chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Cough, Fatigue, Rash, Rash macular
Clinical narrative: DRY COUGH; BREAKAGE HAIR; THINNING HAIR; RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN; TIRED; LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (DRY COUGH), TRICHORRHEXIS (BREAKAGE HAIR), ALOPECIA (THINNING HAIR), RASH MACULAR (RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN) and RASH (LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    Concurrent medical conditions included Crohn's disease and Ulcerative colitis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 14-Dec-2021 to 14-Dec-2021 for COVID-19 vaccination.   In June 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced RASH (LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN). On 01-Jun-2022, the patient experienced FATIGUE (TIRED). In July 2022, the patient experienced RASH MACULAR (RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN). On an unknown date, the patient experienced COUGH (DRY COUGH), TRICHORRHEXIS (BREAKAGE HAIR) and ALOPECIA (THINNING HAIR). The patient was treated with FOLIC ACID at an unspecified dose and frequency and BIOTIN at an unspecified dose and frequency. At the time of the report, COUGH (DRY COUGH), TRICHORRHEXIS (BREAKAGE HAIR), ALOPECIA (THINNING HAIR) and FATIGUE (TIRED) had resolved and RASH MACULAR (RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN) and RASH (LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN) had not resolved.            In June 2022, the patient received second booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular).   This case was linked to MOD-2022-658218 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Trichorrhexis
Clinical narrative: DRY COUGH; BREAKAGE HAIR; THINNING HAIR; RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN; TIRED; LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (DRY COUGH), TRICHORRHEXIS (BREAKAGE HAIR), ALOPECIA (THINNING HAIR), RASH MACULAR (RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN) and RASH (LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Ulcerative colitis.    Concurrent medical conditions included Crohn's disease and Ulcerative colitis. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 14-Dec-2021 to 14-Dec-2021 for COVID-19 vaccination.   In June 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. In 2021, the patient experienced RASH (LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN). On 01-Jun-2022, the patient experienced FATIGUE (TIRED). In July 2022, the patient experienced RASH MACULAR (RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN). On an unknown date, the patient experienced COUGH (DRY COUGH), TRICHORRHEXIS (BREAKAGE HAIR) and ALOPECIA (THINNING HAIR). The patient was treated with FOLIC ACID at an unspecified dose and frequency and BIOTIN at an unspecified dose and frequency. At the time of the report, COUGH (DRY COUGH), TRICHORRHEXIS (BREAKAGE HAIR), ALOPECIA (THINNING HAIR) and FATIGUE (TIRED) had resolved and RASH MACULAR (RASH TO ABDOMEN/LARGE FLAT, PINK BLOTCH TO LEFT SIDE OF ABDOMEN/HIP AREA/BLOTHCH RETURNED AND MORE RED/SMALLER BLOTCHES ON RIGHT SIDE OF ABDOMEN) and RASH (LITTLE RASH ON HER STOMACH FROM COVID-19 VACCINE/NEVER GONE AWAY/FADES SOMETIMES AND GET DARK AGAIN) had not resolved.            In June 2022, the patient received second booster dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular).   This case was linked to MOD-2022-658218 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pustule, Rash, Rash pruritic, Scar
Clinical narrative: Rash/Rash under both elbows/Rash on left calf/Rash on right ankle/Rash of 4 inches; There are bumps in the rash, it has a dead border and, in the middle, a live pustule.; it is almost a scar by now because of the scratching and it measures around 4 inches on right ankle; Itchy rash which is almost a scar because of scratching; This spontaneous case was reported by a patient and describes the occurrence of PUSTULE (There are bumps in the rash, it has a dead border and, in the middle, a live pustule.), SCAR (it is almost a scar by now because of the scratching and it measures around 4 inches on right ankle), RASH PRURITIC (Itchy rash which is almost a scar because of scratching) and RASH (Rash/Rash under both elbows/Rash on left calf/Rash on right ankle/Rash of 4 inches) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no allergies. Patient was never tested COVID-19 positive.  Previously administered products included for Product used for unknown indication: J & J vaccine (Previous dose was J&J). Past adverse reactions to the above products included No adverse event with J & J vaccine. Concurrent medical conditions included Clot blood (Blood coagulation). Concomitant products included APIXABAN (ELIQUIS) and DILTIAZEM for an unknown indication.    In March 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2022, the patient experienced RASH (Rash/Rash under both elbows/Rash on left calf/Rash on right ankle/Rash of 4 inches). In 2022, the patient experienced PUSTULE (There are bumps in the rash, it has a dead border and, in the middle, a live pustule.), SCAR (it is almost a scar by now because of the scratching and it measures around 4 inches on right ankle) and RASH PRURITIC (Itchy rash which is almost a scar because of scratching). At the time of the report, PUSTULE (There are bumps in the rash, it has a dead border and, in the middle, a live pustule.), SCAR (it is almost a scar by now because of the scratching and it measures around 4 inches on right ankle), RASH PRURITIC (Itchy rash which is almost a scar because of scratching) and RASH (Rash/Rash under both elbows/Rash on left calf/Rash on right ankle/Rash of 4 inches) outcome was unknown.            Concomitant medication also included blood coagulation medication. It was reported that there were bumps in the rash. Patient had visited the Doctor. Treatment included Antibiotics, Corticoids.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first dose on 22-Oct-2021 and second dose on 17-Dec-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Oct-2021 and second dose on 17-Dec-2021) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A and 014F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Oct-2021 and second dose on 17-Dec-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Oct-2021 and second dose on 17-Dec-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 22-Oct-2021 and second dose on 17-Dec-2021).    No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-658075. This case was linked to MOD-2022-658197 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658075:patient 2( dose 2)
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medications were not reported.  It was reported that, patient forced to take experiment against patient will, and it had adverse impacts. Patient was asking for compensation otherwise patient reported that, patient will seek other resources. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received another vaccine instead of the Bivalent Booster; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received another vaccine instead of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received another vaccine instead of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received another vaccine instead of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided Patient said she went to her vaccination provider to receive the Covid-19 Bivalent 5th booster and instead she received another vaccine, they switched lot numbers in her vaccination card and they did not know what they gave her. No treatment information provided
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Spikevax appears to have given PMR within 10 days of being vaccinated; This spontaneous case was reported by a patient and describes the occurrence of POLYMYALGIA RHEUMATICA (Spikevax appears to have given PMR within 10 days of being vaccinated) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Osteoporosis.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Spikevax appears to have given PMR within 10 days of being vaccinated) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (Spikevax appears to have given PMR within 10 days of being vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Patient age was over 70.  No concomitant medications were reported.   It was reported that spikevax appeared to have given her PMR within 10 days of being vaccinated.   It was reported that patient would now had to take steroids for a year.  Company comment: This spontaneous case concerns a female patient over 70 years, with no relevant medical history, who experienced the unexpected serious (medically significant) event of polymyalgia rheumatica (reported as Spikevax appears to have given PMR within 10 days of being vaccinated), which occurred within 10 days after a dose (dose number not specified) of mRNA-1273 vaccine. Patient is having osteoporosis, now have to take steroids for a year. At the time of reporting outcome of the event is unknown. No further information on clinical course, lab data, treatment received. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient over 70 years, with no relevant medical history, who experienced the unexpected serious (medically significant) event of polymyalgia rheumatica (reported as Spikevax appears to have given PMR within 10 days of being vaccinated), which occurred within 10 days after a dose (dose number not specified) of mRNA-1273 vaccine. Patient is having osteoporosis, now have to take steroids for a year. At the time of reporting outcome of the event is unknown. No further information on clinical course, lab data, treatment received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic product ineffective
Clinical narrative: Humira was not working; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT INEFFECTIVE (Humira was not working) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe Chronic Plaque Psoriasis). On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen. On an unknown date, the patient experienced THERAPEUTIC PRODUCT INEFFECTIVE (Humira was not working). At the time of the report, THERAPEUTIC PRODUCT INEFFECTIVE (Humira was not working) outcome was unknown.      No relevant concomitant medications were reported. Moderna was reported as 4782589.  No treatment medication reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Opinion was that the causality for the event of Humira was not working with Moderna COVID-19 vaccine (Elasomeran) was not provided.  