chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly 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 (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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 administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.  It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster) 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 WRONG PRODUCT ADMINISTERED (monovalent vaccine given as booster).    No concomitant medications were reported.  It was reported that the caller was the office manager. She had a situation. She found out that they could not give the Moderna as a booster starting 31-Aug-2022, but administered 15 monovalent doses as boosters. She called public health, who said there was no harm in it. She was told that the booster that they received did not cover omicron, so they would need to be revaccinated with the bivalent later.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Monovalent vaccine was given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine was given as booster) and NO ADVERSE EVENT (No adverse event) in an adult female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine was given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine was given as booster) 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 WRONG PRODUCT ADMINISTERED (monovalent vaccine was given as booster).    Concomitant product use was not provided by the reporter.  Reporter found out that they could not give the Moderna as a booster starting 31-Aug-2022, but she administered 15 monovalent doses as boosters.  Reporter called public health, who said there was no harm in it.  Reporter was told that the booster that they received did not cover omicron, so they would need to be revaccinated with the bivalent later.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient received monovalent vaccine given as booster; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event) in an elderly male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster) 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 WRONG PRODUCT ADMINISTERED (Patient received monovalent vaccine given as booster). No concomitant medication was reported.    It was reported that reporter found out that they could not gave the Moderna as a booster starting 31-Aug-2022, but administered monovalent doses as boosters. She was told that booster that they received did not cover omicron, so the patients would need to be revaccinated with the bivalent later.  No treatment information was reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; little fever; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills) and PYREXIA (little fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002L21A, 024M20A and 041L20A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Environmental allergy (allergy shots every month for 20 years), Penicillin allergy, Sulfonamide allergy, Drug allergy, Blood pressure abnormal (taking small dose of blood pressure medication (Amlodipine 2.5mg once a day)) and UTI (low dose Nitrofurantoin 50 mg - to prevent UTI for 2.5 years (to keep it under control)). Concomitant products included AMLODIPINE for Blood pressure abnormal, NITROFURANTOIN (NITROFURAN) for UTI, SIMVASTATIN, SALINE [SODIUM CHLORIDE] and IPRATROPIUM BROMIDE (IPRATROPIUM [IPRATROPIUM BROMIDE]) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CHILLS (chills) and PYREXIA (little fever). At the time of the report, CHILLS (chills) and PYREXIA (little fever) had resolved.            Patient height - 4'11 and 3/4". Patient not ever had COVID positive test. Patient had medical conditions were present prior to getting the vaccine and have not gotten worse. AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). patient did not experience a similar event in the past. Patient reported that she had adverse reactions after getting the 4 doses of the Moderna Covid-19 vaccine (monovalent and bivalent). 1st booster was taken on day 24 of unknown month of year 2021. After she got the 1st and 2nd booster doses and the 1st booster dose, she had chills and little fever and was in bed. This lasted for 2 days and resolved. No treatment medication information provided   This case was linked to MOD-2022-649553 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Photophobia
Clinical narrative: light sensitivity; sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PHOTOPHOBIA (light sensitivity) and PAIN IN EXTREMITY (sore 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 vaccination.     No Medical History information was reported.    On 16-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) 1 dosage form. In September 2022, the patient experienced PHOTOPHOBIA (light sensitivity) and PAIN IN EXTREMITY (sore arm). At the time of the report, PHOTOPHOBIA (light sensitivity) and PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were reported.  On 16-Sep-2022, the patient received booster dose of bivalent Moderna COVID-19 vaccine.  It was reported that the patient was now functioning. The reporter described that none of the side effects of the patient could grab the attention of the reporter's eye.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-649476 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-649476:Wife case, same reporter
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Burning sensation, Chills, Fatigue, Head discomfort
Clinical narrative: popping in her head like a pressure; Jaw flared up; sinusitis congestion; burning on top of head, sculp burning; Sensitive to day light really hypersensitive; vertigo; sever pain in neck; Injection site sore as usual; Lymph nodes under her arm swollen; fever; chills, freezing; nausea; fatigue; massive head ache; woke up some arthritic injuries; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning) and PHOTOPHOBIA (Sensitive to day light really hypersensitive) 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. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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) 1 dosage form. In September 2022, the patient experienced HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning), PHOTOPHOBIA (Sensitive to day light really hypersensitive), VERTIGO (vertigo), NECK PAIN (sever pain in neck), VACCINATION SITE PAIN (Injection site sore as usual), LYMPHADENOPATHY (Lymph nodes under her arm swollen), PYREXIA (fever), CHILLS (chills, freezing), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (massive head ache) and ARTHRALGIA (woke up some arthritic injuries). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning), PHOTOPHOBIA (Sensitive to day light really hypersensitive), VERTIGO (vertigo), NECK PAIN (sever pain in neck), VACCINATION SITE PAIN (Injection site sore as usual), LYMPHADENOPATHY (Lymph nodes under her arm swollen), PYREXIA (fever), CHILLS (chills, freezing), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (massive head ache) and ARTHRALGIA (woke up some arthritic injuries) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative)
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Jaw disorder, Lymphadenopathy, Nausea, Neck pain
Clinical narrative: popping in her head like a pressure; Jaw flared up; sinusitis congestion; burning on top of head, sculp burning; Sensitive to day light really hypersensitive; vertigo; sever pain in neck; Injection site sore as usual; Lymph nodes under her arm swollen; fever; chills, freezing; nausea; fatigue; massive head ache; woke up some arthritic injuries; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning) and PHOTOPHOBIA (Sensitive to day light really hypersensitive) 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. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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) 1 dosage form. In September 2022, the patient experienced HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning), PHOTOPHOBIA (Sensitive to day light really hypersensitive), VERTIGO (vertigo), NECK PAIN (sever pain in neck), VACCINATION SITE PAIN (Injection site sore as usual), LYMPHADENOPATHY (Lymph nodes under her arm swollen), PYREXIA (fever), CHILLS (chills, freezing), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (massive head ache) and ARTHRALGIA (woke up some arthritic injuries). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning), PHOTOPHOBIA (Sensitive to day light really hypersensitive), VERTIGO (vertigo), NECK PAIN (sever pain in neck), VACCINATION SITE PAIN (Injection site sore as usual), LYMPHADENOPATHY (Lymph nodes under her arm swollen), PYREXIA (fever), CHILLS (chills, freezing), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (massive head ache) and ARTHRALGIA (woke up some arthritic injuries) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative)
Sex: F
Vaccine: COVID19-2
Symptoms: Photophobia, Pyrexia, SARS-CoV-2 test, Sinusitis, Vaccination site pain
Clinical narrative: popping in her head like a pressure; Jaw flared up; sinusitis congestion; burning on top of head, sculp burning; Sensitive to day light really hypersensitive; vertigo; sever pain in neck; Injection site sore as usual; Lymph nodes under her arm swollen; fever; chills, freezing; nausea; fatigue; massive head ache; woke up some arthritic injuries; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning) and PHOTOPHOBIA (Sensitive to day light really hypersensitive) 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. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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) 1 dosage form. In September 2022, the patient experienced HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning), PHOTOPHOBIA (Sensitive to day light really hypersensitive), VERTIGO (vertigo), NECK PAIN (sever pain in neck), VACCINATION SITE PAIN (Injection site sore as usual), LYMPHADENOPATHY (Lymph nodes under her arm swollen), PYREXIA (fever), CHILLS (chills, freezing), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (massive head ache) and ARTHRALGIA (woke up some arthritic injuries). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning), PHOTOPHOBIA (Sensitive to day light really hypersensitive), VERTIGO (vertigo), NECK PAIN (sever pain in neck), VACCINATION SITE PAIN (Injection site sore as usual), LYMPHADENOPATHY (Lymph nodes under her arm swollen), PYREXIA (fever), CHILLS (chills, freezing), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (massive head ache) and ARTHRALGIA (woke up some arthritic injuries) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative)
Sex: F
Vaccine: COVID19-2
Symptoms: Vertigo
Clinical narrative: popping in her head like a pressure; Jaw flared up; sinusitis congestion; burning on top of head, sculp burning; Sensitive to day light really hypersensitive; vertigo; sever pain in neck; Injection site sore as usual; Lymph nodes under her arm swollen; fever; chills, freezing; nausea; fatigue; massive head ache; woke up some arthritic injuries; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning) and PHOTOPHOBIA (Sensitive to day light really hypersensitive) 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. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-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) 1 dosage form. In September 2022, the patient experienced HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning), PHOTOPHOBIA (Sensitive to day light really hypersensitive), VERTIGO (vertigo), NECK PAIN (sever pain in neck), VACCINATION SITE PAIN (Injection site sore as usual), LYMPHADENOPATHY (Lymph nodes under her arm swollen), PYREXIA (fever), CHILLS (chills, freezing), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (massive head ache) and ARTHRALGIA (woke up some arthritic injuries). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEAD DISCOMFORT (popping in her head like a pressure), JAW DISORDER (Jaw flared up), SINUSITIS (sinusitis congestion), BURNING SENSATION (burning on top of head, sculp burning), PHOTOPHOBIA (Sensitive to day light really hypersensitive), VERTIGO (vertigo), NECK PAIN (sever pain in neck), VACCINATION SITE PAIN (Injection site sore as usual), LYMPHADENOPATHY (Lymph nodes under her arm swollen), PYREXIA (fever), CHILLS (chills, freezing), NAUSEA (nausea), FATIGUE (fatigue), HEADACHE (massive head ache) and ARTHRALGIA (woke up some arthritic injuries) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative)
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event) in an adult 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 (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) 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 (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.).    No concomitant medications were reported.   It was reported that, nurses had no Standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults.  It was reported that approximately 100 patients were administered an invalid dose of the Moderna COVID-19 bivalent booster.  No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose). No AEs were reported; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose). No AEs were reported) and NO ADVERSE EVENT (No adverse event) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose). No AEs were reported) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose). No AEs were reported) 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 administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose). No AEs were reported). No concomitant product reported by reporter. It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly 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 (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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 administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter.  The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 93 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly 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 (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) 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 (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml).    No concomitant product reported by reporter.  Physician reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So, they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. Patient received under dose of 0.25 ml of Moderna Bivalent Booster. It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL. No adverse events were reported.  No treatment medication reported by reporter.   This case was linked to MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-646512:Master Case
Sex: U
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult 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 (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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 administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event) 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered with 0.25mL instead of 0.5mL of bivalent booster dose) 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 administered with 0.25mL instead of 0.5mL of bivalent booster dose).    Concomitant medications were not reported.  It was reported that patient was administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. No AEs were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose).; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose).) and NO ADVERSE EVENT (No adverse event) in an elderly 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 (Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose).) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose).) 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 (Recipients received underdose of 0.25 Moderna Bivalent Booster/ wrong dose for Bivalent Vaccine booster dose (underdose).).    No concomitant product reported by reporter.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event) in an elderly 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 (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) 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 (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.).    No concomitant medications were reported. No treatment details were reported.  Patient received underdose of 0.25 ml Moderna Bivalent Booster.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. The HCP had asked if the patients need an additional 0.25ml dose now.  It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly 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 (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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 administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    Concomitant medications were not reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. No AEs were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.; No adverse reaction; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse reaction) in an adult 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 (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) and NO ADVERSE EVENT (No adverse reaction) 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 reaction) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (The patient was administered lower than authorized dose of the Moderna COVID-19 bivalent booster i.e 0.25 ml instead of 0.5 ml.) No concomitant medications were reported.  It was reported that, nurses had no Standing orders other than what they had for the second booster, when first administering Bivalent boosters. So, they assumed the same dose as the second booster, hence they were administering 0.25 ml instead of 0.5 ml to uncompromised adults. It was reported that approximately 100 patients were administered an invalid dose  0.25 ml instead of 0.5 ml of the Moderna COVID-19 bivalent booster.  No treatment details were reported.