chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PPV
Symptoms: Pneumonia pneumococcal
Clinical narrative: Streptococcus pneumoniae pneumonia; This spontaneous report has been downloaded from Regulatory Authority and refers to an Elderly male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccianted with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 3 times, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023, the patient experienced Streptococcus pneumoniae pneumonia. At the time of reporting, the outcome was not known. The action taken was Not Applicable.  The causal relationship was unknown.   Upon internal review, the event was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Pneumococcal infection
Clinical narrative: Pneumococcal infection; This spontaneous report has been downloaded from Regulatory Authority and refers to an Elderly male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was vaccianted with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, 1 time, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in 2023, the patient experienced Pneumococcal infection. At the time of reporting, the outcome was not known. The action taken was Not Applicable.  The causal relationship was unknown.   Upon internal review, the event was determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Meningitis
Clinical narrative: Meningitis; Information was received by The Regulatory Authority via Case Line Listing and from a company representative on 25-NOV-2024 concerning an adult (reported as 50-54 years old) female patient. The patient's concurrent condition, medical history and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (serotype unknown) (dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis.  On an unknown date in 2023, the patient experienced meningitis (meningitis pneumococcal). On an unknown date in 2023, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was not provided.  The causal relationship between meningitis pneumococcal and 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of meningitis pneumococcal was determined to be medically significant.
Sex: M
Vaccine: PNC13, PPV
Symptoms: Pneumococcal infection
Clinical narrative: No data provided; Information was received by The Regulatory Authority via Case Line Listing and from a company representative on 25-NOV-2024 concerning an adult (reported as 50-54 years old) male patient. The patient's concurrent condition, medical history and concomitant medication were not provided.  On unknown dates, the patient was vaccinated with two doses of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection (vaccine not available for serotype) (dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis; and with a dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (vaccine not available for serotype) (formulation, dose, lot #, expiry date, and route of administration were not provided) administered for prophylaxis.  On an unknown date in 2023, the patient experienced pneumococcal infection (not data provided). On an unknown date in 2023, streptococcus pneumoniae serotyping was not available. At the time of reporting, the outcome of the event was not provided.  The causal relationship between pneumococcal infection and 23v polysaccharide vaccine (PNEUMOVAX23) was not reported.  Upon internal review, the event of pneumococcal infection was determined to be medically significant.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Red patch and lump at shot site which hurt for 3 days, chills fever and sweating for 3 days,  felt sick for 3 days.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Red patch and lump at shot site which hurt for 3 days, chills fever and sweating for 3 days,  felt sick for 3 days.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: I gave patient a Pneumovax 23 vaccine at his annual physical appointment at the clinic on11/15/2024 at approximately 2:45pm. I donned gloves, cleaned the site with alcohol, and injected the vaccine in his left deltoid IM.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Very swollen at area of shot, red, hot to touch, increase swelling since day of shot, painful
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV1
Symptoms: Urticaria
Clinical narrative: Patient began breaking out in hives all over his body, primarily on his left side. He was taken to the Emergency Department and given Benadryl and the hives subsided.
Age: 4.0
Sex: F
Vaccine: IPV
Symptoms: Affective disorder, Amnesia, Pain in extremity, Pyrexia
Clinical narrative: fever up to 104  w/ feet/leg pain starting day after vaccine, once fever broke after 2 days, mom noted ? memory lapse and some volatility w/ mood
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: pt received the flu shot in sept of 2024 and then again in nov of 2024
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Dyspnoea, Echocardiogram, Fatigue
Clinical narrative: pt had labored breathing, was dizzy, and had difficulty walking. His heart was a 110. He was fatigued and his breathing was labored. He called his doctor and was told to monitor it on his smart watch. Every time it happened it was very irratic. He could only walk about 50 feet with out him being very fatigued. On Nov 27th his went to his cardiologist doctor Dr., and was told this was a reaction from the vaccine and told to keep monitoring his heart rate, write it down and to come back to see him again in Jan unless he needs to see him sooner. He was prescibed him metoprolol tartrate 25mg to take anytime his heart rate goes over 100. This seems to help bring his heart rate down to about 90-80 hrpm. According to the reading of the cardiogram, the doctor seemed to think things were coming back down to normal. --Flu vaccine office on 11/5/2024
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Heart rate increased
Clinical narrative: pt had labored breathing, was dizzy, and had difficulty walking. His heart was a 110. He was fatigued and his breathing was labored. He called his doctor and was told to monitor it on his smart watch. Every time it happened it was very irratic. He could only walk about 50 feet with out him being very fatigued. On Nov 27th his went to his cardiologist doctor Dr., and was told this was a reaction from the vaccine and told to keep monitoring his heart rate, write it down and to come back to see him again in Jan unless he needs to see him sooner. He was prescibed him metoprolol tartrate 25mg to take anytime his heart rate goes over 100. This seems to help bring his heart rate down to about 90-80 hrpm. According to the reading of the cardiogram, the doctor seemed to think things were coming back down to normal. --Flu vaccine office on 11/5/2024
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site pruritus, Injection site swelling
Clinical narrative: patients had swelling, discoloration, pain and itching at injection site beginning 2 days after the vaccine and continuing for 2 more days
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given the incorrect flu vaccine. Was to get low dose but received high dose. Patient did not display any adverse reactions.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Inflammation, Laboratory test, Retinal disorder, Visual impairment
Clinical narrative: Within a few days, started having vision issues in right eye.  Partial loss of vision that would last between 10-20 minutes.  Experienced very dry eyes.  Made appointment with the ophthalmologist who referred me to a retina specialist due to abnormality around the retina.  After a long series of tests,  it was determined to be an inflammation around the retina, that after 2.5 months has started to resolve itself.   They did not find the exact cause of this inflammation, but due to it's start to the proximity of the latest COVID vaccine, I am  reporting it to the CDC>
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Anosmia, Chills, Cough, Oropharyngeal pain
Clinical narrative: 2 days afterward 11/24/24 I got sore throat , 4th day 11/26/26 full blown symptoms chills fever cough runny nose, achey body, no smell or taste! Got worse Wednesday 11/25/24 went to urgent care walk in clinic got prescription for amoxicillin twice/day x7 days
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: 2 days afterward 11/24/24 I got sore throat , 4th day 11/26/26 full blown symptoms chills fever cough runny nose, achey body, no smell or taste! Got worse Wednesday 11/25/24 went to urgent care walk in clinic got prescription for amoxicillin twice/day x7 days
Age: 82.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Contusion, Pain in extremity, Tenderness
Clinical narrative: Patient reported a bruised and sore arm and still tender to the touch two months after vaccine was given. After consultation, patient told pharmacist that she is on a blood thinner and confirmed she is not having any other adverse effects and was advised to inform her primary care provider.
Age: 15.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: After completing the vaccinations the patient briefly fainted upon standing. He regained consciousness a few seconds later. No injuries reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Malaise, Pyrexia, Respiratory disorder
Clinical narrative: Respiratory, sinus, cough, congestion, malaise, fatigue, low grade fever. Over the counter guafiesine, decongestant, acetaminophen as needed. Nyquil at night. Seeing doctor on Tuesday
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Sinus disorder
Clinical narrative: Respiratory, sinus, cough, congestion, malaise, fatigue, low grade fever. Over the counter guafiesine, decongestant, acetaminophen as needed. Nyquil at night. Seeing doctor on Tuesday
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pain, Pain in extremity, Sleep disorder
Clinical narrative: I was awakened from the pain in both my forearms and shivering. Put on another blanket and still kept shivering. These side effects were accompanied by headaches. I went and took (2) Advil ibuprofen 200mg gel tablets. Throughout the next day I felt out of sorts with regard to my normal physical condition, just a general weakness with some minor aches and pain. Upon retiring for bed, I took another dose of Advil. 11/29/2024 Slept thru the night, except for a trip to the bathroom. Upon awakening in the morning, I feel back to normal, no side effects from the Vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Depression, Extremity contracture, Insomnia
Clinical narrative: Insomnia, muscle soreness from unconscious clenching (legs), worsened anxiety and depression
Age: 75.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: No immediate pain or reaction after the dose. Began to develop itching at the site on Tuesday night 11/26 and when he tried to scratch it was hurting too. On Wednesday the 27th it began to be painful and red at injection site.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, HPV9
Symptoms: No adverse event, Product lot number issue
Clinical narrative: While running a lot number report this patient has this HPV vaccine lot number as a received PCV vaccine. Unsure if patient actually  receive HPV or not. No adverse events were reported and after speaking with mother none were reported. (it has bee over a year but nothing significant mom can recall)
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Antibody test, Antinuclear antibody, Antiphospholipid antibodies, Antithrombin III
Clinical narrative: I?ve had repeated blood clots since 2021. 2 DVTs this year alone with multiple superficial clots as well.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: B-cell leukaemia/lymphoma panel, Beta-2 glycoprotein antibody, Blood erythropoietin, Blood homocysteine, Blood immunoglobulin A
Clinical narrative: I?ve had repeated blood clots since 2021. 2 DVTs this year alone with multiple superficial clots as well.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron, Blood lactate dehydrogenase, Blood smear test, Blood testosterone decreased, Cardiolipin antibody
Clinical narrative: I?ve had repeated blood clots since 2021. 2 DVTs this year alone with multiple superficial clots as well.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Differential white blood cell count, Double stranded DNA antibody, Echocardiogram, Iron binding capacity total
Clinical narrative: I?ve had repeated blood clots since 2021. 2 DVTs this year alone with multiple superficial clots as well.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Metabolic function test, Protein C, Protein S, Prothrombin level
Clinical narrative: I?ve had repeated blood clots since 2021. 2 DVTs this year alone with multiple superficial clots as well.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid factor, Serum ferritin, Superficial vein thrombosis, Ultrasound scan
Clinical narrative: I?ve had repeated blood clots since 2021. 2 DVTs this year alone with multiple superficial clots as well.
Age: 68.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood pressure increased, Computerised tomogram head normal, Full blood count normal, Headache, Hypertensive urgency
Clinical narrative: hypertensive urgency:  new headache primarily with newly noted elevated blood pressure 190s
Age: 68.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Renal function test normal
Clinical narrative: hypertensive urgency:  new headache primarily with newly noted elevated blood pressure 190s
Age: 2.0
Sex: F
Vaccine: HIBV, PNC20
Symptoms: Extra dose administered
Clinical narrative: Vaccines administered that were unnecessary. Child had already completed the recommended amount of doses and should not have received either vaccine.
Age: 75.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Patient reported her left arm started hurting the day after the vaccine.  It hurts to lift her arm up and to sleep on it.  The pain radiates down her entire arm to her hands and up into her neck. She said it is not red or warm to the touch.  It occasionally goes away but comes back.  It has been happening since then.  She doesn't know if it is directly related or not but I advised her to seek medical attention (which she is not sure she is going to do).  She informed us today 11/29/24.
Age: 49.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: The patient reports that their upper left arm had swollen to about twice its normal size in the days following the vaccine.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Muscle contractions involuntary
Clinical narrative: Uncontrollable shivering, bordering on seizure. Strong muscle contractions in the legs and arms. Lasted for forty minutes before subsiding.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: WARM, RED SKIN ON THE LOWERPART OF DELTOID AREA
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Impaired driving ability, Insomnia, Mental impairment, Photophobia
Clinical narrative: Led to mental health deterioration (insomnia, unable to operate vehicle, sensitivity to light, depression). Went to psychiatrist who prescribed SSRI which was ineffective. Medications were changed multiple times nevertheless were ineffective. Meanwhile my mental health continued to deteriorate and led to multiple hospitalizations one of which was in a behavioral health unit for a longer period of time.
Age: 57.0
Sex: F
Vaccine: VARZOS, COVID19, VARZOS
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: Patient reported swelling of the hands and feet and trouble breathing and visited the emergency room
Age: 57.0
Sex: F
Vaccine: VARZOS, COVID19, VARZOS
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: Patient reports swelling of the hands and feet and trouble breathing from vaccine. Time and date of symptom onset is not known by reporter
Age: 61.0
Sex: F
Vaccine: COVID19, FLU3, PNC20
Symptoms: Erythema, Pain
Clinical narrative: Patient had redness on right arm. Pain in area. Patient was instructed on 11/27 to put ice and take tylenol for pain. Patient came to pharmacy on 11/29 , redness still on right arm, looks like a red ring forming. Pain slightly decreasing, but still have some pain. Instructed patient to continue to use tylenol and ice for pain.  Instruct patient to follow up with primary care doctor.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Food allergy, Injection site erythema, Injection site warmth
Clinical narrative: Pt reported swelling, redness and warmth to the touch from the should to the elbow of the arm in which the vaccine was administered
Age: 37.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles at the base of my spine appeared the evening of 11/22/2024
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral thrombosis, Computerised tomogram head abnormal, Ischaemic stroke, Magnetic resonance imaging head abnormal, Thrombectomy
Clinical narrative: I had a stroke and it was deemed a "stroke of unknown etiology".   It was an Ischemic stroke.  Because I had no known risk factors and the doctors were unable to identify a source of the clot, I took it upon myself to report to VAERS in case for some reason it is linked to clotting that has been caused by the COVID vaccine.
Age: 62.0
Sex: F
Vaccine: PNC21
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: RED; WARM TO TOUCH; LARGE AREA OF SWELLING, ITCHY
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported.; HCP called for TE for ROTATEQ see TE case 02707452. Products were administered to patients; This spontaneous report was received from a medical assistant referring to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-NOV-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #Y003753, expiration date: 18-OCT-2025, administered orally for prophylaxis (strength and dose not provided) which experienced temperature excursion (TE) below 36 degree Fahrenheit (F) (-28.86F) for 0 hours 2 minutes and 0 seconds (Product storage error). Not supported and no previous TE. No adverse side effects were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2411USA006032: US-009507513-2411USA006083: US-009507513-2411USA006295: US-009507513-2411USA006155:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Medical assistant called to report an expired dose of PNEUMOVAX 23 was administered to a patient. Caller stated the dose expired on 11/22/2024 and was administered on 11/26/2024. Caller stated no patient symptoms have been reported and the product wa; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 26-NOV-2024, the patient was vaccinated with Dose 1 of pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23), formulation: injection, lot # X014729, expiration date: 22-NOV-2024 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Ear infection, Ear irrigation, Otorrhoea, Pain
Clinical narrative: Hearing loss; pain; This serious case was reported by a consumer and described the occurrence of hearing loss in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high. Concomitant products included atenolol.   On 30-AUG-2024, the patient received Shingrix. On 31-AUG-2024, 1 days after receiving Shingrix, the patient experienced hearing loss (Verbatim: Hearing loss) (serious criteria GSK medically significant) and pain (Verbatim: pain). The outcome of the hearing loss and pain were not resolved.   It was unknown if the reporter considered the hearing loss and pain to be related to Shingrix.     The company considered the hearing loss to be unrelated to Shingrix. It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date:30-OCT-2024 Consumer reported that she took the Shingrix vaccine after that she initially received oral antibiotics as well as antibiotic ear drops, the symptoms did not go away, repeated another course of the antibiotic ear drops, symptoms persisted.  The ear irrigated by her doctor, but symptoms did not go away and lots of fluid drained from her right ear daily. She was then put on steroid drops, on her last day of treatment today, symptoms seem to have eased but she stated that, will see what happens once she off the drops.  The symptoms initially started the day after Shingrix shot and to the best of recollection she never had an such ear infection before  in life.; Sender's Comments: Deafness is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Myalgia; This non-serious case was reported by a physician via sales rep and described the occurrence of myalgia 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 myalgia (Verbatim: Myalgia). The outcome of the myalgia was resolved.   The reporter considered the myalgia to be related to Shingrix.     The company considered the myalgia to be related to Shingrix.   Additional Information: GSK receipt date: 31-OCT-2024 The patient received the Shingrix vaccine and experienced Myalgia.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Vomiting
Clinical narrative: double the aches/pains; vomiting,; sickest she has ever been in 82 years/length of time sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-NOV-2019, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: double the aches/pains), sickness (Verbatim: sickest she has ever been in 82 years/length of time sick) and vomiting (Verbatim: vomiting,). The outcome of the pain and vomiting were unknown and the outcome of the sickness was resolved (duration 3 days).   It was unknown if the reporter considered the pain, sickness and vomiting to be related to Shingrix.     It was unknown if the company considered the pain, sickness and vomiting to be related to Shingrix.   Linked case(s) involving the same patient:  US2024135630, US2024AMR144867   Additional Information: GSK Receipt Date: 31-OCT-2024 The patient reported that she received the first dose of Shingrix and had a really bad reaction to both vaccines. The patient reported that she was the sickest she has ever been in 82 years after receiving both the first and second dose of Shingrix. The patient reports that she had double the aches, pains, vomiting, and length of time sick after both the first and second dose of Shingrix, as compared to how she felt after receiving Arexvy. The patient reports that she was sick for 3 full days/72 hours after both the first and second doses of Shingrix. This case is linked with US2024135630 and US2024AMR144867, same patient.; Sender's Comments:  US-GSK-US2024AMR144867:same patient/ dose 2 case US-GSK-US2024135630:
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Impaired work ability, Loss of personal independence in daily activities, Pain
Clinical narrative: Suspected vaccination failure; still got shingles/I got the shot, and still got shingles; This serious case was reported by a pharmacist via interactive digital media and described the occurrence of vaccination failure in a male 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles/I got the shot, and still got 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-NOV-2024 This case was reported by a pharmacist via interactive digital media The reporter had no idea that the shingles could be that debilitating. The patient got the shot (Shingrix) and still got shingles. The patient said to reporter the excruciating pain he felt when he was diagnosed with shingles.  The rash lasted for weeks and the pain kept him from work and spending time with friends and family.  The reporter heard his experience and said he/she knew that did not want to take a chance and talked to his/her doctor about protecting himself or herself from shingles. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles/I got the shot, and still got shingles; This serious case was reported by a pharmacist via interactive digital media and described the occurrence of vaccination failure in a male 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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles/I got the shot, and still got 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-NOV-2024 This case was reported by a pharmacist via interactive digital media The reporter had no idea that the shingles could be that debilitating. The patient got the shot (Shingrix) and still got shingles. The patient said to reporter the excruciating pain he felt when he was diagnosed with shingles.  The rash lasted for weeks and the pain kept him from work and spending time with friends and family.  The reporter heard his experience and said he/she knew that did not want to take a chance and talked to his/her doctor about protecting himself or herself from shingles. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Migraine, Pain, Post herpetic neuralgia
Clinical narrative: Suspected vaccination failure; still got shingles; postherpetic neuralgia; migraines; 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 chickenpox.   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), shingles (Verbatim: still got shingles), post herpetic neuralgia (Verbatim: postherpetic neuralgia) and migraine (Verbatim: migraines). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia and migraine were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and migraine 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, post herpetic neuralgia and migraine to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-NOV-2024 The case was received from the patient via interactive digital media. The patient had the shingles vaccine and still got shingles. Now dealing with postherpetic neuralgia, migraines and fatigue. The patient started an antiviral right away too. The patient knew about shingles, just not how painful they could be long term. 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.; 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.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles; postherpetic neuralgia; migraines; 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 chickenpox.   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), shingles (Verbatim: still got shingles), post herpetic neuralgia (Verbatim: postherpetic neuralgia) and migraine (Verbatim: migraines). The outcome of the vaccination failure and shingles were not reported and the outcome of the post herpetic neuralgia and migraine were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia and migraine 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, post herpetic neuralgia and migraine to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 19-NOV-2024 The case was received from the patient via interactive digital media. The patient had the shingles vaccine and still got shingles. Now dealing with postherpetic neuralgia, migraines and fatigue. The patient started an antiviral right away too. The patient knew about shingles, just not how painful they could be long term. 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.; 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.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: 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.   Previously administered products included Shingrix with an associated reaction of illness (For tolerance of 1st dose refer case US2024AMR136288).   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: sick). Rechallenge with Shingles vaccine was positive. 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: 30-OCT-2024 This case was reported by a patient via interactive digital media. The reporter's daughter got really sick from both of Shingrix doses. The reporter guess it would be better than another bought of shingles. The follow-up could not be possible as no contact details were available. For tolerance of 1st dose refer case US2024AMR136288.; Sender's Comments:  US-GSK-US2024AMR136288:Same patient/ another dose
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 425CR, expiry date 10-AUG-2026) for prophylaxis.   On 30-OCT-2024, the patient received Shingrix (unknown deltoid). On 30-OCT-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-OCT-2024 HCP (occupational health nurse) reported that on 30-OCT-2024, a patient mistakenly received Shingrix adjuvant only, rather than the reconstituted vaccine (AE Inappropriate Reconstitution Technique). Nothing else was reported. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 72-year-old male patient who received HBV (Engerix B) (batch number 8X2D5, expiry date 07-SEP-2024) for prophylaxis.   Previously administered products included Engerix B (received the first Engerix-B in September 2023 of lot number C44K4 and expiry date 07-DEC-2024).   In SEP-2024, the patient received the 2nd dose of Engerix B. In SEP-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long 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: 30-OCT-2024 The patient received second dose of Engerix B later than the recommended interval, which led to drug dose administration interval too long. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose; This non-serious case was reported by a physician via sales rep 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 5 years ago).   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: Late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 31-OCT-2024 The patient asked if they need to repeat their first shot or just complete the series with the second dose. Till the time o reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the third 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 adult patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (Patient received first dose of Engerix B in 2021) and Engerix B (Patient received second dose of Engerix B in 2021).