The reporter's causality for the event(s) of Humira was not working with Adalimumab Solution for Injection was Not Provided The reporter's causality for the event(s) of Humira was not working with Moderna COVID-19 vaccine (Elasomeran) was Reasonable Possibility Opinion was that the causality for the event(s) of Humira was not working with Moderna COVID-19 vaccine (Elasomeran) was Not Provided Opinion was that the causality for the event(s) of Humira was not working with Adalimumab Solution for Injection was Not Provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient was given a 0.25 mL of Moderna Bivalent Booster dose / Invalid Bivalent Dose Administered; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose / Invalid Bivalent Dose Administered) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown that patient had any allergies to medication, food and other products. It was unknown patient ever been diagnosed or tested positive for COVID-19. It was patient had any acute illness or any chronic long-standing health conditions at the time of vaccination.     On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose / Invalid Bivalent Dose Administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose / Invalid Bivalent Dose Administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose / Invalid Bivalent Dose Administered).    No prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event.   It was reported that the patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022. Patient denied having distress at the time of call. Patient denied having to go to the emergency room  or primary care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 15-Sep-2022. However, the patient would like to be re vaccinated.   Treatment medications were not reported.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; The dose was 0.25ml/ Dose 0.25ml administered instead of a 0.5ml dose/ Invalid bivalent dose adminstered; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (The dose was 0.25ml/ Dose 0.25ml administered instead of a 0.5ml dose/ Invalid bivalent dose adminstered) and NO ADVERSE EVENT (No adverse event) in a 19-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 15-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (The dose was 0.25ml/ Dose 0.25ml administered instead of a 0.5ml dose/ Invalid bivalent dose adminstered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (The dose was 0.25ml/ Dose 0.25ml administered instead of a 0.5ml dose/ Invalid bivalent dose adminstered) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered ACCIDENTAL UNDERDOSE (The dose was 0.25ml/ Dose 0.25ml administered instead of a 0.5ml dose/ Invalid bivalent dose adminstered) and NO ADVERSE EVENT (No adverse event) to be not related.    Concomitant product use was not provided by the reporter. Patient did not have any known drug allergy. The patient was called on 28-Sep-2022 and Patient was informed for the dosing error.  Reporter also stated that 2.5 ml was administered but the administration error was 0.25 ml. Patient made aware received a 0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denies having distress currently. Patient denied having to go to the Emergency room or Primary Care provider. It has been also informed to patient that according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 15-Sep-2022. Patient stated would like to be re vaccinate. Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient was given a 0.25 mL of Moderna Bivalent Booster instead of a 0.5ml dose / Invalid Bivalent Dose Administered; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster instead of a 0.5ml dose / Invalid Bivalent Dose Administered) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Patient does not have any known drug allergies. No chronic and acute illness at the time of vaccination and one month prior.     On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 15-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster instead of a 0.5ml dose / Invalid Bivalent Dose Administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster instead of a 0.5ml dose / Invalid Bivalent Dose Administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related and ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster instead of a 0.5ml dose / Invalid Bivalent Dose Administered) to have an unknown relationship.    No prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event.  It was reported that the patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022. Patient documentation showed the lot number for bivalent.  The information was presented to staff on 27-Sep-2022. The patient was called on 28-Sep-2022. Patient was made aware that patient received a 0.25 mL of Moderna Bivalent Booster dose. Patient verbalized understanding. Patient denied having distress at the time of call. Patient denied having to go to the emergency room  or primary care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 15-Sep-2022. Patient stated that patient would like to be re vaccinated. Patient  was made aware and would reach out to patient regarding receiving full vaccination.  Treatment information was not provided.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event; My children received a Moderna bivalent booster yesterday; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday) and NO ADVERSE EVENT (No adverse event) in a 9-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR665B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (Dose 2) in January 2022 and Pfizer COVID-19 vaccine (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 11-Oct-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Oct-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My children received a Moderna bivalent booster yesterday) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported by the reporter.  