chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Myalgia, Peripheral swelling, Product dose omission issue, Skin warm
Clinical narrative: arm swelled up/almost like a baseball/It was humongous; arm was red; arm was inflamed; arm was hot; couldn't get up and walk; when she got up, she got dizzy; had sores on her face; her eye was almost shut because of the swelling; shingles in the left side of her face and left eye and it hurt; whole body started aching; More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot) and GAIT DISTURBANCE (couldn't get up and walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker. Concomitant products included IBUPROFEN and FEXOFENADINE HYDROCHLORIDE (CHILDREN'S ALLEGRA ALLERGY) for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot), GAIT DISTURBANCE (couldn't get up and walk), DIZZINESS (when she got up, she got dizzy), FACIAL PAIN (had sores on her face), SWELLING OF EYELID (her eye was almost shut because of the swelling), HERPES ZOSTER (shingles in the left side of her face and left eye and it hurt), MYALGIA (whole body started aching) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot), GAIT DISTURBANCE (couldn't get up and walk), DIZZINESS (when she got up, she got dizzy), FACIAL PAIN (had sores on her face), SWELLING OF EYELID (her eye was almost shut because of the swelling) and MYALGIA (whole body started aching) outcome was unknown and HERPES ZOSTER (shingles in the left side of her face and left eye and it hurt) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Inhaler..
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: arm swelled up/almost like a baseball/It was humongous; arm was red; arm was inflamed; arm was hot; couldn't get up and walk; when she got up, she got dizzy; had sores on her face; her eye was almost shut because of the swelling; shingles in the left side of her face and left eye and it hurt; whole body started aching; More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot) and GAIT DISTURBANCE (couldn't get up and walk) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker. Concomitant products included IBUPROFEN and FEXOFENADINE HYDROCHLORIDE (CHILDREN'S ALLEGRA ALLERGY) for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot), GAIT DISTURBANCE (couldn't get up and walk), DIZZINESS (when she got up, she got dizzy), FACIAL PAIN (had sores on her face), SWELLING OF EYELID (her eye was almost shut because of the swelling), HERPES ZOSTER (shingles in the left side of her face and left eye and it hurt), MYALGIA (whole body started aching) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PERIPHERAL SWELLING (arm swelled up/almost like a baseball/It was humongous), ERYTHEMA (arm was red), INFLAMMATION (arm was inflamed), SKIN WARM (arm was hot), GAIT DISTURBANCE (couldn't get up and walk), DIZZINESS (when she got up, she got dizzy), FACIAL PAIN (had sores on her face), SWELLING OF EYELID (her eye was almost shut because of the swelling) and MYALGIA (whole body started aching) outcome was unknown and HERPES ZOSTER (shingles in the left side of her face and left eye and it hurt) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Inhaler..
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash papular, Vaccination site erythema
Clinical narrative: Raised rash; red rash at injection site; tired; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Raised rash), VACCINATION SITE ERYTHEMA (red rash at injection site) and FATIGUE (tired) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced FATIGUE (tired). On 19-Aug-2021, the patient experienced RASH PAPULAR (Raised rash) and VACCINATION SITE ERYTHEMA (red rash at injection site). On 11-Aug-2021, FATIGUE (tired) had resolved. At the time of the report, RASH PAPULAR (Raised rash) and VACCINATION SITE ERYTHEMA (red rash at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No treatment medications were provided by reporter. No concomitant medications were provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Hypokinesia, Tachycardia
Clinical narrative: 28 hours straight of tachycardia/Heart rate did not go lower than a 100; cannot move; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (28 hours straight of tachycardia/Heart rate did not go lower than a 100) and HYPOKINESIA (cannot move) 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 TACHYCARDIA (28 hours straight of tachycardia/Heart rate did not go lower than a 100) and HYPOKINESIA (cannot move). At the time of the report, TACHYCARDIA (28 hours straight of tachycardia/Heart rate did not go lower than a 100) and HYPOKINESIA (cannot move) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: abnormal (High) Heart rate did not go lower than a 100.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had auto-inflammatory condition prior to vaccination.  No concomitant medications were provided by reporter.  No treatment details were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Pain
Clinical narrative: flu/cold symptoms; on and off sharp pain behind the sternum; lots of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu/cold symptoms), PAIN (on and off sharp pain behind the sternum) and FATIGUE (lots of fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced INFLUENZA (flu/cold symptoms), PAIN (on and off sharp pain behind the sternum) and FATIGUE (lots of fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA (flu/cold symptoms), PAIN (on and off sharp pain behind the sternum) and FATIGUE (lots of fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drugs were not provided.  Patient was due for her 2nd dose  on 19Aug2021 but the vaccine provider told her to call Moderna before they are able to give her the vaccine.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: My second Moderna Covid-19 vaccination made me very sleepy.; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (My second Moderna Covid-19 vaccination made me very sleepy.) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-1021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (My second Moderna Covid-19 vaccination made me very sleepy.). At the time of the report, SOMNOLENCE (My second Moderna Covid-19 vaccination made me very sleepy.) outcome was unknown.            No concomitant medication were provided by the reporter No treatment medication were provided by the reporter
