chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness, Intentional product use issue, Product dose omission issue
Clinical narrative: They got sick; not able to receive the second dose on time; Because they got sick they were not able to receive the second dose at the appropriate time; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (They got sick), PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose on time) and INTENTIONAL PRODUCT USE ISSUE (Because they got sick they were not able to receive the second dose at the appropriate time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ILLNESS (They got sick), PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose on time) and INTENTIONAL PRODUCT USE ISSUE (Because they got sick they were not able to receive the second dose at the appropriate time). At the time of the report, ILLNESS (They got sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not able to receive the second dose on time) and INTENTIONAL PRODUCT USE ISSUE (Because they got sick they were not able to receive the second dose at the appropriate time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medicaitons are not provided. Treatment information does not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: health effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (health effects) 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 COMPLICATION (health effects). At the time of the report, VACCINATION COMPLICATION (health effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Head discomfort, Myalgia, Vaccination complication
Clinical narrative: Feeling terrible; Can not even hold head up; I get up and eat then go back to bed"; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling terrible), HEAD DISCOMFORT (Can not even hold head up), VACCINATION COMPLICATION (I get up and eat then go back to bed"), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced FEELING ABNORMAL (Feeling terrible), HEAD DISCOMFORT (Can not even hold head up), VACCINATION COMPLICATION (I get up and eat then go back to bed"), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, FEELING ABNORMAL (Feeling terrible), HEAD DISCOMFORT (Can not even hold head up), VACCINATION COMPLICATION (I get up and eat then go back to bed"), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) 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.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness, Pyrexia, Vaccination complication
Clinical narrative: got the vaccine and had a severe reaction to it; Immediately after having the vaccine had flu like symptoms/A flu-like reaction/Flu like symptoms lasted a couple days, 2 days; with a high temperature/ had a temperature of 104.5 for a couple of days; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (got the vaccine and had a severe reaction to it), INFLUENZA LIKE ILLNESS (Immediately after having the vaccine had flu like symptoms/A flu-like reaction/Flu like symptoms lasted a couple days, 2 days) and PYREXIA (with a high temperature/ had a temperature of 104.5 for a couple of days) 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 COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got the vaccine and had a severe reaction to it), INFLUENZA LIKE ILLNESS (Immediately after having the vaccine had flu like symptoms/A flu-like reaction/Flu like symptoms lasted a couple days, 2 days) and PYREXIA (with a high temperature/ had a temperature of 104.5 for a couple of days). At the time of the report, VACCINATION COMPLICATION (got the vaccine and had a severe reaction to it), INFLUENZA LIKE ILLNESS (Immediately after having the vaccine had flu like symptoms/A flu-like reaction/Flu like symptoms lasted a couple days, 2 days) and PYREXIA (with a high temperature/ had a temperature of 104.5 for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.5 (High) temperature of 104.5 for a couple of days.     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 medication was provided.  The reporter added that the patient is about 40 to 50 years  No treatment medication was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slightly sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Slightly sore left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0A50C21 and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 VACCINATION SITE PAIN (Slightly sore left arm). At the time of the report, VACCINATION SITE PAIN (Slightly sore left arm) outcome was unknown.            No concomitant medication information provided by the reporter.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: starting to have or feel like I am getting pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (starting to have or feel like I am getting pneumonia) 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 RESPIRATORY DISORDER (starting to have or feel like I am getting pneumonia). At the time of the report, RESPIRATORY DISORDER (starting to have or feel like I am getting pneumonia) 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.   Reporter did not allow further contact
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient has not received her 2nd dose in 52 days after her 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd dose in 52 days after her 1st dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd dose in 52 days after her 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received her 2nd dose in 52 days after her 1st dose) had resolved.            No Concomitant and Treatment medication was provided. Patient had scheduled Gall Bladder surgery on 15-SEP-2021
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: report an Adverse Event; 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 VACCINATION COMPLICATION (report an Adverse Event) 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 COMPLICATION (report an Adverse Event). At the time of the report, VACCINATION COMPLICATION (report an Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was provided NoTreatment medication was provided
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Hypersensitivity, Illness, Petechiae
Clinical narrative: Red spots all over the body (chest, neck, back); Legs are burning; itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation; was sick; headaches; severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), PRURITUS (itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation), PETECHIAE (Red spots all over the body (chest, neck, back)), BURNING SENSATION (Legs are burning) and ILLNESS (was sick) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (headaches). On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (was sick). On 03-Sep-2021, the patient experienced PRURITUS (itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation). On 13-Sep-2021, the patient experienced BURNING SENSATION (Legs are burning). On an unknown date, the patient experienced PETECHIAE (Red spots all over the body (chest, neck, back)). In August 2021, HEADACHE (headaches) had resolved. On 29-Aug-2021, ILLNESS (was sick) had resolved. At the time of the report, HYPERSENSITIVITY (severe allergic reaction), PRURITUS (itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation), PETECHIAE (Red spots all over the body (chest, neck, back)) and BURNING SENSATION (Legs are burning) outcome was unknown.            Concomitant medications included Cholesterol pills. No Treatment medications were reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Red spots all over the body (chest, neck, back); Legs are burning; itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation; was sick; headaches; severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction), PRURITUS (itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation), PETECHIAE (Red spots all over the body (chest, neck, back)), BURNING SENSATION (Legs are burning) and ILLNESS (was sick) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901 and 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (headaches). On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (was sick). On 03-Sep-2021, the patient experienced PRURITUS (itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation). On 13-Sep-2021, the patient experienced BURNING SENSATION (Legs are burning). On an unknown date, the patient experienced PETECHIAE (Red spots all over the body (chest, neck, back)). In August 2021, HEADACHE (headaches) had resolved. On 29-Aug-2021, ILLNESS (was sick) had resolved. At the time of the report, HYPERSENSITIVITY (severe allergic reaction), PRURITUS (itching and burning sensation/itching at the top of the head and goes down the body/burn itching sensation), PETECHIAE (Red spots all over the body (chest, neck, back)) and BURNING SENSATION (Legs are burning) outcome was unknown.            Concomitant medications included Cholesterol pills. No Treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Nasal discomfort
Clinical narrative: issues breathing; pressure in the chest; I have to breath through my mouth because I feel like I don't get enough oxygen when breathing through my nose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (issues breathing), CHEST DISCOMFORT (pressure in the chest) and NASAL DISCOMFORT (I have to breath through my mouth because I feel like I don't get enough oxygen when breathing through my nose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (issues breathing), CHEST DISCOMFORT (pressure in the chest) and NASAL DISCOMFORT (I have to breath through my mouth because I feel like I don't get enough oxygen when breathing through my nose). At the time of the report, DYSPNOEA (issues breathing), CHEST DISCOMFORT (pressure in the chest) and NASAL DISCOMFORT (I have to breath through my mouth because I feel like I don't get enough oxygen when breathing through my nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient does had COVID-19 history, nor myocarditis/pericarditis history.   No concomitant medication was provided.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Erythema, Gait disturbance
Clinical narrative: Wet with sweat; Weak; (Arm) was red; (Arm) was swollen; Joint Pain where I could hardly walk; Fever; Chills; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Wet with sweat), ASTHENIA (Weak), ERYTHEMA ((Arm) was red), PERIPHERAL SWELLING ((Arm) was swollen) and GAIT DISTURBANCE (Joint Pain where I could hardly walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2021. Concurrent medical conditions included Graves' disease.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced HYPERHIDROSIS (Wet with sweat), ASTHENIA (Weak), ERYTHEMA ((Arm) was red), PERIPHERAL SWELLING ((Arm) was swollen), GAIT DISTURBANCE (Joint Pain where I could hardly walk), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint Pain). On 28-Aug-2021, GAIT DISTURBANCE (Joint Pain where I could hardly walk), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint Pain) had resolved. At the time of the report, HYPERHIDROSIS (Wet with sweat), ASTHENIA (Weak), ERYTHEMA ((Arm) was red) and PERIPHERAL SWELLING ((Arm) was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Peripheral swelling, Pyrexia
Clinical narrative: Wet with sweat; Weak; (Arm) was red; (Arm) was swollen; Joint Pain where I could hardly walk; Fever; Chills; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Wet with sweat), ASTHENIA (Weak), ERYTHEMA ((Arm) was red), PERIPHERAL SWELLING ((Arm) was swollen) and GAIT DISTURBANCE (Joint Pain where I could hardly walk) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2021. Concurrent medical conditions included Graves' disease.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced HYPERHIDROSIS (Wet with sweat), ASTHENIA (Weak), ERYTHEMA ((Arm) was red), PERIPHERAL SWELLING ((Arm) was swollen), GAIT DISTURBANCE (Joint Pain where I could hardly walk), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint Pain). On 28-Aug-2021, GAIT DISTURBANCE (Joint Pain where I could hardly walk), PYREXIA (Fever), CHILLS (Chills) and ARTHRALGIA (Joint Pain) had resolved. At the time of the report, HYPERHIDROSIS (Wet with sweat), ASTHENIA (Weak), ERYTHEMA ((Arm) was red) and PERIPHERAL SWELLING ((Arm) was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: still sick from getting the COVID shot/side effects for 3 weeks; covid from a covid shot; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (still sick from getting the COVID shot/side effects for 3 weeks) and COVID-19 (covid from a covid shot) in a 20-year-old male 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 ILLNESS (still sick from getting the COVID shot/side effects for 3 weeks) and COVID-19 (covid from a covid shot). At the time of the report, ILLNESS (still sick from getting the COVID shot/side effects for 3 weeks) and COVID-19 (covid from a covid shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling in the shot area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling in the shot area) 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 SWELLING (swelling in the shot area). At the time of the report, VACCINATION SITE SWELLING (swelling in the shot area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided. No treatment medications are provided
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Arm pain/arm is hurting; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain/arm is hurting) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Sep-2021, the patient experienced VACCINATION SITE PAIN (Arm pain/arm is hurting) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm pain/arm is hurting) had not resolved and HEADACHE (headache) 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.   No concomitant medications was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Covid Arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (Covid Arm) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) 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 10-Sep-2021, the patient experienced VACCINATION SITE PAIN (Covid Arm). At the time of the report, VACCINATION SITE PAIN (Covid Arm) outcome was unknown. Not Provided      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 medication was reported.  No Treatment medication was reported.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue
Clinical narrative: Upset stomach; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach) and FATIGUE (Fatigue) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included Upset stomach. Concurrent medical conditions included Lactose intolerant.    On 23-Apr-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021 at 4:00 AM, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) and FATIGUE (Fatigue). On 26-Apr-2021, ABDOMINAL DISCOMFORT (Upset stomach) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication details were reported.  Patient  is taking Concomitant  medications since 01-01-2018. Following are the details : 1) Multivitamin (1 per day) - oral route, indication - To be healthy. 2) Calcium ( 300mg/1 per day) -  oral route, indication  -  Extra calcium  because I am  lactose intolerant. 3) iron (65mg/1 per day) - oral route, indication - Anemic. 4) Flaxseed Oil (1000mg/1 per day) - oral route, indication - Dry Eyes.   This case was linked to MOD-2021-314027 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination complication
Clinical narrative: super sleepy; Had the normal arm stuff; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (super sleepy) and VACCINATION COMPLICATION (Had the normal arm stuff) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-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 SOMNOLENCE (super sleepy) and VACCINATION COMPLICATION (Had the normal arm stuff). At the time of the report, SOMNOLENCE (super sleepy) and VACCINATION COMPLICATION (Had the normal arm stuff) outcome was unknown.      No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-320240 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Vaccination site pruritus, Vaccination site rash
Clinical narrative: my chest was a little bit heavy; big rash around the injection site/ round rash; it was very itchy; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (my chest was a little bit heavy), VACCINATION SITE RASH (big rash around the injection site/ round rash) and VACCINATION SITE PRURITUS (it was very itchy) 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 CHEST DISCOMFORT (my chest was a little bit heavy), VACCINATION SITE RASH (big rash around the injection site/ round rash) and VACCINATION SITE PRURITUS (it was very itchy). At the time of the report, CHEST DISCOMFORT (my chest was a little bit heavy), VACCINATION SITE RASH (big rash around the injection site/ round rash) and VACCINATION SITE PRURITUS (it was very itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment drugs were reported  Med Info Agent: I got the Moderna about 28 days ago. I called them because 8 days after receiving the first dose I had a very big round rash around the injection site. It was very itchy. I felt like my chest was a little bit heavy. Went to urgent care when rash appeared on my arm. Told me that before I get the second shot I should bring up this to the vaccination provider. She has called the vaccination provider who referred her to this number.  Caller disconnected prior to answering AE questions. Limited AE sent to safety.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: people are having the same symptoms as me; 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 VACCINATION COMPLICATION (people are having the same symptoms as me) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Meniere's disease.    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 COMPLICATION (people are having the same symptoms as me). At the time of the report, VACCINATION COMPLICATION (people are having the same symptoms as me) 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.  Treatment information was not provided.  Patient felt that people with Meniere's disease should not receive the vaccine.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Myocarditis
Clinical narrative: Myocarditis; Appetite was steadily going away; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDITIS (Myocarditis) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced DECREASED APPETITE (Appetite was steadily going away). On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). The patient was treated with METOPROLOL ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form; SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form; DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form; SPIRONOLACTONE ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form; FUROSEMIDE ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form; DIGOXIN ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form and WARFARIN ongoing since an unknown date for Myocarditis, at a dose of 1 dosage form. At the time of the report, MYOCARDITIS (Myocarditis) and DECREASED APPETITE (Appetite was steadily going away) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   While admitting in the hospital, patient had a right and left heart catheterization, a heart biopsy, MRI and PEt scan and results are unknown.  No relevant concomitant medications were reported.   Patient was given number of medications and treatment in the hospital and details of the treatment medications at hospital are unknown.  Company comment: This case concerns a 37-year-old male patient with no relevant medical history reported, who experienced myocarditis among other events. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The events were considered related to the product. The rechallenge was not applicable since the subject received 2nd dose. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.; Sender's Comments: This case concerns a 37-year-old male patient with no relevant medical history reported, who experienced myocarditis among other events. The event occurred on an unknown date after the second dose of Moderna COVID-19 Vaccine. The events were considered related to the product. The rechallenge was not applicable since the subject received 2nd dose. The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Developed a bruise (after 1st shot); This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Developed a bruise (after 1st shot)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for COPD.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced CONTUSION (Developed a bruise (after 1st shot)). On 08-Apr-2021, CONTUSION (Developed a bruise (after 1st shot)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-320769, MOD-2021-320770 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ascites, Muscle atrophy, Oedema peripheral, Skin striae, Weight increased
Clinical narrative: Developed ascites; It was gradual fluid buildup in the legs\ It was gradual fluid buildup in the feet; Gained about 5 to 10 pounds a month, Probably gained 30 pounds of water; Skin used to tight and it has started getting stretch marks; Lost a lot of her muscle mass in the last 20 days; This spontaneous case was reported by a consumer and describes the occurrence of ASCITES (Developed ascites) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 031620A and 002FZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASCITES (Developed ascites) (seriousness criterion medically significant), OEDEMA PERIPHERAL (It was gradual fluid buildup in the legs\ It was gradual fluid buildup in the feet), WEIGHT INCREASED (Gained about 5 to 10 pounds a month, Probably gained 30 pounds of water), SKIN STRIAE (Skin used to tight and it has started getting stretch marks) and MUSCLE ATROPHY (Lost a lot of her muscle mass in the last 20 days). At the time of the report, ASCITES (Developed ascites), OEDEMA PERIPHERAL (It was gradual fluid buildup in the legs\ It was gradual fluid buildup in the feet), WEIGHT INCREASED (Gained about 5 to 10 pounds a month, Probably gained 30 pounds of water), SKIN STRIAE (Skin used to tight and it has started getting stretch marks) and MUSCLE ATROPHY (Lost a lot of her muscle mass in the last 20 days) outcome was unknown.            Treatment information included paracentesis on 02-Sep-2021.  Company comment: This case concerns a  63 year-old female patient , who experienced the unexpected event of Ascites. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event of Ascites is Medically significant based on medical judgement and reported paracentesis.   This case was linked to MOD-2021-320732, MOD-2021-320770 (Patient Link).; Sender's Comments: This case concerns a  63 year-old female patient , who experienced the unexpected event of Ascites. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The event of Ascites is Medically significant based on medical judgement and reported paracentesis.
Sex: U
Vaccine: COVID19
Symptoms: Death, Product contamination
Clinical narrative: little pieces of steel found in the vials. Also said "flakes of rubber were found in one; three people died in; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (three people died) in a  patient of an unknown age and gender 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 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 DEATH (three people died in) (seriousness criteria death and medically significant) and PRODUCT CONTAMINATION (little pieces of steel found in the vials. Also said "flakes of rubber were found in one). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT CONTAMINATION (little pieces of steel found in the vials. Also said "flakes of rubber were found in one) had resolved.            Concomitant product was not provided by the reporter  Patient reported that that 3 people died after second dose of Moderna vaccine and stated it was not due to the vaccine but to the flakes of rubber and little pieces of steel found in the vaccine.  Treatment information was not provided  Action taken was not applicable.  Company comment This case concerns a patient of unknown age and gender who died after the second dose of the vaccine and also experienced non-serious event of product contamination. . Limited information. Dechallenge and rechallenge is unknown. The benefit-risk relationship is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender who died after the second dose of the vaccine and also experienced non-serious event of product contamination. . Limited information. Dechallenge and rechallenge is unknown. The benefit-risk relationship is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Extra dose administered, Injection site erythema, Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: PT received shot 9/10/21, says symptoms started on Friday 9/17/21, they are are ongoing to present day 9/21/21, pt has reddness 3-4 inches on the site of injection, along with blistering of skin, pt complains of pain/redness/ hot to touch/itchyness. This is the 3rd dose, had no issues with previous 2 doses.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: PT received shot 9/10/21, says symptoms started on Friday 9/17/21, they are are ongoing to present day 9/21/21, pt has reddness 3-4 inches on the site of injection, along with blistering of skin, pt complains of pain/redness/ hot to touch/itchyness. This is the 3rd dose, had no issues with previous 2 doses.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling, Mouth swelling, Sinus pain, Skin discolouration, Swelling face
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: PATIENT CALLED THE PHARMACY ON 9/20/21, STATING THAT SEVERAL DAYS EARLIER HE STARTED TO DEVELOP A LARGE SWOLLEN AREA, PURPLE COLORED ON HIS CHEEK, SEVERE SINUS AREA PAIN AND BLURRED VISION.  PT WAS REFERRED FOR IMMEDIATE ATTENTION.  UNKNOWN AT THIS TIME IF ISSUE IS DETERMINED TO BE VACCINE RELATED.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Swollen tongue, Vision blurred
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: PATIENT CALLED THE PHARMACY ON 9/20/21, STATING THAT SEVERAL DAYS EARLIER HE STARTED TO DEVELOP A LARGE SWOLLEN AREA, PURPLE COLORED ON HIS CHEEK, SEVERE SINUS AREA PAIN AND BLURRED VISION.  PT WAS REFERRED FOR IMMEDIATE ATTENTION.  UNKNOWN AT THIS TIME IF ISSUE IS DETERMINED TO BE VACCINE RELATED.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Computerised tomogram head normal, Electrocardiogram normal, Facial asymmetry, Hypoaesthesia
Clinical narrative: Patient received her second COVID-19 Moderna vaccination at 0941 today.  She remained in the Clinic for observation following the vaccination due to a very long list of allergies and a reported history of developing a headache, "organic taste in her mouth, like cut grass" and severe fatigue hours after receiving her first dose of COVID-19 Moderna vaccine on 8/18/2021.     Approximately 20 minutes following the vaccination patient developed tingling on the lower right side of her mouth.  She had an equal rise in her smile bilaterally.  This tingling progressed to numbness on the right side of her face extending to the right ear and up the side of her right eye.  Patient verbalized that she felt her lips were swelling but visually her lips did not look enlarged.  She repeated several times, "I just don't feel well"    The Emergency Medical Response Team was called.  Patient became progressively less responsive.  She continued to sit upright on the exam room couch.  She was not answering the paramedics questions and not following commands.  She was eased down on the exam room sofa.  An IV was started by the paramedics and patient was transported to ED.  Patient  gradually improved in the ED and was discharged from the ED on the same day of the vaccine reaction at  1409.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia eye, Lip swelling, Malaise, Paraesthesia oral, Specialist consultation
Clinical narrative: Patient received her second COVID-19 Moderna vaccination at 0941 today.  She remained in the Clinic for observation following the vaccination due to a very long list of allergies and a reported history of developing a headache, "organic taste in her mouth, like cut grass" and severe fatigue hours after receiving her first dose of COVID-19 Moderna vaccine on 8/18/2021.     Approximately 20 minutes following the vaccination patient developed tingling on the lower right side of her mouth.  She had an equal rise in her smile bilaterally.  This tingling progressed to numbness on the right side of her face extending to the right ear and up the side of her right eye.  Patient verbalized that she felt her lips were swelling but visually her lips did not look enlarged.  She repeated several times, "I just don't feel well"    The Emergency Medical Response Team was called.  Patient became progressively less responsive.  She continued to sit upright on the exam room couch.  She was not answering the paramedics questions and not following commands.  She was eased down on the exam room sofa.  An IV was started by the paramedics and patient was transported to ED.  Patient  gradually improved in the ED and was discharged from the ED on the same day of the vaccine reaction at  1409.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Vaccination complication
Clinical narrative: Patient received her second COVID-19 Moderna vaccination at 0941 today.  She remained in the Clinic for observation following the vaccination due to a very long list of allergies and a reported history of developing a headache, "organic taste in her mouth, like cut grass" and severe fatigue hours after receiving her first dose of COVID-19 Moderna vaccine on 8/18/2021.     Approximately 20 minutes following the vaccination patient developed tingling on the lower right side of her mouth.  She had an equal rise in her smile bilaterally.  This tingling progressed to numbness on the right side of her face extending to the right ear and up the side of her right eye.  Patient verbalized that she felt her lips were swelling but visually her lips did not look enlarged.  She repeated several times, "I just don't feel well"    The Emergency Medical Response Team was called.  Patient became progressively less responsive.  She continued to sit upright on the exam room couch.  She was not answering the paramedics questions and not following commands.  She was eased down on the exam room sofa.  An IV was started by the paramedics and patient was transported to ED.  Patient  gradually improved in the ED and was discharged from the ED on the same day of the vaccine reaction at  1409.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tachycardia, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Tachycardia-Mild
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure diastolic increased, Blood pressure systolic increased, Chills, Tremor
Clinical narrative: Elevated systolic and diastolic pressure well above normal range into the dangerous range. Chills and widespread shaking.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Injection site erythema
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after manufacturer beyond use date exceeded by 1 day (product expired on 9/8/21 and give on 9/9/21).  No ADRs noted by pt.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Breast discomfort, Breast pain, Lymphadenopathy
Clinical narrative: SEVERE AND SUDDEN ONSET OF SWELLING OF LYMPH NODE UNDER LEFT ARMPIT AND IN THE LEFT BREAST CAUSING EXTREME DISCOMFORT AND PAIN.   THIS REACTION DID NOT OCCUR WITH FIRST DOSE.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after manufacturer beyond use date exceeded by 2 days (product expired on 9/8/21 but was given on 9/10/21).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on arms, back, neck, legs, feet
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given after manufacturer beyond use date exceeded by 2 days (product expired on 9/8/21 but was given on 9/10/21).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Dyspnoea, Headache, Pain
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium