chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Pruritus, Rash
Clinical narrative: Itchy on head; Raised bumps on left and right shoulders, both arms, both wrists, back, scalp; Rash on back, left shoulder, right shoulder, both arms and wrists; Felt tired; Chills; Sweating; Sore arm at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweating), SKIN DISORDER (Raised bumps on left and right shoulders, both arms, both wrists, back, scalp), PRURITUS (Itchy on head), RASH (Rash on back, left shoulder, right shoulder, both arms and wrists) and FATIGUE (Felt tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 08-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), FATIGUE (Felt tired) and CHILLS (Chills). On 09-Apr-2021, the patient experienced RASH (Rash on back, left shoulder, right shoulder, both arms and wrists). On 26-Apr-2021, the patient experienced SKIN DISORDER (Raised bumps on left and right shoulders, both arms, both wrists, back, scalp). On 17-May-2021, the patient experienced PRURITUS (Itchy on head). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CLOBETASOL (topical) at an unspecified dose and frequency and HYDROCORTISONE (topical) at an unspecified dose and frequency. On 08-Apr-2021, HYPERHIDROSIS (Sweating), FATIGUE (Felt tired) and CHILLS (Chills) had resolved. At the time of the report, SKIN DISORDER (Raised bumps on left and right shoulders, both arms, both wrists, back, scalp), PRURITUS (Itchy on head), RASH (Rash on back, left shoulder, right shoulder, both arms and wrists) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.            Concomitant product information was not provided.  On 09-Apr-2021, a rash developed on the patient's back and left shoulder. On 16-Apr-2021, rash developed on the right shoulder, and down both arms and wrists.  On 26-Apr-2021, raised bumps developed on back, both shoulders, both arms, and both wrists.  On 17-May-2021, the scalp developed raised bumps  On unknown date, patient visited an unspecified healthcare provider who recommended a dermatologist consultation.     This case was linked to MOD-2021-211524 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder, Vaccination site pain
Clinical narrative: Itchy on head; Raised bumps on left and right shoulders, both arms, both wrists, back, scalp; Rash on back, left shoulder, right shoulder, both arms and wrists; Felt tired; Chills; Sweating; Sore arm at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweating), SKIN DISORDER (Raised bumps on left and right shoulders, both arms, both wrists, back, scalp), PRURITUS (Itchy on head), RASH (Rash on back, left shoulder, right shoulder, both arms and wrists) and FATIGUE (Felt tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site). On 08-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), FATIGUE (Felt tired) and CHILLS (Chills). On 09-Apr-2021, the patient experienced RASH (Rash on back, left shoulder, right shoulder, both arms and wrists). On 26-Apr-2021, the patient experienced SKIN DISORDER (Raised bumps on left and right shoulders, both arms, both wrists, back, scalp). On 17-May-2021, the patient experienced PRURITUS (Itchy on head). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; CLOBETASOL (topical) at an unspecified dose and frequency and HYDROCORTISONE (topical) at an unspecified dose and frequency. On 08-Apr-2021, HYPERHIDROSIS (Sweating), FATIGUE (Felt tired) and CHILLS (Chills) had resolved. At the time of the report, SKIN DISORDER (Raised bumps on left and right shoulders, both arms, both wrists, back, scalp), PRURITUS (Itchy on head), RASH (Rash on back, left shoulder, right shoulder, both arms and wrists) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.            Concomitant product information was not provided.  On 09-Apr-2021, a rash developed on the patient's back and left shoulder. On 16-Apr-2021, rash developed on the right shoulder, and down both arms and wrists.  On 26-Apr-2021, raised bumps developed on back, both shoulders, both arms, and both wrists.  On 17-May-2021, the scalp developed raised bumps  On unknown date, patient visited an unspecified healthcare provider who recommended a dermatologist consultation.     This case was linked to MOD-2021-211524 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Chills; Body aches; Fever; 2nd dose administered >35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered >35 days after 1st dose), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered >35 days after 1st dose). On 06-Apr-2021, the patient experienced CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) in April 2021 for Adverse event, at an unspecified dose and frequency. On 05-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered >35 days after 1st dose) had resolved. On 07-Apr-2021, CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product also included One A Day Multivitamin for an unknown indication.  Treatment products also included steroids and Sinus Cocktails.   This case was linked to MOD-2021-211523 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Tinnitus
Clinical narrative: Bilateral ringing in the ears after the 1st dose/Tinnitus after the 1st dose; Patient missed the 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (Bilateral ringing in the ears after the 1st dose/Tinnitus after the 1st dose) and PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) in a 77-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 ALBUTEROL SULFATE, EZETIMIBE (ZETIA), FAMOTIDINE (PEPCID AC), LISINOPRIL, ROSUVASTATIN CALCIUM (CRESTOR), SERTRALINE HYDROCHLORIDE (ZOLOFT), SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Feb-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 TINNITUS (Bilateral ringing in the ears after the 1st dose/Tinnitus after the 1st dose) and PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose). At the time of the report, TINNITUS (Bilateral ringing in the ears after the 1st dose/Tinnitus after the 1st dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reportedly, the ringing in the ears were constant and bothering the patient. The patient didn't take any treatment medications.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: warts on my feet are completely gone after taking the 2nd dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (warts on my feet are completely gone after taking the 2nd dose of the Moderna Covid-19 vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 025H21A) for COVID-19 vaccination.     Concurrent medical conditions included Plantar warts (Had warts 5-8 yrs, predominantly on right foot.1 inch cluster of warts that went across the entire width of his right foot, including the great toe. Minimal involvement to left foot.) since 30-Jun-2005 and Blood pressure high. Concomitant products included SIMVASTATIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (warts on my feet are completely gone after taking the 2nd dose of the Moderna Covid-19 vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (warts on my feet are completely gone after taking the 2nd dose of the Moderna Covid-19 vaccine) outcome was unknown.            Patient got positive adverse event which cured Plantar Warts. The patient reports that, he previously tried the over-the-counter medicines, but nothing had worked. He also tried wrapping duct tape around his foot and also wrapped electrical tape around his foot for 4-5 weeks at a time, without successful removal of warts.  Concomitant medication also reported some blood pressure medications. No treatment medication reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up information received. The patient medical history, product dose details and concomitant medication were updated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Disturbance in attention, Feeling abnormal, Irritability, Myalgia
Clinical narrative: Lower back symptom; Irritable; Could not focus on one thing at a time; Strange feeling; woke up with back pain; chills, other cold symptoms; leg achy so bad and cramping; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg achy so bad and cramping), NASOPHARYNGITIS (chills, other cold symptoms), BACK PAIN (Lower back symptom), IRRITABILITY (Irritable) and DISTURBANCE IN ATTENTION (Could not focus on one thing at a time) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX SR) for Anxiety, PARACETAMOL (TYLENOL) for Pain.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced PAIN IN EXTREMITY (leg achy so bad and cramping) and MYALGIA (Body ache). On 06-Jun-2021, the patient experienced NASOPHARYNGITIS (chills, other cold symptoms). On 07-Jun-2021, the patient experienced BACK PAIN (Lower back symptom), IRRITABILITY (Irritable), DISTURBANCE IN ATTENTION (Could not focus on one thing at a time), FEELING ABNORMAL (Strange feeling) and BACK PAIN (woke up with back pain). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, PAIN IN EXTREMITY (leg achy so bad and cramping), NASOPHARYNGITIS (chills, other cold symptoms), BACK PAIN (Lower back symptom), IRRITABILITY (Irritable), DISTURBANCE IN ATTENTION (Could not focus on one thing at a time), FEELING ABNORMAL (Strange feeling), BACK PAIN (woke up with back pain) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pain in extremity
Clinical narrative: Lower back symptom; Irritable; Could not focus on one thing at a time; Strange feeling; woke up with back pain; chills, other cold symptoms; leg achy so bad and cramping; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg achy so bad and cramping), NASOPHARYNGITIS (chills, other cold symptoms), BACK PAIN (Lower back symptom), IRRITABILITY (Irritable) and DISTURBANCE IN ATTENTION (Could not focus on one thing at a time) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX SR) for Anxiety, PARACETAMOL (TYLENOL) for Pain.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced PAIN IN EXTREMITY (leg achy so bad and cramping) and MYALGIA (Body ache). On 06-Jun-2021, the patient experienced NASOPHARYNGITIS (chills, other cold symptoms). On 07-Jun-2021, the patient experienced BACK PAIN (Lower back symptom), IRRITABILITY (Irritable), DISTURBANCE IN ATTENTION (Could not focus on one thing at a time), FEELING ABNORMAL (Strange feeling) and BACK PAIN (woke up with back pain). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, PAIN IN EXTREMITY (leg achy so bad and cramping), NASOPHARYNGITIS (chills, other cold symptoms), BACK PAIN (Lower back symptom), IRRITABILITY (Irritable), DISTURBANCE IN ATTENTION (Could not focus on one thing at a time), FEELING ABNORMAL (Strange feeling), BACK PAIN (woke up with back pain) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Maternal exposure during pregnancy, Myalgia, Nausea, Pyrexia
Clinical narrative: flu-ish symptoms; body aches; Vomiting; fever; Nausea; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-ish symptoms), MYALGIA (body aches), VOMITING (Vomiting), PYREXIA (fever) and NAUSEA (Nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-Dec-2021. On 14-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu-ish symptoms), MYALGIA (body aches), VOMITING (Vomiting), PYREXIA (fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form four times per day. On 14-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-ish symptoms), MYALGIA (body aches), VOMITING (Vomiting), PYREXIA (fever) and NAUSEA (Nausea) outcome was unknown.            Patient reported that the events can be because she was pregnant.   This case was linked to MOD-2021-211534 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: flu-ish symptoms; body aches; Vomiting; fever; Nausea; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-ish symptoms), MYALGIA (body aches), VOMITING (Vomiting), PYREXIA (fever) and NAUSEA (Nausea) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 18-Dec-2021. On 14-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 13-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu-ish symptoms), MYALGIA (body aches), VOMITING (Vomiting), PYREXIA (fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form four times per day. On 14-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-ish symptoms), MYALGIA (body aches), VOMITING (Vomiting), PYREXIA (fever) and NAUSEA (Nausea) outcome was unknown.            Patient reported that the events can be because she was pregnant.   This case was linked to MOD-2021-211534 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: swollen area at the base of my neck and top of my shoulder, swollen area under her armpit; swelling and pain moved under my armpit; injection hurt a lot and stung, sore in the area; After receiving the injection she had a lump; After receiving the injection it was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection hurt a lot and stung, sore in the area), VACCINATION SITE MASS (After receiving the injection she had a lump), VACCINATION SITE SWELLING (After receiving the injection it was swollen), AXILLARY PAIN (swelling and pain moved under my armpit) and SWELLING (swollen area at the base of my neck and top of my shoulder, swollen area under her armpit) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 023721A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE PAIN (injection hurt a lot and stung, sore in the area), VACCINATION SITE MASS (After receiving the injection she had a lump) and VACCINATION SITE SWELLING (After receiving the injection it was swollen). On 05-Jun-2021, the patient experienced AXILLARY PAIN (swelling and pain moved under my armpit). On 07-Jun-2021, the patient experienced SWELLING (swollen area at the base of my neck and top of my shoulder, swollen area under her armpit). The patient was treated with IBUPROFEN for Pain, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (injection hurt a lot and stung, sore in the area), VACCINATION SITE MASS (After receiving the injection she had a lump), VACCINATION SITE SWELLING (After receiving the injection it was swollen), AXILLARY PAIN (swelling and pain moved under my armpit) and SWELLING (swollen area at the base of my neck and top of my shoulder, swollen area under her armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle spasms
