chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Swelling
Clinical narrative: swelling in the armpit area; a little soreness on the arm; swelling of the lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling in the armpit area), PAIN IN EXTREMITY (a little soreness on the arm) and LYMPHADENOPATHY (swelling of the lymph nodes) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 04B21A) for COVID-19 vaccination.     Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), TRAZODONE and NORTRIPTYLINE for an unknown indication.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-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 SWELLING (swelling in the armpit area), PAIN IN EXTREMITY (a little soreness on the arm) and LYMPHADENOPATHY (swelling of the lymph nodes). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) at an unspecified dose and frequency; FAMOTIDINE at a dose of 21 mg and PREDNISONE at an unspecified dose and frequency. At the time of the report, SWELLING (swelling in the armpit area), PAIN IN EXTREMITY (a little soreness on the arm) and LYMPHADENOPATHY (swelling of the lymph nodes) outcome was unknown.            It was reported Birth control pill as concomitant medication.  No medical history of patient was reported by the reporter.   This case was linked to MOD-2022-445586, MOD-2022-445638 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: My booster vaccination is over 2 months of expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (My booster vaccination is over 2 months of expiration date) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (My booster vaccination is over 2 months of expiration date). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (My booster vaccination is over 2 months of expiration date) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) had not resolved.            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-154197 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: He is currently having a medical issue.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He is currently having a medical issue.) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 (He is currently having a medical issue.). At the time of the report, VACCINATION COMPLICATION (He is currently having a medical issue.) outcome was unknown. Not Provided          No Concomitant medication information was reported. No Treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Have been achy; Have a headache; Exhausted all day.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Have been achy), HEADACHE (Have a headache) and FATIGUE (Exhausted all 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 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Have been achy), HEADACHE (Have a headache) and FATIGUE (Exhausted all day.). At the time of the report, PAIN (Have been achy), HEADACHE (Have a headache) and FATIGUE (Exhausted all day.) outcome was unknown.            No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2022-445703 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Have been achy; Have a headache; Exhausted all day; Fever of 102.9; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Have been achy), PYREXIA (Fever of 102.9), HEADACHE (Have a headache) and FATIGUE (Exhausted all day) 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 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, the patient experienced PYREXIA (Fever of 102.9). On an unknown date, the patient experienced PAIN (Have been achy), HEADACHE (Have a headache) and FATIGUE (Exhausted all day). At the time of the report, PAIN (Have been achy), HEADACHE (Have a headache) and FATIGUE (Exhausted all day) outcome was unknown and PYREXIA (Fever of 102.9) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2022, Body temperature: 102.9 (High) 102.9.         No concomitant medications were provided.  No treatment medications were reported.  The patient got their Moderna booster shot last night.The patient have been achy, have a headache and exhausted all day. At the time of report the patient had a fever of 102.9.   This case was linked to MOD-2022-445693 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Palpitations, Tachycardia, Vaccination complication
Clinical narrative: severe reaction to the booster shot; heart started to race; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction to the booster shot), PALPITATIONS (heart started to race) and TACHYCARDIA (Tachycardia) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced PALPITATIONS (heart started to race) and TACHYCARDIA (Tachycardia). On an unknown date, the patient experienced VACCINATION COMPLICATION (severe reaction to the booster shot). On 08-Jan-2022, PALPITATIONS (heart started to race) and TACHYCARDIA (Tachycardia) had resolved. At the time of the report, VACCINATION COMPLICATION (severe reaction to the booster shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, Heart rate: 145/150 bpm (High) 145/150 bpm.         On the night of 07-Jan-2022, the patient's heart started to race and it took around 15 hours for the patient to return to the normal state.  No concomitant medication reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jan-2022: Significant Follow-up - adverse events like palpitation and tachycardia added
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Skin mass
