chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: arms broke out in hives initially on the right where the injection was done then spread to the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (arms broke out in hives initially on the right where the injection was done then spread to the left arm) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced VACCINATION SITE URTICARIA (arms broke out in hives initially on the right where the injection was done then spread to the left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at a dose of 1 dosage form. On 31-Jul-2021, VACCINATION SITE URTICARIA (arms broke out in hives initially on the right where the injection was done then spread to the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were given by the reporter.
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year-old patient received Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old patient received Moderna vaccine) in a 16-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 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old patient received Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old patient received Moderna vaccine) 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 medication history was reported.  HCP reported patients did not experience any adverse reaction.   Reporter did not allow further contact.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dyspnoea, Insomnia, Nausea, Nervousness
Clinical narrative: Confusion; Nausea; Nervous attacks; Shortness of breath; Couldn't sleep at night; Tremors; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervous attacks), DYSPNOEA (Shortness of breath), INSOMNIA (Couldn't sleep at night), TREMOR (Tremors) and CONFUSIONAL STATE (Confusion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced NERVOUSNESS (Nervous attacks), DYSPNOEA (Shortness of breath), INSOMNIA (Couldn't sleep at night), TREMOR (Tremors) and NAUSEA (Nausea). On 11-Aug-2021, the patient experienced CONFUSIONAL STATE (Confusion). At the time of the report, NERVOUSNESS (Nervous attacks), DYSPNOEA (Shortness of breath), INSOMNIA (Couldn't sleep at night), TREMOR (Tremors), CONFUSIONAL STATE (Confusion) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The patient was told to take Benadryl by the pharmacist.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Confusion; Nausea; Nervous attacks; Shortness of breath; Couldn't sleep at night; Tremors; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervous attacks), DYSPNOEA (Shortness of breath), INSOMNIA (Couldn't sleep at night), TREMOR (Tremors) and CONFUSIONAL STATE (Confusion) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced NERVOUSNESS (Nervous attacks), DYSPNOEA (Shortness of breath), INSOMNIA (Couldn't sleep at night), TREMOR (Tremors) and NAUSEA (Nausea). On 11-Aug-2021, the patient experienced CONFUSIONAL STATE (Confusion). At the time of the report, NERVOUSNESS (Nervous attacks), DYSPNOEA (Shortness of breath), INSOMNIA (Couldn't sleep at night), TREMOR (Tremors), CONFUSIONAL STATE (Confusion) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The patient was told to take Benadryl by the pharmacist.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itchy skin below the injection site closer to bicep; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy skin below the injection site closer to bicep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy skin below the injection site closer to bicep). At the time of the report, VACCINATION SITE PRURITUS (Itchy skin below the injection site closer to bicep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     Medical history was not provided.     On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. List of concomitant medication were not given.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: It was very itchy; It was bright red; Swollen right arm at injection site/size of palm of the hand around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (It was very itchy), VACCINATION SITE ERYTHEMA (It was bright red) and VACCINATION SITE SWELLING (Swollen right arm at injection site/size of palm of the hand around injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (It was very itchy), VACCINATION SITE ERYTHEMA (It was bright red) and VACCINATION SITE SWELLING (Swollen right arm at injection site/size of palm of the hand around injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and TRICLOSAN (CETAPHIL ANTIBACTERIAL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (It was very itchy), VACCINATION SITE ERYTHEMA (It was bright red) and VACCINATION SITE SWELLING (Swollen right arm at injection site/size of palm of the hand around injection site) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   List of concomitant medication were not given.   Reporter did not allow further contact
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: He had fever for 2 days and it went away; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (He had fever for 2 days and it went away) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391C20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (He had fever for 2 days and it went away). On 11-Feb-2021, PYREXIA (He had fever for 2 days and it went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported by the reporter.   This case was linked to MOD-2021-283961 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue
Clinical narrative: Lingering fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Lingering fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical information history was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FATIGUE (Lingering fatigue). At the time of the report, FATIGUE (Lingering fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: high (High) High.         No concomitant medications were reported. No treatment medications were mentioned   Reporter did not allow further contact
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hypoacusis, Pain in extremity, Product dose omission issue
Clinical narrative: Doesn't see well anymore; Doesn't hear well anymore; Decided not to get the second dose in the series; "Didn't feel good"; Left arm hurt; Some dizziness; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore) and DIZZINESS (Some dizziness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), DIZZINESS (Some dizziness) and PYREXIA (Slight fever). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore) and PRODUCT DOSE OMISSION ISSUE (Decided not to get the second dose in the series). At the time of the report, FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore), DIZZINESS (Some dizziness) and PYREXIA (Slight fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Decided not to get the second dose in the series) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient had no known drug or food allergies.  No treatment medications were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Visual impairment
Clinical narrative: Doesn't see well anymore; Doesn't hear well anymore; Decided not to get the second dose in the series; "Didn't feel good"; Left arm hurt; Some dizziness; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore) and DIZZINESS (Some dizziness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and ATORVASTATIN for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), DIZZINESS (Some dizziness) and PYREXIA (Slight fever). On an unknown date, the patient experienced VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore) and PRODUCT DOSE OMISSION ISSUE (Decided not to get the second dose in the series). At the time of the report, FEELING ABNORMAL ("Didn't feel good"), PAIN IN EXTREMITY (Left arm hurt), VISUAL IMPAIRMENT (Doesn't see well anymore), HYPOACUSIS (Doesn't hear well anymore), DIZZINESS (Some dizziness) and PYREXIA (Slight fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Decided not to get the second dose in the series) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient had no known drug or food allergies.  No treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Muscular weakness
Clinical narrative: Light headedness; Leg weakness / he even feels it on his legs; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Leg weakness / he even feels it on his legs) and HEADACHE (Headaches) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 0391C20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Leg weakness / he even feels it on his legs) and HEADACHE (Headaches). At the time of the report, DIZZINESS (Light headedness), MUSCULAR WEAKNESS (Leg weakness / he even feels it on his legs) and HEADACHE (Headaches) had not resolved.            Treatment information was not provided. It was reported that the patient went to the emergency room and brain MRI, EEG, PET scan, heart PET scan and stress test was done but results were not known. The patient reported that the symptoms started lasting 1 second, progressively they got worse and now they last for 1 minute which the patient can have up to 10 times a day.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: Pregnant and received 1st dose in March 2021/received 2nd dose 10Aug20221; 1st dose in March 2021/received 2nd dose 10Aug20221; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose in March 2021/received 2nd dose 10Aug20221) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in March 2021/received 2nd dose 10Aug20221) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  No concomitant medication reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 09-Feb-2021 and the estimated date of delivery was 16-Nov-2021. On 10-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in March 2021/received 2nd dose 10Aug20221). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose in March 2021/received 2nd dose 10Aug20221). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 10-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose in March 2021/received 2nd dose 10Aug20221) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant and received 1st dose in March 2021/received 2nd dose 10Aug20221) outcome was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication reported.   Reporter did not allow further contact
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age
Clinical narrative: 17 year old pregnant patient that was given her first dose; 17 year old pregnant patient that was given her first dose; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Aug-2021, the patient experienced EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose). At the time of the report, EXPOSURE DURING PREGNANCY (17 year old pregnant patient that was given her first dose) outcome was unknown and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old pregnant patient that was given her first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment medication details was reported.  Company Comment: This is a case of product exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs for this 17-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy; Sender's Comments: This is a case of product exposure during pregnancy and inappropriate age at vaccine administration with no associated AEs for this 17-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Addison's disease
