chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Ultrasound scan
Clinical narrative: left lymph nodes had multiple enlargements; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (left lymph nodes had multiple enlargements) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rotator cuff tear (Torn rotator cuff). Concurrent medical conditions included CLL (Diagnosed 3-4 years ago) and Arthritis (Left side of arthritis).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (left lymph nodes had multiple enlargements). At the time of the report, LYMPHADENOPATHY (left lymph nodes had multiple enlargements) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: normal (normal) Normal. On an unknown date, Ultrasound scan: abnormal (abnormal) Patient had a sonogram that showed her left lymph nodes had multiple enlargements..         No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue, Inappropriate schedule of product administration
Clinical narrative: Syringe malfunctioned during the process, and I wasn't able to receive a full dose; wasn't able to receive a full dose; Was administered a booster to help make up for what was lost down my arm; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe malfunctioned during the process, and I wasn't able to receive a full dose), ACCIDENTAL UNDERDOSE (wasn't able to receive a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was administered a booster to help make up for what was lost down my arm) 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 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe malfunctioned during the process, and I wasn't able to receive a full dose), ACCIDENTAL UNDERDOSE (wasn't able to receive a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was administered a booster to help make up for what was lost down my arm). On 10-Dec-2021, DEVICE CONNECTION ISSUE (Syringe malfunctioned during the process, and I wasn't able to receive a full dose), ACCIDENTAL UNDERDOSE (wasn't able to receive a full dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Was administered a booster to help make up for what was lost down my arm) had resolved.            No concomitant medications were reported.  Treatment information was not provided. Patient received first vaccine shot and the syringe malfunctioned during the process and was not able to receive a full dose. So to combat the situation an additional dose was administered to make up for what was lost down the arm.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Axillary mass, Breast swelling, Lymphadenopathy, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (It then moved toward her breast. It has moved beyond her breast. She has swelling from the bottom of her breast through her belly), ABDOMINAL DISTENSION (She has swelling from the bottom of her breast through her belly), PAIN (She has states it was sore), VACCINATION SITE MASS (At the shot site there was an area half the size of a lacrosse ball on her arm) and AXILLARY MASS (She states it moved to underneath her arm/She states it feels like jelly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H213) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Had no reaction.) in April 2021 and Pfizer (Had no reaction.) in May 2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer.    On 05-Dec-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 BREAST SWELLING (It then moved toward her breast. It has moved beyond her breast. She has swelling from the bottom of her breast through her belly), ABDOMINAL DISTENSION (She has swelling from the bottom of her breast through her belly), PAIN (She has states it was sore), VACCINATION SITE MASS (At the shot site there was an area half the size of a lacrosse ball on her arm), AXILLARY MASS (She states it moved to underneath her arm/She states it feels like jelly) and LYMPHADENOPATHY (She had swelling underneath her arm). At the time of the report, BREAST SWELLING (It then moved toward her breast. It has moved beyond her breast. She has swelling from the bottom of her breast through her belly), ABDOMINAL DISTENSION (She has swelling from the bottom of her breast through her belly), PAIN (She has states it was sore), VACCINATION SITE MASS (At the shot site there was an area half the size of a lacrosse ball on her arm), AXILLARY MASS (She states it moved to underneath her arm/She states it feels like jelly) and LYMPHADENOPATHY (She had swelling underneath her arm) outcome was unknown.            No Concomitant medication information was reported.  No Treatment medications were provided  It was reported that she had been to the doctor and they have told her they are all normal.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BREAST SWELLING (It then moved toward her breast. It has moved beyond her breast. She has swelling from the bottom of her breast through her belly), ABDOMINAL DISTENSION (She has swelling from the bottom of her breast through her belly), PAIN (She has states it was sore), VACCINATION SITE MASS (At the shot site there was an area half the size of a lacrosse ball on her arm) and AXILLARY MASS (She states it moved to underneath her arm/She states it feels like jelly) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H213) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Had no reaction.) in April 2021 and Pfizer (Had no reaction.) in May 2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and Pfizer.    