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: never received the third dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-OCT-2024 Pharmacist reported that the patient received two Engerix-B doses but patient had never received the third dose. No further patient's information available. The reporter did not consent to follow-up. VAERS details provided corresponding to the previous dose and the case is an incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: hard at injection site; puffy at injection site; injection site redness/large red area at injection site; injection site pain; felt feverish; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site induration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28-OCT-2024, the patient received Shingrix (left arm). In OCT-2024, an unknown time after receiving Shingrix, the patient experienced injection site induration (Verbatim: hard at injection site), injection site swelling (Verbatim: puffy at injection site), injection site erythema (Verbatim: injection site redness/large red area at injection site), injection site pain (Verbatim: injection site pain) and feeling hot (Verbatim: felt feverish). The patient was treated with paracetamol (Tylenol). The outcome of the injection site induration, injection site swelling, injection site erythema, injection site pain and feeling hot were unknown.   It was unknown if the reporter considered the injection site induration, injection site swelling, injection site erythema, injection site pain and feeling hot to be related to Shingrix.     It was unknown if the company considered the injection site induration, injection site swelling, injection site erythema, injection site pain and feeling hot to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-OCT-2024 Husband was the reporter called on behalf of his wife (patient). Reporter stated that, she received a Shingrix vaccine, and she had injection site pain, injection site redness, puffy at injection site, hard at injection site and the site was a large red area. The reporter stated his wife felt feverish, however, no fever was present. She took Tylenol. No other information was provided such as dose number, DOB, initials, address of pharmacy, pharmacy phone number and consumer stated did not know the name or title of the vaccinator.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: received only the diluent of Hiberix; received only the diluent of Hiberix; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 6-month-old male patient who received Hib (Hiberix) (batch number 5L527, expiry date 16-MAR-2026) for prophylaxis.   On 15-OCT-2024, the patient received Hiberix. On 15-OCT-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: received only the diluent of Hiberix) and inappropriate dose of vaccine administered (Verbatim: received only the diluent of Hiberix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-OCT-2024 Reporter reported that a patient received only the diluent of Hiberix during administration (Inappropriate Reconstitution Technique). The patient received only diluent of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with US2024135611 and US2024135616 reported by the same reporter, same product, different patient.; Sender's Comments:  US-GSK-US2024135611:Same reporter/Different patient US-GSK-US2024135618:Same reporter/Different patient
Sex: F
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: received only the diluent ofHiberix during administration (Inappropriate Reconstitution Technique); received only the diluent ofHiberix during administration (Inappropriate Reconstitution Technique); This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 6-month-old female patient who received Hib (Hiberix) (batch number 5L527, expiry date 16-MAR-2026) for prophylaxis.   On 16-OCT-2024, the patient received Hiberix. On 16-OCT-2024, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: received only the diluent ofHiberix during administration (Inappropriate Reconstitution Technique)) and inappropriate dose of vaccine administered (Verbatim: received only the diluent ofHiberix during administration (Inappropriate Reconstitution Technique)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 31-OCT-2024 The reporter reported that the patient had received only the diluent of Hiberix vaccine during administration, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This case had been link with US2024135616 and US2024135611, reported by the same reporter.; Sender's Comments:  US-GSK-US2024135616:Same reporter/Different patient US-GSK-US2024135611:Same reporter/Different patient
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: patient was given PRIORIX intramuscularly instead of subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 22-year-old female patient who received MMR (Priorix) for prophylaxis.   On 30-OCT-2024, the patient received Priorix (intramuscular). On 30-OCT-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: patient was given PRIORIX intramuscularly instead of subcutaneously). The outcome of the subcutaneous injection formulation administered by other route 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: 31-OCT-2024 The pharmacist was the healthcare professional who stated that a patient was given Priorix intramuscularly instead of subcutaneously which led to subcutaneous injection formulation administered by other route.
Age: 55.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Influenza like illness, Pain, Rash
Clinical narrative: flu like symptoms; body aches; rash on the neck and forearms; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Pneumococcal vaccine for prophylaxis.   On 26-OCT-2024, the patient received the 1st dose of Shingrix and Pneumococcal vaccine. In OCT-2024, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms), general body pain (Verbatim: body aches) and rash (Verbatim: rash on the neck and forearms). The outcome of the influenza-like symptoms, general body pain and rash were unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and rash to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms, general body pain and rash to be related to Shingrix.   Additional Information: GSK receipt date: 31-OCT-2024 The patient received his first Shingrix vaccine and stated to developed flu like symptoms, body aches, and a rash on his neck and forearms. The patient also received a pneumonia vaccine the same day he received Shingrix. It was unknown if the reporter considered the influenza-like symptoms, general body pain and rash to be related to Pneumococcal vaccine.