chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Terrible itch all over his body; Terrible red rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Terrible itch all over his body) and RASH ERYTHEMATOUS (Terrible red rash all over his body) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced PRURITUS (Terrible itch all over his body) and RASH ERYTHEMATOUS (Terrible red rash all over his body). The patient was treated with CLOBETASOL for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Terrible itch all over his body) and RASH ERYTHEMATOUS (Terrible red rash all over his body) had not resolved.            No concomitant medications were reported. Patient has been using treatments but it was reported that nothing seemed to help his side effects to completely go away. He was reported to be under doctor's care.
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Pain, Pyrexia
Clinical narrative: Constipation; Sharp pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (constipation), PAIN (sharp pain) and PYREXIA (fever) in a female patient of an unknown age 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, the patient experienced CONSTIPATION (constipation), PAIN (sharp pain) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, CONSTIPATION (constipation) and PAIN (sharp pain) outcome was unknown and PYREXIA (fever) had resolved.            No concomitant medication were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: blood coming out of her right nostril; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (blood coming out of her right nostril) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced EPISTAXIS (blood coming out of her right nostril). On 23-Jan-2021, EPISTAXIS (blood coming out of her right nostril) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-026419 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain at left arm; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle pain at left 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain at left arm). At the time of the report, MYALGIA (Muscle pain at left arm) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: Could not get out of bed; Legs were hurting as if she had restless leg syndrome; Tiredness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Could not get out of bed), PAIN IN EXTREMITY (Legs were hurting as if she had restless leg syndrome), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Tiredness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Restless leg syndrome.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Sore arm). On 27-Mar-2021, the patient experienced BEDRIDDEN (Could not get out of bed), PAIN IN EXTREMITY (Legs were hurting as if she had restless leg syndrome) and FATIGUE (Tiredness). At the time of the report, BEDRIDDEN (Could not get out of bed), PAIN IN EXTREMITY (Legs were hurting as if she had restless leg syndrome), VACCINATION SITE PAIN (Sore arm) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: I got the Moderna shot on Sunday. Today I have green poop. Is that a side effect?; This spontaneous case was reported by a consumer and describes the occurrence of FAECES DISCOLOURED (I got the Moderna shot on Sunday. Today I have green poop. Is that a side effect?) 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 24-Aug-2021, the patient experienced FAECES DISCOLOURED (I got the Moderna shot on Sunday. Today I have green poop. Is that a side effect?). At the time of the report, FAECES DISCOLOURED (I got the Moderna shot on Sunday. Today I have green poop. Is that a side effect?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza, Myalgia
Clinical narrative: flu symptoms; severe headache; aches; chills; This spontaneous case was reported by a non-health professional and describes the occurrence of INFLUENZA (flu symptoms), HEADACHE (severe headache), MYALGIA (aches) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INFLUENZA (flu symptoms), HEADACHE (severe headache), MYALGIA (aches) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 27-Jan-2021, HEADACHE (severe headache) had resolved. At the time of the report, INFLUENZA (flu symptoms), MYALGIA (aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-295648 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Received Moderna vaccine when he wanted Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine). At the time of the report, NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided. This spontaneous case was reported by a consumer and describes the occurrence of NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine). At the time of the report, NO ADVERSE EVENT (Received Moderna vaccine when he wanted Pfizer vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Received 3rd dose 6 months after 2nd dose as a precaution; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 3rd dose 6 months after 2nd dose as a precaution) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received 3rd dose 6 months after 2nd dose as a precaution). At the time of the report, EXTRA DOSE ADMINISTERED (Received 3rd dose 6 months after 2nd dose as a precaution) had resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose of the Moderna Covid vaccine is given after the expiration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Covid vaccine is given after the expiration) 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 EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Covid vaccine is given after the expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose of the Moderna Covid vaccine is given after the expiration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Chest pain, Dizziness, Fatigue
Clinical narrative: red hot patch; big red square right underneath injection site; tired; nauseous; feel pain in my left side of chest / pain in chest sharp short pain; dizzy; Burning; Aching; throbbing; pain shoulder to fingers; under arm lymph note was swollen; arm was severally sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain), DIZZINESS (dizzy), BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching) and MYALGIA (throbbing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced MYALGIA (arm was severally sore). On 20-Aug-2021, the patient experienced BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching), MYALGIA (throbbing), LYMPHADENOPATHY (under arm lymph note was swollen) and ARTHRALGIA (pain shoulder to fingers). On 23-Aug-2021, the patient experienced CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain). 23-Aug-2021, the patient experienced DIZZINESS (dizzy), NAUSEA (nauseous) and FATIGUE (tired). On 24-Aug-2021, the patient experienced INJECTION SITE ERYTHEMA (big red square right underneath injection site). On 25-Aug-2021, the patient experienced RASH (red hot patch). At the time of the report, CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain), RASH (red hot patch) and MYALGIA (arm was severally sore) outcome was unknown and DIZZINESS (dizzy), BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching), MYALGIA (throbbing), NAUSEA (nauseous), LYMPHADENOPATHY (under arm lymph note was swollen), INJECTION SITE ERYTHEMA (big red square right underneath injection site), FATIGUE (tired) and ARTHRALGIA (pain shoulder to fingers) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient was extremely healthy and great cardio shape.  Patient states that she took birth control pills.  No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up received and updated concomitant medication.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Lymphadenopathy, Myalgia, Nausea, Pain in extremity
Clinical narrative: red hot patch; big red square right underneath injection site; tired; nauseous; feel pain in my left side of chest / pain in chest sharp short pain; dizzy; Burning; Aching; throbbing; pain shoulder to fingers; under arm lymph note was swollen; arm was severally sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain), DIZZINESS (dizzy), BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching) and MYALGIA (throbbing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced MYALGIA (arm was severally sore). On 20-Aug-2021, the patient experienced BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching), MYALGIA (throbbing), LYMPHADENOPATHY (under arm lymph note was swollen) and ARTHRALGIA (pain shoulder to fingers). On 23-Aug-2021, the patient experienced CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain). 23-Aug-2021, the patient experienced DIZZINESS (dizzy), NAUSEA (nauseous) and FATIGUE (tired). On 24-Aug-2021, the patient experienced INJECTION SITE ERYTHEMA (big red square right underneath injection site). On 25-Aug-2021, the patient experienced RASH (red hot patch). At the time of the report, CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain), RASH (red hot patch) and MYALGIA (arm was severally sore) outcome was unknown and DIZZINESS (dizzy), BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching), MYALGIA (throbbing), NAUSEA (nauseous), LYMPHADENOPATHY (under arm lymph note was swollen), INJECTION SITE ERYTHEMA (big red square right underneath injection site), FATIGUE (tired) and ARTHRALGIA (pain shoulder to fingers) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient was extremely healthy and great cardio shape.  Patient states that she took birth control pills.  No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up received and updated concomitant medication.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: red hot patch; big red square right underneath injection site; tired; nauseous; feel pain in my left side of chest / pain in chest sharp short pain; dizzy; Burning; Aching; throbbing; pain shoulder to fingers; under arm lymph note was swollen; arm was severally sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain), DIZZINESS (dizzy), BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching) and MYALGIA (throbbing) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced MYALGIA (arm was severally sore). On 20-Aug-2021, the patient experienced BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching), MYALGIA (throbbing), LYMPHADENOPATHY (under arm lymph note was swollen) and ARTHRALGIA (pain shoulder to fingers). On 23-Aug-2021, the patient experienced CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain). 23-Aug-2021, the patient experienced DIZZINESS (dizzy), NAUSEA (nauseous) and FATIGUE (tired). On 24-Aug-2021, the patient experienced INJECTION SITE ERYTHEMA (big red square right underneath injection site). On 25-Aug-2021, the patient experienced RASH (red hot patch). At the time of the report, CHEST PAIN (feel pain in my left side of chest / pain in chest sharp short pain), RASH (red hot patch) and MYALGIA (arm was severally sore) outcome was unknown and DIZZINESS (dizzy), BURNING SENSATION (Burning), PAIN IN EXTREMITY (Aching), MYALGIA (throbbing), NAUSEA (nauseous), LYMPHADENOPATHY (under arm lymph note was swollen), INJECTION SITE ERYTHEMA (big red square right underneath injection site), FATIGUE (tired) and ARTHRALGIA (pain shoulder to fingers) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient was extremely healthy and great cardio shape.  Patient states that she took birth control pills.  No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up received and updated concomitant medication.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (side effects). At the time of the report, ADVERSE EVENT (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: My leg has been asleep for about an hour after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (My leg has been asleep for about an hour after 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 25-Aug-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 HYPOAESTHESIA (My leg has been asleep for about an hour after 2nd dose). At the time of the report, HYPOAESTHESIA (My leg has been asleep for about an hour after 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were reported. no treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient did not receive the second dose injection; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-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 PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose injection). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient did not receive the second dose injection) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Family members experienced a rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Family members experienced a rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Family members experienced a rash). At the time of the report, RASH (Family members experienced a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain assessment, Pain in extremity, Tremor
Clinical narrative: cant grasp, hand start to shake; can barely lift without elbow pain; pain on injected arm; Elbow pain; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (cant grasp, hand start to shake), PAIN (can barely lift without elbow pain), PAIN IN EXTREMITY (pain on injected arm) and ARTHRALGIA (Elbow pain) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis (he was born with rheumatoid arthritis), Seasonal allergy and Shellfish allergy. Concomitant products included LISINOPRIL for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced TREMOR (cant grasp, hand start to shake), PAIN (can barely lift without elbow pain), PAIN IN EXTREMITY (pain on injected arm) and ARTHRALGIA (Elbow pain). The patient was treated with PREDNISONE at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. At the time of the report, TREMOR (cant grasp, hand start to shake), PAIN (can barely lift without elbow pain), PAIN IN EXTREMITY (pain on injected arm) and ARTHRALGIA (Elbow pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pain assessment: 8 to 9 (abnormal) Pain scale could range from 8 to 9 out of 10, 10 being the highest, indicates Very severe pain.         The patient stated  that he was born with rheumatoid arthritis, but after his 1st dose, his knees swell incredibly.  After 2nd dose, it was not nearly as bad but he can barely lift without elbow pain. Pain scale could range from 8 to 9 out of 10, 10 being the highest.   This case was linked to MOD-2021-295807 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Headache, Insomnia, Interchange of vaccine products, Musculoskeletal stiffness
Clinical narrative: pain from neck to shoulder area; both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,; both real stiff; cough; Runny nose; could not leep last night; had a slight headache; body is achy; Received pfizer as the first dose and Moderna as the second; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain from neck to shoulder area), PAIN IN EXTREMITY (both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,), MUSCULOSKELETAL STIFFNESS (both real stiff), COUGH (cough) and RHINORRHOEA (Runny nose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concomitant products included LAMOTRIGINE and IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.   On 03-Aug-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain from neck to shoulder area), PAIN IN EXTREMITY (both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,), MUSCULOSKELETAL STIFFNESS (both real stiff), COUGH (cough), RHINORRHOEA (Runny nose), INSOMNIA (could not leep last night), HEADACHE (had a slight headache), MYALGIA (body is achy) and INTERCHANGE OF VACCINE PRODUCTS (Received pfizer as the first dose and Moderna as the second). At the time of the report, NECK PAIN (pain from neck to shoulder area), PAIN IN EXTREMITY (both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,), MUSCULOSKELETAL STIFFNESS (both real stiff), COUGH (cough), RHINORRHOEA (Runny nose), INSOMNIA (could not leep last night), HEADACHE (had a slight headache) and MYALGIA (body is achy) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Received pfizer as the first dose and Moderna as the second) had resolved.            Reportedly, Patient was planning to visit Emergency room if she did not feel better.  No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: significant Follow up appended.Suspect product information : Start date and Dose number was updated, Events added
