chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, Cardiac monitoring abnormal, Electrocardiogram abnormal
Clinical narrative: I was diagnosed with atrial fibrillation on 10/20/2022 through a routine EKG.  Since then, I have had afib on and off again.  I consulted Dr., who prescribed 2 medications-- Eliquis tablet 5 mp every day and Metoprolol Tartrate tablet 25 mg every day.  I have had EKGs prior to 10/20/2022 but none detected afib.  (I did not have an EKG after first taking the vaccine on 2/9/2021 until 10/20/2022).
Age: 73.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Arterial therapeutic procedure, Arthralgia, Giant cell arteritis, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: With in a week.. hips anf legs pain and stiff
Age: 73.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Pain in extremity
Clinical narrative: With in a week.. hips anf legs pain and stiff
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Loss of consciousness, Mental status changes, Migraine
Clinical narrative: First symptoms started when my left side of my body went numb, I was stumbling, and could not speak.Went to the minor emergency and was told I was having a migraine. Symptoms lasted 30-40 minutes. First siezure was a week later, sister found me passed out on the floor. I was unconscious a day and half. I was in the hostipal for 4 days and I was given Phenytoin ER 300MG daily.  Second siezure was 2 days after I got released from the hosiptal. I was admitted for 3 days. My medication dosage was changed to Phenytoin 25MG/ML Oral suspension 200MG every 12 hours. I had no memory of what had happened to me after the siezures occurred.  Doctor diagnosis altered mental state, syncope, stroke-like episode, siezure disorder
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Speech disorder, Syncope
Clinical narrative: First symptoms started when my left side of my body went numb, I was stumbling, and could not speak.Went to the minor emergency and was told I was having a migraine. Symptoms lasted 30-40 minutes. First siezure was a week later, sister found me passed out on the floor. I was unconscious a day and half. I was in the hostipal for 4 days and I was given Phenytoin ER 300MG daily.  Second siezure was 2 days after I got released from the hosiptal. I was admitted for 3 days. My medication dosage was changed to Phenytoin 25MG/ML Oral suspension 200MG every 12 hours. I had no memory of what had happened to me after the siezures occurred.  Doctor diagnosis altered mental state, syncope, stroke-like episode, siezure disorder
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Headache, Hypersensitivity, Lethargy, Mass
Clinical narrative: Viral IMZ related side effects - lethargy, headache, body aches - happened at all doses and resolved after about 2 days Pain, redness, swelling and a lump  - new to this vaccine and pain increased after other symptoms resolved Went to ER - diagnosed as allergic reaction - given steroids (unknown item and strength) on 1/1 Pt symptoms resolving but not 100% recovered
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Swelling
Clinical narrative: Viral IMZ related side effects - lethargy, headache, body aches - happened at all doses and resolved after about 2 days Pain, redness, swelling and a lump  - new to this vaccine and pain increased after other symptoms resolved Went to ER - diagnosed as allergic reaction - given steroids (unknown item and strength) on 1/1 Pt symptoms resolving but not 100% recovered
Age: 30.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Mechanical urticaria, Pruritus, Skin disorder, Urticaria
Clinical narrative: Hives started during the night but I realize now it?s dermatographia because i have all the symptoms. I?ve never dealt with hives so when it occurred I figured it would go away with time but now realizing I have skin writing (goes away within 20-30 minutes) and itchy skin, it?s something else that happened within 6-10 hours of taking the vaccine
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Chest pain, Echocardiogram abnormal, Fatigue, Heart rate increased
Clinical narrative: Chest pain, elevated heart rate, and exhaustion. Went to the ER and then also went to the cardiologist at local Clinic and was diagnosed with pericarditis through  echo. Was put on a treatment plan with medication  and no exercise.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: Chest pain, elevated heart rate, and exhaustion. Went to the ER and then also went to the cardiologist at local Clinic and was diagnosed with pericarditis through  echo. Was put on a treatment plan with medication  and no exercise.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Palpitations, Pyrexia
Clinical narrative: Palpitations x5 hours, fever, chills and body aches x3 days. Took ibuprofen which somewhat helped with symptoms.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Exfoliative rash, Pityriasis rosea, Rash, Rash pruritic
Clinical narrative: Small scaly rash on left shoulder which is very itchy! Rash continues to spread to chest also very itchy! Researched rash as pityriasis rosea because it has all the characteristics of what has been occurring! The herald Patch continue to be the itchiest!
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood test, Chest discomfort, Dyspnoea, Fatigue, Palpitations
Clinical narrative: Heart palpitations (worse with activity) Fatigue Shortness of breath Chest tightness  * symptoms varied across several weeks
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Troponin
Clinical narrative: Heart palpitations (worse with activity) Fatigue Shortness of breath Chest tightness  * symptoms varied across several weeks
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: Sudden hearing loss right ear. Feels like water in the ear. Condition still persists as of 1/1/23.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Fatigue, Pyrexia
Clinical narrative: Fever, Diarrhea, exhaustion
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Influenza virus test negative, Malaise, Mononucleosis heterophile test negative, SARS-CoV-2 test positive
Clinical narrative: Became infected with COVID and quite ill
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Streptococcus test negative
Clinical narrative: Became infected with COVID and quite ill
Age: 67.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Injection site pain, Nausea, Pain
Clinical narrative: Soreness within 6 inch radius of injection site. All over body aches with lack of energy and general queasiness.  All symptoms lasting a little over a day and a half.
Age: 40.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Fatigue, Headache, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Muscle aches and extreme fatigue lasting over 24 hours, muscle tension in neck and shoulders, headache, tenderness and hard at injection site, rash at injection site
Age: 40.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Muscle tightness, Myalgia
Clinical narrative: Muscle aches and extreme fatigue lasting over 24 hours, muscle tension in neck and shoulders, headache, tenderness and hard at injection site, rash at injection site
Age: 17.0
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No additional AE; was administered to a pregnant patient 11/23/2022. She states the patient has not experienced any issues since being vaccinated and did not know she was pregnant.; This spontaneous report was received from a nurse and refers to a pregnant 17-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 23-NOV-2022, the pregnant patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W005208, expiration date: 14-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided) and sterile diluent solution for injection/infusion (strength, lot #, expiry date, route of administration, and indication were not provided) (exposure during pregnancy). The reporter stated that the patient has not experienced any issues since being vaccinated and did not know she was pregnant. No Varicella Zoster Virus Identification Program (VZVIP) information was being sent as patient did not develop symptoms after being vaccinated and health care professional (HCP) stated the patient did not even want to be pregnant and would most likely not be interested in providing a specimen. Last menstrual period (LMP) was estimated at 2022. At the time of the reporting the outcome of pregnancy was outcome pending and fetal outcome was unknown. There were no adverse events reported (no adverse event).
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; 16 patients were administered pediatric monovalent vaccines instead of bivalent boosters; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (no adverse event) and WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Dec-2022, the patient experienced NO ADVERSE EVENT (no adverse event) and WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters). At the time of the report, NO ADVERSE EVENT (no adverse event) had not resolved and WRONG PRODUCT ADMINISTERED (16 patients were administered pediatric monovalent vaccines instead of bivalent boosters) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-692326, US-MODERNATX, INC.-MOD-2022-692318, US-MODERNATX, INC.-MOD-2022-692319, US-MODERNATX, INC.-MOD-2022-692329, US-MODERNATX, INC.-MOD-2022-692321, US-MODERNATX, INC.-MOD-2022-692322, US-MODERNATX, INC.-MOD-2022-692323, US-MODERNATX, INC.-MOD-2022-692324 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-692326:Master US-MODERNATX, INC.-MOD-2022-692324:Master US-MODERNATX, INC.-MOD-2022-692322:Master US-MODERNATX, INC.-MOD-2022-692318:Master US-MODERNATX, INC.-MOD-2022-692321:Master US-MODERNATX, INC.-MOD-2022-692323:Master US-MODERNATX, INC.-MOD-2022-692329:Master US-MODERNATX, INC.-MOD-2022-692319:Master
Sex: F
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Inflammation, Mass
Clinical narrative: Can cause you Guillain-Barré Syndrome, have a niece flat of her back with that; She got cushions; Germ there and it imflamed it; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), mass and inflammation. On an unknown date, the outcome of the guillain barre syndrome was not recovered/not resolved and the outcome of the mass and inflammation were unknown.   It was unknown if the reporter considered the guillain barre syndrome, mass and inflammation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that they really do not know what caused his/her nieces, but she got cushions and physician stated that the patient already had the germ there and it was imflamed it someway. The physician stated the patient also cause Guillain Barre syndrome and her niece had flat of her back with that now. Additional supportive information: Follow-up would not possible as no contact details were available. This was 1 of the 4 cases, reported by the same reporter; Sender's Comments:  US-GSK-US2022AMR193091:Same reporter US-GSK-US2022AMR193110:Same reporter US-GSK-US2022AMR193098:Same reporter
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Pain
Clinical narrative: Little soreness; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Flu vaccine. On an unknown date, unknown after receiving Shingles vaccine and Flu vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 23-DEC-2022. Reporter's Comment: This case was reported by a consumer via interactive digital media. Patient reported a little soreness for a couple of days and that was all.  Patient reported that much easier than putting up with an outbreak of either.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Conversion disorder
Clinical narrative: HYSTERIA; CONDITIONS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On an unspecified date, the patient experienced hysteria, and conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hysteria and conditions was not reported. This report was non-serious.
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: Follow up received wherein Narrative was 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received wherein Narrative was 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received wherein I Narrative was 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 (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: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 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 (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: Vaccine Underdose; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Vaccine Underdose) 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) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Vaccine Underdose) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Vaccine Underdose).    No concomitant medicine were reported. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live non follow up added.
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) 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 medicine were reported. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up 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).    Concomitant medication list was not provided.  It was reported that 196 patients received 0.25mL of Moderna COVID-19 vaccine, Bivalent.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up: added patient demographic details.
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 a nurse 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 unknown if patient received any other vaccines in the 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) 1 dosage form. 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 medication list was not provided. It was reported that 196 patients received 0.25mL of Moderna COVID-19 vaccine, Bivalent. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up: added patient demographic details.
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) .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 narrative updated.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: Vaccine underdose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Vaccine underdose) 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 (Vaccine underdose) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Vaccine underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Vaccine underdose).    Concomitant medications were not reported.                                       No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live non-significant follow up appended
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes ophthalmic
Clinical narrative: Ocular shingles
Sex: U
Vaccine: COVID19
Symptoms: Leg amputation
Clinical narrative: LEGS AMPUTATED WITHIN ALMOST HOURS (THEY FOUGHT IT FOR 2 DAYS); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was perfectly healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced legs amputated within almost hours (they fought it for 2 days). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of legs amputated within almost hours (they fought it for 2 days) was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with a product quality complaint  This case, from the same reporter is linked to 20221262240.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, Product availability issue
Clinical narrative: Vaccination Provider told the patient that the second dose was not available at the moment; Vaccination Provider told the patient that the second dose was not available at the moment; No Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Vaccination Provider told the patient that the second dose was not available at the moment), PRODUCT AVAILABILITY ISSUE (Vaccination Provider told the patient that the second dose was not available at the moment) and NO ADVERSE EVENT (No Adverse Event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Vaccination Provider told the patient that the second dose was not available at the moment), PRODUCT AVAILABILITY ISSUE (Vaccination Provider told the patient that the second dose was not available at the moment) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Vaccination Provider told the patient that the second dose was not available at the moment), PRODUCT AVAILABILITY ISSUE (Vaccination Provider told the patient that the second dose was not available at the moment) 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 assessments were provided for PRODUCT ADMINISTRATION INTERRUPTED (Vaccination Provider told the patient that the second dose was not available at the moment) and PRODUCT AVAILABILITY ISSUE (Vaccination Provider told the patient that the second dose was not available at the moment).    No concomitant medications were reported.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient received 1st dose on 06-Oct-2021, Vaccination Provider told the patient that the second dose was not available at the moment   No treatment medication was provided.
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 a nurse 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).    Patient received additional booster dose.  Concomitant medication list was not provided.  It was reported that 196 patients received 0.25mL of Moderna COVID-19 vaccine, Bivalent.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received contains significant information: Updated patient demographics and case narrative.
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 medicine were reported. No treatment medicine were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up 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 a nurse 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) 1 dosage form. 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 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 included 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 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) 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 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 included 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.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live significant follow up: Added age group and updated narrative.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: 196 patients received 0.25mL of Moderna Covid-19 Bivalent 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 Moderna Covid-19 Bivalent 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 Moderna Covid-19 Bivalent Vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Bivalent 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 Moderna Covid-19 Bivalent Vaccine).    Concomitant medication was not reported. Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Age group added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916: