chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: RV5
Symptoms: Dependence on respirator, Electroencephalogram abnormal, Encephalitis, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: The patient recieved the RSV vaccine at Pharmacy on 12/4/2024. The patient presented to Health System on 12/17/2024. 70 y/o male admitted with progressive bilateral extremity weakness, areflexia, autonomic dysfunction, respiratory decline likely secondary to acute inflammatory demyelinating polyneuropathy (AIDP) in setting of recent RSV vaccination. IVIG completed 12/17-12/21/2024. Patient has had continued severe impairment and ventilator dependence. Intermittent unresponsiveness, may be secondary to hospital acquired delirium versus infectious encephalopathy (possible aspiration pneumonia) as MRI Brain, CTA H/N were unremarkable, POC EEG only showed diffuse slowing.    AIDP can continue to progress and reaches a nadir 2-4 weeks following symptom onset (patient diagnosed 12/17/2024). Approximately 40% of patients report no clinical improvement after reaching a plateau in four weeks. Additional benefit has typically not been seen in re-trial with second course of IVIG or pursuing plasma exchange (which may filter previously administered IVIG) in this timeframe. If there is progression of symptoms beyond 4 weeks of supportive care, can consider EMG/NCS for further evaluation of developing chronic autoimmune demyelinating polyneuropathy (CIDP) or alternative pathology.    1. AIDP secondary to RSV vaccine.
Age: 70.0
Sex: M
Vaccine: RV5
Symptoms: Magnetic resonance imaging head normal, Muscular weakness, Respiratory disorder, Scan with contrast normal, Unresponsive to stimuli
Clinical narrative: The patient recieved the RSV vaccine at Pharmacy on 12/4/2024. The patient presented to Health System on 12/17/2024. 70 y/o male admitted with progressive bilateral extremity weakness, areflexia, autonomic dysfunction, respiratory decline likely secondary to acute inflammatory demyelinating polyneuropathy (AIDP) in setting of recent RSV vaccination. IVIG completed 12/17-12/21/2024. Patient has had continued severe impairment and ventilator dependence. Intermittent unresponsiveness, may be secondary to hospital acquired delirium versus infectious encephalopathy (possible aspiration pneumonia) as MRI Brain, CTA H/N were unremarkable, POC EEG only showed diffuse slowing.    AIDP can continue to progress and reaches a nadir 2-4 weeks following symptom onset (patient diagnosed 12/17/2024). Approximately 40% of patients report no clinical improvement after reaching a plateau in four weeks. Additional benefit has typically not been seen in re-trial with second course of IVIG or pursuing plasma exchange (which may filter previously administered IVIG) in this timeframe. If there is progression of symptoms beyond 4 weeks of supportive care, can consider EMG/NCS for further evaluation of developing chronic autoimmune demyelinating polyneuropathy (CIDP) or alternative pathology.    1. AIDP secondary to RSV vaccine.
Age: 35.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Immune system disorder, Inflammation, Myocardial infarction
Clinical narrative: Heart Attack, inflamation, immune response change
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PRODUCT WAS 19 DAYS BEYOND USE DATE.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Patients reports developing a "hives like" rash that covered the left side of neck, shoulder and back starting 2-3 days after receiving COVID vaccine. Patient reports still has slight rash on neck, but it is improving (as of 12/30/24). The only treatment they have tried is occasional topical hydrocortisone 1% cream. No other s/sx of allergic reaction.  Patient has received Pfizer COVID vaccines in the past with no issues.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Family did not inform staff that client had received a flu shot in october. Later found in state registry
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection
Clinical narrative: pt says a few days after getting the vaccine broke out with a severe case of herpes out break- flare up. This was around her waist line and a few around her buttocks. She has been applying cool towels and using hydrocortisone cream. She normally take Acyclovir when she has a flare up but she has taken 2 doses and this has not helped at all. She believes that because on this medication she should not have taken this vaccine and the pharmacy should have asked her before giving it to her. She will contact her PCP to find out how to treat.
Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: NO ADVERSE REACTIONS.
Age: 24.0
Sex: M
Vaccine: MMR
Symptoms: Chills, Cough, Dyspnoea
Clinical narrative: Patient reports the day after immunization he had cough, shortness of breath, and chills for 2 days.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction reported by patient. Patient received an additional dose of Arexvy 12/21/2024. Patient received first vaccine 3/8/2024.
Age: 15.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Feeling cold, Immediate post-injection reaction, Pallor, Syncope
Clinical narrative: Vaccine was given, and pt had a vasovagal syncope within seconds of the administration. Pt became pale, cold and clammy.
Age: 6.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injection site erythema, Injection site swelling
Clinical narrative: Patient with her father came back to Pharmacy 4 days later after the vaccination. Father stated the injection site became swollen and red, no fever, did not experience any difficulty breathing. The swelling has subsided but red patches are now visible in other parts of the body (face, neck, stomach). I advised the father to have the child take benadryl and to call her pediatrician. I followed up after 2 days to check if the symptoms have subsided. The  mother stated  child is feeling better.
Age: 35.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Rash
Clinical narrative: Trash developed on torso before spreading to arm a week later. On the 17th took a hepatitis A vaccine by Glaxo SmithKline lot 4T93R
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema
Clinical narrative: pt developed arm redness, cellulitis ~24 hours from time of vaccine given at Pharmacy.  started on keflex for treatment.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Doctor ordered Moderna 5-12 patient was only 3 at a vaccine clinic, patient was given wrong age dose
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient had a rash that started on vaccinated arm and spread to other arm and back.
Age: 14.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness
Clinical narrative: patient did fine while I administered the vaccines and then announced he was going to pass out and his mother caught him.  He instantly woke back up and we provided a beverage and monitored him and made sure he was ok for several minutes.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given Proquad. Patient was to receive MMR and Varicella separately. Patient was not harmed and tolerated well.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Confusional state, Dizziness, Fall, Head injury, Loss of consciousness
Clinical narrative: After flu vaccine and PPD skin test were completed, patient had a syncopal episode and fell from the exam table with loss of consciousness when she landed on the floor. This FNP was unable to catch the patient and her head hit the ground. Patient woke up after approximately 10 seconds of loss of consciousness. Patient was confused about what happened but after a minute, she was alert and oriented x4. States she has never had a reaction like this to vaccines. States she did feel a little bit dizzy before passing out. Vital signs stable. Pupils PERRLA. Small laceration on nose bridge and bump on forehead from the fall. Ice pack given. No nausea/vomiting. Monitored patient for 20 minutes before parents came. Parents assisted patient to the car and states that they will take her to Hospital ED immediately to rule out possible concussion/other trauma. Discussed with parents to follow up with customer service line with any questions/concerns.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Skin laceration, Swelling face, Syncope, Tuberculin test
Clinical narrative: After flu vaccine and PPD skin test were completed, patient had a syncopal episode and fell from the exam table with loss of consciousness when she landed on the floor. This FNP was unable to catch the patient and her head hit the ground. Patient woke up after approximately 10 seconds of loss of consciousness. Patient was confused about what happened but after a minute, she was alert and oriented x4. States she has never had a reaction like this to vaccines. States she did feel a little bit dizzy before passing out. Vital signs stable. Pupils PERRLA. Small laceration on nose bridge and bump on forehead from the fall. Ice pack given. No nausea/vomiting. Monitored patient for 20 minutes before parents came. Parents assisted patient to the car and states that they will take her to Hospital ED immediately to rule out possible concussion/other trauma. Discussed with parents to follow up with customer service line with any questions/concerns.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Injection site rash, Paraesthesia, Rash
Clinical narrative: A few days after vaccination he experiencd headache and tingling in the arms and legs that he had not experienced before. He had a rash to the chest and upper arms as well. These persisted for 2 weeks and then resolved. They have not recurred since.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: diluted 5-11yr dose and gave 0.3ml
Age: 59.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Nothing observed at that time.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Received injection in left arm with Moderna ; later that afternoon started to feel pain in the injection area. Also started to feel warm at the injection area of my left arm. Additionally, it was redness almost like a deep purple,some swelling, and just itchiness in the area of the injection it started to spread across the arm. It lasted approximately 5 days now.. still have itchiness and some redness still there stop back by the pharmacy that gave me the COVID-19 Moderna shot to explain what I was experiencing and was informed to take Benadryl at the date in which I received the injection. I wasn?t given any paperwork so I didn?t know the lot number or any information pertaining to the shot that I had received and so I went back on 12/30 to retrieve that information at which point I was given that information based off of a card that I gave the pharmacist. Not sure if other are experiencing this issue with this lot. But I just wanted this on record because I have had about 8 shot before of the Moderna vaccine and I haven?t had any symptoms/issues/reactions. I?m sure that I might be leaving out some detail because this has been going on for a week now.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature fluctuation, Brain fog, Condition aggravated, Dizziness
Clinical narrative: Long COVID relapse. Increased fatigue, brain fog, headaches, finger numbness, body temperature dysregulation, vertigo, dizziness, facial numbness, high heart rate, joint pain. Treated with radical rest and pacing. Symptoms still ongoing.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Hypoaesthesia, Post-acute COVID-19 syndrome
Clinical narrative: Long COVID relapse. Increased fatigue, brain fog, headaches, finger numbness, body temperature dysregulation, vertigo, dizziness, facial numbness, high heart rate, joint pain. Treated with radical rest and pacing. Symptoms still ongoing.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Long COVID relapse. Increased fatigue, brain fog, headaches, finger numbness, body temperature dysregulation, vertigo, dizziness, facial numbness, high heart rate, joint pain. Treated with radical rest and pacing. Symptoms still ongoing.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Ear swelling, Erythema
Clinical narrative: Red and swollen RT ear
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Injection site pain, Pain in extremity
Clinical narrative: As vaccine was being administered, patient flinched and started complaining about the pain the injection was causing him during the injection. Patient stayed in the store several minutes to watch for an allergic reaction, none was observed. Patient came into store later complaining of severe arm pain, we referred him to Urgent Care or the ED
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: COVID vaccine given after BUD date.
Age: 26.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Arthritis, Autoimmune thyroiditis, Blood test abnormal, Ultrasound thyroid abnormal
Clinical narrative: Shortly after receiving the Covid vaccines I started to experience a myriad of symptoms. When I went to the Dr I was diagnosed with autoimmune thyroid disease (Hashimotos) I have had joint pain since and have arthritis. Will need to be on thyroid medication for the remainder of my life.
Age: 1.5
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: COVID was given after the BUD date. Parents notified patient will come back for another dose.
Age: 17.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Proquad when should have been given MMR and Varicella. Patient tolerated.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient called about 3 hours after receiving the covid vaccine and stated she had hives on some parts of body, no trouble breathing, no swelling. Patient was told to take Benadryl and to call their primary care doctor.  Patient was also told to go to the emergency room if symptoms worsened or if she had any trouble breathing or swelling. Pharmacist called patients primary care doctor to alert them.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given COVID vaccine past the BUD. Parents notified and patient will be revaccinated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Influenza like illness, Peripheral swelling, Rash
Clinical narrative: Pt stated they had their normal cold/flu like body aches like they typically do after a vaccine, but then 1 day later they had swelling in the injection arm w/ rash. Pt states that evening they took Benadryl and had debated utilizing their inhaler. 2 days after the injection, rash had proceeded to their trunk and down to top of legs. Patient required visit to urgent care for evaluation and treatment of rash.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discontinued product administered
Clinical narrative: old formulated covid vaccine was given before clinic was told to pull 2024 stock
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: Beyfortus vaccine 200 mg dose administered on the same anatomical site  (Right Vastus Lateralis) (2 X 100mg/ml). No adverse event noted. Flu vaccine administered on left Vastus Lateralis. PCP and pt's mother notified and mother given home care advice and encouraged to report any signs or symptoms to clinic.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Body tinea, Diarrhoea, Erythema, Pruritus, Swelling
Clinical narrative: I had itching, redness, swelling, ringworm, and diarrhea.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pt is a 33 yo G2P1001 at 31w3d with an EDD of 2/28/2025. She received an MMR vaccine at the Occupational Health Clinic at Hospital Center on 12/30/2024 at 0930 AM as part of onboarding for a new job. I saw her in the clinic 2 hours after vaccine administration for her routine OB appointment. She denied any symptoms at that time and reports telling the occupational health team that she was pregnant before any vaccine was administered.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC15, VARCEL
Symptoms: Extra dose administered, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I went to the 3rd nurse station to get the varicella and the MMR, I didn't triple check the medication I ordered what I needed gave and then went to enter the after I administered it. MMR I had didn't match asked a coworker and she then noticed it was that I grabbed MMRV. I then immediately went to both supervisors. And was instructed to talk with the PCP. TC outgoing call to Pt. Pt was called to advise MOC that he was given MMRV which is normally not given until 4 years of age due to the increased risk of febrile seizures and a dose of varicella. Using the interpreter the Mother stated she has an understanding to give the child Tylenol every 6 hours for the next 24 hours and watch for any high fevers and/or seizures. Mother was asked if she had any questions and she did not.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Blood test normal, Electrocardiogram ambulatory, Erythema, Pain in extremity
Clinical narrative: Severe redness and pain in arm x 5 days, pain down arm into armpit x 1 day, premature ventricular contractions (PVCs) x 18 days and still ongoing. Am currently on a Holter monitor. Am physically fit, exercise regularly, low BP, no cardiac vessel blockages, and do not take caffeine, tobacco, alcohol, etc. that would cause these arrhythmias. The PVCs occur all day and night x 18 days and still happening.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Ventricular extrasystoles
Clinical narrative: Severe redness and pain in arm x 5 days, pain down arm into armpit x 1 day, premature ventricular contractions (PVCs) x 18 days and still ongoing. Am currently on a Holter monitor. Am physically fit, exercise regularly, low BP, no cardiac vessel blockages, and do not take caffeine, tobacco, alcohol, etc. that would cause these arrhythmias. The PVCs occur all day and night x 18 days and still happening.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Atrial fibrillation, CSF glucose increased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count negative
Clinical narrative: Guillain Barre Syndrome  ...Spinal tap 11/14/24  RBC: 1 WBC: 0 Prot: 211 Gluc: 97
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Magnetic resonance imaging
Clinical narrative: Guillain Barre Syndrome  ...Spinal tap 11/14/24  RBC: 1 WBC: 0 Prot: 211 Gluc: 97
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Autoimmune disorder, Brain fog, Computerised tomogram heart, Depression
Clinical narrative: Myocarditis, exercise resistance, autoimmune disorder, racing heart, brain fog, mood swings, depression and anxiety
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Exercise tolerance decreased, Magnetic resonance imaging heart
Clinical narrative: Myocarditis, exercise resistance, autoimmune disorder, racing heart, brain fog, mood swings, depression and anxiety
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Mood swings, Myocarditis, Palpitations, Scan with contrast
Clinical narrative: Myocarditis, exercise resistance, autoimmune disorder, racing heart, brain fog, mood swings, depression and anxiety
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Wrong product administered
Clinical narrative: dose of GARDASIL 9 given to a pregnant patient.; No symptoms reported.; Pt pregnant given Gardasil instead of TDAP; This spontaneous prospective pregnancy report has been received from a medical assistant, referring to a 26-year-old female patient. The information regarding the patient's concurrent conditions, concomitant therapies or medical history was not provided.  The patient was pregnant. Her last menstrual period (LMP) date was estimated to 2024, and the estimated date of delivery (EDD) was unknown.  On 06-DEC-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5 mL, administered in arm, lot# Y007197, expiry date 18-AUG-2026, for prophylaxis (route of administration and exact anatomical location were not reported) (exposure during pregnancy); the vaccine was administered instead of diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (wrong product administered).  Pregnancy outcome was outcome pending. Fetal outcome was unknown. No symptoms were reported (no adverse event).
Age: 0.17
Sex: F
Vaccine: HEP, HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No symptoms or side effects reported; 11 week old received VAQTA inadvertently instead of RECOMBIVAXHB, medication error; This spontaneous report was received from a medical assistant and refers to an 11-week-old female patient.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 19-DEC-2024, the patient was inadvertently vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter once, lot #Y011731, expiration date: 25-OCT-2025, administered for prophylaxis (strength, and route of administration were not provided) instead of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength, dose description, lot #, expiry date, and route of administration were not provided) (wrong vaccine administered).  No symptoms or side effects were reported. Medical assistant inquired about recommendations if hepatitis a vaccine, inactivated (VAQTA) given in infant below 12 months of age as well as recommendations on whether to administer hepatitis b vaccine (recombinant) (RECOMBIVAX HB).
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: HCP drew titers which showed the initial series did not yield protection; she administered a pediatric dose and the patient was 20 years old at the time of booster dose.; This spontaneous report has been received from a physician, referring a 20-year-old patient of unknown gender. The patient's medical history, previous adverse drug reactions, drug allergy, concurrent conditions, and concomitant medication were not provided.   On unspecified date (reported as when patient was an infant), the patient was vaccinated with first, second, and third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) injection (strength, dose, frequency, route of administration, site of administration, vaccination scheme, lot #, and expiration date were not provided) as a prophylaxis. On unspecified date, the physician drew titers which showed the initial series did not yield protection (hepatitis B surface antibody negative). In consequence, the patient was vaccinated with a booster pediatric dose (incorrect dose administered) of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) injection, (strength, dose, frequency, route of administration, site of administration, vaccination scheme, lot #, and expiration date were not provided) as a prophylaxis. No additional information was available.   The causal relationship between suspect vaccine with the event of hepatitis B surface antibody negative was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: only received 1 dose and has not gone back for the second dose; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 1 year ago on an unknown date).   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: only received 1 dose and has not gone back for the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The pharmacist reported that a patient started the Shingrix series, but only received 1 dose and has not gone back for second dose. Other company adverse event had been filed due to the patient not finishing the Shingrix series. No PQC (product quality complaint) was reported. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to an incomplete course of vaccination. No additional information was available.
Age: 12.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number 4L274, expiry date SEP-2024) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number TD2FD) for prophylaxis.   On 20-AUG-2024, the patient received the 1st dose of Bexsero (intramuscular, right deltoid) and the 1st dose of Boostrix (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Bexsero and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 02-DEC-2024 The patient received Bexsero and Boostrix vaccine after temperature excursion, which led to incorrect storage of drug. This was 1 of 16 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR153916:Original Case : US2024AMR153742 US-GSK-US2024AMR153917:Original Case : US2024AMR153742 US-GSK-US2024AMR153918:Original Case : US2024AMR153742 US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024AMR153920:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153924:Original Case : US2024AMR153742 US-GSK-US2024AMR153925:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024123266:Same reporter
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date JAN-2025) for prophylaxis.   On 20-AUG-2024, the patient received the 1st dose of Kinrix (intramuscular, right thigh). On an unknown date, an unknown time after receiving Kinrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 02-DEC-2024 The patient received Kinrix vaccine after temperature excursion, which led to incorrect storage of drug. This was 1 of 16 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR153916:Original Case : US2024AMR153742 US-GSK-US2024AMR153917:Original Case : US2024AMR153742 US-GSK-US2024AMR153918:Original Case : US2024AMR153742 US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024AMR153742:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153924:Original Case : US2024AMR153742 US-GSK-US2024AMR153925:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: the patient received Havrixvaccine after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 9-year-old female patient who received HAV (Havrix) (batch number TF27T, expiry date FEB-2026) for prophylaxis.   On 21-AUG-2024, the patient received the 2nd dose of Havrix (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: the patient received Havrixvaccine after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 02-DEC-2024 The patient received Havrix vaccine after temperature excursion, which led to incorrect storage of drug. This was 1 of 16 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR153916:same reporter US-GSK-US2024AMR153917:same reporter US-GSK-US2024AMR153918:same reporter US-GSK-US2024AMR153919:same reporter US-GSK-US2024AMR153920:same reporter US-GSK-US2024AMR153921:same reporter US-GSK-US2024AMR153922:same reporter US-GSK-US2024AMR153923:same reporter US-GSK-US2024AMR153924:same reporter US-GSK-US2024AMR153925:same reporter US-GSK-US2024AMR153926:same reporter US-GSK-US2024AMR153742:same reporter US-GSK-US2024AMR153928:same reporter US-GSK-US2024123266:same reporter US-GSK-US2024123268:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles vaccine did not stop my recurrent 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.   The patient's past medical history included shingles. Concomitant products included semaglutide (Ozempic).   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: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles vaccine did not stop my recurrent shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-DEC-2024 This case was reported by a patient via interactive digital media.  Reporter stated that shingles vaccine did not stopped his/her recurrent shingles, but ozempic seems to lessen amount of outbreaks. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got Shingles; Had three shots; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got Shingles) and extra dose administered (Verbatim: Had three shots). The outcome of the vaccination failure and shingles were not reported and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-DEC-2024 This case was reported by a patient via interactive digital media. The reporter self reported that had three shots, got shingles, you did not want it. The reporter had three shots which leads to extra dose administered. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1, Dose 2 and extra dose-Dose 3).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles on ear; Shingles on face, head and neck; 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: suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: Shingles on ear) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on face, head and neck). The outcome of the vaccination failure was not reported and the outcome of the herpes zoster otitis externa and shingles were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and herpes zoster otitis externa to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-DEC-2024 This case was reported by a patient via interactive digital media. The patient received the Shingles vaccine and got shingles now (on the day of reporting). The patient was told it could last 6 to 8 weeks. The physician suggested that if patient had not received the vaccine, his/her shingles would have gotten it worse.  The patient had shingles on his/her face, head, ear and neck. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.  Herpes zoster oticus is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Rash
Clinical narrative: rash on arm; got very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   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 rash (Verbatim: rash on arm) and sickness (Verbatim: got very sick). The outcome of the rash and sickness were not reported.   It was unknown if the reporter considered the rash and sickness to be related to Shingles vaccine.     It was unknown if the company considered the rash and sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-DEC-2024 This case was reported by a patient via interactive digital media. Reporter reported that his/her daughter got a large rash on her arm with injected vaccine.  The reporter's friend and daughter took new shot and got very sick.  The reporter's daughter only took one because her doctor did not want her to pursue the second.  She had auto immune disease due to rheumatoid arthritis. The follow-up could not be possible as no contact details were available.  This case is linked with US2024AMR160819 and US2024AMR160913, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR160819:same reporter US-GSK-US2024AMR160913:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: got very 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: 16-DEC-2024 This case was reported by a patient via interactive digital media. Reporter reported that his/her friend and daughter took new shot and got very sick.  His/her friend took both injections. The follow-up could not be possible as no contact details were available.  This case is linked with US2024AMR160819 and US2024AMR160912, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR160912:same reporter US-GSK-US2024AMR160819:same reporter
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Headache
Clinical narrative: Flu-like symptoms; COVID like symptoms; No smell; No taste; Achy joints; fever; chills; headache; coughing up some thick phlegm; sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 74-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis.   In NOV-2024, the patient received Fluarix 2024-2025 season. In NOV-2024, immediately after receiving Fluarix 2024-2025 season, the patient experienced influenza-like symptoms (Verbatim: Flu-like symptoms), symptomatic covid-19 (Verbatim: COVID like symptoms), loss of smell (Verbatim: No smell), taste absent (Verbatim: No taste), joint pain (Verbatim: Achy joints), fever (Verbatim: fever), chills (Verbatim: chills), headache (Verbatim: headache), phlegm (Verbatim: coughing up some thick phlegm) and sickness (Verbatim: sick). The outcome of the influenza-like symptoms, symptomatic covid-19, loss of smell, taste absent, joint pain, fever, chills, headache and phlegm were unknown and the outcome of the sickness was not reported.   The reporter considered the influenza-like symptoms, symptomatic covid-19, loss of smell, taste absent, joint pain, fever, chills, headache, phlegm and sickness to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the influenza-like symptoms, symptomatic covid-19, loss of smell, taste absent, joint pain, fever, chills, headache, phlegm and sickness to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   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: 01-DEC-2024 The reporter reported that the patient had a Fluarix flu vaccine given to the patient a week ago and immediately got reaction from it, flu and covid like symptoms, no taste or smell, achy joints, fever, chills, headache, the patient had it. The patient had been coughing up some thick phlegm. The patient lungs and sinuses and the patient was on antibiotics name. the patient would be 75 in January and the patient never had a reaction from any flu shot. The patient did not know if they all did not use an egg base, it was made in (redacted), so the patient did not know what kind of mammal or what it was grown in but apparently it was still alive when it got in the patient and the patient was going to go monday to the health department when they open after the holiday and got a covid test. The patient did not get sick until the patient had this flu shot, it was caused from the shot, it ought to be taken off the market in the patient opinion.
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Influenza like illness, Malaise, Productive cough, Pyrexia
Clinical narrative: Flu-like symptoms; COVID like symptoms; No smell; No taste; Achy joints; fever; chills; headache; coughing up some thick phlegm; sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 74-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) for prophylaxis.   In NOV-2024, the patient received Fluarix 2024-2025 season. In NOV-2024, immediately after receiving Fluarix 2024-2025 season, the patient experienced influenza-like symptoms (Verbatim: Flu-like symptoms), symptomatic covid-19 (Verbatim: COVID like symptoms), loss of smell (Verbatim: No smell), taste absent (Verbatim: No taste), joint pain (Verbatim: Achy joints), fever (Verbatim: fever), chills (Verbatim: chills), headache (Verbatim: headache), phlegm (Verbatim: coughing up some thick phlegm) and sickness (Verbatim: sick). The outcome of the influenza-like symptoms, symptomatic covid-19, loss of smell, taste absent, joint pain, fever, chills, headache and phlegm were unknown and the outcome of the sickness was not reported.   The reporter considered the influenza-like symptoms, symptomatic covid-19, loss of smell, taste absent, joint pain, fever, chills, headache, phlegm and sickness to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.     The company considered the influenza-like symptoms, symptomatic covid-19, loss of smell, taste absent, joint pain, fever, chills, headache, phlegm and sickness to be related to Fluarix 2024-2025 season and Fluarix Pre-Filled Syringe Device.   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: 01-DEC-2024 The reporter reported that the patient had a Fluarix flu vaccine given to the patient a week ago and immediately got reaction from it, flu and covid like symptoms, no taste or smell, achy joints, fever, chills, headache, the patient had it. The patient had been coughing up some thick phlegm. The patient lungs and sinuses and the patient was on antibiotics name. the patient would be 75 in January and the patient never had a reaction from any flu shot. The patient did not know if they all did not use an egg base, it was made in (redacted), so the patient did not know what kind of mammal or what it was grown in but apparently it was still alive when it got in the patient and the patient was going to go monday to the health department when they open after the holiday and got a covid test. The patient did not get sick until the patient had this flu shot, it was caused from the shot, it ought to be taken off the market in the patient opinion.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: longer interval between doses/lot of people with a big gap between doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose on an unknown date).   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 drug dose administration interval too long (Verbatim: longer interval between doses/lot of people with a big gap between doses). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 03-DEC-2024 Pharmacist called inquiring about effectiveness data after 1 dose of Shingrix and requested information on the gap between recommended time between doses being more than 6 months e.g. a couple years. She stated that they had lot of people with a big gap between doses, but pharmacist could not provide details on how many patients. The patients received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose on 8-OCT-2024 (late dose); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient received first dose of Shingrix on 12-APR-2023).   On 08-OCT-2024, the patient received the 2nd dose of Shingrix. On 08-OCT-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received the second dose on 8-OCT-2024 (late dose)). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2024 Pharmacist stated that a female patient received her first dose of Shingrix on 12-APR-2023 and then received the second dose on 8-OCT-2024 (late dose). No further information was available such as patient demographics or site of injection.  HCP declined to provide any patient demographics The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.