chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination complication
Clinical narrative: Has Not received the Second shot, 6 months post First vaccine; Had Issues after First Shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had Issues after First Shot) and PRODUCT DOSE OMISSION ISSUE (Has Not received the Second shot, 6 months post First vaccine) 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.    In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced VACCINATION COMPLICATION (Had Issues after First Shot). On 25-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has Not received the Second shot, 6 months post First vaccine). At the time of the report, VACCINATION COMPLICATION (Had Issues after First Shot) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Has Not received the Second shot, 6 months post First vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  No treatment medications were reported by the reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Malaise
Clinical narrative: feeling tired; almost flu-like; feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired), INFLUENZA LIKE ILLNESS (almost flu-like) and MALAISE (feeling sick) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) 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 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced FATIGUE (feeling tired) and INFLUENZA LIKE ILLNESS (almost flu-like). 10-Jun-2021, the patient experienced MALAISE (feeling sick). At the time of the report, FATIGUE (feeling tired), INFLUENZA LIKE ILLNESS (almost flu-like) and MALAISE (feeling sick) outcome was unknown.            Concomitant medications include Zenpak. No treatment medication were provided.
Sex: M
Vaccine: COVID19
Symptoms: Anger, Depression
Clinical narrative: depressed; acquaintance of his was depressed, had anger spells was not the same; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depressed) and ANGER (acquaintance of his was depressed, had anger spells was not the same) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced DEPRESSION (depressed) and ANGER (acquaintance of his was depressed, had anger spells was not the same). At the time of the report, DEPRESSION (depressed) and ANGER (acquaintance of his was depressed, had anger spells was not the same) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain, Vaccination site reaction
Clinical narrative: swelling in the injection arm; arm reaction; Pain in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the injection arm), VACCINATION SITE REACTION (arm reaction) and VACCINATION SITE PAIN (Pain in the injection arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in the injection arm), VACCINATION SITE REACTION (arm reaction) and VACCINATION SITE PAIN (Pain in the injection arm). At the time of the report, PERIPHERAL SWELLING (swelling in the injection arm), VACCINATION SITE REACTION (arm reaction) and VACCINATION SITE PAIN (Pain in the injection arm) 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.   Concomitant product was not provided by the reporter   This case was linked to MOD-2021-237309 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Muscle Pain; Chills; Fever (101.9F); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle Pain), CHILLS (Chills) and PYREXIA (Fever (101.9F)) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 051C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and OMEPRAZOLE for an unknown indication.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Jun-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle Pain), CHILLS (Chills) and PYREXIA (Fever (101.9F)). At the time of the report, HEADACHE (Headache), MYALGIA (Muscle Pain), CHILLS (Chills) and PYREXIA (Fever (101.9F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7-101.9f (High) Around 10:00 am 99.7-101.9F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Moderna Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-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 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.    This case was linked to MOD-2021-237427, MOD-2021-237470 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Depression, Suspected COVID-19
Clinical narrative: was just depressed; had covid-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (was just depressed) and SUSPECTED COVID-19 (had covid-like symptoms) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (was just depressed) and SUSPECTED COVID-19 (had covid-like symptoms). At the time of the report, DEPRESSION (was just depressed) and SUSPECTED COVID-19 (had covid-like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a month over due for 2nd dose) 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 21-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 (a month over due for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a month over due for 2nd dose) had resolved. 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 Relevant concomitant medications was reported. Treatment information was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: flaring up psoriasis, a fairly localized reaction, primarily on the groin area; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (flaring up psoriasis, a fairly localized reaction, primarily on the groin area) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ADALIMUMAB (HUMIRA), LEVOTHYROXINE and SILDENAFIL CITRATE (VIAGRA) for an unknown indication.    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 PSORIASIS (flaring up psoriasis, a fairly localized reaction, primarily on the groin area). At the time of the report, PSORIASIS (flaring up psoriasis, a fairly localized reaction, primarily on the groin area) 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 treatment medication was provided
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling, Pharyngeal swelling, Swelling face
Clinical narrative: Swelling of mouth, jaw and throat; Swelling of mouth, jaw and throat; Swelling of mouth, jaw and throat; This spontaneous case was reported by a pharmacist and describes the occurrence of MOUTH SWELLING (Swelling of mouth, jaw and throat), SWELLING FACE (Swelling of mouth, jaw and throat) and PHARYNGEAL SWELLING (Swelling of mouth, jaw and throat) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOUTH SWELLING (Swelling of mouth, jaw and throat), SWELLING FACE (Swelling of mouth, jaw and throat) and PHARYNGEAL SWELLING (Swelling of mouth, jaw and throat). At the time of the report, MOUTH SWELLING (Swelling of mouth, jaw and throat), SWELLING FACE (Swelling of mouth, jaw and throat) and PHARYNGEAL SWELLING (Swelling of mouth, jaw and throat) 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 treatment/concomitant medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: flu-like later that night,similar to the mild flu, but; achy that night; real tired for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like later that night,similar to the mild flu, but), PAIN (achy that night) and FATIGUE (real tired for 3 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 11-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like later that night,similar to the mild flu, but), PAIN (achy that night) and FATIGUE (real tired for 3 days). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like later that night,similar to the mild flu, but), PAIN (achy that night) and FATIGUE (real tired for 3 days) had resolved.        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 treatment medication was provided. Med info agent: Caller states that after second dose patient was more tired and achy that night, but the next day was okay.  Consent to follow-up from safety team if needed. Caller provide name of vaccination  facility and name of health care provider.   This case was linked to MOD-2021-237320 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Consumer missed second dose, on 55th day today; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer missed second dose, on 55th day today) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer missed second dose, on 55th day today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer missed second dose, on 55th day today) 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.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle cramps) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle cramps). At the time of the report, MUSCLE SPASMS (muscle cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.  Treatment medication were not reported.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  Treatment Information was not provided by Reporter.   This case was linked to MOD-2021-115609, MOD-2021-115643, MOD-2021-115655, MOD-2021-115657, MOD-2021-115659, MOD-2021-115661, MOD-2021-115662, MOD-2021-115665, MOD-2021-115666, MOD-2021-115667, MOD-2021-115691, MOD-2021-115695, MOD-2021-115701 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash on the right side of shoulder blade; Itching at the injection site; Swelling of the injection site to the size of a knot; Fine rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the right side of shoulder blade), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling of the injection site to the size of a knot) and VACCINATION SITE RASH (Fine rash at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced RASH (Rash on the right side of shoulder blade), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling of the injection site to the size of a knot) and VACCINATION SITE RASH (Fine rash at the injection site). At the time of the report, RASH (Rash on the right side of shoulder blade), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling of the injection site to the size of a knot) and VACCINATION SITE RASH (Fine rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: more tired and achy that night; more tired and achy that night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (more tired and achy that night) and FATIGUE (more tired and achy that night) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and CARVEDILOL for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced PAIN (more tired and achy that night) and FATIGUE (more tired and achy that night). At the time of the report, PAIN (more tired and achy that night) and FATIGUE (more tired and achy that night) outcome was unknown.            No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.    This case was linked to MOD-2021-237314 (Patient Link).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site pain
Clinical narrative: Arm numbness when raises arm; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm numbness when raises arm) and VACCINATION SITE PAIN (injection site pain) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced HYPOAESTHESIA (Arm numbness when raises arm) and VACCINATION SITE PAIN (injection site pain). At the time of the report, HYPOAESTHESIA (Arm numbness when raises arm) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.            No concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Palpitations, Pruritus, Rash, Rash pruritic
Clinical narrative: Bad rash; itching; Palpitations; Erythema; Painful rash/severe rash on front torso front to waist/up my spine and on my back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Bad rash), PRURITUS (itching), PALPITATIONS (Palpitations), ERYTHEMA (Erythema) and RASH (Painful rash/severe rash on front torso front to waist/up my spine and on my back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031621A and 044A21A) for COVID-19 vaccination.     Previously administered products included for Antiviral prophylaxis: shingles vaccine (Shingrix / Hives on torso) since 2017. Past adverse reactions to the above products included Hives with shingles vaccine. Concurrent medical conditions included Penicillin allergy (Penicillin/ hives), Drug allergy (Sulfa / hives), Allergy to antibiotic (levaquin /  Numbness of hand and feet) and Drug allergy (Codeine /  nausea).   On 11-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PRURITUS (itching), PALPITATIONS (Palpitations), ERYTHEMA (Erythema) and RASH (Painful rash/severe rash on front torso front to waist/up my spine and on my back). On an unknown date, the patient experienced RASH PRURITIC (Bad rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 30-Apr-2021, PRURITUS (itching) outcome was unknown, PALPITATIONS (Palpitations), ERYTHEMA (Erythema) and RASH (Painful rash/severe rash on front torso front to waist/up my spine and on my back) had resolved. At the time of the report, RASH PRURITIC (Bad rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment  Medication included anti-itch cream and ice packs for the pain.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information was received from initial reporter: Patient's medical history, new events erythema, palpitations and start date and end date were added
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient who received a dose of the Moderna vaccine that had expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received a dose of the Moderna vaccine that had expired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received a dose of the Moderna vaccine that had expired). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient who received a dose of the Moderna vaccine that had expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.  The health care professional thinks that the vaccine administered was the patient´s first dose, not completely sure.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna vaccine second dose was administered past it's 12 hour window; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine second dose was administered past it's 12 hour window) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine second dose was administered past it's 12 hour window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine second dose was administered past it's 12 hour window) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: started feeling different; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (started feeling different) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (started feeling different). At the time of the report, FEELING ABNORMAL (started feeling different) outcome was unknown.            No concomitant and treatment medications were reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Myalgia, SARS-CoV-2 antibody test negative
