chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discharge
Clinical narrative: some liquid (blood/vaccine?) run down their arm after the shot; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE DISCHARGE (some liquid (blood/vaccine?) run down their arm after the shot) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION SITE DISCHARGE (some liquid (blood/vaccine?) run down their arm after the shot). On 03-Nov-2021, VACCINATION SITE DISCHARGE (some liquid (blood/vaccine?) run down their arm after the shot) 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 information was reported. Patient stated they have some liquid (blood/vaccine?) run down their arm after the shot, so they believe they did not get the complete dose of the booster and wants to be administered with another dose. HCP is calling to find out if there is any guidance in this respect.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Severe itching on injection site; Redness at injection site; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Severe itching on injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0939904) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Anxiety, Drug allergy, Drug allergy, Drug allergy, Penicillin allergy and Drug allergy.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Severe itching on injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, VACCINATION SITE PRURITUS (Severe itching on injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization and medically significant). At the time of the report, APPENDICITIS (Appendicitis) outcome was unknown.            Concomitant medication not reported.  Treatment medication not reported.  Patient reported that her 4 siblings who had the Moderna COVID-19 vaccine also ended up with appendicitis after second vaccine.  This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of appendicitis. The event occurred on the same year as the received second dose. The rechallenge is not applicable since no information about the first dose was provided.The benefit-risk relationship of the vaccine is not affected by this report   This case was linked to MOD-2021-374939, MOD-2021-373492 (Patient Link).; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected event of appendicitis. The event occurred on the same year as the received second dose. The rechallenge is not applicable since no information about the first dose was provided.The benefit-risk relationship of the vaccine is not affected by this report
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rash pruritic, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash is everywhere, hands, feet, legs, whole body,skin rash,real bad rash), RASH PRURITIC (bad rash in the whole body. It was itching), VACCINATION SITE PAIN (pain in the left arm) and MYALGIA (sore) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Nov-2021, the patient experienced RASH PRURITIC (rash is everywhere, hands, feet, legs, whole body,skin rash,real bad rash) and RASH PRURITIC (bad rash in the whole body. It was itching). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the left arm) and MYALGIA (sore). The patient was treated with ANTIHISTAMINES for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash is everywhere, hands, feet, legs, whole body,skin rash,real bad rash), RASH PRURITIC (bad rash in the whole body. It was itching), VACCINATION SITE PAIN (pain in the left arm) and MYALGIA (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Antihistamine. Also said 2 allergy medications. No concomitant drug details were reported.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cold sweat, Hypoaesthesia, Inflammation, Myalgia
Clinical narrative: Hands are cold/hands frozen/knee cold/feet frozen; vascular inflammation; Sweating cold; Fever; Body aches; Throw up; Trembling; Tingling in hands/feet; Numbness in hands; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Trembling), PARAESTHESIA (Tingling in hands/feet), HYPOAESTHESIA (Numbness in hands), PERIPHERAL COLDNESS (Hands are cold/hands frozen/knee cold/feet frozen) and INFLAMMATION (vascular inflammation) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Pneumonia and had done antibody testing.) in July 2021. Concurrent medical conditions included Blood pressure. Concomitant products included METOPROLOL for Blood pressure.    On 31-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, the patient experienced TREMOR (Trembling), PARAESTHESIA (Tingling in hands/feet), HYPOAESTHESIA (Numbness in hands), PYREXIA (Fever), MYALGIA (Body aches) and VOMITING (Throw up). On 03-Nov-2021, the patient experienced PERIPHERAL COLDNESS (Hands are cold/hands frozen/knee cold/feet frozen), INFLAMMATION (vascular inflammation) and COLD SWEAT (Sweating cold). At the time of the report, TREMOR (Trembling), PARAESTHESIA (Tingling in hands/feet), HYPOAESTHESIA (Numbness in hands), PERIPHERAL COLDNESS (Hands are cold/hands frozen/knee cold/feet frozen), INFLAMMATION (vascular inflammation), COLD SWEAT (Sweating cold), PYREXIA (Fever), MYALGIA (Body aches) and VOMITING (Throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, Body temperature: 95.9 (Low) Decreases (95.9).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness, Pyrexia, Tremor, Vomiting
Clinical narrative: Hands are cold/hands frozen/knee cold/feet frozen; vascular inflammation; Sweating cold; Fever; Body aches; Throw up; Trembling; Tingling in hands/feet; Numbness in hands; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Trembling), PARAESTHESIA (Tingling in hands/feet), HYPOAESTHESIA (Numbness in hands), PERIPHERAL COLDNESS (Hands are cold/hands frozen/knee cold/feet frozen) and INFLAMMATION (vascular inflammation) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Pneumonia and had done antibody testing.) in July 2021. Concurrent medical conditions included Blood pressure. Concomitant products included METOPROLOL for Blood pressure.    On 31-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, the patient experienced TREMOR (Trembling), PARAESTHESIA (Tingling in hands/feet), HYPOAESTHESIA (Numbness in hands), PYREXIA (Fever), MYALGIA (Body aches) and VOMITING (Throw up). On 03-Nov-2021, the patient experienced PERIPHERAL COLDNESS (Hands are cold/hands frozen/knee cold/feet frozen), INFLAMMATION (vascular inflammation) and COLD SWEAT (Sweating cold). At the time of the report, TREMOR (Trembling), PARAESTHESIA (Tingling in hands/feet), HYPOAESTHESIA (Numbness in hands), PERIPHERAL COLDNESS (Hands are cold/hands frozen/knee cold/feet frozen), INFLAMMATION (vascular inflammation), COLD SWEAT (Sweating cold), PYREXIA (Fever), MYALGIA (Body aches) and VOMITING (Throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, Body temperature: 95.9 (Low) Decreases (95.9).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Thyroid mass
Clinical narrative: nodule on her thyroid; /three weeks to a month after the first dose/hesitant of the second dose; This spontaneous case was reported by a consumer and describes the occurrence of THYROID MASS (nodule on her thyroid) and INTENTIONAL DOSE OMISSION (/three weeks to a month after the first dose/hesitant of the second dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THYROID MASS (nodule on her thyroid) and INTENTIONAL DOSE OMISSION (/three weeks to a month after the first dose/hesitant of the second dose). At the time of the report, THYROID MASS (nodule on her thyroid) outcome was unknown and INTENTIONAL DOSE OMISSION (/three weeks to a month after the first dose/hesitant of the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment drug medications were not reported. It was reported that the patient's wife had a biopsy on 25Oct2021.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest X-ray, Chest pain, Computerised tomogram
Clinical narrative: weak; tired/Worn out; Pain off and on/It literally wiped me out; Terrific pain in my upper chest; It started in my back/went to my front from the waist up; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Terrific pain in my upper chest), BACK PAIN (It started in my back/went to my front from the waist up), ASTHENIA (weak), PAIN (Pain off and on/It literally wiped me out) and FATIGUE (tired/Worn out) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C214, 025L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced CHEST PAIN (Terrific pain in my upper chest), BACK PAIN (It started in my back/went to my front from the waist up) and PAIN (Pain off and on/It literally wiped me out). On an unknown date, the patient experienced ASTHENIA (weak). an unknown date, the patient experienced FATIGUE (tired/Worn out). At the time of the report, CHEST PAIN (Terrific pain in my upper chest), BACK PAIN (It started in my back/went to my front from the waist up), ASTHENIA (weak), PAIN (Pain off and on/It literally wiped me out) and FATIGUE (tired/Worn out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The patient had heart monitor test, blood draw whose result were Normal.   This case was linked to MOD-2021-374774 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: weak; tired/Worn out; Pain off and on/It literally wiped me out; Terrific pain in my upper chest; It started in my back/went to my front from the waist up; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Terrific pain in my upper chest), BACK PAIN (It started in my back/went to my front from the waist up), ASTHENIA (weak), PAIN (Pain off and on/It literally wiped me out) and FATIGUE (tired/Worn out) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C214, 025L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced CHEST PAIN (Terrific pain in my upper chest), BACK PAIN (It started in my back/went to my front from the waist up) and PAIN (Pain off and on/It literally wiped me out). On an unknown date, the patient experienced ASTHENIA (weak). an unknown date, the patient experienced FATIGUE (tired/Worn out). At the time of the report, CHEST PAIN (Terrific pain in my upper chest), BACK PAIN (It started in my back/went to my front from the waist up), ASTHENIA (weak), PAIN (Pain off and on/It literally wiped me out) and FATIGUE (tired/Worn out) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.  The patient had heart monitor test, blood draw whose result were Normal.   This case was linked to MOD-2021-374774 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided.  No treatment medications provided.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received a dose more than 30 days in the fridge; Received a dose more than 30 days in the fridge; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose more than 30 days in the fridge) and PRODUCT STORAGE ERROR (Received a dose more than 30 days in the fridge) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose more than 30 days in the fridge) and PRODUCT STORAGE ERROR (Received a dose more than 30 days in the fridge). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received a dose more than 30 days in the fridge) and PRODUCT STORAGE ERROR (Received a dose more than 30 days in the fridge) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (gave 11 patients Moderna Covid-19 Vaccine doses on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021). At the time of the report, PRODUCT STORAGE ERROR (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) 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 provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got the first and second doses in March and mentions may have gotten them one week apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first and second doses in March and mentions may have gotten them one week apart) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first and second doses in March and mentions may have gotten them one week apart). In March 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first and second doses in March and mentions may have gotten them one week apart) had resolved.            No concomitant medication were reported. No  treatment information was provided by the reporter. Patient took  Moderna COVID-19 booster dose on 29Oct2021 in his left deltoid muscle.   This case was linked to MOD-2021-374194 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise, Vaccination site pain
Clinical narrative: Feeling feverish; Arm hurt a lot; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling feverish), VACCINATION SITE PAIN (Arm hurt a lot) and CHILLS (Chills) 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) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling feverish), VACCINATION SITE PAIN (Arm hurt a lot) and CHILLS (Chills). At the time of the report, MALAISE (Feeling feverish), VACCINATION SITE PAIN (Arm hurt a lot) and CHILLS (Chills) outcome was unknown.            No Concomitant medication information was reported. No Treatment medications were provided As per the narrative in source document, the patient is female.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd Dose administered beyond 30-day use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  Date taken out of freezer: 9/8/2021
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: short of breath; could not even walk 3 feet; feel weak; lightheaded; lost their appetite; aching in their legs; are aching in their arms; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), GAIT DISTURBANCE (could not even walk 3 feet), ASTHENIA (feel weak), DIZZINESS (lightheaded) and DECREASED APPETITE (lost their appetite) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 037A21B and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fistula (complications due to their "internals being in a bad shape, intestines were messed up, and developed fistulas an have an ostomy bag. They had those before , 8-9 years ago too) in 2014 and Hospitalization (for 3 and half months) in July 2021. Concomitant products included HYDROCODONE and ACETYLSALICYLIC ACID (ASPIRINE 325 MG) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced DYSPNOEA (short of breath), GAIT DISTURBANCE (could not even walk 3 feet), ASTHENIA (feel weak), DIZZINESS (lightheaded), DECREASED APPETITE (lost their appetite), PAIN IN EXTREMITY (aching in their legs), PAIN IN EXTREMITY (are aching in their arms) and CHILLS (chills). At the time of the report, DYSPNOEA (short of breath), GAIT DISTURBANCE (could not even walk 3 feet), ASTHENIA (feel weak), DIZZINESS (lightheaded), DECREASED APPETITE (lost their appetite), PAIN IN EXTREMITY (aching in their legs), PAIN IN EXTREMITY (are aching in their arms) and CHILLS (chills) outcome was unknown.            No treatment medications was provided by the reporter.  Patient reported that they have not being diagnosed with any heart conditions or had covid-19 before and took several medication but will not provide that information at this time. Also,took 325mg of aspirin a day as a blood thinner and wondering  they should go to the hospital for their symptoms.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: short of breath; could not even walk 3 feet; feel weak; lightheaded; lost their appetite; aching in their legs; are aching in their arms; chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), GAIT DISTURBANCE (could not even walk 3 feet), ASTHENIA (feel weak), DIZZINESS (lightheaded) and DECREASED APPETITE (lost their appetite) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 037A21B and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fistula (complications due to their "internals being in a bad shape, intestines were messed up, and developed fistulas an have an ostomy bag. They had those before , 8-9 years ago too) in 2014 and Hospitalization (for 3 and half months) in July 2021. Concomitant products included HYDROCODONE and ACETYLSALICYLIC ACID (ASPIRINE 325 MG) for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced DYSPNOEA (short of breath), GAIT DISTURBANCE (could not even walk 3 feet), ASTHENIA (feel weak), DIZZINESS (lightheaded), DECREASED APPETITE (lost their appetite), PAIN IN EXTREMITY (aching in their legs), PAIN IN EXTREMITY (are aching in their arms) and CHILLS (chills). At the time of the report, DYSPNOEA (short of breath), GAIT DISTURBANCE (could not even walk 3 feet), ASTHENIA (feel weak), DIZZINESS (lightheaded), DECREASED APPETITE (lost their appetite), PAIN IN EXTREMITY (aching in their legs), PAIN IN EXTREMITY (are aching in their arms) and CHILLS (chills) outcome was unknown.            No treatment medications was provided by the reporter.  Patient reported that they have not being diagnosed with any heart conditions or had covid-19 before and took several medication but will not provide that information at this time. Also,took 325mg of aspirin a day as a blood thinner and wondering  they should go to the hospital for their symptoms.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Myalgia
Clinical narrative: Flushing; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushing) and MYALGIA (Sore arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 027A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included UBIDECARENONE (COQ-10) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FLUSHING (Flushing) and MYALGIA (Sore arm). At the time of the report, FLUSHING (Flushing) and MYALGIA (Sore arm) outcome was unknown.            No treatment medication was provided.   This case was linked to MOD-2021-374206, MOD-2021-374385 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Swelling in the armpit of the same arm that the vaccine was administered; Pain  in the armpit of the same arm that the vaccine was administered; Experienced sore arm on the injection site; Low grade fever of 99.9-100degF; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in the armpit of the same arm that the vaccine was administered), AXILLARY PAIN (Pain  in the armpit of the same arm that the vaccine was administered), VACCINATION SITE PAIN (Experienced sore arm on the injection site), PYREXIA (Low grade fever of 99.9-100degF) and FATIGUE (Fatigue) 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 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (Experienced sore arm on the injection site). 29-Oct-2021, the patient experienced PYREXIA (Low grade fever of 99.9-100degF) and FATIGUE (Fatigue). On 30-Oct-2021, the patient experienced LYMPHADENOPATHY (Swelling in the armpit of the same arm that the vaccine was administered) and AXILLARY PAIN (Pain  in the armpit of the same arm that the vaccine was administered). At the time of the report, LYMPHADENOPATHY (Swelling in the armpit of the same arm that the vaccine was administered), AXILLARY PAIN (Pain  in the armpit of the same arm that the vaccine was administered), VACCINATION SITE PAIN (Experienced sore arm on the injection site), PYREXIA (Low grade fever of 99.9-100degF) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Body temperature: 99.9-100 (High) 99.9-100degF.         Concomitant information was not provided.  It was reported that the patient experienced sore arm at injection site within 2 hours after the shot and also felt fever and fatigue at the same night. On 30-Oct-2021. at morning patient experienced pain and swelling in the armpit of the same arm.  Patient was reported to not take any treatment for the events.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Swelling in the armpit of the same arm that the vaccine was administered; Pain  in the armpit of the same arm that the vaccine was administered; Experienced sore arm on the injection site; Low grade fever of 99.9-100degF; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling in the armpit of the same arm that the vaccine was administered), AXILLARY PAIN (Pain  in the armpit of the same arm that the vaccine was administered), VACCINATION SITE PAIN (Experienced sore arm on the injection site), PYREXIA (Low grade fever of 99.9-100degF) and FATIGUE (Fatigue) 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 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced VACCINATION SITE PAIN (Experienced sore arm on the injection site). 29-Oct-2021, the patient experienced PYREXIA (Low grade fever of 99.9-100degF) and FATIGUE (Fatigue). On 30-Oct-2021, the patient experienced LYMPHADENOPATHY (Swelling in the armpit of the same arm that the vaccine was administered) and AXILLARY PAIN (Pain  in the armpit of the same arm that the vaccine was administered). At the time of the report, LYMPHADENOPATHY (Swelling in the armpit of the same arm that the vaccine was administered), AXILLARY PAIN (Pain  in the armpit of the same arm that the vaccine was administered), VACCINATION SITE PAIN (Experienced sore arm on the injection site), PYREXIA (Low grade fever of 99.9-100degF) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Body temperature: 99.9-100 (High) 99.9-100degF.         Concomitant information was not provided.  It was reported that the patient experienced sore arm at injection site within 2 hours after the shot and also felt fever and fatigue at the same night. On 30-Oct-2021. at morning patient experienced pain and swelling in the armpit of the same arm.  Patient was reported to not take any treatment for the events.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose administered beyond 30 day use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose administered beyond 30 day use) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose administered beyond 30 day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose administered beyond 30 day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   2 vials were taken out of freezer on 08-Sep-2021 and first dose was given to 1 patient, second dose was administered to 9 patients, third dose was given to 2 immunocompromised patient. No temperature excursion was reported.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Pain in extremity
Clinical narrative: experienced sore arm; full dose even though he is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced sore arm) and ACCIDENTAL OVERDOSE (full dose even though he is not immunocompromised) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 002B21A and 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included UBIDECARENONE (COQ-10) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (full dose even though he is not immunocompromised). On an unknown date, the patient experienced PAIN IN EXTREMITY (experienced sore arm). On 03-Nov-2021, ACCIDENTAL OVERDOSE (full dose even though he is not immunocompromised) had resolved. At the time of the report, PAIN IN EXTREMITY (experienced sore arm) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-374206, MOD-2021-374377 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Aches; Nausea; Chills; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headaches) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aches), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, MYALGIA (Aches), NAUSEA (Nausea), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication reported included allergy medicine. No treatment information was provided.  The patient reported that following vaccination, the patient began to experience nauseas, aches, chills, and headaches.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; The patient received a dose more than 30 days in the fridge of the Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a dose more than 30 days in the fridge of the Moderna COVID-19 Vaccine) and PRODUCT STORAGE ERROR (Product storage error) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose more than 30 days in the fridge of the Moderna COVID-19 Vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a dose more than 30 days in the fridge of the Moderna COVID-19 Vaccine) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient received a dose of the Moderna COVID-19 Vaccine which was kept more than 30 days in the fridge.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: Balance problem after booster shot; This spontaneous case was reported by a nurse and describes the occurrence of BALANCE DISORDER (Balance problem after booster shot) in a female 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 an unknown date, the patient experienced BALANCE DISORDER (Balance problem after booster shot). At the time of the report, BALANCE DISORDER (Balance problem after booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient reported that they had balance problems after receiving the COVID-19 booster dose.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm after first vaccine) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm after first vaccine). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm after first vaccine) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-374448 (Patient Link).
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) 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 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that   date the vial was initially stored in the refrigerator 24-Sep-2021.Date of administration of vaccine 24-Oct-2021 - 27-Oct-2021. 44 doses were stored in refrigerator.  Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-374935, MOD-2021-374694 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Myalgia
Clinical narrative: feels weak; very bad chills; headachy; achy; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels weak), CHILLS (very bad chills), HEADACHE (headachy) and MYALGIA (achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ASTHENIA (feels weak), CHILLS (very bad chills), HEADACHE (headachy) and MYALGIA (achy). At the time of the report, ASTHENIA (feels weak), CHILLS (very bad chills), HEADACHE (headachy) and MYALGIA (achy) outcome was unknown.            No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Not immunocompromised got the booster shot for 0.5ml; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Not immunocompromised got the booster shot for 0.5ml) 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) (unknown route) .5 milliliter. On an unknown date, the patient experienced OFF LABEL USE (Not immunocompromised got the booster shot for 0.5ml). At the time of the report, OFF LABEL USE (Not immunocompromised got the booster shot for 0.5ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The reporter stated that they knew someone who was not immunocompromised and got the booster shot for 0.5mL.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-374427 (Patient Link).