chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Felt off; heart was beating faster; sore arm; Fatigue; chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt off), HEART RATE INCREASED (heart was beating faster), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced FEELING ABNORMAL (Felt off), HEART RATE INCREASED (heart was beating faster), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue), CHILLS (chills) and HEADACHE (Headache). At the time of the report, FEELING ABNORMAL (Felt off), HEART RATE INCREASED (heart was beating faster), PAIN IN EXTREMITY (sore arm), FATIGUE (Fatigue), CHILLS (chills) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE], DOCOSAHEXAENOIC ACID (DHA), SERTRALINE HYDROCHLORIDE (ZOLOFT) and BUDESONIDE (PULMICORT) for an unknown indication.    On 21-Jan-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 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site swelling
Clinical narrative: Swollen arm/ swollen under the armpit; Running a fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen arm/ swollen under the armpit), PYREXIA (Running a fever), CHILLS (Chills) and HEADACHE (Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm/ swollen under the armpit), PYREXIA (Running a fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) on 05-Feb-2021 for Adverse event, at a dose. At the time of the report, VACCINATION SITE SWELLING (Swollen arm/ swollen under the armpit), PYREXIA (Running a fever), CHILLS (Chills) and HEADACHE (Headache) had not 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red spot around vaccination area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red spot around vaccination area) in a female 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red spot around vaccination area). At the time of the report, VACCINATION SITE ERYTHEMA (red spot around vaccination area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Injection site rash
Clinical narrative: arm is red; arm is warm; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is red), FEELING HOT (arm is warm) and INJECTION SITE RASH (rash at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included hives (7 years ago and recently returned a month or two prior to report (and before vaccination)). Concurrent medical conditions included Asthma, Hypertension and Hypothyroidism. Concomitant products included MOMETASONE FUROATE (ASMANEX) for Asthma, LEVOTHYROXINE, TRIAMTERENE, METOPROLOL, VITAMIN D3, POTASSIUM CHLORIDE and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 17-Feb-2021, the patient experienced INJECTION SITE RASH (rash at injection site). On 22-Feb-2021, the patient experienced ERYTHEMA (arm is red) and FEELING HOT (arm is warm). At the time of the report, ERYTHEMA (arm is red), FEELING HOT (arm is warm) and INJECTION SITE RASH (rash at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Vomiting
Clinical narrative: Difficulty swallowing; Could not breath; threw up a little in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty swallowing), DYSPNOEA (Could not breath) and VOMITING (threw up a little in her mouth) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Food allergy (unspecified). Concomitant products included VITAMINS NOS, GLATIRAMER ACETATE (COPAXONE), MECLIZINE HCL and OMEPRAZOLE for an unknown indication.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced DYSPHAGIA (Difficulty swallowing), DYSPNOEA (Could not breath) and VOMITING (threw up a little in her mouth). At the time of the report, DYSPHAGIA (Difficulty swallowing), DYSPNOEA (Could not breath) and VOMITING (threw up a little in her mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Urticaria
Clinical narrative: warm red patches in the injected arm; Welts in the injected arm; itching in the injected arm; soreness in the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (warm red patches in the injected arm), URTICARIA (Welts in the injected arm), PRURITUS (itching in the injected arm) and PAIN IN EXTREMITY (soreness in the injected arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced ERYTHEMA (warm red patches in the injected arm), URTICARIA (Welts in the injected arm), PRURITUS (itching in the injected arm) and PAIN IN EXTREMITY (soreness in the injected arm). At the time of the report, ERYTHEMA (warm red patches in the injected arm), URTICARIA (Welts in the injected arm), PRURITUS (itching in the injected arm) and PAIN IN EXTREMITY (soreness in the injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment medication and conmeds were not provided by the reporter.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live-full term birth on date). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Eclampsia.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Sep-2020 and the estimated date of delivery was date. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy.  On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Vaccination site erythema
Clinical narrative: Big red circle about 3 inches by 5 inches at injection site.; Arm soreness; Headaches; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headaches), MYALGIA (body aches) and VACCINATION SITE ERYTHEMA (Big red circle about 3 inches by 5 inches at injection site.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included VITAMIN D [VITAMIN D NOS], PROBIOTICS NOS and COLECALCIFEROL, FISH OIL (OMEGASAN 3) for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headaches) and MYALGIA (body aches). On 21-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Big red circle about 3 inches by 5 inches at injection site.). On 15-Feb-2021, PAIN IN EXTREMITY (Arm soreness), HEADACHE (Headaches) and MYALGIA (body aches) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Big red circle about 3 inches by 5 inches at injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-057826 (E2B Linked Report).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia, SARS-CoV-2 test
Clinical narrative: Cough; Chills; Fever; This spontaneous case was reported by a physician and describes the occurrence of COUGH (Cough), CHILLS (Chills) and PYREXIA (Fever) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included AFib and Pacemaker insertion (cardiac). Concurrent medical conditions included Heart disease, unspecified and Diabetes.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced COUGH (Cough), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with OSELTAMIVIR PHOSPHATE (TAMIFLU) for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Cough), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, SARS-CoV-2 test: negative Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Hyperhidrosis, Myalgia, Nasopharyngitis
Clinical narrative: Blowing stuff out of my nose; Muscle soreness; Coughing; Wakes up with sweat; Fever (99-100 F); Has the chills; Cold like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    A spontaneous report was received from a healthcare professional concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cold like symptoms/nasopharyngitis, fever (99-100 f)/pyrexia, wakes up with sweat/hyperhidrosis, has the chills/chills, muscle soreness/myalgia, blowing stuff out of my nose/productive cough, coughing/cough  The patient's medical history was not provided. Concomitant medications reported were clarithromycin ,diphenhydramine and oxygen for drug use for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L00A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) cold like symptoms. On 16 Feb 2021, the patient experienced the event(s) fever (99-100 f), wakes up with sweat, has the chills. On an unknown date, the patient experienced the event(s) Muscle soreness, Blowing stuff out of my nose, coughing.  Treatment details included Guaifenesin and paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), cold like symptoms, fever (99-100 f), wakes up with sweat, has the chills, muscle soreness, blowing stuff out of my nose, coughing was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia
Clinical narrative: Blowing stuff out of my nose; Muscle soreness; Coughing; Wakes up with sweat; Fever (99-100 F); Has the chills; Cold like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    A spontaneous report was received from a healthcare professional concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cold like symptoms/nasopharyngitis, fever (99-100 f)/pyrexia, wakes up with sweat/hyperhidrosis, has the chills/chills, muscle soreness/myalgia, blowing stuff out of my nose/productive cough, coughing/cough  The patient's medical history was not provided. Concomitant medications reported were clarithromycin ,diphenhydramine and oxygen for drug use for unknown indication.  On 2 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L00A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 7 Feb 2021, the patient experienced the event(s) cold like symptoms. On 16 Feb 2021, the patient experienced the event(s) fever (99-100 f), wakes up with sweat, has the chills. On an unknown date, the patient experienced the event(s) Muscle soreness, Blowing stuff out of my nose, coughing.  Treatment details included Guaifenesin and paracetamol.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), cold like symptoms, fever (99-100 f), wakes up with sweat, has the chills, muscle soreness, blowing stuff out of my nose, coughing was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Delayed arm swelling; delayed itchy arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (delayed itchy arm) and VACCINATION SITE SWELLING (Delayed arm swelling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (delayed itchy arm). On 20-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Delayed arm swelling). At the time of the report, VACCINATION SITE PRURITUS (delayed itchy arm) and VACCINATION SITE SWELLING (Delayed arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided    Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up was received on 27 Apr 2021 included,no new information
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Lymphadenopathy
Clinical narrative: lumps on neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lumps on neck) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced LYMPHADENOPATHY (lumps on neck). On 22-Jan-2021, LYMPHADENOPATHY (lumps on neck) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Laboratory test: unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-073434 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Sensory disturbance
Clinical narrative: Diagnosed with shingles; Experienced sensation below the breast; A spontaneous report was received on 22-FEB-2021 from a concerning female patient of 76 years old, who was administered with Moderna's COVID-19 vaccine for prophylaxis of COVID-19 infection. On12-FEB-2021, patient received the first dose of mRNA-1273 vaccine in the left arm. The patient's medical history was not provided.  Concomitant medications were not provided by the patient.  Patient experienced the adverse events such as sensation below the breast and diagnosed with shingles.  The treatment for the adverse events was Antiviral medications as provided by the patient.  Action taken with the dose of mRNA-1273 vaccine was not reported. Consent to follow up from safety was provided by the patient.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Thyroid disorder NOS. Concomitant products included APIXABAN (ELIQUIS).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Gait disturbance, Hyperhidrosis
Clinical narrative: Full body sweats; Felt dizzy; Difficultly walking; Nauseous; Fatigue; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Full body sweats), DIZZINESS (Felt dizzy), GAIT DISTURBANCE (Difficultly walking), NAUSEA (Nauseous) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced HYPERHIDROSIS (Full body sweats), DIZZINESS (Felt dizzy), GAIT DISTURBANCE (Difficultly walking), NAUSEA (Nauseous), FATIGUE (Fatigue) and CHILLS (Felt cold). At the time of the report, HYPERHIDROSIS (Full body sweats), DIZZINESS (Felt dizzy), GAIT DISTURBANCE (Difficultly walking), NAUSEA (Nauseous), FATIGUE (Fatigue) and CHILLS (Felt cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Full body sweats; Felt dizzy; Difficultly walking; Nauseous; Fatigue; Felt cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Full body sweats), DIZZINESS (Felt dizzy), GAIT DISTURBANCE (Difficultly walking), NAUSEA (Nauseous) and FATIGUE (Fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced HYPERHIDROSIS (Full body sweats), DIZZINESS (Felt dizzy), GAIT DISTURBANCE (Difficultly walking), NAUSEA (Nauseous), FATIGUE (Fatigue) and CHILLS (Felt cold). At the time of the report, HYPERHIDROSIS (Full body sweats), DIZZINESS (Felt dizzy), GAIT DISTURBANCE (Difficultly walking), NAUSEA (Nauseous), FATIGUE (Fatigue) and CHILLS (Felt cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: broke out with itchy hives/hives on thighs, buttocks, legs, seat and back; broke out with itchy hives/hives on thighs, buttocks, legs, seat and back; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (broke out with itchy hives/hives on thighs, buttocks, legs, seat and back) and PRURITUS (broke out with itchy hives/hives on thighs, buttocks, legs, seat and back) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Mononucleosis (At age 21 (broke out in a fine red rash).). Concurrent medical conditions included Penicillin allergy.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced URTICARIA (broke out with itchy hives/hives on thighs, buttocks, legs, seat and back). On an unknown date, the patient experienced PRURITUS (broke out with itchy hives/hives on thighs, buttocks, legs, seat and back). At the time of the report, URTICARIA (broke out with itchy hives/hives on thighs, buttocks, legs, seat and back) and PRURITUS (broke out with itchy hives/hives on thighs, buttocks, legs, seat and back) was resolving.        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 medications included topical calming cream.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Mailing address updated.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Pelvic pain
Clinical narrative: Pain in the arm; Pain in left side of the pelvis area; Pain in the hips joints and left side of pelvis area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), PELVIC PAIN (Pain in left side of the pelvis area) and ARTHRALGIA (Pain in the hips joints and left side of pelvis area) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025520A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 (Pain in the arm), PELVIC PAIN (Pain in left side of the pelvis area) and ARTHRALGIA (Pain in the hips joints and left side of pelvis area). At the time of the report, PAIN IN EXTREMITY (Pain in the arm) had resolved and PELVIC PAIN (Pain in left side of the pelvis area) and ARTHRALGIA (Pain in the hips joints and left side of pelvis area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) 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.   No relevant concomitant medications were reported.   This case was linked to MOD-2021-020650 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia, Vaccination site pain
Clinical narrative: blood sugar level was 40 mg/dL; little soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGLYCAEMIA (blood sugar level was 40 mg/dL) and VACCINATION SITE PAIN (little soreness in the left arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Addison's disease, Hashimoto's disease, Pernicious anemia and Juvenile diabetes. Concomitant products included HYDROCORTISONE (CORTEF [HYDROCORTISONE]) for Addison's disease, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, INSULIN DEGLUDEC (TRESIBA) and INSULIN ASPART (NOVOLOG) for Juvenile diabetes, Injectable B-12 for Pernicious anemia.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (little soreness in the left arm). On 05-Feb-2021, the patient experienced HYPOGLYCAEMIA (blood sugar level was 40 mg/dL). At the time of the report, HYPOGLYCAEMIA (blood sugar level was 40 mg/dL) outcome was unknown and VACCINATION SITE PAIN (little soreness in the left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bowel movement irregularity, Chills, Fatigue, Nausea
Clinical narrative: cramps in stomach; Slept most of the day; bowel movement at 3am; felt nauseous; Very tired; had the chills; threw up; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (cramps in stomach), SOMNOLENCE (Slept most of the day), BOWEL MOVEMENT IRREGULARITY (bowel movement at 3am), NAUSEA (felt nauseous) and FATIGUE (Very tired) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREDNISONE, THYROID (ARMOUR THYROID), RIVASTIGMINE, ZINC, FISH OIL (OMEGA3 JACK), DIOSMIN, HESPERIDIN (FLAVONID), MONTELUKAST SODIUM (ADKAST), DONEPEZIL and SIMVASTATIN for an unknown indication, ABC COMPLETE SENIOR 50+.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (cramps in stomach), SOMNOLENCE (Slept most of the day), BOWEL MOVEMENT IRREGULARITY (bowel movement at 3am), NAUSEA (felt nauseous), FATIGUE (Very tired), CHILLS (had the chills) and VOMITING (threw up). At the time of the report, ABDOMINAL PAIN UPPER (cramps in stomach), SOMNOLENCE (Slept most of the day), BOWEL MOVEMENT IRREGULARITY (bowel movement at 3am), NAUSEA (felt nauseous), FATIGUE (Very tired), CHILLS (had the chills) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.    This case was linked to MOD-2021-021461 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: cramps in stomach; Slept most of the day; bowel movement at 3am; felt nauseous; Very tired; had the chills; threw up; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (cramps in stomach), SOMNOLENCE (Slept most of the day), BOWEL MOVEMENT IRREGULARITY (bowel movement at 3am), NAUSEA (felt nauseous) and FATIGUE (Very tired) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PREDNISONE, THYROID (ARMOUR THYROID), RIVASTIGMINE, ZINC, FISH OIL (OMEGA3 JACK), DIOSMIN, HESPERIDIN (FLAVONID), MONTELUKAST SODIUM (ADKAST), DONEPEZIL and SIMVASTATIN for an unknown indication, ABC COMPLETE SENIOR 50+.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (cramps in stomach), SOMNOLENCE (Slept most of the day), BOWEL MOVEMENT IRREGULARITY (bowel movement at 3am), NAUSEA (felt nauseous), FATIGUE (Very tired), CHILLS (had the chills) and VOMITING (threw up). At the time of the report, ABDOMINAL PAIN UPPER (cramps in stomach), SOMNOLENCE (Slept most of the day), BOWEL MOVEMENT IRREGULARITY (bowel movement at 3am), NAUSEA (felt nauseous), FATIGUE (Very tired), CHILLS (had the chills) and VOMITING (threw up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided by the reporter.    This case was linked to MOD-2021-021461 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Injection site pain
Clinical narrative: mild case of diarrhea; pain at injection site; stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (mild case of diarrhea) and INJECTION SITE PAIN (pain at injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01M20A) for an unknown indication.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache). On an unknown date, the patient experienced DIARRHOEA (mild case of diarrhea) and INJECTION SITE PAIN (pain at injection site). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency and CHARCOAL ACTIVATED for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (mild case of diarrhea) and INJECTION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Birth control medication was reported as concomitant.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Limb discomfort, Malaise, Muscle fatigue
Clinical narrative: Not feeling good; Headache; Itchy arm; It was all red at injection site/an eight-inch red area at injection site.; Left arm was v sore; Swelled arm; Having difficulty walking due to muscle fatigue; She can barely lift it; Muscle fatigue; Slept all day; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Having difficulty walking due to muscle fatigue), LIMB DISCOMFORT (She can barely lift it), MUSCLE FATIGUE (Muscle fatigue), SOMNOLENCE (Slept all day) and MALAISE (Not feeling good) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced GAIT DISTURBANCE (Having difficulty walking due to muscle fatigue), LIMB DISCOMFORT (She can barely lift it), MUSCLE FATIGUE (Muscle fatigue), SOMNOLENCE (Slept all day), VACCINATION SITE SWELLING (Swelled arm) and VACCINATION SITE PAIN (Left arm was v sore). On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (It was all red at injection site/an eight-inch red area at injection site.). On an unknown date, the patient experienced MALAISE (Not feeling good) and HEADACHE (Headache). At the time of the report, GAIT DISTURBANCE (Having difficulty walking due to muscle fatigue), LIMB DISCOMFORT (She can barely lift it), MUSCLE FATIGUE (Muscle fatigue), SOMNOLENCE (Slept all day), VACCINATION SITE SWELLING (Swelled arm) and VACCINATION SITE PAIN (Left arm was v sore) had resolved, MALAISE (Not feeling good) and HEADACHE (Headache) outcome was unknown and VACCINATION SITE PRURITUS (Itchy arm) and VACCINATION SITE ERYTHEMA (It was all red at injection site/an eight-inch red area at injection site.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient post receiving their first dose of vaccine 1st shot and on the next day their left arm was very sore and could barely lift it. The patient reported that they slept whole day, had muscle fatigue which lasted for a week due to which the patient was having difficulty in walking. The patient also experienced swelled arm which went away and on day 11, the patient had itchy arm and it was all red at injection site and was still not going away.  On 24-Jun-2021 the patient reported that the patient had an eight-inch red area at the injection site.  No Concomitant product use was reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up was received on 22-Apr-2021 and contains non significant information. On 24-Jun-2021: Follow-up was received on 24-Jun-2021. Updated the event verbatim of the event Vaccination site erythema.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache; Nausea; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Body aches), CHILLS (Chills) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical history information was provided by the reporter.  Concomitant products included CALCIUM for Bone density increased, GABAPENTIN (NEURONTIN) for Headache, LEVOTHYROXINE, FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN B COMPLEX for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). On 30-Jan-2021 at 2:30 AM, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). On 31-Jan-2021, HEADACHE (Headache), MYALGIA (Body aches) and CHILLS (Chills) had resolved. On 11-Apr-2021, NAUSEA (Nausea) 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.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: follow up received on 29-apr-2021:containes no new information On 06-May-2021: The follow up case received on 06-MAY-2021. Concomitant indications, dosage and start date were added. Lab test is added.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm to the touch; felt very tired; little swelling and redness at the injection site; little swelling and redness at the injection site; Big rash which grew twice in size overnight.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE RASH (Big rash which grew twice in size overnight.), FATIGUE (felt very tired), VACCINATION SITE ERYTHEMA (little swelling and redness at the injection site) and VACCINATION SITE SWELLING (little swelling and redness at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Bee sting.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE RASH (Big rash which grew twice in size overnight.). On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to the touch), FATIGUE (felt very tired), VACCINATION SITE ERYTHEMA (little swelling and redness at the injection site) and VACCINATION SITE SWELLING (little swelling and redness at the injection site). The patient was treated with METHYLPREDNISOLONE for Rash, at a dose of 4 mg. On 16-Feb-2021, VACCINATION SITE RASH (Big rash which grew twice in size overnight.) had resolved. At the time of the report, VACCINATION SITE WARMTH (warm to the touch), FATIGUE (felt very tired), VACCINATION SITE ERYTHEMA (little swelling and redness at the injection site) and VACCINATION SITE SWELLING (little swelling and redness at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       Concomitant product use was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Additional AEs, medication taken, pt initial, 2nd dose information added
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: Bubbles of water pumping up in the hands and body; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Bubbles of water pumping up in the hands and body) in a 39-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLISTER (Bubbles of water pumping up in the hands and body). At the time of the report, BLISTER (Bubbles of water pumping up in the hands and body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: body aches; severly tire; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches) and FATIGUE (severly tire) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (body aches) and FATIGUE (severly tire). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (body aches) and FATIGUE (severly tire) outcome was unknown.            No concomitant medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Rash pruritic
Clinical narrative: itchy rash; red splody rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red splody rash) and RASH PRURITIC (itchy rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red splody rash). On 23-Feb-2021, the patient experienced RASH PRURITIC (itchy rash). The patient was treated with CORTISONE at a dose of cream. On 19-Feb-2021, INJECTION SITE ERYTHEMA (red splody rash) had resolved. At the time of the report, RASH PRURITIC (itchy rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Ice.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Chills, Hyperhidrosis, Pain
Clinical narrative: Sweating; Body aches; chills; slight arm soreness; little fever/had low grade fever 100/102.7; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), PYREXIA (little fever/had low grade fever 100/102.7), PAIN (Body aches), CHILLS (chills) and VACCINATION SITE PAIN (slight arm soreness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029LL0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, LEVOTHYROXINE and ALENDRONATE SODIUM (ALENDRONATE) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (little fever/had low grade fever 100/102.7) and VACCINATION SITE PAIN (slight arm soreness). On 22-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), PAIN (Body aches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Jan-2021, HYPERHIDROSIS (Sweating), PYREXIA (little fever/had low grade fever 100/102.7), PAIN (Body aches), CHILLS (chills) and VACCINATION SITE PAIN (slight arm soreness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Body temperature: 100 (High) High and 102.7 (High) High. On 22-Jan-2021, COVID-19: positive (Positive) POSITIVE.     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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.