Clinical narrative: mildly sore left arm; I have received 4 shots of the Moderna vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mildly sore left arm) and ACCIDENTAL OVERDOSE (I have received 4 shots of the Moderna vaccine) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, MAGNESIUM OXIDE, FISH OIL, CENTRUM VITAMINTS, PANTOPRAZOLE, FINASTERIDE, TAMSULOSIN, AMLODIPINE, FERROUS SULFATE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 12-Jan-2021, the patient experienced ACCIDENTAL OVERDOSE (I have received 4 shots of the Moderna vaccine). On 14-Jan-2021, the patient experienced MYALGIA (mildly sore left arm). On 15-Jan-2021, MYALGIA (mildly sore left arm) had resolved. On 10-May-2021, ACCIDENTAL OVERDOSE (I have received 4 shots of the Moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test negative: Negative. In June 2021, SARS-CoV-2 antibody test negative: Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received 2 more shots of the Moderna COVID-19 vaccine, as he thought that the negative test he took to test for the spike protein antibody in Mar 2021 was due to his autoimmune condition, which he thought was why he was not responding to the first 2 doses of the vaccine. He received the 3rd dose of the COVID-19 vaccine (Lot #: 036B21A) on 13 Apr 2021 and the 4th dose (Lot #: 048B21A) on 10 May 2021. He then got tested again for the spike protein antibody in early Jun 2021, which came back negative again. He said that the only adverse reaction he experienced was a mildly sore arm for 24 hours, 2 days after receiving the vaccination shots.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-238058 (Patient Link).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.; has not received the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.) and PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 050C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.) and PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.) and PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not have an adverse reaction to the vaccine, nor was the vaccine expired.  Concomitant medication was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-237452 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information included patient's demographics, date of first dose, second dose details and earlier events removed and one event added.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days between the First and the Second Moderna Covid-19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the First and the Second Moderna Covid-19 vaccinations) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the First and the Second Moderna Covid-19 vaccinations). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the First and the Second Moderna Covid-19 vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   This case was linked to MOD-2021-237460 (Parent-Child Link).   See case MOD-2021-237460 for details regarding the child case.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021). On 20-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021) 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.   Concomitant medications were not provided by the reporter. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He got his 1st dose on 17/Apr/2021 and his second dose on 24Jun2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his 1st dose on 17/Apr/2021 and his second dose on 24Jun2021) 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 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his 1st dose on 17/Apr/2021 and his second dose on 24Jun2021). On 24-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his 1st dose on 17/Apr/2021 and his second dose on 24Jun2021) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.     No concomitant medications or treatment details were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: didn't receive the second dose in the appropriate timeframe; if they did receive an additional dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (didn't receive the second dose in the appropriate timeframe) and EXTRA DOSE ADMINISTERED (if they did receive an additional dose) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (didn't receive the second dose in the appropriate timeframe) and EXTRA DOSE ADMINISTERED (if they did receive an additional dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (didn't receive the second dose in the appropriate timeframe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On 02mar2021, post vaccination, the patient reported that she didn't receive her second dosage of the vaccine in the proper timeframe. No other reactions reported. Patient declined to provide any other information   No treatment information was provided No concomitant information was provided
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Left Leg More Painful than the Right Leg; Left Leg is more swollen than the Right leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Leg More Painful than the Right Leg) and PERIPHERAL SWELLING (Left Leg is more swollen than the Right leg) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for Product used for unknown indication: flu vaccine in 2014 and Prednisone (Patient stated that years ago she had leg swelling following the use of oral Prednisone); for Swelling face: Clindamycin (Oral Antibiotic treated for 7 days after receiving a high dose Flu Vaccine) in 2014. Past adverse reactions to the above products included Swelling face with flu vaccine; and Swelling of legs with Prednisone. Concurrent medical conditions included Drug allergy (Prednisone) and Allergy to vaccine (Flu high dose). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR), PARACETAMOL (TYLENOL), ESOMEPRAZOLE SODIUM (NEXIUM) and IBUPROFEN for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced PAIN IN EXTREMITY (Left Leg More Painful than the Right Leg) and PERIPHERAL SWELLING (Left Leg is more swollen than the Right leg). The patient was treated with POTASSIUM ongoing since an unknown date at a dose of 1 dosage form and FUROSEMIDE (LASIX) ongoing since an unknown date for  and COVID-19 vaccination, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Left Leg More Painful than the Right Leg) and PERIPHERAL SWELLING (Left Leg is more swollen than the Right leg) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Once patient stated that all tests were normal. Another time she stated that she did not do any tests after vaccination and those tests were from years ago and her kidney function tests were normal from years ago.  Concomitant medication also included High blood pressure medications.   This case was linked to MOD-2021-228465 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received and contains no new information. Corrections made from initial source document reporter address, relevant history, Updated initial event coding from Myalgia to Peripheral swelling.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Deviation from dosing schedule; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     no medical history was provided by reporter.     On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment drugs were not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Moderna Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-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 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.    This case was linked to MOD-2021-237427 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from the syringe that was withdrawn the day before; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) 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 & treatment medications were reported by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (left arm).    On 19-Mar-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 hurts). At the time of the report, PAIN IN EXTREMITY (Arm hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. No treatment information was provided.   This case was linked to MOD-2021-237353 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received and contains no new information.