chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine beyond MFG Exp. Date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.  Expiry date of vaccine was  12 Oct 2021. The reporter thinks it was the second dose but was not sure.   This case was linked to MOD-2021-354381, MOD-2021-354454, MOD-2021-354535, MOD-2021-355209 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: Light headache; 100 fever; Some light fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Light headache), PYREXIA (100 fever) and FATIGUE (Some light fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-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 HEADACHE (Light headache), PYREXIA (100 fever) and FATIGUE (Some light fatigue). At the time of the report, HEADACHE (Light headache), PYREXIA (100 fever) and FATIGUE (Some light fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-354688, MOD-2021-354702 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna Covid-19 vaccine was inadvertently administered to a patient less than 12 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine was inadvertently administered to a patient less than 12 years old) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine was inadvertently administered to a patient less than 12 years old). On 15-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna Covid-19 vaccine was inadvertently administered to a patient less than 12 years old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Treatment information was not provided.  It was reported that the clinic was not yet sure if they gave a dose of Moderna Covid-19 vaccine to a 2 year old or a 12 year old.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided.  No treatment medications were provided
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Product dose omission issue
Clinical narrative: Injection site pain/Arm pain and soreness; received only the first dose of the Moderna COVID-19 vaccine and almost 6 months have passed/ didn't receive the second dose of the Moderna COVID-19 vaccine, more than 5 months after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain/Arm pain and soreness) and PRODUCT DOSE OMISSION ISSUE (received only the first dose of the Moderna COVID-19 vaccine and almost 6 months have passed/ didn't receive the second dose of the Moderna COVID-19 vaccine, more than 5 months after first dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-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 INJECTION SITE PAIN (Injection site pain/Arm pain and soreness) and PRODUCT DOSE OMISSION ISSUE (received only the first dose of the Moderna COVID-19 vaccine and almost 6 months have passed/ didn't receive the second dose of the Moderna COVID-19 vaccine, more than 5 months after first dose). At the time of the report, INJECTION SITE PAIN (Injection site pain/Arm pain and soreness) and PRODUCT DOSE OMISSION ISSUE (received only the first dose of the Moderna COVID-19 vaccine and almost 6 months have passed/ didn't receive the second dose of the Moderna COVID-19 vaccine, more than 5 months after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: prick sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (prick sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, CELECOXIB (CRIL), VITAMIN B NOS (B-COMPLEX [VITAMIN B NOS]), CALCIUM and COLLAGEN for an unknown indication.    On 26-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 PAIN (prick sore). At the time of the report, PAIN (prick sore) 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 included organic collagen and B-shot 1/month.  Aleve in morning and night for a knee that were acting up for about three weeks (that started before shot).   This case was linked to MOD-2021-354443, MOD-2021-354665 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: five expired doses were administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (five expired doses were administered) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (five expired doses were administered). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (five expired doses were administered) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided.   No treatment medications were provided.   This case was linked to MOD-2021-354310 (Patient Link).
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: prick sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (prick sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM for Supplementation therapy, LEVOTHYROXINE, VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]), COLLAGEN, CYANOCOBALAMIN (VITAMIN B-12) and CELECOXIB (CRIL) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (prick sore). The patient was treated with NAPROXEN SODIUM (ALEVE) for Knee pain, at a dose of 1 dosage form twice a day. At the time of the report, PAIN (prick sore) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications included organic collagen and B-shot.  The patient was not immunocompromised.   This case was linked to MOD-2021-354658, MOD-2021-354443 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Feeling hot, Head discomfort
Clinical narrative: Gets short of breath; Weak; Head keeps ringing; Gets too hot; just feel like crap/don't feel good; It itches like crazy; Big lump; It was really sore/it hurts all over; gets chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Gets short of breath), ASTHENIA (Weak), HEAD DISCOMFORT (Head keeps ringing), FEELING HOT (Gets too hot) and MALAISE (just feel like crap/don't feel good) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D2A and 258E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Arthritis (Arthritis in spine), Scoliosis (Scoliosis in spine) and Smoker (Smoking since the patient  was 13 years old).   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced DYSPNOEA (Gets short of breath), ASTHENIA (Weak), HEAD DISCOMFORT (Head keeps ringing), FEELING HOT (Gets too hot), MALAISE (just feel like crap/don't feel good), PRURITUS (It itches like crazy), MASS (Big lump), PAIN (It was really sore/it hurts all over), CHILLS (gets chills) and HEADACHE (Headache). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) on 14-Oct-2021 at a dose of 150 mg twice a day. At the time of the report, DYSPNOEA (Gets short of breath), ASTHENIA (Weak), FEELING HOT (Gets too hot), PRURITUS (It itches like crazy), MASS (Big lump), CHILLS (gets chills) and HEADACHE (Headache) outcome was unknown and HEAD DISCOMFORT (Head keeps ringing), MALAISE (just feel like crap/don't feel good) and PAIN (It was really sore/it hurts all over) had not resolved.            No concomitant medications were provided.  The patient gets epidurals for the pain.   This case was linked to MOD-2021-354701 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Mass, Pain, Pruritus
Clinical narrative: Gets short of breath; Weak; Head keeps ringing; Gets too hot; just feel like crap/don't feel good; It itches like crazy; Big lump; It was really sore/it hurts all over; gets chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Gets short of breath), ASTHENIA (Weak), HEAD DISCOMFORT (Head keeps ringing), FEELING HOT (Gets too hot) and MALAISE (just feel like crap/don't feel good) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D2A and 258E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD, Arthritis (Arthritis in spine), Scoliosis (Scoliosis in spine) and Smoker (Smoking since the patient  was 13 years old).   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced DYSPNOEA (Gets short of breath), ASTHENIA (Weak), HEAD DISCOMFORT (Head keeps ringing), FEELING HOT (Gets too hot), MALAISE (just feel like crap/don't feel good), PRURITUS (It itches like crazy), MASS (Big lump), PAIN (It was really sore/it hurts all over), CHILLS (gets chills) and HEADACHE (Headache). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) on 14-Oct-2021 at a dose of 150 mg twice a day. At the time of the report, DYSPNOEA (Gets short of breath), ASTHENIA (Weak), FEELING HOT (Gets too hot), PRURITUS (It itches like crazy), MASS (Big lump), CHILLS (gets chills) and HEADACHE (Headache) outcome was unknown and HEAD DISCOMFORT (Head keeps ringing), MALAISE (just feel like crap/don't feel good) and PAIN (It was really sore/it hurts all over) had not resolved.            No concomitant medications were provided.  The patient gets epidurals for the pain.   This case was linked to MOD-2021-354701 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash macular
Clinical narrative: red blotches on both of my feet/ blotches on my toes/ blotches up my heel/ feet have red spots on them/ my feet look terrible; feet are itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red blotches on both of my feet/ blotches on my toes/ blotches up my heel/ feet have red spots on them/ my feet look terrible) and PRURITUS (feet are itching) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (red blotches on both of my feet/ blotches on my toes/ blotches up my heel/ feet have red spots on them/ my feet look terrible) and PRURITUS (feet are itching). At the time of the report, RASH MACULAR (red blotches on both of my feet/ blotches on my toes/ blotches up my heel/ feet have red spots on them/ my feet look terrible) and PRURITUS (feet are itching) 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.   No concomitant medications was reported. No treatment drug details was reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second dose of the Moderna COVID-19 vaccine 23 days after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine 23 days after the first dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine 23 days after the first dose). On 15-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine 23 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details was not reported by the reporter. Treatment details was not reported by the reporter.  It was reported that the patient was not experiencing any symptoms.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine beyond amnufacturer expiry date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond amnufacturer expiry date administered) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond amnufacturer expiry date administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond amnufacturer expiry date administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  The reporter did not think that any of the patients were pregnant because of their age. The reporter also thinks that it was the second dose for all recipients but was not sure.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site swelling
