chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed her second dose, passed 42 days window; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed her second dose, passed 42 days window) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039AZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed her second dose, passed 42 days window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed her second dose, passed 42 days window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.  Treatment information not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Was not able to get the 2nd dose/ Patient did not receive the second dose of the Moderna COVID-19 vaccine and it has been more than 35 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Was not able to get the 2nd dose/ Patient did not receive the second dose of the Moderna COVID-19 vaccine and it has been more than 35 days after the first dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was not able to get the 2nd dose/ Patient did not receive the second dose of the Moderna COVID-19 vaccine and it has been more than 35 days after the first dose). On 27-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Was not able to get the 2nd dose/ Patient did not receive the second dose of the Moderna COVID-19 vaccine and it has been more than 35 days after the first dose) 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 relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received included reporter information, patient demographics and vaccine information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: diarrhea daily; headache; chills; shortness of breath; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea daily), HEADACHE (headache), CHILLS (chills), DYSPNOEA (shortness of breath) and FATIGUE (feeling tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cortisol high.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea daily), HEADACHE (headache), CHILLS (chills), DYSPNOEA (shortness of breath), FATIGUE (feeling tired) and CORTISOL INCREASED ("cortisol level was high"). At the time of the report, DIARRHOEA (diarrhea daily), HEADACHE (headache), CHILLS (chills), DYSPNOEA (shortness of breath) and FATIGUE (feeling tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment medication or therapy reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant follow-up appended
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient is planning on getting the second dose of the vaccine more than 42 days after the first dose (time deviation); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is planning on getting the second dose of the vaccine more than 42 days after the first dose (time deviation)) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is planning on getting the second dose of the vaccine more than 42 days after the first dose (time deviation)). On 01-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Patient is planning on getting the second dose of the vaccine more than 42 days after the first dose (time deviation)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received 2nd dose in 8 week after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose in 8 week after 1st dose) in a patient of an unknown age and gender 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose in 8 week after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose in 8 week after 1st dose) had resolved.            Concomitant product information was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Blood pressure measurement, Feeling hot, Flushing, Nausea
Clinical narrative: a lot of itching; sore arm; face is hot; face is flushed; Typical pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (a lot of itching), PAIN IN EXTREMITY (sore arm), FEELING HOT (face is hot), FLUSHING (face is flushed) and PAIN (Typical pain) in a female 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.     Concurrent medical conditions included End stage renal disease and Type 1 diabetes mellitus.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (a lot of itching), PAIN IN EXTREMITY (sore arm), FEELING HOT (face is hot), FLUSHING (face is flushed), PAIN (Typical pain) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL CHILDRENS) at an unspecified dose and frequency. At the time of the report, PRURITUS (a lot of itching), PAIN IN EXTREMITY (sore arm), FEELING HOT (face is hot), FLUSHING (face is flushed), PAIN (Typical pain) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose fluctuation: 200 (abnormal) 200. On an unknown date, Blood pressure measurement: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Symptoms: Patient reported that a Clear liquid was oozing from her face.  No concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pruritus
Clinical narrative: a lot of itching; sore arm; face is hot; face is flushed; Typical pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (a lot of itching), PAIN IN EXTREMITY (sore arm), FEELING HOT (face is hot), FLUSHING (face is flushed) and PAIN (Typical pain) in a female 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.     Concurrent medical conditions included End stage renal disease and Type 1 diabetes mellitus.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (a lot of itching), PAIN IN EXTREMITY (sore arm), FEELING HOT (face is hot), FLUSHING (face is flushed), PAIN (Typical pain) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL CHILDRENS) at an unspecified dose and frequency. At the time of the report, PRURITUS (a lot of itching), PAIN IN EXTREMITY (sore arm), FEELING HOT (face is hot), FLUSHING (face is flushed), PAIN (Typical pain) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose fluctuation: 200 (abnormal) 200. On an unknown date, Blood pressure measurement: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Symptoms: Patient reported that a Clear liquid was oozing from her face.  No concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is mildly sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is mildly sore) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm is mildly sore). At the time of the report, PAIN IN EXTREMITY (Arm is mildly sore) outcome was unknown.        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.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Pruritus
