chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Biliary obstruction, Hypotension, Hypovolaemic shock
Clinical narrative: I95.9 HYPOTENSION 4/17/2023 EXTRAHEPATIC OBSTRUCTIVE BILIARY DISEASE R57.1 HYPOVOLEMIC SHOCK 4/9/2023 EXTRAHEPATIC OBSTRUCTIVE BILIARY DISEASE
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Hypoxia
Clinical narrative: J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/23/2023 HYPOXIA R09.02 HYPOXIA 4/20/2023 HYPOXIA
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Symptom recurrence
Clinical narrative: ACUTE NON ST ELEVATION MI 2/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 0.67
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: The wrong bivalent vaccine and dose were given. The patient was contacted by their PCP, instructed to come back in and received the correct bivalent vaccine per CDC guidelines.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Dr.  placed order for Pentacel for the patient. Only one vial of the Pentacel vaccine obtained by LPN. Vaccine second checked by RN. LPN administered vaccine. Patient only given the liquid form of the pentacel and not the powder. RN called and notified father that a partial dose was given. Patients father was agreeable and scheduled for have vaccine on Friday (06/30/2023).
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: High-frequency, large-volume diarrhea with associated transient fever (Tmax 101F) lasting less than 48 hours; no notable vomiting, no difficulty with oral intake of breastmilk; no treatments needed, symptoms resolved spontaneously
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Obstructive sleep apnoea syndrome, Respiratory failure
Clinical narrative: OBSTRUCTIVE SLEEP APNEA ACUTE RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: The family came to the Covid clinic on 6/26 for pt's second covid shot. The order was pended by me (an RN), and signed by the doctor on duty. I gave the shot for the Moderna Bivalent (pink top) 0.2 ml which is incorrect and an under dose according to the new guidelines. The pt should have received moderna bivalent (blue top) 0.25 ml. Moderna does not scan so the lot number was manually entered therefore not recognized by the system to be incorrect for the order that was put in.  A notice was placed, Provider has been notified.
Age: 1.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: The wrong bivalent vaccine and dose were given. The patient was contacted by their PCP, instructed to come back in and received the correct bivalent vaccine per CDC guidelines.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Blepharospasm, Chest discomfort, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Patient became lightheaded, dizzy, pallor, felt like it was hard to breath with chest heaviness. Extremities fell asleep and then starting contracting. eye twitching, vomiting, diarrhea. Muffled hearing Patient was given sprite and peanut butter crackers. B/P 100/70 Patient sat in the office for approx. 30 minutes and was monitored. She then stated she felt back to normal and left with her father.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Extremity contracture, Hypoacusis, Pallor, Paraesthesia, Vomiting
Clinical narrative: Patient became lightheaded, dizzy, pallor, felt like it was hard to breath with chest heaviness. Extremities fell asleep and then starting contracting. eye twitching, vomiting, diarrhea. Muffled hearing Patient was given sprite and peanut butter crackers. B/P 100/70 Patient sat in the office for approx. 30 minutes and was monitored. She then stated she felt back to normal and left with her father.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: No adverse event
Clinical narrative: No symptoms
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest X-ray, Computerised tomogram abdomen, Laboratory test, Vasculitis
Clinical narrative: developed severe vasculitis
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: The wrong bivalent vaccine and dose were given. The patient was contacted by their PCP, instructed to come back in and received the correct bivalent vaccine per CDC guidelines.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Biopsy kidney, Haematuria, IgA nephropathy, Laboratory test, Proteinuria
Clinical narrative: Diagnosed with IgA nephropathy approximately March 2023.
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Patient was given bivalent dose from bottle that had been punctured almost 24 hours prior. max should have been 12 hours.
Age: 28.0
Sex: M
Vaccine: COVID19-2
Symptoms: Neck mass, Thyroid cancer
Clinical narrative: Patient felt a lump in neck and found out to by a cancerous thyroid nodule
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Extra dose given due to incorrect forecasting
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Haemochromatosis, Myocardial ischaemia, Pain
Clinical narrative: I24.8 DEMAND ISCHEMIA 4/8/2023 CHRONIC PAIN I24.8 DEMAND ISCHEMIA 4/8/2023 HEMOCHROMATOSIS I24.8 DEMAND ISCHEMIA 4/8/2023 ANEMIA
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Hypoxia
Clinical narrative: R09.02 HYPOXIA 4/20/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Extra dose given due to incorrect forecasting
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Chronic respiratory failure, Respiratory failure
Clinical narrative: J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/9/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/9/2022 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Extra dose given due to incorrect forecasting
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Epilepsy, Femur fracture, Idiopathic partial epilepsy, Open fracture
Clinical narrative: EPILEPSY, UNSPECIFIED 4/28/2023 OPEN RIGHT FEMORAL HEAD FX, GRADE 1/2/UNSPECIFIED INIT  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/10/2023 OPEN RIGHT FEMORAL HEAD FX, GRADE 1/2/UNSPECIFIED INIT  EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS 4/10/2023 OPEN RIGHT FEMORAL HEAD FX, GRADE 1/2/UNSPECIFIED INIT
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Extra dose given due to incorrect forecasting
Age: 87.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cardiac disorder, Death
Clinical narrative: Resident died unexpectedly on 6/28/23 at 0510 a.m.  Resident showed no adverse signs or symptoms. Physician thinks it was a cardiac event unrelated to the vaccine.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Osteoarthritis
Clinical narrative: I95.9 HYPOTENSION 4/24/2023 OSTEOARTHRITIS OF LEFT KNEE
Age: 19.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Extra dose given due to incorrect forecasting
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Atrial fibrillation
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/12/2023 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received her first dose of Shingrix on 4/26/2023. Patient and patient's daughter were unsure if the patient had received doses prior at another pharmacy, which is now closed. Patient came in on 6/28/2023 to receive her second dose but after checking system it was found she had received two doses from pharmacy back in 2019 and 2020.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Extra dose given due to incorrect forecasting
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Respiratory failure, Sleep apnoea syndrome
Clinical narrative: G47.30 SLEEP APNEA 4/20/2023 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/17/2023 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/1/2023 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Extra dose given due to incorrect forecasting
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Disturbance in attention, Dysgraphia, Laboratory test, Middle insomnia
Clinical narrative: In April I woke up in the middle of the night to write some on my school paper.  I was not able to write.  I got up again to write and I was still unable to write.  I called a friend, and I was not able to speak.  I saw my primary doctor about two weeks later and learned that I had a mini stroke.  I was prescribed several medications.  I had an event monitor and several tests that I cannot remember exactly.  I think I had a brain scan. I continue to have trouble enunciation and speech issues, concentration,
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: In April I woke up in the middle of the night to write some on my school paper.  I was not able to write.  I got up again to write and I was still unable to write.  I called a friend, and I was not able to speak.  I saw my primary doctor about two weeks later and learned that I had a mini stroke.  I was prescribed several medications.  I had an event monitor and several tests that I cannot remember exactly.  I think I had a brain scan. I continue to have trouble enunciation and speech issues, concentration,
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Extra dose given due to incorrect forecasting
Age: 0.83
Sex: F
Vaccine: UNK
Symptoms: Underdose
Clinical narrative: Moderna Bivalent 10 mcg dose given instead of bivalent 25 mcg dose
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: soreness, stiffness
Age: 1.0
Sex: M
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose given incorrectly due to forecasting
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth, Vomiting
Clinical narrative: Vomiting starting about 30 hours after vaccination; large local reaction at vaccination site -- erythema, induration, warmth
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose given incorrectly due to forecasting
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Pneumonia, Thrombocytopenia
Clinical narrative: Pfizer vaccine was administered outside - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 3/13/2023 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/24/2023 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 3/13/2023 THROMBOCYTOPENIA, UNSPECIFIED (UNKNOWN ETIOLOGY) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/24/2023 THROMBOCYTOPENIA, UNSPECIFIED (UNKNOWN ETIOLOGY)
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: moderna bivalent 10 mcg dose given instead of bivalent 25 mcg dose
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: The wrong bivalent vaccine and dose were given. The patient was contacted by their PCP, instructed to come back in and received the correct bivalent vaccine per CDC guidelines.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination error
Clinical narrative: 3rd dose given incorrectly due to forecasting
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Deep vein thrombosis, Diverticulum intestinal
Clinical narrative: ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 4/1/2023 DIVERTICULOSIS OF SIGMOID ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS 4/1/2023 ABDOMINAL PAIN
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose given incorrectly due to forecasting
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered
Clinical narrative: Moderna bivalent 10mcg dose given instead of bivalent 25 mcg dose
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Biopsy skin abnormal, Polymerase chain reaction, Varicella
Clinical narrative: full brown chicken pox; The spontaneous report was received from a physician referring to a 12-month-old infant patient. The patient's previous adverse drug reaction history and family adverse drug reactions were unknown. The patient's concomitant therapies, medical histories and drug allergies were not reported.   On an unknown date, the 12 months old patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VAVIRAX) (dose, route, lot# and expiration date were not reported) as prophylaxis .  After 5 days, the patient developed full brown chicken pox, the patient was seen in an outpatient setting and was considered to be otherwise healthy. On 23-MAY-2023, the vesicle/lesion sample was obtained (also reported as 24-MAY-2023, conflicting information) and sent to laboratory for polymerase chain reaction (PCR) analysis, the patient was not on an oral antiviral prior to the specimen collections, the results showed cycle threshold value was 17.5 (units not reported), and the presence strain of varicella-zoster virus (VZV) was identified as wild-type strain.   The outcome of event chicken pox and the causal relationship between suspect vaccine and the event was not reported.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptomatic side effects/No additional AE; administration of improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 31-MAY-2023, the patient was vaccinated with improperly stored (Product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin)(PROQUAD) injection, 0.5 milliliter, once, lot # was reported and upon internal validation confirmed as: X011437, expiration date was reported an confirmed as: 18-JUL-2024, administered (site and route of administration were not provided) for prophylaxis. No previous temperature excursion. The patient had no symptomatic side effects. No additional adverse event reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/; patient was administered an expired dose; This spontaneous report has been received from a physician assistant referring to a patient of unspecified age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.  On 20-JUN-2023, the patient was vaccinated with an expired dose of hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) as prophylaxis (dose, route of administration, and anatomical site of vaccination were not reported; lot number W025778 has been verified to be valid, expiration date reported and established as 11-JUN-2023) (expired product administered).  No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AEs; Caller reported patient received a dose of PROQUAD that was reconstituted with Mencyw-135 Liquid Conjugate component  (Diluent for MENVEO) instead of the Merck Diluent.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date, a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with Mencyw-135 Liquid Conjugate component (Diluent for MENVEO) (lot number AMXA764A with an expiration date of 20-SEP-2024) instead of the Merck Diluent (product preparation error). Then, the patient was vaccinated with the reconstitution of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, at a dose 0.5 milliliter administered intramuscularly for prophylaxis (vaccination scheme frequency and anatomical location were not provided; valid lot number W007744 with an expiration date of 04-SEP-2023, therapy type: rHA). No additional adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Caller reported a patient was inadvertently administered GARDASIL9 while pregnant; Patient is asymptomatic at this time.; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No medical history, concurrent conditions nor concomitant medications were reported.  On 16-JUN-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (intramuscularly, 1 dosage form, formulation pre-filled syringe, exact dose, lot #, expiration date and anatomical location were not provided) for prophylaxis.  On 16-JUN-2023, the patient was inadvertently administered a vaccine while pregnant (Vaccine exposure during pregnancy). At the time of reporting, patient was asymptomatic (No adverse event). No further details were provided. No additional adverse event (AE) or product quality complaint (PQC).
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No Adverse Event; HCP (nurse) called to report TE for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023 but she was not made aware until today (06/26/2023).  The product was stored at 10.8F for 8 hours, 23 minutes and 0 seconds with; This spontaneous report was received from a nurse refers to a 4-year-old patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-JUN-2023, the patient was vaccinated with dose of improper storage varicella virus vaccine live (oka/merck)(VARIVAX) lot # W031813, expiration date: 05-OCT-2024, 0.5 milliliter (route of administration and anatomical location were not provided) for prophylaxis.  On 11-MAY-2023, administered dose of vaccine was exposed to the temperature excursion of 10.8 degrees Fahrenheit for 8 hours and 23 minutes, with a supported temperature excursion stability elevation (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy in my left foot; This serious case was reported by a consumer via interactive digital media and described the occurrence of neuropathy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced neuropathy (Verbatim: neuropathy in my left foot) (serious criteria GSK medically significant). The outcome of the neuropathy was not reported.   It was unknown if the reporter considered the neuropathy to be related to Shingles vaccine.     It was unknown if the company considered the neuropathy to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received one dose of Shingles vaccine and experienced neuropathy in his/her left foot.  Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure, Vision blurred
Clinical narrative: shingles in my right eye/ Suspected vacciantion failure; shingles in my right eye; blurred vision; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 23-JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced blurred vision (Verbatim: blurred vision). On an unknown date, the patient experienced vaccination failure (Verbatim: shingles in my right eye/ Suspected vacciantion failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: shingles in my right eye) (serious criteria GSK medically significant). The patient was treated with antivirals nos (Anti-Viral Medicine (Nos)). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and blurred vision were not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and blurred vision to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster and blurred vision to be related to Shingles vaccine.   Additional Information: GSK receipt date: 23-Jun-2023 The case was received from the patient via interactive digital media. The patient stated that had the shingles shot. The patient stated that on the day of reporting, he or she woke up with blurred vision. The patient called his or her ophthalmologist and was seen immediately. The patient was taking an anti viral pill for shingles in his or her right eye. The ophthalmologist will see the patient again in two days. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; I felt bad the day after each of them; Arm was pretty sore but didn't last long; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), feeling bad (Verbatim: I felt bad the day after each of them) and pain in arm (Verbatim: Arm was pretty sore but didn't last long). The outcome of the vaccination failure was unknown and the outcome of the shingles, feeling bad and pain in arm were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, feeling bad and pain in arm to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, feeling bad and pain in arm to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUN-2023 The case was received from the patient interactive digital media. The patient stated that he/she felt bad the day after each of them and it was worsen after 1st one .  The patient's arm was pretty sore but did not last long .  The patient stated that nothing to compare to the pain of shingles . This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I've been vaccinated but still had a bad case while on vacation / Suspected vaccination failure; I've been vaccinated but still had a bad cas while on vacation; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I've been vaccinated but still had a bad case while on vacation / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've been vaccinated but still had a bad cas while on vacation). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2023 This serious case was reported by the patient via interactive digital media. The patient had been recovering from Shingles since April 2023. The patient stated it was what it was. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: broke out in a bad case of them / Suspect vaccination failure; broke out in a bad case of them last week; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JUN-2023, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: broke out in a bad case of them / Suspect vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: broke out in a bad case of them last week). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2023 This case was reported by the patient via interactive digital media The patient got the Shingles shots three years ago from reporting. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles / Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2023 This case was reported by the patient via interactive digital media. The got shingles from the shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the vaccine then a few years later I got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the vaccine then a few years later I got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2023 This case was reported by a patient via interactive digital media. The patient got the vaccine then a few years later experienced shingles, but the vaccine helped not having the pain or itch like some. The patient knew they were there but they didn't bother them. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Bedridden, Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Have so much pain; All my muscles hurt; Arm so hurt; Fever; Couldnt get out off bed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Have so much pain), muscle pain (Verbatim: All my muscles hurt), pain in arm (Verbatim: Arm so hurt), fever (Verbatim: Fever) and bedridden (Verbatim: Couldnt get out off bed). The outcome of the pain, muscle pain, pain in arm, fever and bedridden were not reported.   It was unknown if the reporter considered the pain, muscle pain, pain in arm, fever and bedridden to be related to Shingles vaccine.     It was unknown if the company considered the pain, muscle pain, pain in arm, fever and bedridden to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023 This case was reported by consumer via interactive digital media. The patient reported that he or she had so much pain with the shingles vaccine. The patient's arm was so hurt and his/her muscles hurt and had fever and could not get out off bed. The patient was so hurt that he or she was not looking forward for the second dose which was on 11th September 2023.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness
Clinical narrative: shingles; sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 year after receiving Shingrix, the patient experienced shingles (Verbatim: shingles) and sickness (Verbatim: sick). Shingrix was discontinued. The outcome of the shingles and sickness were not reported.   The reporter considered the shingles and sickness to be related to Shingrix.     The company considered the shingles and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUN-2023 The case was received from the patient interactive digital media. The patient stated that Shingles shot had made him/her really sick, he/she did not took the second one because of reaction to the first one.  The patient stated that still a year later believed it gave me internal shingles, from everything he/she read this was what he/she thought he/she had since taking Shingrix (self-diagnosed). The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Swelling of the face; This non-serious case was reported by a consumer via sales rep and described the occurrence of facial swelling 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 facial swelling (Verbatim: Swelling of the face). The outcome of the facial swelling was not reported.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.     It was unknown if the company considered the facial swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUN-2023 The reporter reported that the patient had swelling of the face after receiving Shingrix (given about the 1st of this year). The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: dizziness normal on day 2 after shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced dizziness (Verbatim: dizziness normal on day 2 after shingles). The outcome of the dizziness was not reported.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     It was unknown if the company considered the dizziness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2023. This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient was asking dizziness normal on day 2 after shingles shot.  The patient had no other symptoms. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUN-2023. This case was reported by a patient via interactive digital media. The patient got shingles a week after getting the first shingles shot patient reported that it was not fun. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: hurts). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles booster it hurts.  Follow up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: My wife got the shot, and got really sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: My wife got the shot, and got really sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2023 This case was reported by a patient's husband via interactive digital media.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Got my shot 2 weeks ago, the amount of pain, needle much easier; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUN-2023, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Got my shot 2 weeks ago, the amount of pain, needle much easier). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2023 This case was reported by a patient via interactive digital media. The patient got his/her shingles shot 2 weeks ago from the day of reporting and the amount of pain and needle was much easier.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Administered a dose of Havrix on 19Jun2023 which expired on 25 May 2023; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 7-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25-MAY-2023) for prophylaxis.   On 19-JUN-2023, the patient received the 2nd dose of Havrix. On 19-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Administered a dose of Havrix on 19Jun2023 which expired on 25 May 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-JUN-2023 The reporter reported that at the time of reporting, the dose was not repeated. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with sterile water instead of the liquid conjugate portion; Administered a dose of Menveo that had been reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA945A, expiry date 31-MAR-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile water instead of the liquid conjugate portion) and inappropriate dose of vaccine administered (Verbatim: Administered a dose of Menveo that had been reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-JUN-2023 The reporter reported that the patient received Menveo vaccine which was reconstituted with sterile water instead of the liquid conjugate portion of the vaccine. The reporter wanted to remain anonymous. The reporter stated that two patients were given Menveo on that day and she did not know which patient received improperly reconstituted dose so she did not had patient information at the time of call. The reporter did consent to follow up via postal. Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received a third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number L32MF, expiry date 31-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2020) and Shingrix (2nd dose received in 2021).   On 21-JUN-2023, the patient received the 3rd dose of Shingrix. On 21-JUN-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2023 The reporter reported that by mistakenly patient received third dose of Shingrix vaccine. The reporter stated that after reviewing patient records he realized that patient already received two doses of Shingrix vaccine. The reporter asked for safety information. The reporter did consent to follow up. The patient received extra dose of Shingrix vaccine in error, which led to extra dose administered.
Sex: F
Vaccine: HEP
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 77-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included HEPATITIS B VACCINE (1st dose received in 1st January1988   ).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, 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: 21-JUN-2023 The pharmacist reported that a patient received their first dose of a hepatitis B vaccine in January 1998 but did not continue the series and wishes to continue with Twinrix.  The information about the previous vaccine was unknown, but the pharmacist gave partial information about the patient. Till the time of reporting, the patient did not receive 2nd dose of Hepatitis B, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose of Shingrix received 7 years ago late for 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 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 7 years ago prior to the reporting).   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 received 7 years ago late for 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2023 The reporter did not have vaccination details for the first dose. The reporter did consent to follow up via postal mail. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Shingrix - Less than recommended dose/during the administration of Shingrix due to a leakage, the total volume of the dose was not administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 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 incomplete dose administered (Verbatim: Shingrix - Less than recommended dose/during the administration of Shingrix due to a leakage, the total volume of the dose was not administered). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 22-Jun-2023 An pharmacist called on behalf of a friend of hers to ask for guidance on the situation. The reporter did not provide patient information nor vaccine data (lot number, expiry date, date of administration) since the person involved in this situation was not her patient. During the administration of Shingrix due to a leakage, the total volume of the dose was not administered, which led to incomplete dose administered.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received her first dose of Engerix-B in October 2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (1st dose received in October 2022).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: patient received her first dose of Engerix-B in October 2022). The outcome of the incomplete course of vaccination 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: 22-JUN-2023 The second dose had not been given yet due to the patient thinking it was to be 6 months after the first dose. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination.