chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Myalgia
Clinical narrative: felt a little bit bad not as bad as after the second one; really severe chills; really severe body aches, it was pretty intense, it knocked them out; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (felt a little bit bad not as bad as after the second one), CHILLS (really severe chills) and MYALGIA (really severe body aches, it was pretty intense, it knocked them out) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-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 FEELING ABNORMAL (felt a little bit bad not as bad as after the second one), CHILLS (really severe chills) and MYALGIA (really severe body aches, it was pretty intense, it knocked them out). At the time of the report, FEELING ABNORMAL (felt a little bit bad not as bad as after the second one) outcome was unknown and CHILLS (really severe chills) and MYALGIA (really severe body aches, it was pretty intense, it knocked them out) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment information was provided by reporter.   This case was linked to MOD-2022-455269, MOD-2022-455278, MOD-2022-455207, MOD-2022-455209 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Felt a little bit bad; This spontaneous case was reported by a pharmacist and describes the occurrence of FEELING ABNORMAL (Felt a little bit bad) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 006M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt a little bit bad). At the time of the report, FEELING ABNORMAL (Felt a little bit bad) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that HCP felt a little bit bad but not as bad as after second dose.  Treatment information was not provided.   This case was linked to MOD-2022-455277, MOD-2022-455269, MOD-2022-455195, MOD-2022-455207, MOD-2022-455209 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: minor skin eruption; This spontaneous case was reported by a consumer and describes the occurrence of RASH (minor skin eruption) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (minor skin eruption). At the time of the report, RASH (minor skin eruption) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient reported not on any medications.  Treatment information was not provided.  After the 1st and 2nd dose Moderna, the patient broke out with minor skin eruption. After the booster dose, the patient had a stinging sensation, itching and took about a 1-2 week before getting an eruption. He visited a medical doctor and a dermatologist, and was prescribed an antihistamine and a steroid pack The symptoms are starting to resolve after taking an antihistamine (either Zyrtec or Claritin).   This case was linked to MOD-2022-454183, MOD-2022-454200 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose with Pfizer and 2nd dose with Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose with Pfizer and 2nd dose with Moderna) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose) on 19-Mar-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose with Pfizer and 2nd dose with Moderna). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose with Pfizer and 2nd dose with Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.  Reporter stated that patient had no symptoms after 2nd dose. And also stated that patient had no medical conditions and no medications.   This case was linked to MOD-2022-455311 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose with Pfizer and 2nd dose with Moderna; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2022 and was forwarded to Moderna on 19-Jan-2022. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose with Pfizer and 2nd dose with Moderna) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose) on 19-Mar-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose with Pfizer and 2nd dose with Moderna). On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose with Pfizer and 2nd dose with Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were reported.  The patient had no symptoms after the 2nd dose. The patient have no medical conditions and no medications.   This case was linked to MOD-2022-455309 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced FATIGUE (Tired). In August 2021, FATIGUE (Tired) had resolved.            No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-024870, MOD-2022-455203 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Change of bowel habit, Fatigue, Pain
Clinical narrative: The bowel habit changes, continued but did not get worst; Achy; Tired for a few days; This spontaneous case was reported by a consumer and describes the occurrence of CHANGE OF BOWEL HABIT (The bowel habit changes, continued but did not get worst), PAIN (Achy) and FATIGUE (Tired for a few days) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHANGE OF BOWEL HABIT (The bowel habit changes, continued but did not get worst), PAIN (Achy) and FATIGUE (Tired for a few days). On 06-Apr-2021, PAIN (Achy) and FATIGUE (Tired for a few days) had resolved. At the time of the report, CHANGE OF BOWEL HABIT (The bowel habit changes, continued but did not get worst) had not resolved.            No concomitant medications were provided.  No treatment medications were reported.  The patient had the usual side effects: achy, and tired for a few days. The bowel habit changes, continued but did not get worst.   This case was linked to MOD-2022-455152, MOD-2022-455073, MOD-2022-455338 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Change of bowel habit, Fatigue, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHANGE OF BOWEL HABIT (bowel habit changes, continued but did not get worst after the booster), MYALGIA (Achy) and FATIGUE (Tired for a few days) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2021, the patient experienced CHANGE OF BOWEL HABIT (bowel habit changes, continued but did not get worst after the booster), MYALGIA (Achy) and FATIGUE (Tired for a few days). On 09-Nov-2021, MYALGIA (Achy) and FATIGUE (Tired for a few days) had resolved. At the time of the report, CHANGE OF BOWEL HABIT (bowel habit changes, continued but did not get worst after the booster) had not resolved. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Her bowel habit never went back to normal. The patient had not seen a doctor. This case was linked to MOD-2022-455073, MOD-2022-455337 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: whole body is achy and sore; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (whole body is achy and 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 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced MYALGIA (whole body is achy and sore). At the time of the report, MYALGIA (whole body is achy and sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided. Patient did not have any reaction to the first two shorts.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: I got vaccinated on Jan 09 and pedending on the batch, the vaccine expired on Dec 01; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I got vaccinated on Jan 09 and pedending on the batch, the vaccine expired on Dec 01) 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 09-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I got vaccinated on Jan 09 and pedending on the batch, the vaccine expired on Dec 01). On 09-Jan-2022, EXPIRED PRODUCT ADMINISTERED (I got vaccinated on Jan 09 and pedending on the batch, the vaccine expired on Dec 01) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea, Feeling abnormal, Pain
Clinical narrative: didn't feel good; The pain at times took her breath away; terrible pains around to the left side of her back at elbow level; terrible pains in her left side/doubled up in pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel good), PAIN (terrible pains in her left side/doubled up in pain), DYSPNOEA (The pain at times took her breath away) and BACK PAIN (terrible pains around to the left side of her back at elbow level) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included Sickness (January/February of 2019, & it lasted 10 to 15 days.) in 2019.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-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 FEELING ABNORMAL (didn't feel good), PAIN (terrible pains in her left side/doubled up in pain), DYSPNOEA (The pain at times took her breath away) and BACK PAIN (terrible pains around to the left side of her back at elbow level). At the time of the report, FEELING ABNORMAL (didn't feel good), PAIN (terrible pains in her left side/doubled up in pain), DYSPNOEA (The pain at times took her breath away) and BACK PAIN (terrible pains around to the left side of her back at elbow level) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to the hospital because she was doubled up in pain. It took about 2 to 3 weeks to go away. They never found a cause. No concomitant medication were provided. No treatment information were given.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 043B21A) for COVID-19 vaccination. Concurrent medical conditions included Allergic rhinitis (can never smell anything). On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine). On 14-Jan-2022, THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine) had resolved.    No Concomitant medication were reported. No treatment medication were reported. This case was linked to MOD-2022-455408, MOD-2022-455409 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nasal congestion
Clinical narrative: congestion; I feel body aches; I experienced a severe headache for a day; This spontaneous case was reported by an other health care professional and describes the occurrence of NASAL CONGESTION (congestion), MYALGIA (I feel body aches) and HEADACHE (I experienced a severe headache for a day) 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 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced NASAL CONGESTION (congestion), MYALGIA (I feel body aches) and HEADACHE (I experienced a severe headache for a day). At the time of the report, NASAL CONGESTION (congestion) and MYALGIA (I feel body aches) had not resolved and HEADACHE (I experienced a severe headache for a day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic rhinitis (Can never smell anything).   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine). On 25-May-2021, THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine) had resolved.            No concomitant medication information was provided. No treatment information was provided.   This case was linked to MOD-2022-455403, MOD-2022-455409 (Patient Link).
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic rhinitis (can never smell anything).    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine). On 26-Apr-2021, THERAPEUTIC RESPONSE UNEXPECTED (Patient with allergic rhinitis who can never smell anything can smell for 2 days after getting the vaccine) had resolved.            No concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-455408, MOD-2022-455403 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Vaccination site swelling
Clinical narrative: Was sick; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-455427, MOD-2022-455428 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old given Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old given Moderna Covid-19 vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old given Moderna Covid-19 vaccine). On 18-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old given Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that a 17 year old patient was administered with the 1st dose of the Moderna Covid-19 vaccine at their facility.  No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Immunocompromised given booster dose instead of 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised given booster dose instead of 3rd dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis and Immunocompromised (severely immunocompromised with rheumatoid arthritis).   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised given booster dose instead of 3rd dose). In November 2021, ACCIDENTAL UNDERDOSE (Immunocompromised given booster dose instead of 3rd dose) had resolved.            It was reported that the doctor recommended the patient to get a third dose but she got the booster dose in Nov 2021.  Concomitant medications reported included medications for rheumatoid arthritis.  No treatment medications were reported.   This case was linked to MOD-2022-455548 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Vaccination site swelling
Clinical narrative: Was sick; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-455416, MOD-2022-455428 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Grip strength decreased, Hypokinesia, Joint stiffness
Clinical narrative: Was sick; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-455416, MOD-2022-455428 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Vaccination complication, Vaccination site discomfort, Vaccination site pain, Vaccination site reaction
Clinical narrative: Was sick; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-455416, MOD-2022-455428 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Was sick; Injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-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 ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen). At the time of the report, ILLNESS (Was sick) and VACCINATION SITE SWELLING (Injection site was swollen) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-455416, MOD-2022-455428 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Vaccination site swelling
Clinical narrative: Lethargic; Shoulder area above the injection site hurts; Injection site was swollen and painful; Injection site was swollen and painful; Tired; Right arm has not felt normal; Feels like her joint is stiff; Can't grip on things; Can't sleep on her right arm; Can't lift her right arm like she used too; she has adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things) and VACCINATION SITE DISCOMFORT (Can't sleep on her right arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things), VACCINATION SITE DISCOMFORT (Can't sleep on her right arm), HYPOKINESIA (Can't lift her right arm like she used too) and VACCINATION COMPLICATION (she has adverse reaction). On an unknown date, the patient experienced LETHARGY (Lethargic), ARTHRALGIA (Shoulder area above the injection site hurts), VACCINATION SITE PAIN (Injection site was swollen and painful), VACCINATION SITE SWELLING (Injection site was swollen and painful) and FATIGUE (Tired). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things), VACCINATION SITE DISCOMFORT (Can't sleep on her right arm), HYPOKINESIA (Can't lift her right arm like she used too), VACCINATION COMPLICATION (she has adverse reaction), ARTHRALGIA (Shoulder area above the injection site hurts), VACCINATION SITE PAIN (Injection site was swollen and painful) and FATIGUE (Tired) had not resolved and VACCINATION SITE SWELLING (Injection site was swollen and painful) was resolving.            Concomitant medications were not reported. Treatment medications were not reported   This case was linked to MOD-2022-455427, MOD-2022-455416 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Grip strength decreased, Hypokinesia, Joint stiffness
Clinical narrative: Lethargic; Shoulder area above the injection site hurts; Injection site was swollen and painful; Injection site was swollen and painful; Tired; Right arm has not felt normal; Feels like her joint is stiff; Can't grip on things; Can't sleep on her right arm; Can't lift her right arm like she used too; she has adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things) and VACCINATION SITE DISCOMFORT (Can't sleep on her right arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things), VACCINATION SITE DISCOMFORT (Can't sleep on her right arm), HYPOKINESIA (Can't lift her right arm like she used too) and VACCINATION COMPLICATION (she has adverse reaction). On an unknown date, the patient experienced LETHARGY (Lethargic), ARTHRALGIA (Shoulder area above the injection site hurts), VACCINATION SITE PAIN (Injection site was swollen and painful), VACCINATION SITE SWELLING (Injection site was swollen and painful) and FATIGUE (Tired). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things), VACCINATION SITE DISCOMFORT (Can't sleep on her right arm), HYPOKINESIA (Can't lift her right arm like she used too), VACCINATION COMPLICATION (she has adverse reaction), ARTHRALGIA (Shoulder area above the injection site hurts), VACCINATION SITE PAIN (Injection site was swollen and painful) and FATIGUE (Tired) had not resolved and VACCINATION SITE SWELLING (Injection site was swollen and painful) was resolving.            Concomitant medications were not reported. Treatment medications were not reported   This case was linked to MOD-2022-455427, MOD-2022-455416 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Vaccination complication, Vaccination site discomfort, Vaccination site pain, Vaccination site reaction
Clinical narrative: Lethargic; Shoulder area above the injection site hurts; Injection site was swollen and painful; Injection site was swollen and painful; Tired; Right arm has not felt normal; Feels like her joint is stiff; Can't grip on things; Can't sleep on her right arm; Can't lift her right arm like she used too; she has adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things) and VACCINATION SITE DISCOMFORT (Can't sleep on her right arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things), VACCINATION SITE DISCOMFORT (Can't sleep on her right arm), HYPOKINESIA (Can't lift her right arm like she used too) and VACCINATION COMPLICATION (she has adverse reaction). On an unknown date, the patient experienced LETHARGY (Lethargic), ARTHRALGIA (Shoulder area above the injection site hurts), VACCINATION SITE PAIN (Injection site was swollen and painful), VACCINATION SITE SWELLING (Injection site was swollen and painful) and FATIGUE (Tired). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things), VACCINATION SITE DISCOMFORT (Can't sleep on her right arm), HYPOKINESIA (Can't lift her right arm like she used too), VACCINATION COMPLICATION (she has adverse reaction), ARTHRALGIA (Shoulder area above the injection site hurts), VACCINATION SITE PAIN (Injection site was swollen and painful) and FATIGUE (Tired) had not resolved and VACCINATION SITE SWELLING (Injection site was swollen and painful) was resolving.            