Clinical narrative: Numb hand; Muscle spasm; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (Numb hand) and MUSCLE SPASMS (Muscle spasm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced HYPOAESTHESIA (Numb hand) and MUSCLE SPASMS (Muscle spasm). At the time of the report, HYPOAESTHESIA (Numb hand) and MUSCLE SPASMS (Muscle spasm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient missed the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.  The patient received first dose in Jan-2021 and was asking if it was too late to receive the second dose at the time of reporting.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Therapeutic response unexpected
Clinical narrative: minimal soreness; 2nd dose given beyond 35 days of 1st; crystal clear vision that lasted for 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given beyond 35 days of 1st), THERAPEUTIC RESPONSE UNEXPECTED (crystal clear vision that lasted for 30 minutes) and PAIN (minimal soreness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic fatigue syndrome.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given beyond 35 days of 1st). 07-Jun-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (crystal clear vision that lasted for 30 minutes). On an unknown date, the patient experienced PAIN (minimal soreness). On 07-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given beyond 35 days of 1st) and THERAPEUTIC RESPONSE UNEXPECTED (crystal clear vision that lasted for 30 minutes) had resolved. At the time of the report, PAIN (minimal soreness) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up information included additional event
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID ARM; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE REACTION (COVID ARM) 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 SITE REACTION (COVID ARM). At the time of the report, VACCINATION SITE REACTION (COVID ARM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-211557 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: rapid heart beat / heart beat had a fluttering quality; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat / heart beat had a fluttering quality) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced HEART RATE INCREASED (rapid heart beat / heart beat had a fluttering quality). At the time of the report, HEART RATE INCREASED (rapid heart beat / heart beat had a fluttering quality) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID ARM; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (COVID ARM) 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, 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 REACTION (COVID ARM). At the time of the report, VACCINATION SITE REACTION (COVID ARM) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: side affects to their menstrual cycle; blood clots on women while on their periods; 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 MENSTRUAL DISORDER (side affects to their menstrual cycle) and HEAVY MENSTRUAL BLEEDING (blood clots on women while on their periods) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (side affects to their menstrual cycle) and HEAVY MENSTRUAL BLEEDING (blood clots on women while on their periods). At the time of the report, MENSTRUAL DISORDER (side affects to their menstrual cycle) and HEAVY MENSTRUAL BLEEDING (blood clots on women while on their periods) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Arm soreness (started that night and lasted for approximately 10 days); Fatigued (For roughly 36 hours); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm soreness (started that night and lasted for approximately 10 days)) and FATIGUE (Fatigued (For roughly 36 hours)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036-A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-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 MYALGIA (Arm soreness (started that night and lasted for approximately 10 days)) and FATIGUE (Fatigued (For roughly 36 hours)). At the time of the report, MYALGIA (Arm soreness (started that night and lasted for approximately 10 days)) and FATIGUE (Fatigued (For roughly 36 hours)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Fatigue, Headache, Heavy menstrual bleeding
Clinical narrative: swollen arm/Swelling of feet; menstrual bleeding 5 days after the second dose which is out of their menstruation cycle; difficulty to focus which is impairing their ability to work; cannot stand very long; swollen ankles and feet; continuous periods with clots of blood; weakness; headache comes and goes, pretty much everyday; general fatigue; muscular pain and weakness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm/Swelling of feet), MENSTRUATION IRREGULAR (menstrual bleeding 5 days after the second dose which is out of their menstruation cycle), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to focus which is impairing their ability to work), DYSSTASIA (cannot stand very long) and JOINT SWELLING (swollen ankles and feet) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M208 and 024M208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm/Swelling of feet), MENSTRUATION IRREGULAR (menstrual bleeding 5 days after the second dose which is out of their menstruation cycle), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to focus which is impairing their ability to work), DYSSTASIA (cannot stand very long), JOINT SWELLING (swollen ankles and feet), HEAVY MENSTRUAL BLEEDING (continuous periods with clots of blood), ASTHENIA (weakness), HEADACHE (headache comes and goes, pretty much everyday), FATIGUE (general fatigue) and MYALGIA (muscular pain and weakness). The patient was treated with IRON (IRON COMPOUND) at a dose of 1 dosage form; PARACETAMOL at a dose of 1 dosage form and ETHINYLESTRADIOL, NORGESTIMATE (ESTARYLLA) at a dose of 1 dosage form. On 11-Mar-2021, PERIPHERAL SWELLING (swollen arm/Swelling of feet) outcome was unknown. At the time of the report, MENSTRUATION IRREGULAR (menstrual bleeding 5 days after the second dose which is out of their menstruation cycle), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to focus which is impairing their ability to work), DYSSTASIA (cannot stand very long), JOINT SWELLING (swollen ankles and feet), HEAVY MENSTRUAL BLEEDING (continuous periods with clots of blood), ASTHENIA (weakness), HEADACHE (headache comes and goes, pretty much everyday), FATIGUE (general fatigue) and MYALGIA (muscular pain and weakness) outcome was unknown.            Concomitant medication was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Loss of personal independence in daily activities, Menstruation irregular, Myalgia, Peripheral swelling
Clinical narrative: swollen arm/Swelling of feet; menstrual bleeding 5 days after the second dose which is out of their menstruation cycle; difficulty to focus which is impairing their ability to work; cannot stand very long; swollen ankles and feet; continuous periods with clots of blood; weakness; headache comes and goes, pretty much everyday; general fatigue; muscular pain and weakness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm/Swelling of feet), MENSTRUATION IRREGULAR (menstrual bleeding 5 days after the second dose which is out of their menstruation cycle), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to focus which is impairing their ability to work), DYSSTASIA (cannot stand very long) and JOINT SWELLING (swollen ankles and feet) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M208 and 024M208) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (swollen arm/Swelling of feet), MENSTRUATION IRREGULAR (menstrual bleeding 5 days after the second dose which is out of their menstruation cycle), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to focus which is impairing their ability to work), DYSSTASIA (cannot stand very long), JOINT SWELLING (swollen ankles and feet), HEAVY MENSTRUAL BLEEDING (continuous periods with clots of blood), ASTHENIA (weakness), HEADACHE (headache comes and goes, pretty much everyday), FATIGUE (general fatigue) and MYALGIA (muscular pain and weakness). The patient was treated with IRON (IRON COMPOUND) at a dose of 1 dosage form; PARACETAMOL at a dose of 1 dosage form and ETHINYLESTRADIOL, NORGESTIMATE (ESTARYLLA) at a dose of 1 dosage form. On 11-Mar-2021, PERIPHERAL SWELLING (swollen arm/Swelling of feet) outcome was unknown. At the time of the report, MENSTRUATION IRREGULAR (menstrual bleeding 5 days after the second dose which is out of their menstruation cycle), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (difficulty to focus which is impairing their ability to work), DYSSTASIA (cannot stand very long), JOINT SWELLING (swollen ankles and feet), HEAVY MENSTRUAL BLEEDING (continuous periods with clots of blood), ASTHENIA (weakness), HEADACHE (headache comes and goes, pretty much everyday), FATIGUE (general fatigue) and MYALGIA (muscular pain and weakness) outcome was unknown.            Concomitant medication was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) 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 ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Bone pain, Fatigue, Feeling abnormal, Injection site erythema
Clinical narrative: bone pain; anxiety climbed up; felt fatigue; redness at the site of injection; surgeon in my body; experienced bad; not well; arm pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of UNEVALUABLE EVENT (surgeon in my body), FEELING ABNORMAL (experienced bad), BONE PAIN (bone pain), ANXIETY (anxiety climbed up) and MALAISE (not well) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid function abnormal and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) and CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]) for Thyroid function abnormal.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced UNEVALUABLE EVENT (surgeon in my body), FEELING ABNORMAL (experienced bad), MALAISE (not well), INJECTION SITE PAIN (arm pain at the injection site) and INJECTION SITE ERYTHEMA (redness at the site of injection). On 06-Jun-2021, the patient experienced BONE PAIN (bone pain), ANXIETY (anxiety climbed up) and FATIGUE (felt fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 UNK, bid. At the time of the report, UNEVALUABLE EVENT (surgeon in my body), FEELING ABNORMAL (experienced bad), BONE PAIN (bone pain), ANXIETY (anxiety climbed up), MALAISE (not well), INJECTION SITE PAIN (arm pain at the injection site), FATIGUE (felt fatigue) and INJECTION SITE ERYTHEMA (redness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Unevaluable event
Clinical narrative: bone pain; anxiety climbed up; felt fatigue; redness at the site of injection; surgeon in my body; experienced bad; not well; arm pain at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of UNEVALUABLE EVENT (surgeon in my body), FEELING ABNORMAL (experienced bad), BONE PAIN (bone pain), ANXIETY (anxiety climbed up) and MALAISE (not well) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Thyroid function abnormal and Anxiety. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) and CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]) for Thyroid function abnormal.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced UNEVALUABLE EVENT (surgeon in my body), FEELING ABNORMAL (experienced bad), MALAISE (not well), INJECTION SITE PAIN (arm pain at the injection site) and INJECTION SITE ERYTHEMA (redness at the site of injection). On 06-Jun-2021, the patient experienced BONE PAIN (bone pain), ANXIETY (anxiety climbed up) and FATIGUE (felt fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 UNK, bid. At the time of the report, UNEVALUABLE EVENT (surgeon in my body), FEELING ABNORMAL (experienced bad), BONE PAIN (bone pain), ANXIETY (anxiety climbed up), MALAISE (not well), INJECTION SITE PAIN (arm pain at the injection site), FATIGUE (felt fatigue) and INJECTION SITE ERYTHEMA (redness at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Vaccination site erythema, Vaccination site pain
Clinical narrative: Itchy rash right elbow; Pain at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash right elbow), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), PREDNISONE, POTASSIUM and LOSARTAN for an unknown indication.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced RASH PRURITIC (Itchy rash right elbow), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 28-Apr-2021, RASH PRURITIC (Itchy rash right elbow), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) 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.   This case was linked to MOD-2021-211582 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cough, Paranasal sinus discomfort, Pyrexia
Clinical narrative: Sinus Pressure; Unproductive Cough; Random Fever; This spontaneous case was reported by a consumer and describes the occurrence of PARANASAL SINUS DISCOMFORT (Sinus Pressure), COUGH (Unproductive Cough) and PYREXIA (Random Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced PARANASAL SINUS DISCOMFORT (Sinus Pressure), COUGH (Unproductive Cough) and PYREXIA (Random Fever). At the time of the report, PARANASAL SINUS DISCOMFORT (Sinus Pressure), COUGH (Unproductive Cough) and PYREXIA (Random Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Highest fever on the shot; 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 PYREXIA (Highest fever on the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Highest fever on the shot). At the time of the report, PYREXIA (Highest fever on the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided.    Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: First dose of the Moderna Covid-19 vaccine administered to a 16 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of the Moderna Covid-19 vaccine administered to a 16 year old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety, Depression and ADHD.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of the Moderna Covid-19 vaccine administered to a 16 year old). On 07-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (First dose of the Moderna Covid-19 vaccine administered to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient was not on any medications. The reporter also confirmed that the patient did not experience any side effects.  A VAERs report was sent by the reporter to the Centers for Disease Control and Prevention (CDC) (VAERs number not provided). The second dose of vaccine was not scheduled at the time of reporting and no treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Patient demographics, medical history and vaccine details were updated. On 30-Jun-2021: No new information was received.