chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Confusional state, Dyspnoea, Pyrexia
Clinical narrative: Presented to ED w/SOB, fever, & confusion; admitted for COVID-19 pna; tx w/abx, remdesivir, Vit-C, zinc,Vit-D3, steroids, O2; pt weaned to 1L O2/NC and discharged on home O2.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Dyspnoea, Fall, SARS-CoV-2 test positive
Clinical narrative: Presents w/c/o frequent falls, gen weakness, SOB X 3-4 days, COVID was suspected for which she did test positive and was tx w/steroids, zinc, Vit-C, Singulair. Remained extremely weak and dc'd to SNF.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 4/6/21 lot# ER8730;  Pfizer 4/27/21 lot# ER8730;
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Arm soreness - began approximately 2 1/2 to 3 hours after the vaccination  Nausea, headache, and chills began approximately 15 hours after the vaccination
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 2/11/21 lot# 015M20A;  Moderna 3/11/21 lot# 044A21A;  Moderna 11/3/21 lot# 033F21A
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 5/29/21 lot# Ew0191;  Pfizer 6/19/21 lot# Ew0181
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 4/9/21 lot# 025B21A;  Moderna 5/5/21 Lot# 048B21A
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 4 vaccines Modern 3/28/21 lot# 018B21A;  Moderna 4/25/21 lot# 025B21A;  Moderna 11/20/21 lot# 013F21A;  Moderna 7/8/22 lot# 004M21A
Age: 83.0
Sex: F
Vaccine: COVID19-2
Symptoms: Coagulopathy, Symptom recurrence
Clinical narrative: coagulopathy, unspecified type 2 mi 1/17/2023 & 3/2/2023  --  recurrence of hospitalization with same symptoms
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 3/11/21 lot# EN6207;  Pfizer 4/1/21 lot# ER8732
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Mobility decreased, Pyrexia, Speech disorder, Tremor
Clinical narrative: Patient experienced a severe fever and violent body tremors throughout the entire body, resulting in speech, movement, and breathing difficulties.
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 Moderna 2/4/21 lot# 038K20A;  Moderna 3/4/21 lot# 030A21A;  Moderna 11/19/21 lot# 065F21A
Age: 91.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebrovascular accident
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 92.0
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# El3248;  Pfizer 3/27/21 lot# EL9265
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose fluctuation, Blood test, Cough, Diabetes mellitus inadequate control, Dizziness
Clinical narrative: retinal aneurysm, loss of job, coughing spells, dizzy spells, blood sugar was very high/low(uncontrollable directly after shot), several emergency room visits,ENT specialist
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Retinal aneurysm
Clinical narrative: retinal aneurysm, loss of job, coughing spells, dizzy spells, blood sugar was very high/low(uncontrollable directly after shot), several emergency room visits,ENT specialist
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Modern 1/23/21 lot4 029l20a;  mODERN 2/27/21 LOT# 002a21a;  mODERNA 11/28/21 LOT# 030h21b
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: LEFT SHOULDER SWELLING AND PAIN AROUND INJECTION SITE FOR 1 WEEK.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Moderna 3/30/21 lot# 023M20A;  Moderna 4/2721 lot# 030A21A
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 9/17/21 lot# FC10312021;  Pfizer 10/8/21 lot# FF2587
Age: 1.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Wrong product administered
Clinical narrative: Gave a Proquad instead of Varicella
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 2 vaccines Pfizer 5/8/21 lot# Ew0164;  pfizer 5/29/21 lot# Ew0172
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Gastrointestinal haemorrhage, Multiple sclerosis
Clinical narrative: I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/23/2023 GI HEMORRHAGE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 4/23/2023 MULTIPLE SCLEROSIS
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Pfizer 3/19/21 lot# Er2613;  Pfizer 4/9/21 lot# Ew0162;  Pfizer 1/7/22 lot# FL3209
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w/ c/o weakness; c/o fever and sore throat; COVID+; pt admitted for COVID infection & sepsis; tx w/abx, steroids, remdesivir; dc home
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Presented to ED w/ c/o weakness; c/o fever and sore throat; COVID+; pt admitted for COVID infection & sepsis; tx w/abx, steroids, remdesivir; dc home
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Malaise, Sepsis
Clinical narrative: Presented to ED w/ c/o COVID symptoms; admitted w/COVID-19 pna, acute resp failure & sepsis; tx w/abx, Mag, Vit C, zinc; dc home
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case after one dose Janssen
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w/ worsening SOB & cough; tested positive  9 days prior to arrival; tx w/abx, steroids, mag, zinc; dc'd home w/ O2
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Confusional state, Fatigue, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w/gen weakness, fatigue & confusion; COVID+; admitted for COVID-19 infection; tx w/abx, steroids, mag, zinc, O2 therapy;
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension
Clinical narrative: HYPOTENSION
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cough, Dyspnoea, Respiratory tract congestion
Clinical narrative: Presented to ED w/SOB, cough, congestion; admitted for COVID-19 pna, acute resp failure; tx w/ O2 therapy, abx, remdesivir, steroids, mag, zinc; dc'd home on baseline O2 therapy
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Dyspnoea
Clinical narrative: Presented to ED w/SOB; admitted for COVID-19 infection and acute resp failure; tx w/O2 therapy, abx, remdesivir, steroids, zinc; weaned to RA; dc'd home
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines Moderna 3/12/21 lot# 044A21A;  Moderna 4/19/21 lot# 025B21A;  Moderna 12/7/21 lot# 069H21A
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Hyperhidrosis, Unresponsive to stimuli
Clinical narrative: Presented to ED w/gen weakness, diaphoresis and decreased responsiveness; reported recent diagnosis of COVID prior to arrival; pt admitted for COVID0-19 infection; tx w/ abx, Vit C, steroids; did not require O2 therapy; dc'd to home
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest pain, Diarrhoea, Pyrexia
Clinical narrative: Presented to ED w/CP, diarrhea, fever; tested positive for COVID-19; admitted for COVID-19 pna & UTI; tx w/ abx, steroids, remdesivir, mag, zinc, O2 therapy; dc'd to home with HHC and O2.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: Presented to ED w/CP, diarrhea, fever; tested positive for COVID-19; admitted for COVID-19 pna & UTI; tx w/ abx, steroids, remdesivir, mag, zinc, O2 therapy; dc'd to home with HHC and O2.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Presented to ED w/ c/o cough; admitted for pneumonia; PCR test returned positive for COVID-19; tx w/abx, melatonin, mag; did not require O2 therapy; Sent home on 7d course of LQN with HHC
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Dyspnoea, Lethargy
Clinical narrative: Presented to ED w/gen weakness, lethargy, SOB x 2 days; admitted for COVID-19 pna; tx w/abx, remdesivir, zinc, mag; did not need O2 therapy; dc'd home
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Reversible ischaemic neurological deficit
Clinical narrative: REVERSIBLE ISCHEMIC NEUROLOGIC DEFICIT SYNDROME
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: STABLE ANGINA
Age: 46.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MMRV given to patient who is over age 12 years of age.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave zoster vaccine on 7/5/23 after expiration date of 7/1/2023. PT did not have symptoms at time of vaccine given.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 1.25
Sex: F
Vaccine: COVID19-2, DTAP, HIBV, PNC13
Symptoms: Product administration error, Product preparation error
Clinical narrative: Nurse did not use the correct amount of diluent when mixing the covid vaccine. Nurse mixed the vaccine with 1.3mL of diluent instead of 2.2mL. Nurse identified error after patient left clinic. Provider aware. Charge nurse reached out to family via phone. No response from family.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Transient ischaemic attack
Clinical narrative: TRANSIENT CEREBRAL ISCHEMIA
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Obstructive sleep apnoea syndrome, Respiratory failure, Symptom recurrence
Clinical narrative: ADULT OBSTRUCTIVE SLEEP APNEA, SEVERE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Angina pectoris
Clinical narrative: STABLE ANGINA
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypotension, Symptom recurrence
Clinical narrative: HYPOTENSION 2/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Crying, Erythema
Clinical narrative: 11:10am  pt received 1yr vaccines ( Havrix, MMR, Varivax)  pt left the exam room with Gma to get labs , noted that bil thighs , arms and face were bright red and pt was crying, ask to come back in exam room for assessment by Dr. STAT order for 1tsp Benadryl give P.O. @ 11:20am Gm reports pt does get red and blotchy when he gets upset, pt able to drink milk from a bottle and calm down, Gm was ask to stay in exam room for further monitoring before leaving ,   11:35am pt reassessed  pt calm and redness much improved and faded
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Coagulopathy
Clinical narrative: COAGULOPATHY, UNSPECIFIED TYPE ACUTE RESPIRATORY FAILURE
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE RESPIRATORY FAILURE 3/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction
Clinical narrative: ACUTE NON ST ELEVATION MI
Age: 80.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: PERIPHERAL NEUROPATHY
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: Severe abdomen pain with continuing fevers.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given two doses of the approved 4 year vaccine schedule 10 months apart.- MFR contacted no adverse reactions occurred and no further action required
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: no adverse reaction reported.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 30.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Exposure during pregnancy, Medication error, Nausea
Clinical narrative: The patient was feeling nauseous after being vaccinated.  It  was then determined that the patient is in early weeks of pregnancy and was given MMR and Varivax in error (unknown how far along pt is)--contacted MD, waiting for MD to call us back.  Advised patient to follow up with MD.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Breathing-related sleep disorder, Hypoventilation, Hypoxia
Clinical narrative: SLEEP RELATED HYPOVENTILATION OR HYPOXEMIA
Age: 11.0
Sex: M
Vaccine: COVID19, HPV9, MNQ
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse reaction reported.
Age: 49.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Patient was administered vaccine that expired on 5/21/23.
Age: 0.5
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV1, DTPPVHBHPB, PNC13, RV1
Symptoms: Pyrexia, Rash
Clinical narrative: Father reported that pt developed fever of 103 -104 deg F 3 hours after injection. Father denied giving pt medication at home. Four days later, father reported that they called pt's PCP regarding fever, and provider advised to take pt to ER. Pt was taken to ER on 7/1/23, and pt was given prescription for Motrin and father was told fever should resolve in 2-3 days. Pt arrived to clinic on 7/5/23, pt with no fever (temp 98.8 tympanic) and in no apparent distress, but presented with generalized rash all over face and body. Father denied taking pt back to ER for rash when it developed. Father reports that rash started after ER visit, but does not know what day exactly. Advised father to take pt back to ER to get evaluated for rash, get blood tests, and treated for rash.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given two doses of the approved 4 year vaccine schedule 10 months apart.- MFR contacted no adverse reactions occurred and no further action required
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Acute respiratory failure, Respiratory failure, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPERCAPNIC RESPIRATORY FAILURE 2/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebral artery occlusion, Cerebrovascular accident
Clinical narrative: ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY
Age: 83.0
Sex: M
Vaccine: UNK
Symptoms: Injection site swelling
Clinical narrative: Swelling  of upper arm just below injection , down to elbow
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, INIT
Age: 11.0
Sex: M
Vaccine: DTAP, HPV9, MNQ
Symptoms: Wrong product administered
Clinical narrative: On 06/30/2023 patient was given Dtap instead of Tdap by mistake. Staff was made aware of mistake by the immunization coordinator after they reviewed the immunizations. Patient's PCP and parent were notified and it has been documented.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Total body rash appeared on the third day post-vaccination.  treatment with Benadryl and cold compresses
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE ON CHRONIC RESPIRATORY FAILURE
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic respiratory failure, Respiratory failure
Clinical narrative: CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 31.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Dizziness, Hyperhidrosis, Malaise, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: pt was dizzy, he said head was not feeling well, stiff hand, sweating. he said legs are tingly .  right arm was tingly (even tho pt had vaccin in left arm)... after 20 mins pt said he is feeing better
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: None.
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypotension, Pulmonary embolism, Symptom recurrence
Clinical narrative: HYPOTENSION ACUTE PULMONARY EMBOLISM 3/1/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: On 6/22/23 the patient was 15 years old and received a dose of MCV4 vaccine. Her records indicated that she previously received doses at the ages of 5 and 10 years of age. The dose given on 6/22/23 was not needed according to CDC guidance.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypotension
Clinical narrative: HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Deep vein thrombosis, Pulmonary embolism
Clinical narrative: ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN ACUTE DVT OF LEFT FEMORAL VEIN ACUTE PULMONARY EMBOLISM
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: OBSTRUCTIVE SLEEP APNEA 3/8/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: There are no symptoms for the patient, it's just the vaccine was expired when administered.
Age: 89.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hypersensitivity
Clinical narrative: ALLERGIC REACTION, INIT
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: There are no symptoms for the patient, it's just the vaccine was expired when administered.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: There are no symptoms for the patient, it's just the vaccine was expired when administered
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pulmonary embolism
Clinical narrative: ACUTE PULMONARY EMBOLISM
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pediarix given  4/7/23, minimum valid date for Hep B component was 4/12/23. administered too early.  No current adverse events noted.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: There are no symptoms, the vaccine was out of date at the time of administration.
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Hypoxia, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA 1/19/2023  &  1/26/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis
Clinical narrative: Child diagnosed with cellulitis at injection site 2 days after injection.  Completed 5 day course of antibiotics and has improved.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Chest discomfort, Injection site reaction
Clinical narrative: LOCAL REACTION AT INJECTION SITE AND CHEST TIGHTNESS
Age: 0.58
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None known
Age: 87.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Pt had no adverse reactions. We called and spoke with the patient on 7/6/2023, he stated he felt fine.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Corneal abrasion, Retinal vein occlusion, Vision blurred
Clinical narrative: initial urgent care visit due to blurred vision- dx as corneal scratch Follow up with Eye physician- DX with Central Retinal Vein OcclusionI continue to get eye shots Bevacizmab  to minimize sx from this occlusion
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Single component of a two-component product administered
Clinical narrative: Only the adjuvant (liquid) portion of the vaccine was administered: the reconstitution step was mistakenly skipped.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient presented to the pharmacy on 7/6/23 with redness and burning just below the deltoid on her right arm. She reported that it started the day after her vaccine and started on the deltoid area and spread down her arm. She reported taking APAP to help with the burning sensation.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Musculoskeletal stiffness, Paraesthesia
Clinical narrative: patient stated that his arm started to get tingly and numb and stiff a couple of days after he received the vaccine.  The patient stated that he has to squeeze his hands into a fist periodically in order to make it feel better.  The problem has remained consistent the past couple of weeks since he first experienced it until now with no improvement nor has it gotten worse, he said.
Age: 5.0
Sex: F
Vaccine: MMR, MMRV
Symptoms: Wrong product administered
Clinical narrative: Pt was accidently given an MMR instead of Dtap-IPV.
Age: 50.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: Patient starting getting an itchy rash on 7/4/23. Rash is on forearms and neck is also itching.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Extra dose administered, Peripheral swelling
Clinical narrative: I POL administered along with Kinrix. Double Dose administered. Administrator notified. PT mother contacted and notifed to watch for swelling in arm and adverse reactions. Mother stated " he is doing well now, thank you for letting me know." Denied other concerns.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Thrombosis
Clinical narrative: Severe bleeding, clots and hemorrhaging for 72 days
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Adverse event: Redness and rash appeared at the injection site 1 hour after injection. New red spots gradually appeared at back, front, on the left palm (both front and back) and in between left fingers. Patient did not take any medication and slept over night. The following morning (07/6/2023), more red spots appeared to the right palms and in between right fingers. Patient denied anaphylaxis symptoms during the time being.  Treatment: Patient was advised to take benadryl 25 mg and waiting for MD evaluation. Benadryl 25mg with unknown dosing and quantity was started around 1 PM 07/06/2023 per patient.  Outcome: Awaiting MD evaluation. Patient denied anaphylaxis symptoms at the time of report
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: No signs or symptoms at this time. Vaccine was expired when given 27 APR23
Age: 38.0
Sex: M
Vaccine: UNK
Symptoms: Abdominal pain, Chills, Diarrhoea, Immunisation reaction, Viral infection
Clinical narrative: 38 years old male with no contributing comorbidities with one week of watery, brown, diarrhea, occurring about 2 times per day. There is no blood in the stool. There is not associated nausea.  No recent camping, travel, or antibiotic use. There are occasional mild abdominal cramps, but generally no pain. Symptoms are not worsened or improved by anything.  No fever. The patient has not been exposed to others with similar symptoms.  Patient states he received a COVID vaccination on Wednesday of last week afterward he got diarrhea and chills. He states his diarrhea has continued to this day, but chills cleared up after day 2. This patient's history and exam are consistent with viral syndrome and post vaccine mild reaction.
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave Moderna pink cap/ yellow cap as primary
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Malaise, Pain in extremity
Clinical narrative: pain I felt when they applied it on my arm; feeling ill; reddened; 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.   On an unknown date, the patient received Shingles vaccine (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: pain I felt when they applied it on my arm), feeling unwell (Verbatim: feeling ill) and erythema of extremities (Verbatim: reddened). The outcome of the pain in arm, feeling unwell and erythema of extremities were not reported.   It was unknown if the reporter considered the pain in arm, feeling unwell and erythema of extremities to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, feeling unwell and erythema of extremities to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2023. This case was reported by a patient via interactive digital media. The reporter itself the patient. The patient was completely fine, but as soon as they put the vaccine, apart from the pain patient felt when they applied it on his/her arm, and it reddened.  The patient started feeling ill, patient called the doctor and they requested patient that he/she had to visit for the other vaccine in two weeks because had to complete this one because patient was injected the herpes zoster and if patient had known, would not had taken the injection because patient had taken all the vaccines. Patient had taken all of them, but they do not tell this. The patient had a friend who was a doctor and he told this to them. The patient realized then when they had already given it to him/her.  They give patient the herpes zoster and then patient had to take it once again to combat. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old male patient who received Herpes zoster (Shingrix) 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 pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Linked case(s) involving the same patient:  US2023090154   Additional Information: GSK Receipt date: 29-JUN-2023 The patient self-reported this case. The patient experienced a sore arm only when he had his first Shingrix vaccination administered. The reporter consent to follow up. For tolerance of 2nd dose, refer case US2023090154, reported by same reporter.; Sender's Comments:  US-GSK-US2023090154:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: second dose he experienced myalgia; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on an unknown date and was fine).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced myalgia (Verbatim: second dose he experienced myalgia). The outcome of the myalgia was unknown.   It was unknown if the reporter considered the myalgia to be related to Shingrix.     It was unknown if the company considered the myalgia to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2023 The patient self-reported this case. The patient received the Shingrix vaccines about a year ago from reporting. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Received a dose of Shingrix by mistake, instead of the Varicella Vaccine; 12 year old patient received Shingrix; Shingrix vaccine was administered Subcutaneously rather than Intramuscularly; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Herpes zoster (Shingrix) (batch number Z3H93, expiry date 07-JUL-2024) for prophylaxis.   On 05-JUN-2023, the patient received the 1st dose of Shingrix (subcutaneous, left deltoid). On 05-JUN-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Received a dose of Shingrix by mistake, instead of the Varicella Vaccine), inappropriate age at vaccine administration (Verbatim: 12 year old patient received Shingrix) and intramuscular formulation administered by other route (Verbatim: Shingrix vaccine was administered Subcutaneously rather than Intramuscularly). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and intramuscular formulation administered by other route were unknown.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter was called on behalf of a patient that that received a dose of Shingrix by mistake in her left deltoid, instead of the Varicella Vaccine, which lead to wrong vaccine administered. The reporter also reported that the Shingrix vaccine was administered subcutaneously rather than intramuscularly, which lead to intramuscular formulation administered by other route. The reporter reported that the patient was doing fine. On call note reporter did not ask for consent to follow up with HCP. The reporter did consent to follow up. The reporter reported that 12 year old patient received Shingrix, which lead to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Off label use
Clinical narrative: Patient´s doctor prescribed 2 more doses of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of off label use in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date) and Shingrix (received 2nd dose on an unknown date). Concurrent medical conditions included shingles (with no rash, internal shingles (life long internal shingles)). Additional patient notes included Patient was immunocompetent.   On an unknown date, the patient received the 3rd dose of Shingrix and the 4th dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced off label use (Verbatim: Patient´s doctor prescribed 2 more doses of Shingrix). The outcome of the off label use was unknown.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter called to request more information about extra doses of Shingrix, because a patient was coming on the reporting day. The reporter had had an immunocompetent patient who already received two doses of Shingrix, however her physician said that she was not cover due her medical history of shingles with no rash, internal shingles (lifelong internal shingles), so patient needs two more doses. The reporter stated that there were no shingles cases reported between doses administered. At the moment of the call, the patient had not received any extra Shingrix dose yet. The reporter did not provided consent for a follow. The reporter intentionally prescribed extra dose of Shingrix to patient, which led to off label use.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Bedridden, Decreased appetite, Dizziness, Headache
Clinical narrative: Nausea; Headache; No appetite; Dizziness; Does not feel well; Sick to her stomach; Swollen Arm /knot on arm; Itchy Arm; Sore Arm; Spent 2 days in bed; This non-serious case was reported by a consumer via call center representative and described the occurrence of appetite absent in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JUN-2023, the patient received the 1st dose of Shingrix (right arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced appetite absent (Verbatim: No appetite), stomach discomfort (Verbatim: Sick to her stomach), nausea (Verbatim: Nausea), headache (Verbatim: Headache) and bedridden (Verbatim: Spent 2 days in bed). On 17-JUN-2023, the patient experienced pain in arm (Verbatim: Sore Arm). On 18-JUN-2023, the patient experienced swelling arm (Verbatim: Swollen Arm /knot on arm) and itchy upper limbs (Verbatim: Itchy Arm). On 20-JUN-2023, the patient experienced feeling unwell (Verbatim: Does not feel well). On 26-JUN-2023, the patient experienced dizziness (Verbatim: Dizziness). The patient was treated with dramamine (nos) (Dramamine). In JUN-2023, the outcome of the appetite absent, nausea and headache were resolved and the outcome of the bedridden was resolved (duration 2 days).  On 21-JUN-2023, the outcome of the feeling unwell was resolved (duration 1 day). The outcome of the stomach discomfort and dizziness were not resolved and the outcome of the swelling arm, itchy upper limbs and pain in arm were resolved (duration 3 days).   It was unknown if the reporter considered the appetite absent, stomach discomfort, dizziness, nausea, headache, feeling unwell, swelling arm, itchy upper limbs, pain in arm and bedridden to be related to Shingrix.     It was unknown if the company considered the appetite absent, stomach discomfort, dizziness, nausea, headache, feeling unwell, swelling arm, itchy upper limbs, pain in arm and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2023 The patient self-reported this case. The patient's arm was sore on the vaccination day evening.  The next day the patient reported that her arm was very sore, itchy, swollen, and she had a knot, and these side effects all went away after 3 to 4 days (no specific date provided).  Patient also reported that she did not feel well, and it comes and goes that on Tuesday and Wednesday. The patient had nausea, dizziness, felt sick to her stomach, had no appetite and had a headache. Patient took Dramamine one day and spent 2 days in bed during this time.  Patient also reported that all the side effects went away but on reporting day, she was feeling dizzy and sick to her stomach again.  Reported all the patient was able to share about these events. The reporter consent to follow up with herself and with healthcare professional.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Nausea; Headache; No appetite; Dizziness; Does not feel well; Sick to her stomach; Swollen Arm /knot on arm; Itchy Arm; Sore Arm; Spent 2 days in bed; This non-serious case was reported by a consumer via call center representative and described the occurrence of appetite absent in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JUN-2023, the patient received the 1st dose of Shingrix (right arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced appetite absent (Verbatim: No appetite), stomach discomfort (Verbatim: Sick to her stomach), nausea (Verbatim: Nausea), headache (Verbatim: Headache) and bedridden (Verbatim: Spent 2 days in bed). On 17-JUN-2023, the patient experienced pain in arm (Verbatim: Sore Arm). On 18-JUN-2023, the patient experienced swelling arm (Verbatim: Swollen Arm /knot on arm) and itchy upper limbs (Verbatim: Itchy Arm). On 20-JUN-2023, the patient experienced feeling unwell (Verbatim: Does not feel well). On 26-JUN-2023, the patient experienced dizziness (Verbatim: Dizziness). The patient was treated with dramamine (nos) (Dramamine). In JUN-2023, the outcome of the appetite absent, nausea and headache were resolved and the outcome of the bedridden was resolved (duration 2 days).  On 21-JUN-2023, the outcome of the feeling unwell was resolved (duration 1 day). The outcome of the stomach discomfort and dizziness were not resolved and the outcome of the swelling arm, itchy upper limbs and pain in arm were resolved (duration 3 days).   It was unknown if the reporter considered the appetite absent, stomach discomfort, dizziness, nausea, headache, feeling unwell, swelling arm, itchy upper limbs, pain in arm and bedridden to be related to Shingrix.     It was unknown if the company considered the appetite absent, stomach discomfort, dizziness, nausea, headache, feeling unwell, swelling arm, itchy upper limbs, pain in arm and bedridden to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUN-2023 The patient self-reported this case. The patient's arm was sore on the vaccination day evening.  The next day the patient reported that her arm was very sore, itchy, swollen, and she had a knot, and these side effects all went away after 3 to 4 days (no specific date provided).  Patient also reported that she did not feel well, and it comes and goes that on Tuesday and Wednesday. The patient had nausea, dizziness, felt sick to her stomach, had no appetite and had a headache. Patient took Dramamine one day and spent 2 days in bed during this time.  Patient also reported that all the side effects went away but on reporting day, she was feeling dizzy and sick to her stomach again.  Reported all the patient was able to share about these events. The reporter consent to follow up with herself and with healthcare professional.
Age: 0.5
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Unapproved Age; Wrong Product Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   On 12-JUN-2023, the patient received Havrix. On 12-JUN-2023, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved Age) and wrong vaccine administered (Verbatim: Wrong Product Used). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 29-Jun-2023 The infant's mother was notified and instructed to call the office if the infant showed unusual signs and symptoms and she had called in with any issues. The Vaccine Administration Facility was the same as Primary Reporter. The medical assistant reported that 6 month old infant was supposed to received PCV15 vaccine and was inadvertently administered a dose of Havrix instead, which led to inappropriate age at vaccine administered and wrong vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This serious case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced anaphylaxis (Verbatim: Anaphylaxis) (serious criteria GSK medically significant). The outcome of the anaphylaxis was resolved.   It was unknown if the reporter considered the anaphylaxis to be related to Shingrix.     It was unknown if the company considered the anaphylaxis to be related to Shingrix.   Additional Information: GSK receipt date: 29-Jun-2023 The field staff reported a case of anaphylaxis after Shingrix immunization for a staff member of a client. The reporter learned of the event while taking with office staff of one of her contacts. The event happened perhaps as much as a year ago and the patient reported it at the time. The patient was not hospitalized, but there were no lasting effects. The patient wished to be remain anonymous and did not provide consent to contact her physician because this was a long time ago and she already reported. The reporter did not consent to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test abnormal, Monocyte count increased
Clinical narrative: Elevated monocytes; This non-serious case was reported by a consumer via call center representative and described the occurrence of monocyte count increased in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On unknown day patient received 1st dose).   On 26-JUN-2023, the patient received the 2nd dose of Shingrix. On 29-JUN-2023, 3 days after receiving Shingrix, the patient experienced monocyte count increased (Verbatim: Elevated monocytes). The outcome of the monocyte count increased was unknown.   It was unknown if the reporter considered the monocyte count increased to be related to Shingrix.     It was unknown if the company considered the monocyte count increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter was the wife of the patient.  The reporter asked could Shingrix cause elevated monocyte levels. The patient had routine blood work in preparation for a physical on Thursday 29-Jun-2023.  The lab work showed elevated monocytes.  The reporter consented to follow up with her and healthcare professional (pharmacy). This case was linked with case US2023090629, reported by same reporter.; Sender's Comments:  US-GSK-US2023090629:Same Reporter
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Herpetic rash; This non-serious case was reported by a physician via call center representative and described the occurrence of rash herpetiform in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash herpetiform (Verbatim: Herpetic rash). The outcome of the rash herpetiform was unknown.   It was unknown if the reporter considered the rash herpetiform to be related to Shingrix.     It was unknown if the company considered the rash herpetiform to be related to Shingrix.   Additional Information: GSK receipt date: 30-Jun-2023 A physician called to report that their sister suffered herpetic rash after receiving an unspecified dose of Shingrix. Partial information about the case was provided. The suspect product received a couple of months ago. The reporter consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included surgery (Had right leg, hip, testicles removed), infection, testicular operation and accident. Previously administered products included Antibiotics and Shingrix (1st dose received on 30 December 2019). Concurrent medical conditions included paraplegia, bedridden and bone cancer.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 03-JUL-2023 The pharmacist called to report that a patient had a first dose of Shingrix in 2019 and had not received a second dose yet. The reporter mentioned that patient had been in bed over a year paraplegic after a motorcycle accident and had right leg, hip, testicles removed because of bone cancer from a dead sore.  The reporter was unsure if patient was immunocompromised but mentioned had a history of a lot of infections treated with antibiotics in the last 6 months. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The vaccine administration facility is the same as primary reporter for 1st dose. No lot number reported. The reporter consented to follow up via email.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: patient mistakenly got adult dose of Engerix B instead of the pediatric; patient mistakenly got adult dose of Engerix B instead of the pediatric; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 9-month-old female patient who received HBV (Engerix B adult) for prophylaxis.   On 03-JUL-2023, the patient received Engerix B adult. On 03-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: patient mistakenly got adult dose of Engerix B instead of the pediatric) and inappropriate age at vaccine administration (Verbatim: patient mistakenly got adult dose of Engerix B instead of the pediatric). The outcome of the accidental 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: 03-JUL-2023 The pharmacist stated that a 9 month old patient mistakenly got the adult dose of Engerix B instead of the pediatric dose which led to inappropriate age at vaccine administration and accidental overdose. The reporter consented to follow up via postal.