chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of 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 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 20-May-2021, the patient experienced CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.    The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant and treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: red swelled hot circle around the injection site for 3 days and counting; diarrhea; red swelled hot circle around the injection site for 3 days and counting; red swelled hot circle around the injection site for 3 days and counting; 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 VACCINATION SITE WARMTH (red swelled hot circle around the injection site for 3 days and counting), DIARRHOEA (diarrhea), VACCINATION SITE ERYTHEMA (red swelled hot circle around the injection site for 3 days and counting), VACCINATION SITE SWELLING (red swelled hot circle around the injection site for 3 days and counting) 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 22-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 VACCINATION SITE WARMTH (red swelled hot circle around the injection site for 3 days and counting), VACCINATION SITE ERYTHEMA (red swelled hot circle around the injection site for 3 days and counting) and VACCINATION SITE SWELLING (red swelled hot circle around the injection site for 3 days and counting). an unknown date, the patient experienced DIARRHOEA (diarrhea) and HEADACHE (headache). At the time of the report, VACCINATION SITE WARMTH (red swelled hot circle around the injection site for 3 days and counting), DIARRHOEA (diarrhea) and HEADACHE (headache) outcome was unknown and VACCINATION SITE ERYTHEMA (red swelled hot circle around the injection site for 3 days and counting) and VACCINATION SITE SWELLING (red swelled hot circle around the injection site for 3 days and counting) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, COVID-19, Dyspnoea, Hypersensitivity
Clinical narrative: Got  positive test for COVID three days after the first shot; asthma got worse; allergies got worse; My breathing was difficult; 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 COVID-19 (Got  positive test for COVID three days after the first shot), ASTHMA (asthma got worse), HYPERSENSITIVITY (allergies got worse) and DYSPNOEA (My breathing was difficult) 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 COVID-19 (Got  positive test for COVID three days after the first shot), ASTHMA (asthma got worse), HYPERSENSITIVITY (allergies got worse) and DYSPNOEA (My breathing was difficult). At the time of the report, COVID-19 (Got  positive test for COVID three days after the first shot), ASTHMA (asthma got worse), HYPERSENSITIVITY (allergies got worse) and DYSPNOEA (My breathing was difficult) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; 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 ALOPECIA (hair loss) 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 ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications are provided. treatment to the events not reported. No lab data has been provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Ear pain, Pain in extremity, Pyrexia, Toothache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her hand), BACK PAIN (Pain in her back), EAR PAIN (Pain in her left ear), TOOTHACHE (Pain in her teeth/ it is the bone that hurts from her upper and down teeth) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 025BL1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Chronic bronchitis. Concomitant products included LOSARTAN POTASSIUM for Hypertension. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced TOOTHACHE (Pain in her teeth/ it is the bone that hurts from her upper and down teeth). On 28-Apr-2021, the patient experienced PYREXIA (Fever). On 30-Apr-2021, the patient experienced BACK PAIN (Pain in her back). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in her hand), EAR PAIN (Pain in her left ear) and VACCINATION SITE PAIN (Doses administered in left arm, left side is the one that hurts). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency; IBUPROFEN for Back pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ANAPROX) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in her hand), BACK PAIN (Pain in her back), EAR PAIN (Pain in her left ear), TOOTHACHE (Pain in her teeth/ it is the bone that hurts from her upper and down teeth), PYREXIA (Fever) and VACCINATION SITE PAIN (Doses administered in left arm, left side is the one that hurts) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was prescribed with Meloxicam for pa in and Cyclobenzaprine for muscles to relax, but has not taken these medications at the time of this report. .
