chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Joint stiffness, Joint swelling, Musculoskeletal stiffness, Pain
Clinical narrative: Couldn't get out of bed the second day; Tenderness in kidney; Stiffness and tension in neck and collar/Stiffness in shoulder; Swelling of joints; Deep bone pains; Stiffness in joints; Joint pain; Severe headache; Woke up very weak; Couldn't pick myself up; Hurt everywhere; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (Woke up very weak), HYPOKINESIA (Couldn't pick myself up), PAIN (Hurt everywhere), BEDRIDDEN (Couldn't get out of bed the second day) and RENAL PAIN (Tenderness in kidney) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (cervical spine surgery.), Surgery (dire placement), Surgery (Orthopedic surgery on back and nose.) and Renal surgery (renal surgery).   On 12-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) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ASTHENIA (Woke up very weak), HYPOKINESIA (Couldn't pick myself up), PAIN (Hurt everywhere), RENAL PAIN (Tenderness in kidney), MUSCULOSKELETAL STIFFNESS (Stiffness and tension in neck and collar/Stiffness in shoulder), JOINT SWELLING (Swelling of joints), BONE PAIN (Deep bone pains), JOINT STIFFNESS (Stiffness in joints), ARTHRALGIA (Joint pain) and HEADACHE (Severe headache). On 15-Feb-2021, the patient experienced BEDRIDDEN (Couldn't get out of bed the second day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Woke up very weak), HYPOKINESIA (Couldn't pick myself up), PAIN (Hurt everywhere), BEDRIDDEN (Couldn't get out of bed the second day), RENAL PAIN (Tenderness in kidney), MUSCULOSKELETAL STIFFNESS (Stiffness and tension in neck and collar/Stiffness in shoulder), JOINT SWELLING (Swelling of joints), BONE PAIN (Deep bone pains), JOINT STIFFNESS (Stiffness in joints), ARTHRALGIA (Joint pain) and HEADACHE (Severe headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was not provided by reporter. Along with other treatment medications 'Hot bath for stiffness' was also reported by reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Couldn't get out of bed the second day; Tenderness in kidney; Stiffness and tension in neck and collar/Stiffness in shoulder; Swelling of joints; Deep bone pains; Stiffness in joints; Joint pain; Severe headache; Woke up very weak; Couldn't pick myself up; Hurt everywhere; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (Woke up very weak), HYPOKINESIA (Couldn't pick myself up), PAIN (Hurt everywhere), BEDRIDDEN (Couldn't get out of bed the second day) and RENAL PAIN (Tenderness in kidney) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (cervical spine surgery.), Surgery (dire placement), Surgery (Orthopedic surgery on back and nose.) and Renal surgery (renal surgery).   On 12-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) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ASTHENIA (Woke up very weak), HYPOKINESIA (Couldn't pick myself up), PAIN (Hurt everywhere), RENAL PAIN (Tenderness in kidney), MUSCULOSKELETAL STIFFNESS (Stiffness and tension in neck and collar/Stiffness in shoulder), JOINT SWELLING (Swelling of joints), BONE PAIN (Deep bone pains), JOINT STIFFNESS (Stiffness in joints), ARTHRALGIA (Joint pain) and HEADACHE (Severe headache). On 15-Feb-2021, the patient experienced BEDRIDDEN (Couldn't get out of bed the second day). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Woke up very weak), HYPOKINESIA (Couldn't pick myself up), PAIN (Hurt everywhere), BEDRIDDEN (Couldn't get out of bed the second day), RENAL PAIN (Tenderness in kidney), MUSCULOSKELETAL STIFFNESS (Stiffness and tension in neck and collar/Stiffness in shoulder), JOINT SWELLING (Swelling of joints), BONE PAIN (Deep bone pains), JOINT STIFFNESS (Stiffness in joints), ARTHRALGIA (Joint pain) and HEADACHE (Severe headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was not provided by reporter. Along with other treatment medications 'Hot bath for stiffness' was also reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Is it normal to still not feel really great after having us a vaccine; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (Is it normal to still not feel really great after having us a 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Is it normal to still not feel really great after having us a vaccine). At the time of the report, VACCINATION COMPLICATION (Is it normal to still not feel really great after having us a vaccine) 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: M
Vaccine: COVID19
Symptoms: Eczema, Erythema, Influenza, Malaise, Pruritus
Clinical narrative: inactive for about 2 and half days; thought that come down with flu or that had any physical reaction to the vaccination; eczema like patches/had an outburst from the one on the wrist and developed the one from the left knee/flared up two or three weeks after the second dose; it's a larger patch and it gets itchier; it's a larger patch and it gets itchier; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (inactive for about 2 and half days), INFLUENZA (thought that come down with flu or that had any physical reaction to the vaccination), ECZEMA (eczema like patches/had an outburst from the one on the wrist and developed the one from the left knee/flared up two or three weeks after the second dose), ERYTHEMA (it's a larger patch and it gets itchier) and PRURITUS (it's a larger patch and it gets itchier) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (inactive for about 2 and half days), INFLUENZA (thought that come down with flu or that had any physical reaction to the vaccination), ECZEMA (eczema like patches/had an outburst from the one on the wrist and developed the one from the left knee/flared up two or three weeks after the second dose), ERYTHEMA (it's a larger patch and it gets itchier) and PRURITUS (it's a larger patch and it gets itchier). The patient was treated with BIFONAZOLE (TOPICAL [BIFONAZOLE]) at an unspecified dose and frequency. At the time of the report, MALAISE (inactive for about 2 and half days), INFLUENZA (thought that come down with flu or that had any physical reaction to the vaccination), ECZEMA (eczema like patches/had an outburst from the one on the wrist and developed the one from the left knee/flared up two or three weeks after the second dose), ERYTHEMA (it's a larger patch and it gets itchier) and PRURITUS (it's a larger patch and it gets itchier) outcome was unknown.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose administered to a 17 year old patient; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient). On 31-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 17 year old patient) 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 were reported. No treatment information was reported
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure during pregnancy, Pain, Pregnancy test, Ultrasound scan
Clinical narrative: Vaccine exposure during pregnancy; aches; chills; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN (aches) and CHILLS (chills) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (compazine), Asthma since 1994 and Hypertension (has improved recently) since 2016.   On 13-Jan-2021 at 1:00 PM, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 13-Aug-2020 and the estimated date of delivery was 20-May-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN (aches) and CHILLS (chills). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved and PAIN (aches) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2020, Pregnancy test: positive (Positive) positive. On 12-Dec-2020, Ultrasound scan: normal (normal) Normal. On 30-Dec-2020, Ultrasound scan: normal (normal) normal.         No concomitant medications were reported. Treatment details were not provided. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-010749 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received and contains No New Information.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Off label use
Clinical narrative: I had my second vaccine dose with moderna 5 days ago after having an AZ first dose 10 weeks ago; Today, after 5 days I awoke being lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (I had my second vaccine dose with moderna 5 days ago after having an AZ first dose 10 weeks ago) and DIZZINESS (Today, after 5 days I awoke being lightheaded) 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 OFF LABEL USE (I had my second vaccine dose with moderna 5 days ago after having an AZ first dose 10 weeks ago) and DIZZINESS (Today, after 5 days I awoke being lightheaded). At the time of the report, OFF LABEL USE (I had my second vaccine dose with moderna 5 days ago after having an AZ first dose 10 weeks ago) and DIZZINESS (Today, after 5 days I awoke being lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: pain on my left side; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (pain on my left 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 provided by the reporter.    In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, 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 MYALGIA (pain on my left side). At the time of the report, MYALGIA (pain on my left side) had resolved. Not Provided          No concomitant medications was provided by the reporter. Treatment medications steroids was used 6 days. Action taken with mRNA-1273 in response to the events was not applicable   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain on my left side; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on my left 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 IN EXTREMITY (pain on my left side). At the time of the report, PAIN IN EXTREMITY (pain on my left side) had resolved. Not Provided          The doctor prescribed steroids for the pain in left side. No concomitant drugs were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I have patient who got the 1st dose of moderna,Now they want second dose, can I give it to them after this long ?; 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 (I have patient who got the 1st dose of moderna,Now they want second dose, can I give it to them after this long ?) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have patient who got the 1st dose of moderna,Now they want second dose, can I give it to them after this long ?). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I have patient who got the 1st dose of moderna,Now they want second dose, can I give it to them after this long ?) 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.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non significant follow up
Sex: U
Vaccine: COVID19
Symptoms: Dysphonia, Feeling abnormal, Oropharyngeal pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (I feel kinda yucky today), oropharyngeal pain (very sore throat) and dysphonia (possibly losing my voice) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 28, 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 29, 2021, patient experienced feeling abnormal (I feel kinda yucky today), oropharyngeal pain (very sore throat). On an unknown date, the patient experienced oropharyngeal pain (very sore throat) and dysphonia (possibly losing my voice). At the time of the report, feeling abnormal (I feel kinda yucky today), oropharyngeal pain (very sore throat) and dysphonia (possibly losing my voice) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable. No concomitant medication or treatment information reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Condition aggravated, Dyspnoea, Headache
Clinical narrative: Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine; Has been falling asleep when watching TV; Getting worse; Some edema; Feels like crap; Some weakness; Neck pain; Pains; Pain in left shoulder; Muscle aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema) and MALAISE (Feels like crap) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema), MALAISE (Feels like crap), ASTHENIA (Some weakness), NECK PAIN (Neck pain), PAIN (Pains), ARTHRALGIA (Pain in left shoulder), MYALGIA (Muscle aches) and HEADACHE (Headaches). At the time of the report, DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema), MALAISE (Feels like crap), ASTHENIA (Some weakness), NECK PAIN (Neck pain), PAIN (Pains), ARTHRALGIA (Pain in left shoulder), MYALGIA (Muscle aches) and HEADACHE (Headaches) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Neck pain, Oedema, Pain
Clinical narrative: Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine; Has been falling asleep when watching TV; Getting worse; Some edema; Feels like crap; Some weakness; Neck pain; Pains; Pain in left shoulder; Muscle aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema) and MALAISE (Feels like crap) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema), MALAISE (Feels like crap), ASTHENIA (Some weakness), NECK PAIN (Neck pain), PAIN (Pains), ARTHRALGIA (Pain in left shoulder), MYALGIA (Muscle aches) and HEADACHE (Headaches). At the time of the report, DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema), MALAISE (Feels like crap), ASTHENIA (Some weakness), NECK PAIN (Neck pain), PAIN (Pains), ARTHRALGIA (Pain in left shoulder), MYALGIA (Muscle aches) and HEADACHE (Headaches) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine; Has been falling asleep when watching TV; Getting worse; Some edema; Feels like crap; Some weakness; Neck pain; Pains; Pain in left shoulder; Muscle aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema) and MALAISE (Feels like crap) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema), MALAISE (Feels like crap), ASTHENIA (Some weakness), NECK PAIN (Neck pain), PAIN (Pains), ARTHRALGIA (Pain in left shoulder), MYALGIA (Muscle aches) and HEADACHE (Headaches). At the time of the report, DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema), MALAISE (Feels like crap), ASTHENIA (Some weakness), NECK PAIN (Neck pain), PAIN (Pains), ARTHRALGIA (Pain in left shoulder), MYALGIA (Muscle aches) and HEADACHE (Headaches) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I only received the first dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I only received the first dose of Moderna) 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 PRODUCT DOSE OMISSION ISSUE (I only received the first dose of Moderna). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I only received the first dose of Moderna) 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: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at the injection site) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore at the injection site). At the time of the report, VACCINATION SITE PAIN (Sore at the injection site) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.   This case was linked to MOD-2021-034014 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days since the first shot; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days since the first shot) had resolved.        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.   Concomitant medications included unspecified  blood pressure medication. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) 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 (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Decreased activity, Depressed mood, Vaccination site erythema
