chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, Tonsillar disorder, Vaccination site pain
Clinical narrative: Swollen fingers; Mild headache; Site of injection started itching; Feeling lethargic; Joint pain in hips; Joint pain in her neck; Joint pain in finger; Feeling run down; Coughing; Tonsil area was hard like a rock; Restlessness; sore arm; Hot episodes; Flush episodes; Wakes up in the pool of sweat; Internally she is on fire; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (Restlessness), TONSILLAR DISORDER (Tonsil area was hard like a rock), LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips) and ARTHRALGIA (Joint pain in her neck) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 RESTLESSNESS (Restlessness), FEELING HOT (Hot episodes), FLUSHING (Flush episodes), HYPERHIDROSIS (Wakes up in the pool of sweat), FEELING HOT (Internally she is on fire) and VACCINATION SITE PAIN (sore arm). On 27-Mar-2021, the patient experienced TONSILLAR DISORDER (Tonsil area was hard like a rock). On 28-Mar-2021, the patient experienced FEELING ABNORMAL (Feeling run down) and COUGH (Coughing). On 01-Apr-2021, the patient experienced LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips), ARTHRALGIA (Joint pain in her neck), ARTHRALGIA (Joint pain in finger) and INJECTION SITE PRURITUS (Site of injection started itching). On 03-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen fingers) and HEADACHE (Mild headache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, RESTLESSNESS (Restlessness) and VACCINATION SITE PAIN (sore arm) had resolved and TONSILLAR DISORDER (Tonsil area was hard like a rock), LETHARGY (Feeling lethargic), ARTHRALGIA (Joint pain in hips), ARTHRALGIA (Joint pain in her neck), ARTHRALGIA (Joint pain in finger), PERIPHERAL SWELLING (Swollen fingers), FEELING HOT (Hot episodes), FLUSHING (Flush episodes), HYPERHIDROSIS (Wakes up in the pool of sweat), FEELING HOT (Internally she is on fire), FEELING ABNORMAL (Feeling run down), COUGH (Coughing), INJECTION SITE PRURITUS (Site of injection started itching) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included paracetamol and unspecified cough medicine.  Concomitant medications details were not reported by the reporter. The patient reported taking an antihistamine for her seasonal allergies as well.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Myalgia, Pain in extremity
Clinical narrative: Pain in arms; Feling sick; Chills; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arms), MALAISE (Feling sick), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history 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 PAIN IN EXTREMITY (Pain in arms), MALAISE (Feling sick), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, Myalgia and Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arms), MALAISE (Feling sick), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown.            The patient reports that he had taken concomitant medication but no further information was provided. Action taken was not applicable as the patient has taken both the doses of vaccine.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 041B21A) for COVID-19 vaccination.  The patient's past medical history included Sepsis (sepsis following birth for mother) on 04-Sep-2019 and Alcohol use (one mixed drink/month) on 28-Feb-2021. Concurrent medical conditions included Food allergy (nuts, some fruits and vegetables), Allergy to animal, Allergy (nature), Asthma and Drug allergy. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Mar-2021 and the estimated date of delivery was 06-Dec-2021. On 27-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 27-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Pregnancy test: positive (Positive) Positive.         No treatment information provided by Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Internal review on 28 JUL 2021, resulted in the update of pregnancy details(birth type, fetal outcome, LMP, para and dravida) , pregnancy test, history(alcohol use), route of administration of concomitant medications.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this30-year-old female. The event of exposure during pregnancy remains as not applicable
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: Product Temperature frozen 47 minutes -13.79 degree C and refrigerator 59 minutes 12degree C; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product Temperature frozen 47 minutes -13.79 degree C and refrigerator 59 minutes 12degree C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product Temperature frozen 47 minutes -13.79 degree C and refrigerator 59 minutes 12degree C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product Temperature frozen 47 minutes -13.79 degree C and refrigerator 59 minutes 12degree C) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter Treatment details was not reported by the reporter.   This case was linked to MOD21-068707, MOD21-068705, MOD21-068620, MOD21-068645, MOD21-068696 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Malaise
Clinical narrative: dizziness; feeling unwell; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), MALAISE (feeling unwell), CHILLS (chills) and HEADACHE (headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prostatic disorder NOS. Concomitant products included METFORMIN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), MALAISE (feeling unwell), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), MALAISE (feeling unwell), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included unspecified medication for prostatic disease. Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) 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 information were not provided  Treatment medication information were not reported
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: Sore Arm; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication information provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Little bit soreness after the first dose at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 045A21A) 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 01-Mar-2021, the patient experienced VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE PAIN outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.    Relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash around the injection site, it is mildly itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash around the injection site, it is mildly itchy) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced RASH PRURITIC (rash around the injection site, it is mildly itchy). At the time of the report, RASH PRURITIC (rash around the injection site, it is mildly itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by patient  Treatment information was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Pyrexia, Vaccination site pain, Vaccination site swelling, Vomiting
Clinical narrative: Feels like her guts are going to fall out; Vomiting; Feverish; Injection site is the left arm which is swollen; Hurts until today but not as bad as when she got it; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (Feels like her guts are going to fall out), VOMITING (Vomiting), PYREXIA (Feverish), VACCINATION SITE SWELLING (Injection site is the left arm which is swollen) and VACCINATION SITE PAIN (Hurts until today but not as bad as when she got it) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Cough and Stomach virus.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection site is the left arm which is swollen) and VACCINATION SITE PAIN (Hurts until today but not as bad as when she got it). On 02-Apr-2021, the patient experienced GASTROINTESTINAL DISORDER (Feels like her guts are going to fall out), VOMITING (Vomiting) and PYREXIA (Feverish). In April 2021, GASTROINTESTINAL DISORDER (Feels like her guts are going to fall out), VOMITING (Vomiting), PYREXIA (Feverish), VACCINATION SITE SWELLING (Injection site is the left arm which is swollen) and VACCINATION SITE PAIN (Hurts until today but not as bad as when she got it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  The patent's second dose was due on 27-Apr-2021.  On 29-Jun-2021, the patient reported that her symptoms lasted 3 weeks and then went away. She felt better and it was all taken care of.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up report received included non-significant information. On 29-Jun-2021: Significant follow up report received included information about the events. Outcome and stop date for the events were updated to recovered/resolved.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: popped up welt; tender to touch; itchy; sore arm; redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (popped up welt), VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (tender to touch) and VACCINATION SITE PRURITUS (itchy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concomitant products included SERTRALINE, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and VITAMIN D [VITAMIN D NOS] 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 VACCINATION SITE PAIN (sore arm) and VACCINATION SITE ERYTHEMA (redness). On 02-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (popped up welt), VACCINATION SITE PAIN (tender to touch) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE URTICARIA (popped up welt), VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (redness), VACCINATION SITE PAIN (tender to touch) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: began having very bad diarrhea; feels pressure in her stomach; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (began having very bad diarrhea), ABDOMINAL DISCOMFORT (feels pressure in her stomach) and NAUSEA (nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LISINOPRIL, IBUPROFEN and HYDROCHLOROTHIAZIDE for an unknown indication.    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 DIARRHOEA (began having very bad diarrhea), ABDOMINAL DISCOMFORT (feels pressure in her stomach) and NAUSEA (nausea). At the time of the report, DIARRHOEA (began having very bad diarrhea), ABDOMINAL DISCOMFORT (feels pressure in her stomach) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; 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. Further information has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: hot to the touch; Arm is red at the injection site; sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE ERYTHEMA (Arm is red at the injection site) and VACCINATION SITE PAIN (sore) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE ERYTHEMA (Arm is red at the injection site) and VACCINATION SITE PAIN (sore). At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE ERYTHEMA (Arm is red at the injection site) and VACCINATION SITE PAIN (sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter.treatment details not included.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Irregular vaginal bleeding; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Irregular vaginal bleeding) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) 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 VAGINAL HAEMORRHAGE (Irregular vaginal bleeding). At the time of the report, VAGINAL HAEMORRHAGE (Irregular vaginal bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Peripheral swelling, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: elliptical eight inch area reaching from the elbow to the shoulder/ area is increasing in redness, still warm to touch, with slight swelling; Three and one-half inch diameter circular area around elbow that was slightly swollen; Warm to the touch; Red; Hurting; This spontaneous case was reported by a non-health professional and describes the occurrence of CONDITION AGGRAVATED (elliptical eight inch area reaching from the elbow to the shoulder/ area is increasing in redness, still warm to touch, with slight swelling), PERIPHERAL SWELLING (Three and one-half inch diameter circular area around elbow that was slightly swollen), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Hurting) and VACCINATION SITE ERYTHEMA (Red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Hurting). On 29-Mar-2021, the patient experienced PERIPHERAL SWELLING (Three and one-half inch diameter circular area around elbow that was slightly swollen), VACCINATION SITE WARMTH (Warm to the touch) and VACCINATION SITE ERYTHEMA (Red). On 02-Apr-2021, the patient experienced CONDITION AGGRAVATED (elliptical eight inch area reaching from the elbow to the shoulder/ area is increasing in redness, still warm to touch, with slight swelling). At the time of the report, CONDITION AGGRAVATED (elliptical eight inch area reaching from the elbow to the shoulder/ area is increasing in redness, still warm to touch, with slight swelling), PERIPHERAL SWELLING (Three and one-half inch diameter circular area around elbow that was slightly swollen), VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE PAIN (Hurting) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included ice pack. Action taken with mRNA-1273 in response to the events was not applicable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypersensitivity, Lymphadenopathy, Pruritus, Rash
Clinical narrative: rash all over her body, itchiness and weakness for past 5 days; rash all over her body, itchiness and weakness for past 5 days; rash all over her body, itchiness and weakness for past 5 days; was rash and now it spread all over the body; started on 22Mar2021 as mild rash (delayed allergic reaction) on the arm and chest that was hot/swelling is down but rash is still persistent that looks like a allergic reaction; swelling under the armpits where lymph nodes are and stated that the underlying tissues was kind; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (rash all over her body, itchiness and weakness for past 5 days), ASTHENIA (rash all over her body, itchiness and weakness for past 5 days), RASH (rash all over her body, itchiness and weakness for past 5 days), RASH (was rash and now it spread all over the body) and HYPERSENSITIVITY (started on 22Mar2021 as mild rash (delayed allergic reaction) on the arm and chest that was hot/swelling is down but rash is still persistent that looks like a allergic reaction) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced RASH (was rash and now it spread all over the body), HYPERSENSITIVITY (started on 22Mar2021 as mild rash (delayed allergic reaction) on the arm and chest that was hot/swelling is down but rash is still persistent that looks like a allergic reaction) and LYMPHADENOPATHY (swelling under the armpits where lymph nodes are and stated that the underlying tissues was kind). On 28-Mar-2021, the patient experienced PRURITUS (rash all over her body, itchiness and weakness for past 5 days), ASTHENIA (rash all over her body, itchiness and weakness for past 5 days) and RASH (rash all over her body, itchiness and weakness for past 5 days). At the time of the report, PRURITUS (rash all over her body, itchiness and weakness for past 5 days), ASTHENIA (rash all over her body, itchiness and weakness for past 5 days), RASH (rash all over her body, itchiness and weakness for past 5 days), RASH (was rash and now it spread all over the body), HYPERSENSITIVITY (started on 22Mar2021 as mild rash (delayed allergic reaction) on the arm and chest that was hot/swelling is down but rash is still persistent that looks like a allergic reaction) and LYMPHADENOPATHY (swelling under the armpits where lymph nodes are and stated that the underlying tissues was kind) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment details were given.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid Positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid Positive) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension since 1995.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced COVID-19 (Covid Positive). The patient was treated with MONOCLONAL ANTIBODY 17-1A (intravenous) 28-Jan-2021 for SARS-CoV-2 infection, at a dose of 1 dosage form. At the time of the report, COVID-19 (Covid Positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) RT-PCR positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment reported   This case was linked to MOD-2021-063975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2021: Follow-up information received on 27-JUN-2021, it had Historical condition, treatment date,COVID-19 symptoms experienced by the patient were updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vaccine given to patients without reaching room temperature; vaccine given to patients without reaching room temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given to patients without reaching room temperature) and PRODUCT STORAGE ERROR (vaccine given to patients without reaching room temperature) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given to patients without reaching room temperature). On 31-Mar-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine given to patients without reaching room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given to patients without reaching room temperature) and PRODUCT STORAGE ERROR (vaccine given to patients without reaching room temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.      Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Limb discomfort
Clinical narrative: very red arm, redness getting progressively worse; cannot life arm, not even one inch; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (very red arm, redness getting progressively worse) and LIMB DISCOMFORT (cannot life arm, not even one inch) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ERYTHEMA (very red arm, redness getting progressively worse) and LIMB DISCOMFORT (cannot life arm, not even one inch). At the time of the report, ERYTHEMA (very red arm, redness getting progressively worse) and LIMB DISCOMFORT (cannot life arm, not even one inch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain
Clinical narrative: little pain at the injection site of her left arm; Redness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Apr-2021 and was forwarded to Moderna on 02-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little pain at the injection site of her left arm) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 019B21A) 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (little pain at the injection site of her left arm) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PAIN (little pain at the injection site of her left arm) outcome was unknown and INJECTION SITE ERYTHEMA (Redness at the injection site) had resolved.            Treatment and concomitant medicines were not included  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.    This case was linked to MOD-2021-070527 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant was provided. Patient treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.  The patient was not clear if the injection site pain happened with Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: No new information
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: After getting the 2nd shot everything went haywire; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (After getting the 2nd shot everything went haywire) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced ADVERSE EVENT (After getting the 2nd shot everything went haywire). At the time of the report, ADVERSE EVENT (After getting the 2nd shot everything went haywire) outcome was unknown.            relevant concomitant products usage were not reported by the reporter.treatment details not included.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included CEFOPERAZONE SODIUM (BACTIMED [CEFOPERAZONE SODIUM]) for an unknown indication.    On 08-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 URINARY TRACT INFECTION (UTI). At the time of the report, URINARY TRACT INFECTION (UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after temperature excursion; Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   02Apr2021 that they had power outage on 02Apr2021 and vials were in Freezer and Refrigerator where Temperature dropped to Frozen Vaccine 47Minutes -13.79 C and Refrigerator 59 Minutes 12 C were noted. No concomitant information were provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after temperature excursion) and PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Illness, Pain in extremity, Sciatica
Clinical narrative: Uncomfortable feeling up and down the left lower leg; Moderate pain in the left lower calf muscle; "its like a Sciatica pain"; Skin over the calf muscle was warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Uncomfortable feeling up and down the left lower leg), PAIN IN EXTREMITY (Moderate pain in the left lower calf muscle), SCIATICA ("its like a Sciatica pain") and FEELING HOT (Skin over the calf muscle was warm to touch) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-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 ILLNESS (Uncomfortable feeling up and down the left lower leg), PAIN IN EXTREMITY (Moderate pain in the left lower calf muscle), SCIATICA ("its like a Sciatica pain") and FEELING HOT (Skin over the calf muscle was warm to touch). At the time of the report, ILLNESS (Uncomfortable feeling up and down the left lower leg), PAIN IN EXTREMITY (Moderate pain in the left lower calf muscle) and SCIATICA ("its like a Sciatica pain") outcome was unknown and FEELING HOT (Skin over the calf muscle was warm to touch) had resolved.            concomitant medication included 3 Hypertension Medications and Statins. Treatment information included took one pill of Aleve.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Injection site pain, Rash
Clinical narrative: Soreness has moved from right arm to the to right side of the back; Soreness has moved from right arm to the to right side of the breast/Front side of the breast aches; Rash on the right side of the back/Rash on the right side of the breast; Soreness in right arm at the injection site after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness in right arm at the injection site after the second dose), BACK PAIN (Soreness has moved from right arm to the to right side of the back), BREAST PAIN (Soreness has moved from right arm to the to right side of the breast/Front side of the breast aches) and RASH (Rash on the right side of the back/Rash on the right side of the breast) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced INJECTION SITE PAIN (Soreness in right arm at the injection site after the second dose). On 31-Mar-2021, the patient experienced BACK PAIN (Soreness has moved from right arm to the to right side of the back), BREAST PAIN (Soreness has moved from right arm to the to right side of the breast/Front side of the breast aches) and RASH (Rash on the right side of the back/Rash on the right side of the breast). At the time of the report, INJECTION SITE PAIN (Soreness in right arm at the injection site after the second dose), BACK PAIN (Soreness has moved from right arm to the to right side of the back), BREAST PAIN (Soreness has moved from right arm to the to right side of the breast/Front side of the breast aches) and RASH (Rash on the right side of the back/Rash on the right side of the breast) outcome was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; vomiting; Tired; Headache; Doesnt have an appetite; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE, CHILLS, FATIGUE, PYREXIA, and VOMITING in a 65-year-old male 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.     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 04-Mar-2021, the patient experienced CHILLS and FATIGUE. On 01-Apr-2021, the patient experienced DECREASED APPETITE, PYREXIA, VOMITING, FATIGUE, and HEADACHE. On 05-Mar-2021, CHILLS and FATIGUE had resolved. At the time of the report, DECREASED APPETITE, PYREXIA, VOMITING, FATIGUE, and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, FATIGUE, PYREXIA, VOMITING, and FATIGUE in a 65-year-old male 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.     The patient's past medical history included No adverse event.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS and FATIGUE. On 01-Apr-2021, the patient experienced PYREXIA, VOMITING, FATIGUE, DECREASED APPETITE, and HEADACHE. On 05-Mar-2021, CHILLS and FATIGUE had resolved. At the time of the report, PYREXIA, VOMITING, FATIGUE, DECREASED APPETITE, and HEADACHE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.