chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Neurological symptom
Clinical narrative: neurological symptoms; This spontaneous case was reported by a nurse and describes the occurrence of NEUROLOGICAL SYMPTOM (neurological symptoms) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROLOGICAL SYMPTOM (neurological symptoms). At the time of the report, NEUROLOGICAL SYMPTOM (neurological symptoms) outcome was unknown.        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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662850 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662850:(same reporter)
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent 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 (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster).    No concomitant medications were reported.  It was reported that total 3 Adult patients received Moderna's monovalent Pediatrics for primary series 6 to 11 years instead of Moderna's Bivalent booster dose.  No treatment information was reported.  This case is for 1st adult patient.   This case was linked to US-MODERNATX, INC.-MOD-2022-662909, US-MODERNATX, INC.-MOD-2022-662904 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662909:Adult 3 US-MODERNATX, INC.-MOD-2022-662904:Adult 2
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Thrombosis
Clinical narrative: blood clots; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (blood clots) in a 37-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     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 THROMBOSIS (blood clots) (seriousness criteria death and medically significant). The reported cause of death was blood clots. It is unknown if an autopsy was performed.            Concomitant medications details were not reported by the reporter.  It was reported that patient had recently received the booster dose. The patient had dropped dead at the age of 37.   Treatment details was not reported by the reporter. Company comment: This fatal spontaneous case concerns a 37-year-old female patient, with no medical history reported, who received the booster dose of mRNA-1273.222 vaccine and experienced the unexpected and fatal event of thrombosis. Vaccination, event´s onset and death dates were not reported; hence, latency could not be properly assessed. No details of previous doses were provided. The reported cause of death was blood clots (thrombosis). It is unknown if an autopsy was performed. No other clinically relevant information was disclosed. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This fatal spontaneous case concerns a 37-year-old female patient, with no medical history reported, who received the booster dose of mRNA-1273.222 vaccine and experienced the unexpected and fatal event of thrombosis. Vaccination, event´s onset and death dates were not reported; hence, latency could not be properly assessed. No details of previous doses were provided. The reported cause of death was blood clots (thrombosis). It is unknown if an autopsy was performed. No other clinically relevant information was disclosed. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Reported Cause(s) of Death: Blood clots
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: Received 0.25 ml of bivalent dose; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml of bivalent 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 (Received 0.25 ml of bivalent dose).    The concomitant medication was not reported. No treatment medication was reported.  For the past month, nurse had been giving 0.25 ml to the patients. Nurse wants to know recommendation for the 19 patients who received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973, US-MODERNATX, INC.-MOD-2022-662974 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662974:Same reporter US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter US-MODERNATX, INC.-MOD-2022-663147:Same reporter
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No adverse event) in a 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 (received 0.25 ml of bivalent dose).    Concomitant medications were not reported.  It was reported that 19 patients received half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022 and 06-Oct-2022.  For the past month, the reporter had been giving 0.25 ml dose instead of 0.5 ml dose of bivalent vaccine.  Treatment information was not reported.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 49-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 (received 0.25 ml of bivalent dose).    No concomitant information was reported.  It was reported that the dosage was changed to 0.5 ml. For the past month, nurse had been given 0.25 ml to 19 patients who received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022, and 06-Oct-2022.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973, US-MODERNATX, INC.-MOD-2022-662974 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662974:Same reporter US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No Adverse event; received 0.25 ml of bivalent dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent 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 (received 0.25 ml of bivalent dose).    No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-662961, MODERNATX, INC.-MOD-2022-662973, MODERNATX, INC.-MOD-2022-662974 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-662961:Same reporter MODERNATX, INC.-MOD-2022-662973:Same reporter MODERNATX, INC.