chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Aplastic anaemia, Biopsy bone marrow abnormal, Bone marrow transplant, Fatigue, Gingival bleeding
Clinical narrative: Within a couple months of having the first HPV vaccine, pt. began having symptoms of what was eventually diagnosed as Idiopathic Severe Aplastic Anemia in December 2020.  Initial symptoms included extreme fatigue, petechiae, bleeding of gums, and extremely pale skin.  The cause for the disease could not be found by her medical team and genetic factors were ruled out.  There was no active virus in her body at the time of diagnoses.  Pt have a BMT in February of 2021.  Additionally, due to treatment of this disease, pt. suffered from ovarian failure in July 2021.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test abnormal, Ovarian failure, Pallor, Petechiae
Clinical narrative: Within a couple months of having the first HPV vaccine, pt. began having symptoms of what was eventually diagnosed as Idiopathic Severe Aplastic Anemia in December 2020.  Initial symptoms included extreme fatigue, petechiae, bleeding of gums, and extremely pale skin.  The cause for the disease could not be found by her medical team and genetic factors were ruled out.  There was no active virus in her body at the time of diagnoses.  Pt have a BMT in February of 2021.  Additionally, due to treatment of this disease, pt. suffered from ovarian failure in July 2021.
Age: 1.08
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: This is to report vaccine administration error. The 2 nd dose of Hepatitis A was administered earlier than a 6 month recommended interval. The first dose was given on 5/1/2023 and the second dose was administered on 6/14/2023.
Age: 12.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Allergy to vaccine
Clinical narrative: Patient received varicella (varivax) and varicella from MMRV (proQaud) during office visit.  Follow-up performed and patient had no adverse side effects.  Allergy to varicella confirmed with patient's mother but patient's mother wished to proceed (Pt's mother stated her kid has unconfirmed reaction).
Age: 45.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: SADDLE PULMONARY EMBOLISM ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN ACUTE PULMONARY EMBOLISM
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Burning sensation, Chills, Dysuria, Fatigue, Lethargy
Clinical narrative: Extreme fever and chills, huge swollen lymph node in neck, trouble and burning urination after injection. Lethargy and tiredness.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Extreme fever and chills, huge swollen lymph node in neck, trouble and burning urination after injection. Lethargy and tiredness.
Age: 18.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event
Clinical narrative: Patient received varicella (varivax) and varicella from MMRV (proQaud) during office visit.  Follow-up performed and patient had no adverse side effects.
Age: 63.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE
Sex: M
Vaccine: HEP
Symptoms: Acidosis, Blood glucose normal, Blood lactic acid increased, Condition aggravated, Erythromelalgia
Clinical narrative: Turned on the epigenetic acox1 gain of function, unresponsive, hypoglycemia, acidosis
Sex: M
Vaccine: HEP
Symptoms: Hypoglycaemia, Unresponsive to stimuli
Clinical narrative: Turned on the epigenetic acox1 gain of function, unresponsive, hypoglycemia, acidosis
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dehydration, Diarrhoea, Electrolyte imbalance, Intensive care, Pyrexia
Clinical narrative: Patient was given 2 month vaccines on 6/16.  On 6/17, he presented to a local ER with fever, severe diarrhea and dehydration. He had significant electrolyte abnormalities.  He was admitted to the ICU and was admitted for 10 days.  Stools were rotravirus + during admission
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rotavirus test positive
Clinical narrative: Patient was given 2 month vaccines on 6/16.  On 6/17, he presented to a local ER with fever, severe diarrhea and dehydration. He had significant electrolyte abnormalities.  He was admitted to the ICU and was admitted for 10 days.  Stools were rotravirus + during admission
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: Leg swelling for one day. No fever, Area redness and swelling 10cm round warm area and pain with palpitation. Mom advised to call over weekend to on-call if symptoms worsen. Site marked. Mom to start steroid. If redness worsens then start antibiotic.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Intensive care, Pain, Thrombosis
Clinical narrative: Blood Clot, chronic pain ICU for 3 days hospitalization for 6 days
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated
Clinical narrative: Asthma reaction not reactive to albuterol. Continued to progress, secondary asthma attack at midnight following vaccine. Constant asthma since and exacerbations following each additional dose.
Age: 14.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: The COVID vaccine that was administer to the patient was accidently stored in the freezer instead of refrigerator.   No adverse symptoms.
Age: 8.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered
Clinical narrative: Patient received Pfizer bivalent 12+ dose when Pfizer bivalent 5-11yo dose was indicated.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Ischaemic stroke
Clinical narrative: ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY
Age: 19.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: The COVID vaccine that was administer to the patient was accidently stored in the freezer instead of refrigerator.   No adverse symptoms.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA PERIPHERAL NEUROPATHY
Age: 19.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Blood glucose normal, Cardio-respiratory arrest, Fall, Gait disturbance, Hypoaesthesia
Clinical narrative: Patient received vaccines during clinic visit. Patient received HPV, Hepatitis A, and meningococcal vaccines at around 0935. Waited in room after vaccines for 10 minutes. Patient stated feeling okay so proceeded to lobby to obtain vaccine records.  Patient turned in encounter to clerks. While patient was walking back to seat, mother of patient who was also in lobby, noticed patient was walking sideways. When patient got to mother, mother was able to catch patient and keep her from falling. Patient was lowered to floor by mother and legs were raised.  Clerks called nurse station first before calling code to let nurses know that patient was on floor in lobby. Clerks informed to call code immediately and nurses reported to scene. Code called at 0946. Patient found by nursing staff lying on floor with legs raised by mother. Patient verbal and AAOx4 when found. Present at the scene were RNs, and LPN. Blood pressure taken at 0947 by RN, 100/80. At 0948, pulse 70 and SpO2 98%, taken by RN. At 0949 Apple juice given to patient and blood obtained for blood glucose check by LPN. At 0950, patient moved to sitting position, then to standing, then sat in chair. At 0950, pulse 76 and SpO2 99%, taken by RN. At 0952, patient asked to lie back on floor. Blood glucose reading came back at 88. At 0955, patient sitting upright on floor. At 0957, blood pressure 100/80, SpO2 95%, pulse 65, taken by RN. Patient states had not eaten since 1400 yesterday. Patient encouraged for any future vaccine visits to let staff know of syncope after receiving vaccines and also to eat and drink before vaccine visits. At 0959, patient asked to stand up. At 1000, patient still talking, still doing well, standing up. At 1001, patient sat in chair and asked for crackers. At 1003, patient asked for water.  At 1004, patient able to walk to Room and lie on table. At 1005, patient stated hands feel numb. At 1006, SpO2 99% and pulse 65, taken by RN. At 1007, blood pressure 100/75, taken by RN. Patient states right hand feels better, left hand still slightly numb at fingertips. Nurses had pt. straighten arm out. At 1012, patient stated fingers no longer numb. At 1013, patient assisted to sitting. At 1018, patient assisted to standing. At 1019, blood pressure 100/80, SpO2 99%, and pulse 83, taken by RN. At 1020, patient able to walk down hallway to lobby and out to car. Patient left clinic at this time with mother driving.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after two vaccines ; Moderna 1/15/21 lot# 027L20A; Moderna 2/15/21 lot# 032H20A
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Contusion, Erythema, Peripheral swelling, Pruritus
Clinical narrative: mother reporting pts are was "really red" swelling, itching and bruising the day after vaccines were given (06/30), was seen at an Urgent care over the weekend. we called 07/05 for fup and symptoms were improving, only w/little redness and itching, still w/some bruising to side of arm
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Moderna 1/18/21 lot# 012L20A;  Moderna 2/15/21 lot# 010M20A;  Moderna 11/2/21 No LOT#
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Neuropathy peripheral, Respiratory failure
Clinical narrative: NEUROPATHY ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines  Pfizer 4/28/21 lot# Ew0176;  Pfizer 5/28/21 lot# Ew0186;  Pfizer 1/19/22 lot# FJ6369
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension, Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: OBSTRUCTIVE SLEEP APNEA HYPOTENSION 3/2/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after one dose Janssen
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Burning sensation, Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient came into clinic for triage for possible allergic reaction following a vaccine that was given on 06/29/23. Patient stated having flu like symptoms right after vaccine given followed by body aches later that night. vaccine given on right deltoid/ upper arm  site is warm to touch, swollen and red. Patient also complains of burning  sensations, itching and hard to lift arm. Vitals were taken and escalated to provider.
