chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid 19 again/Getting COVID After the Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid 19 again/Getting COVID After the Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid 19 again/Getting COVID After the Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid 19 again/Getting COVID After the Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: sore arm; inappropriate schedule of drug administration; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of drug administration) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-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 (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of drug administration). At the time of the report, MYALGIA (sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of drug administration) outcome was unknown.            No concomitant medication  information was provided by the reporter.  No treatment information was provided by the reporter.  Patient took second dose on 14-JUL-2021 (039A21A) in his eft arm.   This case was linked to MOD-2021-281234 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Followup received on 09-Aug-2021. Patient DOB was added. First dose of vaccination date was updated and second dose details were added.New events (sore arm, inappropriate schedule of drug administration) added. Pre-existing event (missed dose) deleted. Corresponding fields and narrative were updated accordingly.
Sex: U
Vaccine: COVID19
Symptoms: Anosmia
Clinical narrative: lost my sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost my sense of smell) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    In March 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 ANOSMIA (lost my sense of smell). At the time of the report, ANOSMIA (lost my sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received the second dose from a vial that has expired based on the 12 hour expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the second dose from a vial that has expired based on the 12 hour expiration) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the second dose from a vial that has expired based on the 12 hour expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the second dose from a vial that has expired based on the 12 hour expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. No concomitant medication  information was provided by the reporter.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: didn't received the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Jun-2021 and was forwarded to Moderna on 30-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't received the second dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (In september or October 2020 and fully recovered.).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't received the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't received the second dose) had resolved.        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.   Patient stated that 3 weeks after first dose vaccination patient suffered an accident and spent last 5 months away from home.  No concomitant medications were provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: now on day 53 and has not yet received her second shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (now on day 53 and has not yet received her second shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-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 PRODUCT DOSE OMISSION ISSUE (now on day 53 and has not yet received her second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (now on day 53 and has not yet received her second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment was reported for the events.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pyrexia
Clinical narrative: Tired; High Fever; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of CHILLS (chills), FATIGUE (Tired) and PYREXIA (High Fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]) and LISINOPRIL for Hypertension, VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and CLONIDINE for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 30-Jun-2021, the patient experienced FATIGUE (Tired) and PYREXIA (High Fever). The patient was treated with NAPROXEN for Fever, at a dose of 500 mg. On 26-Apr-2021, CHILLS (chills) had resolved. At the time of the report, FATIGUE (Tired) and PYREXIA (High Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jun-2021, Body temperature: 102 to 103 degree Celsius (High) High. On 30-Jun-2021, Body temperature: 101.4 degree Celsius (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Scheduling second vaccine appointment, more than 36 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Scheduling second vaccine appointment, more than 36 days after first dose) 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.    On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Scheduling second vaccine appointment, more than 36 days after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Scheduling second vaccine appointment, more than 36 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information provided by reporter. No treatment information provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: have experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have experienced a side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    In June 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 VACCINATION COMPLICATION (have experienced a side effect). At the time of the report, VACCINATION COMPLICATION (have experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment medications were reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered three shots from a vial left out at room temperature for roughly 20 hours; This spontaneous case was reported by a patient and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered three shots from a vial left out at room temperature for roughly 20 hours) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 011D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered three shots from a vial left out at room temperature for roughly 20 hours). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered three shots from a vial left out at room temperature for roughly 20 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided by reporter. No treatment medication provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up received and Consist of Dosage text and dates were added, Primary reporter information was added and consent to safety was given yes.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Hypoaesthesia
Clinical narrative: felt like could not move or walk; her right hand feels numb and tip of the finger and it could be also the chemotherapy and radiation therapy; hip pain, ankle pain, the ankle pain radiated up and down; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (felt like could not move or walk), HYPOAESTHESIA (her right hand feels numb and tip of the finger and it could be also the chemotherapy and radiation therapy) and ARTHRALGIA (hip pain, ankle pain, the ankle pain radiated up and down) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer in 2016 and Rheumatoid arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (felt like could not move or walk), HYPOAESTHESIA (her right hand feels numb and tip of the finger and it could be also the chemotherapy and radiation therapy) and ARTHRALGIA (hip pain, ankle pain, the ankle pain radiated up and down). The patient was treated with DIETHYLAMINE SALICYLATE, METHYL NICOTINATE (ASPERCREME [DIETHYLAMINE SALICYLATE;METHYL NICOTINATE]) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (felt like could not move or walk), HYPOAESTHESIA (her right hand feels numb and tip of the finger and it could be also the chemotherapy and radiation therapy) and ARTHRALGIA (hip pain, ankle pain, the ankle pain radiated up and down) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: burning in the injected arm normal; 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 BURNING SENSATION (burning in the injected arm normal) 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 BURNING SENSATION (burning in the injected arm normal). At the time of the report, BURNING SENSATION (burning in the injected arm normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) 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 28-Jun-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 28-Jun-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant and fully vaccinated; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and fully vaccinated) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and CHLOROQUINE PHOSPHATE (CHLOROCIN [CHLOROQUINE PHOSPHATE]) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Jan-2021 and the estimated date of delivery was 29-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and fully vaccinated). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant and fully vaccinated) outcome was unknown.            The patient mentioned her Date of last menstrual period: 22-Jan-2021.  No  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-significant Follow Up - (Source Doc added, contact info updated)
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Palpitations
Clinical narrative: heart started racing for a period of 4 hours; felt a little dizzy; fatigued the whole month; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart started racing for a period of 4 hours), DIZZINESS (felt a little dizzy) and FATIGUE (fatigued the whole month) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jun-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 PALPITATIONS (heart started racing for a period of 4 hours), DIZZINESS (felt a little dizzy) and FATIGUE (fatigued the whole month). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PALPITATIONS (heart started racing for a period of 4 hours), DIZZINESS (felt a little dizzy) and FATIGUE (fatigued the whole month) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (sore injection site arm), vaccination site swelling (swollen injection site arm) and vaccination site erythema (red injection site arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026021A and 033B21A) for COVID-19 vaccination. No medical history reported. On May 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 21, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced vaccination site pain (sore injection site arm), vaccination site swelling (swollen injection site arm) and vaccination site erythema (red injection site arm). At the time of the report, vaccination site pain (sore injection site arm), vaccination site swelling (swollen injection site arm) and vaccination site erythema (red injection site arm) outcome: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. Action taken with mRNA-1273 in response to the events: not applicable. This case linked to MOD-2021-220030 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Hot flush, Pain in extremity, Rash
Clinical narrative: hot flashes; rashes all over the body; soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes), PAIN IN EXTREMITY (soreness of the arm) and RASH (rashes all over the body) 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 26-Jun-2021, the patient experienced PAIN IN EXTREMITY (soreness of the arm). On an unknown date, the patient experienced HOT FLUSH (hot flashes) and RASH (rashes all over the body). At the time of the report, HOT FLUSH (hot flashes), PAIN IN EXTREMITY (soreness of the arm) and RASH (rashes all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment medication was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Side effect with vision; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Side effect with vision) 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 VISUAL IMPAIRMENT (Side effect with vision). At the time of the report, VISUAL IMPAIRMENT (Side effect with vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided. For mRNA-1273 (COVID-19 Vaccine Moderna), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist administered three shots from a vial left out at room temperature for roughly 20 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient given first J&J vaccine in March 2021, then given first Moderna Vaccine on 28 May 2021; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient given first J&J vaccine in March 2021, then given first Moderna Vaccine on 28 May 2021) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient given first J&J vaccine in March 2021, then given first Moderna Vaccine on 28 May 2021). On 28-May-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient given first J&J vaccine in March 2021, then given first Moderna Vaccine on 28 May 2021) had resolved.        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.   No concomitant medications were reported.  No treatment information was reported.  On a unknown date in Mar 2021, the patient was vaccinated with Johnson and Johnson vaccine for Covid-19 immunization. Later, the nurse stated that upon transfer from center to another center, there was a mix up between the centers' systems and the patient signed up for COVID-19 vaccine and received Moderna vaccine first dose on 28 May 2021. The patient has not yet received the second dose of Moderna shot.    Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional Follow-up report was received: included patient DOB and gender.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Feeling abnormal, Intentional product use issue, Oral discomfort, Throat irritation
Clinical narrative: only took 1shot/did not take the second shot; burning in my chest that spread to my throat into my mouth; burning in my chest that spread to my throat into my mouth; burning in my chest that spread to my throat into my mouth; Cooking from the injection site that spread across my chest; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (only took 1shot/did not take the second shot), CHEST PAIN (burning in my chest that spread to my throat into my mouth), THROAT IRRITATION (burning in my chest that spread to my throat into my mouth), ORAL DISCOMFORT (burning in my chest that spread to my throat into my mouth) and FEELING ABNORMAL (Cooking from the injection site that spread across my chest) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (only took 1shot/did not take the second shot), CHEST PAIN (burning in my chest that spread to my throat into my mouth), THROAT IRRITATION (burning in my chest that spread to my throat into my mouth), ORAL DISCOMFORT (burning in my chest that spread to my throat into my mouth) and FEELING ABNORMAL (Cooking from the injection site that spread across my chest). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (only took 1shot/did not take the second shot) had resolved and CHEST PAIN (burning in my chest that spread to my throat into my mouth), THROAT IRRITATION (burning in my chest that spread to my throat into my mouth), ORAL DISCOMFORT (burning in my chest that spread to my throat into my mouth) and FEELING ABNORMAL (Cooking from the injection site that spread across my chest) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Social anxiety disorder
Clinical narrative: anxiety when is around other people; This spontaneous case was reported by a consumer and describes the occurrence of SOCIAL ANXIETY DISORDER (anxiety when is around other people) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOCIAL ANXIETY DISORDER (anxiety when is around other people). At the time of the report, SOCIAL ANXIETY DISORDER (anxiety when is around other people) outcome was unknown.            Patient believes that  he had Covid-19 in November 2018 because  he had difficulty breathing but it was not diagnosed. Concomitant products included vitamins. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: she had bad chills with fever for one night and was tired for 4 days; Fever; Was tired for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (she had bad chills with fever for one night and was tired for 4 days), PYREXIA (Fever) and FATIGUE (Was tired for 4 days) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Heart disease, unspecified (Heart problems).   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 21-Jan-2021, the patient experienced FATIGUE (Was tired for 4 days). On 16-Feb-2021, the patient experienced CHILLS (she had bad chills with fever for one night and was tired for 4 days) and PYREXIA (Fever). On 17-Feb-2021, CHILLS (she had bad chills with fever for one night and was tired for 4 days) and PYREXIA (Fever) had resolved. On 19-Feb-2021, FATIGUE (Was tired for 4 days) had resolved.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-242752 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Frequent bowel movements
Clinical narrative: Continuing loose bowel movements without any abdominal discomfort; Loose bowel; This spontaneous case was reported by a consumer and describes the occurrence of FREQUENT BOWEL MOVEMENTS (Continuing loose bowel movements without any abdominal discomfort) and DIARRHOEA (Loose bowel) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039A2EIP) for COVID-19 vaccination.     The patient's past medical history included Colonoscopy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN and LOSARTAN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (Continuing loose bowel movements without any abdominal discomfort) and DIARRHOEA (Loose bowel). At the time of the report, FREQUENT BOWEL MOVEMENTS (Continuing loose bowel movements without any abdominal discomfort) had resolved and DIARRHOEA (Loose bowel) outcome was unknown.            Treatment information was not provided. Patient had a colonoscopy on ??-JULY-2021 and  discovered and removed some polyps.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Significant Follow up received contains - Patient demographics includes age, gender, DOB and reporter phone number , Concomitant medication updated. On 12-Aug-2021: Follow up received containsupdated event out come as recovered and resolved and medical history