Clinical narrative: red spot  in the arm and it is swollen; red spot  in the arm and it is swollen; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot  in the arm and it is swollen), VACCINATION SITE SWELLING (red spot  in the arm and it is swollen) and FATIGUE (feeling tired) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011f21a, 031a21a and 002b21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Dementia (taking medication for dementia) and Heart disorder (taking medication for heart). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), METFORMIN and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (red spot  in the arm and it is swollen), VACCINATION SITE SWELLING (red spot  in the arm and it is swollen) and FATIGUE (feeling tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (red spot  in the arm and it is swollen), VACCINATION SITE SWELLING (red spot  in the arm and it is swollen) and FATIGUE (feeling tired) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included medication for dementia and medication for the patient's heart.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Vaccination site rash
Clinical narrative: After 2nd dose 100 fever; After 2nd dose some light fatigue; After 2nd dose headache was a bit stronger than the first one; After 2nd dose red rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After 2nd dose 100 fever), FATIGUE (After 2nd dose some light fatigue), HEADACHE (After 2nd dose headache was a bit stronger than the first one) and VACCINATION SITE RASH (After 2nd dose red rash on the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A, 039K20A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (After 2nd dose 100 fever), FATIGUE (After 2nd dose some light fatigue), HEADACHE (After 2nd dose headache was a bit stronger than the first one) and VACCINATION SITE RASH (After 2nd dose red rash on the injection site). At the time of the report, PYREXIA (After 2nd dose 100 fever), FATIGUE (After 2nd dose some light fatigue), HEADACHE (After 2nd dose headache was a bit stronger than the first one) and VACCINATION SITE RASH (After 2nd dose red rash on the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-354613, MOD-2021-354702 (Patient Link).
Age: 22.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 22-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Vaccination site pain
Clinical narrative: It was sore the first time; bad fall three weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of FALL (bad fall three weeks ago) and VACCINATION SITE PAIN (It was sore the first time) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 258E21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis (arthritis and scoliosis in the spine), Scoliosis (arthritis and scoliosis in the spine), COPD and Smoker (has been smoking since the patient was 13 years old).    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced FALL (bad fall three weeks ago). On an unknown date, the patient experienced VACCINATION SITE PAIN (It was sore the first time). The patient was treated with CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEINE) on 14-Oct-2021 for Adverse event, at a dose of 150 mg twice a day. At the time of the report, FALL (bad fall three weeks ago) and VACCINATION SITE PAIN (It was sore the first time) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. The patient got epidurals for the pain.  The patient did not have the lump and the itching after the first dose.   This case was linked to MOD-2021-354671.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine was administered 32 days after it was removed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vaccine was administered 32 days after it was removed) 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 EXPIRED PRODUCT ADMINISTERED (The vaccine was administered 32 days after it was removed). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vaccine was administered 32 days after it was removed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose administered from a vial that was greater then 12 hours post puncture at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a vial that was greater then 12 hours post puncture at room temperature) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (dose administered from a vial that was greater then 12 hours post puncture at room temperature). On 07-Oct-2021, PRODUCT STORAGE ERROR (dose administered from a vial that was greater then 12 hours post puncture at room temperature) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The reporter was unable to provide whether first dose or second dose.   This case was linked to MOD-2021-354372, MOD-2021-354517 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired dose that had been left out/vaccinated beyond the 12 hour use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose that had been left out/vaccinated beyond the 12 hour use date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose that had been left out/vaccinated beyond the 12 hour use date). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received expired dose that had been left out/vaccinated beyond the 12 hour use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.   Treatment information was not provided.  A patient received expired dose that had been left out in room temperature past the 12 hours.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine beyond manufacturer expiry date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond manufacturer expiry date administered) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond manufacturer expiry date administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond manufacturer expiry date administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter thinks that it was the second dose for all recipients but was not sure.  No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: People complaining of rash; 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 RASH (People complaining of rash) 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 RASH (People complaining of rash). At the time of the report, RASH (People complaining of rash) outcome was unknown.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medications were reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: sensation of tightness in the chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (sensation of tightness in the chest) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (b.0021  0atch no. 099C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced CHEST DISCOMFORT (sensation of tightness in the chest). At the time of the report, CHEST DISCOMFORT (sensation of tightness in the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives weeks later for only 24 hours.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives weeks later for only 24 hours.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), LEVOCETIRIZINE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced URTICARIA (hives weeks later for only 24 hours.). On 04-Feb-2021, URTICARIA (hives weeks later for only 24 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided.   This case was linked to MOD-2021-354848 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat felt like it was closing; This spontaneous case was reported by an other health care professional and describes the occurrence of THROAT TIGHTNESS (Throat felt like it was closing) 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 THROAT TIGHTNESS (Throat felt like it was closing). At the time of the report, THROAT TIGHTNESS (Throat felt like it was closing) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.  The patient felt like that it was not a good idea to receive the booster dose of the vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site movement impairment, Vaccination site pain, Vaccination site reaction
Clinical narrative: Difficulty driving; A flared up injection site; Soreness in right arm; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty driving), VACCINATION SITE REACTION (A flared up injection site), VACCINATION SITE PAIN (Soreness in right arm), NAUSEA (Nausea) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.   No medical history was provided by the reporter.  Concomitant products included METOPROLOL, POTASSIUM CITRATE, FAMOTIDINE, VITAMIN B NOS, VITAMIN D [VITAMIN D NOS], INSULIN DEGLUDEC (TRESIBA) and LIRAGLUTIDE (VICTOZA) for an unknown indication.  On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty driving), VACCINATION SITE REACTION (A flared up injection site), VACCINATION SITE PAIN (Soreness in right arm), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Difficulty driving), VACCINATION SITE REACTION (A flared up injection site), VACCINATION SITE PAIN (Soreness in right arm), NAUSEA (Nausea) and PYREXIA (Fever) was resolving.      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 details were provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Had hives and they are lasting for over 7 months/it was going away but two weeks ago she had another flared up and it felt like when it first started again; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Had hives and they are lasting for over 7 months/it was going away but two weeks ago she had another flared up and it felt like when it first started again) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FAMOTIDINE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), LEVOCETIRIZINE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (Had hives and they are lasting for over 7 months/it was going away but two weeks ago she had another flared up and it felt like when it first started again). At the time of the report, URTICARIA (Had hives and they are lasting for over 7 months/it was going away but two weeks ago she had another flared up and it felt like when it first started again) had not resolved.            Treatment for the event included antihistamines.   This case was linked to MOD-2021-354823 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Both of my arms were sore after the  first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Both of my arms were sore after the  first vaccination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Both of my arms were sore after the  first vaccination). At the time of the report, PAIN IN EXTREMITY (Both of my arms were sore after the  first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-355105 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site arm was sore after the second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site arm was sore after the second vaccination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site arm was sore after the second vaccination). At the time of the report, VACCINATION SITE PAIN (Injection site arm was sore after the second vaccination) outcome was unknown.      No concomitant medications were reported.  No treatment information was provided.    Patient do not remember which arm she received first and second Moderna vaccinations. The patient injection site arm was sore after the second vaccination did not remember which arm.   This case was linked to MOD-2021-355043 (Patient Link).
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The dose administered past the 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30 day use by date) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30 day use by date). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (The dose administered past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-354306, MOD-2021-354515 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine beyond MFG Exp. Date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) 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 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-354610 (Patient Link).
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose administered past the 30-day use by date was the first or second shot; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Erythema, Headache
Clinical narrative: nauseous; joint aches; temperature 102 degrees Farenheight; headache which lasted for several hours; eyes blood shot; face red; Chills/shaking; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), CHILLS (Chills/shaking), NAUSEA (nauseous) and ARTHRALGIA (joint aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills/shaking). On an unknown date, the patient experienced OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), NAUSEA (nauseous), ARTHRALGIA (joint aches), PYREXIA (temperature 102 degrees Farenheight) and HEADACHE (headache which lasted for several hours). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), CHILLS (Chills/shaking), NAUSEA (nauseous), ARTHRALGIA (joint aches) and PYREXIA (temperature 102 degrees Farenheight) outcome was unknown and HEADACHE (headache which lasted for several hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees farenheight (High) 102 degrees farenheight.