chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Acute respiratory failure, Anticoagulant therapy, Brain natriuretic peptide increased, COVID-19
Clinical narrative: Patient is a 78 y.o. female patient of, MD with history of rheumatic heart disease s/p open mitral valve commissurotomy in 1982, pulmonary hypertension, mitral valve insufficiency, tricuspid regurgitation, mild aortic valve stenosis, paroxysmal atrial fibrillation on Coumadin, hypertension, hypothyroidism, sleep apnea presented to Hospital with complaint of abdominal pain but was found to be hypoxic while in the ER.  Patient had CT abdomen in the ER that was unremarkable other than mild pulmonary interstitial edema.  Patient also had elevated BNP, was hypoxic and needed oxygen.    Acute on chronic diastolic CHF exacerbation Acute hypoxic respiratory failure 2/2 above Rheumatic heart disease status post mitral valve commissurotomy in 1982 and mitral valve balloon valvuloplasty in 2021 Paroxysmal atrial fibrillation status post pulmonary vein isolation Hypertension  Nonobstructive CAD POA Likely diastolic, last echocardiogram showing EF 60% X-ray showed mild scattered haziness in middle and lower lung zones which may represent pneumonitis versus edema or developing atypical pneumonia. CT scan abdomen pelvis showed findings suggestive of pulmonary interstitial edema. Follow-up repeat echocardiogram Start patient on IV Lasix Continue losartan, Coreg, Tikosyn, Cardizem Warfarin dose per pharmacy Strict I's and O's and daily weight The patient improved and feels ready for discharge.  Discharge the patient on same home regimen.  She takes p.o. Lasix at home.   Covid-19 Virus Infection Date of onset of symptoms: Abdominal pain Symptoms present on admission: Hypoxia Date of covid positive test: 4/6/2023 Vaccination status: vaccinated Imaging: Chest x-ray as above. Oxygen requirements on admission: 2 L Current oxygen requirements: There Medical therapy: steroids  Consultants following: None Anticipated special isolation end date: 4/16   Hypokalemia Replete and monitor
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac ablation, Cardiac failure acute, Cardiac failure congestive, Chest X-ray abnormal, Computerised tomogram abdomen abnormal
Clinical narrative: Patient is a 78 y.o. female patient of, MD with history of rheumatic heart disease s/p open mitral valve commissurotomy in 1982, pulmonary hypertension, mitral valve insufficiency, tricuspid regurgitation, mild aortic valve stenosis, paroxysmal atrial fibrillation on Coumadin, hypertension, hypothyroidism, sleep apnea presented to Hospital with complaint of abdominal pain but was found to be hypoxic while in the ER.  Patient had CT abdomen in the ER that was unremarkable other than mild pulmonary interstitial edema.  Patient also had elevated BNP, was hypoxic and needed oxygen.    Acute on chronic diastolic CHF exacerbation Acute hypoxic respiratory failure 2/2 above Rheumatic heart disease status post mitral valve commissurotomy in 1982 and mitral valve balloon valvuloplasty in 2021 Paroxysmal atrial fibrillation status post pulmonary vein isolation Hypertension  Nonobstructive CAD POA Likely diastolic, last echocardiogram showing EF 60% X-ray showed mild scattered haziness in middle and lower lung zones which may represent pneumonitis versus edema or developing atypical pneumonia. CT scan abdomen pelvis showed findings suggestive of pulmonary interstitial edema. Follow-up repeat echocardiogram Start patient on IV Lasix Continue losartan, Coreg, Tikosyn, Cardizem Warfarin dose per pharmacy Strict I's and O's and daily weight The patient improved and feels ready for discharge.  Discharge the patient on same home regimen.  She takes p.o. Lasix at home.   Covid-19 Virus Infection Date of onset of symptoms: Abdominal pain Symptoms present on admission: Hypoxia Date of covid positive test: 4/6/2023 Vaccination status: vaccinated Imaging: Chest x-ray as above. Oxygen requirements on admission: 2 L Current oxygen requirements: There Medical therapy: steroids  Consultants following: None Anticipated special isolation end date: 4/16   Hypokalemia Replete and monitor
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Coronary artery disease, Echocardiogram, Ejection fraction, Hypertension
