chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Pain, Pyrexia
Clinical narrative: was cold in the morning; body ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (was cold in the morning), PAIN (body ache) and PYREXIA (fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (was cold in the morning), PAIN (body ache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING COLD (was cold in the morning), PAIN (body ache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Transfusion
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSFUSION (got a blood transfusion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSFUSION (got a blood transfusion). At the time of the report, TRANSFUSION (got a blood transfusion) outcome was unknown. 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 provided. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: 3 inches around the injection site is red, warm and hard; 3 inches around the injection site is red, warm and hard; 3 inches around the injection site is red, warm and hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (3 inches around the injection site is red, warm and hard), VACCINATION SITE WARMTH (3 inches around the injection site is red, warm and hard) and VACCINATION SITE INDURATION (3 inches around the injection site is red, warm and hard) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (3 inches around the injection site is red, warm and hard), VACCINATION SITE WARMTH (3 inches around the injection site is red, warm and hard) and VACCINATION SITE INDURATION (3 inches around the injection site is red, warm and hard). At the time of the report, VACCINATION SITE ERYTHEMA (3 inches around the injection site is red, warm and hard), VACCINATION SITE WARMTH (3 inches around the injection site is red, warm and hard) and VACCINATION SITE INDURATION (3 inches around the injection site is red, warm and hard) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment products included Advil
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Myalgia, Pain in extremity, Peripheral swelling, Vaccination site discolouration
Clinical narrative: Arm is swollen; Arm is hot; Arm is red; have a terrible pain; muscle pain in her shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Arm is hot), VACCINATION SITE DISCOLOURATION (Arm is red), PAIN IN EXTREMITY (have a terrible pain) and MYALGIA (muscle pain in her shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 045AUA) for COVID-19 vaccination.     Concomitant products included GLICLAZIDE (MICROZIDE [GLICLAZIDE]), LOSARTAN POTASSIUM (COZAAR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), VORTIOXETINE HYDROBROMIDE (TRINTELLIX), Colanapin and ALLOPURINOL (ELAVIL [ALLOPURINOL]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Arm is hot), VACCINATION SITE DISCOLOURATION (Arm is red), PAIN IN EXTREMITY (have a terrible pain) and MYALGIA (muscle pain in her shoulder). At the time of the report, PERIPHERAL SWELLING (Arm is swollen), FEELING HOT (Arm is hot), VACCINATION SITE DISCOLOURATION (Arm is red), PAIN IN EXTREMITY (have a terrible pain) and MYALGIA (muscle pain in her shoulder) outcome was unknown. Not Provided          Treatment details included Tylenol Extra strength.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Pharyngeal swelling
Clinical narrative: Felt throat swelling and tightness of chest; Felt throat swelling and tightness of chest; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Felt throat swelling and tightness of chest) and CHEST DISCOMFORT (Felt throat swelling and tightness of chest) in a 59-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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Felt throat swelling and tightness of chest). 24-Mar-2021, the patient experienced CHEST DISCOMFORT (Felt throat swelling and tightness of chest). On 24-Mar-2021, PHARYNGEAL SWELLING (Felt throat swelling and tightness of chest) and CHEST DISCOMFORT (Felt throat swelling and tightness of chest) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported. No treatment medication was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received an improperly stored dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Received an improperly stored dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received an improperly stored dose). At the time of the report, PRODUCT STORAGE ERROR (Received an improperly stored dose) had resolved.            The action taken with mRNA-1273(Moderna COVID-19 Vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity, Pyrexia, Rash
Clinical narrative: fatigue; elevated temperature; diarrhea; soreness in left arm; rash to left arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in left arm), RASH (rash to left arm), FATIGUE (fatigue) and PYREXIA (elevated temperature) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in left arm), RASH (rash to left arm) and PYREXIA (elevated temperature). On 17-Apr-2021, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) (oral) at an unspecified dose and frequency. On 17-Apr-2021, FATIGUE (fatigue) had resolved. At the time of the report, DIARRHOEA (diarrhea), PAIN IN EXTREMITY (soreness in left arm), RASH (rash to left arm) and PYREXIA (elevated temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Oedema peripheral
Clinical narrative: Right ankle started to swell,Still swelling, getting bigger, bigger as size of grape fruit; Joint pain in right clavicle; arm was sore at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of OEDEMA PERIPHERAL (Right ankle started to swell,Still swelling, getting bigger, bigger as size of grape fruit), ARTHRALGIA (Joint pain in right clavicle) and INJECTION SITE PAIN (arm was sore at injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     The patient's past medical history included Psoriasis and Hepatitis C.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced INJECTION SITE PAIN (arm was sore at injection site). On 18-Apr-2021, the patient experienced ARTHRALGIA (Joint pain in right clavicle). On 19-Apr-2021, the patient experienced OEDEMA PERIPHERAL (Right ankle started to swell,Still swelling, getting bigger, bigger as size of grape fruit). At the time of the report, OEDEMA PERIPHERAL (Right ankle started to swell,Still swelling, getting bigger, bigger as size of grape fruit), ARTHRALGIA (Joint pain in right clavicle) and INJECTION SITE PAIN (arm was sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment medication and concomitant medication provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: significant follow up-contact information updated
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed dose) 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.    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 PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown  This case is crosslinked with MOD21-078568
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Body rash that is coming and going; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Body rash that is coming and going) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Body rash that is coming and going). At the time of the report, RASH (Body rash that is coming and going) outcome was unknown. Not Provided          No concomitant medications reported. No treatment information reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Fever) 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 18-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). At the time of the report, CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No  concomitant medical  provided by the reporter. Treatment includes: paracetamol.   Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, HEADACHE and FATIGUE in a 26-year-old female patient 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) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 17-Apr-2021, the patient experienced ASTHENIA, HEADACHE and FATIGUE. The patient was treated with IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ASTHENIA, HEADACHE and FATIGUE outcome was unknown. Patient declares that she is not taking medication. Concomitant product use was not provided by the reporter.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Injection site pain, Malaise, Pharyngeal swelling, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PHARYNGEAL SWELLING (Felt like throat was going to swell), MALAISE (Felt sick), DYSPHONIA (Throat was a little hoarse), INJECTION SITE PAIN (Injection site pain) and VOMITING (Throwing up) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0s7b21a) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DYSPHONIA (Throat was a little hoarse). On 17-Apr-2021, the patient experienced INJECTION SITE PAIN (Injection site pain). On 18-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Felt like throat was going to swell), MALAISE (Felt sick) and VOMITING (Throwing up). On 18-Apr-2021, VOMITING (Throwing up) had resolved. At the time of the report, PHARYNGEAL SWELLING (Felt like throat was going to swell), MALAISE (Felt sick), DYSPHONIA (Throat was a little hoarse) and INJECTION SITE PAIN (Injection site pain) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient experienced a swollen throat after having 3 drinks in a 6 hour period. Her throat was a little hoarse on 16-Apr-2021, and patient almost went to emergency room (felt like throat was going to swell shut). The patient also experienced injection site pain which lasted 3 days. On 19-Apr-2021, the patient felt a lot better. The patient took ibuprofen and allegra treat the symptoms caused by covid vaccine. The concomitant medications were not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Myalgia, Product storage error
Clinical narrative: needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose; body aches; headache; lethargic; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PRODUCT STORAGE ERROR (needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose), MYALGIA (body aches) and HEADACHE (headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced LETHARGY (lethargic), MYALGIA (body aches) and HEADACHE (headache). On 19-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose). On 19-Apr-2021, PRODUCT STORAGE ERROR (needs to receive another dose of the vaccine due to temperature issue with the second dose or possibly expired dose) had resolved. At the time of the report, LETHARGY (lethargic), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.     No treatment information was provided. No relevant concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin discolouration, Vaccination site haematoma, Vaccination site mass
Clinical narrative: huge hematoma moved down in to the wrist; huge lump at patient's injection arm; arm was painful; arm became black in color; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMATOMA (huge hematoma moved down in to the wrist), VACCINATION SITE MASS (huge lump at patient's injection arm), PAIN IN EXTREMITY (arm was painful) and SKIN DISCOLORATION (arm became black in color) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure inadequately controlled. Concomitant products included METOPROLOL and LISINOPRIL for Blood pressure inadequately controlled, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BABY ASPIRIN), IRON, LEVOTHYROXINE, VITAMIN D3, FUROSEMIDE (LASIX [FUROSEMIDE]) and NAPROXEN for an unknown indication.    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 VACCINATION SITE HAEMATOMA (huge hematoma moved down in to the wrist), VACCINATION SITE MASS (huge lump at patient's injection arm), PAIN IN EXTREMITY (arm was painful) and SKIN DISCOLORATION (arm became black in color). At the time of the report, VACCINATION SITE HAEMATOMA (huge hematoma moved down in to the wrist), VACCINATION SITE MASS (huge lump at patient's injection arm), PAIN IN EXTREMITY (arm was painful) and SKIN DISCOLORATION (arm became black in color) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events included application of a cold compress over the hematoma. The patient contacted her physician on 05-Apr-2021 who advised the patient to apply cold compress over the hematoma.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Prenatal screening test, Ultrasound foetal
Clinical narrative: Caller is pregnant and received the 1st dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Caller is pregnant and received the 1st dose of the Moderna vaccine) in a 35-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 017c21a) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (3 drinks/week) from 01-Jan-2004 to 06-Apr-2021.   On 17-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Mar-2021 and the estimated date of delivery was 13-Dec-2021. On 17-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (Caller is pregnant and received the 1st dose of the Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Caller is pregnant and received the 1st dose of the Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Prenatal screening test: low risk (Inconclusive) LOW RISK and normal (Inconclusive) NORMAL. On 04-Jun-2021, Ultrasound foetal: normal (Inconclusive) NORMAL.         Patient had Prenatal Vitamin (Oral) 1/day from 01-APR-2020 (Still taking) as concomitant medication. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was Not Applicable       Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Added Lab information ,updated ethnic group, race and pregnancy information
Age: 79.0
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 a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LEVOTHYROXINE, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080504:Dose 2
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Dyspepsia, Fatigue
Clinical narrative: temperature of 102; elevated blood pressure; stomach burning; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure), DYSPEPSIA (stomach burning), MYALGIA (muscle aches), FATIGUE (fatigue) and PYREXIA (temperature of 102) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    Concurrent medical conditions included Hypertension and Endometrial cancer. Concomitant products included LISINOPRIL from 07-Apr-2021 to an unknown date for Hypertension.   On 03-Mar-2021, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 20 milligram once a day. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure), DYSPEPSIA (stomach burning), MYALGIA (muscle aches) and FATIGUE (fatigue). On 12-Apr-2021, the patient experienced PYREXIA (temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (temperature of 102) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure) had resolved and DYSPEPSIA (stomach burning), MYALGIA (muscle aches) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood pressure measurement: 120/89 (abnormal) 120/89. On 12-Apr-2021, Body temperature: 102 (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: temperature of 102; elevated blood pressure; stomach burning; muscle aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (elevated blood pressure), DYSPEPSIA (stomach burning), MYALGIA (muscle aches), FATIGUE (fatigue) and PYREXIA (temperature of 102) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    Concurrent medical conditions included Hypertension and Endometrial cancer. Concomitant products included LISINOPRIL from 07-Apr-2021 to an unknown date for Hypertension.   On 03-Mar-2021, the patient started LENVATINIB MESILATE (LENVIMA) (Oral) 20 milligram once a day. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (elevated blood pressure), DYSPEPSIA (stomach burning), MYALGIA (muscle aches) and FATIGUE (fatigue). On 12-Apr-2021, the patient experienced PYREXIA (temperature of 102). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 13-Apr-2021, PYREXIA (temperature of 102) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (elevated blood pressure) had resolved and DYSPEPSIA (stomach burning), MYALGIA (muscle aches) and FATIGUE (fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Blood pressure measurement: 120/89 (abnormal) 120/89. On 12-Apr-2021, Body temperature: 102 (High) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: BP 136/78 in the morning; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (BP 136/78 in the morning) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 15M20A and 040A219) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced HYPERTENSION (BP 136/78 in the morning). The patient was treated with AMLODIPINE for Hypertension, at a dose of 7.5 mg and BENAZEPRIL for Blood pressure high, at a dose of 20 mg. At the time of the report, HYPERTENSION (BP 136/78 in the morning) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Blood pressure measurement: 136/78 (High) Increased. On 16-Mar-2021, Blood pressure measurement: 144/? (Inconclusive) Inconclusive. On 18-Apr-2021, Blood pressure measurement: 145/85 (High) increased. On 19-Apr-2021, Blood pressure measurement: 123/77 Inconclusive and 128/69 Inconclusive.     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.   Patient reported that she was previously on 5mg strength amlodipine in first follow up.   This case was linked to MOD-2021-080512 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up (TCR) received on 18-May-2021 does not contain any new information. On 19-May-2021: Treatment medications for the event added. On 25-May-2021: Outcome of event changed to recovering/resolving.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: injection arm soreness; diarrhea; fever on and off; chills on and off; nausea; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (injection arm soreness), DIARRHOEA (diarrhea), PYREXIA (fever on and off), CHILLS (chills on and off) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical History was Provided by Reporter.  Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.    On 09-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 VACCINATION SITE PAIN (injection arm soreness), DIARRHOEA (diarrhea), PYREXIA (fever on and off), CHILLS (chills on and off) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection arm soreness), DIARRHOEA (diarrhea), PYREXIA (fever on and off), CHILLS (chills on and off) and NAUSEA (nausea) 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.   Concomitant medications were provided are High Blood pressure Medication, Coumadin, Medication for Acid Reflux. Treatment medications were provided are Tylenol and Imodium.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; weak cold; not getting the 2nd vaccine; Still not feeling well; shivering; fatigue; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), DYSPNOEA (shortness of breath ), FEELING COLD (weak cold) and PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder and Graves' disease. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and NIFEDIPINE 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 29-Mar-2021, the patient experienced ASTHENIA (weakness) and DIZZINESS (dizziness). On an unknown date, the patient experienced DYSPNOEA (shortness of breath ), FEELING COLD (weak cold), PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine), MALAISE (Still not feeling well), CHILLS (shivering) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness), DYSPNOEA (shortness of breath ), FEELING COLD (weak cold), PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine), MALAISE (Still not feeling well), CHILLS (shivering) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided/unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-080292 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: New AE's and other relevant history was added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080292:son case
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Malaise, Product dose omission issue
Clinical narrative: shortness of breath; weak cold; not getting the 2nd vaccine; Still not feeling well; shivering; fatigue; weakness; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness), DYSPNOEA (shortness of breath ), FEELING COLD (weak cold) and PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder and Graves' disease. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and NIFEDIPINE 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 29-Mar-2021, the patient experienced ASTHENIA (weakness) and DIZZINESS (dizziness). On an unknown date, the patient experienced DYSPNOEA (shortness of breath ), FEELING COLD (weak cold), PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine), MALAISE (Still not feeling well), CHILLS (shivering) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness), DYSPNOEA (shortness of breath ), FEELING COLD (weak cold), PRODUCT DOSE OMISSION ISSUE (not getting the 2nd vaccine), MALAISE (Still not feeling well), CHILLS (shivering) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided/unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-080292 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: New AE's and other relevant history was added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080292:son case
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Bedridden, Feeling cold, Somnolence
Clinical narrative: slept all day; no memory at all/He does not remember anything from the whole day/completely lost; Cold/spent the whole day in bed under the covers because he was cold; he does not remember getting up on Saturday until about 11:30pm at night; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (no memory at all/He does not remember anything from the whole day/completely lost), FEELING COLD (Cold/spent the whole day in bed under the covers because he was cold), BEDRIDDEN (he does not remember getting up on Saturday until about 11:30pm at night) and SOMNOLENCE (slept all day) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.). Concomitant products included METFORMIN, LEVOTHYROXINE, LOSARTAN and HYDROCHLOROTHIAZIDE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced AMNESIA (no memory at all/He does not remember anything from the whole day/completely lost), FEELING COLD (Cold/spent the whole day in bed under the covers because he was cold) and BEDRIDDEN (he does not remember getting up on Saturday until about 11:30pm at night). On an unknown date, the patient experienced SOMNOLENCE (slept all day). At the time of the report, AMNESIA (no memory at all/He does not remember anything from the whole day/completely lost), FEELING COLD (Cold/spent the whole day in bed under the covers because he was cold), BEDRIDDEN (he does not remember getting up on Saturday until about 11:30pm at night) and SOMNOLENCE (slept all day) outcome was unknown.            No treatment information was provided. Patient is overweight.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-080485 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-080485:Dose 1