Age: 61.0
Sex: M
Vaccine: TDAP
Symptoms: Mobility decreased, Pain, Pruritus
Clinical narrative: Patient came into clinic for triage for possible allergic reaction following a vaccine that was given on 06/29/23. Patient stated having flu like symptoms right after vaccine given followed by body aches later that night. vaccine given on right deltoid/ upper arm  site is warm to touch, swollen and red. Patient also complains of burning  sensations, itching and hard to lift arm. Vitals were taken and escalated to provider.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Pfizer 2/16/21 lot# El9267;  Pfizer 3/8/21 lot# En6206;  Moderna 11/19/21 lot# 069F21A;  Moderna 7/25/22 lot# FP7139
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 1/27/21 lot# El9261;  Pfizer 2/16/21 lot# EN6201;  Pfizer 10/18/21 lot# FH8020
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 4/3/21 lot# ER8734;  Pfizer 4/24/21 lot# EW0172 ; Moderna 12/6/21 lot# 060
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/10/21 lot# EN6205;  Pfizer 4/1/21 lot# Ew0150;  Moderna 12/18/21 lot# 060H21A
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: gave expired vaccine; no adverse reaction reported; moderna was contacted and said vaccine was ok
Age: 90.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/2/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 4/14/21 lot# EP6955;  Pfizer 5/5/21 lot# Ew0168;  Pfizer 11/19/21 lot# Ew0186
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 7/1/22 lot# FP7135;  Pfizer 7/28/22 lot# FP7139
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Breathing-related sleep disorder, Obstructive sleep apnoea syndrome
Clinical narrative: BREATHING RELATED SLEEP DISORDER OBSTRUCTIVE SLEEP APNEA
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine given no adverse reaction reported contacted moderna and they said the vaccine was still good
Age: 12.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Covid vaccine that was administer was accidently stored in the freezer instead of the fridge.  No adverse reactions.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Injection site discolouration, Injection site erythema, Pain, Pruritus
Clinical narrative: Patient began having discoloration  on right upper arm that was purple/red in color, itchiness, pain , dizziness. Benadryl given to patient in office, patient transported to hospital to be evaluated.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: On about 4/24/2022, I developed a cough and runny nose. I took a home antigen test on 4/25/2022 and got a positive result. On 4/26/2023, I went to a clinic at a pharmacy and underwent a rapid test, which confirmed the positive result of the home test. I was prescribed Paxlovid, which I began taking 4/26/2022. The medication left a nasty, metallic aftertaste in my mouth, but aside from that, I had no other side effects. Within 24 hours of beginning the Paxlovid, I began to feel better. I finished the five-day course of Paxlovid, and I tested negative on 5/6/2022. I followed the CDC protocols for self-isolation during this time. On 6/13/2022, I had a cough and runny nose, At 3:46 PM on that day, I took a home antigen test and got a positive result. I called my NP and had a telehealth visit with him. Because of the timing of the illness, I asked him if it could be a rebound case. He didn't think it was a rebound, but he also decided not to prescribe me Paxlovid, because at that time, there was no guidance regarding prescribing it so soon after having already prescribed it. At this time, there was a new omicron subvariant of COVID-19, and my NP thought that this may have been the reason why I caught COVID-19 again so quickly after having gotten it the first time. However, he didn't run any tests to determine the strain that I had. Again, I followed the CDC protocols for self-isolation, and I felt better a few days after the onset of symptoms. On 6/23/2022, I took a home antigen test and got a negative result.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired vaccine given no adverse event reported contact moderna and they said vaccines maintained activity
Age: 13.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error
Clinical narrative: Covid vaccine that was administer was accidently stored in the freezer instead of the fridge.  No adverse reactions.
