chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate increased, Nausea
Clinical narrative: dizziness; nausea; headache; heart was pounding (HR 98); This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart was pounding (HR 98)), DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced HEART RATE INCREASED (heart was pounding (HR 98)). On an unknown date, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (headache). On 17-Mar-2021, HEART RATE INCREASED (heart was pounding (HR 98)) had resolved. At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Fatigue, Heart rate increased, Injection site inflammation
Clinical narrative: Arm broke out: from Shoulder half way towards the Elbow was red; inflamed injection site; Injection Site Felt Fevered (Clarified Hot to the touch); heart palpilation; Tiredness; had no energy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), ASTHENIA (had no energy), ERYTHEMA (Arm broke out: from Shoulder half way towards the Elbow was red), INJECTION SITE INFLAMMATION (inflamed injection site) and VACCINATION SITE WARMTH (Injection Site Felt Fevered (Clarified Hot to the touch)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart rate increased.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Tiredness), ASTHENIA (had no energy) and HEART RATE INCREASED (heart palpilation). On 25-Mar-2021, the patient experienced ERYTHEMA (Arm broke out: from Shoulder half way towards the Elbow was red), INJECTION SITE INFLAMMATION (inflamed injection site) and VACCINATION SITE WARMTH (Injection Site Felt Fevered (Clarified Hot to the touch)). On 25-Mar-2021, FATIGUE (Tiredness), ASTHENIA (had no energy) and HEART RATE INCREASED (heart palpilation) had resolved. At the time of the report, ERYTHEMA (Arm broke out: from Shoulder half way towards the Elbow was red), INJECTION SITE INFLAMMATION (inflamed injection site) and VACCINATION SITE WARMTH (Injection Site Felt Fevered (Clarified Hot to the touch)) 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  treatment she took was Antihistamine also has been rubbing the Injection Site with Alcohol.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Arm broke out: from Shoulder half way towards the Elbow was red; inflamed injection site; Injection Site Felt Fevered (Clarified Hot to the touch); heart palpilation; Tiredness; had no energy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), ASTHENIA (had no energy), ERYTHEMA (Arm broke out: from Shoulder half way towards the Elbow was red), INJECTION SITE INFLAMMATION (inflamed injection site) and VACCINATION SITE WARMTH (Injection Site Felt Fevered (Clarified Hot to the touch)) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart rate increased.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Tiredness), ASTHENIA (had no energy) and HEART RATE INCREASED (heart palpilation). On 25-Mar-2021, the patient experienced ERYTHEMA (Arm broke out: from Shoulder half way towards the Elbow was red), INJECTION SITE INFLAMMATION (inflamed injection site) and VACCINATION SITE WARMTH (Injection Site Felt Fevered (Clarified Hot to the touch)). On 25-Mar-2021, FATIGUE (Tiredness), ASTHENIA (had no energy) and HEART RATE INCREASED (heart palpilation) had resolved. At the time of the report, ERYTHEMA (Arm broke out: from Shoulder half way towards the Elbow was red), INJECTION SITE INFLAMMATION (inflamed injection site) and VACCINATION SITE WARMTH (Injection Site Felt Fevered (Clarified Hot to the touch)) 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  treatment she took was Antihistamine also has been rubbing the Injection Site with Alcohol.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Contusion, Fatigue, Headache, Myalgia
Clinical narrative: Still suffering fatigue; Soreness in left arm; Chills; Fever; Headache; Sore arm; Bruising that went all the way down to the rib cage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), CONTUSION (Bruising that went all the way down to the rib cage), FATIGUE (Still suffering fatigue), MYALGIA (Soreness in left arm) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus since 2000, Drug allergy and Latex allergy.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), CONTUSION (Bruising that went all the way down to the rib cage), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced FATIGUE (Still suffering fatigue) and MYALGIA (Soreness in left arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Sore arm), CONTUSION (Bruising that went all the way down to the rib cage), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved and FATIGUE (Still suffering fatigue) and MYALGIA (Soreness in left arm) outcome was unknown.            Concomitant medication was not provided.  Patient was still suffering from fatigue and soreness in the left arm at injection site six weeks later.   This case was linked to MOD-2021-162127 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient was received second dose. Updated the outcome of events (from  unknown to recovered). On 19-Jun-2021: Follow-up received on 19-JUN-2021. It contains significant information. Patient medical history was added and events were added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Still suffering fatigue; Soreness in left arm; Chills; Fever; Headache; Sore arm; Bruising that went all the way down to the rib cage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), CONTUSION (Bruising that went all the way down to the rib cage), FATIGUE (Still suffering fatigue), MYALGIA (Soreness in left arm) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes mellitus since 2000, Drug allergy and Latex allergy.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), CONTUSION (Bruising that went all the way down to the rib cage), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced FATIGUE (Still suffering fatigue) and MYALGIA (Soreness in left arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Sore arm), CONTUSION (Bruising that went all the way down to the rib cage), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) had resolved and FATIGUE (Still suffering fatigue) and MYALGIA (Soreness in left arm) outcome was unknown.            Concomitant medication was not provided.  Patient was still suffering from fatigue and soreness in the left arm at injection site six weeks later.   This case was linked to MOD-2021-162127 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Patient was received second dose. Updated the outcome of events (from  unknown to recovered). On 19-Jun-2021: Follow-up received on 19-JUN-2021. It contains significant information. Patient medical history was added and events were added.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Day 48 since receiving 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Day 48 since receiving 1st dose) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Day 48 since receiving 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Day 48 since receiving 1st dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: muscle pain; arm was extremely sore; could not move arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), PAIN IN EXTREMITY (arm was extremely sore) and MOBILITY DECREASED (could not move arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination.     The patient's past medical history included Asthma since an unknown date and Multiple sclerosis since an unknown date.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 08-Jan-2021, the patient experienced MYALGIA (muscle pain) and PAIN IN EXTREMITY (arm was extremely sore). 08-Jan-2021, the patient experienced MOBILITY DECREASED (could not move arm). At the time of the report, MYALGIA (muscle pain), PAIN IN EXTREMITY (arm was extremely sore) and MOBILITY DECREASED (could not move arm) outcome was unknown.            Patient reports that she uses an INHALER (NOS).     This case was linked to MOD-2021-019093 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Nausea, Pruritus, Rash, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (I was so shaky last night), CHEST DISCOMFORT (Weird chest sensation), PRURITUS (Itching), RASH (Rash in the mild of the night; all across the trunk of my body and the right /  rash come on my trunk, both breasts, under both arm pits, down the arms close to the elbow and then reappeared on the wrest and palm area on the right wrest) and NAUSEA (I am currently feeling a little nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. C48A21A and 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced NERVOUSNESS (I was so shaky last night), PRURITUS (Itching), RASH (Rash in the mild of the night; all across the trunk of my body and the right /  rash come on my trunk, both breasts, under both arm pits, down the arms close to the elbow and then reappeared on the wrest and palm area on the right wrest) and NAUSEA (I am currently feeling a little nausea). On an unknown date, the patient experienced CHEST DISCOMFORT (Weird chest sensation). The patient was treated with CALAMINE ongoing since an unknown date for Adverse event NOS, at an unspecified dose and frequency. On 29-Mar-2021, NERVOUSNESS (I was so shaky last night) had resolved. At the time of the report, CHEST DISCOMFORT (Weird chest sensation), PRURITUS (Itching) and NAUSEA (I am currently feeling a little nausea) outcome was unknown and RASH (Rash in the mild of the night; all across the trunk of my body and the right /  rash come on my trunk, both breasts, under both arm pits, down the arms close to the elbow and then reappeared on the wrest and palm area on the right wrest) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient reported that rash had gone away completely and it was more like hives and it would come and go, sometimes visible for an hour then it would disappear. This lasted for 2 days and it resolved on its own. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: follow up received contains additional event.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Hypoaesthesia, Pain in extremity
Clinical narrative: Arm was pretty sore; Entire head (gum and face) completely numb; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was pretty sore), HYPOAESTHESIA (Entire head (gum and face) completely numb) and HEADACHE (Headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was pretty sore), HYPOAESTHESIA (Entire head (gum and face) completely numb) and HEADACHE (Headache). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event NOS, at an unspecified dose and frequency. On 13-Mar-2021, HYPOAESTHESIA (Entire head (gum and face) completely numb) and HEADACHE (Headache) had resolved. On 16-Mar-2021, PAIN IN EXTREMITY (Arm was pretty sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Heart rate: 107 (High) 107.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Body aches/ muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches/ muscle aches) and PYREXIA (Fever) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (Body aches/ muscle aches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (Body aches/ muscle aches) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PAIN IN EXTREMITY (sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No Concomitant  information was  provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort, Headache, Pain
Clinical narrative: body felt heavy; body felt achy; head felt heavy; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (body felt heavy), PAIN (body felt achy), HEAD DISCOMFORT (head felt heavy) and HEADACHE (headache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included VITAMIN D3 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (body felt heavy), PAIN (body felt achy), HEAD DISCOMFORT (head felt heavy) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (body felt heavy), PAIN (body felt achy), HEAD DISCOMFORT (head felt heavy) and HEADACHE (headache) had resolved. Not Provided          Concomitant product also include Blood pressure medications. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-129741 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow up received and updated the Event out come updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-129741:First dose case
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Fatigue, Headache, Hypertension
Clinical narrative: Breathing declined; Increased Blood Pressure; Headache; Fatigue; Fever of 103.3 degrees Fahrenheit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing declined), HYPERTENSION (Increased Blood Pressure), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever of 103.3 degrees Fahrenheit) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included AFib.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (Breathing declined), HYPERTENSION (Increased Blood Pressure), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever of 103.3 degrees Fahrenheit). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 03-Mar-2021 at an unspecified dose and frequency. On 05-Mar-2021, DYSPNOEA (Breathing declined), HYPERTENSION (Increased Blood Pressure), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever of 103.3 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure measurement: High. On 03-Mar-2021, Pyrexia: 103.3 (High) 103.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Breathing declined; Increased Blood Pressure; Headache; Fatigue; Fever of 103.3 degrees Fahrenheit; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing declined), HYPERTENSION (Increased Blood Pressure), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever of 103.3 degrees Fahrenheit) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included AFib.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DYSPNOEA (Breathing declined), HYPERTENSION (Increased Blood Pressure), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever of 103.3 degrees Fahrenheit). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 03-Mar-2021 at an unspecified dose and frequency. On 05-Mar-2021, DYSPNOEA (Breathing declined), HYPERTENSION (Increased Blood Pressure), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever of 103.3 degrees Fahrenheit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Blood pressure measurement: High. On 03-Mar-2021, Pyrexia: 103.3 (High) 103.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Somnolence, Vaccination site pain
Clinical narrative: pain in lower back on the right side; sleepy; shoulder is sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in lower back on the right side), SOMNOLENCE (sleepy) and VACCINATION SITE PAIN (shoulder is sore at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008v21a and 025a21a) for COVID-19 vaccination.     Concomitant products included WARFARIN, LOSARTAN, LEVOTHYROXINE, INSULIN LISPRO (HUMALOG), METOPROLOL, ATORVASTATIN, DONEPEZIL, INSULIN DEGLUDEC (TRESIBA), VITAMIN D3, VITAMIN C [ASCORBIC ACID], ACETYLSALICYLIC ACID (ASPIRIN LOW) and ZINC for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced BACK PAIN (pain in lower back on the right side), SOMNOLENCE (sleepy) and VACCINATION SITE PAIN (shoulder is sore at injection site). At the time of the report, BACK PAIN (pain in lower back on the right side) and SOMNOLENCE (sleepy) outcome was unknown and VACCINATION SITE PAIN (shoulder is sore at injection site) was resolving.            other concomitant medications reported were insulin, hydrochlorthiazide and lactase with diary. Treatment included use of ice at injection site.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (Pain in the arm). At the time of the report, VACCINATION SITE PAIN (Pain in the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-036540.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Patient updated event outcome as Resolved. and declined for further follow-up on this.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chills, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: lost the sense of smell; sore throat; chills; headaches; body aches; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19), ANOSMIA (lost the sense of smell), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and HEADACHE (headaches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical reported history provided by the reporter.  Concomitant products included OMEPRAZOLE and PARACETAMOL (TYLENOL) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), HEADACHE (headaches) and MYALGIA (body aches). On 20-Mar-2021, the patient experienced ANOSMIA (lost the sense of smell). On 02-Apr-2021, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19), ANOSMIA (lost the sense of smell), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), HEADACHE (headaches) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Became COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medicine. treatment(symptomatic) include cough syrup.  It was reported that the patient I would like to be able to receive the second dose of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-May 2021, patient details updated, event outcome updated.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: lost the sense of smell; sore throat; chills; headaches; body aches; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19), ANOSMIA (lost the sense of smell), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills) and HEADACHE (headaches) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical reported history provided by the reporter.  Concomitant products included OMEPRAZOLE and PARACETAMOL (TYLENOL) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), HEADACHE (headaches) and MYALGIA (body aches). On 20-Mar-2021, the patient experienced ANOSMIA (lost the sense of smell). On 02-Apr-2021, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19), ANOSMIA (lost the sense of smell), OROPHARYNGEAL PAIN (sore throat), CHILLS (chills), HEADACHE (headaches) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 test: positive (Positive) Became COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure medicine. treatment(symptomatic) include cough syrup.  It was reported that the patient I would like to be able to receive the second dose of the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-May 2021, patient details updated, event outcome updated.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Erythema, Feeling abnormal, Pain in extremity, Peripheral swelling
Clinical narrative: Arm pain; arm swelling; arm redness; felt weird; "didn't feel like myself in my head"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (arm swelling), ERYTHEMA (arm redness), FEELING ABNORMAL (felt weird) and CONFUSIONAL STATE ("didn't feel like myself in my head") in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PERIPHERAL SWELLING (arm swelling), ERYTHEMA (arm redness), FEELING ABNORMAL (felt weird) and CONFUSIONAL STATE ("didn't feel like myself in my head"). On 08-Mar-2021, PAIN IN EXTREMITY (Arm pain) had resolved. On 11-Mar-2021, FEELING ABNORMAL (felt weird) and CONFUSIONAL STATE ("didn't feel like myself in my head") had resolved. On 18-Mar-2021, PERIPHERAL SWELLING (arm swelling) and ERYTHEMA (arm redness) had resolved.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: TCR was received  Patient did not report AE from 2nd vaccine as she stated they all seem to be pretty normal to her. Patient declined to provide additional contact info for further follow up as everything has resolved and she doesn't feel the need
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Skin burning sensation
Clinical narrative: shingles in same arm as injection; shingles burned; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles in same arm as injection) and SKIN BURNING SENSATION (shingles burned) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Chickenpox.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced HERPES ZOSTER (shingles in same arm as injection) and SKIN BURNING SENSATION (shingles burned). At the time of the report, HERPES ZOSTER (shingles in same arm as injection) and SKIN BURNING SENSATION (shingles burned) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The patient went to the Emergency Room because of the blistery looking bites underneath her left arm from her shoulder to her elbow, that's when she was diagnosed. The patient  had 12 bumps total. Concomitant medication information was not reported. Treatment information as not reported.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash morbilliform
Clinical narrative: The second day, the rash looked like measles; rash after the first day almost like dots through the skin; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH MORBILLIFORM (The second day, the rash looked like measles) and RASH (rash after the first day almost like dots through the skin) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MORBILLIFORM (The second day, the rash looked like measles) and RASH (rash after the first day almost like dots through the skin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. At the time of the report, RASH MORBILLIFORM (The second day, the rash looked like measles) and RASH (rash after the first day almost like dots through the skin) 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy; painful, swollen rash; painful, swollen rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (painful, swollen rash) and VACCINATION SITE RASH (painful, swollen rash) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (painful, swollen rash) and VACCINATION SITE RASH (painful, swollen rash). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE PRURITUS (itchy), VACCINATION SITE PAIN (painful, swollen rash) and VACCINATION SITE RASH (painful, swollen rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient applied cold compress on the area with rash Concomitant medication information was not reported. Treatment information as not reported. .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.   This case was linked to MOD-2021-058648 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Infusion site warmth, Peripheral swelling, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: (at injection site) little lump the size of a tangerine; (at injection site) warm to touch; swollen arm; (at injection site) itchiness; (at injection site) soreness; (at injection site) redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS ((at injection site) little lump the size of a tangerine), INFUSION SITE WARMTH ((at injection site) warm to touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS ((at injection site) itchiness) and VACCINATION SITE PAIN ((at injection site) soreness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS ((at injection site) little lump the size of a tangerine), INFUSION SITE WARMTH ((at injection site) warm to touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS ((at injection site) itchiness), VACCINATION SITE PAIN ((at injection site) soreness) and VACCINATION SITE ERYTHEMA ((at injection site) redness). The patient was treated with Manual therapy (iceand alcohol rubbing) for Vaccination site mass; Manual therapy (Ice and alcohol rubbing) for Infusion site warmth; Manual therapy (Ice and alcohol rubbing) for Peripheral swelling; Manual therapy (Ice and alcohol rubbing) for Vaccination site pruritus; Manual therapy (Ice and alcohol rubbing) for Vaccination site pain and Manual therapy (Ice and alcohol rubbing) for Vaccination site erythema. At the time of the report, VACCINATION SITE MASS ((at injection site) little lump the size of a tangerine), INFUSION SITE WARMTH ((at injection site) warm to touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS ((at injection site) itchiness), VACCINATION SITE PAIN ((at injection site) soreness) and VACCINATION SITE ERYTHEMA ((at injection site) redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has been applying ice and rubbing alcohol at site.  Treatment information was not provided.   This case was linked to MOD-2021-131421 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional information received on 14-May-2021 was updated with additional event of swollen arm and rechallenge information was updated.; 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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: (at injection site) little lump the size of a tangerine; (at injection site) warm to touch; swollen arm; (at injection site) itchiness; (at injection site) soreness; (at injection site) redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS ((at injection site) little lump the size of a tangerine), INFUSION SITE WARMTH ((at injection site) warm to touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS ((at injection site) itchiness) and VACCINATION SITE PAIN ((at injection site) soreness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS ((at injection site) little lump the size of a tangerine), INFUSION SITE WARMTH ((at injection site) warm to touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS ((at injection site) itchiness), VACCINATION SITE PAIN ((at injection site) soreness) and VACCINATION SITE ERYTHEMA ((at injection site) redness). The patient was treated with Manual therapy (iceand alcohol rubbing) for Vaccination site mass; Manual therapy (Ice and alcohol rubbing) for Infusion site warmth; Manual therapy (Ice and alcohol rubbing) for Peripheral swelling; Manual therapy (Ice and alcohol rubbing) for Vaccination site pruritus; Manual therapy (Ice and alcohol rubbing) for Vaccination site pain and Manual therapy (Ice and alcohol rubbing) for Vaccination site erythema. At the time of the report, VACCINATION SITE MASS ((at injection site) little lump the size of a tangerine), INFUSION SITE WARMTH ((at injection site) warm to touch), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE PRURITUS ((at injection site) itchiness), VACCINATION SITE PAIN ((at injection site) soreness) and VACCINATION SITE ERYTHEMA ((at injection site) redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has been applying ice and rubbing alcohol at site.  Treatment information was not provided.   This case was linked to MOD-2021-131421 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Additional information received on 14-May-2021 was updated with additional event of swollen arm and rechallenge information was updated.; 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Headache, Pyrexia, Vaccination site erythema
Clinical narrative: Severe Pounding Headache; Red patch at the injection site that felt warm to touch; Swelling of arm (left) she received injection in; Loss of appetite; FEVER; CHILLS; This spontaneous case was reported by a pharmacist and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (FEVER), CHILLS (CHILLS), HEADACHE (Severe Pounding Headache) and VACCINATION SITE SWELLING (Swelling of arm (left) she received injection in) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-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-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (FEVER), CHILLS (CHILLS) and VACCINATION SITE SWELLING (Swelling of arm (left) she received injection in). On 29-Mar-2021, the patient experienced HEADACHE (Severe Pounding Headache) and VACCINATION SITE ERYTHEMA (Red patch at the injection site that felt warm to touch). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 28-Mar-2021, PYREXIA (FEVER) and CHILLS (CHILLS) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite), HEADACHE (Severe Pounding Headache), VACCINATION SITE SWELLING (Swelling of arm (left) she received injection in) and VACCINATION SITE ERYTHEMA (Red patch at the injection site that felt warm to touch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Severe Pounding Headache; Red patch at the injection site that felt warm to touch; Swelling of arm (left) she received injection in; Loss of appetite; FEVER; CHILLS; This spontaneous case was reported by a pharmacist and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (FEVER), CHILLS (CHILLS), HEADACHE (Severe Pounding Headache) and VACCINATION SITE SWELLING (Swelling of arm (left) she received injection in) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-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-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (FEVER), CHILLS (CHILLS) and VACCINATION SITE SWELLING (Swelling of arm (left) she received injection in). On 29-Mar-2021, the patient experienced HEADACHE (Severe Pounding Headache) and VACCINATION SITE ERYTHEMA (Red patch at the injection site that felt warm to touch). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 28-Mar-2021, PYREXIA (FEVER) and CHILLS (CHILLS) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite), HEADACHE (Severe Pounding Headache), VACCINATION SITE SWELLING (Swelling of arm (left) she received injection in) and VACCINATION SITE ERYTHEMA (Red patch at the injection site that felt warm to touch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.