chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Mouth swelling, Oropharyngeal pain, Rash, Rash pruritic
Clinical narrative: Rash gets itchy and flares up and down; Rash still spreading; Developed rash from injection site to almost elbow / Rash still spreading; sore throat; mouth is swollen and feels like it is going down her throat; top lip went numb; sores on the roof of her mouth; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (top lip went numb), STOMATITIS (sores on the roof of her mouth), OROPHARYNGEAL PAIN (sore throat), MOUTH SWELLING (mouth is swollen and feels like it is going down her throat) and RASH PRURITIC (Rash gets itchy and flares up and down) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Coronavirus test positive in February 2021, Lichen planus and Biopsy.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced HYPOAESTHESIA ORAL (top lip went numb) and STOMATITIS (sores on the roof of her mouth). On 28-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and MOUTH SWELLING (mouth is swollen and feels like it is going down her throat). On 05-Jun-2021, the patient experienced RASH PRURITIC (Rash gets itchy and flares up and down), RASH (Rash still spreading) and VACCINATION SITE RASH (Developed rash from injection site to almost elbow / Rash still spreading). At the time of the report, HYPOAESTHESIA ORAL (top lip went numb), STOMATITIS (sores on the roof of her mouth), OROPHARYNGEAL PAIN (sore throat), MOUTH SWELLING (mouth is swollen and feels like it is going down her throat), RASH PRURITIC (Rash gets itchy and flares up and down), RASH (Rash still spreading) and VACCINATION SITE RASH (Developed rash from injection site to almost elbow / Rash still spreading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not specified. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Updated contact email address of the reporter. Added new events vaccination site rash, rash aggravated and itchy rash.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis, Vaccination site rash
Clinical narrative: Rash gets itchy and flares up and down; Rash still spreading; Developed rash from injection site to almost elbow / Rash still spreading; sore throat; mouth is swollen and feels like it is going down her throat; top lip went numb; sores on the roof of her mouth; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (top lip went numb), STOMATITIS (sores on the roof of her mouth), OROPHARYNGEAL PAIN (sore throat), MOUTH SWELLING (mouth is swollen and feels like it is going down her throat) and RASH PRURITIC (Rash gets itchy and flares up and down) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Coronavirus test positive in February 2021, Lichen planus and Biopsy.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced HYPOAESTHESIA ORAL (top lip went numb) and STOMATITIS (sores on the roof of her mouth). On 28-May-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) and MOUTH SWELLING (mouth is swollen and feels like it is going down her throat). On 05-Jun-2021, the patient experienced RASH PRURITIC (Rash gets itchy and flares up and down), RASH (Rash still spreading) and VACCINATION SITE RASH (Developed rash from injection site to almost elbow / Rash still spreading). At the time of the report, HYPOAESTHESIA ORAL (top lip went numb), STOMATITIS (sores on the roof of her mouth), OROPHARYNGEAL PAIN (sore throat), MOUTH SWELLING (mouth is swollen and feels like it is going down her throat), RASH PRURITIC (Rash gets itchy and flares up and down), RASH (Rash still spreading) and VACCINATION SITE RASH (Developed rash from injection site to almost elbow / Rash still spreading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not specified. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Updated contact email address of the reporter. Added new events vaccination site rash, rash aggravated and itchy rash.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: toes are very sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (toes are very sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) UNK dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (toes are very sore). At the time of the report, PAIN IN EXTREMITY (toes are very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications and treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Sciatica
Clinical narrative: he had sciatica after his shot; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (he had sciatica after his shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SCIATICA (he had sciatica after his shot). At the time of the report, SCIATICA (he had sciatica after his shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arrhythmia, Arthralgia, Headache, Heavy menstrual bleeding
Clinical narrative: Before the period starts, she had severe abdominal pain. She had to take pain killer to relieve the pain.; Flu like symptoms; Muscle pain; Joint pain; Headache; Heart palpitation; She started having her period, which includes excessive bleeding and clotting; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart palpitation) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting). On 29-Apr-2021, the patient experienced ARRHYTHMIA (Heart palpitation) (seriousness criterion medically significant), ABDOMINAL PAIN (Before the period starts, she had severe abdominal pain. She had to take pain killer to relieve the pain.), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ARRHYTHMIA (Heart palpitation), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Before the period starts, she had severe abdominal pain. She had to take pain killer to relieve the pain.), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She took Tylenol, which did not  work before taking Ibuprofen.  No concomitant medication information was provided.   This case was linked to MOD-2021-187152 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Before the period starts, she had severe abdominal pain. She had to take pain killer to relieve the pain.; Flu like symptoms; Muscle pain; Joint pain; Headache; Heart palpitation; She started having her period, which includes excessive bleeding and clotting; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart palpitation) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting). On 29-Apr-2021, the patient experienced ARRHYTHMIA (Heart palpitation) (seriousness criterion medically significant), ABDOMINAL PAIN (Before the period starts, she had severe abdominal pain. She had to take pain killer to relieve the pain.), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and INFLUENZA LIKE ILLNESS (Flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, ARRHYTHMIA (Heart palpitation), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Before the period starts, she had severe abdominal pain. She had to take pain killer to relieve the pain.), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She took Tylenol, which did not  work before taking Ibuprofen.  No concomitant medication information was provided.   This case was linked to MOD-2021-187152 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Electrocardiogram, Heart rate
Clinical narrative: sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cancer (throat cancer) on 01-May-2019. Concomitant products included TAMSULOSIN and FINASTERIDE for Enlarged prostate, XYLITOL (XYLIMELTS) for Mouth dry.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ARTHRALGIA (sore shoulder). On 28-May-2021, ARTHRALGIA (sore shoulder) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Electrocardiogram: abnormal (abnormal) premature atrial contraction. On 05-May-2021, Heart rate: low (Low) bradycardia was diagnosed more than 1 time and 36 (Inconclusive) The patient normal pulse rate is in the low 50s. On 27-May-2021, Heart rate: 47-48 (Inconclusive) 47-48,which is closer to his normal pulse rate.         No Treatment information was reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt bad; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (Felt bad) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included COVID-19.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 FEELING ABNORMAL (Felt bad). At the time of the report, FEELING ABNORMAL (Felt bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.  Patient was 18 year old had a difficult time with her first dose, and received her second dose,  She is feeling very badly after this dose also, low grade fever, fatigue, cold and hot, lethargic, and pain in the site that radiates to her arm and chest.  Also she did have COVID19 in late December   This case was linked to MOD-2021-186957 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: stomach upset; diarrhea; 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 ABDOMINAL DISCOMFORT (stomach upset) and DIARRHOEA (diarrhea) 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 ABDOMINAL DISCOMFORT (stomach upset) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (stomach upset) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: sleep a lot 9 sft; 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 HYPERSOMNIA (sleep a lot 9 sft) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (sleep a lot 9 sft). At the time of the report, HYPERSOMNIA (sleep a lot 9 sft) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use not provided.  Treatment information not provided
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick as a dog for 5 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick as a dog for 5 days after the 1st dose) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 ILLNESS (Sick as a dog for 5 days after the 1st dose). At the time of the report, ILLNESS (Sick as a dog for 5 days after the 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication was reported.  No treatment was reported.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Sore throat; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 29-May-2021, PYREXIA (Fever) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat) had not resolved.            Concomitant medications were not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: pain all over the body; fever; headache; tiredness; pain all over the body; tiredness; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN (pain all over the body), the second episode of PAIN (pain all over the body), the first episode of PYREXIA (fever), the second episode of PYREXIA (fever) and the first episode of HEADACHE (headache) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient medical history was not reported.  Concomitant products included VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced the first episode of PAIN (pain all over the body), the first episode of PYREXIA (fever), the first episode of HEADACHE (headache) and the first episode of FATIGUE (tiredness). On 28-May-2021, the patient experienced the second episode of PAIN (pain all over the body), the second episode of PYREXIA (fever) and the second episode of HEADACHE (headache). 28-May-2021, the patient experienced the second episode of FATIGUE (tiredness). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, last episode of PAIN (pain all over the body), the last episode of PYREXIA (fever), the last episode of HEADACHE (headache) and the last episode of FATIGUE (tiredness) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Illness, Pyrexia
Clinical narrative: I feel sick; headache; fever; 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 ILLNESS (I feel sick), HEADACHE (headache) and PYREXIA (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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (I feel sick), HEADACHE (headache) and PYREXIA (fever). At the time of the report, ILLNESS (I feel sick), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination complication
Clinical narrative: she developed a very bad reaction with itching and rash around her lower legs; she developed a very bad reaction with itching and rash around her lower legs; she developed a very bad reaction with itching and rash around her lower legs; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she developed a very bad reaction with itching and rash around her lower legs), PRURITUS (she developed a very bad reaction with itching and rash around her lower legs) and RASH (she developed a very bad reaction with itching and rash around her lower legs) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and CYCLOBENZAPRINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-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 VACCINATION COMPLICATION (she developed a very bad reaction with itching and rash around her lower legs), PRURITUS (she developed a very bad reaction with itching and rash around her lower legs) and RASH (she developed a very bad reaction with itching and rash around her lower legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; LORATADINE for Adverse event, at an unspecified dose and frequency; BETAMETHASONE for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE for Adverse event, at an unspecified dose and frequency; TRIAMTERENE for Adverse event, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (she developed a very bad reaction with itching and rash around her lower legs), PRURITUS (she developed a very bad reaction with itching and rash around her lower legs) and RASH (she developed a very bad reaction with itching and rash around her lower legs) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-187189 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Musculoskeletal chest pain, Myalgia, Neck pain
Clinical narrative: chills and can't stop shaking; neck and rib cage is so sore; chills and can't stop shaking; can't relax my body; neck and rib cage is so sore; arm was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was pretty sore), CHILLS (chills and can't stop shaking), FATIGUE (can't relax my body), NECK PAIN (neck and rib cage is so sore) and TREMOR (chills and can't stop shaking) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (arm was pretty sore). On 28-May-2021, the patient experienced CHILLS (chills and can't stop shaking), FATIGUE (can't relax my body) and NECK PAIN (neck and rib cage is so sore). On an unknown date, the patient experienced TREMOR (chills and can't stop shaking) and MUSCULOSKELETAL CHEST PAIN (neck and rib cage is so sore). At the time of the report, MYALGIA (arm was pretty sore), CHILLS (chills and can't stop shaking), FATIGUE (can't relax my body), NECK PAIN (neck and rib cage is so sore), TREMOR (chills and can't stop shaking) and MUSCULOSKELETAL CHEST PAIN (neck and rib cage is so sore) outcome was unknown.            No concomitant medication provided by the reporter no treatment information reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: chills and can't stop shaking; neck and rib cage is so sore; chills and can't stop shaking; can't relax my body; neck and rib cage is so sore; arm was pretty sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm was pretty sore), CHILLS (chills and can't stop shaking), FATIGUE (can't relax my body), NECK PAIN (neck and rib cage is so sore) and TREMOR (chills and can't stop shaking) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (arm was pretty sore). On 28-May-2021, the patient experienced CHILLS (chills and can't stop shaking), FATIGUE (can't relax my body) and NECK PAIN (neck and rib cage is so sore). On an unknown date, the patient experienced TREMOR (chills and can't stop shaking) and MUSCULOSKELETAL CHEST PAIN (neck and rib cage is so sore). At the time of the report, MYALGIA (arm was pretty sore), CHILLS (chills and can't stop shaking), FATIGUE (can't relax my body), NECK PAIN (neck and rib cage is so sore), TREMOR (chills and can't stop shaking) and MUSCULOSKELETAL CHEST PAIN (neck and rib cage is so sore) outcome was unknown.            No concomitant medication provided by the reporter no treatment information reported by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Cough, Decreased appetite, Feeling abnormal
Clinical narrative: Cough; Just sleeping in bed; no appetite; Sneezing; Feeling horrible; Body aches; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), BEDRIDDEN (Just sleeping in bed), DECREASED APPETITE (no appetite), SNEEZING (Sneezing) and FEELING ABNORMAL (Feeling horrible) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), BEDRIDDEN (Just sleeping in bed), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), FEELING ABNORMAL (Feeling horrible), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COUGH (Cough), BEDRIDDEN (Just sleeping in bed), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), FEELING ABNORMAL (Feeling horrible), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Sneezing
Clinical narrative: Cough; Just sleeping in bed; no appetite; Sneezing; Feeling horrible; Body aches; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), BEDRIDDEN (Just sleeping in bed), DECREASED APPETITE (no appetite), SNEEZING (Sneezing) and FEELING ABNORMAL (Feeling horrible) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough), BEDRIDDEN (Just sleeping in bed), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), FEELING ABNORMAL (Feeling horrible), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COUGH (Cough), BEDRIDDEN (Just sleeping in bed), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), FEELING ABNORMAL (Feeling horrible), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; 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 RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arrhythmia, Arthralgia, Headache, Heavy menstrual bleeding
Clinical narrative: Heart palpitation; Flu like symptoms; She started having her period, which includes excessive bleeding and clotting; Severe abdominal pain; Muscle pain; Joint pain; Headache; Fever; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (Heart palpitation), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Severe abdominal pain) and MYALGIA (Muscle pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced ARRHYTHMIA (Heart palpitation), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Severe abdominal pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, ARRHYTHMIA (Heart palpitation), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Severe abdominal pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            No treatment information was reported.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-187152 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Heart palpitation; Flu like symptoms; She started having her period, which includes excessive bleeding and clotting; Severe abdominal pain; Muscle pain; Joint pain; Headache; Fever; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (Heart palpitation), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Severe abdominal pain) and MYALGIA (Muscle pain) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced ARRHYTHMIA (Heart palpitation), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Severe abdominal pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, ARRHYTHMIA (Heart palpitation), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEAVY MENSTRUAL BLEEDING (She started having her period, which includes excessive bleeding and clotting), ABDOMINAL PAIN (Severe abdominal pain), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.            No treatment information was reported.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-187152 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Electrocardiogram, Heart rate, Heart rate irregular, Supraventricular extrasystoles
Clinical narrative: Heartbeats irregular; bradycardia; the monitor said I have premature atrial contraction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (bradycardia), SUPRAVENTRICULAR EXTRASYSTOLES (the monitor said I have premature atrial contraction) and HEART RATE IRREGULAR (Heartbeats irregular) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A.) for COVID-19 vaccination.     The patient's past medical history included Cancer on 01-May-2019. Concomitant products included XYLITOL (XYLIMELTS) for Dry mouth, TAMSULOSIN and FINASTERIDE for Enlarged prostate.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced BRADYCARDIA (bradycardia) and SUPRAVENTRICULAR EXTRASYSTOLES (the monitor said I have premature atrial contraction). On 16-Jun-2021, the patient experienced HEART RATE IRREGULAR (Heartbeats irregular). On 05-May-2021, BRADYCARDIA (bradycardia) and SUPRAVENTRICULAR EXTRASYSTOLES (the monitor said I have premature atrial contraction) had resolved. At the time of the report, HEART RATE IRREGULAR (Heartbeats irregular) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Electrocardiogram: abnormal (abnormal) premature atrial contraction. On 05-May-2021, Heart rate: low (Low) bradycardia was diagnosed more than 1 time and 36 (Low) The patient normal pulse rate is in the low 50s. On 27-May-2021, Heart rate: 47-48 (Inconclusive) 47-48,which is closer to his normal pulse rate.         Patient has historical condition of cancer which was treated with HCP radiation. Patient is using high fluoride toothpaste to not have infection in mouth due to patient's throat cancer. patient went in on 05MAY2021 for a 2-year follow-up of his throat cancer and was told that he was in remission. patient was admitted to ER had no other symptoms, so  was released from the Emergency Room.Patient had an appointment with cardiologist physiologist on 07MAY2021.The patient was asymptomatic so not treated with  any medication treatment for the event of low pulse rate.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-187134.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up added on 16-Jun-2021 included significant data: New event added. Reporter details updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Pyrexia
Clinical narrative: temperature of 101; 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 PYREXIA (temperature of 101) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (temperature of 101). At the time of the report, PYREXIA (temperature of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Body temperature: 101 (Inconclusive) temperature of 101. On 28-May-2021, Heart rate: 129 (High) rapid heart beat of 129.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Pyrexia, Sleep deficit
Clinical narrative: injection site itchy; not feeling well; headache/ slight headche; nausea; fever 100.5; pain at injection site; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (could not sleep), MALAISE (not feeling well), HEADACHE (headache/ slight headche), NAUSEA (nausea) and PYREXIA (fever 100.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced SLEEP DEFICIT (could not sleep). On 11-May-2021, the patient experienced HEADACHE (headache/ slight headche), NAUSEA (nausea), PYREXIA (fever 100.5) and VACCINATION SITE PAIN (pain at injection site). On 12-May-2021, the patient experienced MALAISE (not feeling well). On 13-May-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy). On 13-May-2021, SLEEP DEFICIT (could not sleep), MALAISE (not feeling well), HEADACHE (headache/ slight headche), NAUSEA (nausea), PYREXIA (fever 100.5), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE PRURITUS (injection site itchy) had resolved.            Treatment information was not provided. Concomitant product use was not provided. Lab data was not provided.   This case was linked to MOD-2021-089116 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 and does not contain any new information
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: injection site itchy; not feeling well; headache/ slight headche; nausea; fever 100.5; pain at injection site; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DEFICIT (could not sleep), MALAISE (not feeling well), HEADACHE (headache/ slight headche), NAUSEA (nausea) and PYREXIA (fever 100.5) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced SLEEP DEFICIT (could not sleep). On 11-May-2021, the patient experienced HEADACHE (headache/ slight headche), NAUSEA (nausea), PYREXIA (fever 100.5) and VACCINATION SITE PAIN (pain at injection site). On 12-May-2021, the patient experienced MALAISE (not feeling well). On 13-May-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy). On 13-May-2021, SLEEP DEFICIT (could not sleep), MALAISE (not feeling well), HEADACHE (headache/ slight headche), NAUSEA (nausea), PYREXIA (fever 100.5), VACCINATION SITE PAIN (pain at injection site) and VACCINATION SITE PRURITUS (injection site itchy) had resolved.            Treatment information was not provided. Concomitant product use was not provided. Lab data was not provided.   This case was linked to MOD-2021-089116 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow up received on 28-MAY-2021 and does not contain any new information
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-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 OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (sore throat) and PYREXIA (fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not reported. The reporter stated that the symptoms only lasted for a day or two and were not as bad as his symptoms from second dose.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Headache, Mobility decreased, Rash
Clinical narrative: Weak; Legs could not carry her; Looks like a sunburn; Rash; Itchy vaccine arm; Pain on the injection arm; Painful joints; Shooting pain in head; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), MOBILITY DECREASED (Legs could not carry her), SKIN DISCOLOURATION (Looks like a sunburn), RASH (Rash) and VACCINATION SITE PRURITUS (Itchy vaccine arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced ASTHENIA (Weak), MOBILITY DECREASED (Legs could not carry her), SKIN DISCOLOURATION (Looks like a sunburn), RASH (Rash), VACCINATION SITE PRURITUS (Itchy vaccine arm), VACCINATION SITE PAIN (Pain on the injection arm), ARTHRALGIA (Painful joints) and HEADACHE (Shooting pain in head). The patient was treated with CALAMINE for Itchy, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weak), MOBILITY DECREASED (Legs could not carry her), SKIN DISCOLOURATION (Looks like a sunburn), RASH (Rash), VACCINATION SITE PRURITUS (Itchy vaccine arm), ARTHRALGIA (Painful joints) and HEADACHE (Shooting pain in head) outcome was unknown and VACCINATION SITE PAIN (Pain on the injection arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include unspecified Thyroid medication  It was reported that patient felt pain is still on and off.   This case was linked to MOD-2021-222545 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information was received from initial reporter: reporter mail ID was added