chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site erythema
Clinical narrative: hot at the injection site; hard at the injection site; red at the injection site; Fever; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site), PYREXIA (Fever) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID before receiving the vaccine).    On 17-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 VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive had COVID before receiving the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site warmth
Clinical narrative: hot at the injection site; hard at the injection site; red at the injection site; Fever; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site), PYREXIA (Fever) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had COVID before receiving the vaccine).    On 17-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 VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, VACCINATION SITE WARMTH (hot at the injection site), VACCINATION SITE INDURATION (hard at the injection site), VACCINATION SITE ERYTHEMA (red at the injection site), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive had COVID before receiving the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Probably had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Probably had a sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney transplant. Concurrent medical conditions included Kidney disorder.    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 MYALGIA (Probably had a sore arm). At the time of the report, MYALGIA (Probably had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (Red rash). At the time of the report, RASH ERYTHEMATOUS (Red rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Parosmia
Clinical narrative: loss of taste; Also my gas has a different smell as well; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste) and PAROSMIA (Also my gas has a different smell as well) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste) and PAROSMIA (Also my gas has a different smell as well). At the time of the report, AGEUSIA (loss of taste) and PAROSMIA (Also my gas has a different smell as well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient had a significant loss of taste. Just had bacon and sausage. Have noticed this for over a week now. Also, patient's gas has a different smell as well. Seems that meat is the real issue with taste.   No information on treatment is provided by the reporter.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Patient received vaccine affected by the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion) 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 considered PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion) to be not related.    The expiration date of  lot # in question LOT: 009D21A was 02-Jul-2021 and the excursion event occurred on 09-Jun-2021.  No concomitant medications information was provided. No treatment medications information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow Up received on 27 Jul 2021 contains Updated Causality of Events, lot expiration date. Expired product administered was removed..
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Patient received vaccine affected by the excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion). On 11-Jun-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion) 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 considered PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received vaccine affected by the excursion) to be not related.    No concomitant medications were reported.  No adverse events have occurred.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Patient demographics were updated. Date and batch/lot number of vaccine were added.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient mentions that he has read online that there are other people who tinnitus has gotten worse after the vaccine or they had developed tinnitus after receiving the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Patient mentions that he has read online that there are other people who tinnitus has gotten worse after the vaccine or they had developed tinnitus after receiving the vaccine) 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 21-Jun-2021, the patient experienced TINNITUS (Patient mentions that he has read online that there are other people who tinnitus has gotten worse after the vaccine or they had developed tinnitus after receiving the vaccine). At the time of the report, TINNITUS (Patient mentions that he has read online that there are other people who tinnitus has gotten worse after the vaccine or they had developed tinnitus after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided. No lab data was provided by the reporter.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose, Wrong technique in device usage process
Clinical narrative: It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient; It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient; Syringe Connection Issue; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient), UNDERDOSE (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient) and DEVICE CONNECTION ISSUE (Syringe Connection Issue) in a 55-year-old female patient 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) (Intramuscular) 1 dosage form. On 20-Jun-2021, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient), UNDERDOSE (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient) and DEVICE CONNECTION ISSUE (Syringe Connection Issue). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient), UNDERDOSE (It looked like part of the dose came out of the shoulder or in the syringe upon administration of the vaccine to a patient) and DEVICE CONNECTION ISSUE (Syringe Connection Issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication was provided
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: When can I book my second shot when first shot was May 6; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (When can I book my second shot when first shot was May 6) 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 06-May-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 (When can I book my second shot when first shot was May 6). At the time of the report, PRODUCT DOSE OMISSION ISSUE (When can I book my second shot when first shot was May 6) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: sore everywhere/quite achy; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore everywhere/quite achy), HEADACHE (headaches) and CHILLS (chills) 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 MYALGIA (sore everywhere/quite achy), HEADACHE (headaches) and CHILLS (chills). At the time of the report, MYALGIA (sore everywhere/quite achy), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.            No concomitant medications were provided. No treatment details were provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Sluggishness, Vaccination site discomfort, Vaccination site pain
Clinical narrative: uncomfortable at injection site; half of my arm is red and spread out; sluggish; hot at injection site; swollen on injection site; felt sore on the injection site,; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (uncomfortable at injection site), ERYTHEMA (half of my arm is red and spread out), SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (hot at injection site) and VACCINATION SITE SWELLING (swollen on injection site) in a 62-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 was provided by the reporter.     On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE DISCOMFORT (uncomfortable at injection site), ERYTHEMA (half of my arm is red and spread out), SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE SWELLING (swollen on injection site), VACCINATION SITE PAIN (felt sore on the injection site,) and FATIGUE (tired). At the time of the report, VACCINATION SITE DISCOMFORT (uncomfortable at injection site), ERYTHEMA (half of my arm is red and spread out), SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE SWELLING (swollen on injection site), VACCINATION SITE PAIN (felt sore on the injection site,) and FATIGUE (tired) 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.   Concomitants included Thyroid medication.  No treatment information was provided.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: uncomfortable at injection site; half of my arm is red and spread out; sluggish; hot at injection site; swollen on injection site; felt sore on the injection site,; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (uncomfortable at injection site), ERYTHEMA (half of my arm is red and spread out), SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (hot at injection site) and VACCINATION SITE SWELLING (swollen on injection site) in a 62-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 was provided by the reporter.     On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced VACCINATION SITE DISCOMFORT (uncomfortable at injection site), ERYTHEMA (half of my arm is red and spread out), SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE SWELLING (swollen on injection site), VACCINATION SITE PAIN (felt sore on the injection site,) and FATIGUE (tired). At the time of the report, VACCINATION SITE DISCOMFORT (uncomfortable at injection site), ERYTHEMA (half of my arm is red and spread out), SLUGGISHNESS (sluggish), VACCINATION SITE WARMTH (hot at injection site), VACCINATION SITE SWELLING (swollen on injection site), VACCINATION SITE PAIN (felt sore on the injection site,) and FATIGUE (tired) 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.   Concomitants included Thyroid medication.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: I got Pfizer on my first dose due to lack of supply I'm getting Moderna for second dose; This spontaneous case was reported by a patient and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (I got Pfizer on my first dose due to lack of supply I'm getting Moderna for second 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, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (I got Pfizer on my first dose due to lack of supply I'm getting Moderna for second dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (I got Pfizer on my first dose due to lack of supply I'm getting Moderna for second dose) had resolved.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Somnolence, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot at the injection site; Felt off; Slept all day; Swelling at the injection site; tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), FEELING ABNORMAL (Felt off), SOMNOLENCE (Slept all day), VACCINATION SITE SWELLING (Swelling at the injection site) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 VACCINATION SITE WARMTH (Hot at the injection site), FEELING ABNORMAL (Felt off), SOMNOLENCE (Slept all day), VACCINATION SITE SWELLING (Swelling at the injection site) and FATIGUE (tired). At the time of the report, VACCINATION SITE WARMTH (Hot at the injection site), FEELING ABNORMAL (Felt off), SOMNOLENCE (Slept all day), VACCINATION SITE SWELLING (Swelling at the injection site) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: sore everywhere; with headaches; quite achy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (sore everywhere), HEADACHE (with headaches) and MYALGIA (quite achy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced MYALGIA (sore everywhere), HEADACHE (with headaches) and MYALGIA (quite achy). At the time of the report, MYALGIA (sore everywhere), HEADACHE (with headaches) and MYALGIA (quite achy) outcome was unknown.            Concomitant medication use was unknown Treatment information was unknown
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: she is not feeling well; she is really fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she is not feeling well) and FATIGUE (she is really fatigued) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 MALAISE (she is not feeling well) and FATIGUE (she is really fatigued). At the time of the report, MALAISE (she is not feeling well) and FATIGUE (she is really fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cyanosis, Erythema, Off label use, Pain in extremity, Pruritus
Clinical narrative: Patient was told by their health care provider to not get the second dose of the Moderna COVID-19 vaccine; Left arm soreness; Entire body swelling \ water weight\ arthritis feeling; Gained 5-10lbs.; Hands looked black/blue; Palms looked red; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), SWELLING (Entire body swelling \ water weight\ arthritis feeling), WEIGHT INCREASED (Gained 5-10lbs.), CYANOSIS (Hands looked black/blue) and ERYTHEMA (Palms looked red) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness), SWELLING (Entire body swelling \ water weight\ arthritis feeling), WEIGHT INCREASED (Gained 5-10lbs.), CYANOSIS (Hands looked black/blue), ERYTHEMA (Palms looked red) and PRURITUS (Itching). On an unknown date, the patient experienced OFF LABEL USE (Patient was told by their health care provider to not get the second dose of the Moderna COVID-19 vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency. On 23-Apr-2021, CYANOSIS (Hands looked black/blue), ERYTHEMA (Palms looked red) and PRURITUS (Itching) had resolved. On 24-Apr-2021, PAIN IN EXTREMITY (Left arm soreness) had resolved. On 05-May-2021, SWELLING (Entire body swelling \ water weight\ arthritis feeling) and WEIGHT INCREASED (Gained 5-10lbs.) had resolved. At the time of the report, OFF LABEL USE (Patient was told by their health care provider to not get the second dose of the Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Weight increased
Clinical narrative: Patient was told by their health care provider to not get the second dose of the Moderna COVID-19 vaccine; Left arm soreness; Entire body swelling \ water weight\ arthritis feeling; Gained 5-10lbs.; Hands looked black/blue; Palms looked red; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness), SWELLING (Entire body swelling \ water weight\ arthritis feeling), WEIGHT INCREASED (Gained 5-10lbs.), CYANOSIS (Hands looked black/blue) and ERYTHEMA (Palms looked red) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness), SWELLING (Entire body swelling \ water weight\ arthritis feeling), WEIGHT INCREASED (Gained 5-10lbs.), CYANOSIS (Hands looked black/blue), ERYTHEMA (Palms looked red) and PRURITUS (Itching). On an unknown date, the patient experienced OFF LABEL USE (Patient was told by their health care provider to not get the second dose of the Moderna COVID-19 vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Itching, at an unspecified dose and frequency. On 23-Apr-2021, CYANOSIS (Hands looked black/blue), ERYTHEMA (Palms looked red) and PRURITUS (Itching) had resolved. On 24-Apr-2021, PAIN IN EXTREMITY (Left arm soreness) had resolved. On 05-May-2021, SWELLING (Entire body swelling \ water weight\ arthritis feeling) and WEIGHT INCREASED (Gained 5-10lbs.) had resolved. At the time of the report, OFF LABEL USE (Patient was told by their health care provider to not get the second dose of the Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting every day/ Vomiting multiple times a day; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting every day/ Vomiting multiple times a day) 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 18-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting every day/ Vomiting multiple times a day). At the time of the report, VOMITING (Vomiting every day/ Vomiting multiple times a day) outcome was unknown.            Patient received the first dose on May-2021.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Potential 2nd dose given outside recommendation range; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Potential 2nd dose given outside recommendation range) 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 18-May-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 (Potential 2nd dose given outside recommendation range). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Potential 2nd dose given outside recommendation range) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not provided.  It was reported that the second vaccine was scheduled for June 15. Because patient had a procedure involving back on June 15, the physician who did the procedure said needed to wait two weeks after the procedure to receive the second dose. That would make the date of the second test June 29. Questioned if that too late to receive a second dose.
Sex: U
Vaccine: COVID19
Symptoms: Blood blister
Clinical narrative: blood blisters on the plams of my hands; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD BLISTER (blood blisters on the plams of my hands) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD BLISTER (blood blisters on the plams of my hands). At the time of the report, BLOOD BLISTER (blood blisters on the plams of my hands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications  were not reported  Treatment was not specified.  Patient started to get blood blisters on the palms of hands. Bloodwork and everything was normal.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: a little bit of cold; a slight rise of temperature; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (a little bit of cold) and PYREXIA (a slight rise of temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced NASOPHARYNGITIS (a little bit of cold) and PYREXIA (a slight rise of temperature). At the time of the report, NASOPHARYNGITIS (a little bit of cold) and PYREXIA (a slight rise of temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site rash
Clinical narrative: developed a rash on left arm; different arm due to rash on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (developed a rash on left arm) and PAIN IN EXTREMITY (different arm due to rash on the left arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PAIN IN EXTREMITY (different arm due to rash on the left arm). On 27-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE RASH (developed a rash on left arm). At the time of the report, VACCINATION SITE RASH (developed a rash on left arm) and PAIN IN EXTREMITY (different arm due to rash on the left arm) had not resolved.            No information about concomitants was provided. No information about treatment medication was provided.   This case was linked to c (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Myalgia
Clinical narrative: leg was burning all the time; red patches on my right leg; body was aching all over like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (leg was burning all the time), ERYTHEMA (red patches on my right leg) and MYALGIA (body was aching all over like I had the flu) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced BURNING SENSATION (leg was burning all the time), ERYTHEMA (red patches on my right leg) and MYALGIA (body was aching all over like I had the flu). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (leg was burning all the time), ERYTHEMA (red patches on my right leg) and MYALGIA (body was aching all over like I had the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: TCR : email obtained
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain, Vaccination site swelling
Clinical narrative: 15 year old patient received vaccine; The site where my 15 year old daughter is swollen; The site where my 15 year old daughter is tender; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received vaccine), VACCINATION SITE SWELLING (The site where my 15 year old daughter is swollen) and VACCINATION SITE PAIN (The site where my 15 year old daughter is tender) in a 15-year-old female patient 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received vaccine), VACCINATION SITE SWELLING (The site where my 15 year old daughter is swollen) and VACCINATION SITE PAIN (The site where my 15 year old daughter is tender). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received vaccine), VACCINATION SITE SWELLING (The site where my 15 year old daughter is swollen) and VACCINATION SITE PAIN (The site where my 15 year old daughter is tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.     Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccine trouble weeks after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine trouble weeks after second shot) 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 VACCINATION COMPLICATION (Vaccine trouble weeks after second shot). At the time of the report, VACCINATION COMPLICATION (Vaccine trouble weeks after second shot) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Product dose omission issue
Clinical narrative: cough; cold symptoms; second dose in the Moderna vaccination series was postponed/more than 60 days since the patient received the first Moderna 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 COUGH (cough), NASOPHARYNGITIS (cold symptoms) and PRODUCT DOSE OMISSION ISSUE (second dose in the Moderna vaccination series was postponed/more than 60 days since the patient received the first Moderna 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 20-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 COUGH (cough), NASOPHARYNGITIS (cold symptoms) and PRODUCT DOSE OMISSION ISSUE (second dose in the Moderna vaccination series was postponed/more than 60 days since the patient received the first Moderna dose). At the time of the report, COUGH (cough), NASOPHARYNGITIS (cold symptoms) and PRODUCT DOSE OMISSION ISSUE (second dose in the Moderna vaccination series was postponed/more than 60 days since the patient received the first Moderna dose) 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.   Description of Event or Problem:The HCP stated it has been more than 60 days since the patient received the first dose in the Moderna series   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Followup received contains no new information
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Malaise, Pyrexia
Clinical narrative: both shots of moderna without knowing that I was pregnant; feeling unwell; headache; fever; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (both shots of moderna without knowing that I was pregnant), MALAISE (feeling unwell   ), HEADACHE (headache) and PYREXIA (fever) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 12-Jun-2021, the patient experienced MALAISE (feeling unwell   ), HEADACHE (headache) and PYREXIA (fever). On 16-Jun-2021, the patient experienced EXPOSURE DURING PREGNANCY (both shots of moderna without knowing that I was pregnant). On 13-Jun-2021, PYREXIA (fever) had resolved. On 15-Jun-2021, MALAISE (feeling unwell   ) and HEADACHE (headache) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (both shots of moderna without knowing that I was pregnant) outcome was unknown.            It was reported that the patient should consult the doctor first, therefore could not provide the details of her LMP or due dates.  Concomitant medication information was not reported  Treatment information was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow up received on 21-JUN-2021 contains information regarding the chat between the consumer and the Moderna Assistance (Chatbot Follow up Information)
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: mild soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mild soreness in her arm) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tuberous sclerosis complex, Physical impairment (right side of patient is paralyzed,but she can walk) and Mental disability. Concomitant products included LAMOTRIGINE for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (mild soreness in her arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MYALGIA (mild soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: a rash in her upper body/a rash in her torso after the 2nd dose/ rash is still there, on  face, back, thighs, all in different places, it's getting better, but it hasn't disappeared; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a rash in her upper body/a rash in her torso after the 2nd dose/ rash is still there, on  face, back, thighs, all in different places, it's getting better, but it hasn't disappeared) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-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 RASH (a rash in her upper body/a rash in her torso after the 2nd dose/ rash is still there, on  face, back, thighs, all in different places, it's getting better, but it hasn't disappeared). The patient was treated with PREDNISONE for Rash, at a dose of UNK dosage form and HYDROXYZINE for Rash, at a dose of UNK dosage form. At the time of the report, RASH (a rash in her upper body/a rash in her torso after the 2nd dose/ rash is still there, on  face, back, thighs, all in different places, it's getting better, but it hasn't disappeared) outcome was unknown.            No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Additional1
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Dry skin, Lymphadenopathy, Pyrexia, Rash
Clinical narrative: Skin was  dry under his  arm; spots of  rashes under his both arms; fever; lymph node  behind ear was swelled up; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Skin was  dry under his  arm), RASH (spots of  rashes under his both arms), PYREXIA (fever) and LYMPHADENOPATHY (lymph node  behind ear was swelled up) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY SKIN (Skin was  dry under his  arm), RASH (spots of  rashes under his both arms), PYREXIA (fever) and LYMPHADENOPATHY (lymph node  behind ear was swelled up). At the time of the report, DRY SKIN (Skin was  dry under his  arm), RASH (spots of  rashes under his both arms), PYREXIA (fever) and LYMPHADENOPATHY (lymph node  behind ear was swelled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included as Medication for cancer.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received  contain no new information
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, Nausea, Oropharyngeal pain
Clinical narrative: coughing; sore throat; nausea; headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included Diabetic and Liver disorder.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-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 COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, COUGH (coughing), OROPHARYNGEAL PAIN (sore throat), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body aches) outcome was unknown.            No concomitant medications were reported.  The patient ?reported she was concerned she had COVID-19. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: feels hot to the touch; swelling on the injection site; redness on the injection site/has been getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (feels hot to the touch), VACCINATION SITE SWELLING (swelling on the injection site) and VACCINATION SITE ERYTHEMA (redness on the injection site/has been getting bigger) 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 20-Jun-2021, the patient experienced VACCINATION SITE WARMTH (feels hot to the touch), VACCINATION SITE SWELLING (swelling on the injection site) and VACCINATION SITE ERYTHEMA (redness on the injection site/has been getting bigger). At the time of the report, VACCINATION SITE WARMTH (feels hot to the touch), VACCINATION SITE SWELLING (swelling on the injection site) and VACCINATION SITE ERYTHEMA (redness on the injection site/has been getting bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. It was not reported if any treatment was administered in response to the events.   Reporter did not allow further contact