chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash ten days later in some parts of body/the rash appears in one part of the body and sometimes in another part; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash ten days later in some parts of body/the rash appears in one part of the body and sometimes in another part) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third 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 and 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 ten days later in some parts of body/the rash appears in one part of the body and sometimes in another part). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (rash ten days later in some parts of body/the rash appears in one part of the body and sometimes in another part) had not resolved.            No concomitant medication were reported. Other treatment drugs included antihistamine, for rash.  Patient received the Booster dose of the Moderna COVID-19 vaccine and was experiencing a rash ten days later in some parts of his body. Sometimes the rash appeared in one part of the body and sometimes in another part. The reporter mentioned having seen the doctor, who prescribed prednisone and antihistamine. However nothing seemed to cure the patient.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Hypokinesia
Clinical narrative: Intense cold sensation, cold all over the body; Was not able to move; Shivering and Teeth trembling (like a start of hypothermia); This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Intense cold sensation, cold all over the body), HYPOKINESIA (Was not able to move) and CHILLS (Shivering and Teeth trembling (like a start of hypothermia)) 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.    In May 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 FEELING COLD (Intense cold sensation, cold all over the body), HYPOKINESIA (Was not able to move) and CHILLS (Shivering and Teeth trembling (like a start of hypothermia)). At the time of the report, FEELING COLD (Intense cold sensation, cold all over the body), HYPOKINESIA (Was not able to move) and CHILLS (Shivering and Teeth trembling (like a start of hypothermia)) outcome was unknown. Not Provided          No concomitant medications were provided.  No treatment medications were provided.  Patient had shivering and teeth trembling (like a start of hypothermia) and this went on for a few hours the patient was not able to move.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I had a headache, I've had constant headaches, since I got that booster shot.; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I had a headache, I've had constant headaches, since I got that booster shot.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (I had a headache, I've had constant headaches, since I got that booster shot.). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (I had a headache, I've had constant headaches, since I got that booster shot.) had not resolved.            Concomitant product use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: still have fever of 101; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (still have fever of 101) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PYREXIA (still have fever of 101). At the time of the report, PYREXIA (still have fever of 101) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) fever of 101.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant treatment was provided.  No treatment medication was provided.  Patient had received booster dose on 15-DEC-2021 at 3 O Clock. Patient was still experiencing Fever of 101.
Sex: U
Vaccine: COVID19
Symptoms: Dysuria, Mobility decreased, Somnolence
Clinical narrative: couldnt hardly move/went to sleep and didn't wake up until time to get ready for work; had to take off of work and slept the whole day unt; cant urinate properly; This spontaneous case was reported by an other health care professional and describes the occurrence of MOBILITY DECREASED (couldnt hardly move/went to sleep and didn't wake up until time to get ready for work), SOMNOLENCE (had to take off of work and slept the whole day unt) and DYSURIA (cant urinate properly) 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 MOBILITY DECREASED (couldnt hardly move/went to sleep and didn't wake up until time to get ready for work), SOMNOLENCE (had to take off of work and slept the whole day unt) and DYSURIA (cant urinate properly). At the time of the report, MOBILITY DECREASED (couldnt hardly move/went to sleep and didn't wake up until time to get ready for work), SOMNOLENCE (had to take off of work and slept the whole day unt) and DYSURIA (cant urinate properly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Today is dizzy; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Today is dizzy) 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 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced DIZZINESS (Today is dizzy). At the time of the report, DIZZINESS (Today is dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported.   Reporter did not allow further contact
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Vaccination complication
Clinical narrative: Feeling like a vegetable; Sick; My body was a bit upside down; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling like a vegetable), ILLNESS (Sick) and VACCINATION COMPLICATION (My body was a bit upside down) in a 55-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 FEELING ABNORMAL (Feeling like a vegetable), ILLNESS (Sick) and VACCINATION COMPLICATION (My body was a bit upside down). At the time of the report, FEELING ABNORMAL (Feeling like a vegetable), ILLNESS (Sick) and VACCINATION COMPLICATION (My body was a bit upside down) outcome was unknown. Not Provided          It was reported that the patient took the second dose 2 months ago and body was a bit upside down but since 2 weeks now the patient had sick feeling like a vegetable.  No Concomitant medication were reported. No treatment medication were reported.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Rash erythematous, Rash pruritic, Skin mass