Clinical narrative: very itchy; Have some bumps on my skin; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (very itchy) and SKIN MASS (Have some bumps on my skin) 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 PRURITUS (very itchy) and SKIN MASS (Have some bumps on my skin). At the time of the report, PRURITUS (very itchy) and SKIN MASS (Have some bumps on my skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported . The patient was very itchy and had some bumps on my skin.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Feeling hot, Malaise
Clinical narrative: a site reaction; felt different; she did not receive the second dose in the series.; tired; left arm was sore for 4 days; had a reaction to the first dose; left arm swelled from her elbow to shoulder; left arm red; left arm hot; dizzy for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a reaction to the first dose), PERIPHERAL SWELLING (left arm swelled from her elbow to shoulder), ERYTHEMA (left arm red), FEELING HOT (left arm hot) and VACCINATION SITE REACTION (a site reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION COMPLICATION (had a reaction to the first dose), PERIPHERAL SWELLING (left arm swelled from her elbow to shoulder), ERYTHEMA (left arm red), FEELING HOT (left arm hot) and PAIN IN EXTREMITY (left arm was sore for 4 days). On an unknown date, the patient experienced VACCINATION SITE REACTION (a site reaction), MALAISE (felt different), PRODUCT DOSE OMISSION ISSUE (she did not receive the second dose in the series.), DIZZINESS (dizzy for 4 days) and FATIGUE (tired). In April 2021, PAIN IN EXTREMITY (left arm was sore for 4 days) had resolved. At the time of the report, VACCINATION COMPLICATION (had a reaction to the first dose), PERIPHERAL SWELLING (left arm swelled from her elbow to shoulder), ERYTHEMA (left arm red), FEELING HOT (left arm hot), VACCINATION SITE REACTION (a site reaction), MALAISE (felt different) and FATIGUE (tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she did not receive the second dose in the series.) and DIZZINESS (dizzy for 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No Concomitant medication was reported.    No treatment medications were reported.  Patient stated that, she thinks she had a shift in the cellular blood cells.   This case was linked to MOD-2022-445279, MOD-2022-445950, MOD-2022-447065 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Product dose omission issue, Vaccination complication, Vaccination site reaction
Clinical narrative: a site reaction; felt different; she did not receive the second dose in the series.; tired; left arm was sore for 4 days; had a reaction to the first dose; left arm swelled from her elbow to shoulder; left arm red; left arm hot; dizzy for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a reaction to the first dose), PERIPHERAL SWELLING (left arm swelled from her elbow to shoulder), ERYTHEMA (left arm red), FEELING HOT (left arm hot) and VACCINATION SITE REACTION (a site reaction) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION COMPLICATION (had a reaction to the first dose), PERIPHERAL SWELLING (left arm swelled from her elbow to shoulder), ERYTHEMA (left arm red), FEELING HOT (left arm hot) and PAIN IN EXTREMITY (left arm was sore for 4 days). On an unknown date, the patient experienced VACCINATION SITE REACTION (a site reaction), MALAISE (felt different), PRODUCT DOSE OMISSION ISSUE (she did not receive the second dose in the series.), DIZZINESS (dizzy for 4 days) and FATIGUE (tired). In April 2021, PAIN IN EXTREMITY (left arm was sore for 4 days) had resolved. At the time of the report, VACCINATION COMPLICATION (had a reaction to the first dose), PERIPHERAL SWELLING (left arm swelled from her elbow to shoulder), ERYTHEMA (left arm red), FEELING HOT (left arm hot), VACCINATION SITE REACTION (a site reaction), MALAISE (felt different) and FATIGUE (tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she did not receive the second dose in the series.) and DIZZINESS (dizzy for 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No Concomitant medication was reported.    No treatment medications were reported.  Patient stated that, she thinks she had a shift in the cellular blood cells.   This case was linked to MOD-2022-445279, MOD-2022-445950, MOD-2022-447065 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Astrazeneca COVID-19 Vaccine (Both Dose 1 and Dose 2 was from  Astrazeneca). Past adverse reactions to the above products included No adverse event with Astrazeneca COVID-19 Vaccine.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) had not resolved.      After 48 hours, patient still have fever. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feel sick; This spontaneous case was reported by another health care professional and describes the occurrence of MALAISE (Feel sick) 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 05-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced MALAISE (Feel sick). At the time of the report, MALAISE (Feel sick) had not 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.   No Concomitant product use was reported.  The reporter stated that their son who was the patient took the shot on 05-Jan-2022, Wednesday night. And got up this morning on 07-Jan-2022, feeling sick and can smell.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Hurting in the shot area; Hurting in the hip area; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Hurting in the shot area) and ARTHRALGIA (Hurting in the hip 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 PAIN (Hurting in the shot area) and ARTHRALGIA (Hurting in the hip area). At the time of the report, VACCINATION SITE PAIN (Hurting in the shot area) and ARTHRALGIA (Hurting in the hip area) had not 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.   No concomitant medications were reported   No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Nasopharyngitis, Vaccination complication
Clinical narrative: Had all the reactions symptom just keeps going to get worse; Cold; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Had all the reactions symptom just keeps going to get worse) and NASOPHARYNGITIS (Cold) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had all the reactions symptom just keeps going to get worse) and NASOPHARYNGITIS (Cold). At the time of the report, VACCINATION COMPLICATION (Had all the reactions symptom just keeps going to get worse) and NASOPHARYNGITIS (Cold) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.  On Friday night at 5 o'clock patient got the Moderna booster and  by 2 AM patient  had all the reactions symptoms. It was reported that patient  took an home test (unspecified test)  and it was negative.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Musculoskeletal pain, Myalgia, Pyrexia
Clinical narrative: right side of my butt hurts like nerve wise; entire right side of my body is aching; fever without knowing I had a fever; some mental foggines; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL PAIN (right side of my butt hurts like nerve wise), FEELING ABNORMAL (some mental foggines), MYALGIA (entire right side of my body is aching) and PYREXIA (fever without knowing I had a fever) 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 09-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced FEELING ABNORMAL (some mental foggines) and PYREXIA (fever without knowing I had a fever). On 10-Jan-2022, the patient experienced MUSCULOSKELETAL PAIN (right side of my butt hurts like nerve wise) and MYALGIA (entire right side of my body is aching). At the time of the report, MUSCULOSKELETAL PAIN (right side of my butt hurts like nerve wise) and MYALGIA (entire right side of my body is aching) had not resolved and FEELING ABNORMAL (some mental foggines) and PYREXIA (fever without knowing I had a fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash/systemic rash localized in joints; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash/systemic rash localized in joints) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 028L20A and 010M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GUSELKUMAB (TREMFYA) for Psoriasis.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash/systemic rash localized in joints). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Rash, at a dose of every day. At the time of the report, RASH (Rash/systemic rash localized in joints) had not resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included: unspecified steroids
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Gait disturbance, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk; sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk; sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk; sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk; sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk), FEELING ABNORMAL (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk), GAIT DISTURBANCE (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk), MYALGIA (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk) and PYREXIA (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced PAIN IN EXTREMITY (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk), FEELING ABNORMAL (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk), GAIT DISTURBANCE (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk), MYALGIA (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk) and PYREXIA (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk). At the time of the report, PAIN IN EXTREMITY (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk), FEELING ABNORMAL (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk), GAIT DISTURBANCE (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk), MYALGIA (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk) and PYREXIA (sore arm, fever - not knowing i had a fever, fogginess, right side body aches a lot, difficulty walk) had not resolved.            No concomitant medications were reported No treatment medications were reported  It was reported that the seriousness of the side effect was unknown. The patient's weight reported in source document was 4 kg The patient's height reported in source document was 5 cm
