chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Started aching and that it was painful), MYALGIA (Soreness/started aching) and FATIGUE (Tiredness) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included Amlodipine Besylate; Buspirone HCL; Paroxetine HCL for an unknown indication. On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PAIN (Started aching and that it was painful), MYALGIA (Soreness/started aching) and FATIGUE (Tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Started aching and that it was painful), MYALGIA (Soreness/started aching) and FATIGUE (Tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated a patient who was 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated a patient who was 16 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccinated a patient who was 16 years old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given Moderna Vaccine Covid-19 on 30JUNE2021 at 4:48pm, however the beyond use date was 29JUNE2021 6pm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jun-2021 at 4:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given Moderna Vaccine Covid-19 on 30JUNE2021 at 4:48pm, however the beyond use date was 29JUNE2021 6pm). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given Moderna Vaccine Covid-19 on 30JUNE2021 at 4:48pm, however the beyond use date was 29JUNE2021 6pm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were mentioned. No treatment details were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine as a 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine as a 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: Pain at site of injection; Moderna vaccine administered to patient of 17 years; first dose on 14 APRIL 2021 and second dose on  27MAY2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jul-2021 and was forwarded to Moderna on 01-Jul-2021.     This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Pain at site of injection), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to patient of 17 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 14 APRIL 2021 and second dose on  27MAY2021) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-May-2021, the patient experienced VACCINATION SITE PAIN (Pain at site of injection), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to patient of 17 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 14 APRIL 2021 and second dose on  27MAY2021).   On 27-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to patient of 17 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 14 APRIL 2021 and second dose on  27MAY2021) had resolved. On 30-May-2021, VACCINATION SITE PAIN (Pain at site of injection) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Pain at site of injection) to be possibly related.   No further causality assessments were provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to patient of 17 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 14 APRIL 2021 and second dose on  27MAY2021).    Concomitant product information was not provided. Treatment medication was not provided.   This case was linked to MOD-2021-162254 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Next morning I was really wiped out\ felt very tired that morning; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Next morning I was really wiped out\ felt very tired that morning) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced FATIGUE (Next morning I was really wiped out\ felt very tired that morning). On 02-Jun-2021, FATIGUE (Next morning I was really wiped out\ felt very tired that morning) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: extreme hives / welts; 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 URTICARIA (extreme hives / welts) and RASH (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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (extreme hives / welts) and RASH (rash). At the time of the report, URTICARIA (extreme hives / welts) and RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine vial that was punctured and stored in the fridge for 24 hours, a dose from it was given to a patient as their 2nd dose after it expired) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine vial that was punctured and stored in the fridge for 24 hours, a dose from it was given to a patient as their 2nd dose after it expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine vial that was punctured and stored in the fridge for 24 hours, a dose from it was given to a patient as their 2nd dose after it expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia
Clinical narrative: More than 42 days from first dose; high fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 42 days from first dose) and PYREXIA (high fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D3 5000), LISINOPRIL and TOPIRAMATE for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days from first dose) and PYREXIA (high fever). On 29-Apr-2021, PYREXIA (high fever) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days from first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose not received in allowed timeframe; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not received in allowed timeframe) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not received in allowed timeframe). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not received in allowed timeframe) had resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Dyspnoea, Muscle spasms