Clinical narrative: feeling down; difficulty maintaining previous activities; "big drop" in energy; Redness at injection site; Burning in legs; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (feeling down), DECREASED ACTIVITY (difficulty maintaining previous activities), ASTHENIA ("big drop" in energy), VACCINATION SITE ERYTHEMA (Redness at injection site) and BURNING SENSATION (Burning in legs) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M204) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (Bypass surgery). Concomitant products included ATENOLOL and CITALOPRAM HYDROCHLORIDE (CITALOPRAM [CITALOPRAM HYDROCHLORIDE]) for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (feeling down), DECREASED ACTIVITY (difficulty maintaining previous activities), ASTHENIA ("big drop" in energy), VACCINATION SITE ERYTHEMA (Redness at injection site) and BURNING SENSATION (Burning in legs). The patient was treated with IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) at a dose of 1 dosage form. At the time of the report, DEPRESSED MOOD (feeling down), DECREASED ACTIVITY (difficulty maintaining previous activities), ASTHENIA ("big drop" in energy), VACCINATION SITE ERYTHEMA (Redness at injection site) and BURNING SENSATION (Burning in legs) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-241696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: significant follow-up
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Injection site erythema, Pain in extremity
Clinical narrative: experience drops in their energy levels/ feeling down/big drop" in energy / Low energy levels; Burning in legs; leg pain; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (experience drops in their energy levels/ feeling down/big drop" in energy / Low energy levels), BURNING SENSATION (Burning in legs), PAIN IN EXTREMITY (leg pain) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M204) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included ATENOLOL for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-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 ASTHENIA (experience drops in their energy levels/ feeling down/big drop" in energy / Low energy levels), BURNING SENSATION (Burning in legs), PAIN IN EXTREMITY (leg pain) and INJECTION SITE ERYTHEMA (Redness at injection site). The patient was treated with IBUPROFEN for Adverse reaction, at a dose of UNK dosage form. At the time of the report, ASTHENIA (experience drops in their energy levels/ feeling down/big drop" in energy / Low energy levels), BURNING SENSATION (Burning in legs), PAIN IN EXTREMITY (leg pain) and INJECTION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported that the symptoms started gradually after the second dose Reported that she had to quit walking because of symptoms  Patient and her husband  were not overweight, stay very  active, exercises atleast 4 days a week and eats healthy food. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), was not applicable.   This case was linked to MOD-2021-241681 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up information received and contains significant information- Date of birth added
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness). At the time of the report, ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.  List of concomitant medication were not given.   This case was linked to MOD-2021-207963 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: my legs itching bad; rash on my leg; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (my legs itching bad) and RASH (rash on my leg) 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 Lupus erythematosus.   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 PRURITUS (my legs itching bad) and RASH (rash on my leg). At the time of the report, PRURITUS (my legs itching bad) and RASH (rash on my leg) outcome was unknown.            No treatment/concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of vaccine in patients from the vial which had surpassed its 'Beyond Use Date' (BUD);Doses were still frozen but temperature in the cooler during transportation was 36.98 degree F./Administered a vial 1 day beyond use date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of vaccine in patients from the vial which had surpassed its 'Beyond Use Date' (BUD);Doses were still frozen but temperature in the cooler during transportation was 36.98 degree F./Administered a vial 1 day beyond use date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) 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 EXPIRED PRODUCT ADMINISTERED (administration of vaccine in patients from the vial which had surpassed its 'Beyond Use Date' (BUD);Doses were still frozen but temperature in the cooler during transportation was 36.98 degree F./Administered a vial 1 day beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of vaccine in patients from the vial which had surpassed its 'Beyond Use Date' (BUD);Doses were still frozen but temperature in the cooler during transportation was 36.98 degree F./Administered a vial 1 day beyond use date) 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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: FU received
Sex: U
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: nerve pain in calf; This spontaneous case was reported by a patient and describes the occurrence of NEURALGIA (nerve pain in calf) 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 NEURALGIA (nerve pain in calf). At the time of the report, NEURALGIA (nerve pain in calf) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination complication
Clinical narrative: Potential side effects; very sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Potential side effects), MYALGIA (very sore) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 VACCINATION COMPLICATION (Potential side effects), MYALGIA (very sore) and HEADACHE (headache). At the time of the report, VACCINATION COMPLICATION (Potential side effects), MYALGIA (very sore) and HEADACHE (headache) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Heart rate irregular
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of irregular heart rate (erratic heart rate) and increased heart rate (many times over 100 bpm when resting) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced irregular heart rate (erratic heart rate) and increased heart rate (many times over 100 bpm when resting). At the time of the report, irregular heart rate (erratic heart rate) and increased heart rate (many times over 100 bpm when resting) outcome: unknown. Diagnostic results: On an unknown date, heart rate: 100 (high) increased. Concomitant product use and treatment information, if any, not provided. Action taken with mRNA-1273 in response to the event: not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Dehydration, Headache, Vomiting
Clinical narrative: I'm throwing up; have intense body chills; a severe headache.; I also dehydrate really quickly; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (I'm throwing up), CHILLS (have intense body chills), HEADACHE (a severe headache.) and DEHYDRATION (I also dehydrate really quickly) 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 VOMITING (I'm throwing up), CHILLS (have intense body chills), HEADACHE (a severe headache.) and DEHYDRATION (I also dehydrate really quickly). At the time of the report, VOMITING (I'm throwing up), CHILLS (have intense body chills), HEADACHE (a severe headache.) and DEHYDRATION (I also dehydrate really quickly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching; hives & welts; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and URTICARIA (hives & welts) 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 PRURITUS (itching) and URTICARIA (hives & welts). At the time of the report, PRURITUS (itching) and URTICARIA (hives & welts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: arm is still very sore 9 days after my shot; arm and shoulder are still very sore, arm and shoulder pain has lasted 9 days now; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is still very sore 9 days after my shot) and ARTHRALGIA (arm and shoulder are still very sore, arm and shoulder pain has lasted 9 days now) 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 PAIN IN EXTREMITY (arm is still very sore 9 days after my shot) and ARTHRALGIA (arm and shoulder are still very sore, arm and shoulder pain has lasted 9 days now). At the time of the report, PAIN IN EXTREMITY (arm is still very sore 9 days after my shot) and ARTHRALGIA (arm and shoulder are still very sore, arm and shoulder pain has lasted 9 days now) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous) 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. In June 2021, the patient experienced NAUSEA (Nauseous). At the time of the report, NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information were provided. No treatment information were given.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Significant body rash from second vax; Very itchy all over tat night particularly if I have any insect bite; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Significant body rash from second vax) and PRURITUS (Very itchy all over tat night particularly if I have any insect bite) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 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 RASH (Significant body rash from second vax) and PRURITUS (Very itchy all over tat night particularly if I have any insect bite). At the time of the report, RASH (Significant body rash from second vax) and PRURITUS (Very itchy all over tat night particularly if I have any insect bite) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  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.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Amnesia, Asthenia, Decreased appetite, Fatigue
Clinical narrative: Head Ache; Stomach Pain; Loss of memory; Loss of appetite; fatigue; Weakness; Sore muscules; I am still sick; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Head Ache), ABDOMINAL PAIN UPPER (Stomach Pain), AMNESIA (Loss of memory), DECREASED APPETITE (Loss of appetite) and FATIGUE (fatigue) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Head Ache), ABDOMINAL PAIN UPPER (Stomach Pain), AMNESIA (Loss of memory), DECREASED APPETITE (Loss of appetite), FATIGUE (fatigue), ASTHENIA (Weakness), MYALGIA (Sore muscules) and ILLNESS (I am still sick). At the time of the report, HEADACHE (Head Ache), ABDOMINAL PAIN UPPER (Stomach Pain), AMNESIA (Loss of memory), DECREASED APPETITE (Loss of appetite), FATIGUE (fatigue), ASTHENIA (Weakness), MYALGIA (Sore muscules) and ILLNESS (I am still sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not given.