasted for almost a week and subsided slowly over that period of time. After two weeks later, the patient had same experience. The information was unknown whether the patient experienced any additional symptoms.  The concomitant medication was not reported. The treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received Bivalent Moderna COVID-19 vaccine instead of a monovalent; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received Bivalent Moderna COVID-19 vaccine instead of a monovalent) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient received Bivalent Moderna COVID-19 vaccine instead of a monovalent) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received Bivalent Moderna COVID-19 vaccine instead of a monovalent) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received Bivalent Moderna COVID-19 vaccine instead of a monovalent).    No concomitant information provided No treatment information provided
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: 30 days in the refrigerator on 18JAN2023; No adverse event; Patient received expired 2nd primary dose; Patient received first Moderna dose on 22-Nov-2022 and 2nd dose on 18-Jan-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd primary dose), PRODUCT STORAGE ERROR (30 days in the refrigerator on 18JAN2023), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna dose on 22-Nov-2022 and 2nd dose on 18-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: FLU VACCINE VII in November 2022. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII.   On 22-Nov-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd primary dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna dose on 22-Nov-2022 and 2nd dose on 18-Jan-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (30 days in the refrigerator on 18JAN2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd primary dose), PRODUCT STORAGE ERROR (30 days in the refrigerator on 18JAN2023), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna dose on 22-Nov-2022 and 2nd dose on 18-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired 2nd primary dose), PRODUCT STORAGE ERROR (30 days in the refrigerator on 18JAN2023) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna dose on 22-Nov-2022 and 2nd dose on 18-Jan-2023).    Concomitant and treatment medications were not reported.  The patient received expired 2nd primary dose of Moderna COVID-19 vaccine beyond 30 days in the refrigerator on 18-Jan-2023. The patient did not have any other vaccine on 18-Jan-2023 or 4 weeks prior to 18-Jan-2023. Parents have not reported any adverse reactions.  Monovalent Lot number: AR9236 and MFG EXP Date: 23-Feb-2023 Individual vial in the refrigerator with vial size of 2.5 ml (6M-5Y Vial). Date the vial was initially stored in the refrigerator: 14-Dec-2022 The vial did not undergo any temperature excursions.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other adverse reactions were observed; Patient received expired Spikevax monovalent vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Spikevax monovalent vaccine) and NO ADVERSE EVENT (No other adverse reactions were observed) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 051C22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 18-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Spikevax monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No other adverse reactions were observed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Spikevax monovalent vaccine) and NO ADVERSE EVENT (No other adverse reactions were observed) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No other adverse reactions were observed) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Spikevax monovalent vaccine).    Concomitant and treatment medications were not reported.  It was not known which arm the patient had received the vaccine. Patient received expired Spikevax monovalent vaccine. No other adverse reactions were observed.
Sex: U
Vaccine: COVID19-2
Symptoms: Cough
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing spell) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing spell). At the time of the report, COUGH (coughing spell) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  Wife or reporter took booster and experience coughing spell after receiving bivalent booster.  No treatment medication reported by reporter.   Reporter did not allow further contact
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The patient received his first dose of the Moderna Covid-19 vaccine Spikevax on 25Jan2023 lot number 051C22A expiration date of the vaccine is 13January 2023.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received his first dose of the Moderna Covid-19 vaccine Spikevax on 25Jan2023 lot number 051C22A expiration date of the vaccine is 13January 2023.) and NO ADVERSE EVENT (No adverse event) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 051C22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 25-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received his first dose of the Moderna Covid-19 vaccine Spikevax on 25Jan2023 lot number 051C22A expiration date of the vaccine is 13January 2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received his first dose of the Moderna Covid-19 vaccine Spikevax on 25Jan2023 lot number 051C22A expiration date of the vaccine is 13January 2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The patient received his first dose of the Moderna Covid-19 vaccine Spikevax on 25Jan2023 lot number 051C22A expiration date of the vaccine is 13January 2023.).    No concomitant or treatment medications were reported.  Patient received expired vaccine. No other adverse reactions were observed.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Initial date when the vaccine was stored in the refrigerator: 02Dec2022; No adverse event; accidentally administered a dose of the Moderna Covid-19 vaccine which was beyond the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered a dose of the Moderna Covid-19 vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Initial date when the vaccine was stored in the refrigerator: 02Dec2022) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 015B22A and 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Jan-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered a dose of the Moderna Covid-19 vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initial date when the vaccine was stored in the refrigerator: 02Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered a dose of the Moderna Covid-19 vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Initial date when the vaccine was stored in the refrigerator: 02Dec2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered a dose of the Moderna Covid-19 vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Initial date when the vaccine was stored in the refrigerator: 02Dec2022).    No concomitant or treatment medications were provided. Initial date when the vaccine was stored in the refrigerator was 02-Dec-2022. The patient was being monitored at the facility at the time of the call and no adverse events have been reported so far.