chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Rash pruritic, Vaccination site erythema
Clinical narrative: completely sweating; broke out in red, whelpy, described as with whelps, and itching rash; broke out in red, whelpy, described as with whelps, and itching rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (broke out in red, whelpy, described as with whelps, and itching rash), HYPERHIDROSIS (completely sweating) and VACCINATION SITE ERYTHEMA (broke out in red, whelpy, described as with whelps, and itching rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Itch. Concomitant products included AMLODIPINE, ATORVASTATIN and ASCORBIC ACID, COLECALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (MULTIVITAMIN HP) for an unknown indication.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced RASH PRURITIC (broke out in red, whelpy, described as with whelps, and itching rash) and VACCINATION SITE ERYTHEMA (broke out in red, whelpy, described as with whelps, and itching rash). On 22-Mar-2021, the patient experienced HYPERHIDROSIS (completely sweating). At the time of the report, RASH PRURITIC (broke out in red, whelpy, described as with whelps, and itching rash), HYPERHIDROSIS (completely sweating) and VACCINATION SITE ERYTHEMA (broke out in red, whelpy, described as with whelps, and itching rash) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment. Already had some previous medications for itching which she used to treat the rash yesterday 23Mar2021, including triamcinolone ointment and hydroxyzine 10 mg.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: redness over armpit area; itching over armpit area; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness over armpit area) and PRURITUS (itching over armpit area) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ERYTHEMA (redness over armpit area) and PRURITUS (itching over armpit area). At the time of the report, ERYTHEMA (redness over armpit area) and PRURITUS (itching over armpit area) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: "face tingling"; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ("face tingling") in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PARAESTHESIA ("face tingling"). At the time of the report, PARAESTHESIA ("face tingling") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination complication
Clinical narrative: had a reaction; Aches; Pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a reaction), PAIN (Aches) and PAIN (Pains) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse effect and COVID-19 (hospitalized.) in December 2020.    On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had a reaction), PAIN (Aches) and PAIN (Pains). At the time of the report, VACCINATION COMPLICATION (had a reaction), PAIN (Aches) and PAIN (Pains) outcome was unknown. Not Provided          No concomitant medicine reported. treatment include Aleve.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm Pain; Arm is Swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain) and PERIPHERAL SWELLING (Arm is Swollen) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00124216) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain) and PERIPHERAL SWELLING (Arm is Swollen). At the time of the report, PAIN IN EXTREMITY (Arm Pain) and PERIPHERAL SWELLING (Arm is Swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for COVID-19 after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19 after 1st dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19 after 1st dose). At the time of the report, COVID-19 (Tested positive for COVID-19 after 1st dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant details were provided No treatment details were provided
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Joint pain; Fever; Chills; Nausea; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (advil) at a dose of UNK dosage form. At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Joint pain; Fever; Chills; Nausea; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN (advil) at a dose of UNK dosage form. At the time of the report, ARTHRALGIA (Joint pain), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Vaccination site warmth
Clinical narrative: This spontaneous case reported by a consumer (subsequently medically confirmed), describes the occurrence of erythema (red arm), vaccination site warmth (hot to the touch), pain in extremity (sore arm) and peripheral swelling (swollen arm) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001A21A) for COVID-19 immunization. The patient's past medical history included no adverse event. On Mar 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced erythema (red arm), vaccination site warmth (hot to the touch), pain in extremity (sore arm) and peripheral swelling (swollen arm). At the time of the report, erythema (red arm), vaccination site warmth (hot to the touch), pain in extremity (sore arm) and peripheral swelling (swollen arm): resolving. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. Concomitant medications not provided. Treatment for the events: antibiotic.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Nauseous; Headache; Normal sore arm after shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Normal sore arm after shot), NAUSEA (Nauseous) and HEADACHE (Headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Normal sore arm after shot). On 14-Mar-2021, the patient experienced NAUSEA (Nauseous) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Normal sore arm after shot), NAUSEA (Nauseous) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Pain
Clinical narrative: bone pain; body pain; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain) and PAIN (body pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (bone pain) and PAIN (body pain).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Dizziness, Dyspepsia, Feeling abnormal, Headache
