chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous case reported by a healthcare professional, describes the occurrence of peripheral swelling (right hand has been puffy for two weeks and painful); and pain in extremity (right hand has been puffy for two weeks and painful) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011A21A and 008B212A) for COVID-19 vaccination. Concurrent medical conditions included high blood pressure. Concomitant products included insulin for an unknown indication. On Mar 1, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 29, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced peripheral swelling (right hand has been puffy for two weeks and painful); and pain in extremity (right hand has been puffy for two weeks and painful). At the time of the report, peripheral swelling (right hand has been puffy for two weeks and painful); and pain in extremity (right hand has been puffy for two weeks and painful) resolved. The reporter did not provide any causality assessments, laboratory data was provided or treatment information. The patient received both scheduled doses of mRNA-1273 prior to the events. The action taken with the drug in response to the events: not applicable. Reporter did not allow further contact.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: She feels that the vaccine caused some swelling in the upper and lower lip; Woke up the next morning and the swelling was worse causing disfigurement. I was really scary; Facial Swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (She feels that the vaccine caused some swelling in the upper and lower lip), SWELLING FACE (Facial Swelling) and SWELLING FACE (Woke up the next morning and the swelling was worse causing disfigurement. I was really scary) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced SWELLING FACE (Facial Swelling). On 26-Mar-2021, the patient experienced SWELLING FACE (Woke up the next morning and the swelling was worse causing disfigurement. I was really scary). On 29-Mar-2021, the patient experienced LIP SWELLING (She feels that the vaccine caused some swelling in the upper and lower lip). On 25-Mar-2021, SWELLING FACE (Facial Swelling) had resolved. At the time of the report, LIP SWELLING (She feels that the vaccine caused some swelling in the upper and lower lip) and SWELLING FACE (Woke up the next morning and the swelling was worse causing disfigurement. I was really scary) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment information included benadryl
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: experienced swelling in the throat 4 hours after getting the vaccine; This spontaneous case was reported by a physician and describes the occurrence of PHARYNGEAL SWELLING (experienced swelling in the throat 4 hours after getting the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced PHARYNGEAL SWELLING (experienced swelling in the throat 4 hours after getting the vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Throat swelling, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (experienced swelling in the throat 4 hours after getting the vaccine) 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 product use was not provided by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up  received: Contain Non significant information
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Pain in extremity
Clinical narrative: Achy upper right leg; Felt very much like the flu, felt sick; Got sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achy upper right leg), INFLUENZA LIKE ILLNESS (Felt very much like the flu, felt sick) and ILLNESS (Got sick) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Achy upper right leg), INFLUENZA LIKE ILLNESS (Felt very much like the flu, felt sick) and ILLNESS (Got sick). At the time of the report, PAIN IN EXTREMITY (Achy upper right leg) had not resolved and INFLUENZA LIKE ILLNESS (Felt very much like the flu, felt sick) and ILLNESS (Got sick) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient refused second dose. No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Injection site rash, Rash, Rash erythematous, Urticaria
Clinical narrative: Dizziness; Almost a hive of a rash; a red and sometimes bumpy rash on the arm.; Rash at or near the injection site; Rashes, described as mysterious, sometimes red and bumpy on the arm; 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 DIZZINESS (Dizziness), URTICARIA (Almost a hive of a rash), RASH ERYTHEMATOUS (a red and sometimes bumpy rash on the arm.), INJECTION SITE RASH (Rash at or near the injection site) and RASH (Rashes, described as mysterious, sometimes red and bumpy on the arm) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), URTICARIA (Almost a hive of a rash), RASH ERYTHEMATOUS (a red and sometimes bumpy rash on the arm.), INJECTION SITE RASH (Rash at or near the injection site) and RASH (Rashes, described as mysterious, sometimes red and bumpy on the arm). At the time of the report, DIZZINESS (Dizziness), URTICARIA (Almost a hive of a rash), RASH ERYTHEMATOUS (a red and sometimes bumpy rash on the arm.), INJECTION SITE RASH (Rash at or near the injection site) and RASH (Rashes, described as mysterious, sometimes red and bumpy on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain assessment, Vaccination site pain