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her left arm hurt for a while; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (her left arm hurt for a while) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (her left arm hurt for a while). At the time of the report, PAIN IN EXTREMITY (her left arm hurt for a while) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment information was mentioned.   This case was linked to MOD-2021-292149 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: eczema got worse; This spontaneous case was reported by an other health care professional and describes the occurrence of ECZEMA (eczema got worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (eczema got worse). At the time of the report, ECZEMA (eczema got worse) 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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Impaired driving ability, Pyrexia
Clinical narrative: Felt Weak  after second shot; Could not drive after second shot; Fever after second shot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt Weak  after second shot), IMPAIRED DRIVING ABILITY (Could not drive after second shot) and PYREXIA (Fever after second shot) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced ASTHENIA (Felt Weak  after second shot), IMPAIRED DRIVING ABILITY (Could not drive after second shot) and PYREXIA (Fever after second shot). On 12-Feb-2021, ASTHENIA (Felt Weak  after second shot), IMPAIRED DRIVING ABILITY (Could not drive after second shot) and PYREXIA (Fever after second shot) had resolved.            concomitant product was not provided treatment information was not provided   This case was linked to MOD-2021-292321 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Joint effusion, Product dose omission issue
Clinical narrative: 2 days later developed severe deactivation of my gout/polyarticular attack every 3-4 weeks; 2 days later developed severe deactivation of my gout with significant knee effusion; Did not receive second shot; This spontaneous case was reported by a physician and describes the occurrence of GOUT (2 days later developed severe deactivation of my gout/polyarticular attack every 3-4 weeks), JOINT EFFUSION (2 days later developed severe deactivation of my gout with significant knee effusion) and PRODUCT DOSE OMISSION ISSUE (Did not receive second shot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GOUT (2 days later developed severe deactivation of my gout/polyarticular attack every 3-4 weeks), JOINT EFFUSION (2 days later developed severe deactivation of my gout with significant knee effusion) and PRODUCT DOSE OMISSION ISSUE (Did not receive second shot). At the time of the report, GOUT (2 days later developed severe deactivation of my gout/polyarticular attack every 3-4 weeks) and JOINT EFFUSION (2 days later developed severe deactivation of my gout with significant knee effusion) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive second shot) 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.   No relevant concomitant medications were reported by reporter  2 days later developed severe deactivation of my gout with significant knee effusion that required needle aspiration twice along with polyarticular attack every 3-4 weeks  that was still ongoing despite traditional gout treatments.  Treatment information was not provided by reporter.      Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow up done and does not contain any significant information
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oral disorder, Oral pain, Vaccination site pain
Clinical narrative: makes you hurt your arm; Strange sore in my mouth; Not like a blister, just a peculiar little white bump; This spontaneous case was reported by an other health care professional and describes the occurrence of ORAL PAIN (Strange sore in my mouth), ORAL DISORDER (Not like a blister, just a peculiar little white bump) and VACCINATION SITE PAIN (makes you hurt your arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced ORAL PAIN (Strange sore in my mouth) and ORAL DISORDER (Not like a blister, just a peculiar little white bump). On 03-Aug-2021, the patient experienced VACCINATION SITE PAIN (makes you hurt your arm). On 05-Aug-2021, VACCINATION SITE PAIN (makes you hurt your arm) was resolving. At the time of the report, ORAL PAIN (Strange sore in my mouth) and ORAL DISORDER (Not like a blister, just a peculiar little white bump) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. No treatment medication was reported. Second dose scheduled for 30Aug2021.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: stomach ache; diarrhea; nausea; feel extremly tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), NAUSEA (nausea), FATIGUE (feel extremly tired) and HEADACHE (headache) 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 ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), NAUSEA (nausea), FATIGUE (feel extremly tired) and HEADACHE (headache). At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), NAUSEA (nausea), FATIGUE (feel extremly tired) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. Treatment information was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Formication, Paraesthesia
Clinical narrative: Started having tingling up and down his left arm; Feels like something is crawling up and down his left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Started having tingling up and down his left arm) and FORMICATION (Feels like something is crawling up and down his left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2020, the patient experienced PARAESTHESIA (Started having tingling up and down his left arm) and FORMICATION (Feels like something is crawling up and down his left arm). At the time of the report, PARAESTHESIA (Started having tingling up and down his left arm) and FORMICATION (Feels like something is crawling up and down his left arm) had not resolved.            No concomitant medications were reported.  Treatment information was not provided.  The patient had events after 2 weeks of his second shot of COVID-19 vaccine. Patient had seen his doctor and they don't know what's wrong.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chills, Decreased appetite, Malaise
Clinical narrative: Covid-19; chills; fever; weakness; heat of the day that evening did not make him feel well; do not want anything to eat; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MALAISE (heat of the day that evening did not make him feel well), DECREASED APPETITE (do not want anything to eat), COVID-19 (Covid-19) and CHILLS (chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced ASTHENIA (weakness), MALAISE (heat of the day that evening did not make him feel well), DECREASED APPETITE (do not want anything to eat), CHILLS (chills) and PYREXIA (fever). On 12-Aug-2021, the patient experienced COVID-19 (Covid-19). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), MALAISE (heat of the day that evening did not make him feel well), DECREASED APPETITE (do not want anything to eat), COVID-19 (Covid-19), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that the heat of the day that evening did not make him feel well  Concomitant product was not provided by the reporter  Treatment information was not provided
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Covid-19; chills; fever; weakness; heat of the day that evening did not make him feel well; do not want anything to eat; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), MALAISE (heat of the day that evening did not make him feel well), DECREASED APPETITE (do not want anything to eat), COVID-19 (Covid-19) and CHILLS (chills) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced ASTHENIA (weakness), MALAISE (heat of the day that evening did not make him feel well), DECREASED APPETITE (do not want anything to eat), CHILLS (chills) and PYREXIA (fever). On 12-Aug-2021, the patient experienced COVID-19 (Covid-19). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), MALAISE (heat of the day that evening did not make him feel well), DECREASED APPETITE (do not want anything to eat), COVID-19 (Covid-19), CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that the heat of the day that evening did not make him feel well  Concomitant product was not provided by the reporter  Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm; 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 PAIN IN EXTREMITY (had a sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had a sore arm). At the time of the report, PAIN IN EXTREMITY (had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not reported. The concomitant medication was not reported.   This case was linked to MOD-2021-292156 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Psoriasis, Rash, Rash pruritic
Clinical narrative: sometimes it itches, sometimes it does not; allergic reaction; has some psoriasis on the back and the sides of the ribs; like a rash all over the body, mostly in the lower legs, it's like circle light spots, they are like little round spots, the middle section is like dry. They spreaded in her arms also, but the ones on her legs can really be seen, they're pretty big; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (sometimes it itches, sometimes it does not), HYPERSENSITIVITY (allergic reaction), PSORIASIS (has some psoriasis on the back and the sides of the ribs) and RASH (like a rash all over the body, mostly in the lower legs, it's like circle light spots, they are like little round spots, the middle section is like dry. They spreaded in her arms also, but the ones on her legs can really be seen, they're pretty big,) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis (psoriasis since before this but only on the head, never in her body). Concomitant products included METFORMIN, ATORVASTATIN and ATENOLOL for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (sometimes it itches, sometimes it does not), HYPERSENSITIVITY (allergic reaction), PSORIASIS (has some psoriasis on the back and the sides of the ribs) and RASH (like a rash all over the body, mostly in the lower legs, it's like circle light spots, they are like little round spots, the middle section is like dry. They spreaded in her arms also, but the ones on her legs can really be seen, they're pretty big,). At the time of the report, RASH PRURITIC (sometimes it itches, sometimes it does not), HYPERSENSITIVITY (allergic reaction), PSORIASIS (has some psoriasis on the back and the sides of the ribs) and RASH (like a rash all over the body, mostly in the lower legs, it's like circle light spots, they are like little round spots, the middle section is like dry. They spreaded in her arms also, but the ones on her legs can really be seen, they're pretty big,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Patient noticed after dose started having rash all over body,mostly in the lower legs, circle light spots, On April  patient went to the doctor and confirmed it was an allergic reaction and gave some treatment for it.
Sex: U
Vaccine: COVID19
Symptoms: Limb mass, Papule, Peripheral swelling, Pruritus, Vaccination site erythema
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (My arm swelled up), LIMB MASS (I had a golf ball size knot), PRURITUS (My arm was itching for about 9 days), PAPULE (I got water pumps on the arm that I received the shot in / Water pumps on the arm) and VACCINATION SITE ERYTHEMA (My arm was red for about 9 days) 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 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (My arm swelled up), LIMB MASS (I had a golf ball size knot), PRURITUS (My arm was itching for about 9 days), PAPULE (I got water pumps on the arm that I received the shot in / Water pumps on the arm) and VACCINATION SITE ERYTHEMA (My arm was red for about 9 days). At the time of the report, PERIPHERAL SWELLING (My arm swelled up), LIMB MASS (I had a golf ball size knot), PRURITUS (My arm was itching for about 9 days), PAPULE (I got water pumps on the arm that I received the shot in / Water pumps on the arm) and VACCINATION SITE ERYTHEMA (My arm was red for about 9 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient stated that - Patient got water pumps on the arm that I received the shot in No concomitant medications provided. No treatment medications provided.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received both doses of the moderna vaccine 14 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses of the moderna vaccine 14 days apart) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027D21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses of the moderna vaccine 14 days apart). On 12-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received both doses of the moderna vaccine 14 days apart) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Follow up received included phone number and fax number of reporter was added.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills, Diarrhoea, Parosmia, Rhinorrhoea
Clinical narrative: Has been having problems with his sense of smell; Diarrhea is very very common/diarrhea just seems to be getting worse; Can't taste anything; Has a runny nose; Has slight chills; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Has been having problems with his sense of smell), DIARRHOEA (Diarrhea is very very common/diarrhea just seems to be getting worse), AGEUSIA (Can't taste anything), RHINORRHOEA (Has a runny nose) and CHILLS (Has slight chills) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L2CA) for COVID-19 vaccination.     Concurrent medical conditions included Spinal cord disorder (Cannot walk without a walker).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAROSMIA (Has been having problems with his sense of smell), DIARRHOEA (Diarrhea is very very common/diarrhea just seems to be getting worse), AGEUSIA (Can't taste anything), RHINORRHOEA (Has a runny nose) and CHILLS (Has slight chills). At the time of the report, PAROSMIA (Has been having problems with his sense of smell), DIARRHOEA (Diarrhea is very very common/diarrhea just seems to be getting worse), AGEUSIA (Can't taste anything), RHINORRHOEA (Has a runny nose) and CHILLS (Has slight chills) outcome was unknown.            Concomitant medications were not reported.  Treatment information was not provided by the reporter.  The week before reporting patient started to experience the adverse events. Normally Patient  is a warm body person and experience loss of taste and worsening of diarrhea  and running nose in the last over 6 weeks.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: More than 42 days for administration of the second dose; Daughter received Moderna shot at 16 years of age; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Daughter received Moderna shot at 16 years of age) and PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of the second dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Daughter received Moderna shot at 16 years of age). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of the second dose). On 02-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Daughter received Moderna shot at 16 years of age) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 42 days for administration of the second dose) had resolved.            No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Sluggishness
Clinical narrative: Sluggishness; fever; Chills; 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 SLUGGISHNESS (Sluggishness), PYREXIA (fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggishness), PYREXIA (fever) and CHILLS (Chills). At the time of the report, SLUGGISHNESS (Sluggishness), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.            Concomitant medications were not reported. Treatment information was  not provided.   This case was linked to MOD-2021-292140 (Patient Link).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Fatigue, Malaise, Product dose omission issue
Clinical narrative: Got wicked anxiety; Felt kind of sick; Freaked him out enough not to get the 2nd one; Tested positive for Covid Jun or Jul 13 2021; More than 35 days and hasn't received 2nd shot; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Got wicked anxiety), MALAISE (Felt kind of sick), VACCINATION COMPLICATION (Freaked him out enough not to get the 2nd one), COVID-19 (Tested positive for Covid Jun or Jul 13 2021) and PRODUCT DOSE OMISSION ISSUE (More than 35 days and hasn't received 2nd shot) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Got wicked anxiety), MALAISE (Felt kind of sick), VACCINATION COMPLICATION (Freaked him out enough not to get the 2nd one), COVID-19 (Tested positive for Covid Jun or Jul 13 2021), PRODUCT DOSE OMISSION ISSUE (More than 35 days and hasn't received 2nd shot) and FATIGUE (Really tired). At the time of the report, ANXIETY (Got wicked anxiety), MALAISE (Felt kind of sick), VACCINATION COMPLICATION (Freaked him out enough not to get the 2nd one), COVID-19 (Tested positive for Covid Jun or Jul 13 2021) and FATIGUE (Really tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days and hasn't received 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for Covid.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       No concomitant product information was provided.  Treatment information was not provided.  Patient tested positive for COVID-19 on 13-JUN-2021 or 13-JUL-2021 and not remember the exact date.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination complication
Clinical narrative: Got wicked anxiety; Felt kind of sick; Freaked him out enough not to get the 2nd one; Tested positive for Covid Jun or Jul 13 2021; More than 35 days and hasn't received 2nd shot; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Got wicked anxiety), MALAISE (Felt kind of sick), VACCINATION COMPLICATION (Freaked him out enough not to get the 2nd one), COVID-19 (Tested positive for Covid Jun or Jul 13 2021) and PRODUCT DOSE OMISSION ISSUE (More than 35 days and hasn't received 2nd shot) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Got wicked anxiety), MALAISE (Felt kind of sick), VACCINATION COMPLICATION (Freaked him out enough not to get the 2nd one), COVID-19 (Tested positive for Covid Jun or Jul 13 2021), PRODUCT DOSE OMISSION ISSUE (More than 35 days and hasn't received 2nd shot) and FATIGUE (Really tired). At the time of the report, ANXIETY (Got wicked anxiety), MALAISE (Felt kind of sick), VACCINATION COMPLICATION (Freaked him out enough not to get the 2nd one), COVID-19 (Tested positive for Covid Jun or Jul 13 2021) and FATIGUE (Really tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days and hasn't received 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for Covid.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       No concomitant product information was provided.  Treatment information was not provided.  Patient tested positive for COVID-19 on 13-JUN-2021 or 13-JUL-2021 and not remember the exact date.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Swelling around eyes; Lip swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lip swelling) and EYE SWELLING (Swelling around eyes) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced LIP SWELLING (Lip swelling). On an unknown date, the patient experienced EYE SWELLING (Swelling around eyes). At the time of the report, LIP SWELLING (Lip swelling) and EYE SWELLING (Swelling around eyes) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not  provided.  Patient's wife received first dose on 1Feb2021. Developed a severe headache and flu-like symptoms. Around June 4th she developed lip swelling and ended up in the emergency department. She developed lip swelling a second time and around her eyes. Wants to know about facial swelling   This case was linked to MOD-2021-292078 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Pyrexia, Tremor
Clinical narrative: had the shakes real bad; I had a fever of 104F; achy joints; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (had the shakes real bad), PYREXIA (I had a fever of 104F) and ARTHRALGIA (achy joints) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021. Concomitant products included METFORMIN, DILTIAZEM (CARDIZEM [DILTIAZEM]), FLECAINIDE and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced TREMOR (had the shakes real bad), PYREXIA (I had a fever of 104F) and ARTHRALGIA (achy joints). On 31-Jul-2021, TREMOR (had the shakes real bad), PYREXIA (I had a fever of 104F) and ARTHRALGIA (achy joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, Body temperature: 104 (High) fever of 104 degrees Fahrenheit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient scheduled for his 2nd dose on 23AUG2021.  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: bad cough / it progressively got worse / coughs more than before; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (bad cough / it progressively got worse / coughs more than before) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced COUGH (bad cough / it progressively got worse / coughs more than before). At the time of the report, COUGH (bad cough / it progressively got worse / coughs more than before) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported by reporter Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Hasn't had her second dose and is past the six week mark; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Hasn't had her second dose and is past the six week mark) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Hasn't had her second dose and is past the six week mark). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Hasn't had her second dose and is past the six week mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects last after the first injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects last after the first injection) 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 VACCINATION COMPLICATION (Side effects last after the first injection). At the time of the report, VACCINATION COMPLICATION (Side effects last after the first injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Had some soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Had some soreness at the injection site) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Had some soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (Had some soreness at the injection site) had resolved.            No concomitant medications were provided by reporter. No treatment details were provided by reporter. Patient did not get any side effects after the second dose.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Little lumps inside his forearms, calf muscle, and veins,some are small and some are the size of little socket holes; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Little lumps inside his forearms, calf muscle, and veins,some are small and some are the size of little socket holes) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced MASS (Little lumps inside his forearms, calf muscle, and veins,some are small and some are the size of little socket holes). At the time of the report, MASS (Little lumps inside his forearms, calf muscle, and veins,some are small and some are the size of little socket holes) had not resolved.            Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient was slim and could see the veins easily, he had seen 20-30 or more small lumps and he had never seen them there before. He noticed these small lumps look like blood clots. Some are small, and some are the size of little socket holes, or like filling bubble on the floor. It has been 6 months now since his vaccination. He's concerned whether these are blood clots.