The reporter was not sure if the patient was eligible to receive a booster dose at the time of administration. Patient was inadvertently administered a dose of the Moderna COVID-19 bivalent vaccine, instead. Reporter was told by the clinic that the Moderna COVID-19 bivalent vaccine just got authorized for use in children 6 and older and that it should not be an issue. Patient was okay so far and did not reported any adverse reactions at the time report.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Achy arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Achy arm) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022, the patient experienced PAIN IN EXTREMITY (Achy arm). At the time of the report, PAIN IN EXTREMITY (Achy arm) outcome was unknown.            No concomitant medications were provided. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-658776, US-MODERNATX, INC.-MOD-2022-658814; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658776:wife (second booster dose) US-MODERNATX, INC.-MOD-2022-658814:Wife (1,2. 1st booster)
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event; I don't think the needle went into my muscle/Patient was pretty sure that received the vaccine at skin level but not intramuscularly/it pinch only patient's skin; This spontaneous case was reported by a patient and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I don't think the needle went into my muscle/Patient was pretty sure that received the vaccine at skin level but not intramuscularly/it pinch only patient's skin) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I don't think the needle went into my muscle/Patient was pretty sure that received the vaccine at skin level but not intramuscularly/it pinch only patient's skin). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (I don't think the needle went into my muscle/Patient was pretty sure that received the vaccine at skin level but not intramuscularly/it pinch only patient's skin) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     Concomitant medications details were not reported by the reporter. Patient did not think the needle went into muscle, Patient did not feel any soreness and was pretty sure that she received the vaccine at skin level but not intramuscularly and it pinch only skin. Patient thought that because she was not having any side effects and wants to know if patient was protected. Treatment details were not reported by the reporter.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Adult patient received expired Moderna Covid-19 vaccine for the second series of his primary series of the Moderna Covid-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Moderna Covid-19 vaccine for the second series of his primary series of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Moderna Covid-19 vaccine for the second series of his primary series of the Moderna Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Moderna Covid-19 vaccine for the second series of his primary series of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired Moderna Covid-19 vaccine for the second series of his primary series of the Moderna Covid-19 vaccine.).    No concomitant medications were reported.  The patient received his first primary series dose of the Moderna COVID-19 vaccine on 07-Sep-2022 lot number 082B22A expiration date was 22-Nov-2022 in the left arm. No adverse reactions experienced.  Vial size was 5.5ml. Vial was initially stored in the refrigerator on 12-Oct-2022. The vial did not undergo any temperature excursions.  No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2022: Follow-up received wherein patient demographics and suspect product indication updated.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: came down with Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (came down with Covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2022, the patient experienced COVID-19 (came down with Covid). At the time of the report, COVID-19 (came down with Covid) outcome was unknown.            Concomitant medications were not reported. Caller was scheduled to get the new booster on Thursday. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: received the new Bivalent and were given 0.25 mL dose instead of the 0.5mL; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (received the new Bivalent and were given 0.25 mL dose instead of the 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (received the new Bivalent and were given 0.25 mL dose instead of the 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received the new Bivalent and were given 0.25 mL dose instead of the 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (received the new Bivalent and were given 0.25 mL dose instead of the 0.5mL).    Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mobility decreased, Pain
