chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: experiencing horrific pain in Right side of neck, it almost kills me when I turn my head, I can barley move my head head, I holler out when I do, its very painful, it almost drops me to me knees, its like lightening shoots down to my back.; right sided neck stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (right sided neck stiffness) and NECK PAIN (experiencing horrific pain in Right side of neck, it almost kills me when I turn my head, I can barley move my head head, I holler out when I do, its very painful, it almost drops me to me knees, its like lightening shoots down to my back.) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026A21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included WARFARIN, FINASTERIDE, EZETIMIBE, ROSUVASTATIN, ESOMEPRAZOLE MAGNESIUM and GABAPENTIN for an unknown indication.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 27-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (right sided neck stiffness). On 30-Mar-2021, the patient experienced NECK PAIN (experiencing horrific pain in Right side of neck, it almost kills me when I turn my head, I can barley move my head head, I holler out when I do, its very painful, it almost drops me to me knees, its like lightening shoots down to my back.). At the time of the report, MUSCULOSKELETAL STIFFNESS (right sided neck stiffness) and NECK PAIN (experiencing horrific pain in Right side of neck, it almost kills me when I turn my head, I can barley move my head head, I holler out when I do, its very painful, it almost drops me to me knees, its like lightening shoots down to my back.) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Caller states taking Tylenol and applying ice and muscle cream to help relieve side effects.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: fever; Slight pink 4" circle at injection site near shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Slight pink 4" circle at injection site near shoulder) and PYREXIA (fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and :044A214) for COVID-19 vaccination.     The patient's past medical history included No adverse event and No adverse event.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Slight pink 4" circle at injection site near shoulder). On 13-Mar-2021, the patient experienced PYREXIA (fever). At the time of the report, VACCINATION SITE ERYTHEMA (Slight pink 4" circle at injection site near shoulder) and PYREXIA (fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-062497 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062497:Dose 1
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vials were compromised at high temperatures; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (vials were compromised at high temperatures) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PRODUCT STORAGE ERROR (vials were compromised at high temperatures). At the time of the report, PRODUCT STORAGE ERROR (vials were compromised at high temperatures) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: In bed a lot over the last 6 days; Shakes; Sweating; Vomiting; Huge Headache; Very fatigued; Fever of 103F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed a lot over the last 6 days), TREMOR (Shakes), HYPERHIDROSIS (Sweating), VOMITING (Vomiting) and HEADACHE (Huge Headache) in a 66-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.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included No adverse event.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced BEDRIDDEN (In bed a lot over the last 6 days), TREMOR (Shakes), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Huge Headache), FATIGUE (Very fatigued), PYREXIA (Fever of 103F) and CHILLS (Chills). On 24-Mar-2021, VOMITING (Vomiting) had resolved. On 30-Mar-2021, BEDRIDDEN (In bed a lot over the last 6 days), TREMOR (Shakes), HYPERHIDROSIS (Sweating), HEADACHE (Huge Headache), FATIGUE (Very fatigued), PYREXIA (Fever of 103F) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Second COVID-19 shot is due on 20 Apr 2021. Treatment details included Tylenol.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: In bed a lot over the last 6 days; Shakes; Sweating; Vomiting; Huge Headache; Very fatigued; Fever of 103F; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (In bed a lot over the last 6 days), TREMOR (Shakes), HYPERHIDROSIS (Sweating), VOMITING (Vomiting) and HEADACHE (Huge Headache) in a 66-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.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included No adverse event.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced BEDRIDDEN (In bed a lot over the last 6 days), TREMOR (Shakes), HYPERHIDROSIS (Sweating), VOMITING (Vomiting), HEADACHE (Huge Headache), FATIGUE (Very fatigued), PYREXIA (Fever of 103F) and CHILLS (Chills). On 24-Mar-2021, VOMITING (Vomiting) had resolved. On 30-Mar-2021, BEDRIDDEN (In bed a lot over the last 6 days), TREMOR (Shakes), HYPERHIDROSIS (Sweating), HEADACHE (Huge Headache), FATIGUE (Very fatigued), PYREXIA (Fever of 103F) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Second COVID-19 shot is due on 20 Apr 2021. Treatment details included Tylenol.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Nausea, Pain, Pyrexia
Clinical narrative: Aches and pains; sweating; Fever 99.4 -100.8; chills; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches and pains), HYPERHIDROSIS (sweating), PYREXIA (Fever 99.4 -100.8), CHILLS (chills) and NAUSEA (Nauseated) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Aches and pains), HYPERHIDROSIS (sweating), PYREXIA (Fever 99.4 -100.8), CHILLS (chills) and NAUSEA (Nauseated). At the time of the report, PAIN (Aches and pains), HYPERHIDROSIS (sweating), PYREXIA (Fever 99.4 -100.8), CHILLS (chills) and NAUSEA (Nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Fatigue, Skin discolouration, Vaccination site induration
Clinical narrative: Pinkish in color; Warm to touch; Hardness at injection site; Sore; Clammy; Felt washed out; Pain across shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clammy), SKIN DISCOLOURATION (Pinkish in color), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hardness at injection site) and ARTHRALGIA (Pain across shoulder) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028AZ1A and 025AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Chronic hives years ago.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced ARTHRALGIA (Pain across shoulder) and FATIGUE (Felt washed out). On 29-Mar-2021, the patient experienced COLD SWEAT (Clammy). On 30-Mar-2021, the patient experienced SKIN DISCOLOURATION (Pinkish in color), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Sore). At the time of the report, COLD SWEAT (Clammy), SKIN DISCOLOURATION (Pinkish in color), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hardness at injection site), ARTHRALGIA (Pain across shoulder), VACCINATION SITE PAIN (Sore) and FATIGUE (Felt washed out) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Pinkish in color; Warm to touch; Hardness at injection site; Sore; Clammy; Felt washed out; Pain across shoulder; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Clammy), SKIN DISCOLOURATION (Pinkish in color), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hardness at injection site) and ARTHRALGIA (Pain across shoulder) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028AZ1A and 025AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hives (Chronic hives years ago.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced ARTHRALGIA (Pain across shoulder) and FATIGUE (Felt washed out). On 29-Mar-2021, the patient experienced COLD SWEAT (Clammy). On 30-Mar-2021, the patient experienced SKIN DISCOLOURATION (Pinkish in color), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hardness at injection site) and VACCINATION SITE PAIN (Sore). At the time of the report, COLD SWEAT (Clammy), SKIN DISCOLOURATION (Pinkish in color), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE INDURATION (Hardness at injection site), ARTHRALGIA (Pain across shoulder), VACCINATION SITE PAIN (Sore) and FATIGUE (Felt washed out) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) 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) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old). On 03-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old male) for mRNA-1273 (lot number 01A21A) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Muscle spasms, SARS-CoV-2 test
Clinical narrative: diarrhea; Cramping flare up; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), MUSCLE SPASMS (Cramping flare up) and FATIGUE (fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Crohn's disease. Concomitant products included VEDOLIZUMAB (ENTYVIO) for Infusion.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea), MUSCLE SPASMS (Cramping flare up) and FATIGUE (fatigue). At the time of the report, DIARRHOEA (diarrhea), MUSCLE SPASMS (Cramping flare up) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, SARS-CoV-2 test: Negative. In November 2020, SARS-CoV-2 test: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included VEDOLIZUMAB (ENTYVIO).  No treatment medication included.   This case was linked to MOD-2021-137759 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Non- Significant FU - Second dose AE reported, Further contact denied.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Paraesthesia, Presyncope, Vomiting
Clinical narrative: felt like she was going to pass out; Tingling; blood pressure bottomed out; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (felt like she was going to pass out), PARAESTHESIA (Tingling), BLOOD PRESSURE DECREASED (blood pressure bottomed out) and VOMITING (vomiting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No medical history reported). Concomitant products included PROPOFOL, AMLODIPINE, ATORVASTATIN CALCIUM (LIPITOR), VITAMIN D NOS and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PRESYNCOPE (felt like she was going to pass out), PARAESTHESIA (Tingling), BLOOD PRESSURE DECREASED (blood pressure bottomed out) and VOMITING (vomiting). On 29-Mar-2021, PRESYNCOPE (felt like she was going to pass out), PARAESTHESIA (Tingling), BLOOD PRESSURE DECREASED (blood pressure bottomed out) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A, 044A214) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-062481 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062481:Dose 1
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bedridden, Gait disturbance, Pyrexia
Clinical narrative: Lower back hurting and getting worse,Pain in lower back above tailbone like band across back; Could not get out of bed; Difficult to walk; Fever of 102.7; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Lower back hurting and getting worse,Pain in lower back above tailbone like band across back), PYREXIA (Fever of 102.7), BEDRIDDEN (Could not get out of bed) and GAIT DISTURBANCE (Difficult to walk) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014m204) for COVID-19 vaccination.     The patient's past medical history included Back pain.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced BACK PAIN (Lower back hurting and getting worse,Pain in lower back above tailbone like band across back), PYREXIA (Fever of 102.7), BEDRIDDEN (Could not get out of bed) and GAIT DISTURBANCE (Difficult to walk). At the time of the report, BACK PAIN (Lower back hurting and getting worse,Pain in lower back above tailbone like band across back), PYREXIA (Fever of 102.7), BEDRIDDEN (Could not get out of bed) and GAIT DISTURBANCE (Difficult to walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Thyroid meds for an unknown indication.   Treatment included  hydrocodone steroid dose, muscle relaxer and anti inflammatory.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, SARS-CoV-1 test
Clinical narrative: Soreness; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Soreness) and PYREXIA (Fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced PAIN (Soreness). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. On 30-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN (Soreness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Body temperature: 99.4 DF. On an unknown date, SARS-CoV-1 test: negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Fatigue, Mass, Pain, Product dose omission issue
Clinical narrative: I skipped and did not receive 2nd shot.; Severe allergic reaction within 24 hrs.; started as little bumps and then it started spreading.; broke out in hives on both hands, around her neck; feeling tired; itchy underneath her legs, around the ankles, and on both hands.; Body aches/soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I skipped and did not receive 2nd shot.), ALLERGY TO VACCINE (Severe allergic reaction within 24 hrs.), PAIN (Body aches/soreness), MASS (started as little bumps and then it started spreading.) and PRURITUS (itchy underneath her legs, around the ankles, and on both hands.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN (Body aches/soreness). 22-Mar-2021, the patient experienced PRURITUS (itchy underneath her legs, around the ankles, and on both hands.). On 23-Mar-2021, the patient experienced MASS (started as little bumps and then it started spreading.), URTICARIA (broke out in hives on both hands, around her neck) and FATIGUE (feeling tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I skipped and did not receive 2nd shot.) and ALLERGY TO VACCINE (Severe allergic reaction within 24 hrs.). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (I skipped and did not receive 2nd shot.) and ALLERGY TO VACCINE (Severe allergic reaction within 24 hrs.) outcome was unknown, PAIN (Body aches/soreness) and FATIGUE (feeling tired) had not resolved and MASS (started as little bumps and then it started spreading.), PRURITUS (itchy underneath her legs, around the ankles, and on both hands.) and URTICARIA (broke out in hives on both hands, around her neck) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 7-JUN-2021, updated reporter mail address, initials, added events ( allergy to vaccine, product dose omission) and updated action taken.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: I skipped and did not receive 2nd shot.; Severe allergic reaction within 24 hrs.; started as little bumps and then it started spreading.; broke out in hives on both hands, around her neck; feeling tired; itchy underneath her legs, around the ankles, and on both hands.; Body aches/soreness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I skipped and did not receive 2nd shot.), ALLERGY TO VACCINE (Severe allergic reaction within 24 hrs.), PAIN (Body aches/soreness), MASS (started as little bumps and then it started spreading.) and PRURITUS (itchy underneath her legs, around the ankles, and on both hands.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN (Body aches/soreness). 22-Mar-2021, the patient experienced PRURITUS (itchy underneath her legs, around the ankles, and on both hands.). On 23-Mar-2021, the patient experienced MASS (started as little bumps and then it started spreading.), URTICARIA (broke out in hives on both hands, around her neck) and FATIGUE (feeling tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I skipped and did not receive 2nd shot.) and ALLERGY TO VACCINE (Severe allergic reaction within 24 hrs.). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (I skipped and did not receive 2nd shot.) and ALLERGY TO VACCINE (Severe allergic reaction within 24 hrs.) outcome was unknown, PAIN (Body aches/soreness) and FATIGUE (feeling tired) had not resolved and MASS (started as little bumps and then it started spreading.), PRURITUS (itchy underneath her legs, around the ankles, and on both hands.) and URTICARIA (broke out in hives on both hands, around her neck) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 7-JUN-2021, updated reporter mail address, initials, added events ( allergy to vaccine, product dose omission) and updated action taken.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: constant pain from hand to neck in left arm; pain in vaccination arm; constant pain from hand to neck in left arm; difficulty raising arm and moving head; difficulty raising arm and moving head; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (constant pain from hand to neck in left arm), VACCINATION SITE PAIN (pain in vaccination arm; constant pain from hand to neck in left arm), VACCINATION SITE MOVEMENT IMPAIRMENT (difficulty raising arm and moving head) and MUSCULOSKELETAL STIFFNESS (difficulty raising arm and moving head) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 002821A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Seasonal allergy, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced NECK PAIN (constant pain from hand to neck in left arm), VACCINATION SITE PAIN (pain in vaccination arm; constant pain from hand to neck in left arm), VACCINATION SITE MOVEMENT IMPAIRMENT (difficulty raising arm and moving head) and MUSCULOSKELETAL STIFFNESS (difficulty raising arm and moving head). On 16-Apr-2021, NECK PAIN (constant pain from hand to neck in left arm), VACCINATION SITE PAIN (pain in vaccination arm; constant pain from hand to neck in left arm), VACCINATION SITE MOVEMENT IMPAIRMENT (difficulty raising arm and moving head) and MUSCULOSKELETAL STIFFNESS (difficulty raising arm and moving head) had resolved. Not Provided          Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Completed ADR Form, updated information includes: patient demographic details, action taken, event outcome date, second dose information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Further information has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Itching on and off at the injection location; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on and off at the injection location) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PRURITUS (Itching on and off at the injection location). At the time of the report, VACCINATION SITE PRURITUS (Itching on and off at the injection location) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: friends who had COVID and when they received the vaccine friend had bad side effects.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (friends who had COVID and when they received the vaccine friend had bad side effects.) 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 ADVERSE DRUG REACTION (friends who had COVID and when they received the vaccine friend had bad side effects.). At the time of the report, ADVERSE DRUG REACTION (friends who had COVID and when they received the vaccine friend had bad side effects.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatments medications were reported. No concomitant medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Chills, Cough, Lymphoedema
Clinical narrative: lymphedema; bronchitis; chills; coughing; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (bronchitis), CHILLS (chills), COUGH (coughing) and LYMPHOEDEMA (lymphedema) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Bronchitis and Lymphedema.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced BRONCHITIS (bronchitis), CHILLS (chills) and COUGH (coughing). On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema). At the time of the report, BRONCHITIS (bronchitis), CHILLS (chills), COUGH (coughing) and LYMPHOEDEMA (lymphedema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Tender injection site; Mildly swollen injection site; Erythema (redness) which was a size of an egg at the injection site; Itching injection site; Itching from her arm to the right side of her neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tender injection site), VACCINATION SITE SWELLING (Mildly swollen injection site), VACCINATION SITE ERYTHEMA (Erythema (redness) which was a size of an egg at the injection site), VACCINATION SITE PRURITUS (Itching injection site) and PRURITUS (Itching from her arm to the right side of her neck) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tender injection site), VACCINATION SITE SWELLING (Mildly swollen injection site), VACCINATION SITE ERYTHEMA (Erythema (redness) which was a size of an egg at the injection site), VACCINATION SITE PRURITUS (Itching injection site) and PRURITUS (Itching from her arm to the right side of her neck). At the time of the report, VACCINATION SITE PAIN (Tender injection site), VACCINATION SITE SWELLING (Mildly swollen injection site), VACCINATION SITE ERYTHEMA (Erythema (redness) which was a size of an egg at the injection site), VACCINATION SITE PRURITUS (Itching injection site) and PRURITUS (Itching from her arm to the right side of her neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Pain
Clinical narrative: Achy; Tired; Nauseated; Joints felt like pins and needles; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), FATIGUE (Tired), NAUSEA (Nauseated), ARTHRALGIA (Joints felt like pins and needles) and PYREXIA (Slight fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient stated that she had COVID-19 between thanksgiving and Christmas.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (Achy), FATIGUE (Tired), NAUSEA (Nauseated), ARTHRALGIA (Joints felt like pins and needles), PYREXIA (Slight fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achy), FATIGUE (Tired), NAUSEA (Nauseated), ARTHRALGIA (Joints felt like pins and needles), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Achy; Tired; Nauseated; Joints felt like pins and needles; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), FATIGUE (Tired), NAUSEA (Nauseated), ARTHRALGIA (Joints felt like pins and needles) and PYREXIA (Slight fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient stated that she had COVID-19 between thanksgiving and Christmas.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN (Achy), FATIGUE (Tired), NAUSEA (Nauseated), ARTHRALGIA (Joints felt like pins and needles), PYREXIA (Slight fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achy), FATIGUE (Tired), NAUSEA (Nauseated), ARTHRALGIA (Joints felt like pins and needles), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia, Nausea
Clinical narrative: nauseated /queasy; Heartburn; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NAUSEA and DYSPEPSIA 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 NAUSEA and DYSPEPSIA. The patient was treated with ZOFRAN for Nauseated, at an unspecified dose and frequency. At the time of the report, NAUSEA and DYSPEPSIA was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. symptoms are lasted for 4 days now. Her HCP wrote a prescription for Zofran and she would like to know if she can take it before her second dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Heart rate increased, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: About 5 hours after the injection, her heart started racing very fast; Her abdomen area started getting swollen.; Her arm was hard to touch; Her arm swelled up quite large; Immediately after receiving 1st dose, she had a sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (About 5 hours after the injection, her heart started racing very fast), ABDOMINAL DISTENSION (Her abdomen area started getting swollen.), VACCINATION SITE INDURATION (Her arm was hard to touch), VACCINATION SITE SWELLING (Her arm swelled up quite large) and VACCINATION SITE PAIN (Immediately after receiving 1st dose, she had a sore left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Egg allergy. Concomitant products included LOSARTAN and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 20-Mar-2021, the patient experienced HEART RATE INCREASED (About 5 hours after the injection, her heart started racing very fast), ABDOMINAL DISTENSION (Her abdomen area started getting swollen.), VACCINATION SITE INDURATION (Her arm was hard to touch), VACCINATION SITE SWELLING (Her arm swelled up quite large) and VACCINATION SITE PAIN (Immediately after receiving 1st dose, she had a sore left arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Tachycardia, unspecified, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (About 5 hours after the injection, her heart started racing very fast), ABDOMINAL DISTENSION (Her abdomen area started getting swollen.), VACCINATION SITE INDURATION (Her arm was hard to touch), VACCINATION SITE SWELLING (Her arm swelled up quite large) and VACCINATION SITE PAIN (Immediately after receiving 1st dose, she had a sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that about 5 hours after receiving the vaccine, her heart started racing very fast and had taken Benadryl. Her abdomen area started getting swollen and she stated that she has a history of severe allergies. She also had a reaction to the flu as well.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Feeling abnormal, Feeling hot, Mobility decreased, Pain in extremity
Clinical narrative: Couldn't lift arm; Dermatitis on the right side; Felt like radioactive dye injection; Extreme heat/Heat sensation all over body; Extreme arm pain; Swelling; Injection site felt tender; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldn't lift arm), DERMATITIS (Dermatitis on the right side), FEELING ABNORMAL (Felt like radioactive dye injection), FEELING HOT (Extreme heat/Heat sensation all over body) and PAIN IN EXTREMITY (Extreme arm pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol) and drug allergy (codeine).    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MOBILITY DECREASED (Couldn't lift arm), DERMATITIS (Dermatitis on the right side), FEELING ABNORMAL (Felt like radioactive dye injection), FEELING HOT (Extreme heat/Heat sensation all over body), PAIN IN EXTREMITY (Extreme arm pain), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Injection site felt tender). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Couldn't lift arm), DERMATITIS (Dermatitis on the right side), FEELING ABNORMAL (Felt like radioactive dye injection), FEELING HOT (Extreme heat/Heat sensation all over body), PAIN IN EXTREMITY (Extreme arm pain), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Injection site felt tender) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. no concomitant medications are provided.  nurse advised him to take Tylenol but he took naproxen instead. Patient also stated that several days after the injection he had dermatitis on the right side which lasted a few days.   This case was linked to US-MODERNATX, INC.-MOD-2021-054713 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054713:case for dose 1
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Couldn't lift arm; Dermatitis on the right side; Felt like radioactive dye injection; Extreme heat/Heat sensation all over body; Extreme arm pain; Swelling; Injection site felt tender; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Couldn't lift arm), DERMATITIS (Dermatitis on the right side), FEELING ABNORMAL (Felt like radioactive dye injection), FEELING HOT (Extreme heat/Heat sensation all over body) and PAIN IN EXTREMITY (Extreme arm pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Tylenol) and drug allergy (codeine).    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MOBILITY DECREASED (Couldn't lift arm), DERMATITIS (Dermatitis on the right side), FEELING ABNORMAL (Felt like radioactive dye injection), FEELING HOT (Extreme heat/Heat sensation all over body), PAIN IN EXTREMITY (Extreme arm pain), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Injection site felt tender). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Couldn't lift arm), DERMATITIS (Dermatitis on the right side), FEELING ABNORMAL (Felt like radioactive dye injection), FEELING HOT (Extreme heat/Heat sensation all over body), PAIN IN EXTREMITY (Extreme arm pain), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE PAIN (Injection site felt tender) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. no concomitant medications are provided.  nurse advised him to take Tylenol but he took naproxen instead. Patient also stated that several days after the injection he had dermatitis on the right side which lasted a few days.   This case was linked to US-MODERNATX, INC.-MOD-2021-054713 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-054713:case for dose 1
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old daughter received the first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the first dose of the vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the first dose of the vaccine). On 26-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old daughter received the first dose of the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female) for mRNA-1273 (lot number 016B21A) with no associated AEs reported.