Clinical narrative: Redness; Itching; Feeling hot; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itching), FEELING HOT (Feeling hot) and CHILLS (Chills) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEXA [CELECOXIB]) and FINASTERIDE (PROPECIA) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness), PRURITUS (Itching), FEELING HOT (Feeling hot) and CHILLS (Chills). At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching), FEELING HOT (Feeling hot) and CHILLS (Chills) outcome was unknown.            No treatment medications were provided.   This case was linked to MOD-2021-221142 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hyperhidrosis
Clinical narrative: felt wicked buzz; elmers glue on arms; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt wicked buzz) and HYPERHIDROSIS (elmers glue on arms) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported. .     On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt wicked buzz) and HYPERHIDROSIS (elmers glue on arms). At the time of the report, FEELING ABNORMAL (felt wicked buzz) and HYPERHIDROSIS (elmers glue on arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided. No lab data has been provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown.        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.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: a lump next to it after having the vaccine; I have a swelling in my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a lump next to it after having the vaccine) and VACCINATION SITE SWELLING (I have a swelling in my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (a lump next to it after having the vaccine) and VACCINATION SITE SWELLING (I have a swelling in my arm). At the time of the report, VACCINATION SITE MASS (a lump next to it after having the vaccine) and VACCINATION SITE SWELLING (I have a swelling in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sluggishness
Clinical narrative: Sluggish; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish) and FATIGUE (Fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced SLUGGISHNESS (Sluggish) and FATIGUE (Fatigue). At the time of the report, SLUGGISHNESS (Sluggish) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Sore  arm; Fatigue; A little bit of nausea; A little headache; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore  arm), FATIGUE (Fatigue), NAUSEA (A little bit of nausea) and HEADACHE (A little headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-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), FATIGUE (Fatigue), NAUSEA (A little bit of nausea) and HEADACHE (A little headache). At the time of the report, PAIN IN EXTREMITY (Sore  arm), FATIGUE (Fatigue) and NAUSEA (A little bit of nausea) outcome was unknown and HEADACHE (A little headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-245602 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received included no new information.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Eating disorder, Headache, Illness
Clinical narrative: Sick as a dog; Diarrhea; Stomach issues; Has lost 10 pounds; Has not been able to eat for weeks; Lost work days; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick as a dog), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach issues), WEIGHT DECREASED (Has lost 10 pounds) and EATING DISORDER (Has not been able to eat for weeks) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced ILLNESS (Sick as a dog), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach issues), WEIGHT DECREASED (Has lost 10 pounds), EATING DISORDER (Has not been able to eat for weeks), JOB DISSATISFACTION (Lost work days) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; PANTOPRAZOLE at a dose of 1 dosage form and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form. At the time of the report, ILLNESS (Sick as a dog), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach issues), WEIGHT DECREASED (Has lost 10 pounds), EATING DISORDER (Has not been able to eat for weeks), JOB DISSATISFACTION (Lost work days) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient second dose scheduled for 07 Jul 2021 his asking taken or not. Concomitant product use was not provided by the reporter.  No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received contains no new information.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Job dissatisfaction, Weight decreased
Clinical narrative: Sick as a dog; Diarrhea; Stomach issues; Has lost 10 pounds; Has not been able to eat for weeks; Lost work days; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick as a dog), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach issues), WEIGHT DECREASED (Has lost 10 pounds) and EATING DISORDER (Has not been able to eat for weeks) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.     On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced ILLNESS (Sick as a dog), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach issues), WEIGHT DECREASED (Has lost 10 pounds), EATING DISORDER (Has not been able to eat for weeks), JOB DISSATISFACTION (Lost work days) and HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; PANTOPRAZOLE at a dose of 1 dosage form and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at a dose of 1 dosage form. At the time of the report, ILLNESS (Sick as a dog), DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Stomach issues), WEIGHT DECREASED (Has lost 10 pounds), EATING DISORDER (Has not been able to eat for weeks), JOB DISSATISFACTION (Lost work days) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient second dose scheduled for 07 Jul 2021 his asking taken or not. Concomitant product use was not provided by the reporter.  No lab data has been provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received contains no new information.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Lymph node pain, Lymphadenopathy
Clinical narrative: lymph node painful/ it is pain, soreness, and some minor swelling that are the issues for this patient with respect to lymph node in his left shoulder; lymph node in his left arm pit swelled to the size of a golf ball/lymph node enlarged; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (lymph node in his left arm pit swelled to the size of a golf ball/lymph node enlarged) and LYMPH NODE PAIN (lymph node painful/ it is pain, soreness, and some minor swelling that are the issues for this patient with respect to lymph node in his left shoulder) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced LYMPHADENOPATHY (lymph node in his left arm pit swelled to the size of a golf ball/lymph node enlarged). On an unknown date, the patient experienced LYMPH NODE PAIN (lymph node painful/ it is pain, soreness, and some minor swelling that are the issues for this patient with respect to lymph node in his left shoulder). At the time of the report, LYMPHADENOPATHY (lymph node in his left arm pit swelled to the size of a golf ball/lymph node enlarged) and LYMPH NODE PAIN (lymph node painful/ it is pain, soreness, and some minor swelling that are the issues for this patient with respect to lymph node in his left shoulder) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: negative (Negative) negative.     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 Medications were not reported.  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.   This case was linked to MOD-2021-245583 (Patient Link).; 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Heavy menstrual bleeding
Clinical narrative: Afvacine i had no period and these two/Menstrual cycle is disruptive/skipped a period/ I noticed a change in my menstrual cycle; Ive never had such heavy long menstrual cycles/Menstrual cycle is disruptive/then the following 2 months my menstrual cycles are heavy/ last 2 more than normal/ I noticed a change in my menstrual cycle; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Afvacine i had no period and these two/Menstrual cycle is disruptive/skipped a period/ I noticed a change in my menstrual cycle) and HEAVY MENSTRUAL BLEEDING (Ive never had such heavy long menstrual cycles/Menstrual cycle is disruptive/then the following 2 months my menstrual cycles are heavy/ last 2 more than normal/ I noticed a change in my menstrual cycle) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the Reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMENORRHOEA (Afvacine i had no period and these two/Menstrual cycle is disruptive/skipped a period/ I noticed a change in my menstrual cycle) and HEAVY MENSTRUAL BLEEDING (Ive never had such heavy long menstrual cycles/Menstrual cycle is disruptive/then the following 2 months my menstrual cycles are heavy/ last 2 more than normal/ I noticed a change in my menstrual cycle). At the time of the report, AMENORRHOEA (Afvacine i had no period and these two/Menstrual cycle is disruptive/skipped a period/ I noticed a change in my menstrual cycle) and HEAVY MENSTRUAL BLEEDING (Ive never had such heavy long menstrual cycles/Menstrual cycle is disruptive/then the following 2 months my menstrual cycles are heavy/ last 2 more than normal/ I noticed a change in my menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow-up received on 04-JUL-2021 and Patient's Age and Event information was updated.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Rash, Skin burning sensation
Clinical narrative: Patient hasn't received 2nd dose yet.; eash was burning; 2 days after receiving 1st dose, she broke out in a rash on her arm/Rash was also on her neck/Rash was burning; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet.), RASH (2 days after receiving 1st dose, she broke out in a rash on her arm/Rash was also on her neck/Rash was burning) and SKIN BURNING SENSATION (eash was burning) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CHOLESTEROL for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced RASH (2 days after receiving 1st dose, she broke out in a rash on her arm/Rash was also on her neck/Rash was burning). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet.) and SKIN BURNING SENSATION (eash was burning). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of UNK dosage form and HYDROCORTISONE SODIUM SUCCINATE (HYDROCORTISONE SODIUM) for Rash, at a dose of UNK dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet.), RASH (2 days after receiving 1st dose, she broke out in a rash on her arm/Rash was also on her neck/Rash was burning) and SKIN BURNING SENSATION (eash was burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment include Anti-bacterial cream and Vaseline.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It was more than two months after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It was more than two months after first shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 47B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It was more than two months after first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It was more than two months after first shot) had 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.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Off label use
Clinical narrative: 1st dose AZ, 2nd dose Moderna; extremely dizzy; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (1st dose AZ, 2nd dose Moderna) and DIZZINESS (extremely dizzy) in a  patient of an unknown age and gender 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 OFF LABEL USE (1st dose AZ, 2nd dose Moderna) and DIZZINESS (extremely dizzy). At the time of the report, OFF LABEL USE (1st dose AZ, 2nd dose Moderna) had resolved and DIZZINESS (extremely dizzy) outcome was unknown.            Concomitant medications were not provided.  Co-suspect product included non-company product for an unknown indication. Patient reportedly received AZ vaccine for the first dose.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive the second dose of the Moderna COVID-19 vaccine, and 49 days have elapsed since the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine, and 49 days have elapsed since the first dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were 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 PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine, and 49 days have elapsed since the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine, and 49 days have elapsed since the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided. No lab data has been provided by the reporter.    Reporter did not allow further contact
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Feeling of body temperature change, Myalgia, Pyrexia
Clinical narrative: Arm pain; Felt like having a mild case of covid-19; Feeling hot and cold; Having chills; Fever; Body Ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain), COVID-19 (Felt like having a mild case of covid-19), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHILLS (Having chills) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain), COVID-19 (Felt like having a mild case of covid-19), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHILLS (Having chills), PYREXIA (Fever) and MYALGIA (Body Ache). At the time of the report, VACCINATION SITE PAIN (Arm pain), COVID-19 (Felt like having a mild case of covid-19), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHILLS (Having chills), PYREXIA (Fever) and MYALGIA (Body Ache) outcome was unknown.            Treatment medication was not provided    This case was linked to MOD-2021-246784 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 2 July 2021 contains no new information
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm pain; Felt like having a mild case of covid-19; Feeling hot and cold; Having chills; Fever; Body Ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain), COVID-19 (Felt like having a mild case of covid-19), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHILLS (Having chills) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain), COVID-19 (Felt like having a mild case of covid-19), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHILLS (Having chills), PYREXIA (Fever) and MYALGIA (Body Ache). At the time of the report, VACCINATION SITE PAIN (Arm pain), COVID-19 (Felt like having a mild case of covid-19), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), CHILLS (Having chills), PYREXIA (Fever) and MYALGIA (Body Ache) outcome was unknown.            Treatment medication was not provided    This case was linked to MOD-2021-246784 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 2 July 2021 contains no new information
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Pain in extremity, Product dose omission issue
Clinical narrative: Past the 42 day mark; really bad body pain/aches from head to toe; bad headache; vomiting at least 3 times; bad swelling in lymph nodes under left arm/little swelling in lymph nodes under right arm; slept 2-3 hours at a time all day; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept 2-3 hours at a time all day), PAIN IN EXTREMITY (sore arm), PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark), MYALGIA (really bad body pain/aches from head to toe) and HEADACHE (bad headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ANASTROZOLE (ARIMIDEX), PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), LISINOPRIL, VITAMINS NOS and PROBIOTICS NOS for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SOMNOLENCE (slept 2-3 hours at a time all day), MYALGIA (really bad body pain/aches from head to toe), HEADACHE (bad headache), VOMITING (vomiting at least 3 times) and LYMPHADENOPATHY (bad swelling in lymph nodes under left arm/little swelling in lymph nodes under right arm). In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) in April 2021 for Adverse event, at an unspecified dose and frequency. In April 2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, SOMNOLENCE (slept 2-3 hours at a time all day), PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark), MYALGIA (really bad body pain/aches from head to toe), HEADACHE (bad headache), VOMITING (vomiting at least 3 times) and LYMPHADENOPATHY (bad swelling in lymph nodes under left arm/little swelling in lymph nodes under right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment included Advil.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vomiting
Clinical narrative: Past the 42 day mark; really bad body pain/aches from head to toe; bad headache; vomiting at least 3 times; bad swelling in lymph nodes under left arm/little swelling in lymph nodes under right arm; slept 2-3 hours at a time all day; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept 2-3 hours at a time all day), PAIN IN EXTREMITY (sore arm), PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark), MYALGIA (really bad body pain/aches from head to toe) and HEADACHE (bad headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ANASTROZOLE (ARIMIDEX), PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), LISINOPRIL, VITAMINS NOS and PROBIOTICS NOS for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SOMNOLENCE (slept 2-3 hours at a time all day), MYALGIA (really bad body pain/aches from head to toe), HEADACHE (bad headache), VOMITING (vomiting at least 3 times) and LYMPHADENOPATHY (bad swelling in lymph nodes under left arm/little swelling in lymph nodes under right arm). In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) in April 2021 for Adverse event, at an unspecified dose and frequency. In April 2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, SOMNOLENCE (slept 2-3 hours at a time all day), PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark), MYALGIA (really bad body pain/aches from head to toe), HEADACHE (bad headache), VOMITING (vomiting at least 3 times) and LYMPHADENOPATHY (bad swelling in lymph nodes under left arm/little swelling in lymph nodes under right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment included Advil.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Blood urea nitrogen/creatinine ratio, Protein total increased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (Close to diabetes diagnosis) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The patient's past medical history included Cervical cancer (Surgery on unknown date) and Hepatitis C. Concurrent medical conditions included Myelodysplastic syndrome, Chronic obstructive pulmonary disease and Obstructive sleep apnea syndrome. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for Antacid therapy, BUMETANIDE for Diuretic therapy, METOPROLOL for Heart disorder, POTASSIUM for an unknown indication. On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jun-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced BLOOD GLUCOSE INCREASED (Close to diabetes diagnosis) (seriousness criterion medically significant). At the time of the report, BLOOD GLUCOSE INCREASED (Close to diabetes diagnosis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Blood glucose: 133 (High) blood glucose increased. On 24-Jun-2021, Blood urea nitrogen/creatinine ratio: 21 (High) Blood urea nitrogen/creatinine ratio increased. Bun/Creatinine ratio 21. On 24-Jun-2021, Protein total increased: 8.1 (High) Total protein increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included Unspecified medication for heart. Patient reported that she experienced diabetes diagnosis, metabolic panel showed elevated glucose and before there are no signs of diabetes. She also had bun/creatinine and total protein is high. Treatment information was not provided. Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old who received the first dose of Moderna COVID-19 Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old who received the first dose of Moderna COVID-19 Vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history were reported. .     On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old who received the first dose of Moderna COVID-19 Vaccine). On 02-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old who received the first dose of Moderna COVID-19 Vaccine) 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 concomitant medication was reported. No treatment medication were provided. No lab data has been provided by the reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on her left arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (High Blood Pressure) and High cholesterol.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain on her left arm). At the time of the report, PAIN IN EXTREMITY (Pain on her left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications reported were blood pressure pill and cholesterol pill.  No treatment information was provided.   This case was linked to MOD-2021-245629 (Patient Link).
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Groin pain
Clinical narrative: pain in groin area; hard to walk on my right side; pain in joint,pain in knee area; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (pain in groin area), GAIT DISTURBANCE (hard to walk on my right side) and ARTHRALGIA (pain in joint,pain in knee area) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced GROIN PAIN (pain in groin area), GAIT DISTURBANCE (hard to walk on my right side) and ARTHRALGIA (pain in joint,pain in knee area). At the time of the report, GROIN PAIN (pain in groin area), GAIT DISTURBANCE (hard to walk on my right side) and ARTHRALGIA (pain in joint,pain in knee area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medication were provided. No treatment medication were provided. No lab data has been provided by the reporter.    This case was linked to MOD-2021-245626 (Patient Link).