chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Nausea
Clinical narrative: she started with brain fog in end of May; She had difficulty breathing that started around 13Jun2021.; nausea after the 2nd dose/She had nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had difficulty breathing that started around 13Jun2021.), FEELING ABNORMAL (she started with brain fog in end of May) and NAUSEA (nausea after the 2nd dose/She had nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 048B21A) for COVID-19 vaccination.     No medical reported history provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced NAUSEA (nausea after the 2nd dose/She had nausea). On 13-Jun-2021, the patient experienced DYSPNOEA (She had difficulty breathing that started around 13Jun2021.). On an unknown date, the patient experienced FEELING ABNORMAL (she started with brain fog in end of May). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DYSPNOEA (She had difficulty breathing that started around 13Jun2021.), FEELING ABNORMAL (she started with brain fog in end of May) and NAUSEA (nausea after the 2nd dose/She had nausea) outcome was unknown. Inhaler for breathing      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included pepto bismol and Inhaler for breathing.     This case was linked to MOD-2021-118645 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up added: new adverse event Nausea was added.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: Fever 100.3 degrees Fahrenheit; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever 100.3 degrees Fahrenheit) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21N and 246A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ASCORBIC ACID (VITAMIN C ACID), ZINC and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-May-2021, the patient experienced PYREXIA (Fever 100.3 degrees Fahrenheit). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever 100.3 degrees Fahrenheit) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 100.3 (High) 100.3 F high.   Treatment information  provided was 6 tablets of aspirin 81mg   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Outcome was updated to resolved.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: A little pain; A little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little pain) and FATIGUE (A little fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (A little pain) and FATIGUE (A little fatigue). At the time of the report, PAIN (A little pain) and FATIGUE (A little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Crosslinked cases MOD21-089411 and MOD21-089413 Limited report.   This case was linked to INC.-MOD-2021-117969, MOD21-089413, INC.-MOD-2021-118966 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: INC.-MOD-2021-117969: MOD21-089413: INC.-MOD-2021-118966:Husband case.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache after getting the vaccine; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache after getting the vaccine). At the time of the report, HEADACHE (Headache after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: Injury of left hand with steel staples and contaminated gloves, inflammation was next day on the wound; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Injury of left hand with steel staples and contaminated gloves, inflammation was next day on the wound) in a 54-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 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced LIMB INJURY (Injury of left hand with steel staples and contaminated gloves, inflammation was next day on the wound). The patient was treated with CEPHALEXIN [CEFALEXIN] for Inflammation of wound, at a dose of 1 dosage form and LEVOFLOXACIN for Inflammation of wound, at a dose of 1 dosage form. At the time of the report, LIMB INJURY (Injury of left hand with steel staples and contaminated gloves, inflammation was next day on the wound) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment included T-dap vaccine Concomitant product information, if any, was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: total of 30 patients have been vaccinated over the period of 3 weeks from a punctured vial that was stored in the refrigerator for more than 12 hours after the first puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (total of 30 patients have been vaccinated over the period of 3 weeks from a punctured vial that was stored in the refrigerator for more than 12 hours after the first puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (total of 30 patients have been vaccinated over the period of 3 weeks from a punctured vial that was stored in the refrigerator for more than 12 hours after the first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (total of 30 patients have been vaccinated over the period of 3 weeks from a punctured vial that was stored in the refrigerator for more than 12 hours after the first puncture) had resolved. 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.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   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 medication use was not provided by the reporter.   This case was linked to MOD-2021-118750 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Rash
