chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: sores radiating to throat on the injection side (left side) of the body; Coughing; Calcium level Dropped; nose bleeding while blowing nose; body aches; Chills; Diarrhea; Nausea; fever (103); tired; unable to get out of bed; Mouth Sores radiating to the throat on the body side of injection; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (fever (103)), FATIGUE (tired), SOMNOLENCE (unable to get out of bed) and ORAL PAIN (Mouth Sores radiating to the throat on the body side of injection) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included TOPIRAMATE (TOPAMAX), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced NAUSEA (Nausea), PYREXIA (fever (103)), FATIGUE (tired), SOMNOLENCE (unable to get out of bed), ORAL PAIN (Mouth Sores radiating to the throat on the body side of injection), MYALGIA (body aches), CHILLS (Chills), DIARRHOEA (Diarrhea) and EPISTAXIS (nose bleeding while blowing nose). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sores radiating to throat on the injection side (left side) of the body), COUGH (Coughing) and BLOOD CALCIUM DECREASED (Calcium level Dropped). At the time of the report, NAUSEA (Nausea), PYREXIA (fever (103)), FATIGUE (tired), SOMNOLENCE (unable to get out of bed), ORAL PAIN (Mouth Sores radiating to the throat on the body side of injection), OROPHARYNGEAL PAIN (sores radiating to throat on the injection side (left side) of the body), MYALGIA (body aches), CHILLS (Chills), DIARRHOEA (Diarrhea), COUGH (Coughing), EPISTAXIS (nose bleeding while blowing nose) and BLOOD CALCIUM DECREASED (Calcium level Dropped) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Topamax 50mg BID, Wellbutrin 100mg daily, Vitamin D 2000mg. Treatment products included Benadryl.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Invalid Dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Invalid Dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) 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 24-Mar-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Invalid Dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Invalid Dose) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Limb discomfort
Clinical narrative: Skin sensitivity at the injection site area; Severe arm pain; Fatigue; 102.8 fever, lasted 3 days to 101.2; Massive and violent chills; Throwing up, projectile vomiting; nausea; Stomach cramping; Non stop diarrhea; Violent shaking; Radiating arm pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violent shaking), LIMB DISCOMFORT (Radiating arm pain), ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea) and VACCINATION SITE PAIN (Skin sensitivity at the injection site area) in a 48-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 Information was reported.     On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea), PYREXIA (102.8 fever, lasted 3 days to 101.2), CHILLS (Massive and violent chills), VOMITING PROJECTILE (Throwing up, projectile vomiting) and NAUSEA (nausea). On an unknown date, the patient experienced TREMOR (Violent shaking), LIMB DISCOMFORT (Radiating arm pain), VACCINATION SITE PAIN (Skin sensitivity at the injection site area), PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue). The patient was treated with HYDROXYZINE at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 07-Apr-2021, ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea), PYREXIA (102.8 fever, lasted 3 days to 101.2), CHILLS (Massive and violent chills), VOMITING PROJECTILE (Throwing up, projectile vomiting) and NAUSEA (nausea) had resolved. At the time of the report, TREMOR (Violent shaking) and LIMB DISCOMFORT (Radiating arm pain) had resolved and VACCINATION SITE PAIN (Skin sensitivity at the injection site area), PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue) outcome was unknown.            Patient reports adhering to a diet of energy drinks, water, hot tea, ginger ale, and broth to treat nausea and vomiting after receiving her second moderna dose on 5Apr2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-069999 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email received from reporter with additional AEs (violent shaking, radiating arm pain) for this second dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069999:First dose case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Skin sensitivity at the injection site area; Severe arm pain; Fatigue; 102.8 fever, lasted 3 days to 101.2; Massive and violent chills; Throwing up, projectile vomiting; nausea; Stomach cramping; Non stop diarrhea; Violent shaking; Radiating arm pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violent shaking), LIMB DISCOMFORT (Radiating arm pain), ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea) and VACCINATION SITE PAIN (Skin sensitivity at the injection site area) in a 48-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 Information was reported.     On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea), PYREXIA (102.8 fever, lasted 3 days to 101.2), CHILLS (Massive and violent chills), VOMITING PROJECTILE (Throwing up, projectile vomiting) and NAUSEA (nausea). On an unknown date, the patient experienced TREMOR (Violent shaking), LIMB DISCOMFORT (Radiating arm pain), VACCINATION SITE PAIN (Skin sensitivity at the injection site area), PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue). The patient was treated with HYDROXYZINE at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 07-Apr-2021, ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea), PYREXIA (102.8 fever, lasted 3 days to 101.2), CHILLS (Massive and violent chills), VOMITING PROJECTILE (Throwing up, projectile vomiting) and NAUSEA (nausea) had resolved. At the time of the report, TREMOR (Violent shaking) and LIMB DISCOMFORT (Radiating arm pain) had resolved and VACCINATION SITE PAIN (Skin sensitivity at the injection site area), PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue) outcome was unknown.            Patient reports adhering to a diet of energy drinks, water, hot tea, ginger ale, and broth to treat nausea and vomiting after receiving her second moderna dose on 5Apr2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-069999 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email received from reporter with additional AEs (violent shaking, radiating arm pain) for this second dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069999:First dose case
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting projectile
Clinical narrative: Skin sensitivity at the injection site area; Severe arm pain; Fatigue; 102.8 fever, lasted 3 days to 101.2; Massive and violent chills; Throwing up, projectile vomiting; nausea; Stomach cramping; Non stop diarrhea; Violent shaking; Radiating arm pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Violent shaking), LIMB DISCOMFORT (Radiating arm pain), ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea) and VACCINATION SITE PAIN (Skin sensitivity at the injection site area) in a 48-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 Information was reported.     On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea), PYREXIA (102.8 fever, lasted 3 days to 101.2), CHILLS (Massive and violent chills), VOMITING PROJECTILE (Throwing up, projectile vomiting) and NAUSEA (nausea). On an unknown date, the patient experienced TREMOR (Violent shaking), LIMB DISCOMFORT (Radiating arm pain), VACCINATION SITE PAIN (Skin sensitivity at the injection site area), PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue). The patient was treated with HYDROXYZINE at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. On 07-Apr-2021, ABDOMINAL PAIN UPPER (Stomach cramping), DIARRHOEA (Non stop diarrhea), PYREXIA (102.8 fever, lasted 3 days to 101.2), CHILLS (Massive and violent chills), VOMITING PROJECTILE (Throwing up, projectile vomiting) and NAUSEA (nausea) had resolved. At the time of the report, TREMOR (Violent shaking) and LIMB DISCOMFORT (Radiating arm pain) had resolved and VACCINATION SITE PAIN (Skin sensitivity at the injection site area), PAIN IN EXTREMITY (Severe arm pain) and FATIGUE (Fatigue) outcome was unknown.            Patient reports adhering to a diet of energy drinks, water, hot tea, ginger ale, and broth to treat nausea and vomiting after receiving her second moderna dose on 5Apr2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-069999 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Email received from reporter with additional AEs (violent shaking, radiating arm pain) for this second dose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069999:First dose case
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bone pain, Dyspnoea, Fatigue
Clinical narrative: Shortness of breath; bone pain; Back pain; Sores in mouth; Headache; Pain in elbow; Fatigue; overall arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), BONE PAIN (bone pain), BACK PAIN (Back pain), STOMATITIS (Sores in mouth) and PAIN IN EXTREMITY (overall arm pain) in a 46-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.     The patient's past medical history included Hashimoto's thyroiditis. Concurrent medical conditions included Shellfish allergy (Allergic to scallops and mollusks).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (overall arm pain). On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath), BONE PAIN (bone pain), BACK PAIN (Back pain), STOMATITIS (Sores in mouth), HEADACHE (Headache), ARTHRALGIA (Pain in elbow) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Shortness of breath), BONE PAIN (bone pain), BACK PAIN (Back pain), STOMATITIS (Sores in mouth), PAIN IN EXTREMITY (overall arm pain), HEADACHE (Headache), ARTHRALGIA (Pain in elbow) and FATIGUE (Fatigue) outcome was unknown.            Per reporter, the patient received a COVID test and awaiting result. No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-070003 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070003:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Stomatitis
Clinical narrative: Shortness of breath; bone pain; Back pain; Sores in mouth; Headache; Pain in elbow; Fatigue; overall arm pain; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), BONE PAIN (bone pain), BACK PAIN (Back pain), STOMATITIS (Sores in mouth) and PAIN IN EXTREMITY (overall arm pain) in a 46-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.     The patient's past medical history included Hashimoto's thyroiditis. Concurrent medical conditions included Shellfish allergy (Allergic to scallops and mollusks).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (overall arm pain). On 02-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath), BONE PAIN (bone pain), BACK PAIN (Back pain), STOMATITIS (Sores in mouth), HEADACHE (Headache), ARTHRALGIA (Pain in elbow) and FATIGUE (Fatigue). At the time of the report, DYSPNOEA (Shortness of breath), BONE PAIN (bone pain), BACK PAIN (Back pain), STOMATITIS (Sores in mouth), PAIN IN EXTREMITY (overall arm pain), HEADACHE (Headache), ARTHRALGIA (Pain in elbow) and FATIGUE (Fatigue) outcome was unknown.            Per reporter, the patient received a COVID test and awaiting result. No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-070003 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-070003:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Erythema
Clinical narrative: she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,; No appetite; Left arm was in pain and red; Developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨; Strange felling on her head; Joint pains; He started feeling like ¨a car had hit me and ran over me¨/terrible body aches; Fever; Headache ( worse than the one she had with the 1st dose); Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (Headache ( worse than the one she had with the 1st dose)) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Thyroid Medication,   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills). On 01-Apr-2021, the patient experienced MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), HEADACHE (Headache ( worse than the one she had with the 1st dose)), NAUSEA (nausea) and ASTHENIA (she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,). On 02-Apr-2021, the patient experienced DECREASED APPETITE (no appetite), ERYTHEMA (left arm was in pain and red) and FEELING ABNORMAL (strange felling on her head). On an unknown date, the patient experienced INJECTION SITE REACTION (m developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨) and ARTHRALGIA (joint pains). At the time of the report, MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (Headache ( worse than the one she had with the 1st dose)), NAUSEA (nausea), ASTHENIA (she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,), DECREASED APPETITE (no appetite), ERYTHEMA (left arm was in pain and red), INJECTION SITE REACTION (m developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨) and FEELING ABNORMAL (strange felling on her head) outcome was unknown.     Treatment details included Tylenol 500mg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Injection site reaction, Myalgia, Nausea
Clinical narrative: she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,; No appetite; Left arm was in pain and red; Developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨; Strange felling on her head; Joint pains; He started feeling like ¨a car had hit me and ran over me¨/terrible body aches; Fever; Headache ( worse than the one she had with the 1st dose); Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (Headache ( worse than the one she had with the 1st dose)) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Thyroid Medication,   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills). On 01-Apr-2021, the patient experienced MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), HEADACHE (Headache ( worse than the one she had with the 1st dose)), NAUSEA (nausea) and ASTHENIA (she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,). On 02-Apr-2021, the patient experienced DECREASED APPETITE (no appetite), ERYTHEMA (left arm was in pain and red) and FEELING ABNORMAL (strange felling on her head). On an unknown date, the patient experienced INJECTION SITE REACTION (m developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨) and ARTHRALGIA (joint pains). At the time of the report, MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (Headache ( worse than the one she had with the 1st dose)), NAUSEA (nausea), ASTHENIA (she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,), DECREASED APPETITE (no appetite), ERYTHEMA (left arm was in pain and red), INJECTION SITE REACTION (m developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨) and FEELING ABNORMAL (strange felling on her head) outcome was unknown.     Treatment details included Tylenol 500mg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,; No appetite; Left arm was in pain and red; Developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨; Strange felling on her head; Joint pains; He started feeling like ¨a car had hit me and ran over me¨/terrible body aches; Fever; Headache ( worse than the one she had with the 1st dose); Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (Headache ( worse than the one she had with the 1st dose)) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Thyroid Medication,   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills). On 01-Apr-2021, the patient experienced MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), HEADACHE (Headache ( worse than the one she had with the 1st dose)), NAUSEA (nausea) and ASTHENIA (she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,). On 02-Apr-2021, the patient experienced DECREASED APPETITE (no appetite), ERYTHEMA (left arm was in pain and red) and FEELING ABNORMAL (strange felling on her head). On an unknown date, the patient experienced INJECTION SITE REACTION (m developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨) and ARTHRALGIA (joint pains). At the time of the report, MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (Headache ( worse than the one she had with the 1st dose)), NAUSEA (nausea), ASTHENIA (she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,), DECREASED APPETITE (no appetite), ERYTHEMA (left arm was in pain and red), INJECTION SITE REACTION (m developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨) and FEELING ABNORMAL (strange felling on her head) outcome was unknown.     Treatment details included Tylenol 500mg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Tremor, Vaccination site reaction
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of vaccination site reaction (vaccination site reaction), tremor (tremor in the right arm), pyrexia (fever) and headache in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028A21A) for COVID-19 immunization. No medical history reported. Concomitant products included losartan for an unknown indication. On Mar 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 4, 2021, received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site reaction (vaccination site reaction), tremor (tremor in the right arm), pyrexia (fever) and headache. At the time of the report, vaccination site reaction (vaccination site reaction), pyrexia (fever) and headache outcome: unknown; and tremor (tremor in the right arm): not resolved. The reporter did not provide any causality assessments or treatment information. Action taken with mRNA-1273 in response to events: not applicable.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: 4 centimeter roundish area at the injection site; Slight itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Slight itching at the injection site) and VACCINATION SITE ERYTHEMA (4 centimeter roundish area at the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MOMETASONE FUROATE (ASMANEX), AZELASTINE, FEXOFENADINE, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LEVOTHYROXINE, FLUOXETINE HYDROCHLORIDE (PROZAC), BISOPROLOL, BUPROPION and ETHINYLESTRADIOL, NORETHISTERONE (OVCON-35) 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 03-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Slight itching at the injection site). On 07-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (4 centimeter roundish area at the injection site). At the time of the report, VACCINATION SITE PRURITUS (Slight itching at the injection site) and VACCINATION SITE ERYTHEMA (4 centimeter roundish area at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Treatment medications were not provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance
Clinical narrative: "walking strange"; feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE ("walking strange") and DIZZINESS (feeling dizzy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 GAIT DISTURBANCE ("walking strange") and DIZZINESS (feeling dizzy). At the time of the report, GAIT DISTURBANCE ("walking strange") and DIZZINESS (feeling dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were provided. No treatment medication was reported.  "walking strange" and feeling dizzy were recurred on 06Apr2021 and they were thinking that might be due to patient's sugar level. The patient was scheduled to get the 2nd dose today (07Apr2021) but they want to have patient checked first.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 33-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Spontaneous abortion) on Nov-2017 and Pregnancy on Jul-2019. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Dec-2020 and the estimated date of delivery was 24-Sep-2021. On 29-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 27-Feb-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Pregnancy test: positive (Positive) positive pregnancy test. On 16-Mar-2021, Ultrasound scan: normal (normal) Normal.         Concomitant drug include Vitamin B-13 1 Daily via Oral route used for indication Pregnancy  from FEB 2021.  No treatment information was provided.   For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in  response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Mild itchy rash developed on the face and chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Mild itchy rash developed on the face and chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A.) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concomitant products included SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for Asthma.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH PRURITIC (Mild itchy rash developed on the face and chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Mild itchy rash developed on the face and chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS 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 12-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 INFLUENZA LIKE ILLNESS. At the time of the report, INFLUENZA LIKE ILLNESS outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Concomitant product includes Blood pressure medication and Cancer medication. No treatment medication was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Epistaxis, Fatigue, Myalgia, Pyrexia
Clinical narrative: nose bleeds; fever; chills; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleeds), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for an unknown indication.   On 05-Apr-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced EPISTAXIS (nose bleeds), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue). At the time of the report, EPISTAXIS (nose bleeds), PYREXIA (fever), CHILLS (chills), MYALGIA (body aches) and FATIGUE (fatigue) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No treatment medications were provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen arm at Injection site; Pain at the site of Injection radiating to the back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen arm at Injection site) and VACCINATION SITE PAIN (Pain at the site of Injection radiating to the back) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm at Injection site) and VACCINATION SITE PAIN (Pain at the site of Injection radiating to the back). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swollen arm at Injection site) and VACCINATION SITE PAIN (Pain at the site of Injection radiating to the back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Concomitant medications include birth control medication.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Weak; Fever; Chills; Body aches; Horrible headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Horrible headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ASTHENIA (Weak), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Horrible headache) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Weak), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Horrible headache) and FATIGUE (Fatigue) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided. Treatment medication include ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Weak; Fever; Chills; Body aches; Horrible headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches) and HEADACHE (Horrible headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ASTHENIA (Weak), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Horrible headache) and FATIGUE (Fatigue). At the time of the report, ASTHENIA (Weak), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Body aches), HEADACHE (Horrible headache) and FATIGUE (Fatigue) outcome was unknown.            For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided. Treatment medication include ibuprofen.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Erythema, Inflammation, Nausea
Clinical narrative: some inflammation; dizzyness; pale; was pale and weak; was trying to read on the phone and the words where waving, words where like waves in an; really painful arm; nausea; redness; swelling; This spontaneous case was reported by a physician and describes the occurrence of READING DISORDER (was trying to read on the phone and the words where waving, words where like waves in an), PAIN IN EXTREMITY (really painful arm), ERYTHEMA (redness), INFLAMMATION (some inflammation) and DIZZINESS (dizzyness) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 MONTELUKAST and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced READING DISORDER (was trying to read on the phone and the words where waving, words where like waves in an), PAIN IN EXTREMITY (really painful arm), ERYTHEMA (redness), INFLAMMATION (some inflammation), PALLOR (pale), ASTHENIA (was pale and weak), SWELLING (swelling) and NAUSEA (nausea). an unknown date, the patient experienced DIZZINESS (dizzyness). At the time of the report, READING DISORDER (was trying to read on the phone and the words where waving, words where like waves in an), PAIN IN EXTREMITY (really painful arm), INFLAMMATION (some inflammation), DIZZINESS (dizzyness), PALLOR (pale) and ASTHENIA (was pale and weak) outcome was unknown and ERYTHEMA (redness), SWELLING (swelling) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Concomitant medications were added.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pallor, Reading disorder, Swelling
Clinical narrative: some inflammation; dizzyness; pale; was pale and weak; was trying to read on the phone and the words where waving, words where like waves in an; really painful arm; nausea; redness; swelling; This spontaneous case was reported by a physician and describes the occurrence of READING DISORDER (was trying to read on the phone and the words where waving, words where like waves in an), PAIN IN EXTREMITY (really painful arm), ERYTHEMA (redness), INFLAMMATION (some inflammation) and DIZZINESS (dizzyness) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 MONTELUKAST and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced READING DISORDER (was trying to read on the phone and the words where waving, words where like waves in an), PAIN IN EXTREMITY (really painful arm), ERYTHEMA (redness), INFLAMMATION (some inflammation), PALLOR (pale), ASTHENIA (was pale and weak), SWELLING (swelling) and NAUSEA (nausea). an unknown date, the patient experienced DIZZINESS (dizzyness). At the time of the report, READING DISORDER (was trying to read on the phone and the words where waving, words where like waves in an), PAIN IN EXTREMITY (really painful arm), INFLAMMATION (some inflammation), DIZZINESS (dizzyness), PALLOR (pale) and ASTHENIA (was pale and weak) outcome was unknown and ERYTHEMA (redness), SWELLING (swelling) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Concomitant medications were added.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site warmth
Clinical narrative: warm to touch; sore arm; red, itchy patch on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (red, itchy patch on arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warm to touch), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (red, itchy patch on arm). The patient was treated with MOMETASONE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (warm to touch), PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (red, itchy patch on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up received on 21-MAY-2021: Reporter contact details added
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: sore arm after second dose; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (sore arm after second dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AXILLARY PAIN (sore arm after second dose). At the time of the report, AXILLARY PAIN (sore arm after second dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-069647 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069647:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: swollen lymph nodes on the left side of the neck; soreness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes on the left side of the neck) and VACCINATION SITE PAIN (soreness at the site of injection) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No significant historical event reported.).    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 04-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on the left side of the neck) and VACCINATION SITE PAIN (soreness at the site of injection). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes on the left side of the neck) and VACCINATION SITE PAIN (soreness at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment was taken for the events with Tylenol and Lidocaine patches.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Asthenia, Body temperature, Chills, Fatigue
Clinical narrative: unable to eat; weakness; Weight loss; chills; fever of 102 degrees F; nausea; tiredness; pain in arm; red ring around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (unable to eat), ASTHENIA (weakness), ABNORMAL LOSS OF WEIGHT (Weight loss), VACCINATION SITE PAIN ( pain in arm ) and VACCINATION SITE ERYTHEMA (red ring around the injection site) in a 77-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 information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN ( pain in arm ) and VACCINATION SITE ERYTHEMA (red ring around the injection site). On 22-Mar-2021, the patient experienced FEEDING DISORDER (unable to eat), ASTHENIA (weakness), ABNORMAL LOSS OF WEIGHT (Weight loss), CHILLS (chills), PYREXIA (fever of 102 degrees F), NAUSEA (nausea) and FATIGUE (tiredness). On 25-Mar-2021, FEEDING DISORDER (unable to eat), ASTHENIA (weakness), ABNORMAL LOSS OF WEIGHT (Weight loss), CHILLS (chills), PYREXIA (fever of 102 degrees F), NAUSEA (nausea) and FATIGUE (tiredness) had resolved. At the time of the report, VACCINATION SITE PAIN ( pain in arm ) and VACCINATION SITE ERYTHEMA (red ring around the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 102 (Inconclusive) 102 degrees F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant and treatment medications were provided. The patient was due for  second dose on 14Apr2021, but had concerns about getting the second dose due to the side effects patient was experienced after the first vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.