-MOD-2022-662974:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested positive for covid today; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (she tested positive for covid today) 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 prophylaxis.     No Medical History information was reported.    In October 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 24-Oct-2022, the patient experienced COVID-19 (she tested positive for covid today). At the time of the report, COVID-19 (she tested positive for covid today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2022, SARS-CoV-2 test: (Positive) tested positive for covid today.         No concomitant medication information was provided.  Patient asked "Did she get a breakthrough infection? Did she catch a variant that the booster did not cover.  No treatment medication was provided.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore injection site arm; little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (little tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 031A21A and 032M20A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concomitant products included SILDENAFIL and OMEPRAZOLE for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (little tired). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and FATIGUE (little tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received second Moderna Covid 19 vaccine booster dose on 08-MAY-2022, Lot number 049L21A, expiration date was not known, right arm of administration. Patient reported no Adverse Reactions.        The patient received first Moderna Covid 19 bivalent vaccine booster dose on 17-OCT-2022, Lot number 060F22A, expiration date was 31-OCT-2022, right arm of administration. Patient reported no Adverse Reactions.  No treatment medications were reported.   This case was linked to MOD-2022-663250, MOD-2022-663256 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Administration error: patient received 0.25 mL dose instead of 0.50 mL of bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administration error: patient received 0.25 mL dose instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Administration error: patient received 0.25 mL dose instead of 0.50 mL of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administration error: patient received 0.25 mL dose instead of 0.50 mL of bivalent) 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 (Administration error: patient received 0.25 mL dose instead of 0.50 mL of bivalent).    Concomitant product use was not provided by the reporter.  It was unknown if patient reported any adverse events.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-663507, US-MODERNATX, INC.-MOD-2022-663578, US-MODERNATX, INC.-MOD-2022-663502, US-MODERNATX, INC.-MOD-2022-663552, US-MODERNATX, INC.-MOD-2022-663563, US-MODERNATX, INC.-MOD-2022-663577 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663578:Same reporter US-MODERNATX, INC.-MOD-2022-663507:Same reporter US-MODERNATX, INC.-MOD-2022-663502:Same reporter US-MODERNATX, INC.-MOD-2022-663552:Same reporter US-MODERNATX, INC.-MOD-2022-663563:Same reporter US-MODERNATX, INC.-MOD-2022-663577:Same reporter
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dizziness, Fatigue, Feeling drunk, Headache, Influenza like illness
Clinical narrative: was given the shot on 10/12/22. Had normal flu-like symptoms (aches, tired, very sore arm, headache) on 10/13. On 10/16/22 I started getting a positional headache when bending over to pick something up and stand up again. Was minor, like a momentary throbbing, or flash and then went away. Happened at least 2-3 times at least.  On 10/17/22 I had the positional headache again. That transformed into a slower persistent headache as the day went on, centrally located in the top of my head. Had gotten worse towards bedtime. Eventually crept behind my eyes some too. Also felt a little woozy with the headache today, like I was slightly buzzed, or mildly inebriated.  on 10/18, no headache, but the mild dizzy/inebriated feeling on and off all day.   10/19-10/24/22. Mostly felt the intermittent mild dizzy/inebriated feeling, along with occasional positional momentary headache.   10/25/22. I had a repeat of the 10/17 episode, with wooziness, positional headache and growing and spreading dull headache centered on the top of my head.   10/26/22. Mostly felt fine, light intermittent buzzed/inebriated feeling throughout the day.   10/27/22. Woke up and immediately felt positional headache after sitting down to use the bathroom after waking. Felt the buzzed, inebriated feeling and sharper positional headaches on and off throughout the day, with some of the dull top center headache coming on in the afternoon. By evening, headaches mostly backed off on their own, left with the woozy feeling.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain, Pain in extremity
Clinical narrative: was given the shot on 10/12/22. Had normal flu-like symptoms (aches, tired, very sore arm, headache) on 10/13. On 10/16/22 I started getting a positional headache when bending over to pick something up and stand up again. Was minor, like a momentary throbbing, or flash and then went away. Happened at least 2-3 times at least.  On 10/17/22 I had the positional headache again. That transformed into a slower persistent headache as the day went on, centrally located in the top of my head. Had gotten worse towards bedtime. Eventually crept behind my eyes some too. Also felt a little woozy with the headache today, like I was slightly buzzed, or mildly inebriated.  on 10/18, no headache, but the mild dizzy/inebriated feeling on and off all day.   10/19-10/24/22. Mostly felt the intermittent mild dizzy/inebriated feeling, along with occasional positional momentary headache.   10/25/22. I had a repeat of the 10/17 episode, with wooziness, positional headache and growing and spreading dull headache centered on the top of my head.   10/26/22. Mostly felt fine, light intermittent buzzed/inebriated feeling throughout the day.   10/27/22. Woke up and immediately felt positional headache after sitting down to use the bathroom after waking. Felt the buzzed, inebriated feeling and sharper positional headaches on and off throughout the day, with some of the dull top center headache coming on in the afternoon. By evening, headaches mostly backed off on their own, left with the woozy feeling.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site induration, Injection site rash, Pruritus, Rash, Rash papular
Clinical narrative: Circular rash 2 inches in diameter with raised, hard center at injection site for monkeypox noticed in the morning 10/27 and worsened throughout the day. Itchiness responds to hydrocortisone. No further symptoms at this time
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Computerised tomogram thorax normal, Electrocardiogram normal, Heart rate increased, Laboratory test
Clinical narrative: I started having heart palpitations that came and went the first and second day. The third day they became constant and felt like a rapid heartbeat. I went to the hospital emergency. The EKG and pulse were normal. A blood test showed a slight inclination of a blood clot. I had a pain in my left leg calf. A CAT scan of my lungs and ultrasound of my left leg was done. There was no blood clot. I was referred to a cardiologist and advised to make an appointment in the next week. I was given no medicine. On the fourth day the heart palpitations began to ease up and each day since. They have not ceased completely, but are less and less.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Ultrasound Doppler normal
Clinical narrative: I started having heart palpitations that came and went the first and second day. The third day they became constant and felt like a rapid heartbeat. I went to the hospital emergency. The EKG and pulse were normal. A blood test showed a slight inclination of a blood clot. I had a pain in my left leg calf. A CAT scan of my lungs and ultrasound of my left leg was done. There was no blood clot. I was referred to a cardiologist and advised to make an appointment in the next week. I was given no medicine. On the fourth day the heart palpitations began to ease up and each day since. They have not ceased completely, but are less and less.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received 0.25 mL doses instead of 0.50 mL of bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 mL doses instead of 0.50 mL of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 mL doses instead of 0.50 mL of bivalent) 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 received 0.25 mL doses instead of 0.50 mL of bivalent).    No concomitant medications were reported.  It was unknown if patients reported any adverse events or not.  No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-663507, MODERNATX, INC.-MOD-2022-663578, MODERNATX, INC.-MOD-2022-663474 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-663578: MODERNATX, INC.-MOD-2022-663474:Same reporter MODERNATX, INC.-MOD-2022-663507:
Age: 46.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fatigue, headache, fever, nausea, body aches
Age: 1.17
Sex: M
Vaccine: DTAPIPV, FLU4, HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Quadracel given in error. Patient was due for DTap. No adverse signs/symptoms noted. MD discussed with family.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Cardiac disorder, Sudden death, Thrombosis, Toxicologic test
Clinical narrative: My daughter received the 3rd covid vaccine about January 10, 2022. She died suddenly on 01/12/2022, The coroner's report said she died of heart disease.  I had my primary care physician go over the  report with me and he told me it was caused by blood clots and that it was hard to tell the exact cause without a toxicology report. I called the coroner and requested the toxicology report and he refused.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Herpes virus infection
Clinical narrative: As stated earlier, I have had HSV since 1984 and have consistently had 2-3 outbreaks per year treated only with Valtrex during the outbreak. Since having my 3rd Moderna Vaccine, I have noted monthly outbreaks requiring daily Valtrex and have even broken through that once since starting daily dosing of it. No other changes have happened in my life and I have not been sexually active since 2009.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial stored in the refrigerator after 30 day use by date; No adverse event; 1 dose of an expired vaccine administered to one patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of an expired vaccine administered to one patient), PRODUCT STORAGE ERROR (The vial stored in the refrigerator after 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of an expired vaccine administered to one patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial stored in the refrigerator after 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of an expired vaccine administered to one patient), PRODUCT STORAGE ERROR (The vial stored in the refrigerator after 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 dose of an expired vaccine administered to one patient) and PRODUCT STORAGE ERROR (The vial stored in the refrigerator after 30 day use by date).    The vial size was unknown. The vial was initially stored in the refrigerator on 03-Aug-2022. The vial does not undergone any temperature excursions.  No concomitant medications was reported. No treatment medications was reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Coronavirus; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Coronavirus) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Coronavirus). On 04-Oct-2022, COVID-19 (Coronavirus) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2022, SARS-CoV-2 test: (Negative) Negative.         Patient was not on any concomitant medications before the vaccine.  Patient's COVID-19 symptoms include headache, slight cough and running nose, very mild, no sense of taste and smell. Patient had been negative for 21 days ago. Patient had no other reaction to the shots.  Treatment information was not provided.   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Myalgia
Clinical narrative: Muscles Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscles Aches) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) film-coated tablet for Mantle cell lymphoma.    Concurrent medical conditions included Blood pressure high, High cholesterol, Type II diabetes mellitus, Prostate cancer, Non-tobacco user, Abstains from alcohol, Mantle cell lymphoma and Vitamin B1 supplementation. Concomitant products included RAMIPRIL (ALTACE) for Blood pressure high, ATORVASTATIN CALCIUM for High cholesterol, METFORMIN HYDROCHLORIDE for Type II diabetes mellitus, CYANOCOBALAMIN (VITAMIN B 12 [CYANOCOBALAMIN]) for Vitamin B12 supplementation.   In 2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2022, the patient experienced MYALGIA (Muscles Aches). At the time of the report, MYALGIA (Muscles Aches) had not resolved.            No known allergies were reported. Primary reporter did not have the lot number information, because the packaging was discarded. MPID number was given as 4782590. Patient was not enrolled in a COVID-19 Vaccine Trial. No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: had soreness in her arm; she was extra tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (had soreness in her arm) and FATIGUE (she was extra tired) 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 prophylaxis.     No Medical History information was reported.    In October 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 an unknown date, the patient experienced PAIN IN EXTREMITY (had soreness in her arm) and FATIGUE (she was extra tired). At the time of the report, PAIN IN EXTREMITY (had soreness in her arm) and FATIGUE (she was extra tired) outcome was unknown.            No concomitant medications were reported.  Caller stated that her sister had soreness in her arm and she was extra tired after receiving the Moderna COVID-19 bivalent vaccine 3 weeks ago.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-663909 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663909:Reporter Case (Crosslink Case Number)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received a Bivalent Moderna COVID-19 booster as first primary dose by mistake; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received a Bivalent Moderna COVID-19 booster as first primary dose by mistake) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received a Bivalent Moderna COVID-19 booster as first primary dose by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received a Bivalent Moderna COVID-19 booster as first primary dose by mistake) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant information was reported. It was reported that patient never had any brand of COVID-19 vaccine in the past, prior to the bivalent booster and had first dose Bivalent Moderna COVID-19 vaccine No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Mammogram, Oral herpes, Pain in extremity
Clinical narrative: had a cold sore breakout; soreness in arm; had lymph node enlargement on mammogram; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ORAL HERPES (had a cold sore breakout), PAIN IN EXTREMITY (soreness in arm) and LYMPHADENOPATHY (had lymph node enlargement on mammogram) 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 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 ORAL HERPES (had a cold sore breakout), PAIN IN EXTREMITY (soreness in arm) and LYMPHADENOPATHY (had lymph node enlargement on mammogram). At the time of the report, ORAL HERPES (had a cold sore breakout), PAIN IN EXTREMITY (soreness in arm) and LYMPHADENOPATHY (had lymph node enlargement on mammogram) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: had lymph node enlargement detected.         No concomitant information was reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-663907, US-MODERNATX, INC.-MOD-2022-664322 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663907:Reporter Case(Crosslink Case Number) US-MODERNATX, INC.-MOD-2022-664322:Same reporter(Crosslink Case Number)
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder
Clinical narrative: Wonders if the vaccine has damaged his heart; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (Wonders if the vaccine has damaged his heart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Wonders if the vaccine has damaged his heart). At the time of the report, CARDIAC DISORDER (Wonders if the vaccine has damaged his heart) outcome was unknown.            No concomitant medications were reported.   It was unknown if the patient had any adverse events following dose 1 vaccination.  Reporter assessed event wonders if the vaccine has damaged his heart as possibly related to Janssen COVID-19 vaccine.  No treatment details were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Medication error, 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL).    No concomitant medication information was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2022: Live Significant follow up received: Patient demographics updated, Reporter phone no added, date of vaccine received and case narrative updated.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Myalgia, Pain in extremity, Product storage error
Clinical narrative: The dose was moved from the freezer to the refrigerator on 18SEP2022 and administered on 22OCT2022; sore arm; body aches; A patient received a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), EXPIRED PRODUCT ADMINISTERED (A patient received a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The dose was moved from the freezer to the refrigerator on 18SEP2022 and administered on 22OCT2022) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Oct-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Oct-2022, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (body aches) and EXPIRED PRODUCT ADMINISTERED (A patient received a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The dose was moved from the freezer to the refrigerator on 18SEP2022 and administered on 22OCT2022). At the time of the report, PAIN IN EXTREMITY (sore arm), MYALGIA (body aches), EXPIRED PRODUCT ADMINISTERED (A patient received a dose of the Moderna COVID-19 vaccine after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The dose was moved from the freezer to the refrigerator on 18SEP2022 and administered on 22OCT2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that vaccine was administered from individual vials and size of vial  was reported as 5.5mL. No temperature excursions occurred. The patient experienced sore arm and body aches since this dose. No treatments, medications, or additional doses had been administered at the time of report.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: itchiness; soreness on her arm; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itchiness) and PAIN IN EXTREMITY (soreness on her arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient did not have any allergies and never had COVID disease.  Concomitant products included LISINOPRIL for an unknown indication.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PRURITUS (itchiness) and PAIN IN EXTREMITY (soreness on her arm). At the time of the report, PRURITUS (itchiness) and PAIN IN EXTREMITY (soreness on her arm) had not resolved.            No concomitant medications were reported.  Patient still had soreness on arm and itchiness after vaccination with the second dose of the Moderna COVID19 vaccine one year ago.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient got the wrong one; Patient administered 0.25mL, instead of 0.5mL; This spontaneous case was reported by a patient and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient got the wrong one), ACCIDENTAL UNDERDOSE (Patient administered 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 63B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient got the wrong one) and ACCIDENTAL UNDERDOSE (Patient administered 0.25mL, instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient got the wrong one), ACCIDENTAL UNDERDOSE (Patient administered 0.25mL, instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  The pharmacist was multitasking while he was getting the shot ready.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Unspecified AEs after getting 2 Moderna shots; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Unspecified AEs after getting 2 Moderna shots) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Unspecified AEs after getting 2 Moderna shots). At the time of the report, IMMUNISATION REACTION (Unspecified AEs after getting 2 Moderna shots) outcome was unknown.            No concomitant medications were provided.  It was reported that patient already got 2 Moderna vaccines and experienced AEs after getting both shots.  No treatment medications were provided.   Reporter did not allow further contact
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; received a Moderna original vaccine as a booster instead of a bivalent Moderna COVID19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (received a Moderna original vaccine as a booster instead of a bivalent Moderna COVID19 vaccine) and NO ADVERSE EVENT (No Adverse Event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (1st dose, lot number FK5127) on 10-Nov-2021, Pfizer vaccine (2nd dose,lot number FK5127) on 01-Dec-2021, Pfizer vaccine (BOOSTER andlot number FL8095) on 23-May-2022. Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 23-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received a Moderna original vaccine as a booster instead of a bivalent Moderna COVID19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (received a Moderna original vaccine as a booster instead of a bivalent Moderna COVID19 vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant medications was provided. No treatment medications was provided.