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her hand), BACK PAIN (Pain in her back), EAR PAIN (Pain in her left ear), TOOTHACHE (Pain in her teeth/ it is the bone that hurts from her upper and down teeth) and PYREXIA (Fever) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 025BL1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Chronic bronchitis. Concomitant products included LOSARTAN POTASSIUM for Hypertension. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced TOOTHACHE (Pain in her teeth/ it is the bone that hurts from her upper and down teeth). On 28-Apr-2021, the patient experienced PYREXIA (Fever). On 30-Apr-2021, the patient experienced BACK PAIN (Pain in her back). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in her hand), EAR PAIN (Pain in her left ear) and VACCINATION SITE PAIN (Doses administered in left arm, left side is the one that hurts). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency; IBUPROFEN for Back pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ANAPROX) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in her hand), BACK PAIN (Pain in her back), EAR PAIN (Pain in her left ear), TOOTHACHE (Pain in her teeth/ it is the bone that hurts from her upper and down teeth), PYREXIA (Fever) and VACCINATION SITE PAIN (Doses administered in left arm, left side is the one that hurts) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was prescribed with Meloxicam for pa in and Cyclobenzaprine for muscles to relax, but has not taken these medications at the time of this report. .
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pain in their hand after second dose; Fever after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in their hand after second dose) and PYREXIA (Fever after second dose) 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 medication history was provided.    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 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 IN EXTREMITY (Pain in their hand after second dose) and PYREXIA (Fever after second dose). At the time of the report, PAIN IN EXTREMITY (Pain in their hand after second dose) and PYREXIA (Fever after second dose) outcome was unknown.            Concomitant medication were not reported  Treatment information were not reported
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: on and off 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 CHILLS (on and off 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 CHILLS (on and off chills). At the time of the report, CHILLS (on and off chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants were reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Productive cough
Clinical narrative: Phlegm; allergies in the fall; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (Phlegm) and HYPERSENSITIVITY (allergies in the fall) 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 PRODUCTIVE COUGH (Phlegm) and HYPERSENSITIVITY (allergies in the fall). At the time of the report, PRODUCTIVE COUGH (Phlegm) and HYPERSENSITIVITY (allergies in the fall) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Panic reaction, Paraesthesia, Vaccination site pain
Clinical narrative: 5 little pricks (like in Acupuncture); Panicked; Palpitations/ heart palpitations; Tenderness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (5 little pricks (like in Acupuncture)), PANIC REACTION (Panicked), PALPITATIONS (Palpitations/ heart palpitations) and VACCINATION SITE PAIN (Tenderness on the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 09-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 PARAESTHESIA (5 little pricks (like in Acupuncture)). an unknown date, the patient experienced PANIC REACTION (Panicked) and VACCINATION SITE PAIN (Tenderness on the injection site). an unknown date, the patient experienced PALPITATIONS (Palpitations/ heart palpitations). At the time of the report, PARAESTHESIA (5 little pricks (like in Acupuncture)), PANIC REACTION (Panicked) and VACCINATION SITE PAIN (Tenderness on the injection site) outcome was unknown and PALPITATIONS (Palpitations/ heart palpitations) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       It was reported that the patient never tested positive for COVID-19 and did not have any acute illness at the time of vaccination and up to 1 month before. Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Significant Follow up information received included information about concurrent condition, concomitant medication, outcome of the event (palpitation), patient demographics and narrative was updated.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Myalgia, Pain in extremity, Urine abnormality
Clinical narrative: hand pain; low blood pressure; Muscle pain; dizziness; cloudy urine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (hand pain), URINE ABNORMALITY (cloudy urine), HYPOTENSION (low blood pressure), DIZZINESS (dizziness) and MYALGIA (Muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was Provided by Reporter.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 11-May-2021, the patient experienced URINE ABNORMALITY (cloudy urine) and DIZZINESS (dizziness). On an unknown date, the patient experienced PAIN IN EXTREMITY (hand pain), HYPOTENSION (low blood pressure) and MYALGIA (Muscle pain). The patient was treated with MAGNESIUM at an unspecified dose and frequency and DIHYDROERGOCRISTINE, LOMIFYLLINE (ANTIVERT [DIHYDROERGOCRISTINE;LOMIFYLLINE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (hand pain), URINE ABNORMALITY (cloudy urine), HYPOTENSION (low blood pressure), DIZZINESS (dizziness) and MYALGIA (Muscle pain) outcome was unknown.            Treatment included as fluids, magnesium drip, magnesium tablets and Antivert.  Action taken was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Rash; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 RASH (Rash) and PYREXIA (Fever). At the time of the report, RASH (Rash) and PYREXIA (Fever) outcome was unknown.            No treatment information was reported.  No concomitant medication ere reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Dizziness, Fatigue, Hyperhidrosis