Clinical narrative: Upset stomach; Dizziness; Weakness; Nauseous; Vomited; Vomitive; Fevers; Labored breathing; Cramps in her calfs; Upset stomach; body aches; Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Labored breathing) and MUSCLE SPASMS (Cramps in her calfs) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. X51621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced DYSPNOEA (Labored breathing), MUSCLE SPASMS (Cramps in her calfs), the first episode of ABDOMINAL DISCOMFORT (Upset stomach), MYALGIA (body aches), VACCINATION SITE PAIN (Sore right injection site arm), VOMITING (Vomitive) and PYREXIA (Fevers). On 29-Jun-2021, the patient experienced VOMITING (Vomited). On an unknown date, the patient experienced the second episode of ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nauseous). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at a dose of 1 dosage form every four hours. On 29-Jun-2021, DYSPNOEA (Labored breathing), MUSCLE SPASMS (Cramps in her calfs), MYALGIA (body aches), VOMITING (Vomited) and VOMITING (Vomitive) had resolved. On 30-Jun-2021, VACCINATION SITE PAIN (Sore right injection site arm) had resolved. At the time of the report, last episode of ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nauseous) outcome was unknown and PYREXIA (Fevers) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  First dose  Lot number X51621A. The reporter was unsure about the X, said it looks like a 0 with a slash. And also was not sure if the 6 was a number or a parenthesis.   This case was linked to MOD-2021-268636 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information included new events (vomitive, labored breathing, cramps in her calfs, body aches and upset stomach). On 08-Sep-2021: Follow Up received on 08-sep-2021 contain non significant information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Upset stomach; Dizziness; Weakness; Nauseous; Vomited; Vomitive; Fevers; Labored breathing; Cramps in her calfs; Upset stomach; body aches; Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), ASTHENIA (Weakness), DYSPNOEA (Labored breathing) and MUSCLE SPASMS (Cramps in her calfs) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. X51621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced DYSPNOEA (Labored breathing), MUSCLE SPASMS (Cramps in her calfs), the first episode of ABDOMINAL DISCOMFORT (Upset stomach), MYALGIA (body aches), VACCINATION SITE PAIN (Sore right injection site arm), VOMITING (Vomitive) and PYREXIA (Fevers). On 29-Jun-2021, the patient experienced VOMITING (Vomited). On an unknown date, the patient experienced the second episode of ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nauseous). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Fever, at a dose of 1 dosage form every four hours. On 29-Jun-2021, DYSPNOEA (Labored breathing), MUSCLE SPASMS (Cramps in her calfs), MYALGIA (body aches), VOMITING (Vomited) and VOMITING (Vomitive) had resolved. On 30-Jun-2021, VACCINATION SITE PAIN (Sore right injection site arm) had resolved. At the time of the report, last episode of ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (Dizziness), ASTHENIA (Weakness) and NAUSEA (Nauseous) outcome was unknown and PYREXIA (Fevers) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  First dose  Lot number X51621A. The reporter was unsure about the X, said it looks like a 0 with a slash. And also was not sure if the 6 was a number or a parenthesis.   This case was linked to MOD-2021-268636 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information included new events (vomitive, labored breathing, cramps in her calfs, body aches and upset stomach). On 08-Sep-2021: Follow Up received on 08-sep-2021 contain non significant information
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Myalgia, Peripheral swelling, Rash macular, Vaccination site erythema
Clinical narrative: Left arm is still inflammated; Blotchy; Swollen; Covid Arm/Reaction; Warm to touch; Red; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Left arm is still inflammated), RASH MACULAR (Blotchy), PERIPHERAL SWELLING (Swollen), MYALGIA (Covid Arm/Reaction) and VACCINATION SITE WARMTH (Warm to touch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced INFLAMMATION (Left arm is still inflammated), RASH MACULAR (Blotchy), PERIPHERAL SWELLING (Swollen), MYALGIA (Covid Arm/Reaction), VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, INFLAMMATION (Left arm is still inflammated), RASH MACULAR (Blotchy), PERIPHERAL SWELLING (Swollen), MYALGIA (Covid Arm/Reaction), VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Red) 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Left arm is still inflammated; Blotchy; Swollen; Covid Arm/Reaction; Warm to touch; Red; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Left arm is still inflammated), RASH MACULAR (Blotchy), PERIPHERAL SWELLING (Swollen), MYALGIA (Covid Arm/Reaction) and VACCINATION SITE WARMTH (Warm to touch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced INFLAMMATION (Left arm is still inflammated), RASH MACULAR (Blotchy), PERIPHERAL SWELLING (Swollen), MYALGIA (Covid Arm/Reaction), VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, INFLAMMATION (Left arm is still inflammated), RASH MACULAR (Blotchy), PERIPHERAL SWELLING (Swollen), MYALGIA (Covid Arm/Reaction), VACCINATION SITE WARMTH (Warm to touch) and VACCINATION SITE ERYTHEMA (Red) 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.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: still got the red, itchy patches after second dose; still got the red, itchy patches after second dose; little bit of arm swelling; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (still got the red, itchy patches after second dose), PRURITUS (still got the red, itchy patches after second dose), PERIPHERAL SWELLING (little bit of arm swelling) and PAIN IN EXTREMITY (arm pain) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (amoxicillin) and Allergy to antibiotic (cefzil). Concomitant products included MINERALS NOS, VITAMINS NOS (EQUATE ONE DAILY WOMEN'S HEALTH) from 01-Jan-2017 to an unknown date for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced ERYTHEMA (still got the red, itchy patches after second dose), PRURITUS (still got the red, itchy patches after second dose), PERIPHERAL SWELLING (little bit of arm swelling) and PAIN IN EXTREMITY (arm pain). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 30-Apr-2021, ERYTHEMA (still got the red, itchy patches after second dose), PRURITUS (still got the red, itchy patches after second dose), PERIPHERAL SWELLING (little bit of arm swelling) and PAIN IN EXTREMITY (arm pain) had resolved.            This case was linked to MOD-2021-067349, MOD-2021-067349 (Patient Link).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red spot on the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot on the site of the injection) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure high, ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red spot on the site of the injection). At the time of the report, VACCINATION SITE ERYTHEMA (red spot on the site of the injection) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other concomitant medication included  Solcore 5mg once a day& acid reflux medicine.  No treatment medication was reported for 1st dose.   This case was linked to MOD-2021-244804 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Information received contains Non-Significant information On 23-Aug-2021: Information received contains non-significant information
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for Cholesterol, DONEPEZIL HYDROCHLORIDE (ARICEPT) for Stroke, HYDROXYCARBAMIDE (HYDROXYUREA), FINASTERIDE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MULTIVITAMIN [VITAMINS NOS] and POTASSIUM for an unknown indication.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 800 mg. At the time of the report, CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2021, Body temperature: 100.4 (High) about 100.4.     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.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administer from punctured vial after 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administer from punctured vial after 12 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-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 EXPIRED PRODUCT ADMINISTERED (Dose administer from punctured vial after 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administer from punctured vial after 12 hours) 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 concomitant medications reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional patient and vaccine information received and Reporter information updated
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine stored in refrigerator for more than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine stored in refrigerator for more than 30 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) 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 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine stored in refrigerator for more than 30 days). On 29-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine stored in refrigerator for more than 30 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.   HCP claims that they had vaccines (unknown number of vials) taken out from the freezer and stored in the refrigerator on 15May2021 at 8:00am. An unknown number of vials were taken out on 15Jun2021 and 60 individuals were administered with these vaccines from 15Jun2021 (10:00am) - 29Jun2021 in one vaccination site.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred, Visual impairment
Clinical narrative: lost 50% of vision in right eye, and there was 50% eye loss; noticed a bit cloudiness; This spontaneous case was reported by an other health care professional and describes the occurrence of VISUAL IMPAIRMENT (lost 50% of vision in right eye, and there was 50% eye loss) and VISION BLURRED (noticed a bit cloudiness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Delusion, Memory impairment, Behavior disorder, Headache, Hashimoto's disease, Frozen shoulder, Heart disease, unspecified, Heart valve disorders, Allergic to poison ivy, Latex allergy, Allergy to metals, Diabetic and Blood pressure high. Concomitant products included MIRTAZAPINE, AMLODIPINE BESILATE (NORVASC), LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL (TENORMIN), OLANZAPINE (ZYPREXA), APIXABAN (ELIQUIS) and INSULIN ASPART (NOVOLOG) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VISUAL IMPAIRMENT (lost 50% of vision in right eye, and there was 50% eye loss) and VISION BLURRED (noticed a bit cloudiness). At the time of the report, VISUAL IMPAIRMENT (lost 50% of vision in right eye, and there was 50% eye loss) and VISION BLURRED (noticed a bit cloudiness) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient medical history includes reflux and concomitant medication as Protonix Dr and "Aspart".  Patient went to her eye doctor, who did an annual exam, and he noticed all the vessels were clear prior to the second dose.  The patient noted some cloudiness the day after the second dose. She lost eye sight after the second dose.  No treatment information was provided by reporter.  Action taken with suspect drug is not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Arm redness; 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 ERYTHEMA (Arm redness) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Arm redness). At the time of the report, ERYTHEMA (Arm redness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose given from vial that had been open for 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given from vial that had been open for 24 hours) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given from vial that had been open for 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given from vial that had been open for 24 hours) 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.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Outside of dosing interval from first and second dose; She was diagnosed with COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She was diagnosed with COVID-19) and PRODUCT DOSE OMISSION ISSUE (Outside of dosing interval from first and second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PHENYTOIN SODIUM (DILANTIN [PHENYTOIN SODIUM]) and OXCARBAZEPINE (TRILEPTAL) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced COVID-19 (She was diagnosed with COVID-19). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Outside of dosing interval from first and second dose). At the time of the report, COVID-19 (She was diagnosed with COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Outside of dosing interval from first and second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Fatigue, Heart rate increased, Vertigo
Clinical narrative: shortness of breath; elevated heart rate; dizziness; vertigo; exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), HEART RATE INCREASED (elevated heart rate), DIZZINESS (dizziness), VERTIGO (vertigo) and FATIGUE (exhaustion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 DYSPNOEA (shortness of breath), HEART RATE INCREASED (elevated heart rate), DIZZINESS (dizziness), VERTIGO (vertigo) and FATIGUE (exhaustion). At the time of the report, DYSPNOEA (shortness of breath), HEART RATE INCREASED (elevated heart rate), DIZZINESS (dizziness), VERTIGO (vertigo) and FATIGUE (exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive test for Covid after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive test for Covid after being vaccinated) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive test for Covid after being vaccinated). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive test for Covid after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received and contains No New Information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Cough, Dyspnoea, Headache
Clinical narrative: Nasal Congestion; Runny nose; took the vaccine back in February and I have covid; Shortness of breath; cough; Loss of smell; Muscle aches; headache; nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion) and RHINORRHOEA (Runny nose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID symptoms.) on 28-Jun-2021. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose), ANOSMIA (Loss of smell), MYALGIA (Muscle aches), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting). At the time of the report, COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose), ANOSMIA (Loss of smell), MYALGIA (Muscle aches), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment  medications includes :-Vitamin A, C and D,Ginger and Zinc,Inhaler   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Medical history, lab data, Treatment medication and New events added
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Nausea, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Nasal Congestion; Runny nose; took the vaccine back in February and I have covid; Shortness of breath; cough; Loss of smell; Muscle aches; headache; nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion) and RHINORRHOEA (Runny nose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID symptoms.) on 28-Jun-2021. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose), ANOSMIA (Loss of smell), MYALGIA (Muscle aches), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting). At the time of the report, COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose), ANOSMIA (Loss of smell), MYALGIA (Muscle aches), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment  medications includes :-Vitamin A, C and D,Ginger and Zinc,Inhaler   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Medical history, lab data, Treatment medication and New events added
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nasal Congestion; Runny nose; took the vaccine back in February and I have covid; Shortness of breath; cough; Loss of smell; Muscle aches; headache; nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion) and RHINORRHOEA (Runny nose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (COVID symptoms.) on 28-Jun-2021. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose), ANOSMIA (Loss of smell), MYALGIA (Muscle aches), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting). At the time of the report, COVID-19 (took the vaccine back in February and I have covid), DYSPNOEA (Shortness of breath), COUGH (cough), NASAL CONGESTION (Nasal Congestion), RHINORRHOEA (Runny nose), ANOSMIA (Loss of smell), MYALGIA (Muscle aches), HEADACHE (headache), NAUSEA (nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment  medications includes :-Vitamin A, C and D,Ginger and Zinc,Inhaler   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Medical history, lab data, Treatment medication and New events added
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test, Vaccination site discomfort, Vaccination site pain
Clinical narrative: Headache; Fatigue; He reports that he the injection site was bothersome; injection site hurts a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (He reports that he the injection site was bothersome), VACCINATION SITE PAIN (injection site hurts a little bit), HEADACHE (Headache) and FATIGUE (Fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 22-Mar-2021. Concurrent medical conditions included Multiple sclerosis (worst balance, fatigue ,gait. Received a monoclonal antibody treatment in March of 2021.) since 06-Jan-2008. Concomitant products included FAMPRIDINE (AMPYRA), MODAFINIL (PROVIGIL [MODAFINIL]), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), BACLOFEN, TELMISARTAN, DILTIAZEM, METHOTREXATE SODIUM (METHOTREXATE INJECTION BP), METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL), MIRABEGRON (MYRBETRIQ), ROSUVASTATIN CALCIUM (CRESTOR), MONTELUKAST SODIUM (SINGULAIR), SAXAGLIPTIN HYDROCHLORIDE (ONGLYZA [SAXAGLIPTIN HYDROCHLORIDE]), LORAZEPAM (ATIVAN), ALBUTEROL [SALBUTAMOL], VITAMIN D [VITAMIN D NOS], CALCIUM, SERENOA REPENS FRUIT (SAW PALMETTO [SERENOA REPENS FRUIT]) and RITUXIMAB (RITUXAN) for an unknown indication.    On 30-Jun-2021 at 7:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced VACCINATION SITE DISCOMFORT (He reports that he the injection site was bothersome) and VACCINATION SITE PAIN (injection site hurts a little bit). On 30-Jun-2021 at 10:00 PM, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 01-Jul-2021, HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, VACCINATION SITE DISCOMFORT (He reports that he the injection site was bothersome) and VACCINATION SITE PAIN (injection site hurts a little bit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient took dose 2 on 28-Jul-2021.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-272092 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Added patient demographic, added medical history, added lab data, added dose 2 details, updated concomitant medication details, added event fatigue and updated event outcome.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine stored in the refrigerator for more than 30 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine stored in the refrigerator for more than 30 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine stored in the refrigerator for more than 30 days). On 30-Jun-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine stored in the refrigerator for more than 30 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 Relevant concomitant medications was reported.  Treatment information was not provided.