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Neck pain, Pain in extremity, Rhinorrhoea
Clinical narrative: pain from neck to shoulder area; both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,; both real stiff; cough; Runny nose; could not leep last night; had a slight headache; body is achy; Received pfizer as the first dose and Moderna as the second; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain from neck to shoulder area), PAIN IN EXTREMITY (both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,), MUSCULOSKELETAL STIFFNESS (both real stiff), COUGH (cough) and RHINORRHOEA (Runny nose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concomitant products included LAMOTRIGINE and IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication.   On 03-Aug-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (pain from neck to shoulder area), PAIN IN EXTREMITY (both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,), MUSCULOSKELETAL STIFFNESS (both real stiff), COUGH (cough), RHINORRHOEA (Runny nose), INSOMNIA (could not leep last night), HEADACHE (had a slight headache), MYALGIA (body is achy) and INTERCHANGE OF VACCINE PRODUCTS (Received pfizer as the first dose and Moderna as the second). At the time of the report, NECK PAIN (pain from neck to shoulder area), PAIN IN EXTREMITY (both arms are hurting/opposite arm that got the shot is hurting,stabbing pain her left leg,), MUSCULOSKELETAL STIFFNESS (both real stiff), COUGH (cough), RHINORRHOEA (Runny nose), INSOMNIA (could not leep last night), HEADACHE (had a slight headache) and MYALGIA (body is achy) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Received pfizer as the first dose and Moderna as the second) had resolved.            Reportedly, Patient was planning to visit Emergency room if she did not feel better.  No treatment medication was provided   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: significant Follow up appended.Suspect product information : Start date and Dose number was updated, Events added
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal
Clinical narrative: Issues with being fuzzy headed; Achy joints; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Issues with being fuzzy headed) and ARTHRALGIA (Achy joints) 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 FEELING ABNORMAL (Issues with being fuzzy headed) and ARTHRALGIA (Achy joints). At the time of the report, FEELING ABNORMAL (Issues with being fuzzy headed) and ARTHRALGIA (Achy joints) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported.  Treatment medication were not reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Insomnia, Menstrual disorder, Myalgia
Clinical narrative: bad peroid; insomnia; drowsiness; sore arm; tired; bad body pains; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (bad peroid), INSOMNIA (insomnia), SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) for an unknown indication.    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 MENSTRUAL DISORDER (bad peroid), INSOMNIA (insomnia), SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and MYALGIA (bad body pains). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, MENSTRUAL DISORDER (bad peroid), INSOMNIA (insomnia), SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and MYALGIA (bad body pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: higher (High) Increased.         Patient mentioned that  Would get tired and then by the time she she gets in bed drowsiness goes away and heart rate will increases preventing her from falls asleep and is no longer tired and took Nyquil and other medications to fall asleep which did not help.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: bad peroid; insomnia; drowsiness; sore arm; tired; bad body pains; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (bad peroid), INSOMNIA (insomnia), SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) for an unknown indication.    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 MENSTRUAL DISORDER (bad peroid), INSOMNIA (insomnia), SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and MYALGIA (bad body pains). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, MENSTRUAL DISORDER (bad peroid), INSOMNIA (insomnia), SOMNOLENCE (drowsiness), PAIN IN EXTREMITY (sore arm), FATIGUE (tired) and MYALGIA (bad body pains) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate increased: higher (High) Increased.         Patient mentioned that  Would get tired and then by the time she she gets in bed drowsiness goes away and heart rate will increases preventing her from falls asleep and is no longer tired and took Nyquil and other medications to fall asleep which did not help.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: got first dose on 15/May/2021 and didn't get second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got first dose on 15/May/2021 and didn't get second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-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 PRODUCT DOSE OMISSION ISSUE (got first dose on 15/May/2021 and didn't get second dose).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Product dose omission issue, Pruritus, SARS-CoV-2 test