Age: 43.0
Sex: M
Vaccine: COVID19-2
Symptoms: Cerebral artery occlusion, Cerebrovascular accident, Lacunar stroke
Clinical narrative: ACUTE STROKE DUE TO OCCLUSION OF LEFT CEREBELLAR ARTERY ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Joint range of motion decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: It has been 6 weeks and my arm is still painful. He did not place the shot in the deltoid muscle but rather in the front part of my left upper arm. The pain severely limits my range of motion and what I can do with my left arm. My Doctor is aware.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Unevaluable event
Clinical narrative: It has been 6 weeks and my arm is still painful. He did not place the shot in the deltoid muscle but rather in the front part of my left upper arm. The pain severely limits my range of motion and what I can do with my left arm. My Doctor is aware.
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthritis, Gait disturbance, Scan
Clinical narrative: arthritus had advanced 10 fold and I can hardly walk[ambulate]. Before my scan showed it would be reversible arthritus.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, X-ray
Clinical narrative: injection site pain
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient had no adverse reaction - vaccine exp. 6-30-23 and was given in office 7-3-23.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Pulmonary embolism
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Neck pain, Pain in extremity
Clinical narrative: Pain in arm immediately. No sign of redness or swelling. No heat to touch. Pain lasted two days with some neck pain associated.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Muscle tightness, Nervousness
Clinical narrative: Pt appeared nervous during vaccination, but appeared to tolerate well for about a minute or two.  Pt advised to remain seated. Pt lost consciousness, tensed her muscles and began to shake. This lasted about 10 seconds. Her mother and myself touched and aroused pt. Advised pt to remain seated another 15 minutes. Pt reported feeling dizzy and sweaty. Pt remained alert and oriented and was able to walk out of office after resting 15 minutes.  Pt sat in waiting room during check out. She reported feeling okay and was able to walk out with her mom.
Age: 14.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Tremor
Clinical narrative: Pt appeared nervous during vaccination, but appeared to tolerate well for about a minute or two.  Pt advised to remain seated. Pt lost consciousness, tensed her muscles and began to shake. This lasted about 10 seconds. Her mother and myself touched and aroused pt. Advised pt to remain seated another 15 minutes. Pt reported feeling dizzy and sweaty. Pt remained alert and oriented and was able to walk out of office after resting 15 minutes.  Pt sat in waiting room during check out. She reported feeling okay and was able to walk out with her mom.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient had no adverse reaction - vaccine exp. 6-30-23 and was given in office 7-3-23.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines  Pfizer 1/26/21 lot# EL3249;  Pfizer 2/16/21 lot# EN6200;  Pfizer 9/24/21 lot# FF2588;  Pfizer 4/6/22 lot# FK9894
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines  Moderna 1/5/21 lot# 039K20A ; Moderna 2/2/21 lot# 028L20A
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 3/6/21 lot# EN6199;  Pfizer 3/27/21 lot# ER8732
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines moderna 2/18/21 lot# 006M20A;  Moderna 3/18/21 lot# 045A21A;  Moderna 11/26/21 lot# 045J21A;  Moderna 4/16/22 lot# 002M21A
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypotension
Clinical narrative: HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines ; Pfizer 1/21/21 Lot# EL3249;  Pfizer 2/1/21 lot# EL9267
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia, Respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXIA
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 4/6/21 lot# EW0153;  Pfizer 5/4/21 lot# Ew0171;  Moderna 1/14/22 lot# 068H21A;
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 3/12/21 lot# EN6207;  Pfizer 4/7/21 lot# ER2613
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Infection, Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: 6/23/23 - severe Charlie horse in left inner thigh muscle (may be unrelated!) 6/24/23 - increased redness at injection site, warm to touch, mildly itchy - cellulitis confirmed 6/26/23, treated with 7 day course of Keflex.  Infection now resolved.