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: I just receive my 3rd dose of Moderna and I am Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I just receive my 3rd dose of Moderna and I am Pregnant) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I just receive my 3rd dose of Moderna and I am Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I just receive my 3rd dose of Moderna and I am Pregnant) had resolved.            No concomitant and treatment medication details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Today the headache is bad; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Today the headache is bad) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced HEADACHE (Today the headache is bad). At the time of the report, HEADACHE (Today the headache is bad) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  No Treatment medication was provided.  Patient received booster on Thursday. And felt good on 09 Jan 2022, but at the time of this report the headache was bad.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of vaccination site warmth (redness at injection site is warm), vaccination site pruritus (redness at injection site is itchy) and vaccination site erythema (redness at injection site/red) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site warmth (redness at injection site is warm), vaccination site pruritus (redness at injection site is itchy) and vaccination site erythema (redness at injection site/red). At the time of the report, vaccination site warmth (redness at injection site is warm), vaccination site pruritus (redness at injection site is itchy) and vaccination site erythema (redness at injection site/red) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain, Urticaria
Clinical narrative: Hives/rashes like Hives; Body pains; Allergic reaction on my skin; This spontaneous case was reported by another health care professional and describes the occurrence of URTICARIA (Hives/rashes like Hives), PAIN (Body pains) and HYPERSENSITIVITY (Allergic reaction on my skin) 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 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives/rashes like Hives), PAIN (Body pains) and HYPERSENSITIVITY (Allergic reaction on my skin). At the time of the report, URTICARIA (Hives/rashes like Hives) and HYPERSENSITIVITY (Allergic reaction on my skin) had not resolved and PAIN (Body pains) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient experienced body pain for two to three days.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Maternal exposure during pregnancy
Clinical narrative: booster she received was expired/Expired booster dose; 7 months pregnant; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster she received was expired/Expired booster dose) and MATERNAL EXPOSURE DURING PREGNANCY (7 months pregnant) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster she received was expired/Expired booster dose) and MATERNAL EXPOSURE DURING PREGNANCY (7 months pregnant). At the time of the report, EXPIRED PRODUCT ADMINISTERED (booster she received was expired/Expired booster dose) and MATERNAL EXPOSURE DURING PREGNANCY (7 months pregnant) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported. No concomitant medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: skin rashes; This spontaneous case was reported by another health care professional and describes the occurrence of RASH (skin rashes) 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 RASH (skin rashes). At the time of the report, RASH (skin rashes) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction question; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (reaction question) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction question). At the time of the report, VACCINATION COMPLICATION (reaction question) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Rhinorrhoea
Clinical narrative: cold; congested; running nose; This spontaneous case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (cold), NASAL CONGESTION (congested) and RHINORRHOEA (running nose) 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 NASOPHARYNGITIS (cold), NASAL CONGESTION (congested) and RHINORRHOEA (running nose). At the time of the report, NASOPHARYNGITIS (cold), NASAL CONGESTION (congested) and RHINORRHOEA (running nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported.  Patient is due for second Moderna shot (near miss-delay).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Lethargy, Nausea
Clinical narrative: Diarrhea; Lethargy; Queasy stomach; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), LETHARGY (Lethargy) and NAUSEA (Queasy stomach) in a patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced DIARRHOEA (Diarrhea), LETHARGY (Lethargy) and NAUSEA (Queasy stomach). At the time of the report, DIARRHOEA (Diarrhea), LETHARGY (Lethargy) and NAUSEA (Queasy stomach) had not resolved.        For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination complication
Clinical narrative: When the general side effects list was read, he said the only thing he did not have was nausea or vomiting/ had symptoms and they went away; Freezing with chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (When the general side effects list was read, he said the only thing he did not have was nausea or vomiting/ had symptoms and they went away) and CHILLS (Freezing with chills) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 93H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced CHILLS (Freezing with chills). On an unknown date, the patient experienced VACCINATION COMPLICATION (When the general side effects list was read, he said the only thing he did not have was nausea or vomiting/ had symptoms and they went away). At the time of the report, VACCINATION COMPLICATION (When the general side effects list was read, he said the only thing he did not have was nausea or vomiting/ had symptoms and they went away) and CHILLS (Freezing with chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient had symptoms and they went away but on 10-Jan-2022, the patient woke up freezing with chills. When the agent read general side effects list, the patient said the only thing the patient did not have was nausea or vomiting and said the patient never loses their appetite.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Follow-up received contains No new information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired booster dose; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 047A21A and 034B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine was expired on 22 December 2021. The vial was initially stored in the refrigerator on 06 January 2022. The vial did not undergo any temperature excursions. No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-447243 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Illness, Pyrexia, Scan brain, Tinnitus
Clinical narrative: ringing in his right ear ever since/ringing is so bad that he will get up in the night and think it's a phone.; upset stomach; really sick.; he got a fever,; This spontaneous case was reported by a non-health professional and describes the occurrence of TINNITUS (ringing in his right ear ever since/ringing is so bad that he will get up in the night and think it's a phone.), ABDOMINAL DISCOMFORT (upset stomach), ILLNESS (really sick.) and PYREXIA (he got a fever,) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced TINNITUS (ringing in his right ear ever since/ringing is so bad that he will get up in the night and think it's a phone.), ABDOMINAL DISCOMFORT (upset stomach), ILLNESS (really sick.) and PYREXIA (he got a fever,). At the time of the report, TINNITUS (ringing in his right ear ever since/ringing is so bad that he will get up in the night and think it's a phone.) had not resolved and ABDOMINAL DISCOMFORT (upset stomach), ILLNESS (really sick.) and PYREXIA (he got a fever,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Scan brain: everything was clear (normal) everything was clear.         Treatment information was not provided. Medical history was not provided by the reporter. Patient weight is 142.   This case was linked to MOD-2022-447286 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Exposed to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID-19) in a 90-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 EXPOSURE TO SARS-COV-2 (Exposed to COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID-19) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  It was reported that patient's son was exposed and tested positive for COVID-19 and she was exposed to her son.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Urticaria
Clinical narrative: Severe hives; Sleep of one hour a day; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Severe hives) and INSOMNIA (Sleep of one hour a day) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Dec-2021, the patient 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 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 06-Jan-2022, the patient experienced URTICARIA (Severe hives) and INSOMNIA (Sleep of one hour a day). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and FAMOTIDINE for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Severe hives) and INSOMNIA (Sleep of one hour a day) outcome was unknown.            No concomitant medications reported by reporter  Patient stated that last Thursday, he experienced severe hives and added he only gets one hour of sleep a day. He went to a walk-in clinic for a check-up and he was given Prednisone and Famotidine.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: reaction to the Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the Moderna booster) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the Moderna booster). At the time of the report, VACCINATION COMPLICATION (reaction to the Moderna booster) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) 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 EXPIRED PRODUCT ADMINISTERED (Expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine had expired on 23-Dec-2021 No concomitant medication were provided. No treatment information were given.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Malaise, Peripheral swelling
Clinical narrative: She has not been doing good; Experiencing a growth near her right arm and under her arm at the site of injection; Experiencing a growth near her right arm and under her arm at the site of injection; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (She has not been doing good), PERIPHERAL SWELLING (Experiencing a growth near her right arm and under her arm at the site of injection) and AXILLARY MASS (Experiencing a growth near her right arm and under her arm at the site of injection) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced MALAISE (She has not been doing good), PERIPHERAL SWELLING (Experiencing a growth near her right arm and under her arm at the site of injection) and AXILLARY MASS (Experiencing a growth near her right arm and under her arm at the site of injection). At the time of the report, MALAISE (She has not been doing good), PERIPHERAL SWELLING (Experiencing a growth near her right arm and under her arm at the site of injection) and AXILLARY MASS (Experiencing a growth near her right arm and under her arm at the site of injection) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication list was not known to the reporter.