Clinical narrative: first dose on 17 july, second dose not yet taken; my skin was itching; headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (my skin was itching), HEADACHE (headache) and PRODUCT DOSE OMISSION ISSUE (first dose on 17 july, second dose not yet taken) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Jul-2021, the patient experienced PRURITUS (my skin was itching) and HEADACHE (headache). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose on 17 july, second dose not yet taken). On 19-Jul-2021, PRURITUS (my skin was itching) and HEADACHE (headache) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose on 17 july, second dose not yet taken) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, SARS-CoV-2 test: positve (Positive) POSITVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Body temperature, Dysphonia, Dyspnoea, Ear pain
Clinical narrative: sudden loss of memory/memory problems; Head fullness; Tinnitus; Irregular heart rate/palpitations; Difficulty breathing; Hoarseness; Numbness; Inner ear pain; Acid reflux; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations) and DYSPNOEA (Difficulty breathing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Ciproflocxin drug allergy neuropathy temporary 5 most) since 23-Jun-2021 and Drug hypersensitivity (Botox drug allergy throat tightness for one week.) since 01-Apr-2009. Concomitant products included VITAMIN D NOS for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), HYPOAESTHESIA (Numbness), EAR PAIN (Inner ear pain) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). At the time of the report, AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), HYPOAESTHESIA (Numbness), EAR PAIN (Inner ear pain) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.7 °F (normal) 98.7 degree F. On an unknown date, Heart rate: 120 (High) Beats per minute and >100 (High) >100 beats per min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided by the reporter.  Patient taken X-RAY on July 2021 by ENT.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Head discomfort, Heart rate, Hypoaesthesia, Palpitations
Clinical narrative: sudden loss of memory/memory problems; Head fullness; Tinnitus; Irregular heart rate/palpitations; Difficulty breathing; Hoarseness; Numbness; Inner ear pain; Acid reflux; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations) and DYSPNOEA (Difficulty breathing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Ciproflocxin drug allergy neuropathy temporary 5 most) since 23-Jun-2021 and Drug hypersensitivity (Botox drug allergy throat tightness for one week.) since 01-Apr-2009. Concomitant products included VITAMIN D NOS for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), HYPOAESTHESIA (Numbness), EAR PAIN (Inner ear pain) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). At the time of the report, AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), HYPOAESTHESIA (Numbness), EAR PAIN (Inner ear pain) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.7 °F (normal) 98.7 degree F. On an unknown date, Heart rate: 120 (High) Beats per minute and >100 (High) >100 beats per min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided by the reporter.  Patient taken X-RAY on July 2021 by ENT.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: sudden loss of memory/memory problems; Head fullness; Tinnitus; Irregular heart rate/palpitations; Difficulty breathing; Hoarseness; Numbness; Inner ear pain; Acid reflux; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations) and DYSPNOEA (Difficulty breathing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Ciproflocxin drug allergy neuropathy temporary 5 most) since 23-Jun-2021 and Drug hypersensitivity (Botox drug allergy throat tightness for one week.) since 01-Apr-2009. Concomitant products included VITAMIN D NOS for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), HYPOAESTHESIA (Numbness), EAR PAIN (Inner ear pain) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux). At the time of the report, AMNESIA (sudden loss of memory/memory problems), HEAD DISCOMFORT (Head fullness), TINNITUS (Tinnitus), PALPITATIONS (Irregular heart rate/palpitations), DYSPNOEA (Difficulty breathing), DYSPHONIA (Hoarseness), HYPOAESTHESIA (Numbness), EAR PAIN (Inner ear pain) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.7 °F (normal) 98.7 degree F. On an unknown date, Heart rate: 120 (High) Beats per minute and >100 (High) >100 beats per min.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided by the reporter.  Patient taken X-RAY on July 2021 by ENT.