Age: 50.0
Sex: F
Vaccine: PNC20
Symptoms: Muscle spasms
Clinical narrative: 6/23/23 - severe Charlie horse in left inner thigh muscle (may be unrelated!) 6/24/23 - increased redness at injection site, warm to touch, mildly itchy - cellulitis confirmed 6/26/23, treated with 7 day course of Keflex.  Infection now resolved.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 4/10/21 lot# Ew0150;  Pfizer 5/1/21 lot# EW0179
Age: 46.0
Sex: M
Vaccine: COVID19-2
Symptoms: Epilepsy
Clinical narrative: PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE EPILEPSY, UNSPECIFIED
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient had swelling, redness, and itchiness on Left arm.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 1/2/21 lot# 011L20A;  Moderna 1/29/21 lot# 004M20A;  Moderna 11/11/21 lot# 077C21B
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: she called in saying she got pain and redness at injection site . pain is going away but redness was spreading around was the concern . she has not reported other symptoms.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 1.0
Sex: M
Vaccine: COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: Patient was given a non authorized covid-19 bivalent vaccine for age group 6mo-4yrs, non authorized interchangeable for age group, patient started series with Moderna Mono vaccine and was given a Pfizer 6mo-4yrs bivalent, recommends same manufacture for age group.
Age: 40.0
Sex: M
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, MILD
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Interchange of vaccine products
Clinical narrative: patient was given a non authorized covid-19 bivalent vaccine for age group 6mo-4yrs, non authorized interchangeable for age group, patient started series with Moderna Mono vaccine and was given a Pfizer 6mo-4yrs bivalent, recommends same manufacture for age group.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/5/21 lot# EN6206;  Pfizer 3/26/21 lot# ER8732;  Moderna 12/26/21 lot# 068H21A
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Antibody test positive, Blood test, Brain fog
Clinical narrative: Since 05/21/23:Lots of fatigue with exertion, Chronic cough, lack of taste or smell, poor sleep, night sweats, nausea, no appetite, intermittent headache, serious brain fog, copious mucus production, trouble breathing,, low grade fever, chills, and more I can't think of right now. 8 or 9 home tests and 2 PRCs over time I have never tested positive for Covid. Blood test shows antibodies for spike protein from vaccine only.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Decreased appetite, Dyspnoea, Fatigue
Clinical narrative: Since 05/21/23:Lots of fatigue with exertion, Chronic cough, lack of taste or smell, poor sleep, night sweats, nausea, no appetite, intermittent headache, serious brain fog, copious mucus production, trouble breathing,, low grade fever, chills, and more I can't think of right now. 8 or 9 home tests and 2 PRCs over time I have never tested positive for Covid. Blood test shows antibodies for spike protein from vaccine only.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Nausea, Night sweats, Poor quality sleep, Pyrexia
Clinical narrative: Since 05/21/23:Lots of fatigue with exertion, Chronic cough, lack of taste or smell, poor sleep, night sweats, nausea, no appetite, intermittent headache, serious brain fog, copious mucus production, trouble breathing,, low grade fever, chills, and more I can't think of right now. 8 or 9 home tests and 2 PRCs over time I have never tested positive for Covid. Blood test shows antibodies for spike protein from vaccine only.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Secretion discharge
Clinical narrative: Since 05/21/23:Lots of fatigue with exertion, Chronic cough, lack of taste or smell, poor sleep, night sweats, nausea, no appetite, intermittent headache, serious brain fog, copious mucus production, trouble breathing,, low grade fever, chills, and more I can't think of right now. 8 or 9 home tests and 2 PRCs over time I have never tested positive for Covid. Blood test shows antibodies for spike protein from vaccine only.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Hypoaesthesia
Clinical narrative: Was feeling numbness on left arm 20-30 mins after getting her HPV #2 vaccine. Also felt dizzy.
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: No adverse reaction. Wrong concentration of Moderna Bivalent vaccine given. The patient was to receive the Moderna Bivalent Booster (blue cap) that had 0.25mcg/0.25ml but received 0.2 from the pink cap Pediatric vial that had 10mcg/0.2ml. Lower dose then needed given.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Erythema, warmth, swelling, pain, at the injection site.  Fever 101-102F for 2 days Parents giving Tylenol and Benadryl
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: Mother stated patient got 2nd HPV vaccine, then after vaccine she had 2 nodules/mass next to each other on injection site and it hurts to the touch.  Was seen by provider on 07/03/2023 and stated it was getting better nodule/mass was getting smaller, and no longer in pain. Called mother on 07/05/2023 to check in on pt. and mother stated nodule/mass still there, but is doing a lot better.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Inflammation, Pharyngeal swelling, Swelling face, Urticaria
Clinical narrative: Anaphylaxis with first injection with full body hives, full body inflammation,  and throat and facial swelling, then chronic urticaria there after that progressively worsened with 2nd dose.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria chronic
Clinical narrative: Anaphylaxis with first injection with full body hives, full body inflammation,  and throat and facial swelling, then chronic urticaria there after that progressively worsened with 2nd dose.
Age: 37.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Chills, Nausea
Clinical narrative: Joint aches, chills, nausea
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (had shingles twice when he was a teenager) and ulcerative colitis.   On 21-JUN-2023, the patient received the 1st dose of Shingrix. In JUN-2023, an unknown time after receiving Shingrix, the patient experienced diarrhea (Verbatim: diarrhea). The outcome of the diarrhea was not resolved.   It was unknown if the reporter considered the diarrhea to be related to Shingrix.     It was unknown if the company considered the diarrhea to be related to Shingrix.   Additional Information: GSK receipt date: 26-JUN-2023 The patient he had diarrhea for the past 4 days and was unresolved.  Sending PI. Referred to HCP. The reporter did not consent to follow-up.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only diluent administered.; Only diluent administered.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20-JUN-2023, the patient received Menveo. On 20-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only diluent administered.) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 26-JUN-2023 The reporter consented to follow up. A patient was inadvertently administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter asked if the patient had to restart the series. The reported did not provide patient information nor vaccine data (lot number, expiry date). Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 69.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix was exposed to 15.6 F and administered to a patient/inadvertently administered the havrix vaccine following a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 69-year-old male patient who received HAV (Havrix 1440) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 26-JUN-2023, the patient received Havrix 1440 (left deltoid). On an unknown date, an unknown time after receiving Havrix 1440, the patient experienced incorrect storage of drug (Verbatim: Havrix was exposed to 15.6 F and administered to a patient/inadvertently administered the havrix vaccine following a temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Jun-2023 The reporter believed that health care professional (HCP) stated that the vaccine expired on August30, 2025 but batch number identifier pulled up as August 31, 2025 so that was what was coded. The vaccine coordinator stated that Havrix was 15.6 degree Fahrenheit and administered to the patient which led to incorrect storage of drug. The reporter consented to follow up via email. The case is linked with US2023088674, by same reporter.; Sender's Comments:  US-GSK-US2023088674:Same reporter
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HAV (Havrix) (batch number NZ7GR, expiry date 17-JUN-2023) for prophylaxis.   On 26-JUN-2023, the patient received Havrix. On 26-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 26-JUN-2023 The reporter consented to follow up via email. The vaccine administration facility was the same as primary reporter. The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Duodenogastric reflux, Extra dose administered, Vomiting
Clinical narrative: threw up bile this morning; Four Shingrix doses were administered; Four Shingrix doses were administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of bile reflux (esophageal) in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number X9KC7, expiry date 25-OCT-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on 25 September 2018) and shingrix (received 2nd dose on 11th December 2018). Concurrent medical conditions included neoplasm malignant, cigarette smoker, chronic obstructive pulmonary disease and polyp.   On 26-JUN-2023, the patient received the 4th dose of Shingrix. On 28-MAR-2023, the patient received the 3rd dose of Shingrix. On 28-MAR-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Four Shingrix doses were administered). On 26-JUN-2023, the patient experienced extra dose administered (Verbatim: Four Shingrix doses were administered). On 27-JUN-2023, the patient experienced bile reflux (esophageal) (Verbatim: threw up bile this morning). The outcome of the bile reflux (esophageal) was resolving and the outcome of the extra dose administered and extra dose administered were unknown.   It was unknown if the reporter considered the bile reflux (esophageal) to be related to Shingrix.     It was unknown if the company considered the bile reflux (esophageal) to be related to Shingrix.   Additional Information: GSK receipt date 29 Jun 2023. The pharmacist reported that a patient received two doses of Shingrix this year on 2023, but there were a prior vaccination history of 2 Shingrix doses administered on 2018.  On 27th Jul 2023, patient reported the he threw up bile this morning and after this episode he felt better. The reporter consented to follow up via email. HCP declined providing patient´s date of birth and initials. The patient received 4 doses of shingrix vaccine which led to extra dose administered.
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received by error Havrix pediatric formulation instead of Engerix-B; 6 month male baby, received by error Havrix pediatric formulation instead of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old male patient who received HAV (Havrix pediatric) (batch number 9R5LC, expiry date 24-NOV-2024) for prophylaxis.   Previously administered products included Hepatitis B vaccine (1st dose received on an unknown date) and Hepatitis B vaccine (2nd dose received on an unknown date).   On 23-JUN-2023, the patient received Havrix pediatric. On 23-JUN-2023, an unknown time after receiving Havrix pediatric, the patient experienced wrong vaccine administered (Verbatim: Received by error Havrix pediatric formulation instead of Engerix-B) and inappropriate age at vaccine administration (Verbatim: 6 month male baby, received by error Havrix pediatric formulation instead of Engerix-B). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 27-JUN-2023 The patient had no previous hepatitis A vaccination. The reporter consented to follow up. 6-month patient received by error Havrix pediatric formulation instead of Engerix-B, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: instead of receiving a 0.5 mL dose, a 1 mL dose was administered; instead of receiving a 0.5 mL dose, a 1 mL dose was administered to 19-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 23-JUN-2023, the patient received the 1st dose of Engerix B 1 ml. On 23-JUN-2023, an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: instead of receiving a 0.5 mL dose, a 1 mL dose was administered) and inappropriate age at vaccine administration (Verbatim: instead of receiving a 0.5 mL dose, a 1 mL dose was administered to 19-year-old patient). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUN-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received 1 ml dose of Engerix B before recommended age, which led to overdose and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique/ inadvertently administered the Shingrix diluent (AS01b) component without the lyophilized component; Inappropriate Reconstitution Technique/ inadvertently administered the Shingrix diluent (AS01b) component without the lyophilized component; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number XL7RB, expiry date 05-AUG-2024) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/ inadvertently administered the Shingrix diluent (AS01b) component without the lyophilized component) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/ inadvertently administered the Shingrix diluent (AS01b) component without the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-JUN-2023 Clinical Supervisor/medical assistant called to inquire how to proceed. Supervisor reported a patient was inadvertently administered the Shingrix diluent (AS01b) component without the lyophilized component on an unknown date. Supervisor confirmed this was an attempt at the first dose of Shingrix.  Also mentioned they were they are still investigating so unable to provide any patient details.  Did not consent to follow-up.  HCP declined follow-up from safety.
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administration of an expired Kinrix dose to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 29-MAY-2023) for prophylaxis.   On 28-JUN-2023, the patient received Kinrix. On 28-JUN-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administration of an expired Kinrix dose to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUN-2023 The reporter was a medical assistant. The reporter asked if the patient had to be revaccinated. The reporter consented to follow up. The patient received an expired dose of Kinrix, which led to expire vaccine used.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Additional dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number M9F2T, expiry date 06-AUG-2024) for prophylaxis.   On 26-JUN-2023, the patient received the 3rd dose of Shingrix. On 26-JUN-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Additional dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 29-JUN-2023 Nurse reported that the patient inadvertently received a third dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; received the first and second doses of Twinrix six months apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received HAB (Twinrix) (batch number 4KF75) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 11th August 2022).   On 17-JAN-2023, the patient received the 2nd dose of Twinrix. On an unknown date, the patient did not receive the 3rd dose of Twinrix. On 17-JAN-2023, an unknown time after receiving Twinrix and not applicable after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received the first and second doses of Twinrix six months apart). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-JUN-2023 The reporter reported that a patient received the first and second doses of Twinrix six months apart and wished to know what information was available.  They provided limited information about patient, vaccines and event. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccinations schedule. Till the time of reporting, the patient did not receive the 3rd dose of Twinrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix in 2020 and is late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (The patient received first dose Shingrix in year 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose of Shingrix in 2020 and is late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-JUN-2023. A pharmacist reported that a patient received the 1st dose of Shingrix in 2020 and was late for the 2nd dose. The reporter consented to follow up. The healthcare professional did not have any patient details and exact date of 1st dose was unknown. The healthcare professional consented to follow-up via postal mail. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination