chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Decreased appetite, Headache, Impaired work ability
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), DECREASED APPETITE (Decreased appetite,), SWELLING (Swelling on the left side), ABDOMINAL DISCOMFORT (Upset stomach) and PAIN IN EXTREMITY (thumb and wrist pian) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MALAISE (Malaise), DECREASED APPETITE (Decreased appetite,), SWELLING (Swelling on the left side), ABDOMINAL DISCOMFORT (Upset stomach), PAIN IN EXTREMITY (thumb and wrist pian), IMPAIRED WORK ABILITY (Left knee pain, thumba nd wrist pain, hard to work), ARTHRALGIA (Left knee pain), MYALGIA (Muscle soreness,), HEADACHE (Headache) and PYREXIA (Low-grade fever). At the time of the report, MALAISE (Malaise), DECREASED APPETITE (Decreased appetite,), SWELLING (Swelling on the left side), ABDOMINAL DISCOMFORT (Upset stomach), ARTHRALGIA (Left knee pain), MYALGIA (Muscle soreness,), HEADACHE (Headache) and PYREXIA (Low-grade fever) outcome was unknown and PAIN IN EXTREMITY (thumb and wrist pian) and IMPAIRED WORK ABILITY (Left knee pain, thumba nd wrist pain, hard to work) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment included ibuprofen and acetaminophen.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: updated additional information- events (left knee pain, thumb and wrist pain upset stomach and hard to work)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain in extremity, Pyrexia, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise), DECREASED APPETITE (Decreased appetite,), SWELLING (Swelling on the left side), ABDOMINAL DISCOMFORT (Upset stomach) and PAIN IN EXTREMITY (thumb and wrist pian) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MALAISE (Malaise), DECREASED APPETITE (Decreased appetite,), SWELLING (Swelling on the left side), ABDOMINAL DISCOMFORT (Upset stomach), PAIN IN EXTREMITY (thumb and wrist pian), IMPAIRED WORK ABILITY (Left knee pain, thumba nd wrist pain, hard to work), ARTHRALGIA (Left knee pain), MYALGIA (Muscle soreness,), HEADACHE (Headache) and PYREXIA (Low-grade fever). At the time of the report, MALAISE (Malaise), DECREASED APPETITE (Decreased appetite,), SWELLING (Swelling on the left side), ABDOMINAL DISCOMFORT (Upset stomach), ARTHRALGIA (Left knee pain), MYALGIA (Muscle soreness,), HEADACHE (Headache) and PYREXIA (Low-grade fever) outcome was unknown and PAIN IN EXTREMITY (thumb and wrist pian) and IMPAIRED WORK ABILITY (Left knee pain, thumba nd wrist pain, hard to work) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment included ibuprofen and acetaminophen.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: updated additional information- events (left knee pain, thumb and wrist pain upset stomach and hard to work)
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Diarrhoea, Haematochezia, Headache
Clinical narrative: "bowel movements with bleeding"; "diarrhea"; "high blood pressure."; "headache"; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA ("bowel movements with bleeding"), DIARRHOEA ("diarrhea"), BLOOD PRESSURE INCREASED ("high blood pressure.") and HEADACHE ("headache") in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced HAEMATOCHEZIA ("bowel movements with bleeding"), DIARRHOEA ("diarrhea"), BLOOD PRESSURE INCREASED ("high blood pressure.") and HEADACHE ("headache"). At the time of the report, HAEMATOCHEZIA ("bowel movements with bleeding"), DIARRHOEA ("diarrhea"), BLOOD PRESSURE INCREASED ("high blood pressure.") and HEADACHE ("headache") had not resolved.            The patient reported no concomitant medications.  There was no treatment for the side effects.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Hypersomnia
Clinical narrative: terrible sleeping; arm from elbow to shoulder had a bruised feeling; dull headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (terrible sleeping), CONTUSION (arm from elbow to shoulder had a bruised feeling) and HEADACHE (dull headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HYPERSOMNIA (terrible sleeping), CONTUSION (arm from elbow to shoulder had a bruised feeling) and HEADACHE (dull headache). At the time of the report, HYPERSOMNIA (terrible sleeping), CONTUSION (arm from elbow to shoulder had a bruised feeling) and HEADACHE (dull headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever; chills; headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (tiredness) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FATIGUE (tiredness). On 23-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and FATIGUE (tiredness) outcome was unknown. Not Provided          No concomitant medications were provided. No treatment drugs were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lymphadenopathy, Nausea, Pain
Clinical narrative: sore; slight bruising; swelling of the lymph node underneath the arm pit of the vaccination site; nauseous; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (sore), CONTUSION (slight bruising), NAUSEA (nauseous) and LYMPHADENOPATHY (swelling of the lymph node underneath the arm pit of the vaccination site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy (tree pollen allergy) and Epinephrine. Concomitant products included FAMOTIDINE and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 16-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 NAUSEA (nauseous). On 22-Apr-2021, the patient experienced LYMPHADENOPATHY (swelling of the lymph node underneath the arm pit of the vaccination site). On 23-Apr-2021, the patient experienced PAIN (sore) and CONTUSION (slight bruising). At the time of the report, PAIN (sore), CONTUSION (slight bruising), NAUSEA (nauseous) and LYMPHADENOPATHY (swelling of the lymph node underneath the arm pit of the vaccination site) 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 included maintanence inhaler for seasonal tree pollen allergy.  Patient reports waiting 30 minutes after receiving the vaccine due to an undiagnosed connective tissue autoimmune disease. Patient stated that in the past she had experienced body chills, feeling really hot, bad periods from autoimmune disease.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: arm is sore; body is achy; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore), PAIN (body is achy) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (LEVOXYL) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm is sore), PAIN (body is achy) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (arm is sore), PAIN (body is achy) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information does not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Lymphadenopathy
Clinical narrative: swollen lymph nodes on both sides of her neck; felt horrible; Dizzy; Chills; Headache; Nausea; Throw up; She had hives about 15 minutes in on her feet; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (She had hives about 15 minutes in on her feet), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (The patient is allergic to tetanus, diphtheria, and pertussis (TDAP) vaccine.).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced URTICARIA (She had hives about 15 minutes in on her feet). On 21-Apr-2021, the patient experienced DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up). On 22-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on both sides of her neck) and FEELING ABNORMAL (felt horrible). On 21-Apr-2021, URTICARIA (She had hives about 15 minutes in on her feet) had resolved. On 22-Apr-2021, VOMITING (Throw up) had resolved. On 23-Apr-2021, DIZZINESS (Dizzy), CHILLS (Chills) and FEELING ABNORMAL (felt horrible) had resolved. At the time of the report, HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (swollen lymph nodes on both sides of her neck) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She has non-fatty liver disease. She has been drinking ginger ale and taking Tylenol (from 2nd day until 3rd day).   This case was linked to US-MODERNATX, INC.-MOD-2021-089362, US-MODERNATX, INC.-MOD-2021-089601 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089362:cross linked case US-MODERNATX, INC.-MOD-2021-089601:patient 1
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Urticaria, Vomiting
Clinical narrative: swollen lymph nodes on both sides of her neck; felt horrible; Dizzy; Chills; Headache; Nausea; Throw up; She had hives about 15 minutes in on her feet; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (She had hives about 15 minutes in on her feet), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (The patient is allergic to tetanus, diphtheria, and pertussis (TDAP) vaccine.).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced URTICARIA (She had hives about 15 minutes in on her feet). On 21-Apr-2021, the patient experienced DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up). On 22-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on both sides of her neck) and FEELING ABNORMAL (felt horrible). On 21-Apr-2021, URTICARIA (She had hives about 15 minutes in on her feet) had resolved. On 22-Apr-2021, VOMITING (Throw up) had resolved. On 23-Apr-2021, DIZZINESS (Dizzy), CHILLS (Chills) and FEELING ABNORMAL (felt horrible) had resolved. At the time of the report, HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (swollen lymph nodes on both sides of her neck) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She has non-fatty liver disease. She has been drinking ginger ale and taking Tylenol (from 2nd day until 3rd day).   This case was linked to US-MODERNATX, INC.-MOD-2021-089362, US-MODERNATX, INC.-MOD-2021-089601 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089362:cross linked case US-MODERNATX, INC.-MOD-2021-089601:patient 1
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: heat at the vaccination site; Soreness at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat at the vaccination site) and VACCINATION SITE PAIN (Soreness at the vaccination site) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE WARMTH (heat at the vaccination site) and VACCINATION SITE PAIN (Soreness at the vaccination site). At the time of the report, VACCINATION SITE WARMTH (heat at the vaccination site) outcome was unknown and VACCINATION SITE PAIN (Soreness at the vaccination site) had not resolved.            Treatment include Tylenol.  Concomitant medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-089055, MOD21-081609, US-MODERNATX, INC.-MOD-2021-089063, US-MODERNATX, INC.-MOD-2021-089217 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089055:Wife 1st dose case MOD21-081609:Son's case US-MODERNATX, INC.-MOD-2021-089063:wife;s case US-MODERNATX, INC.-MOD-2021-089217:sons  case
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Paraesthesia
Clinical narrative: Pain in right leg; Tingling sensation in right leg; Light headedness; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headedness), PAIN IN EXTREMITY (Pain in right leg), PARAESTHESIA (Tingling sensation in right leg), HEADACHE (Headache) and FATIGUE (Fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), CLARITHROMYCIN, OMEPRAZOLE, TINIDAZOLE (OTC-HP) and ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ) for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced FATIGUE (Fatigue). On 21-Apr-2021, the patient experienced HEADACHE (Headache). On 22-Apr-2021, the patient experienced DIZZINESS (Light headedness). On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in right leg) and PARAESTHESIA (Tingling sensation in right leg). At the time of the report, DIZZINESS (Light headedness), PAIN IN EXTREMITY (Pain in right leg), PARAESTHESIA (Tingling sensation in right leg), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            No treatment drugs were reported.   This case was linked to MOD-2021-089056 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cardiac flutter, Chills, Confusional state, Fatigue
Clinical narrative: like her heart wanted to go out; almost could not speak; tired legs; tongue a bit heavy; mouth started to be heavy; confusion, a bit; vaccine burned a bit; felt very tired; forehead a bit heavy too; chills; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (like her heart wanted to go out), APHONIA (almost could not speak), LIMB DISCOMFORT (tired legs), TONGUE DISCOMFORT (tongue a bit heavy) and ORAL DISCOMFORT (mouth started to be heavy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history was provided by the reporter.  Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) 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 CARDIAC FLUTTER (like her heart wanted to go out), APHONIA (almost could not speak), LIMB DISCOMFORT (tired legs), TONGUE DISCOMFORT (tongue a bit heavy), ORAL DISCOMFORT (mouth started to be heavy), CONFUSIONAL STATE (confusion, a bit), VACCINATION SITE PAIN (vaccine burned a bit), FATIGUE (felt very tired), HEADACHE (forehead a bit heavy too) and CHILLS (chills). On 19-Apr-2021, VACCINATION SITE PAIN (vaccine burned a bit) had resolved. At the time of the report, CARDIAC FLUTTER (like her heart wanted to go out), APHONIA (almost could not speak), LIMB DISCOMFORT (tired legs), TONGUE DISCOMFORT (tongue a bit heavy), ORAL DISCOMFORT (mouth started to be heavy), CONFUSIONAL STATE (confusion, a bit), FATIGUE (felt very tired), HEADACHE (forehead a bit heavy too) and CHILLS (chills) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant medication was not reported.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Limb discomfort, Oral discomfort, Tongue discomfort, Vaccination site pain
Clinical narrative: like her heart wanted to go out; almost could not speak; tired legs; tongue a bit heavy; mouth started to be heavy; confusion, a bit; vaccine burned a bit; felt very tired; forehead a bit heavy too; chills; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (like her heart wanted to go out), APHONIA (almost could not speak), LIMB DISCOMFORT (tired legs), TONGUE DISCOMFORT (tongue a bit heavy) and ORAL DISCOMFORT (mouth started to be heavy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 008B212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history was provided by the reporter.  Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) 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 CARDIAC FLUTTER (like her heart wanted to go out), APHONIA (almost could not speak), LIMB DISCOMFORT (tired legs), TONGUE DISCOMFORT (tongue a bit heavy), ORAL DISCOMFORT (mouth started to be heavy), CONFUSIONAL STATE (confusion, a bit), VACCINATION SITE PAIN (vaccine burned a bit), FATIGUE (felt very tired), HEADACHE (forehead a bit heavy too) and CHILLS (chills). On 19-Apr-2021, VACCINATION SITE PAIN (vaccine burned a bit) had resolved. At the time of the report, CARDIAC FLUTTER (like her heart wanted to go out), APHONIA (almost could not speak), LIMB DISCOMFORT (tired legs), TONGUE DISCOMFORT (tongue a bit heavy), ORAL DISCOMFORT (mouth started to be heavy), CONFUSIONAL STATE (confusion, a bit), FATIGUE (felt very tired), HEADACHE (forehead a bit heavy too) and CHILLS (chills) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Concomitant medication was not reported.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Illness, Vaccination site pain
Clinical narrative: feel weak; feel "off"; Vaccination site pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feel weak), ILLNESS (feel "off"), HEADACHE (headache) and VACCINATION SITE PAIN (Vaccination site pain) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced HEADACHE (headache). On 23-Apr-2021, the patient experienced ASTHENIA (feel weak), ILLNESS (feel "off") and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, ASTHENIA (feel weak), ILLNESS (feel "off"), HEADACHE (headache) and VACCINATION SITE PAIN (Vaccination site pain) 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 provided.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 008B212A) 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) (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 an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Unknown          No concomitant medications were reported.  No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event (no medical history reported). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced HEADACHE (Headache). On 26-Mar-2021, HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    This case was linked to US-MODERNATX, INC.-MOD-2021-089050, US-MODERNATX, INC.-MOD-2021-089217 (E2B Linked Report). This case was linked to MOD-2021-089063 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089050:Husband's case US-MODERNATX, INC.-MOD-2021-089217:Son case
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity, Paraesthesia
Clinical narrative: the leg veins are more prominent than before.; tingling sensation in the right leg; pain in the right leg, the leg veins are more prominent than before; lightheadedness; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in the right leg, the leg veins are more prominent than before) and VARICOSE VEIN (the leg veins are more prominent than before.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Restless leg syndrome and Varicose veins. Concomitant products included NYSTATIN (STATIN [NYSTATIN]) for Cholesterol, ANTIHISTAMINES and CLARITHROMYCIN, OMEPRAZOLE, TINIDAZOLE (OTC-HP) for Hypersensitivity.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced FATIGUE (Fatigue). On 21-Apr-2021, the patient experienced HEADACHE (Headache). On 22-Apr-2021, the patient experienced DIZZINESS (lightheadedness). On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the right leg, the leg veins are more prominent than before) and PARAESTHESIA (tingling sensation in the right leg). On an unknown date, the patient experienced VARICOSE VEIN (the leg veins are more prominent than before.). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in the right leg, the leg veins are more prominent than before), VARICOSE VEIN (the leg veins are more prominent than before.) and PARAESTHESIA (tingling sensation in the right leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.   This case was linked to MOD-2021-089051 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Varicose vein
Clinical narrative: the leg veins are more prominent than before.; tingling sensation in the right leg; pain in the right leg, the leg veins are more prominent than before; lightheadedness; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in the right leg, the leg veins are more prominent than before) and VARICOSE VEIN (the leg veins are more prominent than before.) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Restless leg syndrome and Varicose veins. Concomitant products included NYSTATIN (STATIN [NYSTATIN]) for Cholesterol, ANTIHISTAMINES and CLARITHROMYCIN, OMEPRAZOLE, TINIDAZOLE (OTC-HP) for Hypersensitivity.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced FATIGUE (Fatigue). On 21-Apr-2021, the patient experienced HEADACHE (Headache). On 22-Apr-2021, the patient experienced DIZZINESS (lightheadedness). On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the right leg, the leg veins are more prominent than before) and PARAESTHESIA (tingling sensation in the right leg). On an unknown date, the patient experienced VARICOSE VEIN (the leg veins are more prominent than before.). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in the right leg, the leg veins are more prominent than before), VARICOSE VEIN (the leg veins are more prominent than before.) and PARAESTHESIA (tingling sensation in the right leg) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.   This case was linked to MOD-2021-089051 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: urine was becoming discolored and becoming a little darker than usual; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (urine was becoming discolored and becoming a little darker than usual) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced CHROMATURIA (urine was becoming discolored and becoming a little darker than usual). At the time of the report, CHROMATURIA (urine was becoming discolored and becoming a little darker than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Itchy rash; Red rash all over the body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash all over the body) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash all over the body). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash all over the body) outcome was unknown. Unknown          Treatment included Tylenol and Benadryl
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Pain in extremity, Rash macular, Skin exfoliation
Clinical narrative: skin fell off; skin looks reddish, a light pink color; Fatigue; Dark spot on right hand below fingers area, like a large brown mole; Bad pain on left arm if had to lift it; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Dark spot on right hand below fingers area, like a large brown mole), PAIN IN EXTREMITY (Bad pain on left arm if had to lift it), SKIN EXFOLIATION (skin fell off), ERYTHEMA (skin looks reddish, a light pink color) and FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced RASH MACULAR (Dark spot on right hand below fingers area, like a large brown mole), PAIN IN EXTREMITY (Bad pain on left arm if had to lift it) and FATIGUE (Fatigue). On 25-Apr-2021, the patient experienced SKIN EXFOLIATION (skin fell off) and ERYTHEMA (skin looks reddish, a light pink color). On 11-Apr-2021, PAIN IN EXTREMITY (Bad pain on left arm if had to lift it) had resolved. On 12-Apr-2021, FATIGUE (Fatigue) had resolved. On 24-Apr-2021, RASH MACULAR (Dark spot on right hand below fingers area, like a large brown mole) had resolved. At the time of the report, SKIN EXFOLIATION (skin fell off) and ERYTHEMA (skin looks reddish, a light pink color) 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 treatment medications were reported
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Influenza like illness, Myalgia
Clinical narrative: flu-like symptoms; lockjaw; "feeling like they were going to die"; Fever; chills; soreness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS, TRISMUS (lockjaw), FEELING ABNORMAL (feeling like they were going to die), PYREXIA, and CHILLS in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS, TRISMUS (lockjaw), FEELING ABNORMAL (feeling like they were going to die), PYREXIA, CHILLS, MYALGIA, and FATIGUE. The patient was treated with TYLENOL at an unspecified dose and frequency. On 24-Apr-2021, TRISMUS (lockjaw), FEELING ABNORMAL (feeling like they were going to die), PYREXIA, CHILLS, MYALGIA, and FATIGUE had resolved. At the time of the report, INFLUENZA LIKE ILLNESS outcome was unknown. Not Provided.          Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC-MOD-2021-089050, MOD21-081609, US-MODERNATX, INC-MOD-2021-089217. This case was linked to MOD-2021-089055 (Patient Link). Sender's Comments:  US-MODERNATX, INC-MOD-2021-089050: MOD21-081609: US-MODERNATX, INC.-MOD-2021-089217: 2nd dosage case.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Trismus
Clinical narrative: flu-like symptoms; lockjaw; "feeling like they were going to die"; Fever; chills; soreness; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS, TRISMUS (lockjaw), FEELING ABNORMAL (feeling like they were going to die), PYREXIA, and CHILLS in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS, TRISMUS (lockjaw), FEELING ABNORMAL (feeling like they were going to die), PYREXIA, CHILLS, MYALGIA, and FATIGUE. The patient was treated with TYLENOL at an unspecified dose and frequency. On 24-Apr-2021, TRISMUS (lockjaw), FEELING ABNORMAL (feeling like they were going to die), PYREXIA, CHILLS, MYALGIA, and FATIGUE had resolved. At the time of the report, INFLUENZA LIKE ILLNESS outcome was unknown. Not Provided.          Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC-MOD-2021-089050, MOD21-081609, US-MODERNATX, INC-MOD-2021-089217. This case was linked to MOD-2021-089055 (Patient Link). Sender's Comments:  US-MODERNATX, INC-MOD-2021-089050: MOD21-081609: US-MODERNATX, INC.-MOD-2021-089217: 2nd dosage case.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Headache, Pyrexia
Clinical narrative: really bloody nose; chills; fever of 101; headache; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (really bloody nose), CHILLS (chills), PYREXIA (fever of 101) and HEADACHE (headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced EPISTAXIS (really bloody nose), CHILLS (chills), PYREXIA (fever of 101) and HEADACHE (headache). At the time of the report, EPISTAXIS (really bloody nose), CHILLS (chills), PYREXIA (fever of 101) and HEADACHE (headache) outcome was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Lacrimation increased, Nasal congestion
Clinical narrative: Congestion; Watery eyes; Allergy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion), LACRIMATION INCREASED (Watery eyes), HYPERSENSITIVITY (Allergy) and HEADACHE (Headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Since some years the patient has allergies.).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion), LACRIMATION INCREASED (Watery eyes), HYPERSENSITIVITY (Allergy) and HEADACHE (Headache). At the time of the report, NASAL CONGESTION (Congestion), LACRIMATION INCREASED (Watery eyes), HYPERSENSITIVITY (Allergy) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided. It was reported that the patient took Allegra, whenever she had allergy.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: could hardly move her right arm yesterday because it was kind of sore; right arm pain at the injection site, described as pain right where it was picked and a kind of; . This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (could hardly move her right arm yesterday because it was kind of sore) and VACCINATION SITE PAIN (right arm pain at the injection site, described as pain right where it was picked and a kind of) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DOCUSATE SODIUM (COLACE CLEAR) for Constipation, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (right arm pain at the injection site, described as pain right where it was picked and a kind of). On 22-Apr-2021, the patient experienced PAIN IN EXTREMITY (could hardly move her right arm yesterday because it was kind of sore). At the time of the report, PAIN IN EXTREMITY (could hardly move her right arm yesterday because it was kind of sore) and VACCINATION SITE PAIN (right arm pain at the injection site, described as pain right where it was picked and a kind of) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient said she did not want to do a form but she is OK  no problems   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR: AE outcome
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy mind), PAIN IN EXTREMITY (pain and soreness in the arm of injection), CHILLS (Chills), FATIGUE (Tiredness) and HEADACHE (Headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Acid reflux (oesophageal). On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced FEELING ABNORMAL (Foggy mind), CHILLS (Chills) and FATIGUE (Tiredness). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain and soreness in the arm of injection) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Foggy mind), CHILLS (Chills) and FATIGUE (Tiredness) outcome was unknown and PAIN IN EXTREMITY (pain and soreness in the arm of injection) and HEADACHE (Headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications included medications for acid reflux. This case was linked to US-MODERNATX, INC.-MOD-2021-089453 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-089453:Case for wife.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) 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) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced DYSPNOEA (shortness of breath). On 23-Mar-2021, DYSPNOEA (shortness of breath) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Concomitant medication includes 22 different medication  Treatment medication include IV Benadryl, IV steroids and Benadryl by mouth .   This case was linked to US-MODERNATX, INC.-MOD-2021-089077 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089077:2 nd Dose case
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Hypersensitivity, Loss of personal independence in daily activities, Rash
Clinical narrative: Unable to perform his routine work, cannot put clothes on his body; Allergy all over the body; Rash; Small pimples in red color; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Small pimples in red color), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform his routine work, cannot put clothes on his body), HYPERSENSITIVITY (Allergy all over the body) and RASH (Rash) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], METFORMIN, INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (BASAGLAR) and LISINOPRIL for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced ACNE (Small pimples in red color), HYPERSENSITIVITY (Allergy all over the body) and RASH (Rash). On 19-Apr-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform his routine work, cannot put clothes on his body). The patient was treated with LORATADINE for Adverse event, at an unspecified dose and frequency. At the time of the report, ACNE (Small pimples in red color), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Unable to perform his routine work, cannot put clothes on his body), HYPERSENSITIVITY (Allergy all over the body) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient stated that he stopped taking all the medicines.