Clinical narrative: Side effects with addison disease; This spontaneous case was reported by a consumer and describes the occurrence of ADDISON'S DISEASE (Side effects with Addison disease) 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 ADDISON'S DISEASE (Side effects with Addison disease) (seriousness criterion medically significant). At the time of the report, ADDISON'S DISEASE (Side effects with Addison disease) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment medication were not reported.  Company comment: This is a spontaneous report. Hence, the causality is implied. Very limited information regarding this event has been provided at this time.  Further information cannot be obtained.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous report. Hence, the causality is implied. Very limited information regarding this event has been provided at this time.  Further information cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patients who stated they received the first dose 6 weeks ago or longer; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients who stated they received the first dose 6 weeks ago or longer) 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 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients who stated they received the first dose 6 weeks ago or longer). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patients who stated they received the first dose 6 weeks ago or longer) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment medications were reported   Reporter did not allow further contact
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Feeling abnormal, Influenza, Pyrexia, Viral titre
Clinical narrative: didn't feel good at all; showed some type of reaction; more like the flu; vomited; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel good at all), ADVERSE REACTION (showed some type of reaction), INFLUENZA (more like the flu), VOMITING (vomited) and PYREXIA (slight fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Neuromyelitis optica. Concurrent medical conditions included Autoimmune disorder. Concomitant products included RITUXIMAB (RITUXAN), LEVOTHYROXINE, PANTOPRAZOLE SODIUM, CURCUMA LONGA ROOT (TURMERIC CURCUMIN [CURCUMA LONGA ROOT]), METOPROLOL, HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HYDROCHLOROTHIAZIDE), MONTELUKAST SODIUM, FLUCONAZOLE, LORATADINE, LUBIPROSTONE, GABAPENTIN, OXCARBAZEPINE, BACLOFEN, FLUTICASONE PROPIONATE, MUPIROCIN, TRIAMCINOLONE ACETONIDE, DENOSUMAB (PROLIA), VACCINIUM MACROCARPON FRUIT (THERACRAN ONE), MAGNESIUM CITRATE, FOLIC ACID, VITAMIN B COMPLEX, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), ZINC, BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS GASSERI (PHILLIPS COLON HEALTH) and VITAMIN B12 NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel good at all), ADVERSE REACTION (showed some type of reaction), INFLUENZA (more like the flu), VOMITING (vomited) and PYREXIA (slight fever). At the time of the report, FEELING ABNORMAL (didn't feel good at all), ADVERSE REACTION (showed some type of reaction), INFLUENZA (more like the flu), VOMITING (vomited) and PYREXIA (slight fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral titre: negative (Negative) Patient says she had no B cells and no T cells..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant included 500mg of steroid at that time of Rituxan,mybetriq,Vitamin D 4000 mg were added. Patient has a history of neuromyelitis optica as a primary diagnosis which she states can effect the brain/has effected her brain stem. Patient provided prescription medications and reports that vitamins are recommended by physician. Second dose done on 07April2021 was noted.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: didn't feel good at all; showed some type of reaction; more like the flu; vomited; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel good at all), ADVERSE REACTION (showed some type of reaction), INFLUENZA (more like the flu), VOMITING (vomited) and PYREXIA (slight fever) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Neuromyelitis optica. Concurrent medical conditions included Autoimmune disorder. Concomitant products included RITUXIMAB (RITUXAN), LEVOTHYROXINE, PANTOPRAZOLE SODIUM, CURCUMA LONGA ROOT (TURMERIC CURCUMIN [CURCUMA LONGA ROOT]), METOPROLOL, HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN/HYDROCHLOROTHIAZIDE), MONTELUKAST SODIUM, FLUCONAZOLE, LORATADINE, LUBIPROSTONE, GABAPENTIN, OXCARBAZEPINE, BACLOFEN, FLUTICASONE PROPIONATE, MUPIROCIN, TRIAMCINOLONE ACETONIDE, DENOSUMAB (PROLIA), VACCINIUM MACROCARPON FRUIT (THERACRAN ONE), MAGNESIUM CITRATE, FOLIC ACID, VITAMIN B COMPLEX, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), ZINC, BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS GASSERI (PHILLIPS COLON HEALTH) and VITAMIN B12 NOS for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel good at all), ADVERSE REACTION (showed some type of reaction), INFLUENZA (more like the flu), VOMITING (vomited) and PYREXIA (slight fever). At the time of the report, FEELING ABNORMAL (didn't feel good at all), ADVERSE REACTION (showed some type of reaction), INFLUENZA (more like the flu), VOMITING (vomited) and PYREXIA (slight fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Viral titre: negative (Negative) Patient says she had no B cells and no T cells..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant included 500mg of steroid at that time of Rituxan,mybetriq,Vitamin D 4000 mg were added. Patient has a history of neuromyelitis optica as a primary diagnosis which she states can effect the brain/has effected her brain stem. Patient provided prescription medications and reports that vitamins are recommended by physician. Second dose done on 07April2021 was noted.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Exposure to SARS-CoV-2, Fatigue, Headache, Myalgia
Clinical narrative: Worried because he was exposed to COVID-19; Redness; Sore arm; Light headache; Little fatigued; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Worried because he was exposed to COVID-19), ERYTHEMA (Redness), MYALGIA (Sore arm), HEADACHE (Light headache) and FATIGUE (Little fatigued) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced ERYTHEMA (Redness), MYALGIA (Sore arm), HEADACHE (Light headache) and FATIGUE (Little fatigued). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Worried because he was exposed to COVID-19). On 11-Aug-2021, ERYTHEMA (Redness), MYALGIA (Sore arm), HEADACHE (Light headache) and FATIGUE (Little fatigued) had resolved. At the time of the report, EXPOSURE TO SARS-COV-2 (Worried because he was exposed to COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant treatment was provided. No treatment medication was provided.  The patient was exposed to COVID-19 since the patient works in close quarters with the people and the patient's boss was tested positive for COVID-19. The patient did not had any COVID-19 symptoms but was worried about being asymptomatic and if that might affect the efficacy of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Neck is breaking out; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Neck is breaking out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Neck is breaking out). At the time of the report, RASH (Neck is breaking out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment medication were reported.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration, Mobility decreased, Muscular weakness
Clinical narrative: Limited range for motion in left shoulder; Left shoulder weakness; Patient had concerns that the vaccination provider incorrectly administered the shot in his joint, instead of the deltoid muscle; Left shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Limited range for motion in left shoulder), MUSCULAR WEAKNESS (Left shoulder weakness), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had concerns that the vaccination provider incorrectly administered the shot in his joint, instead of the deltoid muscle) and ARTHRALGIA (Left shoulder pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MOBILITY DECREASED (Limited range for motion in left shoulder), MUSCULAR WEAKNESS (Left shoulder weakness), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had concerns that the vaccination provider incorrectly administered the shot in his joint, instead of the deltoid muscle) and ARTHRALGIA (Left shoulder pain). At the time of the report, MOBILITY DECREASED (Limited range for motion in left shoulder), MUSCULAR WEAKNESS (Left shoulder weakness) and ARTHRALGIA (Left shoulder pain) had not resolved and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had concerns that the vaccination provider incorrectly administered the shot in his joint, instead of the deltoid muscle) had resolved.            No concomitant medications were provided by the reporter No treatment information was provided by the reporter Patient reported that he might have shoulder injury related to vaccine administration SIRVA  It was reported that the patient experienced problems with his left shoulder at the time of report and scheduled for appointment with his doctor next week
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Out of system,  It's a vastly shot that I got; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Out of system,  It's a vastly shot that I got) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 FEELING ABNORMAL (Out of system,  It's a vastly shot that I got). At the time of the report, FEELING ABNORMAL (Out of system,  It's a vastly shot that I got) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient was 17; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 17) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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 an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient was 17) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment medications was not reported. Pharmacist realized that she vaccinated a patient that was 17, but turning 18 before the patients second dose.   This case was linked to MOD-2021-283794 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received both doses about 5 months apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses about 5 months apart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses about 5 months apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses about 5 months apart) had resolved.            No Concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Skin burning sensation
