chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; chills; muscle aches; left arm red; left arm swollen; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ERYTHEMA (left arm red) and PERIPHERAL SWELLING (left arm swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037KZOA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historic conditions for the patient.).    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 PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ERYTHEMA (left arm red) and PERIPHERAL SWELLING (left arm swollen). At the time of the report, PYREXIA (fever), CHILLS (chills), MYALGIA (muscle aches), ERYTHEMA (left arm red) and PERIPHERAL SWELLING (left arm swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 101.     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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dizziness, Heart rate increased, Pyrexia
Clinical narrative: Rapid heart beat and pulse; Fever; Diarrhea; Lightheadedness; This spontaneous case was reported by a physician and describes the occurrence of HEART RATE INCREASED (Rapid heart beat and pulse), PYREXIA (Fever), DIARRHOEA (Diarrhea) and DIZZINESS (Lightheadedness) in a 58-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 07-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 HEART RATE INCREASED (Rapid heart beat and pulse), PYREXIA (Fever), DIARRHOEA (Diarrhea) and DIZZINESS (Lightheadedness). At the time of the report, HEART RATE INCREASED (Rapid heart beat and pulse), PYREXIA (Fever), DIARRHOEA (Diarrhea) and DIZZINESS (Lightheadedness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100-101 100-101F.     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.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: New events added
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Nausea, Pain in extremity
Clinical narrative: Temperature of 99.7°F; Pain in the arm; Joint pains; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature of 99.7°F), PAIN IN EXTREMITY (Pain in the arm), ARTHRALGIA (Joint pains) and NAUSEA (Nausea) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature of 99.7°F), PAIN IN EXTREMITY (Pain in the arm), ARTHRALGIA (Joint pains) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BODY TEMPERATURE INCREASED (Temperature of 99.7°F), PAIN IN EXTREMITY (Pain in the arm), ARTHRALGIA (Joint pains) and NAUSEA (Nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 99.7°f (High) 99.7°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of vaccination site movement impairment (could not move arm after receiving the vaccine) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced vaccination site movement impairment (could not move arm after receiving the vaccine). At the time of the report, vaccination site movement impairment (could not move arm after receiving the vaccine): unresolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments or concomitant medications. The patient is currently on physical therapy. Sender's comments: Based on the current available information, which includes a temporal association between the use of the product and the start date of the reported events, and excluding any other etiology, a causal relationship with the event cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair started falling in clumps; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair started falling in clumps) 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 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced ALOPECIA (Hair started falling in clumps). At the time of the report, ALOPECIA (Hair started falling in clumps) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Pyrexia
Clinical narrative: dizziness; very shaky; extremely weak; chills; headache; fever 99.3 F; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), TREMOR (very shaky), ASTHENIA (extremely weak) and CHILLS (chills) in an 87-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 (no reported medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (dizziness), TREMOR (very shaky), ASTHENIA (extremely weak) and CHILLS (chills). At the time of the report, DIZZINESS (dizziness), TREMOR (very shaky), ASTHENIA (extremely weak) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: dizziness; very shaky; extremely weak; chills; headache; fever 99.3 F; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), TREMOR (very shaky), ASTHENIA (extremely weak) and CHILLS (chills) in an 87-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 (no reported medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (dizziness), TREMOR (very shaky), ASTHENIA (extremely weak) and CHILLS (chills). At the time of the report, DIZZINESS (dizziness), TREMOR (very shaky), ASTHENIA (extremely weak) and CHILLS (chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Vaccination site pruritus
Clinical narrative: Swollen arm; red; Itchy really bad; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itchy really bad) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20/2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition reported.).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itchy really bad). At the time of the report, PERIPHERAL SWELLING (Swollen arm), ERYTHEMA (red) and VACCINATION SITE PRURITUS (Itchy really bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: cold like mild side effects; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (cold like mild side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-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 FEELING COLD (cold like mild side effects). At the time of the report, FEELING COLD (cold like mild side effects) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Tremor, Vaccination site pain
Clinical narrative: Shaking; Chills; Headache; Tired; Swelling at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swelling at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03ZHZUA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced TREMOR (Shaking), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Tired), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, TREMOR (Shaking), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Tired), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Shaking; Chills; Headache; Tired; Swelling at injection site; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Tired) and VACCINATION SITE SWELLING (Swelling at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03ZHZUA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced TREMOR (Shaking), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Tired), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, TREMOR (Shaking), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Tired), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Got administered both doses of vaccine while being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Got administered both doses of vaccine while being pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-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 an unknown date and the estimated date of delivery was 11-May-2021. On 25-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Got administered both doses of vaccine while being pregnant). On 22-Jan-2021, EXPOSURE DURING PREGNANCY (Got administered both doses of vaccine while being pregnant) had resolved. Not Provided          Concomitant medication not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: Follow up received patient's address, date of birth, vaccine dates updated; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia
Clinical narrative: Shoulder pain; Fever; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Shoulder pain) and PYREXIA (Fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ARTHRALGIA (Shoulder pain) and PYREXIA (Fever). At the time of the report, ARTHRALGIA (Shoulder pain) and PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Pain in extremity, Pruritus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pruritus (itching), pain in extremity (arm feels achy and a little bit tender), myalgia (felt soreness) and lymphadenopathy  (underneath her arm was swollen) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The patient's past medical history included no adverse event. On Jan 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 7, 2021, patient experienced myalgia (felt soreness). On Jan 9, 2021, patient experienced lymphadenopathy (underneath her arm was swollen). On Jan 14, 2021, patient experienced pruritus (itching). On an unknown date, patient experienced pain in extremity (arm feels achy and a little bit tender). At the time of the report, pruritus (itching), pain in extremity (arm feels achy and a little bit tender), myalgia (felt soreness) and lymphadenopathy (underneath her arm was swollen) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: Felt like fainting, did not faint; Felt like it was anxiety; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt like fainting, did not faint) and ANXIETY (Felt like it was anxiety) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (Felt like fainting, did not faint) and ANXIETY (Felt like it was anxiety). At the time of the report, DIZZINESS (Felt like fainting, did not faint) and ANXIETY (Felt like it was anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at administration site; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Soreness at administration site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 14-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 VACCINATION SITE PAIN (Soreness at administration site). At the time of the report, VACCINATION SITE PAIN (Soreness at administration site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-008560 (Linked Report).; Sender's Comments:  MOD-2021-008560:2 patients (father case), crosslinked case- Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney stones and Thyroid nodule.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Infusion site warmth, Injection site erythema, Injection site pruritus
Clinical narrative: warm to the touch; redness around injection site; a little itchy; This spontaneous case was reported by a consumer and describes the occurrence of INFUSION SITE WARMTH (warm to the touch), INJECTION SITE ERYTHEMA (redness around injection site) and INJECTION SITE PRURITUS (a little itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Abscess on 15-Jan-2021, Pruritus on 15-Jan-2021 and Erythema on 15-Jan-2021.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INFUSION SITE WARMTH (warm to the touch), INJECTION SITE ERYTHEMA (redness around injection site) and INJECTION SITE PRURITUS (a little itchy). At the time of the report, INFUSION SITE WARMTH (warm to the touch), INJECTION SITE ERYTHEMA (redness around injection site) and INJECTION SITE PRURITUS (a little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety disorder
Clinical narrative: History of PDC and is happening again; This spontaneous case was reported by a physical therapist and describes the occurrence of ANXIETY DISORDER (History of PDC and is happening again) in a 39-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 (no historical condition was reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ANXIETY DISORDER (History of PDC and is happening again). At the time of the report, ANXIETY DISORDER (History of PDC and is happening again) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ear with increasing volume; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ear with increasing volume) in a 75-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 (no historical condition was reported).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced TINNITUS (Ringing in ear with increasing volume). At the time of the report, TINNITUS (Ringing in ear with increasing volume) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: slight sore throat; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.; 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. Further information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (Vomiting) and CHILLS (Chilling) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart attack and Stent placement.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced NAUSEA (nausea), VOMITING (Vomiting) and CHILLS (Chilling). At the time of the report, NAUSEA (nausea), VOMITING (Vomiting) and CHILLS (Chilling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   Reporter did not allow further contact; 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Insomnia
Clinical narrative: Hard time sleeping; Lacks full breath; Feels fatigued; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Hard time sleeping), DYSPNOEA (Lacks full breath) and FATIGUE (Feels fatigued) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer and Polio.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INSOMNIA (Hard time sleeping), DYSPNOEA (Lacks full breath) and FATIGUE (Feels fatigued). At the time of the report, INSOMNIA (Hard time sleeping), DYSPNOEA (Lacks full breath) and FATIGUE (Feels fatigued) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant and received Moderna COVID-19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID-19 vaccine) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (prior use, 1-2 servings a week). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 22-Jan-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Jul-2020 and the estimated date of delivery was 28-Apr-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID-19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID-19 vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2020, Pregnancy test: positive (Positive) positive. On an unknown date, Ultrasound scan: normal (normal) anatomical was normal at 20 weeks.         Treatment medication was not reported.  This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Noninfective sialoadenitis, Salivary gland pain
Clinical narrative: parotid gland inflamed and swollen; acute onset parotid pain; This spontaneous case was reported by a physician and describes the occurrence of SALIVARY GLAND PAIN (acute onset parotid pain) and NONINFECTIVE SIALOADENITIS (parotid gland inflamed and swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition reported).    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced SALIVARY GLAND PAIN (acute onset parotid pain). On 16-Jan-2021, the patient experienced NONINFECTIVE SIALOADENITIS (parotid gland inflamed and swollen). On 16-Jan-2021, SALIVARY GLAND PAIN (acute onset parotid pain) had resolved. At the time of the report, NONINFECTIVE SIALOADENITIS (parotid gland inflamed and swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Blood pressure measurement, Malaise, Throat tightness
Clinical narrative: Not feeling 100%; Throat closing; BP 200/something; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat closing), BLOOD PRESSURE ABNORMAL (BP 200/something) and MALAISE (Not feeling 100%) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced THROAT TIGHTNESS (Throat closing) and BLOOD PRESSURE ABNORMAL (BP 200/something). On 16-Jan-2021, the patient experienced MALAISE (Not feeling 100%). At the time of the report, THROAT TIGHTNESS (Throat closing), BLOOD PRESSURE ABNORMAL (BP 200/something) and MALAISE (Not feeling 100%) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Blood pressure measurement: 200 mmHg. On 16-Jan-2021, Blood pressure measurement: high mmHg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (really knocked down) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included POTASSIUM CHLORIDE, VALSARTAN, CABERGOLINE, FUROSEMIDE, ALLOPURINOL, PANTOPRAZOLE, APIXABAN, SOTALOL, CARVEDILOL and ROSUVASTATIN for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FATIGUE (really knocked down). At the time of the report, FATIGUE (really knocked down) 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: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling, raised, red where she got the shot; swelling, raised, red where she got the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling, raised, red where she got the shot) and VACCINATION SITE ERYTHEMA (swelling, raised, red where she got the shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 07-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 VACCINATION SITE SWELLING (swelling, raised, red where she got the shot) and VACCINATION SITE ERYTHEMA (swelling, raised, red where she got the shot). At the time of the report, VACCINATION SITE SWELLING (swelling, raised, red where she got the shot) and VACCINATION SITE ERYTHEMA (swelling, raised, red where she got the shot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Fatigue, Inflammation, Injection site swelling, Lip swelling
Clinical narrative: Eyes swell; Lips started to swell; Sore and swollen; Injection site swelling; Felt really tired during three days; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swell), LIP SWELLING (Lips started to swell), INFLAMMATION (Sore and swollen), INJECTION SITE SWELLING (Injection site swelling) and FATIGUE (Felt really tired during three days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis (Anaphylaxis with other medications.). Concurrent medical conditions included Rheumatoid arthritis and Drug allergy (Lot of medication (Unspecified)). Concomitant products included RITUXIMAB for Rheumatoid arthritis.    On 13-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 EYE SWELLING (Eyes swell), LIP SWELLING (Lips started to swell), INFLAMMATION (Sore and swollen), INJECTION SITE SWELLING (Injection site swelling) and FATIGUE (Felt really tired during three days). At the time of the report, EYE SWELLING (Eyes swell), LIP SWELLING (Lips started to swell), INFLAMMATION (Sore and swollen), INJECTION SITE SWELLING (Injection site swelling) and FATIGUE (Felt really tired during three days) 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Induration, Nausea, Pain in extremity
Clinical narrative: Itchiness; Nausea (all day); Headache; Sigificant arm pain; Redness; Swelling; Hard lump; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sigificant arm pain), ERYTHEMA (Redness), SWELLING (Swelling), INDURATION (Hard lump) and PRURITUS (Itchiness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sigificant arm pain), ERYTHEMA (Redness), SWELLING (Swelling), INDURATION (Hard lump), NAUSEA (Nausea (all day)) and HEADACHE (Headache). On an unknown date, the patient experienced PRURITUS (Itchiness). On 09-Jan-2021, PAIN IN EXTREMITY (Sigificant arm pain), SWELLING (Swelling), INDURATION (Hard lump), NAUSEA (Nausea (all day)) and HEADACHE (Headache) had resolved. At the time of the report, ERYTHEMA (Redness) and PRURITUS (Itchiness) 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: Itchiness; Nausea (all day); Headache; Sigificant arm pain; Redness; Swelling; Hard lump; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sigificant arm pain), ERYTHEMA (Redness), SWELLING (Swelling), INDURATION (Hard lump) and PRURITUS (Itchiness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sigificant arm pain), ERYTHEMA (Redness), SWELLING (Swelling), INDURATION (Hard lump), NAUSEA (Nausea (all day)) and HEADACHE (Headache). On an unknown date, the patient experienced PRURITUS (Itchiness). On 09-Jan-2021, PAIN IN EXTREMITY (Sigificant arm pain), SWELLING (Swelling), INDURATION (Hard lump), NAUSEA (Nausea (all day)) and HEADACHE (Headache) had resolved. At the time of the report, ERYTHEMA (Redness) and PRURITUS (Itchiness) 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: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: slight fever 99.8 F; soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on the injection site) and PYREXIA (slight fever 99.8 F) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included ATORVASTATIN CALCIUM, EZETIMIBE (STATIN EZ).    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness on the injection site). On an unknown date, the patient experienced PYREXIA (slight fever 99.8 F). On 13-Jan-2021, VACCINATION SITE PAIN (soreness on the injection site) outcome was unknown. At the time of the report, PYREXIA (slight fever 99.8 F) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: left arm became swollen; left arm is itching; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm became swollen) and PRURITUS (left arm is itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included COPD and Shoulder deformity NOS.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PERIPHERAL SWELLING (left arm became swollen) and PRURITUS (left arm is itching). At the time of the report, PERIPHERAL SWELLING (left arm became swollen) and PRURITUS (left arm is itching) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Temperature of 99.1; Not feeling well; Headaches; Muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 99.1), VACCINATION COMPLICATION (Not feeling well), HEADACHE (Headaches), MYALGIA (Muscle pain) and CHILLS (Chills) 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 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Temperature of 99.1), VACCINATION COMPLICATION (Not feeling well), HEADACHE (Headaches), MYALGIA (Muscle pain) and CHILLS (Chills). At the time of the report, PYREXIA (Temperature of 99.1), VACCINATION COMPLICATION (Not feeling well), HEADACHE (Headaches), MYALGIA (Muscle pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Limb discomfort, Neck pain
Clinical narrative: arm ache; shoulder ache; neck ache; A spontaneous report was received from a Consumer concerning an unknown patient of  unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm ache,neck ache and shoulder aches.  The patient's medical history was not provided. Concomitant medications history was not provided.  On  15 Jan 2021  the patient received dose of  mRNA-1273 (Lot number: unknown)for prophylaxis of COVID-19 infection.  After the administration of vaccine the patient experienced ache,neck ache and shoulder aches.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events experienced a  ache,neck ache and shoulder aches was considered as unknown at th e time of the report .; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: vaccination site erythema; vaccination site swelling; injection site hard to the touch; vaccination site warmth; vaccination site pruritus; lymph nodes that were large and swollen near collar bone; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm pain), VACCINATION SITE ERYTHEMA (vaccination site erythema), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE INDURATION (injection site hard to the touch) and VACCINATION SITE PRURITUS (vaccination site pruritus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L204A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm pain). On 12-Jan-2021, the patient experienced LYMPHADENOPATHY (lymph nodes that were large and swollen near collar bone). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritus). On 15-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (vaccination site erythema), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE INDURATION (injection site hard to the touch) and VACCINATION SITE WARMTH (vaccination site warmth). On 09-Jan-2021, VACCINATION SITE PAIN (arm pain) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (vaccination site erythema), VACCINATION SITE SWELLING (vaccination site swelling), VACCINATION SITE INDURATION (injection site hard to the touch), VACCINATION SITE PRURITUS (vaccination site pruritus), VACCINATION SITE WARMTH (vaccination site warmth) and LYMPHADENOPATHY (lymph nodes that were large and swollen near collar bone) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Last night (14JAN2021) before going to bed, she noticed her arm near the injection was itching and red. This morning (15JAN2021) the area became round as a softball, hard to the touch, much bigger, itchy, and hot.  No history of concomitant medications were taken by the patient.   Patient was able to get hold of health department who suggested her using heat, cold and ice in the effected area. She has not started following the suggestion which health department gave.