chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain
Clinical narrative: under arm pain (lymph node); headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (under arm pain (lymph node)) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (She is a Breast cancer Survivor .).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced LYMPH NODE PAIN (under arm pain (lymph node)) and HEADACHE (headache). At the time of the report, LYMPH NODE PAIN (under arm pain (lymph node)) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-016238 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016238:
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Haematuria, Pain in extremity
Clinical narrative: Urine bleeding "like a slightly pink in the urine"; sore arm; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Urine bleeding "like a slightly pink in the urine"), PAIN IN EXTREMITY (sore arm) and DIARRHOEA (Diarrhea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01320MA) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported ).    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HAEMATURIA (Urine bleeding "like a slightly pink in the urine"), PAIN IN EXTREMITY (sore arm) and DIARRHOEA (Diarrhea). On 23-Feb-2021, HAEMATURIA (Urine bleeding "like a slightly pink in the urine") and DIARRHOEA (Diarrhea) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Sore arm; Low grade fever of 99.6°F; 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 low grade fever of 99.6°F/ pyrexia, sore arm/ pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection. On 17 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the events low grade fever of 99.6°F, sore arm.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable. The outcome of events, low grade fever of 99.6°F, sore arm 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Limb discomfort
Clinical narrative: discomfort worsened; Discomfort in the arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Discomfort in the arm) and CONDITION AGGRAVATED (discomfort worsened) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 immunization.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced LIMB DISCOMFORT (Discomfort in the arm). On 17-Feb-2021, the patient experienced CONDITION AGGRAVATED (discomfort worsened). At the time of the report, LIMB DISCOMFORT (Discomfort in the arm) and CONDITION AGGRAVATED (discomfort worsened) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.  The patient reported seems to be a rotator cuff issue.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swelling at the injection site; Red at the injection site; Itchy at the injection site; Low grade fever which she managed; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever which she managed), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.    Co-suspect product included non-company product DENOSUMAB (PROLIA) for an unknown indication.    No Medical History information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient started DENOSUMAB (PROLIA) (unknown route) at an unspecified dose. On 10-Feb-2021, the patient experienced PYREXIA (Low grade fever which she managed). On 18-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site). On 10-Feb-2021, PYREXIA (Low grade fever which she managed) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PRURITUS (Itchy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the low grade fever included ibuprofen.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Really bad stomach cramps that is getting worse; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Really bad stomach cramps that is getting worse) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Really bad stomach cramps that is getting worse). At the time of the report, ABDOMINAL PAIN UPPER (Really bad stomach cramps that is getting worse) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Injection site itchy; Knot on the injection site; Injection site red; A spontaneous report was received from a consumer (patient), a 66 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine injection site itchy, knot on the vaccine injection site, and vaccine injection site red.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 06-FEB-2021, the patient developed knot on the vaccine injection site, which was itchy and red. No treatment information was provided.   Action taken with the second dose of mRNA-1273 in response to the events was not reported.  The outcome for the events, vaccine injection site itchy, knot on the vaccine injection site, and vaccine injection site red, was not reported.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pyrexia, Vaccination complication
Clinical narrative: Kind of sick; Cold; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Kind of sick), FEELING COLD (Cold) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007m20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-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 COMPLICATION (Kind of sick), FEELING COLD (Cold) and PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (Kind of sick), FEELING COLD (Cold) and PYREXIA (Fever) 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.   Treatment information not 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.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance
Clinical narrative: Could not walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could not walk) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043120A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced GAIT DISTURBANCE (Could not walk). At the time of the report, GAIT DISTURBANCE (Could not walk) outcome was unknown.            No relevant concomitant medications were reported On 17-Feb-2021, the patient was fed up and could not walk. The patient's husband had to carry her to the bathroom. The patient shuffled and was not able to move the feet. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Polymerase chain reaction, SARS-CoV-2 test positive
Clinical narrative: Tested COVID19 Positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested COVID19 Positive) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested COVID19 Positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested COVID19 Positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Polymerase chain reaction: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Rash on arm, 4 inches wide from injection site to elbow; soreness of the injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE RASH (Rash on arm, 4 inches wide from injection site to elbow) and VACCINATION SITE PAIN (soreness of the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash on arm, 4 inches wide from injection site to elbow) and VACCINATION SITE PAIN (soreness of the injection site). At the time of the report, VACCINATION SITE RASH (Rash on arm, 4 inches wide from injection site to elbow) and VACCINATION SITE PAIN (soreness of the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Throat irritation, Tongue disorder
Clinical narrative: peppery tongue; scratchy throat; low grade fever of 99.0F; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (peppery tongue), THROAT IRRITATION (scratchy throat) and PYREXIA (low grade fever of 99.0F) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TONGUE DISORDER (peppery tongue), THROAT IRRITATION (scratchy throat) and PYREXIA (low grade fever of 99.0F). At the time of the report, TONGUE DISORDER (peppery tongue), THROAT IRRITATION (scratchy throat) and PYREXIA (low grade fever of 99.0F) outcome was unknown.            No relevant concomitant medications were reported. Treatment details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) 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 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 25-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The delivery occurred on an unknown date. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications and treatment details was not provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Discomfort, Fatigue, Pain
Clinical narrative: felt like hit by a truck; chills; lost appetite; fatigued; fever; very achy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (very achy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.Medication for diabetes three times a day and medication for hypertension twice a week   On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (very achy) (seriousness criterion medically significant), DECREASED APPETITE (lost appetite), FATIGUE (fatigued) and PYREXIA (fever). On an unknown date, the patient experienced DISCOMFORT (felt like hit by a truck) and CHILLS (chills).      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt like hit by a truck; chills; lost appetite; fatigued; fever; very achy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (very achy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypertension.Medication for diabetes three times a day and medication for hypertension twice a week   On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (very achy) (seriousness criterion medically significant), DECREASED APPETITE (lost appetite), FATIGUE (fatigued) and PYREXIA (fever). On an unknown date, the patient experienced DISCOMFORT (felt like hit by a truck) and CHILLS (chills).      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   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.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Hypertension
Clinical narrative: elevated blood pressure after injection; dizzy; foggy; rash on the left arm 7 inches long and 3 inches in diameter; extreme headache; Fatigue/brain fatigue/exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (elevated blood pressure after injection), DIZZINESS (dizzy), FEELING ABNORMAL (foggy), RASH (rash on the left arm 7 inches long and 3 inches in diameter) and HEADACHE (extreme headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (elevated blood pressure after injection), DIZZINESS (dizzy), FEELING ABNORMAL (foggy), RASH (rash on the left arm 7 inches long and 3 inches in diameter), HEADACHE (extreme headache) and FATIGUE (Fatigue/brain fatigue/exhaustion). At the time of the report, HYPERTENSION (elevated blood pressure after injection), DIZZINESS (dizzy), FEELING ABNORMAL (foggy), RASH (rash on the left arm 7 inches long and 3 inches in diameter), HEADACHE (extreme headache) and FATIGUE (Fatigue/brain fatigue/exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: elevated blood pressure after injection; dizzy; foggy; rash on the left arm 7 inches long and 3 inches in diameter; extreme headache; Fatigue/brain fatigue/exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (elevated blood pressure after injection), DIZZINESS (dizzy), FEELING ABNORMAL (foggy), RASH (rash on the left arm 7 inches long and 3 inches in diameter) and HEADACHE (extreme headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (elevated blood pressure after injection), DIZZINESS (dizzy), FEELING ABNORMAL (foggy), RASH (rash on the left arm 7 inches long and 3 inches in diameter), HEADACHE (extreme headache) and FATIGUE (Fatigue/brain fatigue/exhaustion). At the time of the report, HYPERTENSION (elevated blood pressure after injection), DIZZINESS (dizzy), FEELING ABNORMAL (foggy), RASH (rash on the left arm 7 inches long and 3 inches in diameter), HEADACHE (extreme headache) and FATIGUE (Fatigue/brain fatigue/exhaustion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: burns like an allergic reaction; itches; slight redness; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PRURITUS (itches), INJECTION SITE ERYTHEMA (slight redness) and INJECTION SITE PAIN (burns like an allergic reaction) in a 75-year-old male patient 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) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced INJECTION SITE PRURITUS (itches) and INJECTION SITE ERYTHEMA (slight redness). On 16-Feb-2021, the patient experienced INJECTION SITE PAIN (burns like an allergic reaction). At the time of the report, INJECTION SITE PRURITUS (itches), INJECTION SITE ERYTHEMA (slight redness) and INJECTION SITE PAIN (burns like an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medications included unspecified cholesterol medications.   No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Woke up on the middle of the night extremely dizzy  this interrupted her sleep; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Woke up on the middle of the night extremely dizzy  this interrupted her sleep) and PAIN IN EXTREMITY (Sore arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Feb-2021, the patient experienced DIZZINESS (Woke up on the middle of the night extremely dizzy  this interrupted her sleep). On 11-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 17-Feb-2021, DIZZINESS (Woke up on the middle of the night extremely dizzy  this interrupted her sleep) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure to SARS-CoV-2, Headache, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Patient thinks she was exposed to Covid from someone she lives with; Itchiness around the injection site; Headache; Chills; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Patient thinks she was exposed to Covid from someone she lives with), VACCINATION SITE PRURITUS (Itchiness around the injection site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010m20a) for COVID-19 vaccination.     No medical history reported.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LOSARTAN and PANTOPRAZOLE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness around the injection site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness around the injection site). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Patient thinks she was exposed to Covid from someone she lives with). At the time of the report, EXPOSURE TO SARS-COV-2 (Patient thinks she was exposed to Covid from someone she lives with), VACCINATION SITE PRURITUS (Itchiness around the injection site), HEADACHE (Headache), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not receive any treatment.  The patient underwent COVID-19 virus test on an unspecified date and was waiting for the results. Patient is quarantining because of the Covid virus and he is on his 13th day.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm was sore in the area of injection; Arm was very swollen in the area of injection; Very tired and slept all day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired and slept all day), VACCINATION SITE PAIN (Arm was sore in the area of injection) and VACCINATION SITE SWELLING (Arm was very swollen in the area of injection) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (Very tired and slept all day). On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore in the area of injection) and VACCINATION SITE SWELLING (Arm was very swollen in the area of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Very tired and slept all day) and VACCINATION SITE PAIN (Arm was sore in the area of injection) outcome was unknown and VACCINATION SITE SWELLING (Arm was very swollen in the area of injection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: Adverse reaction that she was experiencing after her first dose; This spontaneous case was reported by a patient and describes the occurrence of ADVERSE REACTION (Adverse reaction that she was experiencing after her first dose) 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 ADVERSE REACTION (Adverse reaction that she was experiencing after her first dose). At the time of the report, ADVERSE REACTION (Adverse reaction that she was experiencing after her first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pain in extremity, Pregnancy test
Clinical narrative: pregnancy; sore arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) in a 31-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 30-Oct-2021. On 18-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). On 18-Feb-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus
Clinical narrative: Rashes on right arm; Itching near the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes on right arm) and VACCINATION SITE PRURITUS (Itching near the injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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 an unknown date, the patient experienced RASH (Rashes on right arm) and VACCINATION SITE PRURITUS (Itching near the injection site). On 11-Feb-2021, VACCINATION SITE PRURITUS (Itching near the injection site) had resolved. On 14-Feb-2021, RASH (Rashes on right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. Treatment include unknown cream or ointment.; 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: 98.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, 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) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.  Company Comment: 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Headache, Vaccination site erythema, Vaccination site pain
Clinical narrative: A spontaneous report was received from a consumer, who was a 63-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dry mouth, pain at vaccination site, swelling and redness at the vaccination site that travelled up to her neck, heat, headache and fatigue. The patient's medical history, as provided by the reporter, included immune disorders. Concomitant products reported included ascorbic acid, gentiana lutea root, primula spp. flower, rumex acetosa, sambucus nigra flower and verbena officinalis herb, valaciclovir hydrochloride, rosuvastatin calcium and hormone replacement therapy. On 14 Feb 2021, the patient received second dose of mRNA-1273 (Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. On 14 Feb 2021, immediately following administration, the patient experienced dry mouth sensation and pain at the vaccination site. On 15-Feb-2021, a day after receiving the second dose of vaccine, the patient experienced some swelling and redness at the vaccination site that extended to her neck following which the patient felt vaccination site heat. On 17 Feb 2021, three days after receiving the vaccine, the patient experienced headache and some fatigue. Treatment of the events included Tylenol and application of ice pack. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, dry mouth, pain, swelling and redness at the vaccination site that travelled up to her neck, heat, headache, fatigue, were considered unknown on 18 Feb 2021; 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: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: A spontaneous report was received from a consumer, who was a 63-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dry mouth, pain at vaccination site, swelling and redness at the vaccination site that travelled up to her neck, heat, headache and fatigue. The patient's medical history, as provided by the reporter, included immune disorders. Concomitant products reported included ascorbic acid, gentiana lutea root, primula spp. flower, rumex acetosa, sambucus nigra flower and verbena officinalis herb, valaciclovir hydrochloride, rosuvastatin calcium and hormone replacement therapy. On 14 Feb 2021, the patient received second dose of mRNA-1273 (Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. On 14 Feb 2021, immediately following administration, the patient experienced dry mouth sensation and pain at the vaccination site. On 15-Feb-2021, a day after receiving the second dose of vaccine, the patient experienced some swelling and redness at the vaccination site that extended to her neck following which the patient felt vaccination site heat. On 17 Feb 2021, three days after receiving the vaccine, the patient experienced headache and some fatigue. Treatment of the events included Tylenol and application of ice pack. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, dry mouth, pain, swelling and redness at the vaccination site that travelled up to her neck, heat, headache, fatigue, were considered unknown on 18 Feb 2021; 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
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Bloody nose that lasted 1 half hour.; This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Bloody nose that lasted 1 half hour.) 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 16-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced EPISTAXIS (Bloody nose that lasted 1 half hour.). On 16-Feb-2021, EPISTAXIS (Bloody nose that lasted 1 half hour.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea
Clinical narrative: Joint pain; Shortness of breath; Very bad chills; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), CHILLS (Very bad chills) and ARTHRALGIA (Joint pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DYSPNOEA (Shortness of breath) and CHILLS (Very bad chills). On 18-Feb-2021, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved and CHILLS (Very bad chills) and ARTHRALGIA (Joint pain) outcome was unknown.            No concomitant medications were reported.   No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Candida infection
Clinical narrative: Thrush; This spontaneous case was reported by a consumer and describes the occurrence of   in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Lung cancer stage III and Breast cancer (breast cancer 2 years ago).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication were provided. 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.   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.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Significant FU TCR added on 13-JUL-2021 : contact information and event outcome  updated. On 14-Jul-2021: Follow up correspondence attached
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID test after vaccination; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Positive COVID test after vaccination) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.  Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 25-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 COVID-19 (Positive COVID test after vaccination). The patient was treated with REMDESIVIR for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (Positive COVID test after vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) After receiving the vaccine.     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 27-Apr-2021: Follow-up received on 27-APR-2021 indicated, the patient did not have any reactions from the vaccine and did not have COVID-19 after receiving the vaccine.; Sender's Comments: The causality for this event is not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Tongue blistering
Clinical narrative: Pain; Blisters on his tongue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and TONGUE BLISTERING (Blisters on his tongue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 13-Feb-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 (Pain) and TONGUE BLISTERING (Blisters on his tongue). At the time of the report, PAIN (Pain) and TONGUE BLISTERING (Blisters on his tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's concomitant medication included an unspecified high blood pressure medication.   No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slightly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Slightly sore arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-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 (Slightly sore arm). At the time of the report, PAIN IN EXTREMITY (Slightly sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment information was provided    Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-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 (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: Slept for 36 hours the night after getting the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HYPERSOMNIA (Slept for 36 hours the night after getting the shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HYPERSOMNIA (Slept for 36 hours the night after getting the shot). On 01-Feb-2021, HYPERSOMNIA (Slept for 36 hours the night after getting the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided, however, the patient's HCP advised the patient not to receive the second shot.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Rash, Urticaria
Clinical narrative: rashes and hives over his body; rashes and hives over his body; fatigue; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (rashes and hives over his body), RASH (rashes and hives over his body) and FATIGUE (fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease. Concomitant products included ROTIGOTINE (NEUPRO), CARBIDOPA, LEVODOPA (SINEMET) and LEVODOPA for an unknown indication.    On 15-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced URTICARIA (rashes and hives over his body), RASH (rashes and hives over his body) and FATIGUE (fatigue). At the time of the report, URTICARIA (rashes and hives over his body), RASH (rashes and hives over his body) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.