Clinical narrative: Sweating; Felt flu-like; white pale hands; Dizzy spells; blood pressure shot up; Body aches; chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Felt flu-like), PALLOR (white pale hands), DIZZINESS (Dizzy spells) and BLOOD PRESSURE INCREASED (blood pressure shot up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Felt flu-like), PALLOR (white pale hands), DIZZINESS (Dizzy spells), BLOOD PRESSURE INCREASED (blood pressure shot up), MYALGIA (Body aches), CHILLS (chills) and FATIGUE (Tired). The patient was treated with MAGNESIUM at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for Dizziness, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Felt flu-like), PALLOR (white pale hands), DIZZINESS (Dizzy spells), BLOOD PRESSURE INCREASED (blood pressure shot up), MYALGIA (Body aches), CHILLS (chills) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications included fluids, Magnesium drip
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pallor
Clinical narrative: Sweating; Felt flu-like; white pale hands; Dizzy spells; blood pressure shot up; Body aches; chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Felt flu-like), PALLOR (white pale hands), DIZZINESS (Dizzy spells) and BLOOD PRESSURE INCREASED (blood pressure shot up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Felt flu-like), PALLOR (white pale hands), DIZZINESS (Dizzy spells), BLOOD PRESSURE INCREASED (blood pressure shot up), MYALGIA (Body aches), CHILLS (chills) and FATIGUE (Tired). The patient was treated with MAGNESIUM at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) for Dizziness, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (Felt flu-like), PALLOR (white pale hands), DIZZINESS (Dizzy spells), BLOOD PRESSURE INCREASED (blood pressure shot up), MYALGIA (Body aches), CHILLS (chills) and FATIGUE (Tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment medications included fluids, Magnesium drip
Sex: U
Vaccine: COVID19
Symptoms: Gastritis, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in legs and stomach) and GASTRITIS (Swelling in legs and 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 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 (Swelling in legs and stomach) and GASTRITIS (Swelling in legs and stomach). At the time of the report, PERIPHERAL SWELLING (Swelling in legs and stomach) and GASTRITIS (Swelling in legs and stomach) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red, raised patches that are itchy; bump near injection site; sore around injection site; red, raised patches that are itchy; red, raised patches that are itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (bump near injection site), VACCINATION SITE PAIN (sore around injection site), VACCINATION SITE ERYTHEMA (red, raised patches that are itchy), VACCINATION SITE PRURITUS (red, raised patches that are itchy) and RASH (red, raised patches that are itchy) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and # 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced VACCINATION SITE SWELLING (bump near injection site), VACCINATION SITE PAIN (sore around injection site), VACCINATION SITE ERYTHEMA (red, raised patches that are itchy) and VACCINATION SITE PRURITUS (red, raised patches that are itchy). On an unknown date, the patient experienced RASH (red, raised patches that are itchy). The patient was treated with IBUPROFEN (ADVIL 12HOUR) for Itching, at a dose of 1 dosage form and CORTISONE ongoing since an unknown date for Itching, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE SWELLING (bump near injection site), VACCINATION SITE PAIN (sore around injection site), VACCINATION SITE ERYTHEMA (red, raised patches that are itchy), VACCINATION SITE PRURITUS (red, raised patches that are itchy) and RASH (red, raised patches that are itchy) outcome was unknown.            no concomitant medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable
Sex: U
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: my eye floaters ate now bad; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VITREOUS FLOATERS (my eye floaters ate now bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VITREOUS FLOATERS (my eye floaters ate now bad). At the time of the report, VITREOUS FLOATERS (my eye floaters ate now bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling feeling in face after 2nd covid 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 PARAESTHESIA (Tingling feeling in face after 2nd covid 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, the patient experienced PARAESTHESIA (Tingling feeling in face after 2nd covid shot). At the time of the report, PARAESTHESIA (Tingling feeling in face after 2nd covid shot) outcome was unknown.            No concomitant drugs provided.  No treatment drugs provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Arm feels hard at area where I received the shot; Arm is itchy at area where I received the shot; Chills; Headache; My arm is red around the area I received the 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 VACCINATION SITE INDURATION (Arm feels hard at area where I received the shot), VACCINATION SITE PRURITUS (Arm is itchy at area where I received the shot), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (My arm is red around the area I received 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 21-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 VACCINATION SITE INDURATION (Arm feels hard at area where I received the shot), VACCINATION SITE PRURITUS (Arm is itchy at area where I received the shot), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (My arm is red around the area I received the shot.). At the time of the report, VACCINATION SITE INDURATION (Arm feels hard at area where I received the shot), VACCINATION SITE PRURITUS (Arm is itchy at area where I received the shot), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (My arm is red around the area I received the shot.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided.  Treatment information was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache for three days; head especially hurts when I bend over or cough; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache for three days) and HEADACHE (head especially hurts when I bend over or cough) 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 HEADACHE (severe headache for three days) and HEADACHE (head especially hurts when I bend over or cough). At the time of the report, HEADACHE (severe headache for three days) and HEADACHE (head especially hurts when I bend over or cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: No new information
Age: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Pain, Pyrexia
Clinical narrative: congestion; aches; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congestion), PAIN (aches), PYREXIA (fever) and HEADACHE (headache) in a 49-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (congestion), PAIN (aches), PYREXIA (fever) and HEADACHE (headache). At the time of the report, NASAL CONGESTION (congestion), PAIN (aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Pyrexia
Clinical narrative: Weak, Weak body rack, No energy; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak, Weak body rack, No energy) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weak, Weak body rack, No energy) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weak, Weak body rack, No energy) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No concomitant medications provided. No treatment information provided.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia
Clinical narrative: Problem in walking; Numbness in the legs; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Problem in walking) and HYPOAESTHESIA (Numbness in the legs) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 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 GAIT DISTURBANCE (Problem in walking) and HYPOAESTHESIA (Numbness in the legs). At the time of the report, GAIT DISTURBANCE (Problem in walking) and HYPOAESTHESIA (Numbness in the legs) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Feeling of body temperature change, Pyrexia
Clinical narrative: Freezing to death; Feels that it has ruined my life; I don't know when I will be warm again; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing to death), FEELING ABNORMAL (Feels that it has ruined my life), FEELING OF BODY TEMPERATURE CHANGE (I don't know when I will be warm again) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concomitant products included INSULIN, Vitamin D and LOVASTATIN.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1.   On 14-May-2021, the patient experienced FEELING COLD (Freezing to death), FEELING ABNORMAL (Feels that it has ruined my life), FEELING OF BODY TEMPERATURE CHANGE (I don't know when I will be warm again) and PYREXIA (Fever).   At the time of the report, FEELING COLD (Freezing to death), FEELING ABNORMAL (Feels that it has ruined my life), FEELING OF BODY TEMPERATURE CHANGE (I don't know when I will be warm again) and PYREXIA (Fever) outcome was unknown.      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.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Coughing so bad is a dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing so bad is a dry cough) 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 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced COUGH (Coughing so bad is a dry cough). At the time of the report, COUGH (Coughing so bad is a dry cough) 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.  The patient reported that second dose is scheduled on 28 May 2021.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Headache
Clinical narrative: stomach felt wearied; wearied feeling; experiencing headache, which is on and off; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach felt wearied), FEELING ABNORMAL (wearied feeling), HEADACHE (experiencing headache, which is on and off) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach felt wearied), FEELING ABNORMAL (wearied feeling), HEADACHE (experiencing headache, which is on and off) and HEADACHE (Headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach felt wearied), FEELING ABNORMAL (wearied feeling), HEADACHE (experiencing headache, which is on and off) and HEADACHE (Headache) outcome was unknown.            No concomitant products information is provided  No treatment product information is provided   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: clustered dots/ Red Dots; Itchy dots at the injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), VACCINATION SITE ERYTHEMA (clustered dots/ Red Dots) and VACCINATION SITE PRURITUS (Itchy dots at the injection site) in a 42-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced MYALGIA (Sore arm). On 23-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (clustered dots/ Red Dots) and VACCINATION SITE PRURITUS (Itchy dots at the injection site). On 17-May-2021, MYALGIA (Sore arm) outcome was unknown. At the time of the report, VACCINATION SITE ERYTHEMA (clustered dots/ Red Dots) and VACCINATION SITE PRURITUS (Itchy dots at the injection site) 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.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder
Clinical narrative: balance is off, can't keep my balance; 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 BALANCE DISORDER (balance is off, can't keep my balance) 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 BALANCE DISORDER (balance is off, can't keep my balance). At the time of the report, BALANCE DISORDER (balance is off, can't keep my balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  patient's lab test data not reported.  No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: body ache; 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 MYALGIA (body ache) 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 MYALGIA (body ache). At the time of the report, MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication were reported no treatment information was provided    Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: Itching at the injection site; itchy bump at the injection site; Redness at the injection site; Small, swollen bump at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Small, swollen bump at the injection site), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PRURITUS (itchy bump at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure management and Blood cholesterol. Concomitant products included VITAMINS NOS for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Small, swollen bump at the injection site), VACCINATION SITE PRURITUS (itchy bump at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 14-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. On 05-Apr-2021, VACCINATION SITE INDURATION (Small, swollen bump at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site) had not resolved and VACCINATION SITE PRURITUS (itchy bump at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other Concomitant medications included cholesterol medications and BP medications.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow-up information received on 14-APR-2021, contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) 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 01-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 PRODUCT DOSE OMISSION ISSUE (missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment history was not reported .   Reporter did not allow further contact
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of Moderna vaccine given in less than 21 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine given in less than 21 days) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine given in less than 21 days). On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of Moderna vaccine given in less than 21 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Eye pain, Migraine, Neuralgia
Clinical narrative: Migraine; pain behind my eyes; tinnitus; back pain; burning hands; nerve pain; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), EYE PAIN (pain behind my eyes), TINNITUS (tinnitus), BACK PAIN (back pain) and BURNING SENSATION (burning hands) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine), EYE PAIN (pain behind my eyes), TINNITUS (tinnitus), BACK PAIN (back pain), BURNING SENSATION (burning hands), NEURALGIA (nerve pain) and VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, MIGRAINE (Migraine), EYE PAIN (pain behind my eyes), TINNITUS (tinnitus), BACK PAIN (back pain), BURNING SENSATION (burning hands), NEURALGIA (nerve pain) and VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.            No concomitant medications are provided. Treatment to the events not reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination complication
Clinical narrative: Migraine; pain behind my eyes; tinnitus; back pain; burning hands; nerve pain; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), EYE PAIN (pain behind my eyes), TINNITUS (tinnitus), BACK PAIN (back pain) and BURNING SENSATION (burning hands) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine), EYE PAIN (pain behind my eyes), TINNITUS (tinnitus), BACK PAIN (back pain), BURNING SENSATION (burning hands), NEURALGIA (nerve pain) and VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, MIGRAINE (Migraine), EYE PAIN (pain behind my eyes), TINNITUS (tinnitus), BACK PAIN (back pain), BURNING SENSATION (burning hands), NEURALGIA (nerve pain) and VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.            No concomitant medications are provided. Treatment to the events not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose; 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 PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) 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 PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No allergies, current illness, lab data and medical history was reported by patient.  No concomitant medications were reported.  No treatment information was reported.