Clinical narrative: sick as a dog; muscle weakness; digestive issues; light headedness; can't get out of the bed; felt so terrible; nausea; muscle aches; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog), MUSCULAR WEAKNESS (muscle weakness), DYSPEPSIA (digestive issues), DIZZINESS (light headedness) and BED REST (can't get out of the bed) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick as a dog), MUSCULAR WEAKNESS (muscle weakness), DYSPEPSIA (digestive issues), DIZZINESS (light headedness), BED REST (can't get out of the bed), FEELING ABNORMAL (felt so terrible), NAUSEA (nausea), MYALGIA (muscle aches) and HEADACHE (severe headache). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick as a dog), MUSCULAR WEAKNESS (muscle weakness), DYSPEPSIA (digestive issues), DIZZINESS (light headedness), BED REST (can't get out of the bed), FEELING ABNORMAL (felt so terrible), NAUSEA (nausea), MYALGIA (muscle aches) and HEADACHE (severe headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient was sick for 10 days. Declined the Follow up.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Muscular weakness, Myalgia, Nausea
Clinical narrative: sick as a dog; muscle weakness; digestive issues; light headedness; can't get out of the bed; felt so terrible; nausea; muscle aches; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick as a dog), MUSCULAR WEAKNESS (muscle weakness), DYSPEPSIA (digestive issues), DIZZINESS (light headedness) and BED REST (can't get out of the bed) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick as a dog), MUSCULAR WEAKNESS (muscle weakness), DYSPEPSIA (digestive issues), DIZZINESS (light headedness), BED REST (can't get out of the bed), FEELING ABNORMAL (felt so terrible), NAUSEA (nausea), MYALGIA (muscle aches) and HEADACHE (severe headache). The patient was treated with ALPRAZOLAM (XANAX) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick as a dog), MUSCULAR WEAKNESS (muscle weakness), DYSPEPSIA (digestive issues), DIZZINESS (light headedness), BED REST (can't get out of the bed), FEELING ABNORMAL (felt so terrible), NAUSEA (nausea), MYALGIA (muscle aches) and HEADACHE (severe headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.    Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patient was sick for 10 days. Declined the Follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Headache, Heart rate increased, Palpitations
Clinical narrative: rapid heartbeat; developed anxiety; felt like it was going to beat out of my chest; slowed down a bit; beat again in the afternoon after lunch; four hours later, tension headache started in back of my neck; heart was pounding; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS, HEART RATE INCREASED, ANXIETY, CHEST DISCOMFORT, and CHEST DISCOMFORT in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PALPITATIONS and HEADACHE. On 18-Mar-2021, the patient experienced HEART RATE INCREASED, ANXIETY, CHEST DISCOMFORT, CHEST DISCOMFORT, and HEART RATE INCREASED. At the time of the report, PALPITATIONS, HEART RATE INCREASED, ANXIETY, CHEST DISCOMFORT, CHEST DISCOMFORT, HEART RATE INCREASED, and HEADACHE had resolved.        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.   No Concomitant medications were reported. No treatment medications were reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: body aches; diarrhea; high fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), DIARRHOEA (diarrhea) and PYREXIA (high fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 immunization.     The patient's past medical history included COVID-19 in November 2020.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PAIN (body aches), DIARRHOEA (diarrhea) and PYREXIA (high fever). At the time of the report, PAIN (body aches), DIARRHOEA (diarrhea) and PYREXIA (high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and ARTHRALGIA (shoulder area pain) in a male 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm pain) and ARTHRALGIA (shoulder area pain). At the time of the report, PAIN IN EXTREMITY (arm pain) and ARTHRALGIA (shoulder area pain) outcome was unknown. Unknown. Action taken with mRNA-1273 in response to the drug was not applicable. No concomitant medication information was provided. No treatment products information was provided. Reporter did not allow further contact.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Bruise at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (Bruise at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 INJECTION SITE BRUISING (Bruise at injection site). At the time of the report, INJECTION SITE BRUISING (Bruise at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications were not provided. Treatment information was not provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: IgG negative after completing vaccination series (1 moth after); This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (1 month after) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (1 month after). On 24-Mar-2021, SARS-COV-2 ANTIBODY TEST NEGATIVE (1 month after) had resolved. Not Provided    DIAGNOSTIC RESULTS: On 23-Mar-2021, SARS-CoV-2 antibody test: Negative.         No concomitant medications were provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Significant follow up appended. Patient race, weight, and height updated. Moderna Covid vaccine dose 1 and dose2, administration date and batch numbers were updated. On 12-Aug-2021: Follow up received.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Chills, Cough, Myalgia
Clinical narrative: tested positive for COVID-19; sore throat; cough; body aches; joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), OROPHARYNGEAL PAIN (sore throat), COUGH (cough), MYALGIA (body aches) and ARTHRALGIA (joint pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (tested positive for COVID-19), OROPHARYNGEAL PAIN (sore throat), COUGH (cough), MYALGIA (body aches), ARTHRALGIA (joint pain) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PHENOL (CHLORASEPTIC SORE THROAT [PHENOL]) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID-19), OROPHARYNGEAL PAIN (sore throat), COUGH (cough), MYALGIA (body aches), ARTHRALGIA (joint pain) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, COVID-19: positive (Positive) tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No concomitant medications were reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: tested positive for COVID-19; sore throat; cough; body aches; joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19), OROPHARYNGEAL PAIN (sore throat), COUGH (cough), MYALGIA (body aches) and ARTHRALGIA (joint pain) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Mar-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced COVID-19 (tested positive for COVID-19), OROPHARYNGEAL PAIN (sore throat), COUGH (cough), MYALGIA (body aches), ARTHRALGIA (joint pain) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PHENOL (CHLORASEPTIC SORE THROAT [PHENOL]) at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for COVID-19), OROPHARYNGEAL PAIN (sore throat), COUGH (cough), MYALGIA (body aches), ARTHRALGIA (joint pain) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, COVID-19: positive (Positive) tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; 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 DYSPNOEA (shortness of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse events were reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Sinus headache
Clinical narrative: sinus headaches; sore arm; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headaches), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus headache (Patient had sinus headaches at baseline about 4 times a week ). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced SINUS HEADACHE (sinus headaches), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue). At the time of the report, SINUS HEADACHE (sinus headaches), PAIN IN EXTREMITY (sore arm) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Slight fever; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Slight fever) and CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 PYREXIA (Slight fever) and CHILLS (Chills). At the time of the report, PYREXIA (Slight fever) and CHILLS (Chills) had resolved.            The concomitant medications were not provided. The treatment information was not provided. The action taken for mRNA-1273 with the events was considered as not applicable.   This case was linked to MOD21-061320 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pain
Clinical narrative: began itching; rash down my arm down to my elbow; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash down my arm down to my elbow), PRURITUS (began itching) and VACCINATION SITE PAIN (sore at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced RASH (rash down my arm down to my elbow), PRURITUS (began itching) and VACCINATION SITE PAIN (sore at the injection site). At the time of the report, RASH (rash down my arm down to my elbow), PRURITUS (began itching) and VACCINATION SITE PAIN (sore at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Diarrhoea, Headache, Illness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High blood pressure), PAIN (Aching), ILLNESS (She's been sick), ASTHENIA (She's been weak) and DIARRHOEA (Diarrhea) in a 65-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.     The patient's past medical history included Blood pressure abnormal since an unknown date.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (High blood pressure), PAIN (Aching), ILLNESS (She's been sick), ASTHENIA (She's been weak), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore injection site for 2-3 days). On 18-Mar-2021, VACCINATION SITE PAIN (Sore injection site for 2-3 days) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (High blood pressure), PAIN (Aching), ILLNESS (She's been sick), ASTHENIA (She's been weak), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications used were Blood pressure medication. Treatment information include Paracetamol and Loperamide.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (High blood pressure), PAIN (Aching), ILLNESS (She's been sick), ASTHENIA (She's been weak) and DIARRHOEA (Diarrhea) in a 65-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.     The patient's past medical history included Blood pressure abnormal since an unknown date.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (High blood pressure), PAIN (Aching), ILLNESS (She's been sick), ASTHENIA (She's been weak), DIARRHOEA (Diarrhea), HEADACHE (Headache), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore injection site for 2-3 days). On 18-Mar-2021, VACCINATION SITE PAIN (Sore injection site for 2-3 days) had resolved. At the time of the report, BLOOD PRESSURE INCREASED (High blood pressure), PAIN (Aching), ILLNESS (She's been sick), ASTHENIA (She's been weak), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications used were Blood pressure medication. Treatment information include Paracetamol and Loperamide.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain in extremity
Clinical narrative: Arm started getting sored and that lasted for 24 hours; A week later the arm pit started to feel sore, going down to the inside of the elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started getting sored and that lasted for 24 hours) and AXILLARY PAIN (A week later the arm pit started to feel sore, going down to the inside of the elbow) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm started getting sored and that lasted for 24 hours). In March 2021, the patient experienced AXILLARY PAIN (A week later the arm pit started to feel sore, going down to the inside of the elbow). On 06-Mar-2021, PAIN IN EXTREMITY (Arm started getting sored and that lasted for 24 hours) had resolved. At the time of the report, AXILLARY PAIN (A week later the arm pit started to feel sore, going down to the inside of the elbow) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included cholesterol medications. No treatment information was provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pains; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYALGIA (muscle pains) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 24-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced MYALGIA (muscle pains). At the time of the report, MYALGIA (muscle pains) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication were not reported/unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore; A Spontaneous report was received from nonhealth-care professional concerning a female patient of unknown age who received Moderna COVID-19 vaccine (m-RNA-1273). The patient medical history was nothing significant. No relevant concomitant medications are provided. On prior to the onset of the events the patient received his Moderns covid-19 vaccine with no(lot/batch) to for prophylaxis of COVID-19 infection. The very next day she experienced symptoms like swollen arm red and itchy. She received her second shot on 25-feb-2021 and symptoms started on 26-feb-2021. Action taken with mRNA-1273 in response to the events was reported. The outcome of events received after getting the moderna COVID-19 vaccine is not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site warmth
Clinical narrative: hot; itchy; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002BZ1A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (SYNTHROID), CELECOXIB (CELEXA [CELECOXIB]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), INDAPAMIDE, LOSARTAN POTASSIUM (COZAAR), CIMETIDINE, ALLOPURINOL, POTASSIUM CHLORIDE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (hot), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE WARMTH (hot), PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Upon internal review on 24-May-2021, age was corrected to unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site itching; Injection site redness; Injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE PRURITUS (Injection site itching) outcome was unknown.            This case was linked to MOD-2021-030074 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: TCR added. Patient updated e-mail and confirms the evens for first and second dose. No further FU required.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Hot to the touch at the injection site; Broke out with a rash on the arm around the injection site which looks like a solid lump; Itchiness at the injection site; Broke out with a rash on the arm around the injection site which looks like a solid lump; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE MASS (Broke out with a rash on the arm around the injection site which looks like a solid lump), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Broke out with a rash on the arm around the injection site which looks like a solid lump) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch at the injection site), VACCINATION SITE MASS (Broke out with a rash on the arm around the injection site which looks like a solid lump), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Broke out with a rash on the arm around the injection site which looks like a solid lump) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (Hot to the touch at the injection site) was resolving and VACCINATION SITE MASS (Broke out with a rash on the arm around the injection site which looks like a solid lump), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE RASH (Broke out with a rash on the arm around the injection site which looks like a solid lump) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got 2nd dose on 24 day interval; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd dose on 24 day interval) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd dose on 24 day interval). On 23-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd dose on 24 day interval) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: pain; Head ache; Tired; Ball; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head ache), LYMPHADENOPATHY (Ball), PAIN (pain) and FATIGUE (Tired) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 24-Mar-2021, the patient experienced LYMPHADENOPATHY (Ball). On an unknown date, the patient experienced HEADACHE (Head ache), PAIN (pain) and FATIGUE (Tired). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: A spontaneous report was received from a nurse concerning a 57-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced positive for Covid test/ SARS-CoV-2 test positive and 2 months since 1st vaccination/ product dose omission issue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027L20A) intramuscularly in the unknown site for prophylaxis of COVID-19 infection. On 26 Jan 2021, approximately 14 days after vaccination, the patient experienced was tested positive for Covid and 2 months since 1st vaccination. Treatment information was unknown. The second dose of mRNA-1273 was temporarily withheld in response to the event, positive for Covid test. Action taken with mRNA-1273 in response to the event, positive for Covid test, was unknown. Action taken with mRNA-1273 in response to the event, 2 months since 1st vaccination, was not applicable. The outcome of the event, positive for Covid test, was considered to be unknown. The outcome of the event, 2 months since 1st vaccination was considered to be resolved on an unknown date.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on her right arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her right arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Breast Surgery on left side and removed lymph nodes and left arm swollen arm.).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Rash on her right arm). At the time of the report, RASH (Rash on her right arm) had resolved.        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.   This case was linked to MOD-2021-028582 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain
Clinical narrative: No energy; Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), PAIN (Body aches) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis.   On 23-Mar-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 24-Mar-2021, the patient experienced ASTHENIA (No energy), PAIN (Body aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Ache, Chills and Energy decreased, at an unspecified dose and frequency. At the time of the report, ASTHENIA (No energy), PAIN (Body aches) and CHILLS (Chills) outcome was unknown. Not Provided          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.