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: didn't receive the second dose on time; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose on time) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose on time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose on time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-243096 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: "minor congestion"/"little congestion"; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION ("minor congestion"/"little congestion") 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced NASAL CONGESTION ("minor congestion"/"little congestion"). At the time of the report, NASAL CONGESTION ("minor congestion"/"little congestion") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants and treatments medications was reported.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (testing positive for COVID19 following vaccination) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced SARS-COV-2 TEST POSITIVE (testing positive for COVID19 following vaccination). At the time of the report, SARS-COV-2 TEST POSITIVE (testing positive for COVID19 following vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chapped lips
Clinical narrative: severe chapped lips; This spontaneous case was reported by a consumer and describes the occurrence of CHAPPED LIPS (severe chapped lips) 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 28-May-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 an unknown date, the patient experienced CHAPPED LIPS (severe chapped lips). At the time of the report, CHAPPED LIPS (severe chapped lips) outcome was unknown.            Concomitant and treatment medications were not provided by reporter.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Developed COVID; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed COVID) and DRUG INEFFECTIVE (Lack of drug effect) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced COVID-19 (Developed COVID) and DRUG INEFFECTIVE (Lack of drug effect). On 29-Jun-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (Developed COVID) outcome was unknown.            Treatment information was not provided. No concomitant medications were reported. No lab data was provided by the reporter. This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.   This case was linked to MOD-2021-243061 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Up on internal review on 11-AUG-2021, an event LOE has been added to the case.; Sender's Comments: This is a case of lack of efficacy of the vaccine.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Pain in extremity
Clinical narrative: arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022cz1a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Fibrin D dimer: fine range (normal) After first dose-fine range and .55 (High) After second dose- high range .55.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.        Concomitant product use was unknown by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-243192 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 30 patients had been administered a dose past the 30 day mark (expired); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients had been administered a dose past the 30 day mark (expired)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients had been administered a dose past the 30 day mark (expired)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients had been administered a dose past the 30 day mark (expired)) had resolved.        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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant product information was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-015763 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: My wife had her first shot on May 11. Has she waited too long to get the second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (My wife had her first shot on May 11. Has she waited too long to get the second 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 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (My wife had her first shot on May 11. Has she waited too long to get the second shot). On 11-May-2021, PRODUCT DOSE OMISSION ISSUE (My wife had her first shot on May 11. Has she waited too long to get the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity, Periorbital swelling
Clinical narrative: From walking unassited and pain free to now needing crutches gain; Puffy eyes; Scratchy throat; Constant runny nose; Sneezing; Sore arm; Very painful weight bearing on my new hip/weight bering pain on hip on new hip has gotten worse; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of WALKING DISABILITY (From walking unassited and pain free to now needing crutches gain), PERIORBITAL SWELLING (Puffy eyes), THROAT IRRITATION (Scratchy throat), RHINORRHOEA (Constant runny nose) and SNEEZING (Sneezing) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21a and 038b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arthroplasty of hip (Total Arthroplasty of Left Hip) on 13-Apr-2021.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WALKING DISABILITY (From walking unassited and pain free to now needing crutches gain), PERIORBITAL SWELLING (Puffy eyes), THROAT IRRITATION (Scratchy throat), RHINORRHOEA (Constant runny nose), SNEEZING (Sneezing), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Very painful weight bearing on my new hip/weight bering pain on hip on new hip has gotten worse), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, WALKING DISABILITY (From walking unassited and pain free to now needing crutches gain), PERIORBITAL SWELLING (Puffy eyes), THROAT IRRITATION (Scratchy throat), RHINORRHOEA (Constant runny nose), SNEEZING (Sneezing), PAIN IN EXTREMITY (Sore arm), ARTHRALGIA (Very painful weight bearing on my new hip/weight bering pain on hip on new hip has gotten worse), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.            No concomitant medications were reported  No treatment medications were reported  Patient received first dose of Moderna vaccine experienced no side effects.  It was reported that the patient experienced adverse effects started approximately 16 hours after the second dose. Patient reported that the 'seasonal allergy symptoms' were constant for approximately 16 days and became intermittent.  It was reported that the patient has never suffered a single allergy symptom of any kind in the last 53 years. Patient states that the weight bearing pain on the new hip has gotten progressively worse. Patient also states that the two events are related.