chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Fibromyalgia, Joint swelling, Pain, Rash
Clinical narrative: Patient pain in arm at injection site next day after receiving 1st dose; Patient noticed swollen shoulder in arm at injection site; She slept all day.; burning pain all over body; Abdomen was swollen; Right side of her stomach (underneath breast) had some rash; Patient feels like having symptoms of fibromyalgia; Right side of her stomach (underneath breast)was tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient pain in arm at injection site next day after receiving 1st dose), JOINT SWELLING (Patient noticed swollen shoulder in arm at injection site), SOMNOLENCE (She slept all day.), PAIN (burning pain all over body) and ABDOMINAL DISTENSION (Abdomen was swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concomitant products included DEXLANSOPRAZOLE (DEXILANT), SERTRALINE HYDROCHLORIDE (ZOLOFT), ACETYLSALICYLIC ACID (BABY ASPIRIN) and cholesterol medication for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Patient pain in arm at injection site next day after receiving 1st dose), JOINT SWELLING (Patient noticed swollen shoulder in arm at injection site), SOMNOLENCE (She slept all day.), PAIN (burning pain all over body), ABDOMINAL DISTENSION (Abdomen was swollen), RASH (Right side of her stomach (underneath breast) had some rash), FIBROMYALGIA (Patient feels like having symptoms of fibromyalgia) and TENDERNESS (Right side of her stomach (underneath breast)was tender). At the time of the report, VACCINATION SITE PAIN (Patient pain in arm at injection site next day after receiving 1st dose), JOINT SWELLING (Patient noticed swollen shoulder in arm at injection site), SOMNOLENCE (She slept all day.), PAIN (burning pain all over body), ABDOMINAL DISTENSION (Abdomen was swollen), RASH (Right side of her stomach (underneath breast) had some rash), FIBROMYALGIA (Patient feels like having symptoms of fibromyalgia) and TENDERNESS (Right side of her stomach (underneath breast)was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tenderness, Vaccination site pain
Clinical narrative: Patient pain in arm at injection site next day after receiving 1st dose; Patient noticed swollen shoulder in arm at injection site; She slept all day.; burning pain all over body; Abdomen was swollen; Right side of her stomach (underneath breast) had some rash; Patient feels like having symptoms of fibromyalgia; Right side of her stomach (underneath breast)was tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Patient pain in arm at injection site next day after receiving 1st dose), JOINT SWELLING (Patient noticed swollen shoulder in arm at injection site), SOMNOLENCE (She slept all day.), PAIN (burning pain all over body) and ABDOMINAL DISTENSION (Abdomen was swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder. Concomitant products included DEXLANSOPRAZOLE (DEXILANT), SERTRALINE HYDROCHLORIDE (ZOLOFT), ACETYLSALICYLIC ACID (BABY ASPIRIN) and cholesterol medication for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Patient pain in arm at injection site next day after receiving 1st dose), JOINT SWELLING (Patient noticed swollen shoulder in arm at injection site), SOMNOLENCE (She slept all day.), PAIN (burning pain all over body), ABDOMINAL DISTENSION (Abdomen was swollen), RASH (Right side of her stomach (underneath breast) had some rash), FIBROMYALGIA (Patient feels like having symptoms of fibromyalgia) and TENDERNESS (Right side of her stomach (underneath breast)was tender). At the time of the report, VACCINATION SITE PAIN (Patient pain in arm at injection site next day after receiving 1st dose), JOINT SWELLING (Patient noticed swollen shoulder in arm at injection site), SOMNOLENCE (She slept all day.), PAIN (burning pain all over body), ABDOMINAL DISTENSION (Abdomen was swollen), RASH (Right side of her stomach (underneath breast) had some rash), FIBROMYALGIA (Patient feels like having symptoms of fibromyalgia) and TENDERNESS (Right side of her stomach (underneath breast)was tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Headache
Clinical narrative: Light Headedness; Pain was over back of his eye sockets to around the temples and the top of his head; Mild headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light Headedness), EYE PAIN (Pain was over back of his eye sockets to around the temples and the top of his head) and HEADACHE (Mild headaches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 032L20A) for COVID-19 vaccination.     The patient's past medical history included Hyperlipidaemia and Anxiety. Concurrent medical conditions included Hypertension. Concomitant products included IRBESARTAN (AVAPRO), ATORVASTATIN CALCIUM (LIPITOR) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.   On 19-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) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Light Headedness), EYE PAIN (Pain was over back of his eye sockets to around the temples and the top of his head) and HEADACHE (Mild headaches). At the time of the report, DIZZINESS (Light Headedness), EYE PAIN (Pain was over back of his eye sockets to around the temples and the top of his head) and HEADACHE (Mild headaches) outcome was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Skin discolouration, Swelling
Clinical narrative: warm arm; an off-colored dark pink circle the size of a nickel that was not sore/Pink/Off-coloured arm; red arm; swollen 2 inches in diameter; red spot; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red spot), ERYTHEMA (red arm), SWELLING (swollen 2 inches in diameter), FEELING HOT (warm arm) and SKIN DISCOLOURATION (an off-colored dark pink circle the size of a nickel that was not sore/Pink/Off-coloured arm) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced ERYTHEMA (red spot). On 23-Feb-2021, the patient experienced ERYTHEMA (red arm) and SWELLING (swollen 2 inches in diameter). On an unknown date, the patient experienced FEELING HOT (warm arm) and SKIN DISCOLOURATION (an off-colored dark pink circle the size of a nickel that was not sore/Pink/Off-coloured arm). On 13-Feb-2021, ERYTHEMA (red spot) outcome was unknown. At the time of the report, ERYTHEMA (red arm), SWELLING (swollen 2 inches in diameter), FEELING HOT (warm arm) and SKIN DISCOLOURATION (an off-colored dark pink circle the size of a nickel that was not sore/Pink/Off-coloured arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of erythema (after first shot, arm was red) in a patient, of an unknown age (around 30 in age) and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced erythema (after first shot, arm was red). At the time of the report, erythema (after first shot, arm was red) outcome: unknown. For mRNA-1273 (Moderna COVID-19 vaccine), unknown route; dosing remained unchanged. No concomitant medications or treatment information provided. Upon internal review on Aug 4, 2021, age information added to narrative supplement. This case linked to MOD-2021-034326 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-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 (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Asthenia, Diarrhoea, Fatigue
Clinical narrative: Upset stomach; Gas; Cramps in stomach; Difficulty getting to the bathroom; Headache; Tired; Nausea; Got diarrhea again; Intermittent bouts of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Intermittent bouts of diarrhea), ABDOMINAL DISCOMFORT (uUset stomach), FLATULENCE (Gas), ABDOMINAL PAIN UPPER (Cramps in stomach) and ASTHENIA (Difficulty getting to the bathroom) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TRAZODONE, ROSUVASTATIN CALCIUM (CRESTOR) and GABAPENTIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced DIARRHOEA (Got diarrhea again). On an unknown date, the patient experienced DIARRHOEA (Intermittent bouts of diarrhea), ABDOMINAL DISCOMFORT (uUset stomach), FLATULENCE (Gas), ABDOMINAL PAIN UPPER (Cramps in stomach), ASTHENIA (Difficulty getting to the bathroom), HEADACHE (Headache), FATIGUE (Tired) and NAUSEA (Nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event NOS, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Intermittent bouts of diarrhea) had resolved and ABDOMINAL DISCOMFORT (uUset stomach), FLATULENCE (Gas), ABDOMINAL PAIN UPPER (Cramps in stomach), ASTHENIA (Difficulty getting to the bathroom), DIARRHOEA (Got diarrhea again), HEADACHE (Headache), FATIGUE (Tired) and NAUSEA (Nausea) outcome was unknown.            This case was linked to MOD-2021-034265 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Flatulence, Headache, Nausea
Clinical narrative: Upset stomach; Gas; Cramps in stomach; Difficulty getting to the bathroom; Headache; Tired; Nausea; Got diarrhea again; Intermittent bouts of diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Intermittent bouts of diarrhea), ABDOMINAL DISCOMFORT (uUset stomach), FLATULENCE (Gas), ABDOMINAL PAIN UPPER (Cramps in stomach) and ASTHENIA (Difficulty getting to the bathroom) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included TRAZODONE, ROSUVASTATIN CALCIUM (CRESTOR) and GABAPENTIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced DIARRHOEA (Got diarrhea again). On an unknown date, the patient experienced DIARRHOEA (Intermittent bouts of diarrhea), ABDOMINAL DISCOMFORT (uUset stomach), FLATULENCE (Gas), ABDOMINAL PAIN UPPER (Cramps in stomach), ASTHENIA (Difficulty getting to the bathroom), HEADACHE (Headache), FATIGUE (Tired) and NAUSEA (Nausea). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Adverse event NOS, at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Intermittent bouts of diarrhea) had resolved and ABDOMINAL DISCOMFORT (uUset stomach), FLATULENCE (Gas), ABDOMINAL PAIN UPPER (Cramps in stomach), ASTHENIA (Difficulty getting to the bathroom), DIARRHOEA (Got diarrhea again), HEADACHE (Headache), FATIGUE (Tired) and NAUSEA (Nausea) outcome was unknown.            This case was linked to MOD-2021-034265 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Upper respiratory tract infection
Clinical narrative: Sore throat; Diagnosed with upper respiratory infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and UPPER RESPIRATORY TRACT INFECTION (Diagnosed with upper respiratory infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and UPPER RESPIRATORY TRACT INFECTION (Diagnosed with upper respiratory infection). The patient was treated with AZITHROMYCIN for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and UPPER RESPIRATORY TRACT INFECTION (Diagnosed with upper respiratory infection) outcome was unknown.            No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema
Clinical narrative: Swollen arm; Red spots on injected site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red spots on injected site) 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 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red spots on injected site). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE ERYTHEMA (Red spots on injected site) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive for COVID-19) in a 96-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced COVID-19 (Positive for COVID-19). At the time of the report, COVID-19 (Positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2020, SARS-CoV-2 test: positive (Positive) Received Bamlanivimab on 11/19/2020.. On 25-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 01-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Covid arm; Hot; Covid arm It is 6 by 6 inches in size swollen; Red arm; Red arm, it hurts; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (Covid arm It is 6 by 6 inches in size swollen), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Red arm, it hurts) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (Covid arm It is 6 by 6 inches in size swollen), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Red arm, it hurts). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CORTISONE (topical) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (Covid arm It is 6 by 6 inches in size swollen), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE PAIN (Red arm, it hurts) 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.   No relevant concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: bad reaction to the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (bad reaction to the first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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 VACCINATION SITE REACTION (bad reaction to the first dose).            This case was linked to MOD-2021-034320 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Myalgia, Pyrexia
Clinical narrative: little fever about 100.3; joint and muscle pain; joint and muscle pain; headache today; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (little fever about 100.3), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and HEADACHE (headache today) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (little fever about 100.3), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and HEADACHE (headache today). At the time of the report, PYREXIA (little fever about 100.3), ARTHRALGIA (joint and muscle pain), MYALGIA (joint and muscle pain) and HEADACHE (headache today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 100.3 degree Celsius High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Treatment details included not provided
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Vaccination site erythema; 3 inch square below injection site which was really red, swollen and tender to touch and gradually; (square) tender to touch and gradually spread to elbow at shoulder; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (3 inch square below injection site which was really red, swollen and tender to touch and gradually) and VACCINATION SITE PAIN ((square) tender to touch and gradually spread to elbow at shoulder) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event (No medical history reported) since an unknown date.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (3 inch square below injection site which was really red, swollen and tender to touch and gradually) and VACCINATION SITE PAIN ((square) tender to touch and gradually spread to elbow at shoulder). On 29-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Vaccination site erythema), VACCINATION SITE SWELLING (3 inch square below injection site which was really red, swollen and tender to touch and gradually) and VACCINATION SITE PAIN ((square) tender to touch and gradually spread to elbow at shoulder) had resolved.            Treatment for the events included paracetamol, Benadryl.    Reporter did not allow further contact
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 26-Aug-2020 and the estimated date of delivery was 22-May-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported .
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant patient received vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 028L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use and Nicotine dependence. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 24-Sep-2020 and the estimated date of delivery was 01-Jul-2021. On 07-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 04-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2020, Pregnancy test: Positive. In 2021, Ultrasound scan: normal.         The patient took one year to get pregnant. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Injection site has been hurting; Pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site has been hurting) and PAIN (Pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site has been hurting) and PAIN (Pain). At the time of the report, VACCINATION SITE PAIN (Injection site has been hurting) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's medical history was not provided.  Concomitant product use was Cholesterol medicine. No treatment medication was reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain
Clinical narrative: Injection arm tightness; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Injection arm tightness) and VACCINATION SITE PAIN (injection arm soreness) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Colitis. Concomitant products included MESALAZINE (LIALDA) for Colitis, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), MULTIVITAMIN [VITAMINS NOS], PROBIOTICS NOS, FISH OIL and INFLIXIMAB (REMICADE) for an unknown indication.    On 02-Mar-2021, 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 INDURATION (Injection arm tightness) and VACCINATION SITE PAIN (injection arm soreness). At the time of the report, VACCINATION SITE INDURATION (Injection arm tightness) and VACCINATION SITE PAIN (injection arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided by the reporter. Patient is taking additionally unknown Immunosuppressive medications as a concomitant medications.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Concomitant Medication and medical history updated. On 23-Jun-2021: Non-significant Follow-up appended
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Peripheral swelling, Pruritus
Clinical narrative: Itching in right arm; Right Arm Rash; Swollen in right arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Right Arm Rash), PERIPHERAL SWELLING (Swollen in right arm) and PRURITUS (Itching in right arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical records).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced INJECTION SITE RASH (Right Arm Rash) and PERIPHERAL SWELLING (Swollen in right arm). On an unknown date, the patient experienced PRURITUS (Itching in right arm). At the time of the report, INJECTION SITE RASH (Right Arm Rash), PERIPHERAL SWELLING (Swollen in right arm) and PRURITUS (Itching in right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: swelling of lymph node; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness) and LYMPHADENOPATHY (swelling of lymph node) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031220A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm soreness). On 28-Feb-2021, the patient experienced LYMPHADENOPATHY (swelling of lymph node). At the time of the report, VACCINATION SITE PAIN (Arm soreness) and LYMPHADENOPATHY (swelling of lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information were not reported. Treatment information were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue, Vaccination site pain
Clinical narrative: Syringe malfunctioned; Incomplete dose; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of SYRINGE ISSUE (Syringe malfunctioned), INCORRECT DOSE ADMINISTERED (Incomplete dose) and VACCINATION SITE PAIN (Soreness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SYRINGE ISSUE (Syringe malfunctioned), INCORRECT DOSE ADMINISTERED (Incomplete dose) and VACCINATION SITE PAIN (Soreness). On 04-Mar-2021, SYRINGE ISSUE (Syringe malfunctioned) and INCORRECT DOSE ADMINISTERED (Incomplete dose) had resolved. At the time of the report, VACCINATION SITE PAIN (Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to event was not provided.   Follow-up received on 31-MAr-2021 included no new information   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: NNI; Reporter's Comments: This report refers to a case of a 66-year-old, male patient who experienced syringe malfunctioned (Syringe issue and he received an incomplete dose (Incomplete dose administered) for mRNA-1273 (Lot number: unknown). The patient experienced soreness which is consistent with the known safety profile of the vaccine.  The events of syringe issue and incomplete dose administered are considered not applicable
Sex: F
Vaccine: COVID19
Symptoms: Yawning
Clinical narrative: Excessive yawn; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of YAWNING (Excessive yawn) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced YAWNING (Excessive yawn).   At the time of the report, YAWNING (Excessive yawn) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Injection site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE RASH (Injection site rash). On 10-Feb-2021, VACCINATION SITE RASH (Injection site rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-034398 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Chest discomfort, Emotional poverty, Fatigue, Feeling abnormal
Clinical narrative: Very similar to COVID/flu-ish feeling; tightness in the chest (noticed every breath); malaise; achiness; lack of interest; brain fogs; heart doesn't feel like before; just sits there and never done that before; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Very similar to COVID/flu-ish feeling), CHEST DISCOMFORT (tightness in the chest (noticed every breath)), MALAISE (malaise), PAIN (achiness) and EMOTIONAL POVERTY (lack of interest) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 antibody test positive on 22-Feb-2021.    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 INFLUENZA LIKE ILLNESS (Very similar to COVID/flu-ish feeling), CHEST DISCOMFORT (tightness in the chest (noticed every breath)), MALAISE (malaise), PAIN (achiness), EMOTIONAL POVERTY (lack of interest), FEELING ABNORMAL (brain fogs), FEELING ABNORMAL (heart doesn't feel like before), ABNORMAL BEHAVIOUR (just sits there and never done that before) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Very similar to COVID/flu-ish feeling), CHEST DISCOMFORT (tightness in the chest (noticed every breath)), MALAISE (malaise), PAIN (achiness), EMOTIONAL POVERTY (lack of interest), FEELING ABNORMAL (brain fogs), FEELING ABNORMAL (heart doesn't feel like before), ABNORMAL BEHAVIOUR (just sits there and never done that before) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medication details were not provided.   This case was linked to MOD-2021-053819 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Pain
Clinical narrative: Very similar to COVID/flu-ish feeling; tightness in the chest (noticed every breath); malaise; achiness; lack of interest; brain fogs; heart doesn't feel like before; just sits there and never done that before; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 04-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Very similar to COVID/flu-ish feeling), CHEST DISCOMFORT (tightness in the chest (noticed every breath)), MALAISE (malaise), PAIN (achiness) and EMOTIONAL POVERTY (lack of interest) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 antibody test positive on 22-Feb-2021.    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 INFLUENZA LIKE ILLNESS (Very similar to COVID/flu-ish feeling), CHEST DISCOMFORT (tightness in the chest (noticed every breath)), MALAISE (malaise), PAIN (achiness), EMOTIONAL POVERTY (lack of interest), FEELING ABNORMAL (brain fogs), FEELING ABNORMAL (heart doesn't feel like before), ABNORMAL BEHAVIOUR (just sits there and never done that before) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Very similar to COVID/flu-ish feeling), CHEST DISCOMFORT (tightness in the chest (noticed every breath)), MALAISE (malaise), PAIN (achiness), EMOTIONAL POVERTY (lack of interest), FEELING ABNORMAL (brain fogs), FEELING ABNORMAL (heart doesn't feel like before), ABNORMAL BEHAVIOUR (just sits there and never done that before) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medication details were not provided.   This case was linked to MOD-2021-053819 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: severe pain in his right knee; joint swelling; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (severe pain in his right knee) and JOINT SWELLING (joint swelling) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Protein C deficiency (Activated Protein C deficiency). Concomitant products included METHADONE for Chronic pain.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced ARTHRALGIA (severe pain in his right knee) and JOINT SWELLING (joint swelling). At the time of the report, ARTHRALGIA (severe pain in his right knee) and JOINT SWELLING (joint swelling) 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.   Treatment medication included Vicodin up to 4 times a day.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Myalgia, Pain
Clinical narrative: pain all over; muscle aches; freezing but have a fever accompanied with chills; Fatigue; freezing but have a fever accompanied with chills, low grade fever; pain in the arm of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain all over), VACCINATION SITE PAIN (pain in the arm of the injection site), MYALGIA (muscle aches), CHILLS (freezing but have a fever accompanied with chills) and PYREXIA (freezing but have a fever accompanied with chills, low grade fever) in a 69-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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in the arm of the injection site) and PYREXIA (freezing but have a fever accompanied with chills, low grade fever). On an unknown date, the patient experienced PAIN (pain all over), MYALGIA (muscle aches), CHILLS (freezing but have a fever accompanied with chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, Chills, Myalgia and Pain, at an unspecified dose and frequency. At the time of the report, PAIN (pain all over), VACCINATION SITE PAIN (pain in the arm of the injection site), MYALGIA (muscle aches), CHILLS (freezing but have a fever accompanied with chills), PYREXIA (freezing but have a fever accompanied with chills, low grade fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 100.8 °F (High) 100.8 and 101 °F (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: pain all over; muscle aches; freezing but have a fever accompanied with chills; Fatigue; freezing but have a fever accompanied with chills, low grade fever; pain in the arm of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain all over), VACCINATION SITE PAIN (pain in the arm of the injection site), MYALGIA (muscle aches), CHILLS (freezing but have a fever accompanied with chills) and PYREXIA (freezing but have a fever accompanied with chills, low grade fever) in a 69-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 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in the arm of the injection site) and PYREXIA (freezing but have a fever accompanied with chills, low grade fever). On an unknown date, the patient experienced PAIN (pain all over), MYALGIA (muscle aches), CHILLS (freezing but have a fever accompanied with chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, Chills, Myalgia and Pain, at an unspecified dose and frequency. At the time of the report, PAIN (pain all over), VACCINATION SITE PAIN (pain in the arm of the injection site), MYALGIA (muscle aches), CHILLS (freezing but have a fever accompanied with chills), PYREXIA (freezing but have a fever accompanied with chills, low grade fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 100.8 °F (High) 100.8 and 101 °F (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm felt sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm felt sore) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     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 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm felt sore). On 16-Jan-2021, PAIN IN EXTREMITY (arm felt sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  Treatment reported was none for adverse event.   This case was linked to MOD-2021-034426 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Tremor
Clinical narrative: Light headed  very dizzy; Shaking; Weakness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed  very dizzy), TREMOR (Shaking), ASTHENIA (Weakness) and CHILLS (Chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 012L20A) for COVID-19 vaccination.     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 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Light headed  very dizzy), TREMOR (Shaking), ASTHENIA (Weakness) and CHILLS (Chills). At the time of the report, DIZZINESS (Light headed  very dizzy), TREMOR (Shaking), ASTHENIA (Weakness) and CHILLS (Chills) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     This case was linked to MOD-2021-034425 (Patient Link).