Clinical narrative: arm slightly sore/then a few days later it got very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm slightly sore/then a few days later it got very sore) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included Tendinitis (biceps tendinitis) in 2018.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm slightly sore/then a few days later it got very sore). At the time of the report, VACCINATION SITE PAIN (arm slightly sore/then a few days later it got very sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment (1-10): 100 (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Significant: Medical history provided
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensory loss
Clinical narrative: fever of 102.3; lost sensation in both arms; Lost sensation in both legs; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102.3), SENSORY LOSS (lost sensation in both arms) and SENSORY LOSS (Lost sensation in both legs) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 27-Feb-2021, the patient experienced PYREXIA (fever of 102.3), SENSORY LOSS (lost sensation in both arms) and SENSORY LOSS (Lost sensation in both legs). On 28-Feb-2021, SENSORY LOSS (lost sensation in both arms) and SENSORY LOSS (Lost sensation in both legs) had resolved. At the time of the report, PYREXIA (fever of 102.3) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nausea, Pyrexia
Clinical narrative: Cough; Slight fever; "icky" feeling overall; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PYREXIA (Slight fever) and NAUSEA ("icky" feeling overall) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection. Concomitant products included OMEPRAZOLE, CYANOCOBALAMIN (B12-VITAMIIN), VITAMIN D NOS and LEVOTHYROXINE 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 27-Mar-2021, the patient experienced COUGH (Cough), PYREXIA (Slight fever) and NAUSEA ("icky" feeling overall). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Mar-2021, PYREXIA (Slight fever) had resolved. At the time of the report, COUGH (Cough) and NAUSEA ("icky" feeling overall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache; dizziness which has gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and DIZZINESS (dizziness which has gotten worse) in an 82-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 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Headache) and DIZZINESS (dizziness which has gotten worse). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, HEADACHE (Headache) and DIZZINESS (dizziness which has gotten worse) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant Medication was available.   This case was linked to US-MODERNATX, INC.-MOD-2021-060838 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060838:Mother
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site swelling
Clinical narrative: swelling around the injection site; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills) and VACCINATION SITE SWELLING (swelling around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (headache) and CHILLS (chills). On 29-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling around the injection site). At the time of the report, HEADACHE (headache), CHILLS (chills) and VACCINATION SITE SWELLING (swelling around the injection site) outcome was unknown.            The action taken with the event, headache, chills, swelling around the injection site was not applicable. No concomitant medications reported. No treatment reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Chills, Cough, Dyspnoea, Fatigue
Clinical narrative: Shortness of Breath; Shaking; Sweating; Numbness in Arms and Legs; Cold; Became bed ridden; Low Fever; Felt very fatigued; Chills; Cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), TREMOR (Shaking), HYPERHIDROSIS (Sweating), HYPOAESTHESIA (Numbness in Arms and Legs) and COUGH (Cough) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A211A and DO1AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included MELATONIN from 01-Feb-2018 to an unknown date for Sleep disorder.   On 26-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Cough). On 27-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath), TREMOR (Shaking), HYPERHIDROSIS (Sweating), HYPOAESTHESIA (Numbness in Arms and Legs), NASOPHARYNGITIS (Cold), BEDRIDDEN (Became bed ridden), PYREXIA (Low Fever), FATIGUE (Felt very fatigued) and CHILLS (Chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at a dose of 1 dosage form. On 29-Mar-2021, TREMOR (Shaking), HYPERHIDROSIS (Sweating) and HYPOAESTHESIA (Numbness in Arms and Legs) had resolved. On 28-Apr-2021, DYSPNOEA (Shortness of Breath) had resolved. At the time of the report, COUGH (Cough), NASOPHARYNGITIS (Cold), BEDRIDDEN (Became bed ridden), PYREXIA (Low Fever), FATIGUE (Felt very fatigued) and CHILLS (Chills) had resolved.            The action taken with mRNA-1273 in response to the event was not applicable. Patient has taken aspirin for the treatment.  Patient has not been diagnosed with/tested positive for COVID-19.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter details and events outcome was updated. On 14-May-2021: Patient details, concomitant medications, therapy details, event outcome and reporter causality was updated.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypoaesthesia, Nasopharyngitis, Pyrexia, Tremor
