chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: Feeling Odd; Bowel Changes; Lightheadedness, dizziness; trouble sleeping; Extreme Chills; Fatigue; some soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling Odd), ABDOMINAL DISCOMFORT (Bowel Changes), DIZZINESS (Lightheadedness, dizziness), INSOMNIA (trouble sleeping) and CHILLS (Extreme Chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), VITAMIN D3, MULTIVITAMIN [VITAMINS NOS] and FLUOROURACIL for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling Odd), ABDOMINAL DISCOMFORT (Bowel Changes), DIZZINESS (Lightheadedness, dizziness), INSOMNIA (trouble sleeping), CHILLS (Extreme Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (some soreness at the injection site). At the time of the report, FEELING ABNORMAL (Feeling Odd), ABDOMINAL DISCOMFORT (Bowel Changes), DIZZINESS (Lightheadedness, dizziness), INSOMNIA (trouble sleeping), CHILLS (Extreme Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (some soreness at the injection site) had not resolved.            Treatment information was not reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site pain
Clinical narrative: Feeling Odd; Bowel Changes; Lightheadedness, dizziness; trouble sleeping; Extreme Chills; Fatigue; some soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling Odd), ABDOMINAL DISCOMFORT (Bowel Changes), DIZZINESS (Lightheadedness, dizziness), INSOMNIA (trouble sleeping) and CHILLS (Extreme Chills) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, METOPROLOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), VITAMIN D3, MULTIVITAMIN [VITAMINS NOS] and FLUOROURACIL for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling Odd), ABDOMINAL DISCOMFORT (Bowel Changes), DIZZINESS (Lightheadedness, dizziness), INSOMNIA (trouble sleeping), CHILLS (Extreme Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (some soreness at the injection site). At the time of the report, FEELING ABNORMAL (Feeling Odd), ABDOMINAL DISCOMFORT (Bowel Changes), DIZZINESS (Lightheadedness, dizziness), INSOMNIA (trouble sleeping), CHILLS (Extreme Chills), FATIGUE (Fatigue) and VACCINATION SITE PAIN (some soreness at the injection site) had not resolved.            Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia, Peripheral swelling, Rash erythematous
Clinical narrative: Red rash; Scratchy throat; Lightheadedness; Arm swelling; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy throat), PERIPHERAL SWELLING (Arm swelling), DIZZINESS (Lightheadedness), RASH ERYTHEMATOUS (Red rash) and MYALGIA (Body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis. Concomitant products included METOPROLOL, HCTZ, FISH OIL, GLUCOSAMINE and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), MYALGIA (Body aches) and HEADACHE (Headache). On 11-Feb-2021, the patient experienced THROAT IRRITATION (Scratchy throat) and DIZZINESS (Lightheadedness). On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, Swollen arm, Headache, Lightheadedness, Red rash and Throat irritation, at an unspecified dose and frequency. On 12-Feb-2021, DIZZINESS (Lightheadedness) had resolved. At the time of the report, THROAT IRRITATION (Scratchy throat), PERIPHERAL SWELLING (Arm swelling), RASH ERYTHEMATOUS (Red rash), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included centrum gummies and hair, skin and nails gummies. On 01-Feb-2021, body aches, arm swelling and headache went away. On 11-Feb-2021, body aches, arm swelling and headache reappeared.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Red rash; Scratchy throat; Lightheadedness; Arm swelling; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Scratchy throat), PERIPHERAL SWELLING (Arm swelling), DIZZINESS (Lightheadedness), RASH ERYTHEMATOUS (Red rash) and MYALGIA (Body aches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sinusitis. Concomitant products included METOPROLOL, HCTZ, FISH OIL, GLUCOSAMINE and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), MYALGIA (Body aches) and HEADACHE (Headache). On 11-Feb-2021, the patient experienced THROAT IRRITATION (Scratchy throat) and DIZZINESS (Lightheadedness). On 12-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, Swollen arm, Headache, Lightheadedness, Red rash and Throat irritation, at an unspecified dose and frequency. On 12-Feb-2021, DIZZINESS (Lightheadedness) had resolved. At the time of the report, THROAT IRRITATION (Scratchy throat), PERIPHERAL SWELLING (Arm swelling), RASH ERYTHEMATOUS (Red rash), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included centrum gummies and hair, skin and nails gummies. On 01-Feb-2021, body aches, arm swelling and headache went away. On 11-Feb-2021, body aches, arm swelling and headache reappeared.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Tachycardia
Clinical narrative: tachycardia; shortness of breath; dry cough; This spontaneous case was reported by a non-health professional and describes the occurrence of TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and COUGH (dry cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and COUGH (dry cough). At the time of the report, TACHYCARDIA (tachycardia), DYSPNOEA (shortness of breath) and COUGH (dry cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm, hard time lying down on it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm, hard time lying down on it) 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 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm, hard time lying down on it). At the time of the report, PAIN IN EXTREMITY (Sore arm, hard time lying down on it) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Oropharyngeal discomfort, Pain