Clinical narrative: Dose 1:a red rash with pain; Dose 1:  stiffness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Dose 1:a red rash with pain) and MUSCULOSKELETAL STIFFNESS (Dose 1:  stiffness at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced RASH (Dose 1:a red rash with pain) and MUSCULOSKELETAL STIFFNESS (Dose 1:  stiffness at the injection site). At the time of the report, RASH (Dose 1:a red rash with pain) and MUSCULOSKELETAL STIFFNESS (Dose 1:  stiffness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: chest congestion had worsened  than the last time; felt like she had the virus all over again; shortness of breath; lightheaded; felt very weak; Diarrhea; Vomiting; Nausea; fever of 101.8 F; Headache; body hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath) and DIZZINESS (lightheaded) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Syndrome lupus.   On 10-May-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 10-May-2021, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath), DIZZINESS (lightheaded), ASTHENIA (felt very weak), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea), PYREXIA (fever of 101.8 F), HEADACHE (Headache) and MYALGIA (body hurt so bad). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath), DIZZINESS (lightheaded), ASTHENIA (felt very weak), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea), PYREXIA (fever of 101.8 F), HEADACHE (Headache) and MYALGIA (body hurt so bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) 101.8 F..         No concomitant medication was provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-073200, MOD-2021-066597 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: chest congestion had worsened  than the last time; felt like she had the virus all over again; shortness of breath; lightheaded; felt very weak; Diarrhea; Vomiting; Nausea; fever of 101.8 F; Headache; body hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath) and DIZZINESS (lightheaded) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Syndrome lupus.   On 10-May-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 10-May-2021, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath), DIZZINESS (lightheaded), ASTHENIA (felt very weak), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea), PYREXIA (fever of 101.8 F), HEADACHE (Headache) and MYALGIA (body hurt so bad). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath), DIZZINESS (lightheaded), ASTHENIA (felt very weak), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea), PYREXIA (fever of 101.8 F), HEADACHE (Headache) and MYALGIA (body hurt so bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) 101.8 F..         No concomitant medication was provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-073200, MOD-2021-066597 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Vomiting
Clinical narrative: chest congestion had worsened  than the last time; felt like she had the virus all over again; shortness of breath; lightheaded; felt very weak; Diarrhea; Vomiting; Nausea; fever of 101.8 F; Headache; body hurt so bad; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath) and DIZZINESS (lightheaded) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Syndrome lupus.   On 10-May-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 10-May-2021, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath), DIZZINESS (lightheaded), ASTHENIA (felt very weak), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea), PYREXIA (fever of 101.8 F), HEADACHE (Headache) and MYALGIA (body hurt so bad). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, RESPIRATORY TRACT CONGESTION (chest congestion had worsened  than the last time), CONDITION AGGRAVATED (condition aggravated), FEELING ABNORMAL (felt like she had the virus all over again), DYSPNOEA (shortness of breath), DIZZINESS (lightheaded), ASTHENIA (felt very weak), DIARRHOEA (Diarrhea), VOMITING (Vomiting), NAUSEA (Nausea), PYREXIA (fever of 101.8 F), HEADACHE (Headache) and MYALGIA (body hurt so bad) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (High) 101.8 F..         No concomitant medication was provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable   This case was linked to MOD-2021-073200, MOD-2021-066597 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: COPD; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    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 CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). At the time of the report, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: A little pain; A little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A little pain) and FATIGUE (A little fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (A little pain) and FATIGUE (A little fatigue). At the time of the report, PAIN (A little pain) and FATIGUE (A little fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-118867, US-MODERNATX, INC.-MOD-2021-117969 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-118867:Husband case US-MODERNATX, INC.-MOD-2021-117969:Son case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Pain in extremity
Clinical narrative: left arm was; diarrhea; chills for a few dayschills for a few days; extremely fatigued to where she stayed in bed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm was ), DIARRHOEA (diarrhea), CHILLS (chills for a few dayschills for a few days) and FATIGUE (extremely fatigued to where she stayed in bed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Product used for unknown indication, BENAZEPRIL, VITAMIN D;VITAMIN E, SIMVASTATIN and VITAMIN C [ASCORBIC ACID] 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 PAIN IN EXTREMITY (left arm was ), DIARRHOEA (diarrhea), CHILLS (chills for a few dayschills for a few days) and FATIGUE (extremely fatigued to where she stayed in bed). At the time of the report, PAIN IN EXTREMITY (left arm was ) had resolved and DIARRHOEA (diarrhea), CHILLS (chills for a few dayschills for a few days) and FATIGUE (extremely fatigued to where she stayed in bed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medication included gartriptalin Treatment information included use ice packs on arm when needed.   This case was linked to MOD-2021-119093 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chills, Diarrhoea, Dizziness
Clinical narrative: diarrhea; chest tightness; shakiness; dizziness; vertigo; chills; aches; fever; vomiting; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHEST DISCOMFORT (chest tightness), TREMOR (shakiness), DIZZINESS (dizziness) and VERTIGO (vertigo) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced DIARRHOEA (diarrhea), CHEST DISCOMFORT (chest tightness), TREMOR (shakiness), DIZZINESS (dizziness), VERTIGO (vertigo), CHILLS (chills), MYALGIA (aches), PYREXIA (fever), VOMITING (vomiting) and ARTHRALGIA (joint pain). At the time of the report, DIARRHOEA (diarrhea), CHEST DISCOMFORT (chest tightness), TREMOR (shakiness), VERTIGO (vertigo), CHILLS (chills), MYALGIA (aches), PYREXIA (fever), VOMITING (vomiting) and ARTHRALGIA (joint pain) had resolved and DIZZINESS (dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Tremor, Vertigo, Vomiting
Clinical narrative: diarrhea; chest tightness; shakiness; dizziness; vertigo; chills; aches; fever; vomiting; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CHEST DISCOMFORT (chest tightness), TREMOR (shakiness), DIZZINESS (dizziness) and VERTIGO (vertigo) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced DIARRHOEA (diarrhea), CHEST DISCOMFORT (chest tightness), TREMOR (shakiness), DIZZINESS (dizziness), VERTIGO (vertigo), CHILLS (chills), MYALGIA (aches), PYREXIA (fever), VOMITING (vomiting) and ARTHRALGIA (joint pain). At the time of the report, DIARRHOEA (diarrhea), CHEST DISCOMFORT (chest tightness), TREMOR (shakiness), VERTIGO (vertigo), CHILLS (chills), MYALGIA (aches), PYREXIA (fever), VOMITING (vomiting) and ARTHRALGIA (joint pain) had resolved and DIZZINESS (dizziness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: numbness behind his temple area and cheek; tired; headaches have gotten worse; chills; body aches; severe migraines; pain shot up to behind his right eye; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (severe migraines), EYE PAIN (pain shot up to behind his right eye), HYPOAESTHESIA (numbness behind his temple area and cheek), FATIGUE (tired) and HEADACHE (headaches have gotten worse) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tuberculosis (Tuberculosis as a child). Concurrent medical conditions included Malaria.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced EYE PAIN (pain shot up to behind his right eye). On an unknown date, the patient experienced MIGRAINE (severe migraines), HYPOAESTHESIA (numbness behind his temple area and cheek), FATIGUE (tired), HEADACHE (headaches have gotten worse), CHILLS (chills) and MYALGIA (body aches). At the time of the report, MIGRAINE (severe migraines), EYE PAIN (pain shot up to behind his right eye), HYPOAESTHESIA (numbness behind his temple area and cheek), FATIGUE (tired), HEADACHE (headaches have gotten worse), CHILLS (chills) and MYALGIA (body aches) 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 medication reported. No treatment was provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Myalgia
Clinical narrative: numbness behind his temple area and cheek; tired; headaches have gotten worse; chills; body aches; severe migraines; pain shot up to behind his right eye; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (severe migraines), EYE PAIN (pain shot up to behind his right eye), HYPOAESTHESIA (numbness behind his temple area and cheek), FATIGUE (tired) and HEADACHE (headaches have gotten worse) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tuberculosis (Tuberculosis as a child). Concurrent medical conditions included Malaria.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced EYE PAIN (pain shot up to behind his right eye). On an unknown date, the patient experienced MIGRAINE (severe migraines), HYPOAESTHESIA (numbness behind his temple area and cheek), FATIGUE (tired), HEADACHE (headaches have gotten worse), CHILLS (chills) and MYALGIA (body aches). At the time of the report, MIGRAINE (severe migraines), EYE PAIN (pain shot up to behind his right eye), HYPOAESTHESIA (numbness behind his temple area and cheek), FATIGUE (tired), HEADACHE (headaches have gotten worse), CHILLS (chills) and MYALGIA (body aches) 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 medication reported. No treatment was provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Interchange of vaccine products
Clinical narrative: Given the Janssen brand for his second dose; 14 days interval between first and second dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Given the Janssen brand for his second dose) and INCORRECT DOSE ADMINISTERED (14 days interval between first and second dose) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (14 days interval between first and second dose). On 07-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Given the Janssen brand for his second dose). On 07-May-2021, INTERCHANGE OF VACCINE PRODUCTS (Given the Janssen brand for his second dose) and INCORRECT DOSE ADMINISTERED (14 days interval between first and second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.  Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Blood testosterone, Cardiac disorder, Fatigue
Clinical narrative: low cardio; fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (low cardio) and FATIGUE (fatigue) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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 CARDIAC DISORDER (low cardio) and FATIGUE (fatigue). At the time of the report, CARDIAC DISORDER (low cardio) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood testosterone: 197 (Low) decreased.         No concomitant medications were reported. No treatment related information has been reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Device connection issue
Clinical narrative: he syringe malfunction and the vaccine leaked on the patient's arm; re-vaccinated the patient; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (he syringe malfunction and the vaccine leaked on the patient's arm) and ACCIDENTAL OVERDOSE (re-vaccinated the patient) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 004C21A) 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 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced DEVICE CONNECTION ISSUE (he syringe malfunction and the vaccine leaked on the patient's arm) and ACCIDENTAL OVERDOSE (re-vaccinated the patient). On 11-May-2021, DEVICE CONNECTION ISSUE (he syringe malfunction and the vaccine leaked on the patient's arm) and ACCIDENTAL OVERDOSE (re-vaccinated the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass
Clinical narrative: lump in arm that went away and returned; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump in arm that went away and returned) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0KTN120A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced AXILLARY MASS (lump in arm that went away and returned). At the time of the report, AXILLARY MASS (lump in arm that went away and returned) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product details were provided Treatment details include Tylenol.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site, warm but not that painful when touched; Injection site, red and itching like there is no tomorrow; Headache; Injection site, red and itching like there is no tomorrow; Swelling on the injection site about a quarter of an inch; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site, warm but not that painful when touched), VACCINATION SITE PRURITUS (Injection site, red and itching like there is no tomorrow), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site, red and itching like there is no tomorrow) and VACCINATION SITE SWELLING (Swelling on the injection site about a quarter of an inch) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RAMIPRIL (TENAPRIL) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced VACCINATION SITE WARMTH (Injection site, warm but not that painful when touched), VACCINATION SITE PRURITUS (Injection site, red and itching like there is no tomorrow), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site, red and itching like there is no tomorrow), VACCINATION SITE SWELLING (Swelling on the injection site about a quarter of an inch) and PYREXIA (Slight fever). At the time of the report, VACCINATION SITE WARMTH (Injection site, warm but not that painful when touched), VACCINATION SITE PRURITUS (Injection site, red and itching like there is no tomorrow), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site, red and itching like there is no tomorrow), VACCINATION SITE SWELLING (Swelling on the injection site about a quarter of an inch) and PYREXIA (Slight fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   This case was linked to MOD-2021-119154 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Email address provided and correction in patient name
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Injection site, warm but not that painful when touched; Injection site, red and itching like there is no tomorrow; Headache; Injection site, red and itching like there is no tomorrow; Swelling on the injection site about a quarter of an inch; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site, warm but not that painful when touched), VACCINATION SITE PRURITUS (Injection site, red and itching like there is no tomorrow), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site, red and itching like there is no tomorrow) and VACCINATION SITE SWELLING (Swelling on the injection site about a quarter of an inch) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included RAMIPRIL (TENAPRIL) for an unknown indication.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced VACCINATION SITE WARMTH (Injection site, warm but not that painful when touched), VACCINATION SITE PRURITUS (Injection site, red and itching like there is no tomorrow), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site, red and itching like there is no tomorrow), VACCINATION SITE SWELLING (Swelling on the injection site about a quarter of an inch) and PYREXIA (Slight fever). At the time of the report, VACCINATION SITE WARMTH (Injection site, warm but not that painful when touched), VACCINATION SITE PRURITUS (Injection site, red and itching like there is no tomorrow), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site, red and itching like there is no tomorrow), VACCINATION SITE SWELLING (Swelling on the injection site about a quarter of an inch) and PYREXIA (Slight fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   This case was linked to MOD-2021-119154 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Email address provided and correction in patient name
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Fatigue
Clinical narrative: Weakness; confusion; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CONFUSIONAL STATE (confusion) and FATIGUE (tiredness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ASTHENIA (Weakness), CONFUSIONAL STATE (confusion) and FATIGUE (tiredness). On 09-Apr-2021, ASTHENIA (Weakness), CONFUSIONAL STATE (confusion) and FATIGUE (tiredness) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were provide No concomitant medications were reported.   This case was linked to MOD-2021-119177 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Lethargy, Nausea
Clinical narrative: night sweats.; lethargic for 2 weeks after receiving the first dose; feeling wipe out; felt nauseous; chills during the day and night; fever; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (night sweats.), LETHARGY (lethargic for 2 weeks after receiving the first dose), FATIGUE (feeling wipe out), NAUSEA (felt nauseous) and CHILLS (chills during the day and night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Runny nose and Allergy, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL), LEVOTHYROXINE SODIUM (LEVOTHYROXIN), METOPROLOL, CELECOXIB (CELEBREX), PARACETAMOL (TYLENOL) and PANTOPRAZOLE for an unknown indication.    On 12-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 HYPERHIDROSIS (night sweats.), LETHARGY (lethargic for 2 weeks after receiving the first dose), FATIGUE (feeling wipe out), NAUSEA (felt nauseous), CHILLS (chills during the day and night) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (night sweats.), LETHARGY (lethargic for 2 weeks after receiving the first dose), FATIGUE (feeling wipe out), NAUSEA (felt nauseous), CHILLS (chills during the day and night) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       second dose scheduled on 12May2021
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: night sweats.; lethargic for 2 weeks after receiving the first dose; feeling wipe out; felt nauseous; chills during the day and night; fever; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (night sweats.), LETHARGY (lethargic for 2 weeks after receiving the first dose), FATIGUE (feeling wipe out), NAUSEA (felt nauseous) and CHILLS (chills during the day and night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shellfish allergy. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Runny nose and Allergy, AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL), LEVOTHYROXINE SODIUM (LEVOTHYROXIN), METOPROLOL, CELECOXIB (CELEBREX), PARACETAMOL (TYLENOL) and PANTOPRAZOLE for an unknown indication.    On 12-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 HYPERHIDROSIS (night sweats.), LETHARGY (lethargic for 2 weeks after receiving the first dose), FATIGUE (feeling wipe out), NAUSEA (felt nauseous), CHILLS (chills during the day and night) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (night sweats.), LETHARGY (lethargic for 2 weeks after receiving the first dose), FATIGUE (feeling wipe out), NAUSEA (felt nauseous), CHILLS (chills during the day and night) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       second dose scheduled on 12May2021
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Myalgia
Clinical narrative: chills; growing in redness on upper arm; some itchy feeling at times; feels like there is a hard welt or something underneath the skin; feels like there is a hard welt or something underneath the skin; red circle around the injection site on left arm; its kinda sore; joint pain; muscle pain; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (growing in redness on upper arm), PRURITUS (some itchy feeling at times), VACCINATION SITE URTICARIA (feels like there is a hard welt or something underneath the skin), VACCINATION SITE INDURATION (feels like there is a hard welt or something underneath the skin) and VACCINATION SITE ERYTHEMA (red circle around the injection site on left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BENAZEPRIL, VITAMIN C;VITAMIN D NOS;VITAMIN E, NORTRIPTYLINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and SIMVASTATIN for an unknown indication.   On 04-May-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 05-May-2021, the patient experienced ERYTHEMA (growing in redness on upper arm), PRURITUS (some itchy feeling at times), VACCINATION SITE URTICARIA (feels like there is a hard welt or something underneath the skin), VACCINATION SITE INDURATION (feels like there is a hard welt or something underneath the skin), VACCINATION SITE ERYTHEMA (red circle around the injection site on left arm), VACCINATION SITE PAIN (its kinda sore), ARTHRALGIA (joint pain), MYALGIA (muscle pain) and FATIGUE (fatigued). On 06-May-2021, the patient experienced CHILLS (chills). At the time of the report, ERYTHEMA (growing in redness on upper arm), PRURITUS (some itchy feeling at times), VACCINATION SITE URTICARIA (feels like there is a hard welt or something underneath the skin), VACCINATION SITE ERYTHEMA (red circle around the injection site on left arm), VACCINATION SITE PAIN (its kinda sore), ARTHRALGIA (joint pain), MYALGIA (muscle pain), FATIGUE (fatigued) and CHILLS (chills) outcome was unknown.            Treatment includes using ice packs on arm when needed. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable, reporter didn't provide causality assessment.   This case was linked to MOD-2021-118974 (Patient Link).