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Intentional dose omission, SARS-CoV-2 test
Clinical narrative: Instructed not to get the second dose; COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) and INTENTIONAL DOSE OMISSION (Instructed not to get the second dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) 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 09-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Instructed not to get the second dose). At the time of the report, COVID-19 (COVID-19) outcome was unknown and INTENTIONAL DOSE OMISSION (Instructed not to get the second dose) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       Concomitant product use was not provided by the reporter. Treatment information included antibody treatment on 13 Apr 2021 due to which the patient was advised not to receive the second dose for 90 days from the treatment.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: chills; headache; extreme nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), NAUSEA (extreme nausea) and FATIGUE (fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced CHILLS (chills), HEADACHE (headache), NAUSEA (extreme nausea) and FATIGUE (fatigue). At the time of the report, CHILLS (chills), HEADACHE (headache), NAUSEA (extreme nausea) and FATIGUE (fatigue) had not resolved. Not Provided          No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass
Clinical narrative: Red knot at the site of injection; Red knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Red knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (Red knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection). At the time of the report, VACCINATION SITE MASS (Red knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pyrexia
Clinical narrative: blood pressure; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and BLOOD PRESSURE MEASUREMENT (blood pressure) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A219 and 15M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE for Blood pressure high.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced BLOOD PRESSURE MEASUREMENT (blood pressure). On 12-Mar-2021, PYREXIA (Fever) had resolved. At the time of the report, BLOOD PRESSURE MEASUREMENT (blood pressure) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 144/?, 140/? (High) 144/?, 140/?. On 18-Apr-2021, Blood pressure measurement: 145/85 (High) 145/85. On 19-Apr-2021, Blood pressure measurement: 123/77, 128/69 (High) 123/77, 128/69.         No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-080489 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added additional event; Sender's Comments:  MOD-2021-080489:Dose-1
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for Covid-19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 03-Apr-2021, the patient experienced COVID-19 (Positive for Covid-19). The patient was treated with Immunotherapy (MONOCLONAL ANTIBIOTICS) for COVID-19. At the time of the report, COVID-19 (Positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient received treatment on 05 Apr 2021.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Crying, Depressed mood, Heavy menstrual bleeding
Clinical narrative: period came on 2 weeks early and very heavy; period came on 2 weeks early and very heavy; patient is crying a lot; moody; anxious; nervous; sad; Pain; chills; low grade fever; muscle aches; nauseous; This spontaneous case was reported by a patient and describes the occurrence of MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody) and ANXIETY (anxious) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody), ANXIETY (anxious), NERVOUSNESS (nervous), DEPRESSED MOOD (sad), PAIN (Pain), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (muscle aches) and NAUSEA (nauseous). At the time of the report, MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody), ANXIETY (anxious), NERVOUSNESS (nervous), DEPRESSED MOOD (sad), PAIN (Pain), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (muscle aches) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mood altered, Myalgia, Nausea, Nervousness, Pain
Clinical narrative: period came on 2 weeks early and very heavy; period came on 2 weeks early and very heavy; patient is crying a lot; moody; anxious; nervous; sad; Pain; chills; low grade fever; muscle aches; nauseous; This spontaneous case was reported by a patient and describes the occurrence of MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody) and ANXIETY (anxious) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody), ANXIETY (anxious), NERVOUSNESS (nervous), DEPRESSED MOOD (sad), PAIN (Pain), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (muscle aches) and NAUSEA (nauseous). At the time of the report, MENORRHAGIA (period came on 2 weeks early and very heavy), POLYMENORRHOEA (period came on 2 weeks early and very heavy), CRYING (patient is crying a lot), MOOD ALTERED (moody), ANXIETY (anxious), NERVOUSNESS (nervous), DEPRESSED MOOD (sad), PAIN (Pain), CHILLS (chills), PYREXIA (low grade fever), MYALGIA (muscle aches) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment information were not provided.