chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Scar
Clinical narrative: mark on arm size of a ping pong ball; This spontaneous case was reported by a consumer and describes the occurrence of SCAR (mark on arm size of a ping pong ball) 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 SCAR (mark on arm size of a ping pong ball). At the time of the report, SCAR (mark on arm size of a ping pong ball) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Coughing; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing) and OROPHARYNGEAL PAIN (Sore throat) 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 COUGH (Coughing) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, COUGH (Coughing) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant product use was reported.  No treatment details were provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Cough
Clinical narrative: Asthmatic problems; Cough; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021. The most recent information was received on 04-Aug-2021 and was forwarded to Moderna on 04-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthmatic problems) and COUGH (Cough) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, COPD and Seasonal allergy.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced ASTHMA (Asthmatic problems) and COUGH (Cough). At the time of the report, ASTHMA (Asthmatic problems) and COUGH (Cough) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Treatment for the event include nebulizer solution.   This case was linked to US-MODERNATX, INC.-MOD-2021-077836 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Sig Fup received- event outcome/further fup declined; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077836:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Pain
Clinical narrative: Body aches; chills; Felt like "hit by a truck"; Nausea; Fever->101; Soreness in injected arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHILLS (chills), FATIGUE (Felt like "hit by a truck"), NAUSEA (Nausea) and PYREXIA (Fever->101) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Tetracycline).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Body aches), CHILLS (chills), FATIGUE (Felt like "hit by a truck"), NAUSEA (Nausea), PYREXIA (Fever->101) and VACCINATION SITE PAIN (Soreness in injected arm). At the time of the report, PAIN (Body aches), CHILLS (chills), FATIGUE (Felt like "hit by a truck"), NAUSEA (Nausea), PYREXIA (Fever->101) and VACCINATION SITE PAIN (Soreness in injected arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: >101 (High) Increased temperature.         Concomitant product includes Beta Blocker. No Treatment medications were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received on 04-AUG-2021 TCR form states Patient  was not well for 3 days after getting the vaccine but she is doing fine now and declined for a follow-up.She said that she is waiting to get a booster shot.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Body aches; chills; Felt like "hit by a truck"; Nausea; Fever->101; Soreness in injected arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHILLS (chills), FATIGUE (Felt like "hit by a truck"), NAUSEA (Nausea) and PYREXIA (Fever->101) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Tetracycline).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Body aches), CHILLS (chills), FATIGUE (Felt like "hit by a truck"), NAUSEA (Nausea), PYREXIA (Fever->101) and VACCINATION SITE PAIN (Soreness in injected arm). At the time of the report, PAIN (Body aches), CHILLS (chills), FATIGUE (Felt like "hit by a truck"), NAUSEA (Nausea), PYREXIA (Fever->101) and VACCINATION SITE PAIN (Soreness in injected arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: >101 (High) Increased temperature.         Concomitant product includes Beta Blocker. No Treatment medications were provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received on 04-AUG-2021 TCR form states Patient  was not well for 3 days after getting the vaccine but she is doing fine now and declined for a follow-up.She said that she is waiting to get a booster shot.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Erythema, Headache, Induration, Swelling
Clinical narrative: Shoulder is hard; Shoulder is red; Shoulder is swollen with a big knot; Shoulder is very tender; Coughing all night long; Headache; This spontaneous case was reported by a patient and describes the occurrence of INDURATION (Shoulder is hard), ERYTHEMA (Shoulder is red), SWELLING (Shoulder is swollen with a big knot), TENDERNESS (Shoulder is very tender) and COUGH (Coughing all night long) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 016B21A) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, 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 experienced INDURATION (Shoulder is hard), ERYTHEMA (Shoulder is red), SWELLING (Shoulder is swollen with a big knot), TENDERNESS (Shoulder is very tender), COUGH (Coughing all night long) and HEADACHE (Headache). At the time of the report, INDURATION (Shoulder is hard), ERYTHEMA (Shoulder is red), SWELLING (Shoulder is swollen with a big knot), TENDERNESS (Shoulder is very tender) and HEADACHE (Headache) outcome was unknown and COUGH (Coughing all night long) had resolved.            No relevant concomitant product use was reported.  Treatment details included tylenol, Ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-078383 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078383:First dose case
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Shoulder is hard; Shoulder is red; Shoulder is swollen with a big knot; Shoulder is very tender; Coughing all night long; Headache; This spontaneous case was reported by a patient and describes the occurrence of INDURATION (Shoulder is hard), ERYTHEMA (Shoulder is red), SWELLING (Shoulder is swollen with a big knot), TENDERNESS (Shoulder is very tender) and COUGH (Coughing all night long) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 016B21A) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, 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 experienced INDURATION (Shoulder is hard), ERYTHEMA (Shoulder is red), SWELLING (Shoulder is swollen with a big knot), TENDERNESS (Shoulder is very tender), COUGH (Coughing all night long) and HEADACHE (Headache). At the time of the report, INDURATION (Shoulder is hard), ERYTHEMA (Shoulder is red), SWELLING (Shoulder is swollen with a big knot), TENDERNESS (Shoulder is very tender) and HEADACHE (Headache) outcome was unknown and COUGH (Coughing all night long) had resolved.            No relevant concomitant product use was reported.  Treatment details included tylenol, Ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-078383 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078383:First dose case
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Headache, Myalgia, Pain
Clinical narrative: High fever; Pains; Aches; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (High fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028LC0A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 24-Feb-2021, the patient experienced PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced PYREXIA (High fever). At the time of the report, PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (High fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Negative.         Action taken with mRNA-1273 in response to the event was not applicable.  Treatment details included paracetamol for fever.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever; Pains; Aches; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (High fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028LC0A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 24-Feb-2021, the patient experienced PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache) and CHILLS (Chills). On an unknown date, the patient experienced PYREXIA (High fever). At the time of the report, PAIN (Pains), MYALGIA (Aches), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (High fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Negative.         Action taken with mRNA-1273 in response to the event was not applicable.  Treatment details included paracetamol for fever.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: felt like its patch not injection, he did not feel needle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (felt like its patch not injection, he did not feel needle) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE REACTION (felt like its patch not injection, he did not feel needle). At the time of the report, VACCINATION SITE REACTION (felt like its patch not injection, he did not feel needle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product information was reported.  No treatment information was provided.   This case was linked to MOD-2021-077828 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine to a 17 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old). On 15-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine to a 17 year old) 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 relevant concomitant medication was reported.  Treatment details include, none.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Pain in extremity, Restlessness
Clinical narrative: Body aches; sore L arm; Restless; hang over; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (sore L arm), RESTLESSNESS (Restless), FEELING ABNORMAL (hang over) and FATIGUE (tired) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 047A21A) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (sore L arm), RESTLESSNESS (Restless), FEELING ABNORMAL (hang over) and FATIGUE (tired). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (sore L arm), RESTLESSNESS (Restless), FEELING ABNORMAL (hang over) and FATIGUE (tired) outcome was unknown. Not Provided          Patient was taking vitamin for unknown indication. Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable   This case was linked to US-MODERNATX, INC.-MOD-2021-078318 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078318:DOSE1
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Influenza like illness, Pain
Clinical narrative: feeling foggy/ buzzy/; Dizziness; Chills; Feverish; Achy muscles; flu like symptoms; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Achy muscles), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feeling foggy/ buzzy/) and DIZZINESS (Dizziness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iron deficiency (Borderline iron deficiency), Anemia since 2017 and Hypothyroidism. Concomitant products included FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and IRON EXTRA for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Apr-2021, the patient experienced PAIN (Achy muscles), INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (Chills) and PYREXIA (Feverish). On 14-Apr-2021, the patient experienced FEELING ABNORMAL (feeling foggy/ buzzy/) and DIZZINESS (Dizziness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Achy muscles), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feeling foggy/ buzzy/), DIZZINESS (Dizziness), CHILLS (Chills) and PYREXIA (Feverish) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication included Thyroid PX for hypothyroidism , DIMension 3 for estrogen metabolism, Regenemax plus for collagen generator.     This case was linked to US-MODERNATX, INC.-MOD-2021-143633 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient demographics, medical history, product details, concomitant medication were updated, events outcome was updated to recovered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-143633:Dose 2
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: feeling foggy/ buzzy/; Dizziness; Chills; Feverish; Achy muscles; flu like symptoms; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Achy muscles), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feeling foggy/ buzzy/) and DIZZINESS (Dizziness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iron deficiency (Borderline iron deficiency), Anemia since 2017 and Hypothyroidism. Concomitant products included FISH OIL, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and IRON EXTRA for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 09-Apr-2021, the patient experienced PAIN (Achy muscles), INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (Chills) and PYREXIA (Feverish). On 14-Apr-2021, the patient experienced FEELING ABNORMAL (feeling foggy/ buzzy/) and DIZZINESS (Dizziness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Achy muscles), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (feeling foggy/ buzzy/), DIZZINESS (Dizziness), CHILLS (Chills) and PYREXIA (Feverish) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication included Thyroid PX for hypothyroidism , DIMension 3 for estrogen metabolism, Regenemax plus for collagen generator.     This case was linked to US-MODERNATX, INC.-MOD-2021-143633 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Patient demographics, medical history, product details, concomitant medication were updated, events outcome was updated to recovered.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-143633:Dose 2
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Culture throat, Oropharyngeal pain, Pharyngitis streptococcal
Clinical narrative: Sore throat; Strep Throat Confirmed by Throat Swab; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and PHARYNGITIS STREPTOCOCCAL (Strep Throat Confirmed by Throat Swab) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and PHARYNGITIS STREPTOCOCCAL (Strep Throat Confirmed by Throat Swab). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and PHARYNGITIS STREPTOCOCCAL (Strep Throat Confirmed by Throat Swab) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Culture throat: (abnormal) Strep Throat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported.  Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: rash just around the injection site; itchy that comes and goes just around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash just around the injection site) and VACCINATION SITE PRURITUS (itchy that comes and goes just around the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE RASH (rash just around the injection site) and VACCINATION SITE PRURITUS (itchy that comes and goes just around the injection site). At the time of the report, VACCINATION SITE RASH (rash just around the injection site) and VACCINATION SITE PRURITUS (itchy that comes and goes just around the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medicines were not reorted Action taken with mRNA-1273 in response to the event was unknown
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Leukocytosis, Lymphadenopathy
Clinical narrative: WBC counts were too high above 100,000; fever; chills; BP 90/50; body aches; lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), BLOOD PRESSURE DECREASED (BP 90/50), MYALGIA (body aches) and LYMPHADENOPATHY (lymph nodes) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), BLOOD PRESSURE DECREASED (BP 90/50), MYALGIA (body aches) and LYMPHADENOPATHY (lymph nodes). On 10-Apr-2021, the patient experienced LEUKOCYTOSIS (WBC counts were too high above 100,000). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chills), BLOOD PRESSURE DECREASED (BP 90/50), MYALGIA (body aches), LYMPHADENOPATHY (lymph nodes) and LEUKOCYTOSIS (WBC counts were too high above 100,000) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Blood pressure measurement: 90/50 (Low) 90/50. On 10-Apr-2021, White blood cell count: above 100,000 (High) above 100,000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, White blood cell count
Clinical narrative: WBC counts were too high above 100,000; fever; chills; BP 90/50; body aches; lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), BLOOD PRESSURE DECREASED (BP 90/50), MYALGIA (body aches) and LYMPHADENOPATHY (lymph nodes) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), BLOOD PRESSURE DECREASED (BP 90/50), MYALGIA (body aches) and LYMPHADENOPATHY (lymph nodes). On 10-Apr-2021, the patient experienced LEUKOCYTOSIS (WBC counts were too high above 100,000). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (chills), BLOOD PRESSURE DECREASED (BP 90/50), MYALGIA (body aches), LYMPHADENOPATHY (lymph nodes) and LEUKOCYTOSIS (WBC counts were too high above 100,000) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Blood pressure measurement: 90/50 (Low) 90/50. On 10-Apr-2021, White blood cell count: above 100,000 (High) above 100,000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot in injection site; Red area looked as little rush; Swollen injection site; Pain in injection site; Redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot in injection site), ERYTHEMA (Red area looked as little rush), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Redness in injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included METFORMIN and ATORVASTATIN for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot in injection site), ERYTHEMA (Red area looked as little rush), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Redness in injection site). At the time of the report, VACCINATION SITE WARMTH (Hot in injection site), ERYTHEMA (Red area looked as little rush), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Redness in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the event was unknown
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site urticaria
Clinical narrative: red welt of approximately 6 cm, at the injection site; at the injection site and it hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (red welt of approximately 6 cm, at the injection site) and VACCINATION SITE PAIN (at the injection site and it hurts a lot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for Blood pressure.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (red welt of approximately 6 cm, at the injection site) and VACCINATION SITE PAIN (at the injection site and it hurts a lot). At the time of the report, VACCINATION SITE URTICARIA (red welt of approximately 6 cm, at the injection site) and VACCINATION SITE PAIN (at the injection site and it hurts a lot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Action taken with mRNA-1273 in response to the event was unknown   This case was linked to MOD21-076388 (E2B Linked Report).; Sender's Comments:  MOD21-076388:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Duodenogastric reflux, Fatigue, Hyperhidrosis
Clinical narrative: Weak; Spitting up/throw up a yellow fluid; Little bit dizzy; Tired; Running a sweat; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DUODENOGASTRIC REFLUX (Spitting up/throw up a yellow fluid), HYPERHIDROSIS (Running a sweat), DIZZINESS (Little bit dizzy) and FATIGUE (Tired) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced HYPERHIDROSIS (Running a sweat). On 15-Apr-2021, the patient experienced ASTHENIA (Weak), DUODENOGASTRIC REFLUX (Spitting up/throw up a yellow fluid), DIZZINESS (Little bit dizzy) and FATIGUE (Tired). At the time of the report, ASTHENIA (Weak), DUODENOGASTRIC REFLUX (Spitting up/throw up a yellow fluid), HYPERHIDROSIS (Running a sweat), DIZZINESS (Little bit dizzy) and FATIGUE (Tired) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dry throat, Fatigue, Headache
Clinical narrative: Dry throat; Headaches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DRY THROAT (Dry throat), HEADACHE (Headaches) and FATIGUE (Fatigue) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced DRY THROAT (Dry throat), HEADACHE (Headaches) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, DRY THROAT (Dry throat), HEADACHE (Headaches) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Oral candidiasis, Pain in extremity
Clinical narrative: sore arm; thrush; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ORAL CANDIDIASIS (thrush) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-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 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and ORAL CANDIDIASIS (thrush). The patient was treated with NYSTATIN (NISTATIN) for Thrush, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and ORAL CANDIDIASIS (thrush) had resolved. Not Provided          Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Significant FU appended: Treatment medication nistatin was added and outcome of event thrush was updated to resolved.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema
Clinical narrative: red/pinkish injection site after 1st dose; chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red/pinkish injection site after 1st dose) and CHILLS (chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Dizzy and Weakness generalized. Concomitant products included WARFARIN, METOPROLOL, FUROSEMIDE, LORAZEPAM, SIMVASTATIN and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication, ASCORBIC ACID.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (red/pinkish injection site after 1st dose) and CHILLS (chills). On 12-Mar-2021, INJECTION SITE ERYTHEMA (red/pinkish injection site after 1st dose) had resolved and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included trilogy   This case was linked to US-MODERNATX, INC.-MOD-2021-071343 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071343:First dose vaccination
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: Head Infection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (Head Infection) 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 INFECTION (Head Infection). At the time of the report, INFECTION (Head Infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information was not provided
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, 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 experienced DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown. Not Provided          Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: feeling sick; nausea; soreness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), NAUSEA (nausea) and MYALGIA (soreness) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 025A21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced MALAISE (feeling sick), NAUSEA (nausea) and MYALGIA (soreness). At the time of the report, MALAISE (feeling sick), NAUSEA (nausea) and MYALGIA (soreness) outcome was unknown.            Treatment medication include Pepcid  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable
Sex: U
Vaccine: COVID19
Symptoms: Intercepted product storage error
Clinical narrative: Intercepted product storage error; This spontaneous case was reported by a consumer and describes the occurrence of INTERCEPTED PRODUCT STORAGE ERROR (Intercepted product storage error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042460) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCEPTED PRODUCT STORAGE ERROR (Intercepted product storage error). At the time of the report, INTERCEPTED PRODUCT STORAGE ERROR (Intercepted product storage error) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Chills, Cough
Clinical narrative: Breathlessness; TIREDNESS; BODY ACHE; Joint pain; Vaccination site redness; Lots of shivering; Fever is 101.2; Back ache; Headache; Aggravated Cough; Stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), DYSPNOEA (Breathlessness), BACK PAIN (Back ache) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (Recent change in status of chronic condition: after taking the vaccine for a couple of weeks.) in 2004.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), BACK PAIN (Back ache), HEADACHE (Headache), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Vaccination site redness), CHILLS (Lots of shivering) and PYREXIA (Fever is 101.2). On an unknown date, the patient experienced DYSPNOEA (Breathlessness), FATIGUE (TIREDNESS) and MYALGIA (BODY ACHE). The patient was treated with Physical therapy for Back pain. At the time of the report, COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Vaccination site redness), CHILLS (Lots of shivering) and PYREXIA (Fever is 101.2) had resolved, DYSPNOEA (Breathlessness), FATIGUE (TIREDNESS) and MYALGIA (BODY ACHE) outcome was unknown and BACK PAIN (Back ache) and ARTHRALGIA (Joint pain) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-009476 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant FU : AE details provided; Sender's Comments:  MOD-2021-009476:Dose 1
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Breathlessness; TIREDNESS; BODY ACHE; Joint pain; Vaccination site redness; Lots of shivering; Fever is 101.2; Back ache; Headache; Aggravated Cough; Stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), DYSPNOEA (Breathlessness), BACK PAIN (Back ache) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (Recent change in status of chronic condition: after taking the vaccine for a couple of weeks.) in 2004.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), BACK PAIN (Back ache), HEADACHE (Headache), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Vaccination site redness), CHILLS (Lots of shivering) and PYREXIA (Fever is 101.2). On an unknown date, the patient experienced DYSPNOEA (Breathlessness), FATIGUE (TIREDNESS) and MYALGIA (BODY ACHE). The patient was treated with Physical therapy for Back pain. At the time of the report, COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Vaccination site redness), CHILLS (Lots of shivering) and PYREXIA (Fever is 101.2) had resolved, DYSPNOEA (Breathlessness), FATIGUE (TIREDNESS) and MYALGIA (BODY ACHE) outcome was unknown and BACK PAIN (Back ache) and ARTHRALGIA (Joint pain) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-009476 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant FU : AE details provided; Sender's Comments:  MOD-2021-009476:Dose 1
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Breathlessness; TIREDNESS; BODY ACHE; Joint pain; Vaccination site redness; Lots of shivering; Fever is 101.2; Back ache; Headache; Aggravated Cough; Stomach ache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), DYSPNOEA (Breathlessness), BACK PAIN (Back ache) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (Recent change in status of chronic condition: after taking the vaccine for a couple of weeks.) in 2004.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), BACK PAIN (Back ache), HEADACHE (Headache), ARTHRALGIA (Joint pain), VACCINATION SITE ERYTHEMA (Vaccination site redness), CHILLS (Lots of shivering) and PYREXIA (Fever is 101.2). On an unknown date, the patient experienced DYSPNOEA (Breathlessness), FATIGUE (TIREDNESS) and MYALGIA (BODY ACHE). The patient was treated with Physical therapy for Back pain. At the time of the report, COUGH (Aggravated Cough), ABDOMINAL PAIN UPPER (Stomach ache), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Vaccination site redness), CHILLS (Lots of shivering) and PYREXIA (Fever is 101.2) had resolved, DYSPNOEA (Breathlessness), FATIGUE (TIREDNESS) and MYALGIA (BODY ACHE) outcome was unknown and BACK PAIN (Back ache) and ARTHRALGIA (Joint pain) had resolved with sequelae.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to MOD-2021-009476 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant FU : AE details provided; Sender's Comments:  MOD-2021-009476:Dose 1