Clinical narrative: I could take ibuprofen to ease the pain; I could not move my arm or torso; Had a very swollen lymph node in my armpit / The swelling was very intense; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I could take ibuprofen to ease the pain), MOBILITY DECREASED (I could not move my arm or torso) and LYMPHADENOPATHY (Had a very swollen lymph node in my armpit / The swelling was very intense) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced PAIN (I could take ibuprofen to ease the pain), MOBILITY DECREASED (I could not move my arm or torso) and LYMPHADENOPATHY (Had a very swollen lymph node in my armpit / The swelling was very intense). In 2022, PAIN (I could take ibuprofen to ease the pain), MOBILITY DECREASED (I could not move my arm or torso) and LYMPHADENOPATHY (Had a very swollen lymph node in my armpit / The swelling was very intense) had resolved.            Patient received the booster at the on site clinic. Concomitant medication list was not provided. It was mentioned that the symptoms to occupational health and asked if patient could take ibuprofen for pain. The patient stated that it lasted for about 7 days. The swelling had gone down since and the patient was all better. Treatment information was not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Furuncle, Headache
Clinical narrative: Boils on underarm and groin area; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of FURUNCLE (Boils on underarm and groin area) and HEADACHE (Headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa and ACITRETIN for Pustular psoriasis.    Concurrent medical conditions included Pustular psoriasis and Hidradenitis suppurativa (Moderate to Severe Hidradenitis Suppurativa).   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and ACITRETIN (Oral) 25 milligram. On an unknown date, the patient experienced FURUNCLE (Boils on underarm and groin area) and HEADACHE (Headaches). At the time of the report, FURUNCLE (Boils on underarm and groin area) outcome was unknown and HEADACHE (Headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2022, Computerised tomogram: found nothing.         No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial or not.  The reporter causality for the event of headaches was reported as reasonable possibility with respect to co-suspect Acitretin and for the event of boils on underarm and groin area was not provided with respect to co-suspect Acitretin.  The reporter causality for the events of headaches and boils on underarm and groin area was not provided with respect to co-suspect Acitretin.  No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient was vaccinated after the expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date).    At the time of an unannounced visit by a Regulatory Authority representative on 28-Sep-2022, 50 doses of Moderna vaccines were left in the office which were looked well after but they were uncompliant since that lot of Moderna vaccines had expired on 07-Jul-2022.  Additionally it was mentioned that the expiration code on the packaging slip was not the expiration code, instead they had to scan the QR code to determine the actual expiration code, which they failed, by not reading carefully the packing slip.  The patient had received the expired vaccine on 15-Jul-2022.  Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 10 year old given monovalent booster instead of bivalent; 10 year old given monovalent booster instead of bivalent; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (10 year old given monovalent booster instead of bivalent) and NO ADVERSE EVENT (10 year old given monovalent booster instead of bivalent) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1) on 04-Nov-2021, Pfizer (Dose Number: 2) on 21-Jan-2022, Pfizer (Dose Number: 3 and Lot number: FL8095) on 23-May-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 13-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (10 year old given monovalent booster instead of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (10 year old given monovalent booster instead of bivalent). At the time of the report, WRONG PRODUCT ADMINISTERED (10 year old given monovalent booster instead of bivalent) and NO ADVERSE EVENT (10 year old given monovalent booster instead of bivalent) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (10 year old given monovalent booster instead of bivalent) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (10 year old given monovalent booster instead of bivalent).    No concomitant drug were reported.   The pharmacy technician stated that the pediatric dose was approved.   No treatment drug were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient was vaccinated after the expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date).    Concomitant medications details were not reported by the reporter.  Reportedly, at the time of unannounced visit by an representative on 28-Sep-2022, 50 doses of moderna vaccines were left in the health department which were looked well but later on the day stated that were uncompliant due to the same lot of moderna vaccines had expired on 07-Jul-2022.  Additionally it was mentioned that the expiration code on the packaging slip was not the expiration code, had to scan the QR code to determine the actual expiration code, thus failed to did by not reading carefully the packing slip.  Treatment details were not reported by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medications details were not reported by the reporter.  Reportedly, at the time of unannounced visit by an representative on 28-Sep-2022, 50 doses of moderna vaccines were left in the health department which were looked well but later on the day stated that were uncompliant due to the same lot of moderna vaccines had expired on 07-Jul-2022.  Additionally, it was mentioned that the expiration code on the packaging slip was not the expiration code, had to scan the QR code to determine the actual expiration code, thus failed to did by not reading carefully the packing slip.  Treatment details were not reported by the reporter.