chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.75
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: WRONG DOSE OF VACCINE GIVEN ON 4/25/23.  PT RECEIVED BIVALENT BOOSTER DOSE 10MCG DOSE INSTEAD OF 25MCG DOSE .  NO ADVERSE VACCINE REACTIONS.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient came in for Shingles shot and reported it had been "years" since he had one but in reality he had received one on 11/12/2019 and again on 1/14/2020.
Age: 1.5
Sex: M
Vaccine: COVID19, DTAP, HEPA
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25vmL/25ug
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25vmL/25ug
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25mL/25ug
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25vmL/25ug
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Blood test abnormal, Joint swelling, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: In November 2022 I noticed swelling and joint pain in my hands, feet and ankles. It then led to my fingers, wrists and shoulder joints. In December I saw my doctor and received an anti-inflammatory and it did not help. In January, I received methotrexate from a rheumatologist, and it helped. I was diagnosed in February with rheumatoid arthritis. Currently I am on MEDROL.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25mL/25ug
Age: 21.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Diarrhoea, Nausea, Peripheral swelling, Pruritus
Clinical narrative: NOT ADMINISTERED THROUGH OUR CLINIC VACCINATION DETAILS UNKNOWN.  GIVEN IN LEFT DELT.   -GENERALIZED PRURITIS -FINE PAPULAR FACIAL RASH -REPORTED HAND SWELLING -SENSE OF THROAT TIGHTNESS -NAUSEA/VOMITING/DIARRHEA -JOINT PAIN  NO FEVERS, CHILLS, HEADACHES, MYALGIAS, SYNCOPE, DYSPNEA/WHEEZING OR FACIAL SWELLING  BENADRYL ?DOSE YESTERDAY WAS HELPFUL -- >TODAY RECOMMENDING ZYRTEC 10MG QAM, BENADRYL 50MG QHS, PEPCID 20MG BID, MEDROL DOSE PACK
Age: 21.0
Sex: F
Vaccine: HEPAB
Symptoms: Rash, Rash papular, Throat tightness, Vomiting
Clinical narrative: NOT ADMINISTERED THROUGH OUR CLINIC VACCINATION DETAILS UNKNOWN.  GIVEN IN LEFT DELT.   -GENERALIZED PRURITIS -FINE PAPULAR FACIAL RASH -REPORTED HAND SWELLING -SENSE OF THROAT TIGHTNESS -NAUSEA/VOMITING/DIARRHEA -JOINT PAIN  NO FEVERS, CHILLS, HEADACHES, MYALGIAS, SYNCOPE, DYSPNEA/WHEEZING OR FACIAL SWELLING  BENADRYL ?DOSE YESTERDAY WAS HELPFUL -- >TODAY RECOMMENDING ZYRTEC 10MG QAM, BENADRYL 50MG QHS, PEPCID 20MG BID, MEDROL DOSE PACK
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: PT WAS GIVEN THE LOWER DOSE MODERNA BIVALENT 10 MCG INSTEAD OF 25 MCG. NO ADVERSE VACCINE REACTIONS
Age: 1.25
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25mL/25ug
Age: 0.75
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25vmL/25ug
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Dizziness, Dyspnoea, Headache, Impaired work ability
Clinical narrative: I woke up in the middle of the night on 4/18/2023 with a fever. I took my temperature, which was 102. I had a headache and felt lightheaded. My throat was initially sore on the left side. As the week progressed, the extreme pain moved to the rest of the throat. By 4/20/2023, my breathing was more labored. I began taking Paxlovid on 4/21/2023, and I felt a marked improvement in breathing about 12 hours later. From then on, it improved steadily. My worst days were 4/19/2023 and 4/20/2023; I was too sick to do anything those days, and I basically felt lethargic. I was able to return to work on 5/1/2023.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lethargy, Malaise, Middle insomnia, Oropharyngeal pain, Pyrexia
Clinical narrative: I woke up in the middle of the night on 4/18/2023 with a fever. I took my temperature, which was 102. I had a headache and felt lightheaded. My throat was initially sore on the left side. As the week progressed, the extreme pain moved to the rest of the throat. By 4/20/2023, my breathing was more labored. I began taking Paxlovid on 4/21/2023, and I felt a marked improvement in breathing about 12 hours later. From then on, it improved steadily. My worst days were 4/19/2023 and 4/20/2023; I was too sick to do anything those days, and I basically felt lethargic. I was able to return to work on 5/1/2023.
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I woke up in the middle of the night on 4/18/2023 with a fever. I took my temperature, which was 102. I had a headache and felt lightheaded. My throat was initially sore on the left side. As the week progressed, the extreme pain moved to the rest of the throat. By 4/20/2023, my breathing was more labored. I began taking Paxlovid on 4/21/2023, and I felt a marked improvement in breathing about 12 hours later. From then on, it improved steadily. My worst days were 4/19/2023 and 4/20/2023; I was too sick to do anything those days, and I basically felt lethargic. I was able to return to work on 5/1/2023.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25mL/25ug
Age: 1.75
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25vmL/25ug
Age: 1.5
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25mL/25ug
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood test, Burning sensation, Feeling hot, Myalgia, Paraesthesia
Clinical narrative: Patient reported facial tingling about 2 weeks after her Moderna Bivalent vaccination and then it traveled to her shoulder/arm, then body and experienced hot spots and a burning sensation all over her body.  She also has muscle aches in her legs.  She was prescribed Cymbalta by a neurologist which seems to help.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Mental impairment, Pain in extremity
Clinical narrative: Still experiencing bouts of very sore upper arm and was particularly acute today to the point that i called my doctor to figure out therapy.  Right arm where i had the 2nd booster (3rd shot) is very sore and is making it difficult to think clearly today and is as sore today or even more sore than the day after receiving the jab back in December 2021.  Left arm has bouts of soreness that come and go. That shot was 2 years ago on May 21, 2021.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Incorrect route of product administration, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: vaccine was given wrong route intradermal in right forearm caused erythema, edema and site tenderness.  follow up return patient was stable no adverse reactions .
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood glucose, Fatigue, Myalgia, Syncope, Vitamin B12
Clinical narrative: fainting; fatigue; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (fainting) 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 nos. 046L21A and 025L21B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder and Hashimoto's disease.   On an unknown date, the patient received second 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, received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), FATIGUE (fatigue) and MYALGIA (muscle aches). At the time of the report, SYNCOPE (fainting), FATIGUE (fatigue) and MYALGIA (muscle aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: fluctuating for her abnormally. On an unknown date, Vitamin B12: vitamin B12 deficiency. On an unknown date, Vitamin D: vitamin D deficiency.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported. Company comment This spontaneous case concerns a 61-year-old female patient with medical history of Thyroid issues all her life and Hashimoto diagnosis, who experienced the serious (medically significant), unexpected event of Syncope. The patient received the first and second doses of mRNA-1273.222 (BA.4/BA.5). The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. Other non-serious events include fatigue and muscle aches that could be associated with D3 deficiency, B12 deficiency and the medical history of Hashimoto. It was reported that she was seeking treatment through her HCP. No further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vitamin D
Clinical narrative: fainting; fatigue; muscle aches; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (fainting) 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 nos. 046L21A and 025L21B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder and Hashimoto's disease.   On an unknown date, the patient received second 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, received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), FATIGUE (fatigue) and MYALGIA (muscle aches). At the time of the report, SYNCOPE (fainting), FATIGUE (fatigue) and MYALGIA (muscle aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: fluctuating for her abnormally. On an unknown date, Vitamin B12: vitamin B12 deficiency. On an unknown date, Vitamin D: vitamin D deficiency.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported. Company comment This spontaneous case concerns a 61-year-old female patient with medical history of Thyroid issues all her life and Hashimoto diagnosis, who experienced the serious (medically significant), unexpected event of Syncope. The patient received the first and second doses of mRNA-1273.222 (BA.4/BA.5). The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. Other non-serious events include fatigue and muscle aches that could be associated with D3 deficiency, B12 deficiency and the medical history of Hashimoto. It was reported that she was seeking treatment through her HCP. No further clinical information was provided for medical review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) is not affected by this report.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25mL/25ug
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient got 3 doses of Shingrix instead of 2.  Patient didn't remember that she already got 2 doses in 2019.  She got the 3rd dose on 3/22/2023 and came to get another one 5/22/2023.  Pharmacist checked and discovered patient already got 3.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Lymphadenitis
Clinical narrative: pt reported lymph node inflammation and pain associated with it.
Age: 4.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: 9 doses were administered post excursion; 9 doses were administered post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion) and NO ADVERSE EVENT (No adverse event) in a 4-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) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion) and POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion).    Concomitant medication was not reported.  Storage condition at the time of the excursion was frozen. Temperature noted in that condition was -2 to -18 C. Excursion duration was for 2hrs. The vial belongs to one of the following batch numbers AR9236B, Exp date: 22-Aug-2023 / AS1903B, Exp date: 14-Jun-2023 / AS7170B, Exp date: 09-Jun-2023. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Events added.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; daughter received on 23Oct2022 a Monovalent Moderna vaccine instead of a Bivalent Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (daughter received on 23Oct2022 a Monovalent Moderna vaccine instead of a Bivalent Moderna vaccine) and NO ADVERSE EVENT (no adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (daughter received on 23Oct2022 a Monovalent Moderna vaccine instead of a Bivalent Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (daughter received on 23Oct2022 a Monovalent Moderna vaccine instead of a Bivalent Moderna vaccine) 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 (daughter received on 23Oct2022 a Monovalent Moderna vaccine instead of a Bivalent Moderna vaccine).    No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: I was informed by the Department of Health during an audit that we administered Moderna vaccine lot # 041C21A on dates of service 11/2-11/08/21 that were expired. The date of expiration was 11/01/21 unknown to my knowledge.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I was informed by the Department of Health during an audit that we administered Moderna vaccine lot # 041C21A on dates of service 11/2-11/08/21 that were expired. The date of expiration was 11/01/21 unknown to my knowledge.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I was informed by the Department of Health during an audit that we administered Moderna vaccine lot # 041C21A on dates of service 11/2-11/08/21 that were expired. The date of expiration was 11/01/21 unknown to my knowledge.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I was informed by the Department of Health during an audit that we administered Moderna vaccine lot # 041C21A on dates of service 11/2-11/08/21 that were expired. The date of expiration was 11/01/21 unknown to my knowledge.) 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 EXPIRED PRODUCT ADMINISTERED (I was informed by the Department of Health during an audit that we administered Moderna vaccine lot # 041C21A on dates of service 11/2-11/08/21 that were expired. The date of expiration was 11/01/21 unknown to my knowledge.).    No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) 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)) (batch no. AS7162B) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 14-Nov-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 14-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. It was reported that the vaccine was delivered to the hospital on 20-Sep-2022. The vaccine was administered to 5 patients on 14-Nov-2022, 2 patients on 15-Nov-2022 and 2 patients on 22-Dec-2022. Treatment medications were not provided. This case was reported for patient 1 of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-725026, US-MODERNATX, INC.-MOD-2023-725032, US-MODERNATX, INC.-MOD-2023-725033, US-MODERNATX, INC.-MOD-2023-725034, US-MODERNATX, INC.-MOD-2023-725035, US-MODERNATX, INC.-MOD-2023-725036, US-MODERNATX, INC.-MOD-2023-725037, US-MODERNATX, INC.-MOD-2023-725038 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725026:(Patient 02 out of 09) US-MODERNATX, INC.-MOD-2023-725032:(Patient 03 out of 09) US-MODERNATX, INC.-MOD-2023-725033:(Patient 04 out of 09) US-MODERNATX, INC.-MOD-2023-725036:(Patient 07 out of 09) US-MODERNATX, INC.-MOD-2023-725037:(Patient 08 out of 09) US-MODERNATX, INC.-MOD-2023-725034:(Patient 05 out of 09) US-MODERNATX, INC.-MOD-2023-725035:(Patient 06 out of 09) US-MODERNATX, INC.-MOD-2023-725038:(Patient 09 out of 09)
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) 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)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Nov-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 14-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date) 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 EXPIRED PRODUCT ADMINISTERED (9 patients received Moderna Covid-19 Bivalent vaccine vaccine past the 30 day beyond use date).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the vaccine was delivered to the hospital on 20-Sep-2022. The vaccine was administered to 5 patients on 14-Nov-2022, 2 patients on 15-Nov-2022 and 2 patients on 22-Dec-2022. Treatment medications were not provided. This case was reported for patient 8 of 9.   This case was linked to US-MODERNATX, INC.-MOD-2023-725025 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-725025:master case
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Syncope, Vomiting
Clinical narrative: After pt received vaccines, she felt faint and collapsed. Pt also vomited.
Age: 5.0
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine indicated for ages 9+ and the patient is 5 years old.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Guillain-Barre syndrome, Laboratory test abnormal, Lumbar puncture abnormal, Magnetic resonance imaging abnormal
Clinical narrative: Guillain-Barré syndrome,  started in one hand then both and both feet, months later still have numb feet but have regained feeling in hands.  Nerve pain still exist.  strength in right hand has returned as well as left knee.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Guillain-Barré syndrome,  started in one hand then both and both feet, months later still have numb feet but have regained feeling in hands.  Nerve pain still exist.  strength in right hand has returned as well as left knee.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Contusion, Inflammation, Injection site pain, Injection site swelling
Clinical narrative: patient described swelling and severe pain on the site of the shot on right arm. it occurred about a day after the shot and the pain gradually traveled to her right shoulder. she was in so much pain she went to the hospital. she was given steroid to help with inflammation. she showed me her arm today, monday, 5/22/23. you could still see a small amount of swelling and a bruise. she said it was getting better.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pityriasis rosea, Pruritus
Clinical narrative: The patient that she didn't feel well for 5 days. Then she noticed a spot on her abdomen that spread and was itchy. The itchy patched have persisted for 4 weeks and she finally made an appointment to see her doctor.  The doctor diagnosed her with pityriasis rosea and said it was likely caused by the Shingrix vaccine. She is currently being treated with topical steroids and oral Benadryl.
Age: 1.33
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Coworker gave Moderna second dose and upon completing the waste log it was found that the manufacturer's expiration date was 05/21/2023.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Brain fog, Headache, Myalgia
Clinical narrative: Sore muscles, sore bones, headache and head fog.
Age: 7.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Back pain, Cough, Throat irritation
Clinical narrative: Patient began to experience back pain, coughing and itching throat. No rash,  swelling, or significant difficulty breathing occurred.  The paramedics were called and epi-pen and benadryl were administered IM by the paramedics.  The patient was monitored at had recovered by 3pm the same day.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Deafness unilateral
Clinical narrative: In January of 2022 I noticed a hearing deficit in my left ear. I went to a an ENT doctor in April of 2022 and I was found to have a mild to moderate hearing loss. I have imaging to rule out a tumor.   I don?t know if the vaccine is the cause or not.  But after doing some research I read people have experienced hearing problems and tinnitus after receiving a Covid vaccine. I have not had Covid.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: Menstrual cycle is Every 14 days
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SARS-CoV-2 test: (Dec2021) Positive; (Jan2023) Positive; covid test result: Positive; covid test result: Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL9262), in left arm and on 17Feb2021 as dose 2, single (Lot number: EL03247) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hemochromatosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: B VITAMIN COMP [CALCIUM PANTOTHENATE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE].  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "covid test result: Positive"; DISEASE RECURRENCE (medically significant) with onset Jan2023, outcome "unknown", described as "SARS-CoV-2 test: (Dec2021) Positive; (Jan2023) Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2021) Positive; (Jan2023) Positive.  Additional information: Facility type vaccine was Regulatory Authority facility. No other vaccine in four week. Other medications in two weeks was reported as B vitamins. No covid prior vaccination. covid tested post vaccination. Covid test type post vaccination was Nasal Swab.
Age: 39.0
Sex: F
Vaccine: TDAP, VARCEL, VARCEL
Symptoms: Pregnancy, Pregnancy test positive
Clinical narrative: No additional AE reported; Customer called and reported that VARIVAX was administered to a pregnant consumer. The office attempted to contact the consumer to determine if the consumer has experienced any side effects; however, they have not been able to make contact at this ti; This spontaneous prospective pregnancy report was received from an office manager referring to a 39-year-old female patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 01-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot number W032507, expiration date 11-OCT-2024, 0.5 milliliter, subcutaneous for prophylaxis (exposure during pregnancy). No adverse event was reported.       On an unknown date the patient became pregnant. The LMP, EDD and the pregnancy outcome were unknown.
Age: 39.0
Sex: F
Vaccine: TDAP, VARCEL, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AE reported; Customer called and reported that VARIVAX was administered to a pregnant consumer. The office attempted to contact the consumer to determine if the consumer has experienced any side effects; however, they have not been able to make contact at this ti; This spontaneous prospective pregnancy report was received from an office manager referring to a 39-year-old female patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 01-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot number W032507, expiration date 11-OCT-2024, 0.5 milliliter, subcutaneous for prophylaxis (exposure during pregnancy). No adverse event was reported.       On an unknown date the patient became pregnant. The LMP, EDD and the pregnancy outcome were unknown.
Age: 66.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Diarrhoea, Headache, Pyrexia, Weight decreased
Clinical narrative: uncontrolled bowel movements before reaching toilet; diarrhea; pain in arm; headache; fatigue; malaise; At the height feeling of impending doom; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise), ANXIETY (At the height feeling of impending doom), ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (pain in arm) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069h22a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 13-May-2023, the patient experienced MALAISE (malaise), ANXIETY (At the height feeling of impending doom), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (pain in arm), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet). The patient was treated with ACETAMINOPHEN at a dose of 1000 milligram; ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE/ATROPINE) at an unspecified dose and frequency and LOPERAMIDE at an unspecified dose and frequency. At the time of the report, MALAISE (malaise), ANXIETY (At the height feeling of impending doom), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (pain in arm), HEADACHE (headache) and FATIGUE (fatigue) had not resolved and ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient had pain in arm immediately increasing over 4 hours requiring 1000 mg acetaminophen, at 24 hrs headache and malaise, at 48 hrs severe unrelenting diarrhea lasting 4 plus days. Diarrhea uncontrolled by diphenoxylate/atropine. Severe fatigue, headache and diarrhea for 48 hrs then moderate for 24 hrs and now mild but unresolved. Loperamide also ineffective. Over 10 uncontrolled bowel movements before reaching toilet. At the height feeling of impending doom. It was unknown if the patient experienced any additional symptoms/events.
Age: 66.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Anal incontinence, Anxiety, Diarrhoea, Fatigue, Headache
Clinical narrative: uncontrolled bowel movements before reaching toilet; diarrhea; pain in arm; headache; fatigue; malaise; At the height feeling of impending doom; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise), ANXIETY (At the height feeling of impending doom), ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (pain in arm) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069h22a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 13-May-2023, the patient experienced MALAISE (malaise), ANXIETY (At the height feeling of impending doom), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (pain in arm), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet). The patient was treated with ACETAMINOPHEN at a dose of 1000 milligram; ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE/ATROPINE) at an unspecified dose and frequency and LOPERAMIDE at an unspecified dose and frequency. At the time of the report, MALAISE (malaise), ANXIETY (At the height feeling of impending doom), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (pain in arm), HEADACHE (headache) and FATIGUE (fatigue) had not resolved and ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient had pain in arm immediately increasing over 4 hours requiring 1000 mg acetaminophen, at 24 hrs headache and malaise, at 48 hrs severe unrelenting diarrhea lasting 4 plus days. Diarrhea uncontrolled by diphenoxylate/atropine. Severe fatigue, headache and diarrhea for 48 hrs then moderate for 24 hrs and now mild but unresolved. Loperamide also ineffective. Over 10 uncontrolled bowel movements before reaching toilet. At the height feeling of impending doom. It was unknown if the patient experienced any additional symptoms/events.
Age: 66.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Malaise, Vaccination site pain
Clinical narrative: uncontrolled bowel movements before reaching toilet; diarrhea; pain in arm; headache; fatigue; malaise; At the height feeling of impending doom; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise), ANXIETY (At the height feeling of impending doom), ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (pain in arm) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069h22a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 13-May-2023, the patient experienced MALAISE (malaise), ANXIETY (At the height feeling of impending doom), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (pain in arm), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet). The patient was treated with ACETAMINOPHEN at a dose of 1000 milligram; ATROPINE SULFATE, DIPHENOXYLATE HYDROCHLORIDE (DIPHENOXYLATE/ATROPINE) at an unspecified dose and frequency and LOPERAMIDE at an unspecified dose and frequency. At the time of the report, MALAISE (malaise), ANXIETY (At the height feeling of impending doom), DIARRHOEA (diarrhea), VACCINATION SITE PAIN (pain in arm), HEADACHE (headache) and FATIGUE (fatigue) had not resolved and ANAL INCONTINENCE (uncontrolled bowel movements before reaching toilet) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient had pain in arm immediately increasing over 4 hours requiring 1000 mg acetaminophen, at 24 hrs headache and malaise, at 48 hrs severe unrelenting diarrhea lasting 4 plus days. Diarrhea uncontrolled by diphenoxylate/atropine. Severe fatigue, headache and diarrhea for 48 hrs then moderate for 24 hrs and now mild but unresolved. Loperamide also ineffective. Over 10 uncontrolled bowel movements before reaching toilet. At the height feeling of impending doom. It was unknown if the patient experienced any additional symptoms/events.
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Hypersensitivity
Clinical narrative: HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.); This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Gluten sensitivity and Drug hypersensitivity.    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 HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.)). At the time of the report, HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It is unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP says the patient actually did not have reaction to or after the Moderna Covid19 vaccines. HCP reports the patient was concerned with allergies and if they were in the new vaccine. HCP checks and reports that the patient already received a Bivalent vaccine last fall so they should be good. Treatment information was not reported.   This case was linked to MOD-2023-724796 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Condition aggravated, Gluten sensitivity
Clinical narrative: HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.); This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Gluten sensitivity and Drug hypersensitivity.    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 HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.)). At the time of the report, HYPERSENSITIVITY (HCP mentioned patient has a gluten allergy and after each shot things have gotten worse (AE reported.)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It is unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP says the patient actually did not have reaction to or after the Moderna Covid19 vaccines. HCP reports the patient was concerned with allergies and if they were in the new vaccine. HCP checks and reports that the patient already received a Bivalent vaccine last fall so they should be good. Treatment information was not reported.   This case was linked to MOD-2023-724796 (Patient Link).   Reporter did not allow further contact
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Feeling abnormal, Hyperhidrosis, Vaccination site discomfort
Clinical narrative: He stated he has no energy.; he woke up and he was sweating; He did not feel good; He also has discomfort at the side of the injection.; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (He stated he has no energy.), HYPERHIDROSIS (he woke up and he was sweating), FEELING ABNORMAL (He did not feel good) and VACCINATION SITE DISCOMFORT (He also has discomfort at the side of the injection.) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient stated he had no medical History, condition, allergy or disease.     On 16-May-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-May-2023, the patient experienced ASTHENIA (He stated he has no energy.), HYPERHIDROSIS (he woke up and he was sweating), FEELING ABNORMAL (He did not feel good) and VACCINATION SITE DISCOMFORT (He also has discomfort at the side of the injection.). At the time of the report, ASTHENIA (He stated he has no energy.), HYPERHIDROSIS (he woke up and he was sweating), FEELING ABNORMAL (He did not feel good) and VACCINATION SITE DISCOMFORT (He also has discomfort at the side of the injection.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. It was reported that patient woke up and he was sweating. Patient did not feel good. So, Patient took a sleeping pill. Patient stated he had no energy. This is his 4th booster. Patient does not want to do this again. Patient also had discomfort at the side of the injection.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: gave an adult a pediatric vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (gave an adult a pediatric vaccine) 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)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third 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 WRONG PRODUCT ADMINISTERED (gave an adult a pediatric vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (gave an adult a pediatric vaccine) 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 WRONG PRODUCT ADMINISTERED (gave an adult a pediatric vaccine).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.