chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Motion sickness, Nausea, Pain, Pain in extremity, Vomiting
Clinical narrative: sweaty; nausea; When she has her arm down and tries to lift it up, it hurts; Joint in the right arm was hurting; it becomes a little bit more uncomfortable at nigh; headache; feeling tired; pain in her arm; vomited; motions; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomited), MOTION SICKNESS (motions), HEADACHE (headache), FATIGUE (feeling tired) and PAIN IN EXTREMITY (pain in her arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VOMITING (vomited) and MOTION SICKNESS (motions). On 26-Mar-2021, the patient experienced HEADACHE (headache), FATIGUE (feeling tired) and PAIN IN EXTREMITY (pain in her arm). On an unknown date, the patient experienced HYPERHIDROSIS (sweaty), NAUSEA (nausea), PAIN (When she has her arm down and tries to lift it up, it hurts), ARTHRALGIA (Joint in the right arm was hurting) and DISCOMFORT (it becomes a little bit more uncomfortable at nigh). On 25-Mar-2021, VOMITING (vomited) and MOTION SICKNESS (motions) had resolved. At the time of the report, HEADACHE (headache), FATIGUE (feeling tired) and PAIN IN EXTREMITY (pain in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment details included. acetaminophen.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Growing pains, Influenza like illness, Pain in extremity
Clinical narrative: was up all night with leg pain; like I had flu; growing pain that kept me up all night; pain at the vaccination site; pain goes from my shoulder to all the way down behind my back; top of my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (was up all night with leg pain), INFLUENZA LIKE ILLNESS (like I had flu), GROWING PAINS (growing pain that kept me up all night), VACCINATION SITE PAIN (pain at the vaccination site) and BACK PAIN (pain goes from my shoulder to all the way down behind my back) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 013A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (was up all night with leg pain), INFLUENZA LIKE ILLNESS (like I had flu), GROWING PAINS (growing pain that kept me up all night), VACCINATION SITE PAIN (pain at the vaccination site), BACK PAIN (pain goes from my shoulder to all the way down behind my back) and ARTHRALGIA (top of my shoulder). At the time of the report, PAIN IN EXTREMITY (was up all night with leg pain), INFLUENZA LIKE ILLNESS (like I had flu), GROWING PAINS (growing pain that kept me up all night), VACCINATION SITE PAIN (pain at the vaccination site), BACK PAIN (pain goes from my shoulder to all the way down behind my back) and ARTHRALGIA (top of my shoulder) outcome was unknown.            Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: was up all night with leg pain; like I had flu; growing pain that kept me up all night; pain at the vaccination site; pain goes from my shoulder to all the way down behind my back; top of my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (was up all night with leg pain), INFLUENZA LIKE ILLNESS (like I had flu), GROWING PAINS (growing pain that kept me up all night), VACCINATION SITE PAIN (pain at the vaccination site) and BACK PAIN (pain goes from my shoulder to all the way down behind my back) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 013A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (was up all night with leg pain), INFLUENZA LIKE ILLNESS (like I had flu), GROWING PAINS (growing pain that kept me up all night), VACCINATION SITE PAIN (pain at the vaccination site), BACK PAIN (pain goes from my shoulder to all the way down behind my back) and ARTHRALGIA (top of my shoulder). At the time of the report, PAIN IN EXTREMITY (was up all night with leg pain), INFLUENZA LIKE ILLNESS (like I had flu), GROWING PAINS (growing pain that kept me up all night), VACCINATION SITE PAIN (pain at the vaccination site), BACK PAIN (pain goes from my shoulder to all the way down behind my back) and ARTHRALGIA (top of my shoulder) outcome was unknown.            Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Headache, Influenza like illness, Pain
Clinical narrative: feels like she has the flu; She has aches and pains; she feels cold; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feels like she has the flu), PAIN (She has aches and pains), FEELING COLD (she feels cold), FATIGUE (fatigue) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMLODIPINE, LOSARTAN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 26-Mar-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 26-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like she has the flu), PAIN (She has aches and pains), FEELING COLD (she feels cold), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (feels like she has the flu), PAIN (She has aches and pains), FEELING COLD (she feels cold), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.            Treatment information was not provided. The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Vaccination site pain
Clinical narrative: felt like had flu the next day; sore arm; extreme cold chills like shivering; extreme cold chills like shivering; Headache on the left side; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like had flu the next day), VACCINATION SITE PAIN (sore arm), the first episode of CHILLS (extreme cold chills like shivering), the second episode of CHILLS (extreme cold chills like shivering) and HEADACHE (Headache on the left side) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 023M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMLODIPINE for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HEADACHE (Headache on the left side). On 22-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like had flu the next day), VACCINATION SITE PAIN (sore arm) and the second episode of CHILLS (extreme cold chills like shivering). 22-Mar-2021, the patient experienced the first episode of CHILLS (extreme cold chills like shivering). The patient was treated with BACTERIA NOS, YEAST (KOMBUCHA) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like had flu the next day), VACCINATION SITE PAIN (sore arm), the last episode of CHILLS (extreme cold chills like shivering) and HEADACHE (Headache on the left side) outcome was unknown.            The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) was not applicable.   This case was linked to MOD-2021-059524 (Patient Link).
Age: 102.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 102-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.    On 26-Mar-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 26-Mar-2021, the patient experienced DIZZINESS (dizziness). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at a dose of 2 pills. At the time of the report, DIZZINESS (dizziness) outcome was unknown.            Concomitant medications reported were, high blood pressure medication and others (unspecified) used for unknown indication.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up information contains no significant information.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: has not received the 2nd vaccine (First dose received on 05FEB21); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received the 2nd vaccine (First dose received on 05FEB21)) 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 (No relevant medical history provided).    On 05-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 (has not received the 2nd vaccine (First dose received on 05FEB21)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received the 2nd vaccine (First dose received on 05FEB21)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Headache; Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and TINNITUS (Tinnitus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Headache) and TINNITUS (Tinnitus). At the time of the report, HEADACHE (Headache) and TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: right arm was hot; right arm was itching; right arm started to get red; right arm was swollen; right arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (right arm was hot), VACCINATION SITE PRURITUS (right arm was itching), VACCINATION SITE ERYTHEMA (right arm started to get red), VACCINATION SITE SWELLING (right arm was swollen) and VACCINATION SITE PAIN (right arm was hurting) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010MZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included CALCITONIN (CALCITRIN), CALCIUM, LOSARTAN, DENOSUMAB (PROLIA), RALOXIFENE, TRAZODONE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (right arm was hot), VACCINATION SITE PRURITUS (right arm was itching), VACCINATION SITE ERYTHEMA (right arm started to get red), VACCINATION SITE SWELLING (right arm was swollen) and VACCINATION SITE PAIN (right arm was hurting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (right arm was hot), VACCINATION SITE PRURITUS (right arm was itching), VACCINATION SITE ERYTHEMA (right arm started to get red), VACCINATION SITE SWELLING (right arm was swollen) and VACCINATION SITE PAIN (right arm was hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: side effects with first dose lingering for a while; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects with first dose lingering for a while) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects with first dose lingering for a while). At the time of the report, ADVERSE DRUG REACTION (side effects with first dose lingering for a while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Never had anything so painful as this arm; has so much pain in this arm in the muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Never had anything so painful as this arm) and MYALGIA (has so much pain in this arm in the muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Never had anything so painful as this arm) and MYALGIA (has so much pain in this arm in the muscle). At the time of the report, PAIN IN EXTREMITY (Never had anything so painful as this arm) and MYALGIA (has so much pain in this arm in the muscle) outcome was unknown.            Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills and headache; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills and headache) and HEADACHE (headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced CHILLS (Chills and headache) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form every eight hours; ACETAMINOPHEN at a dose of 1 dosage form every eight hours and DEXAMETHASONE at a dose of 1 dosage form. At the time of the report, CHILLS (Chills and headache) and HEADACHE (headache) outcome was unknown.            Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed her 2nd dose after 28 days.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose after 28 days.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose after 28 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose after 28 days.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Inability to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Inability to sleep) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to antibiotic), Allergy (Allergy to Nickel) and Allergy (Allergy to Copper). Concomitant products included METFORMIN, LEVOTHYROXINE SODIUM (SYNTHROID) and LISINOPRIL for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INSOMNIA (Inability to sleep). The patient was treated with MELATONIN at an unspecified dose and frequency and MELATONIN for Insomnia, at a dose of 1 dosage form. At the time of the report, INSOMNIA (Inability to sleep) outcome was unknown.            Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vaccination site rash
Clinical narrative: One day Expired vaccine administered; Small Rash on the Injection Site on the Left Arm; A spontaneous report was received from a consumer, concerning a 35-year old male patient, who received Moderna's COVID-19 vaccine and experienced Injection site rash (vaccination site rash), Expired vaccine used. The patient's medical history was not provided.   Concomitant product use was not provided by the patient.  On 25 Mar 2021, prior to the onset of events, the patient received his first of the two planned vaccine doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis and stated that the vaccine was pre-drawn in a syringe and the paper label on the syringe indicated that it expired the previous day and experiencing small rash on the Injection Site on the left Arm .  Reporter was notified that an answer will be provided to the Nurse manager whom previously called, and she will communicate with the patient. MA Escalation is not necessary as Excursion team is already working on this case.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of Injection site rash was unknown and expired vaccine used, was considered to be recovered at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, Vaccination site rash, a causal relationship cannot be excluded.  This report also refers to a case of Expired product administered, for mRNA-1273, lot # unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Tinnitus
Clinical narrative: tinnitus; worsening of loud ringing in ears; extremely loud; can barely fall asleep; bothersome; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), TINNITUS (worsening of loud ringing in ears), TINNITUS (extremely loud), INSOMNIA (can barely fall asleep) and FEELING ABNORMAL (bothersome) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, EZETIMIBE, LEVOTHYROXINE and PROPRANOLOL HYDROCHLORIDE (PROPANOLOL BOEHRINGER) for an unknown indication.    On 03-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 TINNITUS (tinnitus), TINNITUS (worsening of loud ringing in ears), TINNITUS (extremely loud), INSOMNIA (can barely fall asleep) and FEELING ABNORMAL (bothersome). At the time of the report, TINNITUS (tinnitus), TINNITUS (worsening of loud ringing in ears), TINNITUS (extremely loud), INSOMNIA (can barely fall asleep) and FEELING ABNORMAL (bothersome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Hypersomnia, Myalgia
Clinical narrative: throwing up; slept almost 23 hours per day; headache, really bad headache; chills; Muscle Pain; Joint Pain; feverish; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache, really bad headache), CHILLS (chills), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and PYREXIA (feverish) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 20-Mar-2021, the patient experienced HEADACHE (headache, really bad headache), CHILLS (chills), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), PYREXIA (feverish) and HYPERSOMNIA (slept almost 23 hours per day). On 21-Mar-2021, the patient experienced VOMITING (throwing up). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 21-Mar-2021, VOMITING (throwing up) had resolved. On 25-Mar-2021, HEADACHE (headache, really bad headache), CHILLS (chills), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), PYREXIA (feverish) and HYPERSOMNIA (slept almost 23 hours per day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: throwing up; slept almost 23 hours per day; headache, really bad headache; chills; Muscle Pain; Joint Pain; feverish; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache, really bad headache), CHILLS (chills), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and PYREXIA (feverish) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 20-Mar-2021, the patient experienced HEADACHE (headache, really bad headache), CHILLS (chills), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), PYREXIA (feverish) and HYPERSOMNIA (slept almost 23 hours per day). On 21-Mar-2021, the patient experienced VOMITING (throwing up). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. On 21-Mar-2021, VOMITING (throwing up) had resolved. On 25-Mar-2021, HEADACHE (headache, really bad headache), CHILLS (chills), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), PYREXIA (feverish) and HYPERSOMNIA (slept almost 23 hours per day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy, Pain, Pruritus, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes), LYMPHADENOPATHY (lymph nodes R side of the neck swollen), SWELLING (little ball on the L side of neck), PRURITUS (neck hot and itchy) and PAIN (body pain) in a 35-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.     The patient's past medical history included No adverse event (No medical history was provided.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes) and SWELLING (little ball on the L side of neck). On 25-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph nodes R side of the neck swollen). On an unknown date, the patient experienced PRURITUS (neck hot and itchy), PAIN (body pain) and INJECTION SITE PAIN (pain at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; DEXAMETHASONE at a dose of 1 dosage form and ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, LYMPHADENOPATHY (lymph nodes), LYMPHADENOPATHY (lymph nodes R side of the neck swollen), SWELLING (little ball on the L side of neck), PRURITUS (neck hot and itchy), PAIN (body pain) and INJECTION SITE PAIN (pain at the site of injection) outcome was unknown.            This case was linked to MOD-2021-053380 (Patient Link).   Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Drained out; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Drained out) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included METFORMIN and LOSARTAN for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced FEELING ABNORMAL (Drained out). At the time of the report, FEELING ABNORMAL (Drained out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pruritus
Clinical narrative: icky; headaches; fatigue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (icky), HEADACHE (headaches), FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PRURITUS (icky), HEADACHE (headaches), FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PRURITUS (icky), HEADACHE (headaches), FATIGUE (fatigue) and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site swelling
Clinical narrative: headache; swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen injection site) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included SEMAGLUTIDE (OZEMPIC), METFORMIN, LISINOPRIL, BISOPROLOL, ATORVASTATIN, BUPROPION, CITALOPRAM and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE SWELLING (swollen injection site). On 27-Mar-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swollen injection site) and HEADACHE (headache) outcome was unknown.             Action taken with mRNA-1273 in response to the events was not reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Inability to sleep; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INSOMNIA (Inability to sleep) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.    Co-suspect product included non-company product LISINOPRIL for an unknown indication.    The patient's past medical history included No adverse event (No Medical History reported). Concomitant products included METFORMIN, TRAMADOL and TRAZODONE for an unknown indication.   On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Dosage form. On an unknown date, the patient started LISINOPRIL (unknown route) dosage form. On 09-Mar-2021, the patient experienced INSOMNIA (Inability to sleep). At the time of the report, INSOMNIA (Inability to sleep) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; A spontaneous report was received from a consumer concerning a 82-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 24 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) sore arm.  Treatment details included Advil.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm was unknown.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Itchiness; Redness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), ERYTHEMA (Redness) and RASH (Rash) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, MECLIZINE [MECLOZINE] for Dizziness, LISINOPRIL for Hypertension.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PRURITUS (Itchiness), ERYTHEMA (Redness) and RASH (Rash). The patient was treated with HYDROCORTISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PRURITUS (Itchiness), ERYTHEMA (Redness) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking allergy plus for dust and mites .Patient shared that had EUSTATIAN TUBE DYSFUNCTION.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant and received first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received first dose). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant and received first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was provided. No Treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: felt achy all over; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt achy all over) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Past medical history not provided).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (felt achy all over). At the time of the report, PAIN (felt achy all over) outcome was unknown. Not Provided          Concomitant medications taken by the patient were not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on body) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027AS1A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced URTICARIA (Hives on body). At the time of the report, URTICARIA (Hives on body) outcome was unknown.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: vaccine was injected below the deltoid muscle, in the middle of the biceps and not on the deltoid muscle; A spontaneous report was received from a consumer concerning a 39 Year old male patient, of unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, vaccine was injected below the deltoid muscle(inappropriate route of vaccination).  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 27 Mar 2021 , prior to the onset of the events, the patient received his first of the two planned vaccine doses of mRNA-1273 (Lot number: 017B21A)  via intramuscular route into middle of his biceps for prophylaxis of COVID-19 infection .  On 27 Mar 2021, after receiving the first shot of Moderna vaccine at 8: 30 in the morning, the patient's wife was asking if patient needs to be revaccinated since the vaccine was injected in the middle of biceps and not on deltoid muscle.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event vaccine was injected in the middle of biceps and not on deltoid muscle was considered as resolved.; Reporter's Comments: This report refers to a case of Inappropriate route of Vaccination, for mRNA-1273, lot #:  017B21A, with no associated AEs.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Hyperhidrosis, Pain
Clinical narrative: severe diarrhea(5 times just today); soreness; sweats; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), HYPERHIDROSIS (sweats) and DIARRHOEA (severe diarrhea(5 times just today)) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0474A21) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.   On 24-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 25-Mar-2021, the patient experienced PAIN (soreness) and HYPERHIDROSIS (sweats). On 27-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea(5 times just today)). At the time of the report, PAIN (soreness), HYPERHIDROSIS (sweats) and DIARRHOEA (severe diarrhea(5 times just today)) outcome was unknown.            patient had  been drinking a lot of fluids. patient treatment details was unknown or not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Illness, Pyrexia, Tremor
Clinical narrative: fever for 2 days and body aches.; dizziness; tremors throughout his body; cannot hold the cup of coffee; sicker than the first; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for 2 days and body aches.), ILLNESS (sicker than the first), DIZZINESS (dizziness), TREMOR (tremors throughout his body) and ILLNESS (cannot hold the cup of coffee) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METOPROLOL and ATENOLOL for an unknown indication.   On 14-Feb-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) dosage form. On 14-Feb-2021, the patient experienced ILLNESS (sicker than the first). On 17-Feb-2021, the patient experienced DIZZINESS (dizziness), TREMOR (tremors throughout his body) and ILLNESS (cannot hold the cup of coffee). On an unknown date, the patient experienced PYREXIA (fever for 2 days and body aches.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever for 2 days and body aches.), ILLNESS (sicker than the first), DIZZINESS (dizziness), TREMOR (tremors throughout his body) and ILLNESS (cannot hold the cup of coffee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant meds:Antihypertensive
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and DIZZINESS (Light headedness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced DIZZINESS (Dizziness) and DIZZINESS (Light headedness). At the time of the report, DIZZINESS (Dizziness) and DIZZINESS (Light headedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: follow -up received on 09-JUL-2021,Non-Significant Follow-up, Patients contact information updated.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Swelling
Clinical narrative: Red bright spots all over body; Itchy; red bright spots coming all over and bumpy on the skin line; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red bright spots all over body), PRURITUS (Itchy) and SWELLING (red bright spots coming all over and bumpy on the skin line) 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 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced RASH MACULAR (Red bright spots all over body), PRURITUS (Itchy) and SWELLING (red bright spots coming all over and bumpy on the skin line). At the time of the report, RASH MACULAR (Red bright spots all over body), PRURITUS (Itchy) and SWELLING (red bright spots coming all over and bumpy on the skin line) outcome was unknown.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Myalgia, Nasopharyngitis, Vaccination site bruising
Clinical narrative: Discolored arm; Yellowand purple bruise mark; Head cold; Felt different; More tired than usual; Muscle ache; Hurt when she was vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Discolored arm), VACCINATION SITE BRUISING (Yellowand purple bruise mark), NASOPHARYNGITIS (Head cold), FEELING ABNORMAL (Felt different) and FATIGUE (More tired than usual) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-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) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Discolored arm), VACCINATION SITE BRUISING (Yellowand purple bruise mark), NASOPHARYNGITIS (Head cold), FEELING ABNORMAL (Felt different), FATIGUE (More tired than usual), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (Hurt when she was vaccinated). At the time of the report, VACCINATION SITE DISCOLOURATION (Discolored arm), NASOPHARYNGITIS (Head cold), FEELING ABNORMAL (Felt different), FATIGUE (More tired than usual), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (Hurt when she was vaccinated) outcome was unknown and VACCINATION SITE BRUISING (Yellowand purple bruise mark) was resolving. Not Provided          The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site pain
Clinical narrative: Discolored arm; Yellowand purple bruise mark; Head cold; Felt different; More tired than usual; Muscle ache; Hurt when she was vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Discolored arm), VACCINATION SITE BRUISING (Yellowand purple bruise mark), NASOPHARYNGITIS (Head cold), FEELING ABNORMAL (Felt different) and FATIGUE (More tired than usual) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 18-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) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Discolored arm), VACCINATION SITE BRUISING (Yellowand purple bruise mark), NASOPHARYNGITIS (Head cold), FEELING ABNORMAL (Felt different), FATIGUE (More tired than usual), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (Hurt when she was vaccinated). At the time of the report, VACCINATION SITE DISCOLOURATION (Discolored arm), NASOPHARYNGITIS (Head cold), FEELING ABNORMAL (Felt different), FATIGUE (More tired than usual), MYALGIA (Muscle ache) and VACCINATION SITE PAIN (Hurt when she was vaccinated) outcome was unknown and VACCINATION SITE BRUISING (Yellowand purple bruise mark) was resolving. Not Provided          The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.