chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Pyrexia, Rash, Respiratory rate
Clinical narrative: pressure in my chest; Shortness of breathe; rash; fever; headache; This spontaneous case was reported by a physician and describes the occurrence of CHEST DISCOMFORT (pressure in my chest), DYSPNOEA (Shortness of breathe), RASH (rash), PYREXIA (fever) and HEADACHE (headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Ventricular contractions premature on 01-Jan-2015. Concurrent medical conditions included Penicillin allergy. Concomitant products included FLINTSTONES MULTIVITAMINS WITH IRON from 01-Jan-2000 to an unknown date, PROBIOTICS NOS from 01-Jan-2019 to an unknown date and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) from 01-Jan-2019 to an unknown date for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced HEADACHE (headache). On 21-Apr-2021, the patient experienced CHEST DISCOMFORT (pressure in my chest), DYSPNOEA (Shortness of breathe), RASH (rash) and PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 20-Apr-2021, HEADACHE (headache) had resolved. On 22-Apr-2021, PYREXIA (fever) had resolved. On 25-Apr-2021, DYSPNOEA (Shortness of breathe) had resolved. At the time of the report, CHEST DISCOMFORT (pressure in my chest) and RASH (rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 100.4 (High) 100.4. On 22-Apr-2021, Heart rate: 90-150 (High) Increase 90-150 beats per minute. On 23-Apr-2021, Blood pressure measurement: 128/71 mmHg (High) high. On 23-Apr-2021, Body temperature: 97.5 (High) 97.5. On 23-Apr-2021, Computerised tomogram: abnormal (abnormal) there was a 0.5 cm ground glass optical left.. On 23-Apr-2021, Heart rate: 91 (High) 91 beats per minute. On 23-Apr-2021, Respiratory rate: 18 breaths per minute (abnormal) 18.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   In the ER, patient received a CT chest which showed glass opacities.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: update reporter, patient details, lab data, additional event (shortness of breath) and events outcome.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Migraine, Myalgia, Urticaria
Clinical narrative: hives; migranies; muscle aches; pain at injection site; Joint Pain; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), MIGRAINE (migranies), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at injection site) and ARTHRALGIA (Joint Pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), MIGRAINE (migranies), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at injection site), ARTHRALGIA (Joint Pain) and HEADACHE (Headaches). At the time of the report, URTICARIA (hives), MIGRAINE (migranies), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at injection site), ARTHRALGIA (Joint Pain) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines include Tylenol and Benadryl which helped alleviate some symptoms.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: hives; migranies; muscle aches; pain at injection site; Joint Pain; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), MIGRAINE (migranies), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at injection site) and ARTHRALGIA (Joint Pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), MIGRAINE (migranies), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at injection site), ARTHRALGIA (Joint Pain) and HEADACHE (Headaches). At the time of the report, URTICARIA (hives), MIGRAINE (migranies), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at injection site), ARTHRALGIA (Joint Pain) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines include Tylenol and Benadryl which helped alleviate some symptoms.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Injection site erythema, Injection site swelling, Injection site vesicles, Vaccination site induration
Clinical narrative: Site of injection has hard blister that is red in color; She mumbled they probably injected her with the wrong stuff that could kill her; Site of injection has hard blister that is red in color; Site of injection looks like puff pocket; Site of injection is hard; Site of injection had a little bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Site of injection is hard), INJECTION SITE SWELLING (Site of injection had a little bump), INJECTION SITE VESICLES (Site of injection has hard blister that is red in color), ABNORMAL BEHAVIOUR (She mumbled they probably injected her with the wrong stuff that could kill her) and INJECTION SITE ERYTHEMA (Site of injection has hard blister that is red in color) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced INJECTION SITE SWELLING (Site of injection had a little bump). On 24-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Site of injection is hard), INJECTION SITE VESICLES (Site of injection has hard blister that is red in color), ABNORMAL BEHAVIOUR (She mumbled they probably injected her with the wrong stuff that could kill her), INJECTION SITE ERYTHEMA (Site of injection has hard blister that is red in color) and INJECTION SITE SWELLING (Site of injection looks like puff pocket). At the time of the report, VACCINATION SITE INDURATION (Site of injection is hard), INJECTION SITE SWELLING (Site of injection had a little bump), INJECTION SITE VESICLES (Site of injection has hard blister that is red in color), ABNORMAL BEHAVIOUR (She mumbled they probably injected her with the wrong stuff that could kill her), INJECTION SITE ERYTHEMA (Site of injection has hard blister that is red in color) and INJECTION SITE SWELLING (Site of injection looks like puff pocket) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site was warm, red and swollen to the size of a baseball; Injection site was warm, red and swollen to the size of a baseball; Injection site was warm, red and swollen to the size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site was warm, red and swollen to the size of a baseball), VACCINATION SITE ERYTHEMA (Injection site was warm, red and swollen to the size of a baseball) and VACCINATION SITE SWELLING (Injection site was warm, red and swollen to the size of a baseball) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Injection site was warm, red and swollen to the size of a baseball), VACCINATION SITE ERYTHEMA (Injection site was warm, red and swollen to the size of a baseball) and VACCINATION SITE SWELLING (Injection site was warm, red and swollen to the size of a baseball). At the time of the report, VACCINATION SITE WARMTH (Injection site was warm, red and swollen to the size of a baseball), VACCINATION SITE ERYTHEMA (Injection site was warm, red and swollen to the size of a baseball) and VACCINATION SITE SWELLING (Injection site was warm, red and swollen to the size of a baseball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications or treatment therapy was reported
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever 101 F; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever 101 F) and CHILLS (Chills) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS (Using medications for Heart condition since 20 years) since 2001. Concomitant products included ATORVASTATIN, METOPROLOL, RAMIPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (Fever 101 F) and CHILLS (Chills). At the time of the report, PYREXIA (Fever 101 F) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (upper respiratory infection) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient inquiring about whether to receive the second shot while experiencing an upper respiratory infection. No concomitant medications were reported. No treatment was reported.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site rash, Vaccination site swelling
Clinical narrative: not comfortable; rash from injection site; swelling from injection site; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (not comfortable), VACCINATION SITE RASH (rash from injection site) and VACCINATION SITE SWELLING (swelling from injection 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 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DISCOMFORT (not comfortable), VACCINATION SITE RASH (rash from injection site) and VACCINATION SITE SWELLING (swelling from injection site). At the time of the report, DISCOMFORT (not comfortable), VACCINATION SITE RASH (rash from injection site) and VACCINATION SITE SWELLING (swelling from injection site) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up was received on 26 may 2021 included  non-Significant Fu: Outcome of events was recovered and reporter denied further follow up.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; shivering; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (shivering) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (shivering). At the time of the report, PYREXIA (Fever) and CHILLS (shivering) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Headache, Illness, Pain in extremity
Clinical narrative: she doesn't want to have second shot because afraid to pass through this again; Really sick; Arm is sore; Chills; Running high fever; Throwing up every hours; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (she doesn't want to have second shot because afraid to pass through this again), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm is sore), CHILLS (Chills) and PYREXIA (Running high fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03BB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced ILLNESS (Really sick), PAIN IN EXTREMITY (Arm is sore), CHILLS (Chills), PYREXIA (Running high fever), VOMITING (Throwing up every hours) and HEADACHE (Bad headache). On an unknown date, the patient experienced ANXIETY (she doesn't want to have second shot because afraid to pass through this again). At the time of the report, ANXIETY (she doesn't want to have second shot because afraid to pass through this again), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm is sore), CHILLS (Chills), PYREXIA (Running high fever), VOMITING (Throwing up every hours) and HEADACHE (Bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitants - blood pressure medication. Treatment information as not reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: she doesn't want to have second shot because afraid to pass through this again; Really sick; Arm is sore; Chills; Running high fever; Throwing up every hours; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (she doesn't want to have second shot because afraid to pass through this again), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm is sore), CHILLS (Chills) and PYREXIA (Running high fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03BB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced ILLNESS (Really sick), PAIN IN EXTREMITY (Arm is sore), CHILLS (Chills), PYREXIA (Running high fever), VOMITING (Throwing up every hours) and HEADACHE (Bad headache). On an unknown date, the patient experienced ANXIETY (she doesn't want to have second shot because afraid to pass through this again). At the time of the report, ANXIETY (she doesn't want to have second shot because afraid to pass through this again), ILLNESS (Really sick), PAIN IN EXTREMITY (Arm is sore), CHILLS (Chills), PYREXIA (Running high fever), VOMITING (Throwing up every hours) and HEADACHE (Bad headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitants - blood pressure medication. Treatment information as not reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bacterial vaginosis, Chills, Dyspnoea, Heart rate increased
Clinical narrative: UTI; BV; Short of Breath; Weakness; Rapid heart rate; HgbA1C up to 7.8; Hives; rash; Itching; Swelling; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), URTICARIA (Hives), RASH (rash) and PRURITUS (Itching) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 09-Apr-2021, the patient experienced URTICARIA (Hives), RASH (rash), PRURITUS (Itching) and SWELLING (Swelling). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI), BACTERIAL VAGINOSIS (BV), DYSPNOEA (Short of Breath), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid heart rate) and HYPERGLYCAEMIA (HgbA1C up to 7.8). On 30-Mar-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PRURITUS (Itching), SWELLING (Swelling), URINARY TRACT INFECTION (UTI), BACTERIAL VAGINOSIS (BV), DYSPNOEA (Short of Breath), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid heart rate) and HYPERGLYCAEMIA (HgbA1C up to 7.8) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperglycaemia, Pruritus, Pyrexia, Rash, Swelling
Clinical narrative: UTI; BV; Short of Breath; Weakness; Rapid heart rate; HgbA1C up to 7.8; Hives; rash; Itching; Swelling; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), URTICARIA (Hives), RASH (rash) and PRURITUS (Itching) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 09-Apr-2021, the patient experienced URTICARIA (Hives), RASH (rash), PRURITUS (Itching) and SWELLING (Swelling). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI), BACTERIAL VAGINOSIS (BV), DYSPNOEA (Short of Breath), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid heart rate) and HYPERGLYCAEMIA (HgbA1C up to 7.8). On 30-Mar-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PRURITUS (Itching), SWELLING (Swelling), URINARY TRACT INFECTION (UTI), BACTERIAL VAGINOSIS (BV), DYSPNOEA (Short of Breath), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid heart rate) and HYPERGLYCAEMIA (HgbA1C up to 7.8) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Urticaria
Clinical narrative: UTI; BV; Short of Breath; Weakness; Rapid heart rate; HgbA1C up to 7.8; Hives; rash; Itching; Swelling; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), URTICARIA (Hives), RASH (rash) and PRURITUS (Itching) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 09-Apr-2021, the patient experienced URTICARIA (Hives), RASH (rash), PRURITUS (Itching) and SWELLING (Swelling). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI), BACTERIAL VAGINOSIS (BV), DYSPNOEA (Short of Breath), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid heart rate) and HYPERGLYCAEMIA (HgbA1C up to 7.8). On 30-Mar-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PRURITUS (Itching), SWELLING (Swelling), URINARY TRACT INFECTION (UTI), BACTERIAL VAGINOSIS (BV), DYSPNOEA (Short of Breath), ASTHENIA (Weakness), HEART RATE INCREASED (Rapid heart rate) and HYPERGLYCAEMIA (HgbA1C up to 7.8) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache) 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 product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-089248 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up was received on 28 MAY2021 included reporter details were updated.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash pruritic
Clinical narrative: shingles; itchy spots on her head; itchy spots on her eyebrows; itchy spots became painful; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), RASH PRURITIC (itchy spots on her head), RASH PRURITIC (itchy spots on her eyebrows) and PAIN (itchy spots became painful) in a 73-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 HERPES ZOSTER (shingles), RASH PRURITIC (itchy spots on her head), RASH PRURITIC (itchy spots on her eyebrows) and PAIN (itchy spots became painful). At the time of the report, HERPES ZOSTER (shingles), RASH PRURITIC (itchy spots on her head), RASH PRURITIC (itchy spots on her eyebrows) and PAIN (itchy spots became painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-089287 (E2B Linked Report). This case was linked to MOD21-081347, MOD21-081381 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089287:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Decreased appetite, Headache, Nervousness, Pain
Clinical narrative: nervousness inside; anxiety; headache; achy; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), DECREASED APPETITE (no appetite), NERVOUSNESS (nervousness inside), ANXIETY (anxiety) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PAIN (achy), DECREASED APPETITE (no appetite) and HEADACHE (headache). On an unknown date, the patient experienced NERVOUSNESS (nervousness inside) and ANXIETY (anxiety). On 01-Mar-2021, PAIN (achy) had resolved. On 02-Mar-2021, DECREASED APPETITE (no appetite) and HEADACHE (headache) had resolved. At the time of the report, NERVOUSNESS (nervousness inside) and ANXIETY (anxiety) outcome was unknown. Unknown          Treatment information not reported. Concomitant medication information not reported.   This case was linked to MOD-2021-089245 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Fatigue, Pain in extremity, Post thrombotic syndrome
Clinical narrative: routine blood test showed lipoderma; Tiredness; minor sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (minor sore arm), POST THROMBOTIC SYNDROME (routine blood test showed lipoderma) and FATIGUE (Tiredness) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     The patient's past medical history included Clot blood (two). Concomitant products included RIVAROXABAN (XARELTO) for Clot blood.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (minor sore arm) and FATIGUE (Tiredness). On 19-Apr-2021, the patient experienced POST THROMBOTIC SYNDROME (routine blood test showed lipoderma). On 09-Apr-2021, PAIN IN EXTREMITY (minor sore arm) and FATIGUE (Tiredness) had resolved. At the time of the report, POST THROMBOTIC SYNDROME (routine blood test showed lipoderma) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Blood test: lipoderma (abnormal) lipoderma.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. The patient is due for her second dose of mRNA-1273 (Moderna COVID-19 Vaccine) on 06 May 2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Diarrhoea, Muscular weakness
Clinical narrative: Diarrhea; Middle level back pain; Legs feel week; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), BACK PAIN (Middle level back pain) and MUSCULAR WEAKNESS (Legs feel week) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 020B21A) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), BACK PAIN (Middle level back pain) and MUSCULAR WEAKNESS (Legs feel week). At the time of the report, DIARRHOEA (Diarrhea), BACK PAIN (Middle level back pain) and MUSCULAR WEAKNESS (Legs feel week) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-089588 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up information included AE outcome updated to recovered/resolved.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: she's still having ringing in her ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (she's still having ringing in her ears) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 22-Mar-2021, the patient experienced TINNITUS (she's still having ringing in her ears). At the time of the report, TINNITUS (she's still having ringing in her ears) had not resolved. Not Provided          no concomitant medications reported, no treatment details reported.   This case was linked to MODERNATX, INC.-MOD-2021-089263 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2021-089263:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Head discomfort, Tinnitus
Clinical narrative: ringing in ears; fullness in her head; ears pop; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears), HEAD DISCOMFORT (fullness in her head) and EAR DISCOMFORT (ears pop) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 30L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in ears), HEAD DISCOMFORT (fullness in her head) and EAR DISCOMFORT (ears pop). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; VITAMIN B12 NOS at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency. At the time of the report, TINNITUS (ringing in ears), HEAD DISCOMFORT (fullness in her head) and EAR DISCOMFORT (ears pop) outcome was unknown. Not Provided          No concomitant medications reported. The patient was treated with antihistamine.   This case was linked to US-MODERNATX, INC.-MOD-2021-089224 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089224:1st Dose
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Gait inability, Hypoaesthesia
Clinical narrative: legs were numb; severe dizziness; couldn't walk; fell; was weak; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (legs were numb), DIZZINESS (severe dizziness), GAIT INABILITY (couldn't walk), FALL (fell) and ASTHENIA (was weak) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HYPOAESTHESIA (legs were numb), DIZZINESS (severe dizziness), GAIT INABILITY (couldn't walk), FALL (fell) and ASTHENIA (was weak). At the time of the report, HYPOAESTHESIA (legs were numb), DIZZINESS (severe dizziness), GAIT INABILITY (couldn't walk), FALL (fell) and ASTHENIA (was weak) 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.   No concomitant medications reported.   At around 10:30-10:45am patient received vaccine and about an hour later, at 11:30-11:35am he had symptoms.  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: pain from her arm to her neck; bad headache; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (pain from her arm to her neck) and HEADACHE (bad headache) 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-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN (pain from her arm to her neck) and HEADACHE (bad headache). At the time of the report, PAIN (pain from her arm to her neck) and HEADACHE (bad headache) 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.   No concomitant medication were reported.  No treatment medication were provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            No concomitant medications were reported. Treatment information was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Mycobacterium tuberculosis complex test, Pyrexia
Clinical narrative: high fever for 18 hours; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (high fever for 18 hours) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE for Rheumatoid arthritis.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever for 18 hours). At the time of the report, PYREXIA (high fever for 18 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Mycobacterium tuberculosis complex test: unknown (Negative) Tb Test negative. On 20-Apr-2021, Mycobacterium tuberculosis complex test: unknown (Positive) TB spot test. On an unknown date, Mycobacterium tuberculosis complex test: unknown (Positive) quantiFeron-TB Gold Plus test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information were provided by the reporter.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: patch go away, but comes back; itchy; broke out on hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out on hives), RASH (patch go away, but comes back) and PRURITUS (itchy) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced URTICARIA (broke out on hives). On an unknown date, the patient experienced RASH (patch go away, but comes back) and PRURITUS (itchy). At the time of the report, URTICARIA (broke out on hives), RASH (patch go away, but comes back) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No specific follow-up information recorded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: "I was so bad I could not get out of my bed, even my toes curled when they hit the floor"; "I was so bad I could not get out of my bed, even my toes curled when they hit the floor"; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), PAIN IN EXTREMITY ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 08-Apr-2021, the patient experienced ASTHENIA ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), PAIN IN EXTREMITY ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). On 11-Apr-2021, ASTHENIA ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), PAIN IN EXTREMITY ("I was so bad I could not get out of my bed, even my toes curled when they hit the floor"), PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.   No corrective treatment was provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Oxygen saturation, Pain, Pyrexia
Clinical narrative: shortness of breath/difficulty breathing; aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), PAIN (aches) and PYREXIA (fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003b21a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Hypertension. Concomitant products included VALSARTAN (DIOVAN) for Hypertension.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), PAIN (aches) and PYREXIA (fever). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), PAIN (aches) and PYREXIA (fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 91-92 % (Inconclusive) oxygen was about 91-92 % and normal (normal) this lasted several hours and then returned to normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was included diovan and hydrochlorothiazide.   This case was linked to MOD-2021-114403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 as Suspect vaccine, adverse event, medical history, treatment and concomitant medication information was updated. On 15-Jun-2021: Follow up received on 15-Jun-2021 as reporter information was updated.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears (more in the right ear); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in the ears (more in the right ear)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced TINNITUS (Ringing in the ears (more in the right ear)). At the time of the report, TINNITUS (Ringing in the ears (more in the right ear)) outcome was unknown.            No concomitant medications were reported. No corrective treatment was provided.   This case was linked to MOD-2021-089251 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Irritable bowel syndrome
Clinical narrative: more intense episode of her IBS with diarrhea; more intense episode of her IBS with diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (more intense episode of her IBS with diarrhea) and DIARRHOEA (more intense episode of her IBS with diarrhea) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030a21a) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event. Concomitant products included THYROID (ARMOUR THYROID), prozac/fluoxetine, TRAZODONE, ZINC, MAGNESIUM, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALCIUM CARBONATE, MAGNESIUM CARBONATE, MAGNESIUM TRISILICATE, SODIUM BICARBONATE (PEPPERMINT INDIGESTION) for an unknown indication.    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 IRRITABLE BOWEL SYNDROME (more intense episode of her IBS with diarrhea) and DIARRHOEA (more intense episode of her IBS with diarrhea). At the time of the report, IRRITABLE BOWEL SYNDROME (more intense episode of her IBS with diarrhea) and DIARRHOEA (more intense episode of her IBS with diarrhea) 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.   This case was linked to MOD-2021-089287 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site lymphadenopathy
Clinical narrative: Lymph nodes under her left arm were swollen; Chills; Headache; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under her left arm were swollen), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Low grade fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Low grade fever). On 22-Apr-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under her left arm were swollen). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Lymph nodes under her left arm were swollen), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included BP medicine.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Faeces discoloured, Fatigue, Feeling abnormal
Clinical narrative: loose black stool; loose black stool; she is feeling wobbly; her stomach feels a little funny; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (loose black stool), DIARRHOEA (loose black stool), FEELING ABNORMAL (she is feeling wobbly), ABDOMINAL DISCOMFORT (her stomach feels a little funny) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0428212A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced FAECES DISCOLOURED (loose black stool), DIARRHOEA (loose black stool), FEELING ABNORMAL (she is feeling wobbly), ABDOMINAL DISCOMFORT (her stomach feels a little funny) and FATIGUE (fatigue). At the time of the report, FAECES DISCOLOURED (loose black stool), DIARRHOEA (loose black stool), FEELING ABNORMAL (she is feeling wobbly), ABDOMINAL DISCOMFORT (her stomach feels a little funny) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatments were reported.