chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Gait disturbance, Inappropriate schedule of product administration, Inflammation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose after 90 days), BACK PAIN (Back pain), MALAISE (Malaise), PERIPHERAL SWELLING (Swelling on her right arm and hand/Swelling on her right leg) and GAIT DISTURBANCE (difficulty to walk due the inflammation on her leg) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose after 90 days), BACK PAIN (Back pain), MALAISE (Malaise), PERIPHERAL SWELLING (Swelling on her right arm and hand/Swelling on her right leg), GAIT DISTURBANCE (difficulty to walk due the inflammation on her leg), INFLAMMATION (difficulty to walk due the inflammation on her leg), VOMITING (nausea and Vomiting), FATIGUE (Very tired) and NAUSEA (Nausea and vomiting). The patient was treated with POTASSIUM CHLORIDE (KLOR-CON M20) at a dose of 1 dosage form and FUROSEMIDE at a dose of 1 dosage form. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose after 90 days), BACK PAIN (Back pain), MALAISE (Malaise), PERIPHERAL SWELLING (Swelling on her right arm and hand/Swelling on her right leg), GAIT DISTURBANCE (difficulty to walk due the inflammation on her leg), INFLAMMATION (difficulty to walk due the inflammation on her leg), VOMITING (nausea and Vomiting), FATIGUE (Very tired) and NAUSEA (Nausea and vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Peripheral swelling, Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose after 90 days), BACK PAIN (Back pain), MALAISE (Malaise), PERIPHERAL SWELLING (Swelling on her right arm and hand/Swelling on her right leg) and GAIT DISTURBANCE (difficulty to walk due the inflammation on her leg) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose after 90 days), BACK PAIN (Back pain), MALAISE (Malaise), PERIPHERAL SWELLING (Swelling on her right arm and hand/Swelling on her right leg), GAIT DISTURBANCE (difficulty to walk due the inflammation on her leg), INFLAMMATION (difficulty to walk due the inflammation on her leg), VOMITING (nausea and Vomiting), FATIGUE (Very tired) and NAUSEA (Nausea and vomiting). The patient was treated with POTASSIUM CHLORIDE (KLOR-CON M20) at a dose of 1 dosage form and FUROSEMIDE at a dose of 1 dosage form. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose after 90 days), BACK PAIN (Back pain), MALAISE (Malaise), PERIPHERAL SWELLING (Swelling on her right arm and hand/Swelling on her right leg), GAIT DISTURBANCE (difficulty to walk due the inflammation on her leg), INFLAMMATION (difficulty to walk due the inflammation on her leg), VOMITING (nausea and Vomiting), FATIGUE (Very tired) and NAUSEA (Nausea and vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side affects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side affects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side affects). At the time of the report, VACCINATION COMPLICATION (side affects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided. Treatment information was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Ear pain, Headache, Intentional dose omission
Clinical narrative: throat pain; Hard to swallow; food feels like it goes to sinus cavity; late for second dose and will not be getting it; dizziness; headache; ear pain; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear pain), OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (Hard to swallow), INTENTIONAL DOSE OMISSION (late for second dose and will not be getting it) and NASAL DISCOMFORT (food feels like it goes to sinus cavity) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced EAR PAIN (ear pain), DIZZINESS (dizziness) and HEADACHE (headache). On 26-May-2021, the patient experienced INTENTIONAL DOSE OMISSION (late for second dose and will not be getting it). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (Hard to swallow) and NASAL DISCOMFORT (food feels like it goes to sinus cavity). The patient was treated with PANTOPRAZOLE ongoing since an unknown date at an unspecified dose and frequency. On 26-May-2021, INTENTIONAL DOSE OMISSION (late for second dose and will not be getting it) had resolved. At the time of the report, EAR PAIN (ear pain), OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (Hard to swallow), NASAL DISCOMFORT (food feels like it goes to sinus cavity), DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal discomfort, Oropharyngeal pain
Clinical narrative: throat pain; Hard to swallow; food feels like it goes to sinus cavity; late for second dose and will not be getting it; dizziness; headache; ear pain; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear pain), OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (Hard to swallow), INTENTIONAL DOSE OMISSION (late for second dose and will not be getting it) and NASAL DISCOMFORT (food feels like it goes to sinus cavity) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced EAR PAIN (ear pain), DIZZINESS (dizziness) and HEADACHE (headache). On 26-May-2021, the patient experienced INTENTIONAL DOSE OMISSION (late for second dose and will not be getting it). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (Hard to swallow) and NASAL DISCOMFORT (food feels like it goes to sinus cavity). The patient was treated with PANTOPRAZOLE ongoing since an unknown date at an unspecified dose and frequency. On 26-May-2021, INTENTIONAL DOSE OMISSION (late for second dose and will not be getting it) had resolved. At the time of the report, EAR PAIN (ear pain), OROPHARYNGEAL PAIN (throat pain), DYSPHAGIA (Hard to swallow), NASAL DISCOMFORT (food feels like it goes to sinus cavity), DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: extremely sore arm; Acute body ache; Nausea; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extremely sore arm), PAIN (Acute body ache), NAUSEA (Nausea) and PYREXIA (Fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Nasal Swab test) on 20-Jun-2020. Concurrent medical conditions included Sinus disorder (Severe sinus) since 07-Dec-2020, Fever since 07-Dec-2020, COPD, Thyroid disorder NOS (Thyroid), Gastrointestinal disorder NOS (Esophagus), Gastrointestinal disorder NOS (Stomach), Sinus congestion (Congested everyday), Contrast media allergy (Contrast dye) and Drug allergy (Prednisone). Concomitant products included LEVOTHYROXINE and OMEPRAZOLE for an unknown indication.   On 10-Feb-2021 at 9:20 AM, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (extremely sore arm), PAIN (Acute body ache), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (extremely sore arm), PAIN (Acute body ache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2020, SARS-CoV-2 test: positive Nasal Swab.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-033001 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: arm was really sore after 1st dose; discomfort from head and neck down to shoulder; discomfort from head and neck down to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore after 1st dose), HEAD DISCOMFORT (discomfort from head and neck down to shoulder) and MUSCULOSKELETAL DISCOMFORT (discomfort from head and neck down to shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No medication history was provided.  Concomitant products included METFORMIN for an unknown indication.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was really sore after 1st dose), HEAD DISCOMFORT (discomfort from head and neck down to shoulder) and MUSCULOSKELETAL DISCOMFORT (discomfort from head and neck down to shoulder). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. On 27-Apr-2021, HEAD DISCOMFORT (discomfort from head and neck down to shoulder) and MUSCULOSKELETAL DISCOMFORT (discomfort from head and neck down to shoulder) had resolved. On 08-May-2021, PAIN IN EXTREMITY (arm was really sore after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm still hurt this long after the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Arm still hurt this long after the shot). At the time of the report, MYALGIA (Arm still hurt this long after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided  Treatment medication was not provided
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dysphagia, Dyspnoea, Feeling hot, Mouth swelling
Clinical narrative: severe dry itchy chin; Difficulty in breathing; Difficulty  swallowing; chest tightness; Feeling hot; Sensation of throat closing; Tingling; swollen tongue; Mouth was swollen; Mouth was itchy; Mouth was red; Tingling sensation from her neck up and down her mouth and throat; Jaw was tightened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOUTH SWELLING (Mouth was swollen), ORAL PRURITUS (Mouth was itchy), ORAL MUCOSAL ERYTHEMA (Mouth was red), PARAESTHESIA (Tingling sensation from her neck up and down her mouth and throat) and MUSCLE TIGHTNESS (Jaw was tightened) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MOUTH SWELLING (Mouth was swollen), ORAL PRURITUS (Mouth was itchy), ORAL MUCOSAL ERYTHEMA (Mouth was red) and PARAESTHESIA (Tingling sensation from her neck up and down her mouth and throat). 07-Apr-2021, the patient experienced MUSCLE TIGHTNESS (Jaw was tightened). On an unknown date, the patient experienced CONDITION AGGRAVATED (Symptoms were bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of Hgh dose. At the time of the report, MOUTH SWELLING (Mouth was swollen), ORAL PRURITUS (Mouth was itchy), ORAL MUCOSAL ERYTHEMA (Mouth was red), PARAESTHESIA (Tingling sensation from her neck up and down her mouth and throat) and MUSCLE TIGHTNESS (Jaw was tightened) had not resolved and CONDITION AGGRAVATED (Symptoms were bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Pepcid.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Oral mucosal erythema, Oral pruritus, Oropharyngeal discomfort, Paraesthesia
Clinical narrative: severe dry itchy chin; Difficulty in breathing; Difficulty  swallowing; chest tightness; Feeling hot; Sensation of throat closing; Tingling; swollen tongue; Mouth was swollen; Mouth was itchy; Mouth was red; Tingling sensation from her neck up and down her mouth and throat; Jaw was tightened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOUTH SWELLING (Mouth was swollen), ORAL PRURITUS (Mouth was itchy), ORAL MUCOSAL ERYTHEMA (Mouth was red), PARAESTHESIA (Tingling sensation from her neck up and down her mouth and throat) and MUSCLE TIGHTNESS (Jaw was tightened) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MOUTH SWELLING (Mouth was swollen), ORAL PRURITUS (Mouth was itchy), ORAL MUCOSAL ERYTHEMA (Mouth was red) and PARAESTHESIA (Tingling sensation from her neck up and down her mouth and throat). 07-Apr-2021, the patient experienced MUSCLE TIGHTNESS (Jaw was tightened). On an unknown date, the patient experienced CONDITION AGGRAVATED (Symptoms were bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of Hgh dose. At the time of the report, MOUTH SWELLING (Mouth was swollen), ORAL PRURITUS (Mouth was itchy), ORAL MUCOSAL ERYTHEMA (Mouth was red), PARAESTHESIA (Tingling sensation from her neck up and down her mouth and throat) and MUSCLE TIGHTNESS (Jaw was tightened) had not resolved and CONDITION AGGRAVATED (Symptoms were bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Pepcid.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swollen tongue
Clinical narrative: severe dry itchy chin; Difficulty in breathing; Difficulty  swallowing; chest tightness; Feeling hot; Sensation of throat closing; Tingling; swollen tongue; Mouth was swollen; Mouth was itchy; Mouth was red; Tingling sensation from her neck up and down her mouth and throat; Jaw was tightened; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MOUTH SWELLING (Mouth was swollen), ORAL PRURITUS (Mouth was itchy), ORAL MUCOSAL ERYTHEMA (Mouth was red), PARAESTHESIA (Tingling sensation from her neck up and down her mouth and throat) and MUSCLE TIGHTNESS (Jaw was tightened) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included BUPROPION for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced MOUTH SWELLING (Mouth was swollen), ORAL PRURITUS (Mouth was itchy), ORAL MUCOSAL ERYTHEMA (Mouth was red) and PARAESTHESIA (Tingling sensation from her neck up and down her mouth and throat). 07-Apr-2021, the patient experienced MUSCLE TIGHTNESS (Jaw was tightened). On an unknown date, the patient experienced CONDITION AGGRAVATED (Symptoms were bad). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of Hgh dose. At the time of the report, MOUTH SWELLING (Mouth was swollen), ORAL PRURITUS (Mouth was itchy), ORAL MUCOSAL ERYTHEMA (Mouth was red), PARAESTHESIA (Tingling sensation from her neck up and down her mouth and throat) and MUSCLE TIGHTNESS (Jaw was tightened) had not resolved and CONDITION AGGRAVATED (Symptoms were bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Pepcid.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Ache all over; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021 and was forwarded to Moderna on 26-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Ache all over) 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 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 MYALGIA (Ache all over). At the time of the report, MYALGIA (Ache all over) outcome was unknown.            Med Info Agent:  AE submitted via Chatbot Ache all over is this a side effect. Patient  just received my second shot yesterday.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PAIN (after the second one she has really bad pain all over her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PAIN (after the second one she has really bad pain all over her body). The patient was treated with METHYLPREDNISOLONE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (after the second one she has really bad pain all over her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-176123 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Area is itching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Area is itching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Area is itching). At the time of the report, VACCINATION SITE PRURITUS (Area is itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.     Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.            No concomitants were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain
Clinical narrative: Freezing cold; Aches; 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 FEELING COLD (Freezing cold), PAIN (Aches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Freezing cold), PAIN (Aches) and CHILLS (Chills). At the time of the report, FEELING COLD (Freezing cold), PAIN (Aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold like symptoms; 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 NASOPHARYNGITIS (Cold like symptoms) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold like symptoms). At the time of the report, NASOPHARYNGITIS (Cold like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: tingly feeling; my arm is really sore; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingly feeling) and PAIN IN EXTREMITY (my arm is really sore) 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 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 26-May-2021, the patient experienced PARAESTHESIA (tingly feeling) and PAIN IN EXTREMITY (my arm is really sore). At the time of the report, PARAESTHESIA (tingly feeling) and PAIN IN EXTREMITY (my arm is really sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain upper, Discomfort, Influenza like illness, Sleep disorder
Clinical narrative: flu-like side effect; upset stomach that would come around lunch time and dinner time; stomach ache gave him a hard time to sleep; hard time to sleep due to stomach ache; felt uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like side effect), ABDOMINAL DISCOMFORT (upset stomach that would come around lunch time and dinner time), ABDOMINAL PAIN UPPER (stomach ache gave him a hard time to sleep), SLEEP DISORDER (hard time to sleep due to stomach ache) and DISCOMFORT (felt uncomfortable) 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) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like side effect), ABDOMINAL DISCOMFORT (upset stomach that would come around lunch time and dinner time), ABDOMINAL PAIN UPPER (stomach ache gave him a hard time to sleep), SLEEP DISORDER (hard time to sleep due to stomach ache) and DISCOMFORT (felt uncomfortable). The patient was treated with BISMUTH SUBSALICYLATE (PEPTOBISMOL) for Stomach ache, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like side effect), ABDOMINAL DISCOMFORT (upset stomach that would come around lunch time and dinner time), ABDOMINAL PAIN UPPER (stomach ache gave him a hard time to sleep), SLEEP DISORDER (hard time to sleep due to stomach ache) and DISCOMFORT (felt uncomfortable) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Pneumonia, Pyrexia, Respiratory tract congestion
Clinical narrative: diagnosed to have pneumonia; hard cold; chest congestion; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (diagnosed to have pneumonia) 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 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 PNEUMONIA (diagnosed to have pneumonia) (seriousness criterion medically significant), NASOPHARYNGITIS (hard cold), RESPIRATORY TRACT CONGESTION (chest congestion), PYREXIA (fever) and CHILLS (chills). At the time of the report, PNEUMONIA (diagnosed to have pneumonia), NASOPHARYNGITIS (hard cold), RESPIRATORY TRACT CONGESTION (chest congestion), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Company comment: 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. Very limited information regarding these events has been provided at this time. No further information is expected at this time. 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. Very limited information regarding these events has been provided at this time. No further information is expected at this time.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Palpitations
Clinical narrative: chest pain; strong palpitation; 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 CHEST PAIN (chest pain) and PALPITATIONS (strong palpitation) 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 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) and PALPITATIONS (strong palpitation). At the time of the report, CHEST PAIN (chest pain) and PALPITATIONS (strong palpitation) outcome was unknown.            After a week of the vaccine Patient experienced chest pain and strong palpitation; Doctor prescribed a CTA scanned but the result come back good and no problems. Concomitant Medications were not provided by the reporter. Treatment Medications were  not provided by the reporter.   Reporter did not allow further contact
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest discomfort, Dizziness, Dyspnoea, Heart rate
Clinical narrative: Felt like face and lip were swelling after 1st dose; Felt like face and lip were swelling after 1st dose; Chest heaviness after 1st dose; Severe shortness of breath after 1st dose; Dizziness after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING FACE (Felt like face and lip were swelling after 1st dose), LIP SWELLING (Felt like face and lip were swelling after 1st dose), CHEST DISCOMFORT (Chest heaviness after 1st dose), DYSPNOEA (Severe shortness of breath after 1st dose) and DIZZINESS (Dizziness after 1st dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced SWELLING FACE (Felt like face and lip were swelling after 1st dose), LIP SWELLING (Felt like face and lip were swelling after 1st dose), CHEST DISCOMFORT (Chest heaviness after 1st dose), DYSPNOEA (Severe shortness of breath after 1st dose) and DIZZINESS (Dizziness after 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 50 milligram. At the time of the report, SWELLING FACE (Felt like face and lip were swelling after 1st dose), LIP SWELLING (Felt like face and lip were swelling after 1st dose), CHEST DISCOMFORT (Chest heaviness after 1st dose), DYSPNOEA (Severe shortness of breath after 1st dose) and DIZZINESS (Dizziness after 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 202/116 (High) 202/116. On an unknown date, Heart rate: 134 (High) 134.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received on 29-JUL-2021, contains event outcome updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: Felt like face and lip were swelling after 1st dose; Felt like face and lip were swelling after 1st dose; Chest heaviness after 1st dose; Severe shortness of breath after 1st dose; Dizziness after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING FACE (Felt like face and lip were swelling after 1st dose), LIP SWELLING (Felt like face and lip were swelling after 1st dose), CHEST DISCOMFORT (Chest heaviness after 1st dose), DYSPNOEA (Severe shortness of breath after 1st dose) and DIZZINESS (Dizziness after 1st dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced SWELLING FACE (Felt like face and lip were swelling after 1st dose), LIP SWELLING (Felt like face and lip were swelling after 1st dose), CHEST DISCOMFORT (Chest heaviness after 1st dose), DYSPNOEA (Severe shortness of breath after 1st dose) and DIZZINESS (Dizziness after 1st dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 50 milligram. At the time of the report, SWELLING FACE (Felt like face and lip were swelling after 1st dose), LIP SWELLING (Felt like face and lip were swelling after 1st dose), CHEST DISCOMFORT (Chest heaviness after 1st dose), DYSPNOEA (Severe shortness of breath after 1st dose) and DIZZINESS (Dizziness after 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 202/116 (High) 202/116. On an unknown date, Heart rate: 134 (High) 134.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received on 29-JUL-2021, contains event outcome updated.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever; Aches/ Pain; Sore throat; Bad cough; Felt like someone sitting on his chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches/ Pain), OROPHARYNGEAL PAIN (Sore throat), COUGH (Bad cough), CHEST DISCOMFORT (Felt like someone sitting on his chest) and PYREXIA (Fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Pneumonectomy (half of his lung was removed.). Concurrent medical conditions included Cancer. Concomitant products included CARBAMAZEPINE (TEGRETOL), GABAPENTIN (NEURONTIN), LISINOPRIL, CARVEDILOL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FUROSEMIDE for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PAIN (Aches/ Pain), OROPHARYNGEAL PAIN (Sore throat), COUGH (Bad cough) and CHEST DISCOMFORT (Felt like someone sitting on his chest). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PAIN (Aches/ Pain), OROPHARYNGEAL PAIN (Sore throat), COUGH (Bad cough), CHEST DISCOMFORT (Felt like someone sitting on his chest) and PYREXIA (Fever) 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.   Concomitant medications and treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: significant due to batch number,and event start date were provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Headache