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (lump on my forehead), RASH PRURITIC (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was itchy) and RASH ERYTHEMATOUS (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was red) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced RASH PRURITIC (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was itchy) and RASH ERYTHEMATOUS (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was red). On an unknown date, the patient experienced SKIN MASS (lump on my forehead). At the time of the report, SKIN MASS (lump on my forehead) outcome was unknown and RASH PRURITIC (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was itchy) and RASH ERYTHEMATOUS (Rash on his back which progressed to his upper chest, forehead, shoulders, forearms, and underside of his arms/ rash was red) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: result not provided Result not provided and non-canerous (normal) Non-canerous. Patient took an unspecified 1% lotion for the rash, then a different lotion after seeing the dermatologist which helped with his symptoms. No concomitant medications were reported. Patient's rash started to clear up in October and in the same month he saw a dermatologist.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Sinus congestion
Clinical narrative: sore throat; sinus congestion; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) and SINUS CONGESTION (sinus congestion) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 032M20A) 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) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) and SINUS CONGESTION (sinus congestion). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Sore throat and Sinus congestion, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat) and SINUS CONGESTION (sinus congestion) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative covid-19 tests and negative (Negative) Negative covid-19 tests.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   For the past 2 weeks patient has had a sore throat and sinus congestion that has started to get better. No relevant concomitant medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. In April 2021, CHILLS (chills) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided.   This case was linked to MOD-2021-415851, MOD-2021-415852 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced HEADACHE (headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 1 dosage form once a day. In May 2021, HEADACHE (headache) and CHILLS (chills) had resolved.            No medical history was provided by the reporter No concomitant medications reported.   This case was linked to MOD-2021-415850, MOD-2021-415852 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dizziness, Dyspnoea, Nasal congestion
Clinical narrative: bad breathing problems; heart palpitations; loss of balance; stuffy nose; dizziness; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (bad breathing problems), PALPITATIONS (heart palpitations), BALANCE DISORDER (loss of balance), NASAL CONGESTION (stuffy nose) and DIZZINESS (dizziness) in a 59-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.     Concurrent medical conditions included Asthma.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced DYSPNOEA (bad breathing problems), PALPITATIONS (heart palpitations), BALANCE DISORDER (loss of balance), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (bad breathing problems), PALPITATIONS (heart palpitations), BALANCE DISORDER (loss of balance), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Patient reported that chills and stuffy nose started first, followed by heart palpitations within 4 hours of the start of symptoms. She had no previous diagnoses of COVID-19, myocarditis or pericarditis.  No relevant concomitant medications were reported.   This case was linked to MOD-2021-415851, MOD-2021-415850 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: bad breathing problems; heart palpitations; loss of balance; stuffy nose; dizziness; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (bad breathing problems), PALPITATIONS (heart palpitations), BALANCE DISORDER (loss of balance), NASAL CONGESTION (stuffy nose) and DIZZINESS (dizziness) in a 59-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.     Concurrent medical conditions included Asthma.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient experienced DYSPNOEA (bad breathing problems), PALPITATIONS (heart palpitations), BALANCE DISORDER (loss of balance), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (bad breathing problems), PALPITATIONS (heart palpitations), BALANCE DISORDER (loss of balance), NASAL CONGESTION (stuffy nose), DIZZINESS (dizziness), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Patient reported that chills and stuffy nose started first, followed by heart palpitations within 4 hours of the start of symptoms. She had no previous diagnoses of COVID-19, myocarditis or pericarditis.  No relevant concomitant medications were reported.   This case was linked to MOD-2021-415851, MOD-2021-415850 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose increased, Burning sensation, Chills, Headache
Clinical narrative: arm was swelled up, really hard, hurt, burned; arm was swelled up, really hard, hurt, burned; arm was swelled up, really hard, hurt, burned; arm was swelled up, really hard, hurt, burned/ burning up; freezing,shaking all over,tremors; muscle spasm in legs; chills; joints on neck side and back; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swelled up, really hard, hurt, burned), PAIN IN EXTREMITY (arm was swelled up, really hard, hurt, burned), INDURATION (arm was swelled up, really hard, hurt, burned), BURNING SENSATION (arm was swelled up, really hard, hurt, burned/ burning up) and TREMOR (freezing,shaking all over,tremors) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045T21A, 0c2A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FELODIPINE, LOSARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), ALLOPURINOL, PRAVASTATIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm was swelled up, really hard, hurt, burned), PAIN IN EXTREMITY (arm was swelled up, really hard, hurt, burned), INDURATION (arm was swelled up, really hard, hurt, burned), BURNING SENSATION (arm was swelled up, really hard, hurt, burned/ burning up), TREMOR (freezing,shaking all over,tremors), MUSCLE SPASMS (muscle spasm in legs), CHILLS (chills), ARTHRALGIA (joints on neck side and back) and HEADACHE (terrible headache). At the time of the report, PERIPHERAL SWELLING (arm was swelled up, really hard, hurt, burned), PAIN IN EXTREMITY (arm was swelled up, really hard, hurt, burned), INDURATION (arm was swelled up, really hard, hurt, burned), BURNING SENSATION (arm was swelled up, really hard, hurt, burned/ burning up), TREMOR (freezing,shaking all over,tremors), MUSCLE SPASMS (muscle spasm in legs), CHILLS (chills), ARTHRALGIA (joints on neck side and back) and HEADACHE (terrible headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: 161 (High) blood sugars at high at 161..         No treatment medication information provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Muscle spasms, Pain in extremity, Peripheral swelling, Tremor
Clinical narrative: arm was swelled up, really hard, hurt, burned; arm was swelled up, really hard, hurt, burned; arm was swelled up, really hard, hurt, burned; arm was swelled up, really hard, hurt, burned/ burning up; freezing,shaking all over,tremors; muscle spasm in legs; chills; joints on neck side and back; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swelled up, really hard, hurt, burned), PAIN IN EXTREMITY (arm was swelled up, really hard, hurt, burned), INDURATION (arm was swelled up, really hard, hurt, burned), BURNING SENSATION (arm was swelled up, really hard, hurt, burned/ burning up) and TREMOR (freezing,shaking all over,tremors) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045T21A, 0c2A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FELODIPINE, LOSARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), ALLOPURINOL, PRAVASTATIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm was swelled up, really hard, hurt, burned), PAIN IN EXTREMITY (arm was swelled up, really hard, hurt, burned), INDURATION (arm was swelled up, really hard, hurt, burned), BURNING SENSATION (arm was swelled up, really hard, hurt, burned/ burning up), TREMOR (freezing,shaking all over,tremors), MUSCLE SPASMS (muscle spasm in legs), CHILLS (chills), ARTHRALGIA (joints on neck side and back) and HEADACHE (terrible headache). At the time of the report, PERIPHERAL SWELLING (arm was swelled up, really hard, hurt, burned), PAIN IN EXTREMITY (arm was swelled up, really hard, hurt, burned), INDURATION (arm was swelled up, really hard, hurt, burned), BURNING SENSATION (arm was swelled up, really hard, hurt, burned/ burning up), TREMOR (freezing,shaking all over,tremors), MUSCLE SPASMS (muscle spasm in legs), CHILLS (chills), ARTHRALGIA (joints on neck side and back) and HEADACHE (terrible headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: 161 (High) blood sugars at high at 161..         No treatment medication information provided.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: administered a .5ml booster dose,not aware that she had been administered 2nd dose in February; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (administered a .5ml booster dose,not aware that she had been administered 2nd dose in February) 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) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (administered a .5ml booster dose,not aware that she had been administered 2nd dose in February). At the time of the report, ACCIDENTAL OVERDOSE (administered a .5ml booster dose,not aware that she had been administered 2nd dose in February) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient 2nd dose had been administered in February. No Concomitant Drug details were reported.  No Treatment information was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: They gave a patient Moderna vaccine past 12 hours after vial was punctured. Reporter further stated it was 23 hours after vial was punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave a patient Moderna vaccine past 12 hours after vial was punctured. Reporter further stated it was 23 hours after vial was punctured) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave a patient Moderna vaccine past 12 hours after vial was punctured. Reporter further stated it was 23 hours after vial was punctured). On 16-Dec-2021, EXPIRED PRODUCT ADMINISTERED (They gave a patient Moderna vaccine past 12 hours after vial was punctured. Reporter further stated it was 23 hours after vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No temperature excursion was reported. No concomitant medications were reported.  Treatment information was not provided.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Influenza like illness
Clinical narrative: Flu-like feeling; Had major headaches; I had severe lower backpain.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like feeling), BACK PAIN (I had severe lower backpain.) and HEADACHE (Had major headaches) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like feeling) and HEADACHE (Had major headaches). In December 2021, the patient experienced BACK PAIN (I had severe lower backpain.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 13-Dec-2021, INFLUENZA LIKE ILLNESS (Flu-like feeling) and HEADACHE (Had major headaches) had resolved. In December 2021, BACK PAIN (I had severe lower backpain.) had resolved.            No concomitant medications were reported Patient had reported that she did not had rising temperature.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache, Influenza like illness
Clinical narrative: flu-like feeling; We both had major headaches; i had severe lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like feeling), BACK PAIN (i had severe lower back pain) and HEADACHE (We both had major headaches) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.     On 11-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like feeling) and HEADACHE (We both had major headaches). In December 2021, the patient experienced BACK PAIN (i had severe lower back pain). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) 12-Dec-2021 for Adverse event, at an unspecified dose and frequency. On 13-Dec-2021, INFLUENZA LIKE ILLNESS (flu-like feeling) and HEADACHE (We both had major headaches) had resolved. In December 2021, BACK PAIN (i had severe lower back pain) had resolved.            No concomitant medications was reported.   This case was linked to MOD-2021-415871 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient was given a vaccine that was past the 12 hours viable; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was given a vaccine that was past the 12 hours viable) 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 (patient was given a vaccine that was past the 12 hours viable). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was given a vaccine that was past the 12 hours viable) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: One shot of AstraZeneca and one of Moderna (Interchangeability); Patient received a first shot of AstraZeneca. Then, patient went and got a first shot of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (One shot of AstraZeneca and one of Moderna (Interchangeability)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a first shot of AstraZeneca. Then, patient went to the US, and got a first shot of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Astrazeneca (First shot). Past adverse reactions to the above products included No adverse event with Astrazeneca.    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 INTERCHANGE OF VACCINE PRODUCTS (One shot of AstraZeneca and one of Moderna (Interchangeability)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a first shot of AstraZeneca. Then, patient went and got a first shot of the Moderna vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (One shot of AstraZeneca and one of Moderna (Interchangeability)) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received a first shot of AstraZeneca in India. Then, patient went and got a first shot of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 02-Jul-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not report any adverse events or symptoms. Concomitant medication was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives; Really bad fever; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (Hives) and PYREXIA (Really bad 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives) and PYREXIA (Really bad fever). At the time of the report, URTICARIA (Hives) and PYREXIA (Really bad fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 02-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800 to 900 (Inconclusive) All the patient's antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information  were reported.  It was reported that they got 10 vials Moderna vaccine 037C21A delivered on 24-May-2021 and immediately placed the vaccine into refrigerated storage. Then stated that the doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator and they administered that vaccine to patients after that 30-day mark. That vaccine vials were never punched until use. Reporter reported that the vaccine was given unknown amount to patient past 30-day beyond use date BUD. Patient did not report any adverse events or symptoms.   This case was linked to MOD-2021-415889.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cold sweat, Headache, Myalgia, Presyncope
Clinical narrative: cold sweats (almost fainted as reported by the person),; Pain in chest; almost fainted as reported by the person; Headache; body pains; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats (almost fainted as reported by the person),), CHEST PAIN (Pain in chest), PRESYNCOPE (almost fainted as reported by the person), HEADACHE (Headache) and MYALGIA (body pains) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COLD SWEAT (cold sweats (almost fainted as reported by the person),), CHEST PAIN (Pain in chest), PRESYNCOPE (almost fainted as reported by the person), HEADACHE (Headache) and MYALGIA (body pains). At the time of the report, COLD SWEAT (cold sweats (almost fainted as reported by the person),), CHEST PAIN (Pain in chest), PRESYNCOPE (almost fainted as reported by the person), HEADACHE (Headache) and MYALGIA (body pains) outcome was unknown.            The patient mentioned that he had laxative medication. Treatment information was not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: administered this vaccine to patients after this 30-day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800 to 900 (Inconclusive) All the patient's antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that they got 10 vials Moderna vaccine (037C21A) delivered on 24-May-2021 and immediately placed the vaccine into refrigerated storage. Then stated that the doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator and they administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use. Reporter reported that the vaccine was given unknown amount to patient past 30-day beyond use date (BUD). Patient did not report any adverse events or symptoms.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 15-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  The caller stated that they administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use and the doctor at the office wants to know if what else should be done. The office manager stated that they called ever patient the following day and no adverse events were noted, and they performed an antibody test on all of them and the patients antibody numbers were in the 800-900 range.    This case was linked to (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) 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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            No concomitant medications reported. No treatment medications reported.  It was reported that patient received booster shot 2 days ago.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 23-Jul-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.   This case was linked to (Patient Link).
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: expired doses administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Dec-2021 and was forwarded to Moderna on 15-Dec-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 05-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (abnormal) antibody numbers were in the 800-900 range..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Treatment medications were provided No  Concomitant medications were provided
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, 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 (expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) patients antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that office manager called in and stated that they got 10 vials Moderna vaccine (037C21A) delivered in on 24May2021 and immediately placed the vaccine into refrigerated storage. The indicated that the doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator. The caller stated that they administered this vaccine to patients after this 30-day mark.   This case was linked to MOD-2021-415889 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist's stated that the beyond the use date is 09Dec2021 at 10:00PM. No concomitant medication provided. No treatment information were provided.