chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Fatigue, Feeling cold
Clinical narrative: Cant get warm; Chilled all day; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cant get warm), CHILLS (Chilled all day) and FATIGUE (Tired) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced FEELING COLD (Cant get warm), CHILLS (Chilled all day) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Feb-2021, FEELING COLD (Cant get warm), CHILLS (Chilled all day) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported events, a causal relationship with the event cannot be excluded.  Chills and fatigue are consistent with the established safety profile of mRNA-1273 vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pruritus
Clinical narrative: itching from ankle to head here and there/itchiness/itchiness on his ankle, leg, scalp, and back; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching from ankle to head here and there/itchiness/itchiness on his ankle, leg, scalp, and back) and INJECTION SITE PAIN (soreness at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Patient realized that he was on Meloxicam in 2019 and had allergic reaction.) in 2019. Concomitant products included ADALIMUMAB (HUMIRA) and MELOXICAM for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (itching from ankle to head here and there/itchiness/itchiness on his ankle, leg, scalp, and back) and INJECTION SITE PAIN (soreness at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) on 22-Jan-2021 for Itching all over, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) on 22-Jan-2021 for Itching all over, at an unspecified dose and frequency. On 25-Jan-2021, PRURITUS (itching from ankle to head here and there/itchiness/itchiness on his ankle, leg, scalp, and back) had resolved with sequelae and INJECTION SITE PAIN (soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Contusion, Dizziness, Headache
Clinical narrative: Bruising on arms, legs and torso; Dizziness; Fever; Joint pain; Back pain; Headache; Excessive urination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Bruising on arms, legs and torso), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pain) and BACK PAIN (Back pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-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 27-Jan-2021, the patient experienced CONTUSION (Bruising on arms, legs and torso), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pain), BACK PAIN (Back pain), HEADACHE (Headache) and URINE OUTPUT INCREASED (Excessive urination). At the time of the report, CONTUSION (Bruising on arms, legs and torso), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pain), BACK PAIN (Back pain), HEADACHE (Headache) and URINE OUTPUT INCREASED (Excessive urination) had not resolved.      Treatment information included: Dayquil and Benadryl.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urine output increased
Clinical narrative: Bruising on arms, legs and torso; Dizziness; Fever; Joint pain; Back pain; Headache; Excessive urination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Bruising on arms, legs and torso), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pain) and BACK PAIN (Back pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Jan-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 27-Jan-2021, the patient experienced CONTUSION (Bruising on arms, legs and torso), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pain), BACK PAIN (Back pain), HEADACHE (Headache) and URINE OUTPUT INCREASED (Excessive urination). At the time of the report, CONTUSION (Bruising on arms, legs and torso), DIZZINESS (Dizziness), PYREXIA (Fever), ARTHRALGIA (Joint pain), BACK PAIN (Back pain), HEADACHE (Headache) and URINE OUTPUT INCREASED (Excessive urination) had not resolved.      Treatment information included: Dayquil and Benadryl.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M0A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included CITALOPRAM and CLONAZEPAM for Anxiety, IBUPROFEN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site). At the time of the report, VACCINATION SITE PAIN (soreness at injection site) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   The patient took ibuprofen for the soreness.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and ASTHENIA (Weakness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Lupus anticoagulant, Allergy to chemicals (Patient is allergic to potassium due to a diuretic treatment she had to take) and Penicillin allergy. Concomitant products included METOPROLOL for Hypertension, TRAMADOL for Pain, LEVOTHYROXINE for Thyroid disorder NOS, PREDNISONE, HYDROCORTISONE, VITAMIN B12 [VITAMIN B12 NOS], IRON and CALCIUM for an unknown indication.  On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (Dizziness) and ASTHENIA (Weakness). At the time of the report, DIZZINESS (Dizziness) and ASTHENIA (Weakness) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye pain, Fatigue, Feeling abnormal, Headache
Clinical narrative: I just don't feel like myself; Had sinus congestion; Coughed; My eyes hurt; Vomiting; Headache; My arm was really sore at the injection site; Tired; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (I just don't feel like myself), SINUS CONGESTION (Had sinus congestion), COUGH (Coughed) and EYE PAIN (My eyes hurt) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 29-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), SINUS CONGESTION (Had sinus congestion), COUGH (Coughed), EYE PAIN (My eyes hurt), VOMITING (Vomiting), HEADACHE (Headache), VACCINATION SITE PAIN (My arm was really sore at the injection site) and FATIGUE (Tired).   On 04-Feb-2021, the patient experienced FEELING ABNORMAL (I just don't feel like myself). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (I just don't feel like myself), SINUS CONGESTION (Had sinus congestion), COUGH (Coughed), EYE PAIN (My eyes hurt), VOMITING (Vomiting), HEADACHE (Headache), VACCINATION SITE PAIN (My arm was really sore at the injection site) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test positive: Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test positive, Sinus congestion, Vaccination site pain, Vomiting
Clinical narrative: I just don't feel like myself; Had sinus congestion; Coughed; My eyes hurt; Vomiting; Headache; My arm was really sore at the injection site; Tired; Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (I just don't feel like myself), SINUS CONGESTION (Had sinus congestion), COUGH (Coughed) and EYE PAIN (My eyes hurt) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 29-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), SINUS CONGESTION (Had sinus congestion), COUGH (Coughed), EYE PAIN (My eyes hurt), VOMITING (Vomiting), HEADACHE (Headache), VACCINATION SITE PAIN (My arm was really sore at the injection site) and FATIGUE (Tired).   On 04-Feb-2021, the patient experienced FEELING ABNORMAL (I just don't feel like myself). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), FEELING ABNORMAL (I just don't feel like myself), SINUS CONGESTION (Had sinus congestion), COUGH (Coughed), EYE PAIN (My eyes hurt), VOMITING (Vomiting), HEADACHE (Headache), VACCINATION SITE PAIN (My arm was really sore at the injection site) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test positive: Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pain in extremity
Clinical narrative: she felt crappy; Sore arm; Headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she felt crappy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included COPD.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced MALAISE (she felt crappy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (nausea). At the time of the report, MALAISE (she felt crappy), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and NAUSEA (nausea) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Feeling hot, Hyperhidrosis
Clinical narrative: sweating; he became very hot; couldn't sleep; no appetite; aches and pain; hardness; extreme chills; significantly fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING HOT (he became very hot), INSOMNIA (couldn't sleep), DECREASED APPETITE (no appetite) and PAIN (aches and pain) in a 61-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 COVID-19 from 09-Nov-2020 to 13-Nov-2020.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), FEELING HOT (he became very hot), INSOMNIA (couldn't sleep), DECREASED APPETITE (no appetite), PAIN (aches and pain), VACCINATION SITE INDURATION (hardness), CHILLS (extreme chills) and FATIGUE (significantly fatigue). At the time of the report, HYPERHIDROSIS (sweating), FEELING HOT (he became very hot), INSOMNIA (couldn't sleep), DECREASED APPETITE (no appetite), PAIN (aches and pain), VACCINATION SITE INDURATION (hardness), CHILLS (extreme chills) and FATIGUE (significantly fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2020, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient did not take any treatment.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, SARS-CoV-2 test, Vaccination site induration
Clinical narrative: sweating; he became very hot; couldn't sleep; no appetite; aches and pain; hardness; extreme chills; significantly fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING HOT (he became very hot), INSOMNIA (couldn't sleep), DECREASED APPETITE (no appetite) and PAIN (aches and pain) in a 61-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 COVID-19 from 09-Nov-2020 to 13-Nov-2020.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), FEELING HOT (he became very hot), INSOMNIA (couldn't sleep), DECREASED APPETITE (no appetite), PAIN (aches and pain), VACCINATION SITE INDURATION (hardness), CHILLS (extreme chills) and FATIGUE (significantly fatigue). At the time of the report, HYPERHIDROSIS (sweating), FEELING HOT (he became very hot), INSOMNIA (couldn't sleep), DECREASED APPETITE (no appetite), PAIN (aches and pain), VACCINATION SITE INDURATION (hardness), CHILLS (extreme chills) and FATIGUE (significantly fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2020, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient did not take any treatment.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Red rash which was warm to touch; Red rash which was warm to touch; Itching on the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE WARMTH (Red rash which was warm to touch) and VACCINATION SITE ERYTHEMA (Red rash which was warm to touch) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection site). On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Red rash which was warm to touch) and VACCINATION SITE ERYTHEMA (Red rash which was warm to touch). At the time of the report, VACCINATION SITE PRURITUS (Itching on the injection site), VACCINATION SITE WARMTH (Red rash which was warm to touch) and VACCINATION SITE ERYTHEMA (Red rash which was warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Conmeds not provided. Treatment information not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin swelling, Vaccination site erythema, Vaccination site warmth
Clinical narrative: little puffy where the redness is; vaccination site warmth; Vaccination site erythema; started to itch a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (started to itch a little bit), SKIN SWELLING (little puffy where the redness is), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LISINOPRIL, ROSUVASTATIN, SULFASALAZINE and CLONAZEPAM for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (started to itch a little bit). On 28-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 03-Feb-2021, the patient experienced SKIN SWELLING (little puffy where the redness is) and VACCINATION SITE WARMTH (vaccination site warmth). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date at a dose of UNK dosage form and LEVOCABASTINE HYDROCHLORIDE (ZYRTEC [LEVOCABASTINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PRURITUS (started to itch a little bit), SKIN SWELLING (little puffy where the redness is), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Calf hurting; Right knee hurting; 70 days post first vaccine and forgot to get the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Calf hurting), ARTHRALGIA (Right knee hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (70 days post first vaccine and forgot to get the second vaccine) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.  On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Calf hurting), ARTHRALGIA (Right knee hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (70 days post first vaccine and forgot to get the second vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Calf hurting), ARTHRALGIA (Right knee hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (70 days post first vaccine and forgot to get the second vaccine) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Special situation reported in follow-up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Arm itched a little bit; Rash; Arm started swelling- in the shot area; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Arm itched a little bit), INJECTION SITE RASH (Rash) and INJECTION SITE SWELLING (Arm started swelling- in the shot area) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Arm itched a little bit), INJECTION SITE RASH (Rash) and INJECTION SITE SWELLING (Arm started swelling- in the shot area). The patient was treated with CORTISONE at an unspecified dose and frequency and CHLORPHENAMINE MALEATE (ANTIHISTAMIN) at an unspecified dose and frequency.   At the time of the report, INJECTION SITE PRURITUS (Arm itched a little bit), INJECTION SITE RASH (Rash) and INJECTION SITE SWELLING (Arm started swelling- in the shot area) 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Paraesthesia
Clinical narrative: chest discomfort; tingling of her body; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest discomfort) and PARAESTHESIA (tingling of her body) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced CHEST DISCOMFORT (chest discomfort). On an unknown date, the patient experienced PARAESTHESIA (tingling of her body). At the time of the report, CHEST DISCOMFORT (chest discomfort) and PARAESTHESIA (tingling of her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Small knot about an inch over the injection site; itching is constant and never stopped till now; Large round area, Swollen for 4 days; Red for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Small knot about an inch over the injection site), VACCINATION SITE PRURITUS (itching is constant and never stopped till now), VACCINATION SITE SWELLING (Large round area, Swollen for 4 days) and VACCINATION SITE ERYTHEMA (Red for 4 days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Diabetes and Thyroid disorder NOS.  On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching is constant and never stopped till now), VACCINATION SITE SWELLING (Large round area, Swollen for 4 days) and VACCINATION SITE ERYTHEMA (Red for 4 days). On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (Small knot about an inch over the injection site). On 30-Jan-2021, VACCINATION SITE SWELLING (Large round area, Swollen for 4 days) and VACCINATION SITE ERYTHEMA (Red for 4 days) had resolved. At the time of the report, VACCINATION SITE MASS (Small knot about an inch over the injection site) and VACCINATION SITE PRURITUS (itching is constant and never stopped till now) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Arm was hurting; Huge red lump around the arm; when you touch, it was swollen; m It was hard rock about 2.5 inches in diameter; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (Arm was hurting), VACCINATION SITE ERYTHEMA (Huge red lump around the arm), VACCINATION SITE SWELLING (when you touch, it was swollen) and VACCINATION SITE INDURATION (m It was hard rock about 2.5 inches in diameter) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L2OA) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm was hurting), VACCINATION SITE ERYTHEMA (Huge red lump around the arm), VACCINATION SITE SWELLING (when you touch, it was swollen) and VACCINATION SITE INDURATION (m It was hard rock about 2.5 inches in diameter). At the time of the report, INJECTION SITE PAIN (Arm was hurting), VACCINATION SITE ERYTHEMA (Huge red lump around the arm), VACCINATION SITE SWELLING (when you touch, it was swollen) and VACCINATION SITE INDURATION (m It was hard rock about 2.5 inches in diameter) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema
Clinical narrative: Arm had a red spot; Really fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Arm had a red spot) and FATIGUE (Really fatigued) 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 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Arm had a red spot) and FATIGUE (Really fatigued). At the time of the report, INJECTION SITE ERYTHEMA (Arm had a red spot) and FATIGUE (Really fatigued) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Coronavirus test positive, Pain in extremity, Pyrexia
Clinical narrative: fever of 100.3; arm became sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm became sore) and PYREXIA (fever of 100.3) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 virus test positive in December 2020.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm became sore). On 03-Feb-2021, the patient experienced PYREXIA (fever of 100.3). At the time of the report, PAIN IN EXTREMITY (arm became sore) and PYREXIA (fever of 100.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (abnormal) 100.3. On an unknown date, Coronavirus test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of lymph nodes) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling of lymph nodes). At the time of the report, LYMPHADENOPATHY (Swelling of lymph nodes) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications have not been reported.  Treatment information not provided.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Sore(at the injection site); Redness (at the injection site); Pain(at the injection site); Itchiness(at the injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness (at the injection site)), VACCINATION SITE PAIN (Pain(at the injection site)), VACCINATION SITE PRURITUS (Itchiness(at the injection site)) and VACCINATION SITE PAIN (Sore(at the injection site)) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness (at the injection site)), VACCINATION SITE PAIN (Pain(at the injection site)) and VACCINATION SITE PRURITUS (Itchiness(at the injection site)). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore(at the injection site)). At the time of the report, VACCINATION SITE ERYTHEMA (Redness (at the injection site)), VACCINATION SITE PAIN (Pain(at the injection site)), VACCINATION SITE PRURITUS (Itchiness(at the injection site)) and VACCINATION SITE PAIN (Sore(at the injection site)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Myalgia, Pyrexia
Clinical narrative: low grade fever; coughing; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (low grade fever) and COUGH (coughing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     NO medical history information was reported.  Concomitant products included TOPIRAMATE (TOPAMAX) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced MYALGIA (body aches). On 03-Feb-2021, the patient experienced PYREXIA (low grade fever) and COUGH (coughing). At the time of the report, MYALGIA (body aches), PYREXIA (low grade fever) and COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 03-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches), PYREXIA (low grade fever) and COUGH (coughing) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     NO medical history information was reported.  Concomitant products included TOPIRAMATE (TOPAMAX) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced MYALGIA (body aches). On 03-Feb-2021, the patient experienced PYREXIA (low grade fever) and COUGH (coughing). At the time of the report, MYALGIA (body aches), PYREXIA (low grade fever) and COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; A spontaneous report was received from a consumer concerning herself, a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012M20A) in the right arm for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced arm soreness.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event sore arm was not resolved.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event,  a causal relationship with the event cannot be excluded.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: felt bad; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), PYREXIA (fever) and MYALGIA (body aches) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 27-Jan-2021.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced FEELING ABNORMAL (felt bad), PYREXIA (fever) and MYALGIA (body aches). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (felt bad), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, SARS-CoV-2 test: positive (Positive) positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Treatment medication included paracetamol.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itchiness; Redness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and ERYTHEMA (Redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal.   On 01-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PRURITUS (Itchiness) and ERYTHEMA (Redness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. On 04-Feb-2021, PRURITUS (Itchiness) and ERYTHEMA (Redness) had resolved.            The consumer followed up with her PCP and was informed by PCP that these are common side effect and her immune system is responding to the vaccine.  The consumer stated that she took Tylenol rapid release gel cap and Hydrocortisone 1% to subside her side effect.  The consumer also stated she is currently taking cholesterol and blood pressure medicine which she did specify which ones.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: posetive Positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitant product information was provided.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Causality for COVID-19 test positive is not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Patient contracted with covid-19 infection week after 1st dose; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Patient contracted with covid-19 infection week after 1st dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Hypothyroidism. Concomitant products included LOSARTAN for Product used for unknown indication, SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) and LEVOTHYROXINE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (Patient contracted with covid-19 infection week after 1st dose). The patient was treated with DEXAMETHASONE for Product used for unknown indication, at an unspecified dose and frequency and AZITHROMYCIN at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient contracted with covid-19 infection week after 1st dose) 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.    Second dose was scheduled on 04-FEB-2021
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Headache, Musculoskeletal chest pain, Myalgia
Clinical narrative: Headache; nausea; body ache; muscle ache; pain on left left side in my rib cage; freezing; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), NAUSEA (nausea), PAIN (body ache), MYALGIA (muscle ache) and MUSCULOSKELETAL CHEST PAIN (pain on left left side in my rib cage) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.    On 25-Jan-2021 at 3:30 AM, 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 25-Jan-2021, the patient experienced HEADACHE (Headache), NAUSEA (nausea), PAIN (body ache), MYALGIA (muscle ache), MUSCULOSKELETAL CHEST PAIN (pain on left left side in my rib cage) and FEELING COLD (freezing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), NAUSEA (nausea), PAIN (body ache), MYALGIA (muscle ache), MUSCULOSKELETAL CHEST PAIN (pain on left left side in my rib cage) and FEELING COLD (freezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 98 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received captured no new information.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: Headache; nausea; body ache; muscle ache; pain on left left side in my rib cage; freezing; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (Headache), NAUSEA (nausea), PAIN (body ache), MYALGIA (muscle ache) and MUSCULOSKELETAL CHEST PAIN (pain on left left side in my rib cage) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.    On 25-Jan-2021 at 3:30 AM, 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 25-Jan-2021, the patient experienced HEADACHE (Headache), NAUSEA (nausea), PAIN (body ache), MYALGIA (muscle ache), MUSCULOSKELETAL CHEST PAIN (pain on left left side in my rib cage) and FEELING COLD (freezing). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), NAUSEA (nausea), PAIN (body ache), MYALGIA (muscle ache), MUSCULOSKELETAL CHEST PAIN (pain on left left side in my rib cage) and FEELING COLD (freezing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 98 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up received captured no new information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: covid-19 virus test positive; A spontaneous report was received from a Consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Jan 2021, the patient experienced event- Tested positive for Covid.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tested positive for covid was not reported.; Reporter's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for COVID and the product use is assessed as unlikely,
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Pain, Pain in extremity
Clinical narrative: Body ache; Feels like a horrible flu; Arm hurts; Headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), INFLUENZA LIKE ILLNESS (Feels like a horrible flu), PAIN IN EXTREMITY (Arm hurts), HEADACHE (Headache) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (Body ache), INFLUENZA LIKE ILLNESS (Feels like a horrible flu), PAIN IN EXTREMITY (Arm hurts), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN (Body ache), INFLUENZA LIKE ILLNESS (Feels like a horrible flu), HEADACHE (Headache) and CHILLS (Chills) had not resolved and PAIN IN EXTREMITY (Arm hurts) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications include paracetamol (Tylenol), thyroid medication and blood pressure medication.  Treatment medications were not provided.