chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Vertigo, Vomiting
Clinical narrative: diagnosed her with Migraines; Vomiting; sensation of extreme nausea; Severe headache, pain in the back of head; sweating all my body; like my eyes were going to pop out of my head with pain; pain in the back of neck; Diagnosed her with vertigo; Dizziness; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (sweating all my body), EYE PAIN (like my eyes were going to pop out of my head with pain), NECK PAIN (pain in the back of neck), VERTIGO (Diagnosed her with vertigo) and DIZZINESS (Dizziness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety, Bipolar disorder and Vitamin D deficiency. Concomitant products included CLONAZEPAM (KLONOPIN), PROPRANOLOL HYDROCHLORIDE (INDERAL) and FLUOXETINE HYDROCHLORIDE (PROZAC) for Anxiety, CARBAMAZEPINE (TEGRETOL) for Bipolar disorder, VITAMIN D [VITAMIN D NOS] for Vitamin D deficiency.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced HYPERHIDROSIS (sweating all my body), EYE PAIN (like my eyes were going to pop out of my head with pain), NECK PAIN (pain in the back of neck), VERTIGO (Diagnosed her with vertigo), DIZZINESS (Dizziness) and NAUSEA (sensation of extreme nausea). 03-Apr-2021, the patient experienced HEADACHE (Severe headache, pain in the back of head). On 18-May-2021, the patient experienced MIGRAINE (diagnosed her with Migraines) and VOMITING (Vomiting). The patient was treated with ONDANSETRON for Nausea, at a dose of 4 mg as required; MECLIZINE [MECLOZINE] for Dizziness, at a dose of 25 mg as required; BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Migraine, at a dose of UNK dosage form and IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 18-May-2021, VOMITING (Vomiting) had resolved. At the time of the report, HYPERHIDROSIS (sweating all my body), EYE PAIN (like my eyes were going to pop out of my head with pain), NECK PAIN (pain in the back of neck), VERTIGO (Diagnosed her with vertigo), DIZZINESS (Dizziness), MIGRAINE (diagnosed her with Migraines), NAUSEA (sensation of extreme nausea) and HEADACHE (Severe headache, pain in the back of head) outcome was unknown.            The patient had three episodes of severe head ache and a sensation of extreme nausea, sweating all my body, pain in back of neck and head, like my eyes were going to pop out of my head with pain. The last episode happened on 18-May-2021. The patient could not remember the other two dates of these episodes. The patient went to emergency room on 18-May-2021 and vomited before entering the emergency room. The patient felt that episodes were becoming more frequent.    This case was linked to MOD-2021-142747 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Myalgia
Clinical narrative: "Almost collapsed"; "Severe muscle aches"; The whole weakness thing"; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("The whole weakness thing" "Almost collapsed") and MYALGIA ("Severe muscle aches") 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) at an unspecified dose. On an unknown date, the patient experienced ASTHENIA ("The whole weakness thing" "Almost collapsed") and MYALGIA ("Severe muscle aches"). At the time of the report, MYALGIA ("Severe muscle aches") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided. This case was linked to MOD21-091684, MOD21-091689, INC.-MOD-2021-143088 (E2B Linked Report). This case was linked to MOD-2021-142497 (Patient Link).; Sender's Comments: MOD21-091684:crosslinked, MOD21-091689:crosslinked, INC.-MOD-2021-143088:Crosslink
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Fear, Headache
Clinical narrative: nausea; Headaches; fatigue; joint pain; fear; dizzy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEAR (fear), DIZZINESS (dizzy), NAUSEA (nausea), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (dizzy). On 08-Apr-2021, the patient experienced FEAR (fear), FATIGUE (fatigue) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced NAUSEA (nausea) and HEADACHE (Headaches). At the time of the report, FEAR (fear), DIZZINESS (dizzy), NAUSEA (nausea) and HEADACHE (Headaches) outcome was unknown and FATIGUE (fatigue) and ARTHRALGIA (joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Heart rate increased: heart rate increased Heart rate increased.         No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-142691 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Nausea
Clinical narrative: nausea; Headaches; fatigue; joint pain; fear; dizzy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEAR (fear), DIZZINESS (dizzy), NAUSEA (nausea), FATIGUE (fatigue) and ARTHRALGIA (joint pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DIZZINESS (dizzy). On 08-Apr-2021, the patient experienced FEAR (fear), FATIGUE (fatigue) and ARTHRALGIA (joint pain). On an unknown date, the patient experienced NAUSEA (nausea) and HEADACHE (Headaches). At the time of the report, FEAR (fear), DIZZINESS (dizzy), NAUSEA (nausea) and HEADACHE (Headaches) outcome was unknown and FATIGUE (fatigue) and ARTHRALGIA (joint pain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Heart rate increased: heart rate increased Heart rate increased.         No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-142691 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna shot on 5Jan2021/missed correct interval inter dosis) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037152011) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna shot on 5Jan2021/missed correct interval inter dosis). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the 1st dose of the Moderna shot on 5Jan2021/missed correct interval inter dosis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication history not provided. Treatment information was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Erythema, Rash, Swelling, Urticaria
Clinical narrative: Hives all over face and all over both sides of her neck, up to her hairline and also at her jawline; It resembles acne; Red and raised bumps, not itchy; Red and raised bumps, not itchy; rash all over face and all over both sides of her neck, up to her hairline and also at her jawline/ rash has progressively gotten worse; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives all over face and all over both sides of her neck, up to her hairline and also at her jawline), ACNE (It resembles acne), SWELLING (Red and raised bumps, not itchy), ERYTHEMA (Red and raised bumps, not itchy) and RASH (rash all over face and all over both sides of her neck, up to her hairline and also at her jawline/ rash has progressively gotten worse) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LO LOESTRIN FE) for Birth control.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced URTICARIA (Hives all over face and all over both sides of her neck, up to her hairline and also at her jawline), ACNE (It resembles acne), SWELLING (Red and raised bumps, not itchy), ERYTHEMA (Red and raised bumps, not itchy) and RASH (rash all over face and all over both sides of her neck, up to her hairline and also at her jawline/ rash has progressively gotten worse). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives all over face and all over both sides of her neck, up to her hairline and also at her jawline), ACNE (It resembles acne), SWELLING (Red and raised bumps, not itchy), ERYTHEMA (Red and raised bumps, not itchy) and RASH (rash all over face and all over both sides of her neck, up to her hairline and also at her jawline/ rash has progressively gotten worse) had not 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.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Constipation, Diarrhoea, Dizziness, Influenza
Clinical narrative: Irritable bowel syndrome (IBS); really dizzy; the dose flares it up (IBS); his left sub-mandibular lymph node is tender and swollen; vomiting/ Still vomiting; chills; fever; body ache; constipation; flue like symptoms; diarrhea/ severe diarrhea; This spontaneous case was reported by a nurse and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIARRHOEA (diarrhea/ severe diarrhea) and DIZZINESS (really dizzy) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIARRHOEA (diarrhea/ severe diarrhea), VOMITING (vomiting/ Still vomiting), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), DIZZINESS (really dizzy), IRRITABLE BOWEL SYNDROME (the dose flares it up (IBS)) and LYMPHADENOPATHY (his left sub-mandibular lymph node is tender and swollen). At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIZZINESS (really dizzy), IRRITABLE BOWEL SYNDROME (the dose flares it up (IBS)), LYMPHADENOPATHY (his left sub-mandibular lymph node is tender and swollen), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache) outcome was unknown and DIARRHOEA (diarrhea/ severe diarrhea) and VOMITING (vomiting/ Still vomiting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test increased: increased Increased.     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.   This case was linked to US-MODERNATX, INC.-MOD-2021-142320 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Significant Live follow-up added On 20-May-2021: Significant follow-up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142320:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Liver function test increased, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Irritable bowel syndrome (IBS); really dizzy; the dose flares it up (IBS); his left sub-mandibular lymph node is tender and swollen; vomiting/ Still vomiting; chills; fever; body ache; constipation; flue like symptoms; diarrhea/ severe diarrhea; This spontaneous case was reported by a nurse and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIARRHOEA (diarrhea/ severe diarrhea) and DIZZINESS (really dizzy) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIARRHOEA (diarrhea/ severe diarrhea), VOMITING (vomiting/ Still vomiting), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), DIZZINESS (really dizzy), IRRITABLE BOWEL SYNDROME (the dose flares it up (IBS)) and LYMPHADENOPATHY (his left sub-mandibular lymph node is tender and swollen). At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIZZINESS (really dizzy), IRRITABLE BOWEL SYNDROME (the dose flares it up (IBS)), LYMPHADENOPATHY (his left sub-mandibular lymph node is tender and swollen), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache) outcome was unknown and DIARRHOEA (diarrhea/ severe diarrhea) and VOMITING (vomiting/ Still vomiting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test increased: increased Increased.     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.   This case was linked to US-MODERNATX, INC.-MOD-2021-142320 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Significant Live follow-up added On 20-May-2021: Significant follow-up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142320:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Irritable bowel syndrome (IBS); really dizzy; the dose flares it up (IBS); his left sub-mandibular lymph node is tender and swollen; vomiting/ Still vomiting; chills; fever; body ache; constipation; flue like symptoms; diarrhea/ severe diarrhea; This spontaneous case was reported by a nurse and describes the occurrence of IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIARRHOEA (diarrhea/ severe diarrhea) and DIZZINESS (really dizzy) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIARRHOEA (diarrhea/ severe diarrhea), VOMITING (vomiting/ Still vomiting), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), DIZZINESS (really dizzy), IRRITABLE BOWEL SYNDROME (the dose flares it up (IBS)) and LYMPHADENOPATHY (his left sub-mandibular lymph node is tender and swollen). At the time of the report, IRRITABLE BOWEL SYNDROME (Irritable bowel syndrome (IBS)), CONSTIPATION (constipation), INFLUENZA (flue like symptoms), DIZZINESS (really dizzy), IRRITABLE BOWEL SYNDROME (the dose flares it up (IBS)), LYMPHADENOPATHY (his left sub-mandibular lymph node is tender and swollen), CHILLS (chills), PYREXIA (fever) and MYALGIA (body ache) outcome was unknown and DIARRHOEA (diarrhea/ severe diarrhea) and VOMITING (vomiting/ Still vomiting) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test increased: increased Increased.     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.   This case was linked to US-MODERNATX, INC.-MOD-2021-142320 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Significant Live follow-up added On 20-May-2021: Significant follow-up appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142320:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: patient fell; This spontaneous case was reported by a consumer and describes the occurrence of FALL (patient fell) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TETANUS VACCINE.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced FALL (patient fell). At the time of the report, FALL (patient fell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not provided by the reporter
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heavy menstrual bleeding, Malaise, Myalgia
Clinical narrative: Increased Menstrual Bleeding  from 1 day to 3 days (After Second Vaccine); Feels Something is Wrong with Body (After Second Vaccine); Very Tired (After Second Vaccine)/Intermittent Severe Fatigue (After Second Vaccine); Intermittent Body Pain (After Second Vaccine); This spontaneous case was reported by a health care professional and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Increased Menstrual Bleeding  from 1 day to 3 days (After Second Vaccine)), MALAISE (Feels Something is Wrong with Body (After Second Vaccine)), FATIGUE (Very Tired (After Second Vaccine)/Intermittent Severe Fatigue (After Second Vaccine)) and MYALGIA (Intermittent Body Pain (After Second Vaccine)) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-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 HEAVY MENSTRUAL BLEEDING (Increased Menstrual Bleeding  from 1 day to 3 days (After Second Vaccine)), MALAISE (Feels Something is Wrong with Body (After Second Vaccine)), FATIGUE (Very Tired (After Second Vaccine)/Intermittent Severe Fatigue (After Second Vaccine)) and MYALGIA (Intermittent Body Pain (After Second Vaccine)). At the time of the report, HEAVY MENSTRUAL BLEEDING (Increased Menstrual Bleeding  from 1 day to 3 days (After Second Vaccine)), MALAISE (Feels Something is Wrong with Body (After Second Vaccine)), FATIGUE (Very Tired (After Second Vaccine)/Intermittent Severe Fatigue (After Second Vaccine)) and MYALGIA (Intermittent Body Pain (After Second Vaccine)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash appeared on trunk; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash appeared on trunk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced RASH (Rash appeared on trunk). At the time of the report, RASH (Rash appeared on trunk) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 31-Mar-2021 and the estimated date of delivery was 05-Jan-2022. On 23-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up was received on 18-may-2021 and contains no new information
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: Mental issues related forgetting things; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MEMORY IMPAIRMENT (Mental issues related forgetting things) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced MEMORY IMPAIRMENT (Mental issues related forgetting things). At the time of the report, MEMORY IMPAIRMENT (Mental issues related forgetting things) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Pyrexia, Tenderness
Clinical narrative: broke into a sweat; tenderness; little fatigued; very low fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-May-2021 and was forwarded to Moderna on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very low fever), HYPERHIDROSIS (broke into a sweat), TENDERNESS (tenderness) and FATIGUE (little fatigued) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination.     No Medical History Reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), SOTALOL, LOSARTAN and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PYREXIA (very low fever), TENDERNESS (tenderness) and FATIGUE (little fatigued). On 17-Apr-2021, the patient experienced HYPERHIDROSIS (broke into a sweat). At the time of the report, PYREXIA (very low fever), HYPERHIDROSIS (broke into a sweat), TENDERNESS (tenderness) and FATIGUE (little fatigued) 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) (Unknown), the reporter did not provide any causality assessments.   Treatment information not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-142492 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142492:crosslinked; wife case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash appeared on trunk and is on and off; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash appeared on trunk and is on and off) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced RASH (Rash appeared on trunk and is on and off). At the time of the report, RASH (Rash appeared on trunk and is on and off) had not resolved.            No concomitant medications were provided.  No treatment information provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Back pain.    On 18-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 BACK PAIN (back pain). At the time of the report, BACK PAIN (back pain) 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 considered BACK PAIN (back pain) to be unlikely related.    The patient states that she has history of back pain and currently having back pain, but it is not a side effects from vaccine.  No concomitant medications were reported. Treatment medications were not provided by the reporter.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Hypoaesthesia, Interchange of vaccine products
Clinical narrative: nausea; I'm so tired; numbness in leg; pain in leg; weak; I don't feel good; received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021), HYPOAESTHESIA (numbness in leg), PAIN IN EXTREMITY (pain in leg), ASTHENIA (weak) and FEELING ABNORMAL (I don't feel good) in a 46-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.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021). On 17-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in leg), PAIN IN EXTREMITY (pain in leg), ASTHENIA (weak), FEELING ABNORMAL (I don't feel good) and FATIGUE (I'm so tired). On an unknown date, the patient experienced NAUSEA (nausea). On 16-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021) had resolved. At the time of the report, HYPOAESTHESIA (numbness in leg), PAIN IN EXTREMITY (pain in leg), ASTHENIA (weak), FEELING ABNORMAL (I don't feel good), NAUSEA (nausea) and FATIGUE (I'm so tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was interrupted on an unknown date.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: nausea; I'm so tired; numbness in leg; pain in leg; weak; I don't feel good; received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021), HYPOAESTHESIA (numbness in leg), PAIN IN EXTREMITY (pain in leg), ASTHENIA (weak) and FEELING ABNORMAL (I don't feel good) in a 46-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.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021). On 17-Mar-2021, the patient experienced HYPOAESTHESIA (numbness in leg), PAIN IN EXTREMITY (pain in leg), ASTHENIA (weak), FEELING ABNORMAL (I don't feel good) and FATIGUE (I'm so tired). On an unknown date, the patient experienced NAUSEA (nausea). On 16-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (received the Moderna COVID-19 vaccine on 18Feb2021 and the Pfizer COVID-19 vaccine on 16Mar2021) had resolved. At the time of the report, HYPOAESTHESIA (numbness in leg), PAIN IN EXTREMITY (pain in leg), ASTHENIA (weak), FEELING ABNORMAL (I don't feel good), NAUSEA (nausea) and FATIGUE (I'm so tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was interrupted on an unknown date.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Miliaria, Pyrexia, Tenderness
Clinical narrative: broke into a sweat; slightly tired; very low fever; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (slightly tired), PYREXIA (very low fever), TENDERNESS (tenderness  ) and MILIARIA (broke into a sweat) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 023C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), SOTALOL, LOSARTAN and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 15-Apr-2021, the patient experienced FATIGUE (slightly tired), PYREXIA (very low fever) and TENDERNESS (tenderness  ). On 17-Apr-2021, the patient experienced MILIARIA (broke into a sweat). At the time of the report, FATIGUE (slightly tired), PYREXIA (very low fever), TENDERNESS (tenderness  ) and MILIARIA (broke into a sweat) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-142492 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142492:crosslinked; wife case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Muscle fatigue, Myalgia
Clinical narrative: Shoulder Pain; Muscle Pain; muscle Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder Pain), MYALGIA (Muscle Pain) and MUSCLE FATIGUE (muscle Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced ARTHRALGIA (Shoulder Pain), MYALGIA (Muscle Pain) and MUSCLE FATIGUE (muscle Fatigue). At the time of the report, ARTHRALGIA (Shoulder Pain), MYALGIA (Muscle Pain) and MUSCLE FATIGUE (muscle Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: "Generalized weakness"; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("Generalized weakness") 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 ASTHENIA ("Generalized weakness"). At the time of the report, ASTHENIA ("Generalized weakness") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-142497, US-MODERNATX, INC.-MOD-2021-142886, MOD21-091689 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-142497:Crosslink US-MODERNATX, INC.-MOD-2021-142886:Crosslink MOD21-091689:Crosslink
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Headache, Myalgia
Clinical narrative: feels agitated; a lot of headache; their whole body hurts; This spontaneous case was reported by a consumer and describes the occurrence of AGITATION (feels agitated), HEADACHE (a lot of headache) and MYALGIA (their whole body hurts) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00LCA1A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced AGITATION (feels agitated), HEADACHE (a lot of headache) and MYALGIA (their whole body hurts). At the time of the report, AGITATION (feels agitated), HEADACHE (a lot of headache) and MYALGIA (their whole body hurts) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided    Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Significant follow up document received on 16-JUL-2021 contains event outcome updated as recovered/resolved for all event
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for COVID-19; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Positive for COVID-19) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 17-Feb-2021, the patient experienced COVID-19 (Positive for COVID-19). The patient was treated with BAMLANIVIMAB on 22-Feb-2021 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient received bamlanivimab antibody treatment on 22/Feb/2021.
Sex: M
Vaccine: COVID19
Symptoms: Accident at work
Clinical narrative: caller was hurt at work; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENT AT WORK (caller was hurt at work) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Injury at work: Tetanus Vaccine (Patient was hurt at work and received a tetanus shot). Past adverse reactions to the above products included No adverse event with Tetanus Vaccine.    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 ACCIDENT AT WORK (caller was hurt at work). At the time of the report, ACCIDENT AT WORK (caller was hurt at work) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not provided by reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Cough, Paraesthesia, Product dose omission issue, Vomiting
Clinical narrative: he has not received his 2nd vaccine; threw up; left arm tingling; began coughing quite a bit; ongoing intermittent stomach aches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (left arm tingling), COUGH (began coughing quite a bit), ABDOMINAL PAIN UPPER (ongoing intermittent stomach aches), PRODUCT DOSE OMISSION ISSUE (he has not received his 2nd vaccine) and VOMITING (threw up) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PARAESTHESIA (left arm tingling), COUGH (began coughing quite a bit), ABDOMINAL PAIN UPPER (ongoing intermittent stomach aches) and VOMITING (threw up). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (he has not received his 2nd vaccine). At the time of the report, PARAESTHESIA (left arm tingling), COUGH (began coughing quite a bit), ABDOMINAL PAIN UPPER (ongoing intermittent stomach aches), PRODUCT DOSE OMISSION ISSUE (he has not received his 2nd vaccine) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided.   The patient's arm started tingling and he began coughing quite a bit. He threw up everything that he ate and felt somewhat better after this. He had ongoing intermittent stomach aches ever since then.  During the patient's follow up call on 01-Jul-2021 the patient reported his adverse events from the first vaccine has resolved and stated adverse events finally went away after a month. Patient stated he is doing fine now and declined any further need for follow up. Patient advised he has not received his 2nd vaccine because he is moving. Patient plans on getting the 2nd once he is moved.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Updated events outcome and added information from follow-up call.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: patient did not take second dose; covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) and PRODUCT DOSE OMISSION ISSUE (patient did not take second dose) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (covid-19). On 18-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient did not take second dose). On 18-May-2021, PRODUCT DOSE OMISSION ISSUE (patient did not take second dose) had resolved. At the time of the report, COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. In 2021, SARS-CoV-2 antibody test: plenty of antibodies (Positive) her doctor tested for antibodies and she had plenty of antibodies.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reported concomitant medication included blood pressure and diabetes medication.  Treatment information included as Monoclonal Antibody infusion.  Patient reported that her doctor tested for antibodies and she had plenty of antibodies.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Added lab data and event.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired Moderna COVID-19 vaccine was administered as a possible first dose to a patient; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 vaccine was administered as a possible first dose to a patient) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 vaccine was administered as a possible first dose to a patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired Moderna COVID-19 vaccine was administered as a possible first dose to a patient) had not 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 included.  No treatment medication included.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: injection arm soreness; small headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (injection arm soreness) and HEADACHE (small headache) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    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 PAIN IN EXTREMITY (injection arm soreness) and HEADACHE (small headache). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (injection arm soreness) and HEADACHE (small headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included diabetic medications.   This case was linked to US-sm-MOD-21-091615 (E2B Linked Report).; Sender's Comments:  US-sm-MOD-21-091615:Case Cross Linked with MOD-21091615