chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated beyond use date of 7/6/2022. No symptoms reported by patient.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram head, Echocardiogram, Magnetic resonance imaging, Magnetic resonance imaging spinal, Migraine
Clinical narrative: I RECEIVED THE VACCINE 10-11-22 IN THE AFTERNOON.  I WOKE UP ABOUT 12 OR 1 AM IN EXTREME PAIN.  MY CERVICAL SPINE WAS ON FIRE, MUSCLES HORRIBLY TAUT AND A KILLER AND I DO MEAN KILLER MIGRAINE.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle tightness, Pain, Sleep disorder, Spinal pain
Clinical narrative: I RECEIVED THE VACCINE 10-11-22 IN THE AFTERNOON.  I WOKE UP ABOUT 12 OR 1 AM IN EXTREME PAIN.  MY CERVICAL SPINE WAS ON FIRE, MUSCLES HORRIBLY TAUT AND A KILLER AND I DO MEAN KILLER MIGRAINE.
Age: 57.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 49.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Injection site urticaria, Urticaria
Clinical narrative: PATIENT DEVELOPED HIVES FROM AFLURIA (EGG) VACCINE. THE HIVES BEGAN ABOUT 5 MINUTES AFTER VACCINE ADMINISTRATION AND SPREAD DOWN HER ARMS TO HANDS AND WRIST AT WHICH POINT I ADMINISTERED 8ML OF BENADRYL (2:45PM) AND MARKED THE RASH AROUND THE INJECTION SITE. WITHIN MINUTES THE HIVES ON HER HANDS AND ARM BEGAN TO DISSOLVE. AT APPROXIMATELY 3:20PM THE INJECTION SITE HIVE HAD COMPLETELY DISAPPEARED AND PATIENT WAS FREE OF HIVES. DURING THE WAITING PERIOD I ATTEMPTED TO CALL PTS PCP, OFFICE IS CLOSED FOR THE OBSERVANCE OF THE HOLIDAY. WILL INFORM THEM OF REACTION TOMORROW MORNING. ADVISED BOTH MOM AND DAD TO REDOSE WITH 8ML BENADRYL IF RASH REAPPEARS IN 4 TO 6 HOURS AND TO SEEK MEDICAL EVALUATION. THEY CONFIRMED THEY HAD BENADRYL AT HOME TO DOSE WITH IF NEEDED
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated beyond use date of 5/6/2022. No symptoms reported by patient.
Age: 15.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Incorrect product formulation administered
Clinical narrative: Client and family came by to receive the Bi-valent booster made by Moderna. They received the mono-valent booster in error. The family has been notified, and advised about potential adverse reactions such as a sore arm in the morning. The family was also advised to wait 2 months before getting the bivalent booster in accordance with current recommendations. The family members seemed frustrated, but understanding and appreciative of the pharmacy?s openness with them regarding the situation. Contributing factors include high volume, similarities between the two packages, improper workflow by the pharmacist, and storage of the two similar medications directly next to each other.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 51.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated beyond use date of 7/6/2022. No symptoms reported by patient.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 54.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Client and family came by to receive the Bi-valent booster made by Moderna. They received the mono-valent booster in error. The family has been notified, and advised about potential adverse reactions such as a sore arm in the morning. The family was also advised to wait 2 months before getting the bivalent booster in accordance with current recommendations. The family members seemed frustrated, but understanding and appreciative of the pharmacy?s openness with them regarding the situation. Contributing factors include high volume, similarities between the two packages, improper workflow by the pharmacist, and storage of the two similar medications directly next to each other.
Age: 18.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated beyond use date of 7/6/2022. No symptoms reported by patient.
Age: 55.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 7.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 36.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Paraesthesia, Sensitive skin
Clinical narrative: Facial right sided numbness, tingling and sensitivity lasting 2 days starting a couple hours after receiving covid booster (bivalent)
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated beyond use date of 7/6/2022.  No symptoms reported by patient.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 45.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated beyond use date of 7/6/2022. No symptoms reported by patient.
Age: 25.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered to patient
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated beyond use date of 7/20/2022.  No symptoms reported.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Halo vision, Periorbital swelling
Clinical narrative: Patient stayed in pharmacy for 10 minutes to be monitored, then while walking back to the car felt slightly dizzy. Patient's daughter was with her to drive her home. Then patient's daughter called pharmacy in about 2 hours to notify patient complains of "halo vision" and fatigue. Pharmacist told her to stay hydrated, monitor blood pressure, call PCP office or go to ER if symptom gets worse. Patient then call 4 hours after the vaccine reporting dizziness went away but her eyes are puffed up, similar to when she eats avocado that she's allergic to. She took the allergy pill (allegra) and feels better.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated beyond use date of 7/20/2022. No symptoms reported.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated beyond use date of 10/8/2022. No symptoms reported by patient.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: no symptoms,  pt received bivalent booster shot vs receiving primary series pfizer.  pt has no symptoms of any ILL effect.  pt just notified primary doctor that they received bivalent vs primary series.
Age: 14.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated beyond use date of 10/8/2022. No symptoms reported by patient.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 16.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Rash papular
Clinical narrative: Patient reports a raised rash on 1/2 of his body.  Rash comes and goes and is more severe at times than others.  Patient has used a topical benadryl product along with zyrtec 10mg orally and famotidine 20mg orally
Age: 24.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure fluctuation, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: Fatigue     After second Moderna vaccine given on 3/4/21, Started with pain in her arm and headache that night.  Next day she had a fever 103.0, palpitations, lightheaded, joint pain/muscle pain, SOB, blood pressure 125/55, HR 125.  Many symptoms lasted until Sunday.  Still doesn't feel right.  Has been taking tylenol for the fever.   generalized malaise, fatigue, heart palpitations and blood pressure fluctuations.  Patient reports she received the 2nd Moderna vaccine  and had symptoms that started approximately 24 hours after the vaccine was administered.  Patient reported fever up to 103 initially which is since resolved, she has had continued myalgias, joint pain fatigue and heart palpitations.  Patient denies any shortness of breath or difficulty breathing.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Malaise, Myalgia
Clinical narrative: Fatigue     After second Moderna vaccine given on 3/4/21, Started with pain in her arm and headache that night.  Next day she had a fever 103.0, palpitations, lightheaded, joint pain/muscle pain, SOB, blood pressure 125/55, HR 125.  Many symptoms lasted until Sunday.  Still doesn't feel right.  Has been taking tylenol for the fever.   generalized malaise, fatigue, heart palpitations and blood pressure fluctuations.  Patient reports she received the 2nd Moderna vaccine  and had symptoms that started approximately 24 hours after the vaccine was administered.  Patient reported fever up to 103 initially which is since resolved, she has had continued myalgias, joint pain fatigue and heart palpitations.  Patient denies any shortness of breath or difficulty breathing.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Fatigue     After second Moderna vaccine given on 3/4/21, Started with pain in her arm and headache that night.  Next day she had a fever 103.0, palpitations, lightheaded, joint pain/muscle pain, SOB, blood pressure 125/55, HR 125.  Many symptoms lasted until Sunday.  Still doesn't feel right.  Has been taking tylenol for the fever.   generalized malaise, fatigue, heart palpitations and blood pressure fluctuations.  Patient reports she received the 2nd Moderna vaccine  and had symptoms that started approximately 24 hours after the vaccine was administered.  Patient reported fever up to 103 initially which is since resolved, she has had continued myalgias, joint pain fatigue and heart palpitations.  Patient denies any shortness of breath or difficulty breathing.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 43.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 40.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 85.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chronic spontaneous urticaria, Rash pruritic
Clinical narrative: Chronic Spontaneous idiopathic Urticaria. Onset at twelve days from vacination. Prutic eruptions moveing from one location fading then starting in another location. Whole-body effected. Treatment with prednisone on a tapered dose with Dyphenhyramine and Cetirizine.   After three weeks Ceyirizine daily with Dyphenhyramine as needed for breakthrough.  The time course: currently ungoing from 07/14/2022 to present with daily treatment needed to alleviate symtoms.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue, Underdose
Clinical narrative: Patient was administered vaccine that was found to be over diluted on reconstitution.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 6.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 7.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 11.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 7.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 36.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given a dose of Pfizer Bivalent as her 2nd dose of her primary series instead of the Pfizer (grey cap).
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 10.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 64.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 68.0
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 77.0
Sex: U
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 9.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Overdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of OVERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced OVERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, OVERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, 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 OVERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains age group added and narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, 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 UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received additional booster dose. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Significant follow up received: age group and narrative updated.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains age group added and narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received wherein the patient age group and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, 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 UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    Dosage text was reported as Additional Booster.   196 patients received 0.25ml of Moderna Covid-19 Vaccine, Bivalent. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications was provided. No treatment medications was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live NonSignificant follow up
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: husband also got the COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (husband also got the COVID-19) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    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, received 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, 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 and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (husband also got the COVID-19). At the time of the report, COVID-19 (husband also got the COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  The reporter stated that the patient had none but some mild symptoms of COVID-19, not recently and the reporter was not sure about which medication did the physician prescribed to the patient but believed that it was Paxlovid.   This case was linked to US-MODERNATX, INC.-MOD-2021-385994 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-385994:Wife's case, same reporter
Sex: M
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.    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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        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. It was reported that patient got the booster shot found dead in the morning. No treatment medications were reported.  Company comment- This is a fatal spontaneous case concerning a male patient of unknown age, with medical condition of diabetes, who experienced the serious (death and medically significant) unexpected event of death. A dose of mRNA-1273.222 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported that patient got the booster shot and was found dead in the morning. The cause of death was not reported. It is unknown if an autopsy was performed. No information on detailed clinical course, concomitant medication and treatment of the event was available in the report. Medical condition of diabetes remains as a contributory risk factor for the event. The benefit risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-692839 (E2B Linked Report).; Sender's Comments: This is a fatal spontaneous case concerning a male patient of unknown age, with medical condition of diabetes, who experienced the serious (death and medically significant) unexpected event of death. A dose of mRNA-1273.222 vaccine, given as a booster dose of COVID vaccine schedule, was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported that patient got the booster shot and was found dead in the morning morning. The cause of death was not reported. It is unknown if an autopsy was performed. No information on detailed clinical course, concomitant medication and treatment of the event was available in the report. Medical condition of diabetes remains as a contributory risk factor for the event. The benefit risk relationship of mRNA-1273.222 is not affected by this report. US-MODERNATX, INC.-MOD-2022-692839:Master; Reported Cause(s) of Death: Found dead
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Bivalent Moderna Covid-19 Vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Bivalent Moderna Covid-19 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)) 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 UNDERDOSE (196 patients received 0.25mL of Bivalent Moderna Covid-19 Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Bivalent Moderna Covid-19 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 UNDERDOSE (196 patients received 0.25mL of Bivalent Moderna Covid-19 Vaccine).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received wherein age group and I narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, 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 UNDERDOSE (Patient received 0.25mL of Moderna COVID-19 Vaccine, Bivalent).    No concomitant medication information was provided.  196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.  It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received updated patient age group.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant information provided No treatment information provided    Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up : Age group updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received wherein Age group added and I narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medications were reported. It was unknown if patient received any other vaccines 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up : Age group updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: patient received 0.25mL of Moderna Covid-19 vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (patient received 0.25mL of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that it was unknown if patient received any other vaccine 4 weeks prior to COVID-19 vaccine.     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 UNDERDOSE (patient received 0.25mL of Moderna Covid-19 vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient received 0.25mL of Moderna Covid-19 vaccine, 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 UNDERDOSE (patient received 0.25mL of Moderna Covid-19 vaccine, Bivalent).    Concomitant drugs were not reported. Dosage text for suspect product was reported as additional Booster. 196 patients received 0.25ml of Moderna Covid-19 Vaccine, Bivalent. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up received, added patient age group.