chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: When he touches it, it's hot; He may have received a shot in his bone, not the muscle; Shot site is itching a lot; Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), VACCINATION SITE WARMTH (When he touches it, it's hot), FEELING ABNORMAL (He may have received a shot in his bone, not the muscle) and VACCINATION SITE PRURITUS (Shot site is itching a lot) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-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 PAIN (Pain). On an unknown date, the patient experienced VACCINATION SITE WARMTH (When he touches it, it's hot), FEELING ABNORMAL (He may have received a shot in his bone, not the muscle) and VACCINATION SITE PRURITUS (Shot site is itching a lot). At the time of the report, PAIN (Pain), VACCINATION SITE WARMTH (When he touches it, it's hot), FEELING ABNORMAL (He may have received a shot in his bone, not the muscle) and VACCINATION SITE PRURITUS (Shot site is itching a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were reported.    No treatment information was provided.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; loss of taste and smell; loss of taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (loss of taste and smell), AGEUSIA (loss of taste and smell) and COVID-19 (COVID-19) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ANOSMIA (loss of taste and smell) and AGEUSIA (loss of taste and smell). On 05-Apr-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, ANOSMIA (loss of taste and smell), AGEUSIA (loss of taste and smell) and COVID-19 (COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 antibody test: unknown (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up received on 27APR2021, updated the additional event COVID-19 positive. On 27-Apr-2021: Follow up received on27APR2021, no new information
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: could not get up; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and ILLNESS (could not get up) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N), INSULIN HUMAN (HUMULIN R), CARVEDILOL, HYDRALAZINE, Slomag, IRON, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and FISH OIL for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (Fever). On 01-Apr-2021, the patient experienced ILLNESS (could not get up). At the time of the report, PYREXIA (Fever) and ILLNESS (could not get up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hot flush
Clinical narrative: Hot flashes running through his body; Lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot flashes running through his body) and DIZZINESS (Lightheaded) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes and Obesity. Concurrent medical conditions included Urinary tract infection.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HOT FLUSH (Hot flashes running through his body) and DIZZINESS (Lightheaded). On 03-Apr-2021, HOT FLUSH (Hot flashes running through his body) and DIZZINESS (Lightheaded) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is taking antibiotics for UTI
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included Morbid obesity and Asthma. Concurrent medical conditions included Allergy to metals. Concomitant products included PRENATAL MULTIVITAMIN + DHA for Pregnancy.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Jan-2021 and the estimated date of delivery was 26-Oct-2021. On 05-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  On 05-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported Patient experienced pregnancy associated heartburn and fatigue. Patient has previous one pregnancy which was live birth and full term birth.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Hypoaesthesia, Myalgia, Pain in extremity
Clinical narrative: Numbness on right side of the body; Coughing; Extreme pain in right arm and shoulder still persisting; Muscle soreness; Joint pain; fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A. and 030L20A) for COVID-19 vaccination and experienced COUGH (coughing), PYREXIA (fever of 101F), MYALGIA (muscle soreness) and PAIN IN EXTREMITY (extreme pain in right arm and shoulder still persisting). On 31-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on right side of the body).    The patient's past medical history included No adverse event. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Cough.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient experienced extreme fatigue after receiving the first dose lasting for almost five days.  On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Mar-2021, the patient experienced COUGH (coughing), PYREXIA (fever of 101F), MYALGIA (muscle soreness) and ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (extreme pain in right arm and shoulder still persisting). On 31-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on right side of the body).   On 31-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on right side of the body). The patient visited the hospital, was admitted and sent home the same day with oral treatment for pain.  At the time of the report, COUGH (coughing), PYREXIA (fever of 101F), MYALGIA (muscle soreness), ARTHRALGIA (Joint pain), and HYPOAESTHESIA (numbness on right side of the body) outcome was unknown.  The event of PAIN IN EXTREMITY (extreme pain in right arm and shoulder still persisting) was ongoing at the time of the report.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the events, included paracetamol and provided gabapentin at the hospital   This case was linked to US-MODERNATX, INC.-MOD-2021-067218 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-067218:Crosslinked with dose 1
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Numbness on right side of the body; Coughing; Extreme pain in right arm and shoulder still persisting; Muscle soreness; Joint pain; fever of 101F; This spontaneous case was reported by a consumer and describes the occurrence of a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A. and 030L20A) for COVID-19 vaccination and experienced COUGH (coughing), PYREXIA (fever of 101F), MYALGIA (muscle soreness) and PAIN IN EXTREMITY (extreme pain in right arm and shoulder still persisting). On 31-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on right side of the body).    The patient's past medical history included No adverse event. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Cough.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient experienced extreme fatigue after receiving the first dose lasting for almost five days.  On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Mar-2021, the patient experienced COUGH (coughing), PYREXIA (fever of 101F), MYALGIA (muscle soreness) and ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (extreme pain in right arm and shoulder still persisting). On 31-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on right side of the body).   On 31-Mar-2021, the patient experienced HYPOAESTHESIA (numbness on right side of the body). The patient visited the hospital, was admitted and sent home the same day with oral treatment for pain.  At the time of the report, COUGH (coughing), PYREXIA (fever of 101F), MYALGIA (muscle soreness), ARTHRALGIA (Joint pain), and HYPOAESTHESIA (numbness on right side of the body) outcome was unknown.  The event of PAIN IN EXTREMITY (extreme pain in right arm and shoulder still persisting) was ongoing at the time of the report.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the events, included paracetamol and provided gabapentin at the hospital   This case was linked to US-MODERNATX, INC.-MOD-2021-067218 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-067218:Crosslinked with dose 1
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: redness at injection site; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA and VACCINATION SITE SWELLING in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, ZOLPIDEM, LORAZEPAM, TRAZODONE, PYRIDOSTIGMINE, LATUDA, DULOXETINE, LIOTHYRONINE, LEVOTHYROXINE, and FLUDROCORTISONE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA and VACCINATION SITE SWELLING. At the time of the report, VACCINATION SITE ERYTHEMA and VACCINATION SITE SWELLING outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was taken.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Malaise, Vaccination site erythema
Clinical narrative: Dizzy; Felt off; red, hot, itchy circle; red, hot, itchy circle; red, hot, itchy circle; slight headache; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red, hot, itchy circle), DIZZINESS (Dizzy), MALAISE (Felt off), VACCINATION SITE PRURITUS (red, hot, itchy circle) and VACCINATION SITE ERYTHEMA (red, hot, itchy circle) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (slight headache) and FATIGUE (felt tired). On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (red, hot, itchy circle), VACCINATION SITE PRURITUS (red, hot, itchy circle) and VACCINATION SITE ERYTHEMA (red, hot, itchy circle). On 04-Apr-2021, the patient experienced DIZZINESS (Dizzy) and MALAISE (Felt off). At the time of the report, VACCINATION SITE WARMTH (red, hot, itchy circle), MALAISE (Felt off), VACCINATION SITE PRURITUS (red, hot, itchy circle), VACCINATION SITE ERYTHEMA (red, hot, itchy circle), HEADACHE (slight headache) and FATIGUE (felt tired) outcome was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Dizzy; Felt off; red, hot, itchy circle; red, hot, itchy circle; red, hot, itchy circle; slight headache; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (red, hot, itchy circle), DIZZINESS (Dizzy), MALAISE (Felt off), VACCINATION SITE PRURITUS (red, hot, itchy circle) and VACCINATION SITE ERYTHEMA (red, hot, itchy circle) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (slight headache) and FATIGUE (felt tired). On 03-Apr-2021, the patient experienced VACCINATION SITE WARMTH (red, hot, itchy circle), VACCINATION SITE PRURITUS (red, hot, itchy circle) and VACCINATION SITE ERYTHEMA (red, hot, itchy circle). On 04-Apr-2021, the patient experienced DIZZINESS (Dizzy) and MALAISE (Felt off). At the time of the report, VACCINATION SITE WARMTH (red, hot, itchy circle), MALAISE (Felt off), VACCINATION SITE PRURITUS (red, hot, itchy circle), VACCINATION SITE ERYTHEMA (red, hot, itchy circle), HEADACHE (slight headache) and FATIGUE (felt tired) outcome was unknown.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 Vaccine) had resolved. Not Provided      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 product use was not provided by the reporter.  The patient did not experience any adverse event symptoms and no treatment was administered. This report refers to a case of product administered to patient of inappropriate age,  for mRNA-1273, lot: 016B21A,  with no associated adverse events.   This case was linked to US-MODERNATX, INC.-MOD-2021-067217, US-MODERNATX, INC.-MOD-2021-067645, US-MODERNATX, INC.-MOD-2021-067250, US-MODERNATX, INC.-MOD-2021-067547 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Patient was not Pregnant during vaccination, No adverse event deleted as relevant history.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age,  for mRNA-1273, lot: 016B21A,  with no associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Hypoacusis, Pain in extremity
Clinical narrative: Ear infection; She has trouble hearing in that ear; Her arm was hurting for a little bit on same day after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (Ear infection), PAIN IN EXTREMITY (Her arm was hurting for a little bit on same day after receiving 1st dose) and HYPOACUSIS (She has trouble hearing in that ear) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00782LA) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Glaucoma. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her arm was hurting for a little bit on same day after receiving 1st dose). On 26-Mar-2021, the patient experienced EAR INFECTION (Ear infection) and HYPOACUSIS (She has trouble hearing in that ear). At the time of the report, EAR INFECTION (Ear infection), PAIN IN EXTREMITY (Her arm was hurting for a little bit on same day after receiving 1st dose) and HYPOACUSIS (She has trouble hearing in that ear) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Antibiotic ear drops, steroid ear drops, amoxicillin day.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: longer than 42 days in between first and second doses of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (longer than 42 days in between first and second doses of Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (longer than 42 days in between first and second doses of Moderna Covid-19 vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (longer than 42 days in between first and second doses of Moderna Covid-19 vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This report refers to a case of product dose omission issue, for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments: This report refers to a case of product dose omission issue, for mRNA-1273, lot # unknown, with no associated AEs.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pain, Pyrexia
Clinical narrative: Coughing; Fever; Achy; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), PYREXIA (Fever) and PAIN (Achy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history ).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced COUGH (Coughing), PYREXIA (Fever) and PAIN (Achy). At the time of the report, COUGH (Coughing), PYREXIA (Fever) and PAIN (Achy) outcome was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea
Clinical narrative: Profuse diarrhea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Profuse diarrhea) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart failure. Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for Heart failure.    On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced DIARRHOEA (Profuse diarrhea) and CHILLS (Chills). At the time of the report, DIARRHOEA (Profuse diarrhea) and CHILLS (Chills) outcome was unknown.            No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold symptom; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptom) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included SOTALOL, HYDROCHLOROTHIAZIDE, Parvo statin, POTASSIUM, LEVOTHYROXINE, OMEPRAZOLE, AMLODIPINE and SULFANILAMIDE (VITAMINDERMINA) for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced NASOPHARYNGITIS (Cold symptom). At the time of the report, NASOPHARYNGITIS (Cold symptom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-067304, US-MODERNATX, INC.-MOD-2021-067247 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067304:Crosslinked (family member) US-MODERNATX, INC.-MOD-2021-067247:Crosslinked (family member)
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Headache; Fever; Body Aches; hot and cold; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), PAIN (Body Aches), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and NAUSEA (Nausea) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced HEADACHE (Headache), PYREXIA (Fever), PAIN (Body Aches), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), PYREXIA (Fever), PAIN (Body Aches), FEELING OF BODY TEMPERATURE CHANGE (hot and cold) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Headache, Heart rate increased, Palpitations, Urticaria
Clinical narrative: Hives on left leg on the third day after Moderna vaccine; Headaches; Felt burning in her chest area on the left side; Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Felt burning in her chest area on the left side), PALPITATIONS (Rapid heart beat), URTICARIA (Hives on left leg on the third day after Moderna vaccine) and HEADACHE (Headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced CHEST PAIN (Felt burning in her chest area on the left side), PALPITATIONS (Rapid heart beat) and HEADACHE (Headaches). On 03-Apr-2021, the patient experienced URTICARIA (Hives on left leg on the third day after Moderna vaccine). At the time of the report, CHEST PAIN (Felt burning in her chest area on the left side), PALPITATIONS (Rapid heart beat), URTICARIA (Hives on left leg on the third day after Moderna vaccine) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Heart rate increased: rapid (High) rapid heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Events Chest burning, Palpitation, Hives, Headache- outcome was updated from unknown to resolved.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Left arm very painful; Left arm swollen; Red rash at the injection site; Warm to the touch at injection site; Left arm terribly itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm very painful), VACCINATION SITE SWELLING (Left arm swollen), VACCINATION SITE RASH (Red rash at the injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and PRURITUS (Left arm terribly itchy) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included AMLODIPINE BESYLATE 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 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left arm very painful), VACCINATION SITE SWELLING (Left arm swollen), VACCINATION SITE RASH (Red rash at the injection site), VACCINATION SITE WARMTH (Warm to the touch at injection site) and PRURITUS (Left arm terribly itchy). On 04-Apr-2021, VACCINATION SITE PAIN (Left arm very painful), VACCINATION SITE SWELLING (Left arm swollen), VACCINATION SITE RASH (Red rash at the injection site) and PRURITUS (Left arm terribly itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site bruising
Clinical narrative: Bruise at injection site; Headache off and on; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruise at injection site), HEADACHE (Headache off and on) and FATIGUE (Fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included AMITRIPTYLINE, METOPROLOL and VITAMIN 15 for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Bruise at injection site), HEADACHE (Headache off and on) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Bruise at injection site), HEADACHE (Headache off and on) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Itchy; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced PRURITUS (Itchy). On 05-Apr-2021, PRURITUS (Itchy) had resolved.            This case was linked to US-MODERNATX, INC.-MOD-2021-067234 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067234:1st dose
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Arthralgia, Myalgia
Clinical narrative: Lack of taste; Muscle soreness; joint pains; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lack of taste), MYALGIA (Muscle soreness) and ARTHRALGIA (joint pains) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced AGEUSIA (Lack of taste), MYALGIA (Muscle soreness) and ARTHRALGIA (joint pains). At the time of the report, AGEUSIA (Lack of taste), MYALGIA (Muscle soreness) and ARTHRALGIA (joint pains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-067223 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067223:2nd dose
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (Very tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) 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 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Very tired). On 03-Apr-2021, HEADACHE (Headache) and FATIGUE (Very tired) had resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-067422 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067422:crosslink
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Secretion discharge
Clinical narrative: lost ability to smell but gaining her sense of smell back; mucus discharge; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost ability to smell but gaining her sense of smell back) and SECRETION DISCHARGE (mucus discharge) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure fluctuation, Rheumatoid arthritis, Allergy (Patient stated that she has some allergies(unspecified)), Coughing (during the week of her 2 vaccination (before she got the shot) she was experiencing occasional cough and congestion that she thinks were from her sinuses/allergies) since March 2021, Congestion nasal since March 2021 and Fever (When she got the second vaccination she told the nurse that she had a low grade fever.). Concomitant products included PAROXETINE, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SECRETION DISCHARGE (mucus discharge). On an unknown date, the patient experienced ANOSMIA (lost ability to smell but gaining her sense of smell back). At the time of the report, ANOSMIA (lost ability to smell but gaining her sense of smell back) was resolving and SECRETION DISCHARGE (mucus discharge) outcome was unknown.            Patients concomitant medications also include Blood pressure medications and Rheumatoid arthritis medications. No treatment medications were provided.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 RASH PRURITIC (itchy rash). The patient was treated with PREDNISONE for Itchy rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy rash, at an unspecified dose and frequency. On 01-Apr-2021, RASH PRURITIC (itchy rash) had resolved. Took treatment with Prednisone and Benadryl.          Patient reported that no reported events with second dose and she is doing fine. No concomitant medications reported by reporter. Action taken with mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow up was received Outcome of event after 1st dose changed to recovered/resolved. Dose 2 details were added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Chills, Diabetes mellitus, Fatigue, Feeling abnormal
Clinical narrative: migraine; she is still feeling sick; Sinus infection; she has diabetes and her blood sugar was over 300; canker sore; felt like she was going to die; nauseous; throwing up all night; fever; Chills; Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300) and APHTHOUS ULCER (canker sore) 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.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN GLARGINE (LANTUS) and INSULIN LISPRO (HUMALOG) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) and IRBESARTAN (AVAPRO) for an unknown indication.   On 01-Apr-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 01-Apr-2021, the patient experienced MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300), APHTHOUS ULCER (canker sore), FEELING ABNORMAL (felt like she was going to die), NAUSEA (nauseous), VOMITING (throwing up all night), PYREXIA (fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; AMOXICILLIN at an unspecified dose and frequency and CODEINE at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300), APHTHOUS ULCER (canker sore), FEELING ABNORMAL (felt like she was going to die), NAUSEA (nauseous), VOMITING (throwing up all night), PYREXIA (fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Treatment drug also included Compazine. She was given antibiotic and pain medication also.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Concomitant drugs were added. Treatment medications were added. New events canker sore, sinus infection, body aches, fatigue, blood sugar was over 300 and felt like she was going to die were added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Migraine, Myalgia, Nausea
Clinical narrative: migraine; she is still feeling sick; Sinus infection; she has diabetes and her blood sugar was over 300; canker sore; felt like she was going to die; nauseous; throwing up all night; fever; Chills; Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300) and APHTHOUS ULCER (canker sore) 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.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN GLARGINE (LANTUS) and INSULIN LISPRO (HUMALOG) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) and IRBESARTAN (AVAPRO) for an unknown indication.   On 01-Apr-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 01-Apr-2021, the patient experienced MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300), APHTHOUS ULCER (canker sore), FEELING ABNORMAL (felt like she was going to die), NAUSEA (nauseous), VOMITING (throwing up all night), PYREXIA (fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; AMOXICILLIN at an unspecified dose and frequency and CODEINE at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300), APHTHOUS ULCER (canker sore), FEELING ABNORMAL (felt like she was going to die), NAUSEA (nauseous), VOMITING (throwing up all night), PYREXIA (fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Treatment drug also included Compazine. She was given antibiotic and pain medication also.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Concomitant drugs were added. Treatment medications were added. New events canker sore, sinus infection, body aches, fatigue, blood sugar was over 300 and felt like she was going to die were added.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sinusitis, Vomiting
Clinical narrative: migraine; she is still feeling sick; Sinus infection; she has diabetes and her blood sugar was over 300; canker sore; felt like she was going to die; nauseous; throwing up all night; fever; Chills; Body aches; Headache; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300) and APHTHOUS ULCER (canker sore) 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.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN GLARGINE (LANTUS) and INSULIN LISPRO (HUMALOG) for Diabetes, LEVOTHYROXINE SODIUM (SYNTHROID) and IRBESARTAN (AVAPRO) for an unknown indication.   On 01-Apr-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 01-Apr-2021, the patient experienced MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300), APHTHOUS ULCER (canker sore), FEELING ABNORMAL (felt like she was going to die), NAUSEA (nauseous), VOMITING (throwing up all night), PYREXIA (fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; AMOXICILLIN at an unspecified dose and frequency and CODEINE at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), ILLNESS (she is still feeling sick), SINUSITIS (Sinus infection), DIABETES MELLITUS (she has diabetes and her blood sugar was over 300), APHTHOUS ULCER (canker sore), FEELING ABNORMAL (felt like she was going to die), NAUSEA (nauseous), VOMITING (throwing up all night), PYREXIA (fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Treatment drug also included Compazine. She was given antibiotic and pain medication also.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Concomitant drugs were added. Treatment medications were added. New events canker sore, sinus infection, body aches, fatigue, blood sugar was over 300 and felt like she was going to die were added.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Seventeen year old received vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received vaccine). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Seventeen year old received vaccine) had resolved. Not Provided      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 product use was provided. Treatment information was not available.; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot #: 016B21A , with no associated AEs. US-MODERNATX, INC.-MOD-2021-067250:Crosslinked cases US-MODERNATX, INC.-MOD-2021-067510:Cross link, same reporter US-MODERNATX, INC.-MOD-2021-067198:Crosslinked cases