On 05-Dec-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 BREAST SWELLING (It then moved toward her breast. It has moved beyond her breast. She has swelling from the bottom of her breast through her belly), ABDOMINAL DISTENSION (She has swelling from the bottom of her breast through her belly), PAIN (She has states it was sore), VACCINATION SITE MASS (At the shot site there was an area half the size of a lacrosse ball on her arm), AXILLARY MASS (She states it moved to underneath her arm/She states it feels like jelly) and LYMPHADENOPATHY (She had swelling underneath her arm). At the time of the report, BREAST SWELLING (It then moved toward her breast. It has moved beyond her breast. She has swelling from the bottom of her breast through her belly), ABDOMINAL DISTENSION (She has swelling from the bottom of her breast through her belly), PAIN (She has states it was sore), VACCINATION SITE MASS (At the shot site there was an area half the size of a lacrosse ball on her arm), AXILLARY MASS (She states it moved to underneath her arm/She states it feels like jelly) and LYMPHADENOPATHY (She had swelling underneath her arm) outcome was unknown.            No Concomitant medication information was reported.  No Treatment medications were provided  It was reported that she had been to the doctor and they have told her they are all normal.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Fatigue, Pyrexia
Clinical narrative: Was in bed for two weeks; Three degree above normal temperature; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for two weeks), PYREXIA (Three degree above normal temperature), CHILLS (Chills) and FATIGUE (Fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced BEDRIDDEN (Was in bed for two weeks), PYREXIA (Three degree above normal temperature), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Mar-2021, PYREXIA (Three degree above normal temperature) had resolved. On 24-Mar-2021, BEDRIDDEN (Was in bed for two weeks), CHILLS (Chills) and FATIGUE (Fatigue) had resolved.        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 medication were provided.   This case was linked to MOD-2021-408535 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Gait inability, Loss of personal independence in daily activities
Clinical narrative: Never felt so sick in my life; Can't sleep; Can't shower; Feel horrible/everything is off; Can't walk; Hit me hard; Shook for 3 hours; 103 fever; Severe chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Never felt so sick in my life), SLEEP DISORDER (Can't sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't shower), FEELING ABNORMAL (Feel horrible/everything is off) and GAIT INABILITY (Can't walk) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B and 012F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced MALAISE (Never felt so sick in my life), SLEEP DISORDER (Can't sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't shower), FEELING ABNORMAL (Feel horrible/everything is off), GAIT INABILITY (Can't walk), VACCINATION COMPLICATION (Hit me hard), TREMOR (Shook for 3 hours), PYREXIA (103 fever) and CHILLS (Severe chills). On 09-Dec-2021, TREMOR (Shook for 3 hours), PYREXIA (103 fever) and CHILLS (Severe chills) had resolved. At the time of the report, MALAISE (Never felt so sick in my life), SLEEP DISORDER (Can't sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't shower), FEELING ABNORMAL (Feel horrible/everything is off), GAIT INABILITY (Can't walk) and VACCINATION COMPLICATION (Hit me hard) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2021, Body temperature: 103 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided. No treatment medication was provided.   This case was linked to MOD-2021-408501 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Sleep disorder, Tremor, Vaccination complication
Clinical narrative: Never felt so sick in my life; Can't sleep; Can't shower; Feel horrible/everything is off; Can't walk; Hit me hard; Shook for 3 hours; 103 fever; Severe chills; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (Never felt so sick in my life), SLEEP DISORDER (Can't sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't shower), FEELING ABNORMAL (Feel horrible/everything is off) and GAIT INABILITY (Can't walk) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B and 012F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced MALAISE (Never felt so sick in my life), SLEEP DISORDER (Can't sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't shower), FEELING ABNORMAL (Feel horrible/everything is off), GAIT INABILITY (Can't walk), VACCINATION COMPLICATION (Hit me hard), TREMOR (Shook for 3 hours), PYREXIA (103 fever) and CHILLS (Severe chills). On 09-Dec-2021, TREMOR (Shook for 3 hours), PYREXIA (103 fever) and CHILLS (Severe chills) had resolved. At the time of the report, MALAISE (Never felt so sick in my life), SLEEP DISORDER (Can't sleep), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't shower), FEELING ABNORMAL (Feel horrible/everything is off), GAIT INABILITY (Can't walk) and VACCINATION COMPLICATION (Hit me hard) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2021, Body temperature: 103 (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided. No treatment medication was provided.   This case was linked to MOD-2021-408501 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches/ The sore intensified when pushed; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches/ The sore intensified when pushed) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040821A and 006821A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYALGIA (Body aches/ The sore intensified when pushed). At the time of the report, MYALGIA (Body aches/ The sore intensified when pushed) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2021-408589, MOD-2021-408587 (Patient Link).
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients). On 10-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter.   This case was linked to MOD-2021-408599, MOD-2021-408463 (Patient Link).
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal, Heart disease, unspecified and Stomach discomfort. Concomitant products included AMLODIPINE and LOSARTAN for Blood pressure, ROSUVASTATIN for Cholesterol, CARVEDILOL for Heart disease, unspecified, ASPIRIN [ACETYLSALICYLIC ACID] for Heart disorder, PANTOPRAZOLE for Stomach discomfort.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients). On 10-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown.  The vial was stored in the Refrigerator at the time of the excursion. The maximum or minimum temperatures reached between 2-8 Celsius degrees. The excursion duration was almost 24 to 30 hours. The vial are dropped into a specific container. There was no visual inspection noting any vaccine state change (e.g. were frozen vials thawed, were thawed vials re-frozen, were they visualized at all). The proposed desired use by date was 10-Dec-2021.   This case was linked to MOD-2021-408597, MOD-2021-408595, MOD-2021-408594, MOD-2021-408463 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Brother was walloped after his Moderna Covid-19 vaccine booster.; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Brother was walloped after his Moderna Covid-19 vaccine booster.) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION COMPLICATION (Brother was walloped after his Moderna Covid-19 vaccine booster.). At the time of the report, VACCINATION COMPLICATION (Brother was walloped after his Moderna Covid-19 vaccine booster.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect). At the time of the report, VACCINATION COMPLICATION (Side effect) 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.   Concomitant medication was not reported.  Treatment information was not reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Feeding disorder, Illness, Weight decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost appetite/absolute lack of appetite no interest of eating at all), WEIGHT DECREASED (lost 20% of his body wake for starvation), FEEDING DISORDER (he had to force feed himself, look like he was  in a concertation camp for loosing so much weight.) and ILLNESS (The vaccine made him sick) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     Concurrent medical conditions included Bladder infection (Antibiotics for bladder infection, furosemide,). Concomitant products included FUROSEMIDE for Bladder infection, FINASTERIDE, TAMSULOSIN and CALCIUM for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DECREASED APPETITE (lost appetite/absolute lack of appetite no interest of eating at all). On an unknown date, the patient experienced WEIGHT DECREASED (lost 20% of his body wake for starvation), FEEDING DISORDER (he had to force feed himself, look like he was  in a concertation camp for loosing so much weight.) and ILLNESS (The vaccine made him sick). On 27-May-2021, DECREASED APPETITE (lost appetite/absolute lack of appetite no interest of eating at all) had resolved. At the time of the report, WEIGHT DECREASED (lost 20% of his body wake for starvation), FEEDING DISORDER (he had to force feed himself, look like he was  in a concertation camp for loosing so much weight.) and ILLNESS (The vaccine made him sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment medication was nitriofur mono on the 24nov2021.   This case was linked to MOD-2021-409301 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by an other health care professional and describes the occurrence of SINUSITIS (sinus infection) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient currently an antibiotic for a sinus infection and wanted to see if patient should be concerned getting the booster while finishing up an antibiotic.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: HCP stated that she gave an dose with a temperature excursion to almost 4 patients (she is no sure); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that she gave an dose with a temperature excursion to almost 4 patients (she is no sure)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that she gave an dose with a temperature excursion to almost 4 patients (she is no sure)). On 10-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that she gave an dose with a temperature excursion to almost 4 patients (she is no sure)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.  Excursion information, Storage condition at the time of the excursion- Room temperature. Maximum or minimum temperatures reached, as applicable- 64 degree F. Excursion duration- 32 hours. Date vial(s) moved from freezer to refrigerator- 9 DEC 2021. Where are they stored now? Were thrown into the corresponding trash. Visual inspection- Nothing . Proposed desired Use by Date- 9 JAN 2022. Number of vials impacted- 1 vial Pertinent details- The vials were punctured, no previous excursions.
