chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Colonoscopy, Endoscopy, Myalgia
Clinical narrative: chest pain in the upper left chest with pain radiating to left arm; Pain experienced is with exercise or exertion, can't do activities without having pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain in the upper left chest with pain radiating to left arm) and MYALGIA (Pain experienced is with exercise or exertion, can't do activities without having pain) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 027A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), TACROLIMUS, PREDNISONE, ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D3), ATORVASTATIN, LOSARTAN and MAGNESIUM OXIDE for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced CHEST PAIN (chest pain in the upper left chest with pain radiating to left arm) and MYALGIA (Pain experienced is with exercise or exertion, can't do activities without having pain). At the time of the report, CHEST PAIN (chest pain in the upper left chest with pain radiating to left arm) and MYALGIA (Pain experienced is with exercise or exertion, can't do activities without having pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: inconclusive (Inconclusive) Inconclusive. On an unknown date, Colonoscopy: inconclusive (Inconclusive) Inconclusive. On an unknown date, Endoscopy: inconclusive (Inconclusive) Inconclusive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Glossodynia
Clinical narrative: My tongue has been stinging ever since; difficult for her to eat because of it; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (My tongue has been stinging ever since) and FEEDING DISORDER (difficult for her to eat because of it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Lip operation (procedure to her top lip where liquid nitrogen was used).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced GLOSSODYNIA (My tongue has been stinging ever since) and FEEDING DISORDER (difficult for her to eat because of it). At the time of the report, GLOSSODYNIA (My tongue has been stinging ever since) and FEEDING DISORDER (difficult for her to eat because of it) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Gait inability, Rash
Clinical narrative: Unable to walk; Rash with Blisters all over the body; Rash with Blisters all over the body; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Unable to walk), BLISTER (Rash with Blisters all over the body) and RASH (Rash with Blisters all over the body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced BLISTER (Rash with Blisters all over the body) and RASH (Rash with Blisters all over the body). On 18-Jun-2021, the patient experienced GAIT INABILITY (Unable to walk). The patient was treated with DEXAMETHASONE (DECADRON [DEXAMETHASONE]) at an unspecified dose and frequency. At the time of the report, GAIT INABILITY (Unable to walk), BLISTER (Rash with Blisters all over the body) and RASH (Rash with Blisters all over the body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events were not Applicable. No concomitant medications were reported. The patient was injected with a steroid and waited for results to see if she needed to go to the emergency room.   This case was linked to MOD-2021-229617 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fibromyalgia, Musculoskeletal stiffness, Myalgia
Clinical narrative: Stiffness all over my body; Fibromyalgia; Pain all over my body/muscle pain all over; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness all over my body), FIBROMYALGIA (Fibromyalgia) and MYALGIA (Pain all over my body/muscle pain all over) 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 MUSCULOSKELETAL STIFFNESS (Stiffness all over my body), FIBROMYALGIA (Fibromyalgia) and MYALGIA (Pain all over my body/muscle pain all over). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness all over my body), FIBROMYALGIA (Fibromyalgia) and MYALGIA (Pain all over my body/muscle pain all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient has not received the second dose of the vaccine and it has been more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine and it has been more than 36 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine and it has been more than 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine and it has been more than 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: Can't lift left arm fully or extend it all the way back; Pain in injection arm; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Can't lift left arm fully or extend it all the way back) and VACCINATION SITE PAIN (Pain in injection arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02521A and 04C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MOBILITY DECREASED (Can't lift left arm fully or extend it all the way back) and VACCINATION SITE PAIN (Pain in injection arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (Can't lift left arm fully or extend it all the way back) and VACCINATION SITE PAIN (Pain in injection arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information reported also included heating pad and exercise.  No concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: I have Distorted taste and smell since receiving the vaccine; I have Distorted taste and smell since receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (I have Distorted taste and smell since receiving the vaccine) and PAROSMIA (I have Distorted taste and smell since receiving the vaccine) 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 TASTE DISORDER (I have Distorted taste and smell since receiving the vaccine) and PAROSMIA (I have Distorted taste and smell since receiving the vaccine). At the time of the report, TASTE DISORDER (I have Distorted taste and smell since receiving the vaccine) and PAROSMIA (I have Distorted taste and smell since receiving the vaccine) had not 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.  Concomitant medication not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: Can i get sick after the 1st covid shot; Is it normal to have a fever after the 1st covid shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Can i get sick after the 1st covid shot) and PYREXIA (Is it normal to have a fever after the 1st covid shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Can i get sick after the 1st covid shot) and PYREXIA (Is it normal to have a fever after the 1st covid shot). At the time of the report, ILLNESS (Can i get sick after the 1st covid shot) and PYREXIA (Is it normal to have a fever after the 1st covid shot) 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 medications were provided by the reporter.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken for moderna COVID-19 vaccine was Not  Applicable.  No concomitent medications were provided.  No treatment medications were provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Epistaxis, Headache
Clinical narrative: Nose Bleed and Clotted Blood coming out of his nose sometime 2-3 times daily; Headaches; Pressure around The Heart; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose Bleed and Clotted Blood coming out of his nose sometime 2-3 times daily), HEADACHE (Headaches) and CHEST DISCOMFORT (Pressure around The Heart) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced EPISTAXIS (Nose Bleed and Clotted Blood coming out of his nose sometime 2-3 times daily), HEADACHE (Headaches) and CHEST DISCOMFORT (Pressure around The Heart). At the time of the report, EPISTAXIS (Nose Bleed and Clotted Blood coming out of his nose sometime 2-3 times daily), HEADACHE (Headaches) and CHEST DISCOMFORT (Pressure around The Heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (2nd dose given from beyond use date vial) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 041C21A) for COVID-19 immunization. No medical history reported. On Jun 16, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 16, 2021, patient administered expired product (2nd dose given from beyond use date vial). On Jun 16, 2021, administered expired product (2nd dose given from beyond use date vial) resolved. The reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm where received shot feels hot; arm where I received my shot Begin to swel; arm where received shot is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm where received shot feels hot), VACCINATION SITE SWELLING (arm where I received my shot Begin to swel) and VACCINATION SITE ERYTHEMA (arm where received shot is red) 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 12-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced VACCINATION SITE WARMTH (arm where received shot feels hot), VACCINATION SITE SWELLING (arm where I received my shot Begin to swel) and VACCINATION SITE ERYTHEMA (arm where received shot is red). At the time of the report, VACCINATION SITE WARMTH (arm where received shot feels hot), VACCINATION SITE SWELLING (arm where I received my shot Begin to swel) and VACCINATION SITE ERYTHEMA (arm where received shot is red) 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 medication not provided.  Treatment information not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Small rash on scattered parts of body, arms, legs, and hands; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small rash on scattered parts of body, arms, legs, and hands) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Small rash on scattered parts of body, arms, legs, and hands). At the time of the report, RASH (Small rash on scattered parts of body, arms, legs, and hands) had not resolved.            Treatment medication reported included an unspecified cream.  No concomitant medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Covid-19 positive test after the 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 positive test after the 1st 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 28-Mar-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 SARS-COV-2 TEST POSITIVE (Covid-19 positive test after the 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 positive test after the 1st dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 22-JUN-2021. No New Information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Prostatitis
Clinical narrative: inflamation of the Prostrate; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATITIS (inflamation of the Prostrate) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PROSTATITIS (inflamation of the Prostrate). At the time of the report, PROSTATITIS (inflamation of the Prostrate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. .   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: much fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (much fatigue) 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 17-Jun-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 17-Jun-2021, the patient experienced FATIGUE (much fatigue). At the time of the report, FATIGUE (much fatigue) outcome was unknown.            Concomitant drug was not reported. Treatment medication was not reported. Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects from the shot 5 weeks after the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects from the shot 5 weeks after the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects from the shot 5 weeks after the shot). At the time of the report, VACCINATION COMPLICATION (side effects from the shot 5 weeks after the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: watery bowel movements; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (watery bowel movements) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced DIARRHOEA (watery bowel movements). At the time of the report, DIARRHOEA (watery bowel movements) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  The action taken with mRNA (Moderna COVID-19 Vaccine)(unknown) was Not Applicable.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Burning sensation, Nausea
Clinical narrative: complaining about burning up but no fever; stomach feels like its on fire; cannot sit up from being so nauseated; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (complaining about burning up but no fever), ABDOMINAL DISCOMFORT (stomach feels like its on fire) and NAUSEA (cannot sit up from being so nauseated) 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 09-Jun-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 BURNING SENSATION (complaining about burning up but no fever), ABDOMINAL DISCOMFORT (stomach feels like its on fire) and NAUSEA (cannot sit up from being so nauseated). At the time of the report, BURNING SENSATION (complaining about burning up but no fever), ABDOMINAL DISCOMFORT (stomach feels like its on fire) and NAUSEA (cannot sit up from being so nauseated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: left arm pit developed a rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (left arm pit developed 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 (left arm pit developed a rash). At the time of the report, RASH (left arm pit developed a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: I received the 2nd Moderna vaccination site has been itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (I received the 2nd Moderna vaccination site has been itching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (I received the 2nd Moderna vaccination site has been itching). At the time of the report, VACCINATION SITE PRURITUS (I received the 2nd Moderna vaccination site has been itching) outcome was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Hypersomnia, Myalgia, Pruritus
Clinical narrative: had to lay to sleep until the next day; allergic reaction/ like rosettes on the whole body/ like nuggets from varicella; the whole body itches a lot; body aches; feeling really bad/ felt like blue, like drugged; really sleepy; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling really bad/ felt like blue, like drugged), SOMNOLENCE (really sleepy), HYPERSOMNIA (had to lay to sleep until the next day), HYPERSENSITIVITY (allergic reaction/ like rosettes on the whole body/ like nuggets from varicella) and PRURITUS (the whole body itches a lot) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced FEELING ABNORMAL (feeling really bad/ felt like blue, like drugged), SOMNOLENCE (really sleepy) and MYALGIA (body aches). On 16-Jun-2021, the patient experienced HYPERSENSITIVITY (allergic reaction/ like rosettes on the whole body/ like nuggets from varicella) and PRURITUS (the whole body itches a lot). On an unknown date, the patient experienced HYPERSOMNIA (had to lay to sleep until the next day). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK dosage form; ACETAMINOPHEN at a dose of UNK dosage form and IBUPROFEN at a dose of 1 UNK. At the time of the report, FEELING ABNORMAL (feeling really bad/ felt like blue, like drugged), SOMNOLENCE (really sleepy), HYPERSOMNIA (had to lay to sleep until the next day), HYPERSENSITIVITY (allergic reaction/ like rosettes on the whole body/ like nuggets from varicella), PRURITUS (the whole body itches a lot) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment information was not provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: had to lay to sleep until the next day; allergic reaction/ like rosettes on the whole body/ like nuggets from varicella; the whole body itches a lot; body aches; feeling really bad/ felt like blue, like drugged; really sleepy; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (feeling really bad/ felt like blue, like drugged), SOMNOLENCE (really sleepy), HYPERSOMNIA (had to lay to sleep until the next day), HYPERSENSITIVITY (allergic reaction/ like rosettes on the whole body/ like nuggets from varicella) and PRURITUS (the whole body itches a lot) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced FEELING ABNORMAL (feeling really bad/ felt like blue, like drugged), SOMNOLENCE (really sleepy) and MYALGIA (body aches). On 16-Jun-2021, the patient experienced HYPERSENSITIVITY (allergic reaction/ like rosettes on the whole body/ like nuggets from varicella) and PRURITUS (the whole body itches a lot). On an unknown date, the patient experienced HYPERSOMNIA (had to lay to sleep until the next day). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK dosage form; ACETAMINOPHEN at a dose of UNK dosage form and IBUPROFEN at a dose of 1 UNK. At the time of the report, FEELING ABNORMAL (feeling really bad/ felt like blue, like drugged), SOMNOLENCE (really sleepy), HYPERSOMNIA (had to lay to sleep until the next day), HYPERSENSITIVITY (allergic reaction/ like rosettes on the whole body/ like nuggets from varicella), PRURITUS (the whole body itches a lot) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-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 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: warm; raised lump size of coke can; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm) and VACCINATION SITE SWELLING (raised lump size of coke can) 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 VACCINATION SITE WARMTH (warm) and VACCINATION SITE SWELLING (raised lump size of coke can). At the time of the report, VACCINATION SITE WARMTH (warm) and VACCINATION SITE SWELLING (raised lump size of coke can) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Dysphonia
Clinical narrative: I have had a persistent cough; I have had a persistent hoarseness.; This spontaneous case was reported by a patient and describes the occurrence of COUGH (I have had a persistent cough) and DYSPHONIA (I have had a persistent hoarseness.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COUGH (I have had a persistent cough) and DYSPHONIA (I have had a persistent hoarseness.). At the time of the report, COUGH (I have had a persistent cough) and DYSPHONIA (I have had a persistent hoarseness.) outcome was unknown.            No concomitant medications reported. No treatment reported.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2nd Dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose given from beyond use date vial) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-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 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose given from beyond use date vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose given from beyond use date vial) 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.
Sex: U
Vaccine: COVID19
Symptoms: Skin burning sensation
Clinical narrative: burn from a side; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (burn from a side) 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 SKIN BURNING SENSATION (burn from a side). At the time of the report, SKIN BURNING SENSATION (burn from a side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first covid vaccine on April 19 is it too late to get 2nd one today; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first covid vaccine on April 19 is it too late to get 2nd one today) 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 19-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first covid vaccine on April 19 is it too late to get 2nd one today). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first covid vaccine on April 19 is it too late to get 2nd one today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: flu like feeling; chills; very tired; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like feeling), CHILLS (chills), FATIGUE (very tired) and MYALGIA (muscle aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like feeling), CHILLS (chills), FATIGUE (very tired) and MYALGIA (muscle aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu like feeling), CHILLS (chills), FATIGUE (very tired) and MYALGIA (muscle aches) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I would like to know what is the common side effect of this vaccine?/Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (I would like to know what is the common side effect of this vaccine?/Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I would like to know what is the common side effect of this vaccine?/Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect). At the time of the report, VACCINATION COMPLICATION (I would like to know what is the common side effect of this vaccine?/Consumer answered "Yes" when the ChatBot asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter. No concomitant medications were reported; Sender's Comments: Very limited information regarding this event has been provided at this time. Details regarding the event term and date of vaccination is required for further assessment.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) 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 OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received first Moderna vaccine on 4-29-2021. Patient stated back of card said to return on 5-27-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine on 4-29-2021. Patient stated back of card said to return on 5-27-2021) 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 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine on 4-29-2021. Patient stated back of card said to return on 5-27-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first Moderna vaccine on 4-29-2021. Patient stated back of card said to return on 5-27-2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: really tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (really tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (really tired). At the time of the report, FATIGUE (really tired) outcome was unknown.            No concomitant medications were reported.  No information on treatment is provided by the reporter.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue, Vaccination site pain
Clinical narrative: Sore arm; Has not received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the second dose) and PAIN IN EXTREMITY (Sore arm) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B021A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose) and PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient did not received the second dose due to anxiety and a lot of emotional baggage from the pandemic. Treatment information was not provided.