Concomitant medications were not reported. Treatment medications were not reported   This case was linked to MOD-2022-455427, MOD-2022-455416 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Lethargic; Shoulder area above the injection site hurts; Injection site was swollen and painful; Injection site was swollen and painful; Tired; Right arm has not felt normal; Feels like her joint is stiff; Can't grip on things; Can't sleep on her right arm; Can't lift her right arm like she used too; she has adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things) and VACCINATION SITE DISCOMFORT (Can't sleep on her right arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things), VACCINATION SITE DISCOMFORT (Can't sleep on her right arm), HYPOKINESIA (Can't lift her right arm like she used too) and VACCINATION COMPLICATION (she has adverse reaction). On an unknown date, the patient experienced LETHARGY (Lethargic), ARTHRALGIA (Shoulder area above the injection site hurts), VACCINATION SITE PAIN (Injection site was swollen and painful), VACCINATION SITE SWELLING (Injection site was swollen and painful) and FATIGUE (Tired). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE REACTION (Right arm has not felt normal), JOINT STIFFNESS (Feels like her joint is stiff), GRIP STRENGTH DECREASED (Can't grip on things), VACCINATION SITE DISCOMFORT (Can't sleep on her right arm), HYPOKINESIA (Can't lift her right arm like she used too), VACCINATION COMPLICATION (she has adverse reaction), ARTHRALGIA (Shoulder area above the injection site hurts), VACCINATION SITE PAIN (Injection site was swollen and painful) and FATIGUE (Tired) had not resolved and VACCINATION SITE SWELLING (Injection site was swollen and painful) was resolving.            Concomitant medications were not reported. Treatment medications were not reported   This case was linked to MOD-2022-455427, MOD-2022-455416 (Patient Link).
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: HCP who is reporting administration error on patient and explained patient received Moderna Covid-19 booster shot instead of full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (HCP who is reporting administration error on patient and explained patient received Moderna Covid-19 booster shot instead of full dose) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (HCP who is reporting administration error on patient and explained patient received Moderna Covid-19 booster shot instead of full dose). On 17-Jan-2022, ACCIDENTAL UNDERDOSE (HCP who is reporting administration error on patient and explained patient received Moderna Covid-19 booster shot instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No further information regarding patient side effect was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Chest pain
Clinical narrative: Developed a lump under left arm; Pain under left arm; Pain in chest near heart; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Pain in chest near heart), AXILLARY MASS (Developed a lump under left arm) and AXILLARY PAIN (Pain under left arm) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2022, the patient experienced CHEST PAIN (Pain in chest near heart) and AXILLARY PAIN (Pain under left arm). On 19-Jan-2022, the patient experienced AXILLARY MASS (Developed a lump under left arm). At the time of the report, CHEST PAIN (Pain in chest near heart), AXILLARY MASS (Developed a lump under left arm) and AXILLARY PAIN (Pain under left arm) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: accidentally administered the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (accidentally administered the booster 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-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (accidentally administered the booster dose). On 19-Jan-2022, ACCIDENTAL UNDERDOSE (accidentally administered the booster dose) had resolved.            Concomitant drugs were not reported. Treatment details were not reported. Reporter states that patient came in for 2nd dose of Moderna and they accidentally administered the booster dose.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 43 days since 1st dose/Did not receive 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 43 days since 1st dose/Did not receive 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 43 days since 1st dose/Did not receive 2nd dose). In March 2021, PRODUCT DOSE OMISSION ISSUE (More than 43 days since 1st dose/Did not receive 2nd dose) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 years old patient receiving a dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient receiving a dose of the Moderna COVID19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient receiving a dose of the Moderna COVID19 vaccine). On 27-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 years old patient receiving a dose of the Moderna COVID19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter. No concomitant medication was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Booster dose instead of third dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Booster dose instead of third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included USTEKINUMAB (STELERA) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Booster dose instead of third dose). At the time of the report, ACCIDENTAL UNDERDOSE (Booster dose instead of third dose) had resolved.            No treatment information was reported by the reporter. Patient had been on a drug Stelera which impairs immune system.  Patient had already had 3 shots and believed the third one was a booster.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: got a booster dose of the Moderna vaccine that was expired.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got a booster dose of the Moderna vaccine that was expired.) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (got a booster dose of the Moderna vaccine that was expired.). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (got a booster dose of the Moderna vaccine that was expired.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported.