chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: having pain  in the armpit; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (having pain  in the armpit) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AXILLARY PAIN (having pain  in the armpit). At the time of the report, AXILLARY PAIN (having pain  in the armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: running fever of 100.4; real achy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (running fever of 100.4) and MYALGIA (real achy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (running fever of 100.4) and MYALGIA (real achy). At the time of the report, PYREXIA (running fever of 100.4) and MYALGIA (real achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had first dose of vaccine 4 days ago.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: got Covid; past 42 days to receive the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (got Covid) and PRODUCT DOSE OMISSION ISSUE (past 42 days to receive the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (got Covid) and PRODUCT DOSE OMISSION ISSUE (past 42 days to receive the second dose). At the time of the report, SARS-COV-2 TEST POSITIVE (got Covid) and PRODUCT DOSE OMISSION ISSUE (past 42 days to receive the second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medications were not provided. Treatment information was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Vaccination site pain
Clinical narrative: Diarrhea; Severe pain at the vaccination site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea) and VACCINATION SITE PAIN (Severe pain at the vaccination site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHEA (Diarrhea) and VACCINATION SITE PAIN (Severe pain at the vaccination site). At the time of the report, DIARRHEA (Diarrhea) and VACCINATION SITE PAIN (Severe pain at the vaccination site) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Antibody test, Drug specific antibody absent
Clinical narrative: Antibodies were extremely low; This spontaneous case was reported by a consumer and describes the occurrence of DRUG SPECIFIC ANTIBODY ABSENT (Antibodies were extremely low) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ) for Psoriatic arthritis.    No medical history is provided by the reporter.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started TOFACITINIB CITRATE (XELJANZ) (unknown route) 11 mg. On an unknown date, the patient experienced DRUG SPECIFIC ANTIBODY ABSENT (Antibodies were extremely low). At the time of the report, DRUG SPECIFIC ANTIBODY ABSENT (Antibodies were extremely low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: low (Low) Her antibodies are extremely low.         No treatment medications provided by the reporter.   Patient had the Moderna covid (corona virus disease ) vaccines 2 doses and recently had an antibody test and her doctor thinks she should get the Pfizer covid vaccine but wants her to be off the Xeljanz before she takes it and wait two weeks before she starts  it again. she is asking how long does it take to get out of her system.   This case was linked to MOD-2021-187585.
Sex: F
Vaccine: COVID19
Symptoms: Knee arthroplasty, Pain
Clinical narrative: pain; Knee replacement; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of KNEE ARTHROPLASTY (Knee replacement) and PAIN (pain) 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-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced KNEE ARTHROPLASTY (Knee replacement). On an unknown date, the patient experienced PAIN (pain). On 29-Mar-2021, KNEE ARTHROPLASTY (Knee replacement) had resolved. At the time of the report, PAIN (pain) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Treatment medication was not provided. concomitant product was not provided
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second vaccin19 days from first vaccinee schedule; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccin19 days from first vaccinee schedule) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccin19 days from first vaccinee schedule). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second vaccin19 days from first vaccinee schedule) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of unknown origin (FUO); This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (Fever of unknown origin (FUO)) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of unknown origin (FUO)). At the time of the report, PYREXIA (Fever of unknown origin (FUO)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Temperature; Nausea; Great body ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature), NAUSEA (Nausea), MYALGIA (Great body ache) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression (anti depressant use). Concomitant products included DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) for Antidepressant therapy.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PYREXIA (Temperature), NAUSEA (Nausea), MYALGIA (Great body ache) and HEADACHE (Headache). The patient was treated with ACETAMINOPHEN for Nausea, Headache and Ache, at a dose of 1 dosage form. At the time of the report, PYREXIA (Temperature), NAUSEA (Nausea), MYALGIA (Great body ache) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Patient was uninsured but followed through with going to hospital twice, she was bombarded with bills. Caller was asking if Moderna provides assistance in paying for hospital bills for patients who had an AE.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-187603.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received contains no new information On 01-Jul-2021: Non significant Follow-up received On 29-Jul-2021: Non significant Follow up received HCP is inquiring for funding to cover her hospital bills; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pain) 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 Knee replacement on 29-Mar-2021.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain). At the time of the report, PAIN (pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medicines were not reported Action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient will be receiving 2nd shot 60 days after 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient will be receiving 2nd shot 60 days after 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient will be receiving 2nd shot 60 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient will be receiving 2nd shot 60 days after 1st dose) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Illness, Pain in extremity
Clinical narrative: Sore Arm; felt week; no appetite for 6 days; sick; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ASTHENIA (felt week), DECREASED APPETITE (no appetite for 6 days), ILLNESS (sick) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-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 PAIN IN EXTREMITY (Sore Arm), ASTHENIA (felt week), DECREASED APPETITE (no appetite for 6 days), ILLNESS (sick), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Sore Arm), ASTHENIA (felt week), DECREASED APPETITE (no appetite for 6 days), ILLNESS (sick), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant and treatment medications were reported.   This case was linked to MOD-2021-025303 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Followup was received. Reporter's address was added.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore Arm; felt week; no appetite for 6 days; sick; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), ASTHENIA (felt week), DECREASED APPETITE (no appetite for 6 days), ILLNESS (sick) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-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 PAIN IN EXTREMITY (Sore Arm), ASTHENIA (felt week), DECREASED APPETITE (no appetite for 6 days), ILLNESS (sick), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Sore Arm), ASTHENIA (felt week), DECREASED APPETITE (no appetite for 6 days), ILLNESS (sick), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant and treatment medications were reported.   This case was linked to MOD-2021-025303 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Followup was received. Reporter's address was added.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: major urticaria all over my body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (major urticaria all over my body) 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 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced URTICARIA (major urticaria all over my body). The patient was treated with BILASTINE for Urticaria, at an unspecified dose and frequency. At the time of the report, URTICARIA (major urticaria all over my body) outcome was unknown.            No concomitant medications was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Vaccination site reaction
Clinical narrative: COVID arm; red spot on skin; red spot is hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), ERYTHEMA (red spot on skin) and FEELING HOT (red spot is hot to touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), ERYTHEMA (red spot on skin) and FEELING HOT (red spot is hot to touch). At the time of the report, VACCINATION SITE REACTION (COVID arm), ERYTHEMA (red spot on skin) and FEELING HOT (red spot is hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: shoulder was stiff; shoulder was sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (shoulder was stiff) and ARTHRALGIA (shoulder was sore) 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 (shoulder was stiff) and ARTHRALGIA (shoulder was sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (shoulder was stiff) and ARTHRALGIA (shoulder was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: stomach pain; diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach pain) and DIARRHOEA (diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach pain) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (stomach pain) and DIARRHOEA (diarrhea) outcome was unknown.            No concomitant and treatment medications were provided
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Asthenia, Bone pain, Chest pain, Chromaturia
Clinical narrative: low energy; bones ached; was very bloated; Difficulty  breathing; pain in the middle of her chest once; weight gain; insomnia; urine colouring yellow; really tired; temperature of 100.1; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), BONE PAIN (bones ached), ABDOMINAL DISTENSION (was very bloated), DYSPNOEA (Difficulty  breathing) and CHEST PAIN (pain in the middle of her chest once) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (low energy), BONE PAIN (bones ached), ABDOMINAL DISTENSION (was very bloated), DYSPNOEA (Difficulty  breathing), CHEST PAIN (pain in the middle of her chest once), WEIGHT INCREASED (weight gain), INSOMNIA (insomnia), CHROMATURIA (urine colouring yellow), FATIGUE (really tired) and PYREXIA (temperature of 100.1). At the time of the report, ASTHENIA (low energy), BONE PAIN (bones ached), ABDOMINAL DISTENSION (was very bloated), DYSPNOEA (Difficulty  breathing), CHEST PAIN (pain in the middle of her chest once), WEIGHT INCREASED (weight gain), INSOMNIA (insomnia), CHROMATURIA (urine colouring yellow), FATIGUE (really tired) and PYREXIA (temperature of 100.1) outcome was unknown.            Details regarding concomitant and treatment medications not provided. The patient reported that her white blood count was low (details regarding test not provided). She reported that she was in the second week of the fourth cycle of Ibrance and was to start back on Ibrance on a Friday, but waited until the following Tuesday per her doctor's orders. She reported of having difficulty going up the stairs. She drank more water since she noted her urine was more yellowish. The patient also reported that she was adjusting her eating patterns to help with her sleep but still sometimes she was not able to sleep.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Insomnia, Pyrexia, Weight increased
Clinical narrative: low energy; bones ached; was very bloated; Difficulty  breathing; pain in the middle of her chest once; weight gain; insomnia; urine colouring yellow; really tired; temperature of 100.1; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), BONE PAIN (bones ached), ABDOMINAL DISTENSION (was very bloated), DYSPNOEA (Difficulty  breathing) and CHEST PAIN (pain in the middle of her chest once) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (low energy), BONE PAIN (bones ached), ABDOMINAL DISTENSION (was very bloated), DYSPNOEA (Difficulty  breathing), CHEST PAIN (pain in the middle of her chest once), WEIGHT INCREASED (weight gain), INSOMNIA (insomnia), CHROMATURIA (urine colouring yellow), FATIGUE (really tired) and PYREXIA (temperature of 100.1). At the time of the report, ASTHENIA (low energy), BONE PAIN (bones ached), ABDOMINAL DISTENSION (was very bloated), DYSPNOEA (Difficulty  breathing), CHEST PAIN (pain in the middle of her chest once), WEIGHT INCREASED (weight gain), INSOMNIA (insomnia), CHROMATURIA (urine colouring yellow), FATIGUE (really tired) and PYREXIA (temperature of 100.1) outcome was unknown.            Details regarding concomitant and treatment medications not provided. The patient reported that her white blood count was low (details regarding test not provided). She reported that she was in the second week of the fourth cycle of Ibrance and was to start back on Ibrance on a Friday, but waited until the following Tuesday per her doctor's orders. She reported of having difficulty going up the stairs. She drank more water since she noted her urine was more yellowish. The patient also reported that she was adjusting her eating patterns to help with her sleep but still sometimes she was not able to sleep.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: sickness from Covid-19; sickness from Covid-19; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sickness from Covid-19) and COVID-19 (sickness from Covid-19) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 18-Mar-2021, the patient experienced ILLNESS (sickness from Covid-19) and COVID-19 (sickness from Covid-19). At the time of the report, ILLNESS (sickness from Covid-19) and COVID-19 (sickness from Covid-19) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she is under few medicines.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: Sore arm; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 32-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: as if got hit by the truck; 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 FEELING ABNORMAL (as if got hit by the truck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (as if got hit by the truck). At the time of the report, FEELING ABNORMAL (as if got hit by the truck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment details were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash; Symptoms of shingles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Symptoms of shingles) and RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced HERPES ZOSTER (Symptoms of shingles). On an unknown date, the patient experienced RASH (Rash). At the time of the report, HERPES ZOSTER (Symptoms of shingles) and RASH (Rash) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: Muscle twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Muscle twitching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (Muscle twitching). At the time of the report, MUSCLE TWITCHING (Muscle twitching) outcome was unknown.            Patient experienced muscle twitching a week after second shot. No concomitant and treatment medications were provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: irregular period; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-May-2021 and was forwarded to Moderna on 31-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (irregular period) 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 MENSTRUATION IRREGULAR (irregular period). At the time of the report, MENSTRUATION IRREGULAR (irregular period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications provided by the reporter.   This case was linked to MOD21-103472 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Myalgia, Pyrexia
Clinical narrative: Cough; Low grade fever; Body aches; Chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PYREXIA (Low grade fever), MYALGIA (Body aches) and 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 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 COUGH (Cough), PYREXIA (Low grade fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, COUGH (Cough), PYREXIA (Low grade fever), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: It's been 31 days since my second dose. I started getting dizzy while sitting and standing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (It's been 31 days since my second dose. I started getting dizzy while sitting and standing) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history is provided by the reporter.    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 DIZZINESS (It's been 31 days since my second dose. I started getting dizzy while sitting and standing). At the time of the report, DIZZINESS (It's been 31 days since my second dose. I started getting dizzy while sitting and standing) outcome was unknown.            No treatment medication were provided.  No concomitant medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Soreness and redness at injection site; Redness at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness and redness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness and redness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE PAIN (Soreness and redness at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Knee Pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee Pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included Knee replacement.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) UNK dosage form. In May 2021, the patient experienced ARTHRALGIA (Knee Pain). At the time of the report, ARTHRALGIA (Knee Pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant And treatment medication information was not provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: have back pain starting yesterday.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (have back pain starting yesterday.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (have back pain starting yesterday.). At the time of the report, BACK PAIN (have back pain starting yesterday.) outcome was unknown.            Patient has experienced back pain after having her second dose. No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Rhinorrhoea
Clinical narrative: Mild symptoms of runny nose; Blister in my groin area and it's black and about the size of a dime in diameter; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Mild symptoms of runny nose) and BLISTER (Blister in my groin area and it's black and about the size of a dime in diameter) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Mild symptoms of runny nose) and BLISTER (Blister in my groin area and it's black and about the size of a dime in diameter). At the time of the report, RHINORRHOEA (Mild symptoms of runny nose) and BLISTER (Blister in my groin area and it's black and about the size of a dime in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        Patient noticed a blister in the groin area which is black and about the size of a dime in diameter. Concomitant medication information not provided.  Treatment information not provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: diarrhea; stomach pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pains). At the time of the report, DIARRHOEA (diarrhea) and ABDOMINAL PAIN UPPER (stomach pains) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia
Clinical narrative: Difficulty in breathing; Body ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty in breathing) and MYALGIA (Body ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Difficulty in breathing) and MYALGIA (Body ache). At the time of the report, DYSPNOEA (Difficulty in breathing) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swollen lips; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swollen lips). At the time of the report, LIP SWELLING (swollen lips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Really bad pain in Trapezia muscles; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-May-2021 and was forwarded to Moderna on 31-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of MYALGIA (Really bad pain in Trapezia muscles) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Really bad pain in Trapezia muscles). At the time of the report, MYALGIA (Really bad pain in Trapezia muscles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had  bad pain in Trapezius  muscles Treatment medicines were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Its been past 60 days after my 1st vaccine, is it too late for my 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Its been past 60 days after my 1st vaccine, is it too late for my 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Its been past 60 days after my 1st vaccine, is it too late for my 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Its been past 60 days after my 1st vaccine, is it too late for my 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information reported. Its been past 60 days after my 1st vaccine, is it too late for my 2nd dose.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling in the neck//shoulder area; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in the neck//shoulder area) 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 SWELLING (Swelling in the neck//shoulder area). At the time of the report, SWELLING (Swelling in the neck//shoulder area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications are provided .  No concomitant medications are provided .   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Groin pain
Clinical narrative: groin pain radiating around to me low back.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (groin pain radiating around to me low back.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2020, the patient experienced GROIN PAIN (groin pain radiating around to me low back.). At the time of the report, GROIN PAIN (groin pain radiating around to me low back.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.