Clinical narrative: Shortness of Breath; Shaking; Sweating; Numbness in Arms and Legs; Cold; Became bed ridden; Low Fever; Felt very fatigued; Chills; Cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath), TREMOR (Shaking), HYPERHIDROSIS (Sweating), HYPOAESTHESIA (Numbness in Arms and Legs) and COUGH (Cough) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A211A and DO1AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included MELATONIN from 01-Feb-2018 to an unknown date for Sleep disorder.   On 26-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COUGH (Cough). On 27-Mar-2021, the patient experienced DYSPNOEA (Shortness of Breath), TREMOR (Shaking), HYPERHIDROSIS (Sweating), HYPOAESTHESIA (Numbness in Arms and Legs), NASOPHARYNGITIS (Cold), BEDRIDDEN (Became bed ridden), PYREXIA (Low Fever), FATIGUE (Felt very fatigued) and CHILLS (Chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date at a dose of 1 dosage form. On 29-Mar-2021, TREMOR (Shaking), HYPERHIDROSIS (Sweating) and HYPOAESTHESIA (Numbness in Arms and Legs) had resolved. On 28-Apr-2021, DYSPNOEA (Shortness of Breath) had resolved. At the time of the report, COUGH (Cough), NASOPHARYNGITIS (Cold), BEDRIDDEN (Became bed ridden), PYREXIA (Low Fever), FATIGUE (Felt very fatigued) and CHILLS (Chills) had resolved.            The action taken with mRNA-1273 in response to the event was not applicable. Patient has taken aspirin for the treatment.  Patient has not been diagnosed with/tested positive for COVID-19.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter details and events outcome was updated. On 14-May-2021: Patient details, concomitant medications, therapy details, event outcome and reporter causality was updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, SARS-CoV-2 test
Clinical narrative: Body Aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches) and CHILLS (Chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included HYDROCHLOROTHIAZIDE, METOPROLOL, SIMVASTATIN, PHYTOMENADIONE (VIT K1), PYRIDOXINE HYDROCHLORIDE (B6) and ZN [ZINC] for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN (Body Aches) and CHILLS (Chills). At the time of the report, PAIN (Body Aches) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive.     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 medicines were not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Myalgia
Clinical narrative: Muscle soreness all over body; Burning sensation in middle of chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Burning sensation in middle of chest) and MYALGIA (Muscle soreness all over body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concurrent medical conditions included GERD.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced CHEST PAIN (Burning sensation in middle of chest). On an unknown date, the patient experienced MYALGIA (Muscle soreness all over body). At the time of the report, CHEST PAIN (Burning sensation in middle of chest) and MYALGIA (Muscle soreness all over body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: No specific follow-up information recorded. On 29-Mar-2021: No specific follow-up information recorded.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: blood sugar was160; 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 BLOOD GLUCOSE INCREASED (blood sugar was160) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar was160). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar was160) outcome was unknown. Not Provided          Treatment information not provided. Concomitant medications were not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Insomnia, Pain in extremity, Paraesthesia
Clinical narrative: Felt Numbness in 3 fingers; Right hand was tingling; Arm was Very Sore; Could not sleep; Shoulder to elbow was burning and painful/shoulder still hurts; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Felt Numbness in 3 fingers), PARAESTHESIA (Right hand was tingling), PAIN IN EXTREMITY (Arm was Very Sore), INSOMNIA (Could not sleep) and ARTHRALGIA (Shoulder to elbow was burning and painful/shoulder still hurts) in a 60-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 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Mar-2021, the patient experienced HYPOAESTHESIA (Felt Numbness in 3 fingers), PARAESTHESIA (Right hand was tingling), PAIN IN EXTREMITY (Arm was Very Sore), INSOMNIA (Could not sleep) and ARTHRALGIA (Shoulder to elbow was burning and painful/shoulder still hurts). On 26-Mar-2021, INSOMNIA (Could not sleep) had resolved. On 28-Mar-2021, PAIN IN EXTREMITY (Arm was Very Sore) had resolved. At the time of the report, HYPOAESTHESIA (Felt Numbness in 3 fingers) and ARTHRALGIA (Shoulder to elbow was burning and painful/shoulder still hurts) had not resolved and PARAESTHESIA (Right hand was tingling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment for the event included tylenol.   This case was linked to MOD-2021-101870 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up received on 12-MAY-2021 and the outcome of the event was updated and second dose details and AE related to it was mentioned..
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Vaccination site pain
Clinical narrative: A ball appeared in my axilla, it is swollen, and it hurts a lot ¨; Pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (A ball appeared in my axilla, it is swollen, and it hurts a lot ¨) and VACCINATION SITE PAIN (Pain in the arm of the injection) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LISINOPRIL and METHIMAZOLE for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced AXILLARY MASS (A ball appeared in my axilla, it is swollen, and it hurts a lot ¨) and VACCINATION SITE PAIN (Pain in the arm of the injection). On 27-Mar-2021, VACCINATION SITE PAIN (Pain in the arm of the injection) had resolved. At the time of the report, AXILLARY MASS (A ball appeared in my axilla, it is swollen, and it hurts a lot ¨) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Pain in arm; Diarrhea; Fatigue; Nausea; Headache; Muscle pain; High fever; Rash on both arms and legs; Headaches; Fever; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Headaches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple sclerosis. Concomitant products included TERIFLUNOMIDE (AUBAGIO) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (very sore arm), HEADACHE (Headaches) and PYREXIA (Fever). On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (High fever) and RASH (Rash on both arms and legs). At the time of the report, PAIN IN EXTREMITY (very sore arm), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headaches), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (High fever) and RASH (Rash on both arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Rash
Clinical narrative: Pain in arm; Diarrhea; Fatigue; Nausea; Headache; Muscle pain; High fever; Rash on both arms and legs; Headaches; Fever; very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), FATIGUE (Fatigue) and HEADACHE (Headaches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Multiple sclerosis. Concomitant products included TERIFLUNOMIDE (AUBAGIO) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (very sore arm), HEADACHE (Headaches) and PYREXIA (Fever). On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), FATIGUE (Fatigue), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (High fever) and RASH (Rash on both arms and legs). At the time of the report, PAIN IN EXTREMITY (very sore arm), PAIN IN EXTREMITY (Pain in arm), DIARRHOEA (Diarrhea), FATIGUE (Fatigue), HEADACHE (Headaches), PYREXIA (Fever), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle pain), PYREXIA (High fever) and RASH (Rash on both arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Lip swelling, Rash, Rash pruritic, Swelling
Clinical narrative: this pattern keeps repeating itself daily.; swollen top lip; swollen (rash); itchy(rash); rash; swollen (rash); swollen (rash); This spontaneous case was reported by a consumer and describes the occurrence of the first episode of SWELLING (swollen (rash)), RASH (rash), the third episode of SWELLING (swollen (rash)), the second episode of RASH PRURITIC (itchy(rash)) and the third episode of RASH PRURITIC (itchy(rash)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included METFORMIN and VALSARTAN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Mar-2021, the patient experienced the first episode of SWELLING (swollen (rash)) and the first episode of RASH PRURITIC (itchy(rash)). On 18-Mar-2021, the patient experienced RASH (rash), the second episode of RASH PRURITIC (itchy(rash)) and the second episode of SWELLING (swollen (rash)). On 29-Mar-2021, the patient experienced the third episode of SWELLING (swollen (rash)), the third episode of RASH PRURITIC (itchy(rash)) and LIP SWELLING (swollen top lip). On an unknown date, the patient experienced ADVERSE DRUG REACTION (this pattern keeps repeating itself daily.). On 19-Mar-2021, RASH (rash) had resolved. At the time of the report, last episode of SWELLING (swollen (rash)), the last episode of RASH PRURITIC (itchy(rash)), LIP SWELLING (swollen top lip) and ADVERSE DRUG REACTION (this pattern keeps repeating itself daily.) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Updated reporter information, outcome of events lip swelling and adverse drug reaction from unknown to recovering/resolving.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: cannot lift arm without pain; pain in left arm where she got the shot; joint/elbow hurts; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (cannot lift arm without pain), VACCINATION SITE PAIN (pain in left arm where she got the shot) and ARTHRALGIA (joint/elbow hurts) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (cannot lift arm without pain), VACCINATION SITE PAIN (pain in left arm where she got the shot) and ARTHRALGIA (joint/elbow hurts). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (cannot lift arm without pain), VACCINATION SITE PAIN (pain in left arm where she got the shot) and ARTHRALGIA (joint/elbow hurts) had not resolved. Not Provided          No concomitant medications were provided to the patient.  The reporter stated that the pain was aggravated.  Action taken with mRNA-1273 in response to the event was Not Applicable     Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Additional information was received form the initial reporter: Patient reported that the event pain in arm is still ongoing. It has gotten better, but continues to be a problem, especially above the elbow; Sender's Comments:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: diagnosed with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced COVID-19 (diagnosed with covid) (seriousness criterion hospitalization). At the time of the report, COVID-19 (diagnosed with covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Causality for COVID-19 is not applicable.; Sender's Comments: Causality for COVID-19 is not applicable.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Limb discomfort, Vaccination site pruritus
Clinical narrative: felt tired on right arm; headaches in the morning for the last 1.5 weeks; arm is itchy for 1 week; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (felt tired on right arm), VACCINATION SITE PRURITUS (arm is itchy for 1 week) and HEADACHE (headaches in the morning for the last 1.5 weeks) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (arm is itchy for 1 week). On 17-Mar-2021, the patient experienced HEADACHE (headaches in the morning for the last 1.5 weeks). On 29-Mar-2021, the patient experienced LIMB DISCOMFORT (felt tired on right arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 06-Mar-2021, VACCINATION SITE PRURITUS (arm is itchy for 1 week) had resolved. At the time of the report, LIMB DISCOMFORT (felt tired on right arm) and HEADACHE (headaches in the morning for the last 1.5 weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 100 (High) 100 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe arm pain; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Severe arm pain) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 0616M20A) for COVID-19 vaccination.     Concomitant products included BIOTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and SACCHAROMYCES BOULARDII (FLORASTOR KIDS) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain). On 20-Jan-2021, PAIN IN EXTREMITY (Severe arm pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Night sweats, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: irritated sinuses; night sweats; drippy nose; sore throat; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (irritated sinuses), NIGHT SWEATS (night sweats), RHINORRHOEA (drippy nose), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) in a female patient of an unknown age 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced SINUSITIS (irritated sinuses), NIGHT SWEATS (night sweats), RHINORRHOEA (drippy nose), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and PYREXIA (fever). At the time of the report, SINUSITIS (irritated sinuses), NIGHT SWEATS (night sweats), RHINORRHOEA (drippy nose), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: irritated sinuses; night sweats; drippy nose; sore throat; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (irritated sinuses), NIGHT SWEATS (night sweats), RHINORRHOEA (drippy nose), OROPHARYNGEAL PAIN (sore throat) and CHILLS (chills) in a female patient of an unknown age 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced SINUSITIS (irritated sinuses), NIGHT SWEATS (night sweats), RHINORRHOEA (drippy nose), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and PYREXIA (fever). At the time of the report, SINUSITIS (irritated sinuses), NIGHT SWEATS (night sweats), RHINORRHOEA (drippy nose), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: No specific follow-up information recorded.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Limb discomfort, Pain, Pain in extremity, Vaccination site movement impairment
Clinical narrative: Does not have full use of arm....such big pain; throbbing pain in arm / arm is sore; inappropriate schedule of vaccine administration; cant lift arm; still having problems with her right arm; Does not have full use of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (throbbing pain in arm / arm is sore), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration), LIMB DISCOMFORT (cant lift arm; still having problems with her right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Does not have full use of the arm) and PAIN (Does not have full use of arm....such big pain) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 003A21A) for COVID-19 vaccination.     No medical history was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (throbbing pain in arm / arm is sore), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration), LIMB DISCOMFORT (cant lift arm; still having problems with her right arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (Does not have full use of the arm). On an unknown date, the patient experienced PAIN (Does not have full use of arm....such big pain). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) had resolved. At the time of the report, PAIN IN EXTREMITY (throbbing pain in arm / arm is sore), LIMB DISCOMFORT (cant lift arm; still having problems with her right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Does not have full use of the arm) and PAIN (Does not have full use of arm..such big pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported she had an appointment with orthopedic doctor on 10-May-2021.  Treatment of events was not reported. Concomitant medications as reported by patient included blood thinner, included blood thinner, cholesterol medication and cholesterol medication and blood pressure medication blood pressure medication.   This case was linked to MOD-2021-033836 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Event outcome updated (to not recovered )and new event (pain aggravated) was added On 14-May-2021: Non-significant Follow accepted on 17 May 2021; Sender's Comments:  MOD-2021-033836:First dose
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Renal pain
Clinical narrative: bunch of pain in the kidney area - both sides; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PAIN (Body aches) and RENAL PAIN (bunch of pain in the kidney area - both sides) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (Headache) and PAIN (Body aches). On 29-Mar-2021, the patient experienced RENAL PAIN (bunch of pain in the kidney area - both sides). At the time of the report, HEADACHE (Headache), PAIN (Body aches) and RENAL PAIN (bunch of pain in the kidney area - both sides) outcome was unknown. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications:Tylenol No concomitant medication information was provided by the reporter. No lab data has been provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps). On 22-Feb-2021, ABDOMINAL PAIN UPPER (stomach cramps) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information not provided. Concomitant medications were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Hunger
Clinical narrative: diarrhea; being very fatigued, she has to spend most of the in bed; headache; felt dizzy; 10 minutes after leaving she felt hungry, the hunger just kept becoming worse and worse. She became ravenous; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt dizzy), HUNGER (10 minutes after leaving she felt hungry, the hunger just kept becoming worse and worse. She became ravenous), DIARRHOEA (diarrhea), HEADACHE (headache) and FATIGUE (being very fatigued, she has to spend most of the in bed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Hypertension and Cancer. Concomitant products included ALPRAZOLAM (XANAX), TRAZODONE and ESTRADIOL (ESTROGEN) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DIZZINESS (felt dizzy), HUNGER (10 minutes after leaving she felt hungry, the hunger just kept becoming worse and worse. She became ravenous) and HEADACHE (headache). On 24-Mar-2021, the patient experienced FATIGUE (being very fatigued, she has to spend most of the in bed). On 27-Mar-2021, the patient experienced DIARRHOEA (diarrhea). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Headache, at an unspecified dose and frequency. On 23-Mar-2021, HUNGER (10 minutes after leaving she felt hungry, the hunger just kept becoming worse and worse. She became ravenous) had resolved. On 28-Mar-2021, DIARRHOEA (diarrhea), HEADACHE (headache) and FATIGUE (being very fatigued, she has to spend most of the in bed) had resolved. At the time of the report, DIZZINESS (felt dizzy) 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.   Concomitant medication was provided also includes the diabetes medication, Hight blood pressure medication, Cholesterol medication.