chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Injection area has red bumps around it - left arm; Injection area itches - left arm; Injection area has red bumps around it - left arm; Arm was real sore for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was real sore for 3 days), VACCINATION SITE MASS (Injection area has red bumps around it - left arm), VACCINATION SITE PRURITUS (Injection area itches - left arm) and VACCINATION SITE ERYTHEMA (Injection area has red bumps around it - left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (She had a reaction to some band aids.). Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and CALCIUM for an unknown indication.    On 18-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 PAIN IN EXTREMITY (Arm was real sore for 3 days). On 26-Feb-2021, the patient experienced VACCINATION SITE MASS (Injection area has red bumps around it - left arm), VACCINATION SITE PRURITUS (Injection area itches - left arm) and VACCINATION SITE ERYTHEMA (Injection area has red bumps around it - left arm). The patient was treated with Physical therapy (Heating pad) for Pain in extremity; Physical therapy (Heating pad) for Vaccination site mass; Physical therapy (Heating pad) for Vaccination site pruritus and Physical therapy (Heating pad) for Vaccination site erythema. On 21-Feb-2021, PAIN IN EXTREMITY (Arm was real sore for 3 days) had resolved. At the time of the report, VACCINATION SITE MASS (Injection area has red bumps around it - left arm), VACCINATION SITE PRURITUS (Injection area itches - left arm) and VACCINATION SITE ERYTHEMA (Injection area has red bumps around it - left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Hot flush, Myalgia
Clinical narrative: If I put pressure on the area of head then I can recreate the pain looks like muscle pain; Head pain; I got the worst ear-ache to right ear, within 6 hours ear started feel better; I was standing in bathroom,got super-hot flush from head to toe within 5 minutes gone and no issues later; This spontaneous case was reported by a physician and describes the occurrence of HOT FLUSH (I was standing in bathroom,got super-hot flush from head to toe within 5 minutes gone and no issues later), EAR PAIN (I got the worst ear-ache to right ear, within 6 hours ear started feel better), HEADACHE (Head pain) and MYALGIA (If I put pressure on the area of head then I can recreate the pain looks like muscle pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 041L20A) for COVID-19 vaccination.     Concomitant products included THYROID (ARMOUR THYROID), BUPROPION HYDROCHLORIDE (WELLBUTRIN), SPIRONOLACTONE, MINOXIDIL, BIMATOPROST (LUMIGAN), CICLOSPORIN (RESTASIS), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FISH OIL, VITAMIN B [VITAMIN B NOS] and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced HOT FLUSH (I was standing in bathroom,got super-hot flush from head to toe within 5 minutes gone and no issues later). On 28-Jan-2021, the patient experienced EAR PAIN (I got the worst ear-ache to right ear, within 6 hours ear started feel better). On 29-Jan-2021, the patient experienced HEADACHE (Head pain). On an unknown date, the patient experienced MYALGIA (If I put pressure on the area of head then I can recreate the pain looks like muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Symptomatic treatment, at an unspecified dose and frequency. On 31-Dec-2020, HOT FLUSH (I was standing in bathroom,got super-hot flush from head to toe within 5 minutes gone and no issues later) had resolved. On 28-Jan-2021, EAR PAIN (I got the worst ear-ache to right ear, within 6 hours ear started feel better) had resolved. At the time of the report, HEADACHE (Head pain) and MYALGIA (If I put pressure on the area of head then I can recreate the pain looks like muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-023507 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow up document contains no new information.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Pain, Tachycardia
Clinical narrative: Pain; Tiredness; Chills; Fast heart beat; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast heart beat), DYSPNOEA (Shortness of breath), PAIN (Pain), FATIGUE (Tiredness) and CHILLS (Chills) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Palpitation, Tachycardia and Heart valve disorders (chest congestion due to leaky valve problem). Concomitant products included DIGOXIN, VERAPAMIL and PIROXICAM (MAXIDENE) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced TACHYCARDIA (Fast heart beat), DYSPNOEA (Shortness of breath) and CHILLS (Chills). On an unknown date, the patient experienced PAIN (Pain) and FATIGUE (Tiredness). On 13-Feb-2021, TACHYCARDIA (Fast heart beat), DYSPNOEA (Shortness of breath) and CHILLS (Chills) had resolved. At the time of the report, PAIN (Pain) and FATIGUE (Tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information -Regulatory Authority. Concomitant medication and events(Fatigue, Pain) reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Fever; A little bit of chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (A little bit of chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disease, unspecified.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced PYREXIA (Fever) and CHILLS (A little bit of chills). At the time of the report, PYREXIA (Fever) and CHILLS (A little bit of chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant products included medicine for heart disease and diabetes.   Treatment information was not provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Pyrexia
