chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Painful R arm; shoulder pain following the injection; Foggy feeling in head; Headache; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (Foggy feeling in head), PAIN IN EXTREMITY (Painful R arm), HEADACHE (Headache) and ARTHRALGIA (shoulder pain following the injection) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 024M20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Occlusion coronary artery from September 2020 to December 2020, Pneumonia from 19-Oct-2020 to 31-Oct-2020, Limb injury in July 2020, Broken nose in July 2020, Bursitis worsened, Loss of posture in July 2020, Automobile accident, Back pain (with radiation) in May 2019, Leg pain in May 2019, Alcohol use (6 cans of beer or less than 8 ounce occasionally.) in 1955 and Tobacco user (Half to one pack of cigarettes per day.) in 1999. Concurrent medical conditions included Heart disorder since August 2020, Osteoarthritis since September 2020, Spinal osteoarthritis, Aching joints in March 2020, Pain, Iron deficiency since October 2020, Heart rate irregular, Swelling of hands in December 2019, Bronchiectasis in 2019, Type 2 diabetes mellitus, Asthma and Pollen allergy (Tightness with the bronchioles when breathing.). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), MONTELUKAST for Allergy NOS and Asthma, ASPIRIN [ACETYLSALICYLIC ACID] and ROSUVASTATIN for Anticoagulant therapy, METFORMIN for Glucose, GABAPENTIN for Joint pain, MAGNESIUM for Magnesium supplementation, LEFLUNOMIDE for Rheumatoid arthritis, GLUCOSAMINE for Supplementation therapy, VITAMIN B COMPLEX for Vitamin B complex supplementation, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Vitamin B12 supplementation, VITAMIN D3 for Vitamin D supplementation.   In October 2018, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HEADACHE (Headache). On 21-Feb-2021, the patient experienced FEELING ABNORMAL (Foggy feeling in head). On an unknown date, the patient experienced PAIN IN EXTREMITY (Painful R arm) and ARTHRALGIA (shoulder pain following the injection). At the time of the report, FEELING ABNORMAL (Foggy feeling in head), PAIN IN EXTREMITY (Painful R arm), HEADACHE (Headache) and ARTHRALGIA (shoulder pain following the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling in legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in legs) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sciatica aggravated. Concomitant products included HYDROCHLOROTHIAZIDE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ESOMEPRAZOLE, Furosemede and liprocil for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling in legs). At the time of the report, PERIPHERAL SWELLING (swelling in legs) outcome was unknown. Not Provided          A sonogram  was performed and showed no blood clots nor cysts. No treatment medication listed for event but reports having a steroid injection in back on 16-Apr-2021.  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.; 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: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Ataxia, Back injury, Fall, Joint injury, Memory impairment
Clinical narrative: lost all muscle control; fell out of bed on to the floor; don't remember any of it; normal side effects; injury to elbow and hip; injury to back; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of ATAXIA (lost all muscle control), FALL (fell out of bed on to the floor), MEMORY IMPAIRMENT (don't remember any of it), VACCINATION COMPLICATION (normal side effects) and JOINT INJURY (injury to elbow and hip) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (positive) on 19-Oct-2020, Back ache since 14-Mar-2021, Angioplasty since 2001 and Stent placement since May 2019. Concurrent medical conditions included Crohn's disease since 2017. Concomitant products included HYDROCODONE for Back pain, LOSARTAN for Blood pressure, ATORVASTATIN for Cholesterol, METFORMIN and INSULIN for Diabetes.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATAXIA (lost all muscle control), MEMORY IMPAIRMENT (don't remember any of it), VACCINATION COMPLICATION (normal side effects), JOINT INJURY (injury to elbow and hip), BACK INJURY (injury to back) and PYREXIA (High Fever). an unknown date, the patient experienced FALL (fell out of bed on to the floor). At the time of the report, ATAXIA (lost all muscle control), FALL (fell out of bed on to the floor), MEMORY IMPAIRMENT (don't remember any of it), VACCINATION COMPLICATION (normal side effects), JOINT INJURY (injury to elbow and hip), BACK INJURY (injury to back) and PYREXIA (High Fever) outcome was unknown.            No treatment information was provided Action taken with mRNA-1273 in response to events were not applicable   This case was linked to MOD-2021-082315, MOD-2021-082653 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Significant follow up appendedpatient information was updated. second dose events were updatedconcomitants were updated
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: lost all muscle control; fell out of bed on to the floor; don't remember any of it; normal side effects; injury to elbow and hip; injury to back; High Fever; This spontaneous case was reported by a consumer and describes the occurrence of ATAXIA (lost all muscle control), FALL (fell out of bed on to the floor), MEMORY IMPAIRMENT (don't remember any of it), VACCINATION COMPLICATION (normal side effects) and JOINT INJURY (injury to elbow and hip) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (positive) on 19-Oct-2020, Back ache since 14-Mar-2021, Angioplasty since 2001 and Stent placement since May 2019. Concurrent medical conditions included Crohn's disease since 2017. Concomitant products included HYDROCODONE for Back pain, LOSARTAN for Blood pressure, ATORVASTATIN for Cholesterol, METFORMIN and INSULIN for Diabetes.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ATAXIA (lost all muscle control), MEMORY IMPAIRMENT (don't remember any of it), VACCINATION COMPLICATION (normal side effects), JOINT INJURY (injury to elbow and hip), BACK INJURY (injury to back) and PYREXIA (High Fever). an unknown date, the patient experienced FALL (fell out of bed on to the floor). At the time of the report, ATAXIA (lost all muscle control), FALL (fell out of bed on to the floor), MEMORY IMPAIRMENT (don't remember any of it), VACCINATION COMPLICATION (normal side effects), JOINT INJURY (injury to elbow and hip), BACK INJURY (injury to back) and PYREXIA (High Fever) outcome was unknown.            No treatment information was provided Action taken with mRNA-1273 in response to events were not applicable   This case was linked to MOD-2021-082315, MOD-2021-082653 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Significant follow up appendedpatient information was updated. second dose events were updatedconcomitants were updated
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sorta sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sorta sick) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-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 ILLNESS (sorta sick). At the time of the report, ILLNESS (sorta sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The consumer had  a very small suspicion that the husband possibly could have had covid back in February 2020
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (mild symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (mild symptoms). At the time of the report, ADVERSE EVENT (mild symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment and No Concomitant Medication was provided.   Requested the follow-up forms be mailed and declined email/fax capability. Mailing address provided   This case was linked to MOD-2021-022514 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (vaccination site pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 18-Jun-2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (vaccination site pain). At the time of the report, VACCINATION SITE PAIN (vaccination site pain) had resolved. after first dose      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 treatment medicine is reported by reporter   This case was linked to MOD-2021-087465 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up document received on 24-MAY-2021 and it does not contain any new information
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Influenza, Migraine
Clinical narrative: flu symptoms; headache was similar to a migraine; having some vasovagal symptoms that show his "veins are popping" on the sides of his head; very low grade fever but his body was still emitting heat with a temperature of 99F; pretty severe headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms), MIGRAINE (headache was similar to a migraine), PRESYNCOPE (having some vasovagal symptoms that show his "veins are popping" on the sides of his head), PYREXIA (very low grade fever but his body was still emitting heat with a temperature of 99F) and HEADACHE (pretty severe headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INFLUENZA (flu symptoms), MIGRAINE (headache was similar to a migraine), PRESYNCOPE (having some vasovagal symptoms that show his "veins are popping" on the sides of his head), PYREXIA (very low grade fever but his body was still emitting heat with a temperature of 99F), HEADACHE (pretty severe headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, INFLUENZA (flu symptoms), MIGRAINE (headache was similar to a migraine), PRESYNCOPE (having some vasovagal symptoms that show his "veins are popping" on the sides of his head), PYREXIA (very low grade fever but his body was still emitting heat with a temperature of 99F), HEADACHE (pretty severe headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 99f (High) body temperature little bit high.         Concomitant medication was not provided. Treatment medication include Tylenol and ibuprofen.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: flu symptoms; headache was similar to a migraine; having some vasovagal symptoms that show his "veins are popping" on the sides of his head; very low grade fever but his body was still emitting heat with a temperature of 99F; pretty severe headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms), MIGRAINE (headache was similar to a migraine), PRESYNCOPE (having some vasovagal symptoms that show his "veins are popping" on the sides of his head), PYREXIA (very low grade fever but his body was still emitting heat with a temperature of 99F) and HEADACHE (pretty severe headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced INFLUENZA (flu symptoms), MIGRAINE (headache was similar to a migraine), PRESYNCOPE (having some vasovagal symptoms that show his "veins are popping" on the sides of his head), PYREXIA (very low grade fever but his body was still emitting heat with a temperature of 99F), HEADACHE (pretty severe headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, INFLUENZA (flu symptoms), MIGRAINE (headache was similar to a migraine), PRESYNCOPE (having some vasovagal symptoms that show his "veins are popping" on the sides of his head), PYREXIA (very low grade fever but his body was still emitting heat with a temperature of 99F), HEADACHE (pretty severe headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: 99f (High) body temperature little bit high.         Concomitant medication was not provided. Treatment medication include Tylenol and ibuprofen.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Pregnancy test, Prenatal screening test, Ultrasound scan
Clinical narrative: Exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013020A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, Full-term birth None complications) from August 2017 to 30-May-2018 and Alcohol use (Frequency of use: Rarely). Concomitant products included DOCUSATE SODIUM (COLACE) from 04-Dec-2020 to an unknown date for Constipation, METRONIDAZOLE (FLAGYL 250) from 26-Mar-2021 to 02-Apr-2021 for Gardnerella infection, VITAMIN D3 from 04-Dec-2020 to an unknown date for Vitamin D deficiency, PROBIOTICS NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 18-Sep-2020 and the estimated date of delivery was 25-Jun-2021. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (Exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 12-Feb-2021, EXPOSURE DURING PREGNANCY (Exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2020, Pregnancy test: positive (Positive) positive. On 04-Dec-2020, Prenatal screening test: low risk male (normal) Test name is given as Panorama. Findings: Low Risk Male. On 28-Jan-2021, Alpha 1 foetoprotein normal: negative (Negative) Negative. On 28-Jan-2021, Ultrasound scan: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-009143 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain in extremity, Pyrexia
Clinical narrative: spotty soreness in arm and shoulder; spotty soreness in arm and shoulder; chills; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (spotty soreness in arm and shoulder), ARTHRALGIA (spotty soreness in arm and shoulder), CHILLS (chills) and PYREXIA (slight fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (spotty soreness in arm and shoulder), ARTHRALGIA (spotty soreness in arm and shoulder), CHILLS (chills) and PYREXIA (slight fever). On 16-Apr-2021, PAIN IN EXTREMITY (spotty soreness in arm and shoulder), ARTHRALGIA (spotty soreness in arm and shoulder) and CHILLS (chills) had resolved. On 17-Apr-2021, PYREXIA (slight fever) had resolved. Not Provided          Concomitant medications were not reported. Treatment medications included acetaminophen to help alleviate the symptoms of fever.   This case was linked to MOD-2021-082033 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain
Clinical narrative: Discomfort; pain; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT and MYALGIA (lingering pain in tailbone and upper body) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DISCOMFORT and MYALGIA (lingering pain in tailbone and upper body). At the time of the report, DISCOMFORT and MYALGIA (lingering pain in tailbone and upper body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Swelling
Clinical narrative: swelling; generalized joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (swelling) and ARTHRALGIA (generalized joint pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (unknown route) at an unspecified dose. On 05-Feb-2021, the patient experienced SWELLING (swelling) and ARTHRALGIA (generalized joint pain). In February 2021, SWELLING (swelling) and ARTHRALGIA (generalized joint pain) had resolved.        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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: received 2nd dose while positive with covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (received 2nd dose while positive with covid-19) 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 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (received 2nd dose while positive with covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (received 2nd dose while positive with covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, SARS-CoV-2 test: positive positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information were not provided. On 22-Jul-2021 reporter stated that COVID-19 Test result was a false positive and had three other tests performed and all resulted negative.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Lab data updated
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Swelling
Clinical narrative: swelling; generalized joint pain; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (swelling) and ARTHRALGIA (generalized joint pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included UPADACITINIB (RINVOQ) for Arthritis.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 05-Feb-2021, the patient experienced SWELLING (swelling) and ARTHRALGIA (generalized joint pain). At the time of the report, SWELLING (swelling) and ARTHRALGIA (generalized joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient did not have a reaction for her second moderna shot.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain
Clinical narrative: Itchiness at arm of injection after second dose; Sore arm; Redness at arm of injection after second dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Itchiness at arm of injection after second dose), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness at arm of injection after second dose) in a 60-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. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced INJECTION SITE PRURITUS (Itchiness at arm of injection after second dose), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness at arm of injection after second dose). At the time of the report, INJECTION SITE PRURITUS (Itchiness at arm of injection after second dose), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE ERYTHEMA (Redness at arm of injection after second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment with Cleocin 300 for redness and itchiness usage, were provided by the patient.   This case was linked to MOD-2021-082369 (E2B Linked Report). This case was linked to MOD-2021-082369 (Patient Link).; Sender's Comments:  MOD-2021-082369:1st dose
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Drug screen negative, Priapism, SARS-CoV-2 antibody test positive
Clinical narrative: Priapism lasting 27 hours; This spontaneous case was reported by a physician and describes the occurrence of PRIAPISM (Priapism lasting 27 hours) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included GLIPIZIDE, METFORMIN, AMLODIPINE and HYDROCHLOROTHIAZIDE for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PRIAPISM (Priapism lasting 27 hours). At the time of the report, PRIAPISM (Priapism lasting 27 hours) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Drug screen negative: unknown (Negative) Negative. On 17-Apr-2021, SARS-CoV-2 antibody test positive: unknown (Positive) Positive.     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 treatment medications were reported. Test was reported to be repeated by 2 different labs and results were negative.Patient tested positive for Antibodies to COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Nurse practitioner called to be apart of the Pregnancy Registry.; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Nurse practitioner called to be apart of the Pregnancy Registry.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Oct-2020 and the estimated date of delivery was 08-Jul-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Nurse practitioner called to be apart of the Pregnancy Registry.). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Nurse practitioner called to be apart of the Pregnancy Registry.) had resolved.        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 concomitant medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; Joint Pain; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (Joint Pain), FATIGUE (fatigue) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Spondylitis ankylosing.    The patient's past medical history included Ankylosing spondylitis relapse from 2019 to 2020. Concurrent medical conditions included Non-smoker, Abstains from alcohol and Drug allergy (sulfa allergy associated manifestation for the hives). Concomitant products included MELOXICAM, DROSPIRENONE, ETHINYLESTRADIOL (OCELLA) and ACYCLOVIR [ACICLOVIR] for an unknown indication.   In August 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PYREXIA (Fever), ARTHRALGIA (Joint Pain), FATIGUE (fatigue) and HEADACHE (Headache). In January 2021, PYREXIA (Fever), ARTHRALGIA (Joint Pain) and HEADACHE (Headache) had resolved. In February 2021, FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported.   This case was linked to MOD-2021-082584 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Non significant followup received on 1-Jun-2021 and it contains no new information.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypotension
Clinical narrative: Blood pressure low; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOTENSION (Blood pressure low) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002021A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension in 1998, Diabetes in 1998, Benign prostatic hyperplasia in 1990, Neuropathy in 2008 and Stroke in 2010. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) from 1990 to an unknown date, LISINOPRIL, PRAVASTATIN, GLIPIZIDE, CARVEDILOL, METFORMIN, CLOPIDOGREL BISULFATE (PLAVIX), AMLODIPINE BESILATE (NORVASC) and GLUCOSAMINE & CHONDORITIN.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 26-Feb-2021, the patient experienced HYPOTENSION (Blood pressure low). At the time of the report, HYPOTENSION (Blood pressure low) had resolved.            This case was linked to MOD-2021-019879 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) 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 medical history.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2. On an unknown date, the patient experienced ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown.            No concomitant medications were provided.  No treatment medications were provided.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy liver, Computerised tomogram, Fatigue
Clinical narrative: tiredness; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FATIGUE (tiredness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Diabetes since an unknown date, Non-alcoholic steatohepatitis, Abdominal distension from 30-Nov-2020 to February 2021, Post procedural hemorrhage from 30-Nov-2020 to February 2021 and Abdominal pain from 30-Nov-2020 to February 2021. Concurrent medical conditions included Drug allergy.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 17-Mar-2021, the patient experienced FATIGUE (tiredness). On 17-Mar-2021, FATIGUE (tiredness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Dec-2020, Biopsy liver: abnormal Shows fatty liver and steatohepatitis.  Blood found in liver. On 09-Dec-2020, Computerised tomogram: abnormal Shows abdominal bleeding.     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.   Reporter did not allow further contact
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Excruciating lower back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Excruciating lower back pain) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced BACK PAIN (Excruciating lower back pain). At the time of the report, BACK PAIN (Excruciating lower back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included steroid shot in lower back.  The scheduled date for the second dose was on 19-apr-2021.The patient discussed with his orthopedic doctor potential implications of having a steroid combination with a Covid vaccine and he was confused that will the steroid shot increase risk of getting Covid under the circumstances.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Pyrexia, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), VACCINATION SITE URTICARIA (Vaccination site urticaria), VACCINATION SITE REACTION (Covid arm), CHILLS (Chills) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (allergic to sulfa), Drug allergy (Allergic to clindomycin), Allergy (Allergic to some skin product.), Sunscreen sensitivity and Insect bite allergy. Concomitant products included CALCIUM and VITAMIN D NOS for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced LETHARGY (Lethargy), VACCINATION SITE URTICARIA (Vaccination site urticaria), VACCINATION SITE REACTION (Covid arm), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, LETHARGY (Lethargy), VACCINATION SITE URTICARIA (Vaccination site urticaria), VACCINATION SITE REACTION (Covid arm), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable. Treatment for the event was not reported.  The patient reported experiencing same event with 1st dose.   This case was linked to MOD-2021-016680 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (tinnitus) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Hepatic enzyme, Hepatic enzyme increased, Influenza like illness, Injection site nodule
Clinical narrative: Raw mouth; Injection site nodule; Stiffness; Pain; Flu like symptoms; Pain in extremity; Hepatic enzyme increased; Generalized aching; Pain in elbow; Fever; This spontaneous case was reported by a physician and describes the occurrence of STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No medical history  was provided by the reporter.  Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Pain in extremity), HEPATIC ENZYME INCREASED (Hepatic enzyme increased), MYALGIA (Generalized aching), ARTHRALGIA (Pain in elbow) and PYREXIA (Fever). At the time of the report, STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved, MUSCULOSKELETAL STIFFNESS (Stiffness) outcome was unknown and PAIN (Pain), PAIN IN EXTREMITY (Pain in extremity), HEPATIC ENZYME INCREASED (Hepatic enzyme increased), MYALGIA (Generalized aching) and ARTHRALGIA (Pain in elbow) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: Hepatic enzyme elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: F/U : ADR received on 20 07 2021 contains NNI
Sex: M
Vaccine: COVID19, UNK
Symptoms: Musculoskeletal stiffness, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Raw mouth; Injection site nodule; Stiffness; Pain; Flu like symptoms; Pain in extremity; Hepatic enzyme increased; Generalized aching; Pain in elbow; Fever; This spontaneous case was reported by a physician and describes the occurrence of STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No medical history  was provided by the reporter.  Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Pain in extremity), HEPATIC ENZYME INCREASED (Hepatic enzyme increased), MYALGIA (Generalized aching), ARTHRALGIA (Pain in elbow) and PYREXIA (Fever). At the time of the report, STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved, MUSCULOSKELETAL STIFFNESS (Stiffness) outcome was unknown and PAIN (Pain), PAIN IN EXTREMITY (Pain in extremity), HEPATIC ENZYME INCREASED (Hepatic enzyme increased), MYALGIA (Generalized aching) and ARTHRALGIA (Pain in elbow) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: Hepatic enzyme elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: F/U : ADR received on 20 07 2021 contains NNI
Sex: M
Vaccine: COVID19, UNK
Symptoms: Stomatitis
Clinical narrative: Raw mouth; Injection site nodule; Stiffness; Pain; Flu like symptoms; Pain in extremity; Hepatic enzyme increased; Generalized aching; Pain in elbow; Fever; This spontaneous case was reported by a physician and describes the occurrence of STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No medical history  was provided by the reporter.  Concomitant products included METHOTREXATE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), MUSCULOSKELETAL STIFFNESS (Stiffness), PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN IN EXTREMITY (Pain in extremity), HEPATIC ENZYME INCREASED (Hepatic enzyme increased), MYALGIA (Generalized aching), ARTHRALGIA (Pain in elbow) and PYREXIA (Fever). At the time of the report, STOMATITIS (Raw mouth), INJECTION SITE NODULE (Injection site nodule), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved, MUSCULOSKELETAL STIFFNESS (Stiffness) outcome was unknown and PAIN (Pain), PAIN IN EXTREMITY (Pain in extremity), HEPATIC ENZYME INCREASED (Hepatic enzyme increased), MYALGIA (Generalized aching) and ARTHRALGIA (Pain in elbow) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: Hepatic enzyme elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: F/U : ADR received on 20 07 2021 contains NNI