chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Joint swelling, Pruritus, Vaccination complication
Clinical narrative: covid arm was just starting to appear; induration; itching left hip / local itching; swelling left hip; redness left hip / local redness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching left hip / local itching), JOINT SWELLING (swelling left hip), ERYTHEMA (redness left hip / local redness), VACCINATION COMPLICATION (covid arm was just starting to appear) and INDURATION (induration) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L21A) for COVID-19 vaccination.     no medical history provided.  Concurrent medical conditions included Breast cancer since January 2008, Breast cancer in December 1995, Graves' disease since January 2004 and Insect bite allergy (20 cm of induration, urticari) since 07-Jun-2014. Concomitant products included ANASTROZOLE (ARIMIDEX) from 01-Jan-2009 to an unknown date for Breast cancer, LEVOTHYROXINE from 01-Jun-2005 to an unknown date for Graves' disease.    On 19-Jan-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PRURITUS (itching left hip / local itching), JOINT SWELLING (swelling left hip) and ERYTHEMA (redness left hip / local redness). On 28-Jan-2021, the patient experienced INDURATION (induration). On an unknown date, the patient experienced VACCINATION COMPLICATION (covid arm was just starting to appear). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Induration, at a dose of 1 dosage form and PREDNISONE for Induration, at a dose of 1 dosage form. On 03-Feb-2021, INDURATION (induration) had resolved. At the time of the report, PRURITUS (itching left hip / local itching), JOINT SWELLING (swelling left hip), ERYTHEMA (redness left hip / local redness) and VACCINATION COMPLICATION (covid arm was just starting to appear) 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.   Treatment medication antihistamines dose 25mg given per oral noted.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant FU : patient medical history provided On 19-Jul-2021: Follow-up information received on 19 Jul 2021 contains significant information. added medical history insect bite, added vaccine facility information, added treatment medications prednisone and Benadryl added, added events vaccination adverse reaction and induration.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Muscle aches; Headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Headache) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. frstct/ft) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 01-May-1999 and Postmenopause since 04-Jan-2018. Concomitant products included ESTRADIOL (ESTROGEN) from 25-Nov-2020 to an unknown date and PROGESTERONE from 25-Nov-2020 to an unknown date for Menopause, LEVOTHYROXINE SODIUM (SYNTHROID) from 15-Jan-1999 to an unknown date for Thyroiditis NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 01-Feb-2021 to an unknown date for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-007722 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; Chills; Muscle aches; Headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Headache) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. frstct/ft) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 01-May-1999 and Postmenopause since 04-Jan-2018. Concomitant products included ESTRADIOL (ESTROGEN) from 25-Nov-2020 to an unknown date and PROGESTERONE from 25-Nov-2020 to an unknown date for Menopause, LEVOTHYROXINE SODIUM (SYNTHROID) from 15-Jan-1999 to an unknown date for Thyroiditis NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 01-Feb-2021 to an unknown date for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle aches), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-007722 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Slight fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Slight fever). At the time of the report, CHILLS (Chills) and PYREXIA (Slight fever) had resolved. Not Provided          Treatment included Tylenol   This case was linked to MOD-2021-028937 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site discomfort, Pyrexia
Clinical narrative: Shivering like crazy; Fatigued; Sore arm at the injection site; Fever; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE DISCOMFORT (Sore arm at the injection site), PYREXIA (Fever), CHILLS (Shivering like crazy) and FATIGUE (Fatigued) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anemia on 12-Oct-1958, Palpitations (cardiac palpitations) on 06-Feb-1970 and Dry eyes on 14-Aug-2018. Concurrent medical conditions included Drug allergy (allergic to sulfa). Concomitant products included ESTRADIOL (ESTROGEN) from 01-Jul-2015 to an unknown date, PROGESTERONE and TESTOSTERONE from 01-Jul-2015 to an unknown date for Menopause, MULTIVITAMINS [VITAMINS NOS] and FISH OIL for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE DISCOMFORT (Sore arm at the injection site) and PYREXIA (Fever). On an unknown date, the patient experienced CHILLS (Shivering like crazy) and FATIGUE (Fatigued). At the time of the report, INJECTION SITE DISCOMFORT (Sore arm at the injection site) outcome was unknown and PYREXIA (Fever), CHILLS (Shivering like crazy) and FATIGUE (Fatigued) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-008207 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: More tired than normal; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (More tired than normal) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced FATIGUE (More tired than normal). At the time of the report, FATIGUE (More tired than normal) outcome was unknown.            Treatment medications were not reported by the reporter. No concomitant medications were provided by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Muscle swelling, Palpitations
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and MUSCLE SWELLING (Intercostal swelling of muscle) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Heart palpitations) and MUSCLE SWELLING (Intercostal swelling of muscle). At the time of the report, PALPITATIONS (Heart palpitations) and MUSCLE SWELLING (Intercostal swelling of muscle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.    This case was linked to MOD21-081296, MOD21-081413 (E2B Linked Report).; Sender's Comments:  MOD21-081296: MOD21-081413:
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose not received after 28 Days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not received after 28 Days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose not received after 28 Days). On 23-Apr-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose not received after 28 Days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment information not provided.     Reporter did not allow further contact
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose of Moderna covid vaccine on 4/14/21, patient was given another dose of Moderna vaccine on 4/21/21; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna covid vaccine on 4/14/21, patient was given another dose of Moderna vaccine on 4/21/21) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021 at 8:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 12:01 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna covid vaccine on 4/14/21, patient was given another dose of Moderna vaccine on 4/21/21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna covid vaccine on 4/14/21, patient was given another dose of Moderna vaccine on 4/21/21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. It was reported that no immediate side effect was noted  but the patient will be checked again. The healthcare professional has plan of giving the patient his second real dose on 14 May 2021.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26 May 2021 contains no new information.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 99.9 f 99.9 F.         No concomitant medicines were reported. No treatment information were reported. Action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-021037 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-090097 (Patient Link).   Reporter did not allow further contact
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site hot; injection site itchy; injection site turned red; arm hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE ERYTHEMA (injection site turned red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No relevant medical history provided.     On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt). On 19-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE ERYTHEMA (injection site turned red). On 19-Apr-2021, PAIN IN EXTREMITY (arm hurt) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy) and VACCINATION SITE ERYTHEMA (injection site turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received vaccination at Vaccination place.  Treatment information was not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Flatulence
Clinical narrative: Whole left side of arm was swollen; Felt so cold; Feeling gassy; She could not open her hand or grab something; Fever; Fatigue; Chills; Headache; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Whole left side of arm was swollen), FEELING COLD (Felt so cold), FLATULENCE (Feeling gassy), MUSCULAR WEAKNESS (She could not open her hand or grab something) and PYREXIA (Fever) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (Whole left side of arm was swollen), FEELING COLD (Felt so cold), FLATULENCE (Feeling gassy), MUSCULAR WEAKNESS (She could not open her hand or grab something), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). On 26-Apr-2021, PERIPHERAL SWELLING (Whole left side of arm was swollen), FEELING COLD (Felt so cold), FLATULENCE (Feeling gassy), MUSCULAR WEAKNESS (She could not open her hand or grab something), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscular weakness, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Whole left side of arm was swollen; Felt so cold; Feeling gassy; She could not open her hand or grab something; Fever; Fatigue; Chills; Headache; Joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Whole left side of arm was swollen), FEELING COLD (Felt so cold), FLATULENCE (Feeling gassy), MUSCULAR WEAKNESS (She could not open her hand or grab something) and PYREXIA (Fever) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (Whole left side of arm was swollen), FEELING COLD (Felt so cold), FLATULENCE (Feeling gassy), MUSCULAR WEAKNESS (She could not open her hand or grab something), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). On 26-Apr-2021, PERIPHERAL SWELLING (Whole left side of arm was swollen), FEELING COLD (Felt so cold), FLATULENCE (Feeling gassy), MUSCULAR WEAKNESS (She could not open her hand or grab something), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: sore throat; terrible colds; cough; runny nose, A week after I got the vaccine, I got a mild cold; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), NASOPHARYNGITIS (terrible colds), COUGH (cough) and RHINORRHOEA (runny nose, A week after I got the vaccine, I got a mild cold) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included Schizophrenia.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), NASOPHARYNGITIS (terrible colds), COUGH (cough) and RHINORRHOEA (runny nose, A week after I got the vaccine, I got a mild cold). At the time of the report, OROPHARYNGEAL PAIN (sore throat), NASOPHARYNGITIS (terrible colds), COUGH (cough) and RHINORRHOEA (runny nose, A week after I got the vaccine, I got a mild cold) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received and contain No New Information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Muscle twitching, Vaccination site pain
Clinical narrative: Got red rash on my arm; Lightheaded, but I'm always lightheaded; my right eye & face twitching has increased & gotten worse; I had fatigue; Joint pain; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded, but I'm always lightheaded), MUSCLE TWITCHING (my right eye & face twitching has increased & gotten worse), FATIGUE (I had fatigue), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (My arm was sore at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Lightheaded, but I'm always lightheaded), MUSCLE TWITCHING (my right eye & face twitching has increased & gotten worse), FATIGUE (I had fatigue), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (My arm was sore at the injection site). On 18-Apr-2021, the patient experienced VACCINATION SITE RASH (Got red rash on my arm). At the time of the report, DIZZINESS (Lightheaded, but I'm always lightheaded), MUSCLE TWITCHING (my right eye & face twitching has increased & gotten worse), FATIGUE (I had fatigue), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (My arm was sore at the injection site) and VACCINATION SITE RASH (Got red rash on my arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was provided as chemo & Radiation.    Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Got red rash on my arm; Lightheaded, but I'm always lightheaded; my right eye & face twitching has increased & gotten worse; I had fatigue; Joint pain; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded, but I'm always lightheaded), MUSCLE TWITCHING (my right eye & face twitching has increased & gotten worse), FATIGUE (I had fatigue), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (My arm was sore at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Lightheaded, but I'm always lightheaded), MUSCLE TWITCHING (my right eye & face twitching has increased & gotten worse), FATIGUE (I had fatigue), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (My arm was sore at the injection site). On 18-Apr-2021, the patient experienced VACCINATION SITE RASH (Got red rash on my arm). At the time of the report, DIZZINESS (Lightheaded, but I'm always lightheaded), MUSCLE TWITCHING (my right eye & face twitching has increased & gotten worse), FATIGUE (I had fatigue), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (My arm was sore at the injection site) and VACCINATION SITE RASH (Got red rash on my arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was provided as chemo & Radiation.    Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Lymphadenopathy
Clinical narrative: Vaccine lowered immune system resulted in shingles; Developed small blisters on cheek, itching me; Feel swollen glands on the left side of the same arm of the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Vaccine lowered immune system resulted in shingles), BLISTER (Developed small blisters on cheek, itching me) and LYMPHADENOPATHY (Feel swollen glands on the left side of the same arm of the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced HERPES ZOSTER (Vaccine lowered immune system resulted in shingles), BLISTER (Developed small blisters on cheek, itching me) and LYMPHADENOPATHY (Feel swollen glands on the left side of the same arm of the injection site). At the time of the report, HERPES ZOSTER (Vaccine lowered immune system resulted in shingles), BLISTER (Developed small blisters on cheek, itching me) and LYMPHADENOPATHY (Feel swollen glands on the left side of the same arm of the injection site) 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.   The patient mentioned they were on a lot of other medications as well.  Treatment medication included Valtrex prescribed by Nurse Practitioner.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Underage patient receiving vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient receiving vaccine) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient receiving vaccine). On 25-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underage patient receiving vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment information was not provided.  Upon in internal review on 18 May 2021, the age was corrected to 14 years.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Dizziness / Light headedness; Soreness at injection site; Itchy at injection site; Hardness at injection site / Thickness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness / Light headedness), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE INDURATION (Hardness at injection site / Thickness at injection site) in a 68-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 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced DIZZINESS (Dizziness / Light headedness), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE INDURATION (Hardness at injection site / Thickness at injection site). At the time of the report, DIZZINESS (Dizziness / Light headedness), VACCINATION SITE PAIN (Soreness at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE INDURATION (Hardness at injection site / Thickness at injection site) outcome was unknown.            No concomitant medications were reported. Treatment details included Ice.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Irritability, Pain in extremity
Clinical narrative: severe pain in her upper back; moving around made her cranky/moving around made her nasty; pain down her left arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (severe pain in her upper back), PAIN IN EXTREMITY (pain down her left arm) and IRRITABILITY (moving around made her cranky/moving around made her nasty) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain down her left arm). On 04-Apr-2021, the patient experienced BACK PAIN (severe pain in her upper back). In April 2021, the patient experienced IRRITABILITY (moving around made her cranky/moving around made her nasty). The patient was treated with MENTHOL (BIOFREEZE PAIN RELIEVING) ongoing since an unknown date at an unspecified dose and frequency. In March 2021, PAIN IN EXTREMITY (pain down her left arm) had resolved. In April 2021, BACK PAIN (severe pain in her upper back) and IRRITABILITY (moving around made her cranky/moving around made her nasty) had resolved. Not Provided    no concomitant medications were reported.  Treatent details reported as Biofreeze, hot and cold packs, laid in bed.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Eye swelling, Hypoaesthesia, Nausea
Clinical narrative: Left upper eye lied became swollen; Cannot take second dose; Tingling; Extreme nausea; Dizziness; Pins and needles all over the body; Numbing; Metal taste in mouth; Hurt a little at the site of the vaccine; Bump on the arm turned into a red patch; Bump grew at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), PARAESTHESIA (Pins and needles all over the body), HYPOAESTHESIA (Numbing), DYSGEUSIA (Metal taste in mouth) and PARAESTHESIA (Tingling) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE (COPPER IUD) for an unknown indication.    On 22-Apr-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced DIZZINESS (Dizziness). 22-Apr-2021, the patient experienced PARAESTHESIA (Pins and needles all over the body), HYPOAESTHESIA (Numbing), DYSGEUSIA (Metal taste in mouth) and NAUSEA (Extreme nausea). On 24-Apr-2021, the patient experienced PARAESTHESIA (Tingling). On an unknown date, the patient experienced EYE SWELLING (Left upper eye lied became swollen), RASH ERYTHEMATOUS (Bump on the arm turned into a red patch), VACCINATION SITE MASS (Bump grew at the injection site), OFF LABEL USE (Cannot take second dose) and VACCINATION SITE PAIN (Hurt a little at the site of the vaccine). On 01-May-2021, RASH ERYTHEMATOUS (Bump on the arm turned into a red patch) had resolved. On 17-May-2021, DIZZINESS (Dizziness), PARAESTHESIA (Pins and needles all over the body), PARAESTHESIA (Tingling), EYE SWELLING (Left upper eye lied became swollen), VACCINATION SITE MASS (Bump grew at the injection site), NAUSEA (Extreme nausea) and VACCINATION SITE PAIN (Hurt a little at the site of the vaccine) had resolved, HYPOAESTHESIA (Numbing) and DYSGEUSIA (Metal taste in mouth) outcome was unknown. At the time of the report, OFF LABEL USE (Cannot take second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  The patient stated that she can not take second dose as per the report.   This case was linked to US-MODERNATX, INC.-MOD-2021-090380 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Additional information received on 27-may-2021. Patient demographics updated. suspect drug time, Event details and new events added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090380:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Paraesthesia, Rash erythematous, Vaccination site mass, Vaccination site pain
Clinical narrative: Left upper eye lied became swollen; Cannot take second dose; Tingling; Extreme nausea; Dizziness; Pins and needles all over the body; Numbing; Metal taste in mouth; Hurt a little at the site of the vaccine; Bump on the arm turned into a red patch; Bump grew at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), PARAESTHESIA (Pins and needles all over the body), HYPOAESTHESIA (Numbing), DYSGEUSIA (Metal taste in mouth) and PARAESTHESIA (Tingling) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE (COPPER IUD) for an unknown indication.    On 22-Apr-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced DIZZINESS (Dizziness). 22-Apr-2021, the patient experienced PARAESTHESIA (Pins and needles all over the body), HYPOAESTHESIA (Numbing), DYSGEUSIA (Metal taste in mouth) and NAUSEA (Extreme nausea). On 24-Apr-2021, the patient experienced PARAESTHESIA (Tingling). On an unknown date, the patient experienced EYE SWELLING (Left upper eye lied became swollen), RASH ERYTHEMATOUS (Bump on the arm turned into a red patch), VACCINATION SITE MASS (Bump grew at the injection site), OFF LABEL USE (Cannot take second dose) and VACCINATION SITE PAIN (Hurt a little at the site of the vaccine). On 01-May-2021, RASH ERYTHEMATOUS (Bump on the arm turned into a red patch) had resolved. On 17-May-2021, DIZZINESS (Dizziness), PARAESTHESIA (Pins and needles all over the body), PARAESTHESIA (Tingling), EYE SWELLING (Left upper eye lied became swollen), VACCINATION SITE MASS (Bump grew at the injection site), NAUSEA (Extreme nausea) and VACCINATION SITE PAIN (Hurt a little at the site of the vaccine) had resolved, HYPOAESTHESIA (Numbing) and DYSGEUSIA (Metal taste in mouth) outcome was unknown. At the time of the report, OFF LABEL USE (Cannot take second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  The patient stated that she can not take second dose as per the report.   This case was linked to US-MODERNATX, INC.-MOD-2021-090380 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Additional information received on 27-may-2021. Patient demographics updated. suspect drug time, Event details and new events added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090380:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives spread all over the body; Hives on both palms and fingers; itchy; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives on both palms and fingers), PRURITUS (itchy) and URTICARIA (Hives spread all over the body) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced URTICARIA (Hives on both palms and fingers) and PRURITUS (itchy). On 26-Apr-2021, the patient experienced URTICARIA (Hives spread all over the body). At the time of the report, URTICARIA (Hives on both palms and fingers), PRURITUS (itchy) and URTICARIA (Hives spread all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took steroid pills for itch. No information regarding concomitant medication was given.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Contusion, Myalgia, Pyrexia
Clinical narrative: Bruise; Energy decreased; FEVER; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise), ASTHENIA (Energy decreased), PYREXIA (FEVER) and MYALGIA (Body aches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21-A) for COVID-19 vaccination.     The patient's past medical history included Bipolar disorder since an unknown date.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced CONTUSION (Bruise), ASTHENIA (Energy decreased), PYREXIA (FEVER) and MYALGIA (Body aches). At the time of the report, CONTUSION (Bruise), ASTHENIA (Energy decreased), PYREXIA (FEVER) and MYALGIA (Body aches) outcome was unknown.            Patient stated that she is treated with Tylenol for symptoms. Concomitant medications include Bipolar medications.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Drug interaction
Clinical narrative: Received the Moderna vaccine a week after a cortisone shot; Pain in left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INTERACTION (Received the Moderna vaccine a week after a cortisone shot) and AXILLARY PAIN (Pain in left arm pit) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced AXILLARY PAIN (Pain in left arm pit). On 13-Apr-2021, the patient experienced DRUG INTERACTION (Received the Moderna vaccine a week after a cortisone shot). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 21-Mar-2021, AXILLARY PAIN (Pain in left arm pit) had resolved. On 21-Apr-2021, DRUG INTERACTION (Received the Moderna vaccine a week after a cortisone shot) had resolved.            Patient received a cortisone shot on 13 Apr 2021 for a rash that was on her body before the vaccination. She was instructed by the nurse at the vaccination center to wait a week to receive the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Additional information received on 27-May-2021. No new information provided
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: sneezed; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezed) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 23-Apr-2021, the patient experienced SNEEZING (sneezed). At the time of the report, SNEEZING (sneezed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Anticipated invalid dose greater 37 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Anticipated invalid dose greater 37 days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.     On 12-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Anticipated invalid dose greater 37 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Anticipated invalid dose greater 37 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Slept all day; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day) and PYREXIA (Fever) in a 49-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 SOMNOLENCE (Slept all day) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of UNK dosage form. At the time of the report, SOMNOLENCE (Slept all day) and PYREXIA (Fever) had resolved.            Concomitant product use was not provided by the reporter.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Additional information included, Event outcome was updated.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Loss of appetite; Dizzy in the morning; Fatigue; Headache; Muscle ache; Waves of nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizzy in the morning), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle ache) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2017 and COVID-19 in January 2021. Concomitant products included APIXABAN (ELIQUIS), LETROZOLE, CARVEDILOL, ATORVASTATIN, FAMOTIDINE, VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizzy in the morning), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and NAUSEA (Waves of nausea). At the time of the report, DECREASED APPETITE (Loss of appetite), DIZZINESS (Dizzy in the morning), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle ache) and NAUSEA (Waves of nausea) outcome was unknown.            Treatment for the event, headache included extra strength paracetamol as needed. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-060702, US-MODERNATX, INC.-MOD-2021-035381 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060702:crosslinked US-MODERNATX, INC.-MOD-2021-035381:crosslinked