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Lymphadenopathy, Odynophagia
Clinical narrative: painful/difficulties swallowing; painful/difficulties swallowing; Enlarged lymph nodes in throat; This spontaneous case was reported by a physician and describes the occurrence of ODYNOPHAGIA (painful/difficulties swallowing), DYSPHAGIA (painful/difficulties swallowing) and LYMPHADENOPATHY (Enlarged lymph nodes in throat) 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 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ODYNOPHAGIA (painful/difficulties  swallowing), DYSPHAGIA (painful/difficulties  swallowing) and LYMPHADENOPATHY (Enlarged lymph nodes in throat). In 2021, ODYNOPHAGIA (painful/difficulties  swallowing), DYSPHAGIA (painful/difficulties  swallowing) and LYMPHADENOPATHY (Enlarged lymph nodes in throat) 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 information was reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient received expired vaccine; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer vaccine (First dose) on 28-Apr-2021 and Pfizer vaccine (Second dose) on 19-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pin and soreness after receiving the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Pin and soreness after receiving the booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pin and soreness after receiving the booster). At the time of the report, PAIN (Pin and soreness after receiving the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very sore arm), VACCINATION SITE WARMTH (With pink hot area surrounding the injection site) and VACCINATION SITE ERYTHEMA (With pink hot area surrounding the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included Removal of kidney stone (unsucessful) on 03-Feb-2020, Lithotripsy renal on 04-Mar-2020, Stent removal on 23-Jun-2020 and Lithotripsy renal (kidney stone clear/lithotripsy) on 07-Jun-2021. Concurrent medical conditions included Kidney stone since 26-Jan-2020.    On 27-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Very sore arm), VACCINATION SITE WARMTH (With pink hot area surrounding the injection site) and VACCINATION SITE ERYTHEMA (With pink hot area surrounding the injection site). At the time of the report, PAIN IN EXTREMITY (Very sore arm) had resolved and VACCINATION SITE WARMTH (With pink hot area surrounding the injection site) and VACCINATION SITE ERYTHEMA (With pink hot area surrounding the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication details were not reported by the reporter.  Treatment details was not reported by the reporter.  Patient had  sore arm for about a week. Patient uses hair dye.   This case was linked to MOD-2021-406092, MOD-2021-406101 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: 28 patient received expired vaccine; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer on 24-Mar-2021 and Pfizer on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Facial pain, Fall, Headache, Rash erythematous
Clinical narrative: her face is sore from the fall; her balance was off/lost her balance at the store; the trunk of her body was swollen; fell; got scratches; her whole body was covered in a red rash; headache/hit her head/her head is better but still sore; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (her face is sore from the fall), BALANCE DISORDER (her balance was off/lost her balance at the store), SWELLING (the trunk of her body was swollen), FALL (fell) and SCRATCH (got scratches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced BALANCE DISORDER (her balance was off/lost her balance at the store), SWELLING (the trunk of her body was swollen), FALL (fell), SCRATCH (got scratches), RASH ERYTHEMATOUS (her whole body was covered in a red rash) and HEADACHE (headache/hit her head/her head is better but still sore). On 10-Dec-2021, the patient experienced FACIAL PAIN (her face is sore from the fall). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 10-Dec-2021, RASH ERYTHEMATOUS (her whole body was covered in a red rash) had resolved. At the time of the report, FACIAL PAIN (her face is sore from the fall), BALANCE DISORDER (her balance was off/lost her balance at the store), SWELLING (the trunk of her body was swollen), FALL (fell) and SCRATCH (got scratches) outcome was unknown and HEADACHE (headache/hit her head/her head is better but still sore) had not resolved.            Concomitant medication was not reported. On 09-Dec-2021 her balance was off, her whole body was covered in a red rash and the trunk of her body was swollen. She took Benadryl and it started going away, so she went to the store. She lost her balance at the store, fell, hit her head, got scratches, and a headache.  On 10-Dec-2021 her head was better but still sore, her face was sore from the fall and the rash was gone. She said this had never happened before except when she was little and had a reaction to sulfa: she couldn't walk then and her legs looked beat up. Treatment includes Benadryl.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Scratch, Swelling
Clinical narrative: her face is sore from the fall; her balance was off/lost her balance at the store; the trunk of her body was swollen; fell; got scratches; her whole body was covered in a red rash; headache/hit her head/her head is better but still sore; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (her face is sore from the fall), BALANCE DISORDER (her balance was off/lost her balance at the store), SWELLING (the trunk of her body was swollen), FALL (fell) and SCRATCH (got scratches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced BALANCE DISORDER (her balance was off/lost her balance at the store), SWELLING (the trunk of her body was swollen), FALL (fell), SCRATCH (got scratches), RASH ERYTHEMATOUS (her whole body was covered in a red rash) and HEADACHE (headache/hit her head/her head is better but still sore). On 10-Dec-2021, the patient experienced FACIAL PAIN (her face is sore from the fall). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 10-Dec-2021, RASH ERYTHEMATOUS (her whole body was covered in a red rash) had resolved. At the time of the report, FACIAL PAIN (her face is sore from the fall), BALANCE DISORDER (her balance was off/lost her balance at the store), SWELLING (the trunk of her body was swollen), FALL (fell) and SCRATCH (got scratches) outcome was unknown and HEADACHE (headache/hit her head/her head is better but still sore) had not resolved.            Concomitant medication was not reported. On 09-Dec-2021 her balance was off, her whole body was covered in a red rash and the trunk of her body was swollen. She took Benadryl and it started going away, so she went to the store. She lost her balance at the store, fell, hit her head, got scratches, and a headache.  On 10-Dec-2021 her head was better but still sore, her face was sore from the fall and the rash was gone. She said this had never happened before except when she was little and had a reaction to sulfa: she couldn't walk then and her legs looked beat up. Treatment includes Benadryl.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Patient received expired vaccine; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (1st Dose) on 24-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (Second dose) on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment information was not reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-408551 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.