chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; 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 URTICARIA (Hives) 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 URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Big lump where I got the shot; Itchy and red; Itchy and red; 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 MASS (big lump where I got the shot), VACCINATION SITE PRURITUS (itchy and red) and VACCINATION SITE ERYTHEMA (itchy and red) 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) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE MASS (big lump where I got the shot), VACCINATION SITE PRURITUS (itchy and red) and VACCINATION SITE ERYTHEMA (itchy and red). At the time of the report, VACCINATION SITE MASS (big lump where I got the shot), VACCINATION SITE PRURITUS (itchy and red) and VACCINATION SITE ERYTHEMA (itchy and red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Peripheral swelling, Respiration abnormal
Clinical narrative: legs and feet swollen; breathing issues; Lethargic; les and feet swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (legs and feet swollen), RESPIRATION ABNORMAL (breathing issues), LETHARGY (Lethargic) and PERIPHERAL SWELLING (les and feet swollen) 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 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (legs and feet swollen), RESPIRATION ABNORMAL (breathing issues), LETHARGY (Lethargic) and PERIPHERAL SWELLING (les and feet swollen). At the time of the report, RESPIRATION ABNORMAL (breathing issues), LETHARGY (Lethargic) and PERIPHERAL SWELLING (les and feet swollen) 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.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Everybody else I know that got the vaccine couldn't move their arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Everybody else I know that got the vaccine couldn't move their arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Everybody else I know that got the vaccine couldn't move their arm). At the time of the report, LIMB DISCOMFORT (Everybody else I know that got the vaccine couldn't move their arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-JUN-2021 contains no significant information.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: after 7 days injection site is still warm; 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 WARMTH (after 7 days injection site is still warm) 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 was provided by the reporter.     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 WARMTH (after 7 days injection site is still warm). At the time of the report, VACCINATION SITE WARMTH (after 7 days injection site is still warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.  Treatment information not provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Endoscopy, Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010m21a and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced MYALGIA (Sore arm). On 11-Feb-2021, MYALGIA (Sore arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Endoscopy: normal (normal) normal.         Relevant concomitant medications were not reported.  The treatment information was  not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Pyrexia, Vaccination complication
Clinical narrative: felt sick; dizzy/lightheaded; distraction/unease up to a week after; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt sick), DIZZINESS (dizzy/lightheaded), FEELING ABNORMAL (distraction/unease up to a week after) 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 06-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (felt sick), DIZZINESS (dizzy/lightheaded), FEELING ABNORMAL (distraction/unease up to a week after) and PYREXIA (fever). At the time of the report, VACCINATION COMPLICATION (felt sick), DIZZINESS (dizzy/lightheaded), FEELING ABNORMAL (distraction/unease up to a week after) and PYREXIA (fever) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication details were provided. No treatment medication details were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over stomach; 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 all over stomach) 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 21-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 RASH (rash all over stomach). At the time of the report, RASH (rash all over stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: extreme heartburn; 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 DYSPEPSIA (extreme heartburn) 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 DYSPEPSIA (extreme heartburn). At the time of the report, DYSPEPSIA (extreme heartburn) outcome was unknown.            No concomitant medication was reported. Treatment drug information was not given.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hepatitis C.   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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication include thyroid medication. No concomitant medication information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swollen Feet; 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 PERIPHERAL SWELLING (Swollen Feet) 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 PERIPHERAL SWELLING (Swollen Feet). At the time of the report, PERIPHERAL SWELLING (Swollen Feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm of injection hot to touch; arm swollen at the injection site; 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 WARMTH (arm of injection hot to touch) and VACCINATION SITE SWELLING (arm swollen at the injection site) 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 20-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE WARMTH (arm of injection hot to touch) and VACCINATION SITE SWELLING (arm swollen at the injection site). At the time of the report, VACCINATION SITE WARMTH (arm of injection hot to touch) and VACCINATION SITE SWELLING (arm swollen at the injection site) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: tremors; 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 TREMOR (tremors) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not 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 TREMOR (tremors). At the time of the report, TREMOR (tremors) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported.   Concomitant medication not reported.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: fell on the floor; arm was really sore; felt weak; could not move; fever; This spontaneous case was reported by a patient and describes the occurrence of FALL (fell on the floor), PAIN IN EXTREMITY (arm was really sore), ASTHENIA (felt weak), MOBILITY DECREASED (could not move) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (fell on the floor), PAIN IN EXTREMITY (arm was really sore), ASTHENIA (felt weak), MOBILITY DECREASED (could not move) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at a dose of unk dosage form. At the time of the report, FALL (fell on the floor), PAIN IN EXTREMITY (arm was really sore), ASTHENIA (felt weak), MOBILITY DECREASED (could not move) 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 product use was multiple sclerosis medication.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Dry rash on head after second vaccination; 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 (Dry rash on head after second vaccination) 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 RASH (Dry rash on head after second vaccination). At the time of the report, RASH (Dry rash on head after second vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: PALPHTATIONS; 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 PALPITATIONS (PALPHTATIONS) 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) at an unspecified dose. On an unknown date, the patient experienced PALPITATIONS (PALPHTATIONS). At the time of the report, PALPITATIONS (PALPHTATIONS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Whole side hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Whole side hurts) 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 PAIN (Whole side hurts). At the time of the report, PAIN (Whole side hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Hot flush
Clinical narrative: On and off hot flushes; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-May-2021 and was forwarded to Moderna on 24-May-2021.    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 HOT FLUSH (On and off hot flushes) 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 was provided.     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 HOT FLUSH (On and off hot flushes) and CHILLS (Chills). At the time of the report, HOT FLUSH (On and off hot flushes) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment medication was not provided.
Age: 14.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I'm 14 and just got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I'm 14 and just got the vaccine) in a 14-year-old patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I'm 14 and just got the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (I'm 14 and just got the vaccine) outcome was unknown.            No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling sick; 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 MALAISE (feeling sick) 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 02-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced MALAISE (feeling sick). At the time of the report, MALAISE (feeling sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant products reported
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Mobility decreased, Somnolence
Clinical narrative: napping more often; Head fog; Decrease ability to imitate a task/Decrease ability to stay on task; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Head fog), MOBILITY DECREASED (Decrease ability to imitate a task/Decrease ability to stay on task), FATIGUE (Fatigue) and SOMNOLENCE (napping more often) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included Ritalin                                                        ADHD, Methylphenidate                                                ADHD, Escitalopram                                                   Bipolar Depression, Lexapro                                                        Bipolar depression  and Lemotrigine                                                    Bipolar depression for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced FEELING ABNORMAL (Head fog), MOBILITY DECREASED (Decrease ability to imitate a task/Decrease ability to stay on task) and FATIGUE (Fatigue). On an unknown date, the patient experienced SOMNOLENCE (napping more often). At the time of the report, FEELING ABNORMAL (Head fog), MOBILITY DECREASED (Decrease ability to imitate a task/Decrease ability to stay on task), FATIGUE (Fatigue) and SOMNOLENCE (napping more often) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: weak; tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak) and FATIGUE (tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN for an unknown indication.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced ASTHENIA (weak) and FATIGUE (tired). At the time of the report, ASTHENIA (weak) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided. concomitant medications included bipolarity Patient received first dose of Moderna Covid-19 vaccine on 21May2021. It was administered on the left nondominant arm. Patient has been feeling weak and tired since 22May2021. Symptoms have not improved. Patient did not take medication to treat symptoms.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Eye irritation, Fatigue
Clinical narrative: Nasal irritation; Eye irritation; Feels weak; Nausea; Vomiting; Has chills; Fever; Headache; Spinal nerve pain; Muscle pain; Fatigue; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea) and VOMITING (Vomiting) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Chronic obstructive pulmonary disease and Nerve pain (Severe Nerve problem).    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Has chills), PYREXIA (Fever), HEADACHE (Headache), NEURALGIA (Spinal nerve pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and DIARRHEA (Diarrhea). At the time of the report, NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Has chills), PYREXIA (Fever), HEADACHE (Headache), NEURALGIA (Spinal nerve pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and DIARRHEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that he takes many medications.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal discomfort, Nausea, Neuralgia
Clinical narrative: Nasal irritation; Eye irritation; Feels weak; Nausea; Vomiting; Has chills; Fever; Headache; Spinal nerve pain; Muscle pain; Fatigue; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea) and VOMITING (Vomiting) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Chronic obstructive pulmonary disease and Nerve pain (Severe Nerve problem).    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Has chills), PYREXIA (Fever), HEADACHE (Headache), NEURALGIA (Spinal nerve pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and DIARRHEA (Diarrhea). At the time of the report, NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Has chills), PYREXIA (Fever), HEADACHE (Headache), NEURALGIA (Spinal nerve pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and DIARRHEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that he takes many medications.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nasal irritation; Eye irritation; Feels weak; Nausea; Vomiting; Has chills; Fever; Headache; Spinal nerve pain; Muscle pain; Fatigue; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea) and VOMITING (Vomiting) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Chronic obstructive pulmonary disease and Nerve pain (Severe Nerve problem).    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Has chills), PYREXIA (Fever), HEADACHE (Headache), NEURALGIA (Spinal nerve pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and DIARRHEA (Diarrhea). At the time of the report, NASAL DISCOMFORT (Nasal irritation), EYE IRRITATION (Eye irritation), ASTHENIA (Feels weak), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Has chills), PYREXIA (Fever), HEADACHE (Headache), NEURALGIA (Spinal nerve pain), MYALGIA (Muscle pain), FATIGUE (Fatigue) and DIARRHEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that he takes many medications.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: moderna vaccine given to a 12 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine given to a 12 year old) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine given to a 12 year old). On 23-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (moderna vaccine given to a 12 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm aches more; 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 PAIN (arm aches more) 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 VACCINATION SITE PAIN (arm aches more). At the time of the report, VACCINATION SITE PAIN (arm aches more) outcome was unknown.            Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: severe joint pain after second 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 ARTHRALGIA (severe joint pain after second shot) 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 ARTHRALGIA (severe joint pain after second shot). At the time of the report, ARTHRALGIA (severe joint pain after second shot) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Action taken in response to mRNA-1273 was considered to be not applicable.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, SARS-CoV-2 test
Clinical narrative: 13 year old child received the Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old child received the Moderna vaccine) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old child received the Moderna vaccine). On 22-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old child received the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no concomitant medication. Treatment information was unknown.   This case was linked to MOD-2021-163351 (E2B Linked Report).; Sender's Comments:  MOD-2021-163351:MOD-2021-163351
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: extreme headache; vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (extreme headache) and VOMITING (vomiting) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.    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 HEADACHE (extreme headache) and VOMITING (vomiting). At the time of the report, HEADACHE (extreme headache) and VOMITING (vomiting) had resolved.            No treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: slight pain on my  waist/pain is stronger and spreading all across my waist; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (slight pain on my  waist) and PAIN (pain is stronger and spreading all across my waist) 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 PAIN (slight pain on my  waist) and PAIN (pain is stronger and spreading all across my waist). At the time of the report, PAIN (slight pain on my  waist) and PAIN (pain is stronger and spreading all across my waist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Gait disturbance, Myalgia
Clinical narrative: One month aftee second shot...still no energy; cant hardly walk; Severe muscle and joint pain; Severe muscle and joint pain; 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 ASTHENIA (One month aftee second shot...still no energy), GAIT DISTURBANCE (cant hardly walk), MYALGIA (Severe muscle and joint pain) and ARTHRALGIA (Severe muscle and joint pain) 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) 2 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 ASTHENIA (One month aftee second shot...still no energy), GAIT DISTURBANCE (cant hardly walk), MYALGIA (Severe muscle and joint pain) and ARTHRALGIA (Severe muscle and joint pain). At the time of the report, ASTHENIA (One month aftee second shot..still no energy), GAIT DISTURBANCE (cant hardly walk), MYALGIA (Severe muscle and joint pain) and ARTHRALGIA (Severe muscle and joint pain) outcome was unknown.            Concomitant medications was not provided.  Treatment medications was not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Psoriasis, Pyrexia
Clinical narrative: Psoriasis is stopped; Fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis is stopped) and PYREXIA (Fever of 102) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis (Psoriasis stopped after fever resolved. Follow up: The moderna vaccine reset my immune system, no longer suffering from skin psoriasis).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 10-May-2021, the patient experienced PYREXIA (Fever of 102). On 14-May-2021, the patient experienced PSORIASIS (Psoriasis is stopped). The patient was treated with IBUPROFEN at a dose of UNK dosage form. On 14-May-2021, PYREXIA (Fever of 102) had resolved. At the time of the report, PSORIASIS (Psoriasis is stopped) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) fever of 102 that lasted for 4 days..         Patient had used ointment as a concomitant as medication( name not provided).  The action taken for mRNA-1273  Moderna COVID -19 vaccine was not applicable.  Follow up: Treatment provided by doctor  was antibiotic and it took care of the infection within 4 days.   Patient stated The fever, it turned out to be a urinary infection and was prescribed medication which resolved the event. Patient also stated that the moderna vaccine reset the immune system, no longer suffering from skin psoriasis.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: The event 'Fever' turned out to be due to urinary infection. Added antibiotic as treatment for fever.The event ' Psoriasis is stopped ' turned out to be a current condition which got cured after taking vaccine as per patient's statement.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Influenza like illness, Pyrexia
Clinical narrative: (After receiving the vaccine) was dick that evening/ (After receiving the vaccine) was dick the next day; Like the flu; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ((After receiving the vaccine) was dick that evening/ (After receiving the vaccine) was dick the next day), INFLUENZA LIKE ILLNESS (Like the flu) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL ((After receiving the vaccine) was dick that evening/ (After receiving the vaccine) was dick the next day), INFLUENZA LIKE ILLNESS (Like the flu) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL ((After receiving the vaccine) was dick that evening/ (After receiving the vaccine) was dick the next day), INFLUENZA LIKE ILLNESS (Like the flu) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) Other.         No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes above collarbone after vaccination; 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 LYMPHADENOPATHY (swollen lymph nodes above collarbone after vaccination) 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) at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph nodes above collarbone after vaccination). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes above collarbone after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No lab results /concomitant medications were reported.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: light headed; body has severe aches; headache; 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 DIZZINESS (light headed), MYALGIA (body has severe aches) and HEADACHE (headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 DIZZINESS (light headed), MYALGIA (body has severe aches) and HEADACHE (headache). At the time of the report, DIZZINESS (light headed), MYALGIA (body has severe aches) and HEADACHE (headache) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported No treatment drugs were reported   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rhinitis
Clinical narrative: nose inside is infected; 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 RHINITIS (nose inside is infected) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINITIS (nose inside is infected). At the time of the report, RHINITIS (nose inside is infected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site warmth
Clinical narrative: had my injection 8 days ago and I still have a hard lump; it's hot to the touch; 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 MASS (had my injection 8 days ago and I still have a hard lump) and VACCINATION SITE WARMTH (it's hot to the touch) 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 14-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (had my injection 8 days ago and I still have a hard lump) and VACCINATION SITE WARMTH (it's hot to the touch). At the time of the report, VACCINATION SITE MASS (had my injection 8 days ago and I still have a hard lump) and VACCINATION SITE WARMTH (it's hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hip arthroplasty, Knee arthroplasty, Product administration interrupted
Clinical narrative: hip replacement; hip or knee replacement; came in today to get the second shot at day 56; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HIP ARTHROPLASTY (hip replacement), KNEE ARTHROPLASTY (hip or knee replacement) and PRODUCT ADMINISTRATION INTERRUPTED (came in today to get the second shot at day 56) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 HIP ARTHROPLASTY (hip replacement), KNEE ARTHROPLASTY (hip or knee replacement) and PRODUCT ADMINISTRATION INTERRUPTED (came in today to get the second shot at day 56). At the time of the report, HIP ARTHROPLASTY (hip replacement) and KNEE ARTHROPLASTY (hip or knee replacement) outcome was unknown and PRODUCT ADMINISTRATION INTERRUPTED (came in today to get the second shot at day 56) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Memory impairment
Clinical narrative: Memory impairment; Balance difficulty; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Memory impairment) and BALANCE DISORDER (Balance difficulty) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (Memory impairment) and BALANCE DISORDER (Balance difficulty). At the time of the report, MEMORY IMPAIRMENT (Memory impairment) and BALANCE DISORDER (Balance difficulty) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided  No Treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-Significant follow up appended to AER