Clinical narrative: allergic reaction from the waist down that worsens over time.; after vaccination 4 hours later he felt headache; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction from the waist down that worsens over time.) and HEADACHE (after vaccination 4 hours later he felt headache) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for Headache.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction from the waist down that worsens over time.) and HEADACHE (after vaccination 4 hours later he felt headache). At the time of the report, ALLERGY TO VACCINE (allergic reaction from the waist down that worsens over time.) and HEADACHE (after vaccination 4 hours later he felt headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: My heart rate increased after 2nd shot; 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 HEART RATE INCREASED (My heart rate increased after 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (My heart rate increased after 2nd shot). At the time of the report, HEART RATE INCREASED (My heart rate increased after 2nd shot) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Lymphadenopathy, Myalgia, Nodule
Clinical narrative: Swollen neck and tender; swollen neck and tender; Llittle bump in between collar bone around throat area(about an inch long); Feels like shes trying to catch her breath; Rash on the shoulder and underneath the right breast and lower back (about10 inches long); Swollen around lymph nodes; muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen neck and tender), TENDERNESS (swollen neck and tender), NODULE (Llittle bump in between collar bone around throat area(about an inch long)), DYSPNOEA (Feels like shes trying to catch her breath) and RASH (Rash on the shoulder and underneath the right breast and lower back (about10 inches long)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swollen neck and tender), TENDERNESS (swollen neck and tender), NODULE (Llittle bump in between collar bone around throat area(about an inch long)), DYSPNOEA (Feels like shes trying to catch her breath), RASH (Rash on the shoulder and underneath the right breast and lower back (about10 inches long)), LYMPHADENOPATHY (Swollen around lymph nodes), MYALGIA (muscle pain) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (Swollen neck and tender), TENDERNESS (swollen neck and tender), NODULE (Llittle bump in between collar bone around throat area(about an inch long)), DYSPNOEA (Feels like shes trying to catch her breath), RASH (Rash on the shoulder and underneath the right breast and lower back (about10 inches long)), LYMPHADENOPATHY (Swollen around lymph nodes), MYALGIA (muscle pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-176365 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Tenderness
Clinical narrative: Swollen neck and tender; swollen neck and tender; Llittle bump in between collar bone around throat area(about an inch long); Feels like shes trying to catch her breath; Rash on the shoulder and underneath the right breast and lower back (about10 inches long); Swollen around lymph nodes; muscle pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen neck and tender), TENDERNESS (swollen neck and tender), NODULE (Llittle bump in between collar bone around throat area(about an inch long)), DYSPNOEA (Feels like shes trying to catch her breath) and RASH (Rash on the shoulder and underneath the right breast and lower back (about10 inches long)) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swollen neck and tender), TENDERNESS (swollen neck and tender), NODULE (Llittle bump in between collar bone around throat area(about an inch long)), DYSPNOEA (Feels like shes trying to catch her breath), RASH (Rash on the shoulder and underneath the right breast and lower back (about10 inches long)), LYMPHADENOPATHY (Swollen around lymph nodes), MYALGIA (muscle pain) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING (Swollen neck and tender), TENDERNESS (swollen neck and tender), NODULE (Llittle bump in between collar bone around throat area(about an inch long)), DYSPNOEA (Feels like shes trying to catch her breath), RASH (Rash on the shoulder and underneath the right breast and lower back (about10 inches long)), LYMPHADENOPATHY (Swollen around lymph nodes), MYALGIA (muscle pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-176365 (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm with administration of first Moderna Covid-19 injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm with administration of first Moderna Covid-19 injection) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm with administration of first Moderna Covid-19 injection). At the time of the report, PAIN IN EXTREMITY (Sore arm with administration of first Moderna Covid-19 injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-176314 (Patient Link).