Clinical narrative: Every part of his body was complaining; Super high temperature up 104 F; Bad chills; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Every part of his body was complaining), PYREXIA (Super high temperature up 104 F) and CHILLS (Bad chills) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included Carotid artery stent insertion (he had a stent placed in his right carotid many years ago).   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DISCOMFORT (Every part of his body was complaining), PYREXIA (Super high temperature up 104 F) and CHILLS (Bad chills). On 23-Feb-2021, PYREXIA (Super high temperature up 104 F) and CHILLS (Bad chills) had resolved. At the time of the report, DISCOMFORT (Every part of his body was complaining) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Pyrexia: 104 (High) Super high temperature up 104 F.         The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity, Vaccination site erythema, Vaccination site mass
Clinical narrative: Knot at the injection site; Injection arm very itchy; Redness in the injection arm; Swelling (it's really swollen) in the injection arm; Exhausted; Did not feel well; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Knot at the injection site), VACCINATION SITE PRURITUS (Injection arm very itchy) and VACCINATION SITE ERYTHEMA (Redness in the injection arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included LISINOPRIL, METOPROLOL, ALPRAZOLAM and GABAPENTIN for an unknown indication.    On 16-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 MALAISE (Did not feel well) and PAIN IN EXTREMITY (Sore arm). On 17-Feb-2021, the patient experienced FATIGUE (Exhausted). On an unknown date, the patient experienced VACCINATION SITE MASS (Knot at the injection site), VACCINATION SITE PRURITUS (Injection arm very itchy), VACCINATION SITE ERYTHEMA (Redness in the injection arm) and VACCINATION SITE SWELLING (Swelling (it's really swollen) in the injection arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site erythema and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, MALAISE (Did not feel well), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Knot at the injection site), VACCINATION SITE PRURITUS (Injection arm very itchy), VACCINATION SITE ERYTHEMA (Redness in the injection arm), VACCINATION SITE SWELLING (Swelling (it's really swollen) in the injection arm) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Knot at the injection site; Injection arm very itchy; Redness in the injection arm; Swelling (it's really swollen) in the injection arm; Exhausted; Did not feel well; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Knot at the injection site), VACCINATION SITE PRURITUS (Injection arm very itchy) and VACCINATION SITE ERYTHEMA (Redness in the injection arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included LISINOPRIL, METOPROLOL, ALPRAZOLAM and GABAPENTIN for an unknown indication.    On 16-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 MALAISE (Did not feel well) and PAIN IN EXTREMITY (Sore arm). On 17-Feb-2021, the patient experienced FATIGUE (Exhausted). On an unknown date, the patient experienced VACCINATION SITE MASS (Knot at the injection site), VACCINATION SITE PRURITUS (Injection arm very itchy), VACCINATION SITE ERYTHEMA (Redness in the injection arm) and VACCINATION SITE SWELLING (Swelling (it's really swollen) in the injection arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site erythema and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, MALAISE (Did not feel well), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Knot at the injection site), VACCINATION SITE PRURITUS (Injection arm very itchy), VACCINATION SITE ERYTHEMA (Redness in the injection arm), VACCINATION SITE SWELLING (Swelling (it's really swollen) in the injection arm) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis, Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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 Alcohol use (infrequent). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), COD-LIVER OIL (FISH OIL [COD-LIVER OIL]) and DOCUSATE for an unknown indication.    On 15-Feb-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 16-Apr-2021. On 15-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 15-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Amniocentesis: normal (normal) Normal. On an unknown date, Glucose tolerance test: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.     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.   Past pregnancy details included: Live birth on 20 Apr-2018.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Gait inability, Headache, Hypoacusis
Clinical narrative: Vertigo; Can't walk; Could not hear clear with left ear; Cold sore; Body aches; Vomiting; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Could not hear clear with left ear), VERTIGO (Vertigo), GAIT INABILITY (Can't walk), ORAL HERPES (Cold sore) and PAIN (Body aches) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo (several years ago). Concurrent medical conditions included Hearing loss (Right ear due to ear condition) and Ear disorder NOS. Concomitant products included LISINOPRIL for an unknown indication.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced ORAL HERPES (Cold sore), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 19-Feb-2021, the patient experienced HYPOACUSIS (Could not hear clear with left ear). On 23-Feb-2021, the patient experienced VERTIGO (Vertigo) and GAIT INABILITY (Can't walk). The patient was treated with DIPHENHYDRAMINE ongoing since an unknown date at a dose of 1 dosage form and PARACETAMOL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPOACUSIS (Could not hear clear with left ear), ORAL HERPES (Cold sore), PAIN (Body aches), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and VERTIGO (Vertigo), GAIT INABILITY (Can't walk), VOMITING (Vomiting) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: high (High) 100.2 F.         Action taken with mRNA-1273 in response to the events was not applicable; Reporter'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.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes, Pain, Pyrexia, Vertigo, Vomiting
Clinical narrative: Vertigo; Can't walk; Could not hear clear with left ear; Cold sore; Body aches; Vomiting; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Could not hear clear with left ear), VERTIGO (Vertigo), GAIT INABILITY (Can't walk), ORAL HERPES (Cold sore) and PAIN (Body aches) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo (several years ago). Concurrent medical conditions included Hearing loss (Right ear due to ear condition) and Ear disorder NOS. Concomitant products included LISINOPRIL for an unknown indication.   On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced ORAL HERPES (Cold sore), PAIN (Body aches), VOMITING (Vomiting), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). On 19-Feb-2021, the patient experienced HYPOACUSIS (Could not hear clear with left ear). On 23-Feb-2021, the patient experienced VERTIGO (Vertigo) and GAIT INABILITY (Can't walk). The patient was treated with DIPHENHYDRAMINE ongoing since an unknown date at a dose of 1 dosage form and PARACETAMOL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPOACUSIS (Could not hear clear with left ear), ORAL HERPES (Cold sore), PAIN (Body aches), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and VERTIGO (Vertigo), GAIT INABILITY (Can't walk), VOMITING (Vomiting) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: high (High) 100.2 F.         Action taken with mRNA-1273 in response to the events was not applicable; Reporter'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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Rapid heart rate; Arm tenderness, could not lift arm; Fever; temperature to 102; Chills; Muscle aches; Nausea; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Rapid heart rate), PAIN IN EXTREMITY (Arm tenderness, could not lift arm), PYREXIA (Fever; temperature to 102), CHILLS (Chills) and MYALGIA (Muscle aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 TACHYCARDIA (Rapid heart rate), PAIN IN EXTREMITY (Arm tenderness, could not lift arm), PYREXIA (Fever; temperature to 102), CHILLS (Chills), MYALGIA (Muscle aches), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, TACHYCARDIA (Rapid heart rate), PAIN IN EXTREMITY (Arm tenderness, could not lift arm), PYREXIA (Fever; temperature to 102), CHILLS (Chills), MYALGIA (Muscle aches), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102 (Inconclusive) Inconclusive.     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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Tachycardia
Clinical narrative: Rapid heart rate; Arm tenderness, could not lift arm; Fever; temperature to 102; Chills; Muscle aches; Nausea; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Rapid heart rate), PAIN IN EXTREMITY (Arm tenderness, could not lift arm), PYREXIA (Fever; temperature to 102), CHILLS (Chills) and MYALGIA (Muscle aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 TACHYCARDIA (Rapid heart rate), PAIN IN EXTREMITY (Arm tenderness, could not lift arm), PYREXIA (Fever; temperature to 102), CHILLS (Chills), MYALGIA (Muscle aches), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, TACHYCARDIA (Rapid heart rate), PAIN IN EXTREMITY (Arm tenderness, could not lift arm), PYREXIA (Fever; temperature to 102), CHILLS (Chills), MYALGIA (Muscle aches), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102 (Inconclusive) Inconclusive.     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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Flushing, Headache
Clinical narrative: face was flushed; forehead was red, like she sunburned; affecting her sleeping, was not able to sleep; chills; Fever of 102°F; extreme headache; nauseated; fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm; Itchy area at the injection site of about 4 inches; Itchy area at the injection site of about 4 inches and it was red; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm), SLEEP DISORDER (affecting her sleeping, was not able to sleep), FLUSHING (face was flushed), ERYTHEMA (forehead was red, like she sunburned) and VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Feb-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) and VACCINATION SITE ERYTHEMA (Itchy area at the injection site of about 4 inches and it was red). On 18-Feb-2021 at 9:00 PM, the patient experienced HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm). On 19-Feb-2021, the patient experienced NAUSEA (nauseated). On 19-Feb-2021 at 4:00 AM, the patient experienced SLEEP DISORDER (affecting her sleeping, was not able to sleep), CHILLS (chills), PYREXIA (Fever of 102°F) and HEADACHE (extreme headache). On 20-Feb-2021, the patient experienced FLUSHING (face was flushed) and ERYTHEMA (forehead was red, like she sunburned). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. On 20-Feb-2021, NAUSEA (nauseated), CHILLS (chills), PYREXIA (Fever of 102°F) and HEADACHE (extreme headache) had resolved. At the time of the report, HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm), SLEEP DISORDER (affecting her sleeping, was not able to sleep), FLUSHING (face was flushed), ERYTHEMA (forehead was red, like she sunburned), VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) and VACCINATION SITE ERYTHEMA (Itchy area at the injection site of about 4 inches and it was red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Heart rate: 94-95 (High) 94-95 bpm. On 19-Feb-2021, Body temperature: 102 °F (High) 102. On 19-Feb-2021, Heart rate: 105 (High) 105 bpm.         No concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Nausea, Pyrexia, Sleep disorder
Clinical narrative: face was flushed; forehead was red, like she sunburned; affecting her sleeping, was not able to sleep; chills; Fever of 102°F; extreme headache; nauseated; fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm; Itchy area at the injection site of about 4 inches; Itchy area at the injection site of about 4 inches and it was red; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm), SLEEP DISORDER (affecting her sleeping, was not able to sleep), FLUSHING (face was flushed), ERYTHEMA (forehead was red, like she sunburned) and VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Feb-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) and VACCINATION SITE ERYTHEMA (Itchy area at the injection site of about 4 inches and it was red). On 18-Feb-2021 at 9:00 PM, the patient experienced HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm). On 19-Feb-2021, the patient experienced NAUSEA (nauseated). On 19-Feb-2021 at 4:00 AM, the patient experienced SLEEP DISORDER (affecting her sleeping, was not able to sleep), CHILLS (chills), PYREXIA (Fever of 102°F) and HEADACHE (extreme headache). On 20-Feb-2021, the patient experienced FLUSHING (face was flushed) and ERYTHEMA (forehead was red, like she sunburned). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. On 20-Feb-2021, NAUSEA (nauseated), CHILLS (chills), PYREXIA (Fever of 102°F) and HEADACHE (extreme headache) had resolved. At the time of the report, HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm), SLEEP DISORDER (affecting her sleeping, was not able to sleep), FLUSHING (face was flushed), ERYTHEMA (forehead was red, like she sunburned), VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) and VACCINATION SITE ERYTHEMA (Itchy area at the injection site of about 4 inches and it was red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Heart rate: 94-95 (High) 94-95 bpm. On 19-Feb-2021, Body temperature: 102 °F (High) 102. On 19-Feb-2021, Heart rate: 105 (High) 105 bpm.         No concomitant medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: face was flushed; forehead was red, like she sunburned; affecting her sleeping, was not able to sleep; chills; Fever of 102°F; extreme headache; nauseated; fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm; Itchy area at the injection site of about 4 inches; Itchy area at the injection site of about 4 inches and it was red; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm), SLEEP DISORDER (affecting her sleeping, was not able to sleep), FLUSHING (face was flushed), ERYTHEMA (forehead was red, like she sunburned) and VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Feb-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) and VACCINATION SITE ERYTHEMA (Itchy area at the injection site of about 4 inches and it was red). On 18-Feb-2021 at 9:00 PM, the patient experienced HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm). On 19-Feb-2021, the patient experienced NAUSEA (nauseated). On 19-Feb-2021 at 4:00 AM, the patient experienced SLEEP DISORDER (affecting her sleeping, was not able to sleep), CHILLS (chills), PYREXIA (Fever of 102°F) and HEADACHE (extreme headache). On 20-Feb-2021, the patient experienced FLUSHING (face was flushed) and ERYTHEMA (forehead was red, like she sunburned). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. On 20-Feb-2021, NAUSEA (nauseated), CHILLS (chills), PYREXIA (Fever of 102°F) and HEADACHE (extreme headache) had resolved. At the time of the report, HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm), SLEEP DISORDER (affecting her sleeping, was not able to sleep), FLUSHING (face was flushed), ERYTHEMA (forehead was red, like she sunburned), VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) and VACCINATION SITE ERYTHEMA (Itchy area at the injection site of about 4 inches and it was red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Heart rate: 94-95 (High) 94-95 bpm. On 19-Feb-2021, Body temperature: 102 °F (High) 102. On 19-Feb-2021, Heart rate: 105 (High) 105 bpm.         No concomitant medications were reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue
Clinical narrative: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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 FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 °F (High) 99.9.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment reported was none for adverse event.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Lacrimation increased, Pain, Pruritus
Clinical narrative: Soreness a little bit; Her eyes started watering; Her eyes started itching really bad; Her face started swelling; All red, her ears bright red; Reallly itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness a little bit), LACRIMATION INCREASED (Her eyes started watering), EYE PRURITUS (Her eyes started itching really bad), SWELLING FACE (Her face started swelling) and ERYTHEMA (All red, her ears bright red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN (Soreness a little bit), LACRIMATION INCREASED (Her eyes started watering), EYE PRURITUS (Her eyes started itching really bad), SWELLING FACE (Her face started swelling), ERYTHEMA (All red, her ears bright red) and PRURITUS (Reallly itchy). On 20-Feb-2021, PAIN (Soreness a little bit), LACRIMATION INCREASED (Her eyes started watering), EYE PRURITUS (Her eyes started itching really bad), SWELLING FACE (Her face started swelling), ERYTHEMA (All red, her ears bright red) and PRURITUS (Reallly itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Soreness a little bit; Her eyes started watering; Her eyes started itching really bad; Her face started swelling; All red, her ears bright red; Reallly itchy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness a little bit), LACRIMATION INCREASED (Her eyes started watering), EYE PRURITUS (Her eyes started itching really bad), SWELLING FACE (Her face started swelling) and ERYTHEMA (All red, her ears bright red) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN (Soreness a little bit), LACRIMATION INCREASED (Her eyes started watering), EYE PRURITUS (Her eyes started itching really bad), SWELLING FACE (Her face started swelling), ERYTHEMA (All red, her ears bright red) and PRURITUS (Reallly itchy). On 20-Feb-2021, PAIN (Soreness a little bit), LACRIMATION INCREASED (Her eyes started watering), EYE PRURITUS (Her eyes started itching really bad), SWELLING FACE (Her face started swelling), ERYTHEMA (All red, her ears bright red) and PRURITUS (Reallly itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Myalgia, Pain in extremity
Clinical narrative: felt sick; sore arm; body aches; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to vaccine (mild reaction to flu vaccine), Allergy to nuts (walnuts), Fruit allergy (kiwis), Allergy (a bad reaction to laundry detergent) and Latex allergy (a bad reaction to latex).    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced ILLNESS (felt sick), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, ILLNESS (felt sick), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported. No treatment related information has been reported.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt sick; sore arm; body aches; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to vaccine (mild reaction to flu vaccine), Allergy to nuts (walnuts), Fruit allergy (kiwis), Allergy (a bad reaction to laundry detergent) and Latex allergy (a bad reaction to latex).    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced ILLNESS (felt sick), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, ILLNESS (felt sick), PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported. No treatment related information has been reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pyrexia
Clinical narrative: Dizzy; Fever 99.8 and now 100.2; Super exhausted; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PYREXIA (Fever 99.8 and now 100.2) and FATIGUE (Super exhausted) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced DIZZINESS (Dizzy), PYREXIA (Fever 99.8 and now 100.2) and FATIGUE (Super exhausted). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), PYREXIA (Fever 99.8 and now 100.2) and FATIGUE (Super exhausted) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Pyrexia: 99.8 99.8 and 100.2 100.2.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 23-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 an unknown date and the estimated date of delivery was 17-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Slept all day"; Fatigue; Headache; Muscle pain in injected arm; Chills; Fever of 102.1; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day"), INJECTION SITE PAIN (Sore arm at injection site), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain in injected arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore arm at injection site). On 05-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm), CHILLS (Chills) and PYREXIA (Fever of 102.1). On 06-Feb-2021, the patient experienced SOMNOLENCE (Slept all day"). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept all day"), INJECTION SITE PAIN (Sore arm at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm), CHILLS (Chills) and PYREXIA (Fever of 102.1) outcome was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Slept all day"; Fatigue; Headache; Muscle pain in injected arm; Chills; Fever of 102.1; Sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept all day"), INJECTION SITE PAIN (Sore arm at injection site), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain in injected arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore arm at injection site). On 05-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm), CHILLS (Chills) and PYREXIA (Fever of 102.1). On 06-Feb-2021, the patient experienced SOMNOLENCE (Slept all day"). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Slept all day"), INJECTION SITE PAIN (Sore arm at injection site), FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain in injected arm), CHILLS (Chills) and PYREXIA (Fever of 102.1) outcome was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.