Clinical narrative: Patient is a 78 y.o. female patient of, MD with history of rheumatic heart disease s/p open mitral valve commissurotomy in 1982, pulmonary hypertension, mitral valve insufficiency, tricuspid regurgitation, mild aortic valve stenosis, paroxysmal atrial fibrillation on Coumadin, hypertension, hypothyroidism, sleep apnea presented to Hospital with complaint of abdominal pain but was found to be hypoxic while in the ER.  Patient had CT abdomen in the ER that was unremarkable other than mild pulmonary interstitial edema.  Patient also had elevated BNP, was hypoxic and needed oxygen.    Acute on chronic diastolic CHF exacerbation Acute hypoxic respiratory failure 2/2 above Rheumatic heart disease status post mitral valve commissurotomy in 1982 and mitral valve balloon valvuloplasty in 2021 Paroxysmal atrial fibrillation status post pulmonary vein isolation Hypertension  Nonobstructive CAD POA Likely diastolic, last echocardiogram showing EF 60% X-ray showed mild scattered haziness in middle and lower lung zones which may represent pneumonitis versus edema or developing atypical pneumonia. CT scan abdomen pelvis showed findings suggestive of pulmonary interstitial edema. Follow-up repeat echocardiogram Start patient on IV Lasix Continue losartan, Coreg, Tikosyn, Cardizem Warfarin dose per pharmacy Strict I's and O's and daily weight The patient improved and feels ready for discharge.  Discharge the patient on same home regimen.  She takes p.o. Lasix at home.   Covid-19 Virus Infection Date of onset of symptoms: Abdominal pain Symptoms present on admission: Hypoxia Date of covid positive test: 4/6/2023 Vaccination status: vaccinated Imaging: Chest x-ray as above. Oxygen requirements on admission: 2 L Current oxygen requirements: There Medical therapy: steroids  Consultants following: None Anticipated special isolation end date: 4/16   Hypokalemia Replete and monitor
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokalaemia, Hypoxia, Left ventricular failure, Lung disorder, Pulmonary oedema
Clinical narrative: Patient is a 78 y.o. female patient of, MD with history of rheumatic heart disease s/p open mitral valve commissurotomy in 1982, pulmonary hypertension, mitral valve insufficiency, tricuspid regurgitation, mild aortic valve stenosis, paroxysmal atrial fibrillation on Coumadin, hypertension, hypothyroidism, sleep apnea presented to Hospital with complaint of abdominal pain but was found to be hypoxic while in the ER.  Patient had CT abdomen in the ER that was unremarkable other than mild pulmonary interstitial edema.  Patient also had elevated BNP, was hypoxic and needed oxygen.    Acute on chronic diastolic CHF exacerbation Acute hypoxic respiratory failure 2/2 above Rheumatic heart disease status post mitral valve commissurotomy in 1982 and mitral valve balloon valvuloplasty in 2021 Paroxysmal atrial fibrillation status post pulmonary vein isolation Hypertension  Nonobstructive CAD POA Likely diastolic, last echocardiogram showing EF 60% X-ray showed mild scattered haziness in middle and lower lung zones which may represent pneumonitis versus edema or developing atypical pneumonia. CT scan abdomen pelvis showed findings suggestive of pulmonary interstitial edema. Follow-up repeat echocardiogram Start patient on IV Lasix Continue losartan, Coreg, Tikosyn, Cardizem Warfarin dose per pharmacy Strict I's and O's and daily weight The patient improved and feels ready for discharge.  Discharge the patient on same home regimen.  She takes p.o. Lasix at home.   Covid-19 Virus Infection Date of onset of symptoms: Abdominal pain Symptoms present on admission: Hypoxia Date of covid positive test: 4/6/2023 Vaccination status: vaccinated Imaging: Chest x-ray as above. Oxygen requirements on admission: 2 L Current oxygen requirements: There Medical therapy: steroids  Consultants following: None Anticipated special isolation end date: 4/16   Hypokalemia Replete and monitor
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient is a 78 y.o. female patient of, MD with history of rheumatic heart disease s/p open mitral valve commissurotomy in 1982, pulmonary hypertension, mitral valve insufficiency, tricuspid regurgitation, mild aortic valve stenosis, paroxysmal atrial fibrillation on Coumadin, hypertension, hypothyroidism, sleep apnea presented to Hospital with complaint of abdominal pain but was found to be hypoxic while in the ER.  Patient had CT abdomen in the ER that was unremarkable other than mild pulmonary interstitial edema.  Patient also had elevated BNP, was hypoxic and needed oxygen.    Acute on chronic diastolic CHF exacerbation Acute hypoxic respiratory failure 2/2 above Rheumatic heart disease status post mitral valve commissurotomy in 1982 and mitral valve balloon valvuloplasty in 2021 Paroxysmal atrial fibrillation status post pulmonary vein isolation Hypertension  Nonobstructive CAD POA Likely diastolic, last echocardiogram showing EF 60% X-ray showed mild scattered haziness in middle and lower lung zones which may represent pneumonitis versus edema or developing atypical pneumonia. CT scan abdomen pelvis showed findings suggestive of pulmonary interstitial edema. Follow-up repeat echocardiogram Start patient on IV Lasix Continue losartan, Coreg, Tikosyn, Cardizem Warfarin dose per pharmacy Strict I's and O's and daily weight The patient improved and feels ready for discharge.  Discharge the patient on same home regimen.  She takes p.o. Lasix at home.   Covid-19 Virus Infection Date of onset of symptoms: Abdominal pain Symptoms present on admission: Hypoxia Date of covid positive test: 4/6/2023 Vaccination status: vaccinated Imaging: Chest x-ray as above. Oxygen requirements on admission: 2 L Current oxygen requirements: There Medical therapy: steroids  Consultants following: None Anticipated special isolation end date: 4/16   Hypokalemia Replete and monitor
Age: 1.67
Sex: M
Vaccine: MMRV, UNK, VARCEL
Symptoms: Injection site erythema
Clinical narrative: ProQuad was administered instead of MMR.  Clinic physician was contacted; client's parent has no provider, no phone and speaks different language.  Clinic provider and Merck were consulted for possible reactions and both indicated possible fever/febrile seizures with Merck stating day 5-12 following vaccination. My follow up with client's parent through an interpreter:  There have been NO adverse reactions for the child.  7/6, 7:30 PM - slight redness at injection site, no fever, sleeping; 7/7, 8:30/1 PM - child slept through the night, no fever; interpreter completed previously scheduled home visit, observed the child playing normally, no redness @ site, no fever.  Interpreter relayed info to watch for fever on 7/11-18. Interpreter will follow up with client/child at home visits and by social media messaging. 7/9, 4:00 PM:  Interpreter called mother and child continues with no reaction.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine that was administer was accidently stored improperly. No adverse reactions.
Age: 12.0
Sex: M
Vaccine: HPV9, UNK
Symptoms: Abnormal loss of weight, Antibody test positive, Autoimmune disorder, Biopsy intestine abnormal, Blood glucose increased
Clinical narrative: Hospitalized with Diabetic Ketoacidosis, diagnosed with Type 1 Diabetes (Autoimmune disease) Lethargy, ketone breath, frequent urination, extreme weight loss, extremely high blood sugars and A1C, elevated antibodies for celiac disease (later diagnosed in Jan 2021 after endoscopy and biopsy)
Age: 12.0
Sex: M
Vaccine: HPV9, UNK
Symptoms: Coeliac disease, Diabetic ketoacidosis, Endoscopy abnormal, Glycosylated haemoglobin increased, Ketoacidosis
Clinical narrative: Hospitalized with Diabetic Ketoacidosis, diagnosed with Type 1 Diabetes (Autoimmune disease) Lethargy, ketone breath, frequent urination, extreme weight loss, extremely high blood sugars and A1C, elevated antibodies for celiac disease (later diagnosed in Jan 2021 after endoscopy and biopsy)
Age: 12.0
Sex: M
Vaccine: HPV9, UNK
Symptoms: Lethargy, Pollakiuria, Type 1 diabetes mellitus
Clinical narrative: Hospitalized with Diabetic Ketoacidosis, diagnosed with Type 1 Diabetes (Autoimmune disease) Lethargy, ketone breath, frequent urination, extreme weight loss, extremely high blood sugars and A1C, elevated antibodies for celiac disease (later diagnosed in Jan 2021 after endoscopy and biopsy)
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: STABLE ANGINA
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine that was administer was accidently stored improperly. No adverse reactions.
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Eye disorder
Clinical narrative: Eye dropping
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis
Clinical narrative: ACUTE DVT OF LEFT FEMORAL VEIN
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine that was administer was accidently stored improperly. No adverse reactions.
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Lacunar stroke
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: 10mcg given instead of 25mcg
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Ear discomfort, Facial pain, Fatigue, Lymphadenopathy
Clinical narrative: Fatigue, malaise and weakness, +LAD in left axilla and left cervical nodes, +tenderness in left arm, +left sided facial pain and +ear plugging sensation
Age: 42.0
Sex: F
Vaccine: COVID19-2
Symptoms: Malaise, Tenderness
Clinical narrative: Fatigue, malaise and weakness, +LAD in left axilla and left cervical nodes, +tenderness in left arm, +left sided facial pain and +ear plugging sensation
Age: 14.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine that was administer was accidently stored improperly. No adverse reactions.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: 10 mcg given instead of 25mcg
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine that was administer was accidently stored improperly. No adverse reactions.
Age: 0.75
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: 10 mcg given instead of 25mcg
Age: 35.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Eye swelling, Pain, Pyrexia
Clinical narrative: Body ache/fever 4:00pm Friday- 2:00am Sunday. Left eye swelling  5:00pm Sunday- present.
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine that was administer was accidently stored improperly. No adverse reactions.
Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
Age: 13.0
Sex: F
Vaccine: TDAP
Symptoms: Cyanosis, Gait disturbance, Pallor, Throat tightness
Clinical narrative: 1515 While patient was waiting her 20 minutes after receiving her TdAP Immunization in the lobby, the receptionist  informed me that the patient did not look right and that she was holding onto her brother for support while walking.  Noted that the patient was attempting to leave the facility.  I walked out to the lobby and asked the patient and her father to return to the front clinic nurse 2.  I grabbed the emergency kit and removed the Epinephrine 1mg/ml.   I asked the patient's father her last weight and he informed me that she weighed 120 lbs.  I obtained the patient's vital signs.  The patient stated,  "It feels like my throat is closing".  The patient appeared to be pale and her lips were cyanotic.   I asked someone to call EMS for ambulance transport to the local hospital.   1518 the patient was given  Epinephrine via right thigh.   CNAAA placed ice pack on the patients forehead.   1525EmServ ambulance arrived.  The patient independently ambulated to the ambulance with the paramedic. I completed the documentation for emergency and gave a copy to the EMS driver.   1530 I informed Office manager of the current situation.   1539  ambulance left the Health Department.      Called the patient's father on 7/10/2023 to inquire about the patient's current status.   Informed per the patient's father that they observed his daughter for 3-4 hours and sent her home with a prescription for steroids and an Epi Pen.   The patient's father also informed that they will follow up with her pediatrician but they have not made the appointment yet.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalization, tested positive prior to discharge to SNF
Age: 17.0
Sex: M
Vaccine: DTAPHEPBIP, MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pediarix accidentally given instead of Bexsero, no immediate adverse effect. Bexsero administered 30 minutes after per parent request.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: ANGINA, UNSPECIFIED
Age: 55.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Back pain, Chest discomfort, Injection site pain, Lung disorder, Pyrexia
Clinical narrative: PER PATIENT,  PATIENT  HAS PAIN AT INJECTION SITE, MUSCLE PAIN, BACK PAIN ,FEVER AND FEEL HOT IN HER LUNGS
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Medication error, Product preparation issue
Clinical narrative: MED ERROR - VACCINE WAS NOT RECONSITUTED, PATIENT ONLY RECEIVED LIQUID COMPONENT
Age: 48.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome, Pericarditis
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA ACUTE PERICARDITIS, UNSPECIFIED
Age: 58.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute coronary syndrome, Acute myocardial infarction, Acute respiratory failure, Cardiogenic shock, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED ACUTE RESPIRATORY FAILURE CARDIOGENIC SHOCK 3/4/2023  &  3/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 6/2/2023 - 6/5/2023 (3 days) dc to home IV ceftriaxone and IV azithromycin  COVID + 6/2/2023  EL9267 2/12/2021 EN6206 3/6/2021 FH8028 11/15/2021 FK9894 5/23/2022 pfizer bivalent AS7163B 10/27/2022
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Rectal cancer
Clinical narrative: G62.0 CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA 5/1/2023 RECTAL CANCER
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient developed a red rash on her neck and upper chest within 24 hours of vaccination.  It was still there after 6 days.  Patient did not experience this after the other COVID vaccines.
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: 6/4/2023 - 6/7/2023 (3 days) dc home - Presented the hospital with shortness of breath dexamethasone, remdesivir  039B21A 4/28/2021 027C21A 5/27/2021 025L21B 2/4/2022
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 1.75
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: MA did not dilute pfizer bivalent booster for 6mo-<5 year patient in our clinic today.  This resulted in about 9-10 doses administered in a single event.  The patient was also let go prior to the 15 minute observation period.  MA informed the parent of child of the vaccine administration error.  The parent will be contacted by clinic physicians this afternoon July 10th 2023 to discuss concerns.  MA discussed the following: Parent of child agreed to plan to monitor for local, acute, and systemic vaccine reactions including  but not limited to fever. Parents will return to clinic tomorrow for a more comprehensive evaluation by a physician.
Age: 1.75
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Body height, Body temperature, Inappropriate schedule of product administration, Irritability, Overdose
Clinical narrative: MA did not dilute pfizer bivalent booster for 6mo-<5 year patient in our clinic today.  This resulted in about 9-10 doses administered in a single event.  The patient was also let go prior to the 15 minute observation period.  MA informed the parent of child of the vaccine administration error.  The parent will be contacted by clinic physicians this afternoon July 10th 2023 to discuss concerns.  MA discussed the following: Parent of child agreed to plan to monitor for local, acute, and systemic vaccine reactions including  but not limited to fever. Parents will return to clinic tomorrow for a more comprehensive evaluation by a physician.
Age: 1.75
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Product preparation error, Pyrexia, Weight
Clinical narrative: MA did not dilute pfizer bivalent booster for 6mo-<5 year patient in our clinic today.  This resulted in about 9-10 doses administered in a single event.  The patient was also let go prior to the 15 minute observation period.  MA informed the parent of child of the vaccine administration error.  The parent will be contacted by clinic physicians this afternoon July 10th 2023 to discuss concerns.  MA discussed the following: Parent of child agreed to plan to monitor for local, acute, and systemic vaccine reactions including  but not limited to fever. Parents will return to clinic tomorrow for a more comprehensive evaluation by a physician.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: There are no symptoms of the patient, it is that the vaccine was out of date at the time of administration.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SEQUELA NEUROPATHY
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site rash, Pyrexia, Rash
Clinical narrative: patient began having rash and fever of 103 on 6/30/23. Rash began at site of Proquad vaccine.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: Patient was administered an extra dose of a vaccine (Dtap) instead of another vaccine that was suppose to be given (Hep B), Patient was in good standings after vaccine was given and when patient left clinic and was okay. No reports of any reactions or symptoms to vaccine after it was administered, Patient was immediately called back and informed about extra dose of vaccine that was given and  to come back to the clinic to receive correct vaccine (Hep B)
Age: 0.58
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: 10 mcg given instead of 25 mcg
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Per patient report: pain started minutes after vaccine administration. It became pink the next day and the next day after this it was erythematous and slightly swollen and warm.  This lasted several days and gradually improved. However, she was left with pain with pressure on the deltoid and pain leading up to the anterior shoulder and to the right neck; the pain sometimes goes into her right forearm and hand. No fevers.    Right shoulder still has small swollen area around deltoid; pain with abduction and pressure.   No hand/forearm edema
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Skin discolouration, Skin warm, Swelling, X-ray limb
Clinical narrative: Per patient report: pain started minutes after vaccine administration. It became pink the next day and the next day after this it was erythematous and slightly swollen and warm.  This lasted several days and gradually improved. However, she was left with pain with pressure on the deltoid and pain leading up to the anterior shoulder and to the right neck; the pain sometimes goes into her right forearm and hand. No fevers.    Right shoulder still has small swollen area around deltoid; pain with abduction and pressure.   No hand/forearm edema
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: 10 mcg given instead of 25 mcg
Age: 30.0
Sex: M
Vaccine: JEV1, TDAP, TYP
Symptoms: Blood glucose normal, Dizziness, Dyspnoea, Hyperhidrosis, Pallor
Clinical narrative: 07/08/23 @ 4:06PM SX: PALE, SWEATING, DIZZINESS, BREATHING HEAVILY, ALMOST FAINTING 07/08/23 @ 4:06PM: VITALS: BP: 117/79; P 66.  INSTANTLY AFTER THE ADMINISTRATION OF THE VACCINES. PT WAS SEATED AT THE PHARMACY WAITING AREA. EMS WAS CALLED TO THE PHARMACY. PT WAS CONSCIOUS AS TO PERSON, PLACE, AND TIME. PT WAS COLD TO TOUCH. WHILE WAITING FOR EMS TO COME, PT HAS RECOVERED. SUCH AS HIS SKIN WAS COMING BACK TO BE PINKISH AND HE CAN TALK MORE.
Age: 30.0
Sex: M
Vaccine: JEV1, TDAP, TYP
Symptoms: Peripheral coldness, Presyncope, Skin discolouration
Clinical narrative: 07/08/23 @ 4:06PM SX: PALE, SWEATING, DIZZINESS, BREATHING HEAVILY, ALMOST FAINTING 07/08/23 @ 4:06PM: VITALS: BP: 117/79; P 66.  INSTANTLY AFTER THE ADMINISTRATION OF THE VACCINES. PT WAS SEATED AT THE PHARMACY WAITING AREA. EMS WAS CALLED TO THE PHARMACY. PT WAS CONSCIOUS AS TO PERSON, PLACE, AND TIME. PT WAS COLD TO TOUCH. WHILE WAITING FOR EMS TO COME, PT HAS RECOVERED. SUCH AS HIS SKIN WAS COMING BACK TO BE PINKISH AND HE CAN TALK MORE.
Age: 85.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse reaction: Vaccine was expired.
Age: 0.75
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Given 10mcg instead of recommended 25mcg.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Adacel vaccine was injected in left arm along with ShingRX vaccine (due to extensive scarring on right arm) Wed. afternoon 7/5. Pt experienced some pain at the site of injection (& took Tylenol) and by 7/7/2023 the area was a red and itchy (greater than 4 inch radius) so she informed the pharmacy. 7/7/2023. She was going to take Benadryl as soon as she went home. She didn't not request us to contact her prescriber or her again.
Age: 0.75
Sex: M
Vaccine: COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: Pt given Moderna Bivalent after previously receiving 2 doses of Pfizer, denies symptoms
Age: 0.75
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Incorrect dose of 10mcg instead of recommended 25 mcg.
Age: 0.5
Sex: M
Vaccine: COVID19-2, DTAPIPVHIB
Symptoms: Underdose
Clinical narrative: Given 10 mcg of Moderna Bivalent instead of the recommended 25 mcg
Age: 55.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Diplopia, Dizziness, Fatigue, Rash
Clinical narrative: Patient reported rash, dizziness, double vision, extreme fatigue. Used bendaryl and hydrocortisone cream to alleviate issue
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product preparation issue
Clinical narrative: VACCINE WAS DRAWN UP BEFORE THE 30 MINIUTES RONCONSTITUTION TIME.
Age: 0.5
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Given 10 mcg of Moderna Bivalent instead of recommended 25 mcg
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test normal, Exercise tolerance decreased, Gait inability, Mobility decreased
Clinical narrative: I had symptoms like gout in my toes, but my doctor didn't think it was gout.  This began in June of 2021.  I took medication and these symptoms were gone within a year.  I had trigger in my hand at the same time.  This was in both hands, and I had it these symptoms off and on throughout all vaccines in 2021 and 2022.  In the morning I am unable to move my fingers on both hands until I exercise my fingers.  My hands still don't open all the way.  I continue to take the medications for this because my COVID-19 symptoms were much worse in the first week 2020 before we knew about COVID-19. My stamina has been less than normal since the vaccine and COVID-19.  I am unable to walk as usual, garden, hike or anything as usual.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Trigger finger
Clinical narrative: I had symptoms like gout in my toes, but my doctor didn't think it was gout.  This began in June of 2021.  I took medication and these symptoms were gone within a year.  I had trigger in my hand at the same time.  This was in both hands, and I had it these symptoms off and on throughout all vaccines in 2021 and 2022.  In the morning I am unable to move my fingers on both hands until I exercise my fingers.  My hands still don't open all the way.  I continue to take the medications for this because my COVID-19 symptoms were much worse in the first week 2020 before we knew about COVID-19. My stamina has been less than normal since the vaccine and COVID-19.  I am unable to walk as usual, garden, hike or anything as usual.
Age: 0.58
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Given 10 mcg of the Moderna Bivalent instead of the recommended 25 mcg
Age: 70.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Peripheral swelling
Clinical narrative: Swelling, redness, itchy patches on right arm and shoulder (same arm that both  Shingrix and COVID19 Bivalent Pfizer vaccines were administered).
Age: 70.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Pruritus
Clinical narrative: Swelling, redness, itchy patches on right arm and shoulder (same arm that both  Shingrix and COVID19 Bivalent Pfizer vaccines were administered).
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Conjunctivitis, Endotracheal intubation, Haematology test abnormal, Hypotension
Clinical narrative: on 10th day s/p vaccination, developed fever, rash, conjunctivitis, mucocutaneous changes, abdominal pain, pancytopenia (ALC 300 Plts 49k) hypotensive shock with decreased LV function, very elevated inflammatory markers. no alternative explanation; admit to PICU 7/4-9, ongoing hospitalization. c/f MISC vs severe KD (though hematologic findings atypical). required intubation.  received 7 days empiric broad spectrum antibiotics though infectious etiology never found. had natural COVID-19 illness Fall 2022
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Inflammatory marker increased, Intensive care, Kawasaki's disease, Left ventricular dysfunction, Lymphocyte count decreased
Clinical narrative: on 10th day s/p vaccination, developed fever, rash, conjunctivitis, mucocutaneous changes, abdominal pain, pancytopenia (ALC 300 Plts 49k) hypotensive shock with decreased LV function, very elevated inflammatory markers. no alternative explanation; admit to PICU 7/4-9, ongoing hospitalization. c/f MISC vs severe KD (though hematologic findings atypical). required intubation.  received 7 days empiric broad spectrum antibiotics though infectious etiology never found. had natural COVID-19 illness Fall 2022
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Multisystem inflammatory syndrome in children, Pancytopenia, Platelet count decreased, Pyrexia, Rash
Clinical narrative: on 10th day s/p vaccination, developed fever, rash, conjunctivitis, mucocutaneous changes, abdominal pain, pancytopenia (ALC 300 Plts 49k) hypotensive shock with decreased LV function, very elevated inflammatory markers. no alternative explanation; admit to PICU 7/4-9, ongoing hospitalization. c/f MISC vs severe KD (though hematologic findings atypical). required intubation.  received 7 days empiric broad spectrum antibiotics though infectious etiology never found. had natural COVID-19 illness Fall 2022
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test negative, Shock
Clinical narrative: on 10th day s/p vaccination, developed fever, rash, conjunctivitis, mucocutaneous changes, abdominal pain, pancytopenia (ALC 300 Plts 49k) hypotensive shock with decreased LV function, very elevated inflammatory markers. no alternative explanation; admit to PICU 7/4-9, ongoing hospitalization. c/f MISC vs severe KD (though hematologic findings atypical). required intubation.  received 7 days empiric broad spectrum antibiotics though infectious etiology never found. had natural COVID-19 illness Fall 2022
Age: 23.0
Sex: M
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: PT WAS ADMINISTERED AN EXPIRED FLU VACCINE. STAFF HAS CONTACTED OUR MEDICAL DIRECTOR AND HE ADVISED STAFF TO CONTACT PATIENT, WHICH WE DID AND INFORM HIM OF THE EXPIRED VACCINE AND ALSO LET THEM KNOW THERE WILL BE NO HARM TO HIM. PT HAS BEEN INFORMED
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Apon review of chart.  Nurse mistakenly gave proquad instead of MMR.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE for inadvertent administration of PROQUAD following a TE.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On 12-JUN-2023, the patient was inadvertently vaccinated with the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA))(PROQUAD) injection (0.5 ml, lot # X011437 has been verified to be valid, expiration date reported as established as 18-JUL-2024; strength, and route of administration were not provided) for prophylaxis following a temperature excursion (TE) (product storage error). The storage temperature of the vaccine was 6.4 degree Celsius for a time frame of 191 hours. There was no previous temperature excursion. TE assessment was not evaluated, and products were not back in recommended range. No symptoms were reported. No additional adverse event (AE)/product quality complaint (PQC).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Three times after second vaccination/ Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles about five times).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Three times after second vaccination/ Shingles). The patient was treated with gigartina skottsbergii (Red Marine Algae). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 03-Jul-2023 This case was reported the patient via interactive digital media. The patient had Shingles about five times. After the 2nd vaccination the patient experience three times. The patient started taking red marine algae on daily basis and it had returned. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Off label use, Pain
Clinical narrative: fever aches; fever; feel really bad; doc told me to get shingles vaccine,I had the 2 doses 4 yrs ago so I did not need this; This non-serious case was reported by a consumer and described the occurrence of pain in a 67-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (The patient received 2 doses on an unknown date 4 years ago).   On 27-JUN-2023, the patient received the 3rd dose of Shingles vaccine. On 27-JUN-2023, less than a day after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: feel really bad) and off label use (Verbatim: doc told me to get shingles vaccine,I had the 2 doses 4 yrs ago so I did not need this). On an unknown date, the patient experienced pain (Verbatim: fever aches) and fever (Verbatim: fever). The outcome of the pain and fever were not reported and the outcome of the feeling bad was not resolved and the outcome of the off label use was unknown.   It was unknown if the reporter considered the pain, fever and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the pain, fever and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 30-JUN-2023 This report was via the online direct entry reporting system. This report was submitted by site: Public Reporting. The docter had told the patient  to get shingles vaccine so he got first dose, next day and the day of reporting the patient was feeling really bad.  His wife told him that he had the 2 doses 4 yrs ago so he did not need that. The symptoms were not treated. The reporter consent to follow up. The doctor had told to take Shinges vaccine even when the patient initially had completed 2 dose schedule of Shingles vaccine which led to off label use.
Sex: U
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Muscle spasms, Pain, Pyrexia
Clinical narrative: Leg cramp; A lot of fatigue; a lot of pain after vaccine/Body pain; with fever; diarrhea for mre than 2 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of leg cramps in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27-JUN-2023, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced diarrhea (Verbatim: diarrhea for mre than 2 days). On 29-JUN-2023, the patient experienced fever (Verbatim: with fever) and pain (Verbatim: a lot of pain after vaccine/Body pain). On an unknown date, the patient experienced leg cramps (Verbatim: Leg cramp) and fatigue (Verbatim: A lot of fatigue). The outcome of the leg cramps and fatigue were not reported and the outcome of the fever, diarrhea and pain were not resolved.   It was unknown if the reporter considered the leg cramps, fever, diarrhea, pain and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the leg cramps, fever, diarrhea, pain and fatigue to be related to Shingles vaccine.   Additional Information: GSK receipt date: 2-JUL-2023 This case was reported by a consumer via interactive digital media. The reporter reported that vaccine was given on Tuesday (day before reporting) 3 days with fever and body pain and diarrhea for more than 2 days now. Leg pain and lot of pain after the vaccine and lot of fatigue.
Sex: U
Vaccine: VARZOS
Symptoms: Colitis, Malaise, Pain, Pyrexia
Clinical narrative: i got fever; pain in the body; colitis; felt like had been run over by a train; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: i got fever), general body pain (Verbatim: pain in the body), colitis (Verbatim: colitis) and feeling unwell (Verbatim: felt like had been run over by a train). The outcome of the fever, general body pain, colitis and feeling unwell were not reported.   It was unknown if the reporter considered the fever, general body pain, colitis and feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the fever, general body pain, colitis and feeling unwell to be related to Shingles vaccine.   Additional Information: GSK receipt date:02-JUL-2023 This case was reported by a patient via interactive digital media. The reporter had heard that the vaccine was great.he/she got vaccinated, and had a fever, pain in the body, even colitis, he/she felt like he/she  had been run over by a train. The reporter thanked God that he/she was already vaccinated.  Follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Got fever; Pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 29-JUN-2023, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Got fever) and pain (Verbatim: Pain). The outcome of the fever and pain were not reported.   It was unknown if the reporter considered the fever and pain to be related to Shingles vaccine.     It was unknown if the company considered the fever and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that on Thursday he/she received second vaccination dose. Patient experienced fever and was in pain but she/he already vaccinated. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: Get a fever; Can't  move my hand  for a little bit; It hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced fever (Verbatim: Get a fever), mobility decreased (Verbatim: Can't  move my hand  for a little bit) and pain (Verbatim: It hurt). The outcome of the fever, mobility decreased and pain were not reported.   It was unknown if the reporter considered the fever, mobility decreased and pain to be related to Shingles vaccine.     It was unknown if the company considered the fever, mobility decreased and pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 02-Jul-2023 This case was reported the patient via interactive digital media. The patient got the shot and got fever the next day. Vaccine hurt and not able to move hand for a little bit. The time to onset for mobility decreased and pain was unknown Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: got sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in an unspecified number of patient's who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: got sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-JUL-2023 This case was reported by consumer via interactive digital media. The reporter stated that do not be suckered in on taking the Shingles shot as they will give shingles. The reporter had talked to a lot of people that they got sick after taking it. The reporter stated that just deal with it if you get them naturally and detox yourself. The people would be ok. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: arm is swollen; sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: arm is swollen) and pain in arm (Verbatim: sore arm). The outcome of the swelling arm and pain in arm were not reported.   It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the swelling arm and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 01-JUL-2023 This case was reported by a patient via interactive digital media. It was reported that three days after getting second Shingles shot, patient experienced swollen and sore arm. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Rash, Vaccine positive rechallenge
Clinical narrative: first left my arm sore for most of a week... The second did the same; also got a slight rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of pain in extremity (on an unknown date received 1st dose. for tolerance refer US2023AMR092401.).   On an unknown date, the patient received the 2nd dose of Shingles vaccine (left arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: first left my arm sore for most of a week... The second did the same) and rash (Verbatim: also got a slight rash). Rechallenge with Shingles vaccine was positive. The outcome of the pain in arm and rash were not reported.   It was unknown if the reporter considered the pain in arm and rash to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and rash to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR092401   Additional Information: Additional Information: GSK Receipt Date: 01-Jul-2023 This case was reported by a patient via interactive digital media. The patient got two shots for shingles. The first left his/her arm sore for most of a week. The second did the same but the patient also got a slight rash. The patient had to not scratch it because it reacted badly.  The patient stated that get the shot, just the preview was enough to convince him/her.; Sender's Comments:  US-GSK-US2023AMR092401:Case for first  dose US-GSK-US2023AMR092401:Case for second dose