Clinical narrative: feels like I have the flu; sharp little pains; crabby throat; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feels like I have the flu), PAIN (sharp little pains) and OROPHARYNGEAL DISCOMFORT (crabby throat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     Concomitant products included EZETIMIBE (ZETIA), ZINC, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like I have the flu). 11-Feb-2021, the patient experienced PAIN (sharp little pains) and OROPHARYNGEAL DISCOMFORT (crabby throat). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (feels like I have the flu), PAIN (sharp little pains) and OROPHARYNGEAL DISCOMFORT (crabby throat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication also include Natures's Bounty Hair Skin and Nails. Action taken with the mRNA-123 in response to the events is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (fever) and HEADACHE (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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, CHILLS (Chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided by Reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Headache, Palpitations
Clinical narrative: heart pounding; Dull headache; very elevated Blood pressure,Blood pressure of 165/130which is very abnormal; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart pounding), HEADACHE (Dull headache) and BLOOD PRESSURE ABNORMAL (very elevated Blood pressure,Blood pressure of 165/130which is very abnormal) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028O20A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.). Concomitant products included HYDROCHLOROTHIAZIDE, ATORVASTATIN, SERTRALINE, LORAZEPAM (ATIVAN), FLAXSEED, LORAZEPAM and ESZOPICLONE (LUNESTA) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced PALPITATIONS (heart pounding), HEADACHE (Dull headache) and BLOOD PRESSURE ABNORMAL (very elevated Blood pressure,Blood pressure of 165/130which is very abnormal). At the time of the report, PALPITATIONS (heart pounding) and HEADACHE (Dull headache) outcome was unknown and BLOOD PRESSURE ABNORMAL (very elevated Blood pressure,Blood pressure of 165/130which is very abnormal) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (abnormal) 165/130.         This case was linked to US-MODERNATX, INC.-MOD-2021-090634 (E2B Linked Report). This case was linked to MOD-2021-090634 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090634:Dose 1
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Vaccination complication, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Very mild reactions; The lymph node on injection site arm is painful; I developed a 5 by 2 inch red oval blot at the injection site; The injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Very mild reactions), LYMPH NODE PAIN (The lymph node on injection site arm is painful), VACCINATION SITE ERYTHEMA (I developed a 5 by 2 inch red oval blot at the injection site) and VACCINATION SITE PRURITUS (The injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced LYMPH NODE PAIN (The lymph node on injection site arm is painful), VACCINATION SITE ERYTHEMA (I developed a 5 by 2 inch red oval blot at the injection site) and VACCINATION SITE PRURITUS (The injection site). On an unknown date, the patient experienced VACCINATION COMPLICATION (Very mild reactions). At the time of the report, VACCINATION COMPLICATION (Very mild reactions) outcome was unknown and LYMPH NODE PAIN (The lymph node on injection site arm is painful), VACCINATION SITE ERYTHEMA (I developed a 5 by 2 inch red oval blot at the injection site) and VACCINATION SITE PRURITUS (The injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medicines was not reported by reporter  treatment information was not provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments   Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: fallow up received on 12-feb-2021 contains one new event was added
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: FEVER CHILLS; SORE THROATE; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (FEVER CHILLS) and OROPHARYNGEAL PAIN (SORE THROATE) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (FEVER CHILLS) and OROPHARYNGEAL PAIN (SORE THROATE). At the time of the report, PYREXIA (FEVER CHILLS) and OROPHARYNGEAL PAIN (SORE THROATE) 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever at 102; Chills; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever at 102, chills.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.   Fever at 102, Chills.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever at 102 was Not recovered/Not resolved.The outcome of event(s), chills was Not recovered/Not resolved.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Periarthritis
Clinical narrative: arm sore; adhesive capsulitis; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) and PERIARTHRITIS (adhesive capsulitis) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore) and PERIARTHRITIS (adhesive capsulitis). At the time of the report, PAIN IN EXTREMITY (arm sore) outcome was unknown and PERIARTHRITIS (adhesive capsulitis) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Additional event (NS)
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Rapid heartbeat; Dizziness; Injection site red, sore and swollen at injection site; Injection site red, sore and swollen at injection site; Injection site red, sore and swollen at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heartbeat), DIZZINESS (Dizziness), VACCINATION SITE ERYTHEMA (Injection site red, sore and swollen at injection site), VACCINATION SITE PAIN (Injection site red, sore and swollen at injection site) and VACCINATION SITE SWELLING (Injection site red, sore and swollen at injection site) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.  The patient's past medical history included Dizziness.  In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 13-Feb-2021, the patient experienced HEART RATE INCREASED (Rapid heartbeat), DIZZINESS (Dizziness), VACCINATION SITE ERYTHEMA (Injection site red, sore and swollen at injection site), VACCINATION SITE PAIN (Injection site red, sore and swollen at injection site) and VACCINATION SITE SWELLING (Injection site red, sore and swollen at injection site). At the time of the report, HEART RATE INCREASED (Rapid heartbeat), DIZZINESS (Dizziness), VACCINATION SITE ERYTHEMA (Injection site red, sore and swollen at injection site), VACCINATION SITE PAIN (Injection site red, sore and swollen at injection site) and VACCINATION SITE SWELLING (Injection site red, sore and swollen at injection site) outcome was unknown.     Concomitant medication was not provided. Treatment medications were not provided.  Action taken with mRNA-1273 in response to the event was not applicable  Reporter did not allow further contact
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Blood urine present, Pyrexia
Clinical narrative: Fever; blood in toilet after urination; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and BLOOD URINE PRESENT (blood in toilet after urination) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PYREXIA (Fever) and BLOOD URINE PRESENT (blood in toilet after urination). At the time of the report, PYREXIA (Fever) and BLOOD URINE PRESENT (blood in toilet after urination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments  Concomitant medication not provided.  Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Tenderness, Vomiting
Clinical narrative: tenderness in arm; fever; Vomitting; muscle pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness in arm), PYREXIA (fever), VOMITING (Vomitting), MYALGIA (muscle pain) and HEADACHE (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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tenderness in arm), PYREXIA (fever), VOMITING (Vomitting), MYALGIA (muscle pain) and HEADACHE (headache). At the time of the report, TENDERNESS (tenderness in arm), PYREXIA (fever), VOMITING (Vomitting), MYALGIA (muscle pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: Right side of tongue is numb; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Right side of tongue is numb) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included LOSARTAN POTASSIUM for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (Right side of tongue is numb). At the time of the report, HYPOAESTHESIA ORAL (Right side of tongue is numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Vaccination site pain, Vaccination site pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in hand), DIZZINESS (light headiness), VACCINATION SITE PRURITUS (itching around the injection site) and VACCINATION SITE PAIN (pain around the injection site) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HYPOAESTHESIA (numbness in hand). On 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching around the injection site) and VACCINATION SITE PAIN (pain around the injection site). On 10-Feb-2021, the patient experienced DIZZINESS (light headiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness in hand), DIZZINESS (light headiness), VACCINATION SITE PRURITUS (itching around the injection site) and VACCINATION SITE PAIN (pain around the injection site) outcome was unknown.        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.   Concomitant Medications include Birth Control PIlls
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Felt feverish; Fever; Headache; A spontaneous report was received from a 40-years-old  male patient concerning himself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt feverish, had fever and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the events felt feverish, had fever and headache.  Treatment details included was not reported. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events felt feverish, had fever and headache was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: ear infection; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ear infection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) ear infection.  Treatment details included She was given a 10 day regimen of cefdinir by her primary care physician for an ear infection on, 09FEB2021.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), ear infection,  was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: arm on the injection site was red; arm on the injection site itch a lot.; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm on the injection site was red, arm on the injection site itch a lot,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) arm on the injection site was red. arm on the injection site itch a lot.  Treatment details included not able to gather more information..  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm on the injection site was red, arm on the injection site itch a lot,  was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site warmth, Rash
Clinical narrative: rash; hot sensation; redness; A spontaneous report was received from a type concerning a 78-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash, hot sensation, redness.  The patient's medical history included diabetes mellitus and cholesterol. Concomitant medications reported were Flonex, Humulin for dm, Fenofibrate, Finasteride, Losartan, Timolol for eyes, Metformin for diabetes, Tamsulosin, Atorvastatin for cholesterol for drug use for unknown indication.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 00HN02A (Cannot be read)) intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the event(s) rash. hot sensation, redness.  Treatment details included Neosporin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash, hot sensation,redness was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       NO concomitant medication details were provided. NO treatment medication details were provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: she was awaken because the arm was itchy; in the morning she took a look in the mirror and it is red, it is like a wheel; tenderness in the arm.; soreness in the arm; A spontaneous report was received from a nurse concerning herself, who is a 78-years-old female patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness in the arm, soreness in the arm, she was awaken because the arm was itchy, in the morning she took a look in the mirror and it is red, it is like a wheel.  The patient's medical history was not provided. Concomitant medications reported were atenolol 50mg, losartan 100mg, baby asrpirin for drug use for unknown indication.  On 03 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events tenderness and soreness in the arm. On 11 Feb 2021 she was awaken because the arm was itchy and was tender, in the morning she took a look in the mirror and it is red, it is like a wheel, it is still tender at the touch.  Treatment details included cortisone (roll-on),  Action taken with mRNA-1273 in response to the events was not reported.   On 4 Feb 2021 the outcome of events soreness in the arm was resolved. The outcome of events , she was awaken because the arm was itchy, she took a look in the mirror and it is red, it is like a wheel was unknown. The outcome of event tenderness in the arm was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: pain in arm; swollen arm; discomfort in arm; A spontaneous report (United States) was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain in arm, swollen arm, discomfort in arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced the event(s) pain in arm . On 13 Feb 2021, the patient experienced the event(s) swollen arm . On 13 Feb 2021, the patient experienced the event(s) discomfort in arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), pain in arm was unknown.The outcome of event(s), swollen arm was unknown.The outcome of event(s), discomfort in arm was unknown..
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; A spontaneous report was received from a consumer concerning himself, who is a 39-years-old male patient received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid-19.  The patient's medical history was not provided. Concomitant medications reported were vitamins for drug use for unknown indication.  On 15 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: not provided) via unknown route for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the event tested positive for covid-19.  No treatment details were provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event tested positive for covid-19 was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Decreased appetite, Dehydration
Clinical narrative: overall weakness; lack of appetite; moderate dehydration; injection site was sore; injection site was red; moderate perspiration; fainting symptoms; increase in nausea; dizziness; greater level of fatigue; severe chills; body aches were severe; A spontaneous report was received from a consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced greater level of fatigue, increasing to prominent weakness, severe chills, body aches, dizziness, nausea, fainting symptoms, moderate perspiration, weakness, moderate dehydration, lack of appetite, injection site sore and red.  The patient's medical history includes severe asthma. Concomitant medications reported were Budesonide / Formoterol for drug use for unknown indication.  On 15 Jan 2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 062620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced greater level of fatigue, increasing to prominent weakness, severe chills, fluctuation in her body temperature it alternated from cold to heat, body aches were severe. On 13/Feb/2021, the patient experienced the event(s) dizziness. increase in nausea, fainting symptoms, moderate perspiration. On 14 Feb 2021, the patient experienced  overall weakness. moderate dehydration, lack of appetite, injection site was sore and red. It all lasted 2-3 days  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events,  fatigue, weakness, severe chills, body aches, dizziness, nausea, fainting symptoms, moderate perspiration, overall weakness, moderate dehydration, lack of appetite, injection site sore and red, was recovered on an unknown date.; Reporter'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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Nausea, Presyncope
Clinical narrative: overall weakness; lack of appetite; moderate dehydration; injection site was sore; injection site was red; moderate perspiration; fainting symptoms; increase in nausea; dizziness; greater level of fatigue; severe chills; body aches were severe; A spontaneous report was received from a consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced greater level of fatigue, increasing to prominent weakness, severe chills, body aches, dizziness, nausea, fainting symptoms, moderate perspiration, weakness, moderate dehydration, lack of appetite, injection site sore and red.  The patient's medical history includes severe asthma. Concomitant medications reported were Budesonide / Formoterol for drug use for unknown indication.  On 15 Jan 2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 062620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced greater level of fatigue, increasing to prominent weakness, severe chills, fluctuation in her body temperature it alternated from cold to heat, body aches were severe. On 13/Feb/2021, the patient experienced the event(s) dizziness. increase in nausea, fainting symptoms, moderate perspiration. On 14 Feb 2021, the patient experienced  overall weakness. moderate dehydration, lack of appetite, injection site was sore and red. It all lasted 2-3 days  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events,  fatigue, weakness, severe chills, body aches, dizziness, nausea, fainting symptoms, moderate perspiration, overall weakness, moderate dehydration, lack of appetite, injection site sore and red, was recovered on an unknown date.; Reporter'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.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: overall weakness; lack of appetite; moderate dehydration; injection site was sore; injection site was red; moderate perspiration; fainting symptoms; increase in nausea; dizziness; greater level of fatigue; severe chills; body aches were severe; A spontaneous report was received from a consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced greater level of fatigue, increasing to prominent weakness, severe chills, body aches, dizziness, nausea, fainting symptoms, moderate perspiration, weakness, moderate dehydration, lack of appetite, injection site sore and red.  The patient's medical history includes severe asthma. Concomitant medications reported were Budesonide / Formoterol for drug use for unknown indication.  On 15 Jan 2021, prior to the onset of the events the patient received her first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 062620A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced greater level of fatigue, increasing to prominent weakness, severe chills, fluctuation in her body temperature it alternated from cold to heat, body aches were severe. On 13/Feb/2021, the patient experienced the event(s) dizziness. increase in nausea, fainting symptoms, moderate perspiration. On 14 Feb 2021, the patient experienced  overall weakness. moderate dehydration, lack of appetite, injection site was sore and red. It all lasted 2-3 days  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events,  fatigue, weakness, severe chills, body aches, dizziness, nausea, fainting symptoms, moderate perspiration, overall weakness, moderate dehydration, lack of appetite, injection site sore and red, was recovered on an unknown date.; Reporter'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.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Pain in extremity, Parosmia
Clinical narrative: smelling smoke; burning eyes; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), PAROSMIA (smelling smoke) and EYE IRRITATION (burning eyes) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2CA) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness). On 12-Feb-2021, the patient experienced PAROSMIA (smelling smoke) and EYE IRRITATION (burning eyes). On 07-Feb-2021, PAIN IN EXTREMITY (arm soreness) had resolved. On 13-Feb-2021, PAROSMIA (smelling smoke) and EYE IRRITATION (burning eyes) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details include eye drops.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster
Clinical narrative: Shingles on his right hip; pain on his right hip; A spontaneous report was received from a male patient of unspecified age concerning himself who received Modern's COVID-19 vaccine (mRNA-1273) and experienced pain and shingles on his right hip.  The patient's medical history provided was not provided. No relevant concomitant medications reported.  On 4 Feb 2021, prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in an unknown anatomical location for prophylaxis of COVID-19 infection.    On 7 Feb 2021, the patient experienced pain on his right hip. On 8 Feb 2021, the patient experienced shingles on  his right hip. No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report, the outcome of event pain and shingles on his right hip was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: strange side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strange side effect) 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 an unknown date, the patient experienced VACCINATION COMPLICATION (strange side effect). At the time of the report, VACCINATION COMPLICATION (strange side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Loss of taste; Loss of appetite; Headache; Chills; Fatigue; A spontaneous report was received from a consumer concerning a 79-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, chills, fatigue, loss of taste/ageusia, loss of appetite/decreased appetite.  The patient's medical history included COVID-19 infection. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 010M20A) for prophylaxis of COVID-19 infection.  On 9 Feb 2021 the patient experienced the events full  covid symptoms which included headache, chills, fatigue, loss of taste, loss of appetite.  Treatment details included paracetamol  Action taken with mRNA-1273 in response to the events was not reported.  On 12 Feb 2021 the outcome of events headache, chills, fatigue, loss of taste, loss of appetite was resolved.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial tachycardia, Feeling abnormal, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: felt sweaty feeling; felt very upset; paroxysmal atrial tachycardia; pulse went up to BP of 101.; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (felt sweaty feeling), FEELING ABNORMAL (felt very upset), ATRIAL TACHYCARDIA (paroxysmal atrial tachycardia) and HEART RATE INCREASED (pulse went up to BP of 101.) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced HYPERHIDROSIS (felt sweaty feeling), FEELING ABNORMAL (felt very upset), ATRIAL TACHYCARDIA (paroxysmal atrial tachycardia) and HEART RATE INCREASED (pulse went up to BP of 101.). At the time of the report, HYPERHIDROSIS (felt sweaty feeling), FEELING ABNORMAL (felt very upset), ATRIAL TACHYCARDIA (paroxysmal atrial tachycardia) and HEART RATE INCREASED (pulse went up to BP of 101.) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Heart rate: pulse increased to BP of101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment history includes diazepam. Concomitant medications includes ''3 ''unknown drugs for high blood pressure.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2021: process with initial