Clinical narrative: rash is itching; rash is burning; rash on her chest/rash on her belly; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash is itching), SKIN BURNING SENSATION (rash is burning) and RASH (rash on her chest/rash on her belly) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-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 PRURITIC (rash is itching), SKIN BURNING SENSATION (rash is burning) and RASH (rash on her chest/rash on her belly). At the time of the report, RASH PRURITIC (rash is itching), SKIN BURNING SENSATION (rash is burning) and RASH (rash on her chest/rash on her belly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: i have them too, i  got them after my vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (i have them too, i  got them after my vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     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 VITREOUS FLOATERS (i have them too, i  got them after my vaccine). At the time of the report, VITREOUS FLOATERS (i have them too, i  got them after my vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow-up received contains no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Myalgia, Peripheral swelling
Clinical narrative: her arm felt hot; arm swollen; red; very sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (her arm felt hot), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (red) and MYALGIA (very sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced FEELING HOT (her arm felt hot), PERIPHERAL SWELLING (arm swollen), ERYTHEMA (red) and MYALGIA (very sore). At the time of the report, FEELING HOT (her arm felt hot), PERIPHERAL SWELLING (arm swollen) and MYALGIA (very sore) outcome was unknown and ERYTHEMA (red) had resolved.            No concomitant medication was provided No treatment received by the patient
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-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 DYSPNOEA (difficulty breathing). At the time of the report, DYSPNOEA (difficulty breathing) outcome was unknown.            No concomitant medication and treatment information provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size; Consumer was given 2nd dose too early; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer was given 2nd dose too early) and LYMPHADENOPATHY (Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer was given 2nd dose too early). On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size). On 15-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Consumer was given 2nd dose too early) had resolved. At the time of the report, LYMPHADENOPATHY (Lymph node swollen on left side of the neck, Lymph node swelling and size is gold ball size) outcome was unknown.            Concomitant medications were provided for Cholesterol (low dose 5 mg) and Blood pressure.  No treatment information was provided.  The patient visited the local ED and did tests. Radiologist looked at the tests and notified consumer the swelling and size of the lymph node was size of golf ball. Patient has got 4 ultrasounds since swelling. Consumer got a ultrasound on 11-Aug-2021 and awaiting results.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: He was too young; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He was too young) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He was too young). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (He was too young) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided. The pharmacist recommended getting the Pfizer vaccine as the second dose.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (cardiac arrest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criteria death and medically significant). The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  This is a fatal case of cardiac arrest in a female, age unknown, who received mRNA-1273 on an unknown date. Cause of death was cardiac arrest. Very limited information has been provided at this time. Further information has been requested.; Sender's Comments: This is a fatal case of cardiac arrest in a female, age unknown, who received mRNA-1273 on an unknown date. Cause of death was cardiac arrest. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac arrest
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right shoulder deltoid muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right shoulder deltoid muscle) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Nervous system disorder NOS (Patient has a long history of nerve problems prior to vaccination).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore right shoulder deltoid muscle). At the time of the report, VACCINATION SITE PAIN (sore right shoulder deltoid muscle) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had my second shot and am very ill; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had my second shot and am very ill) 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 VACCINATION COMPLICATION (had my second shot and am very ill). At the time of the report, VACCINATION COMPLICATION (had my second shot and am very ill) outcome was unknown.            NO Concomitant drug reported. NO Treatment drug reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to patient from a vial punctured more than 24 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from a vial punctured more than 24 hours ago) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and CITALOPRAM for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from a vial punctured more than 24 hours ago). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from a vial punctured more than 24 hours ago) 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.