chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blindness, Dyskinesia, Dyspnoea, Dyspnoea exertional, Electric shock sensation
Clinical narrative: I received the vaccine in Feb. and March of 2021. That summer, I climbed a flight of stairs and noticed my heart was pounding and I was out of breath. After this continued, I asked doctors about it and I was dismissed. Within several more months I started twitching involuntarily. Even my eye balls would twitch in their sockets. I could visually see my muscles having spasms throughout my body. My skin would raise up and down. My feet and hands began to fall asleep on their own accord. I would get zaps in my face and feet so painful I would yell out in pain. I lost vision and have lived with a significant reduction in my vision. The overall impact on my body took away my ability to work out like I used to. Just the other day I gasped for air and almost threw up after just a short workout trying to push it like I used to. My life got taken away from me. I "all of a sudden" tested positive for herpes two. EVEN THOUGH I was negative (I have the test) when I got the vaccine and I had NO new partners. The stupid thing triggered my T cells to malfunction.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exercise tolerance decreased, Facial pain, Herpes simplex test positive, Hypoaesthesia, Impaired work ability
Clinical narrative: I received the vaccine in Feb. and March of 2021. That summer, I climbed a flight of stairs and noticed my heart was pounding and I was out of breath. After this continued, I asked doctors about it and I was dismissed. Within several more months I started twitching involuntarily. Even my eye balls would twitch in their sockets. I could visually see my muscles having spasms throughout my body. My skin would raise up and down. My feet and hands began to fall asleep on their own accord. I would get zaps in my face and feet so painful I would yell out in pain. I lost vision and have lived with a significant reduction in my vision. The overall impact on my body took away my ability to work out like I used to. Just the other day I gasped for air and almost threw up after just a short workout trying to push it like I used to. My life got taken away from me. I "all of a sudden" tested positive for herpes two. EVEN THOUGH I was negative (I have the test) when I got the vaccine and I had NO new partners. The stupid thing triggered my T cells to malfunction.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test normal, Loss of personal independence in daily activities, Muscle spasms, Muscle twitching, Pain in extremity
Clinical narrative: I received the vaccine in Feb. and March of 2021. That summer, I climbed a flight of stairs and noticed my heart was pounding and I was out of breath. After this continued, I asked doctors about it and I was dismissed. Within several more months I started twitching involuntarily. Even my eye balls would twitch in their sockets. I could visually see my muscles having spasms throughout my body. My skin would raise up and down. My feet and hands began to fall asleep on their own accord. I would get zaps in my face and feet so painful I would yell out in pain. I lost vision and have lived with a significant reduction in my vision. The overall impact on my body took away my ability to work out like I used to. Just the other day I gasped for air and almost threw up after just a short workout trying to push it like I used to. My life got taken away from me. I "all of a sudden" tested positive for herpes two. EVEN THOUGH I was negative (I have the test) when I got the vaccine and I had NO new partners. The stupid thing triggered my T cells to malfunction.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Screaming, Skin swelling, Visual impairment
Clinical narrative: I received the vaccine in Feb. and March of 2021. That summer, I climbed a flight of stairs and noticed my heart was pounding and I was out of breath. After this continued, I asked doctors about it and I was dismissed. Within several more months I started twitching involuntarily. Even my eye balls would twitch in their sockets. I could visually see my muscles having spasms throughout my body. My skin would raise up and down. My feet and hands began to fall asleep on their own accord. I would get zaps in my face and feet so painful I would yell out in pain. I lost vision and have lived with a significant reduction in my vision. The overall impact on my body took away my ability to work out like I used to. Just the other day I gasped for air and almost threw up after just a short workout trying to push it like I used to. My life got taken away from me. I "all of a sudden" tested positive for herpes two. EVEN THOUGH I was negative (I have the test) when I got the vaccine and I had NO new partners. The stupid thing triggered my T cells to malfunction.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash on arm around injection site started to develop 2 days afterward. Measures ~15cm long and 7.5 cm wide
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling
Clinical narrative: Swelling of the injection site within 3 minutes of injections. No systemic allergic reaction present. Pharmacist reccomended Benadryl.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Arm became sore within 24 hours with slight swelling around injection site; symptoms progressed to moderate pain with more profuse swelling and localized erythema and heat; oral antibiotic and topical antibiotic administered at ER 36 hours post injection; swelling and pain worsened and patient admitted to hospital 48 hours post injection with diagnosis of cellulitis not ruling out reaction to vaccine. This was the newest Spikevax for 2023-2024.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Swelling
Clinical narrative: Arm became sore within 24 hours with slight swelling around injection site; symptoms progressed to moderate pain with more profuse swelling and localized erythema and heat; oral antibiotic and topical antibiotic administered at ER 36 hours post injection; swelling and pain worsened and patient admitted to hospital 48 hours post injection with diagnosis of cellulitis not ruling out reaction to vaccine. This was the newest Spikevax for 2023-2024.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Lymphadenopathy, Pyrexia
Clinical narrative: Adverse event: Swollen left lymph node: bigger than golf ball Fever Spotty period Treatment: run warm water on lymph node, lymph nodes would swell before period, not as big reaction after 3 dose of vaccine
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The adult strength Comirnaty vaccine was given to a 9 yr old. There are no symptoms yet when speaking with the mother to advise her to watch for adverse reactions.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bursitis, Feeling hot, Magnetic resonance imaging abnormal, Mobility decreased
Clinical narrative: The arm and shoulder was sore, which is not abnormal. I noticed around Nov, my shoulder socket seemed sore. It progressively got worse. I could feel heat on my skin by that shoulder. I couldn't lift it to put my hair in a ponytail, couldn't reach behind to undo my bra. I had to put my left arm in first when I put on a jacket. Couldn't, and still can't sleep on that side. I went to a chiropractor and he was really afraid to touch it. I found Osteo Biflex online and started taking it. It seems to have helped a lot. I noticed when I got the shot that the injection site seemed high.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Periarthritis, Sleep disorder
Clinical narrative: The arm and shoulder was sore, which is not abnormal. I noticed around Nov, my shoulder socket seemed sore. It progressively got worse. I could feel heat on my skin by that shoulder. I couldn't lift it to put my hair in a ponytail, couldn't reach behind to undo my bra. I had to put my left arm in first when I put on a jacket. Couldn't, and still can't sleep on that side. I went to a chiropractor and he was really afraid to touch it. I found Osteo Biflex online and started taking it. It seems to have helped a lot. I noticed when I got the shot that the injection site seemed high.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: One day after vaccination developed large red local reaction below the injection. The local reaction is tennis ball sized, red, hot painful and itchy. Still present 4 days later.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: PATIENT FELT LIGHT HEADED, DIZZY AND NAUSEATED AND HIS FACE WAS PALE.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Fatigue, Headache, Myalgia, Tremor
Clinical narrative: Onset of headache, full body muscle aches from head to toes and fingers, shaking chills, extreme exhaustion These all lasted about 9 hours.  Took two Tylenol PO.  Took a hot bath.
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Headache, Injection site pruritus, Injection site swelling, Injection site warmth, Malaise
Clinical narrative: For past 36 hours and continuing as of this report, itchy, very warm and swollen at site of injection, slight malaise, slight headache
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Bone marrow oedema, COVID-19, Cholecystectomy, Colectomy
Clinical narrative: 3 days after J & J Shot got out of bed, couldn't walk, stress fractures of feet, went to Drs. sent for MRI, Bone marrow Edema. Referred to 4/21 Dr Autoimmune (Raynauds). Lt arm pain 4/22 saw Dr, Rotator cuff tear w/Bicept tendon resection after Moderna got GI Issues, Ga;; bladder removed 10/3/22 12/02/22, sycmoid colon removal. RSV & covid. 12/22, 2/23
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Foot fracture, Gait inability, Gastrointestinal disorder, Magnetic resonance imaging abnormal
Clinical narrative: 3 days after J & J Shot got out of bed, couldn't walk, stress fractures of feet, went to Drs. sent for MRI, Bone marrow Edema. Referred to 4/21 Dr Autoimmune (Raynauds). Lt arm pain 4/22 saw Dr, Rotator cuff tear w/Bicept tendon resection after Moderna got GI Issues, Ga;; bladder removed 10/3/22 12/02/22, sycmoid colon removal. RSV & covid. 12/22, 2/23
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Raynaud's phenomenon, Respiratory syncytial virus infection, Rotator cuff syndrome, Stress fracture
Clinical narrative: 3 days after J & J Shot got out of bed, couldn't walk, stress fractures of feet, went to Drs. sent for MRI, Bone marrow Edema. Referred to 4/21 Dr Autoimmune (Raynauds). Lt arm pain 4/22 saw Dr, Rotator cuff tear w/Bicept tendon resection after Moderna got GI Issues, Ga;; bladder removed 10/3/22 12/02/22, sycmoid colon removal. RSV & covid. 12/22, 2/23
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Surgery, Tenoplasty
Clinical narrative: 3 days after J & J Shot got out of bed, couldn't walk, stress fractures of feet, went to Drs. sent for MRI, Bone marrow Edema. Referred to 4/21 Dr Autoimmune (Raynauds). Lt arm pain 4/22 saw Dr, Rotator cuff tear w/Bicept tendon resection after Moderna got GI Issues, Ga;; bladder removed 10/3/22 12/02/22, sycmoid colon removal. RSV & covid. 12/22, 2/23
Age: 61.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported; HBP called to report that a patient was inadvertently administered an expired dose of PNEUMOVAX 23.  Expired 8/21/2023 and was administered on 9/19/2023. No adverse effects were reported. HCP said HCP also had questions about the potency of the dose.; This spontaneous report has been received from an official manager, regarding a 61-years-old patient of unreported gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 19-SEP-2023, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliters as prophylaxis (lot number: U032086, which was determined to be valid as syringe formulation, with an expiration date on 29-AUG-2023) (strength, route and anatomical location of administration were not reported) (Expired product administered).  No additional adverse event was reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for ROTATEQ. Vaccine administered experienced a temperature excursion. No side effects reported. No other medical information known. See additional AE cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02476000; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 19-JUN-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (lot number: W026137, which was determined to be valid, with an expiration date on 05-FEB-2024) (strength, dose, scheme, route of administration were not reported) (Product storage error).  The administered dose underwent a temperature excursion of 8.74 degrees Celsius for 35 minutes. No previous temperature excursion was reported.   No additional adverse event was provided.  This case is one of several reports from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; HCP calling to report AE for ROTATEQ. Vaccine administered experienced a temperature excursion. No side effects reported. No other medical information known. See additional AE cases 02475713, 02475789, 02475811, 02475849, 02475861, 02475818, 02475985; This spontaneous report has been received from a medical assistant, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-JUN-2023, the patient was vaccinated with an improperly storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (lot number: W026137, which was determined to be valid, with an expiration date on 05-FEB-2024) (strength, dose, scheme, route of administration were not reported) (Product storage error).  The administered dose underwent a temperature excursion of 8.74 degrees Celsius for 35 minutes. No previous temperature excursion was reported.   No additional adverse event was provided.  This case is one of several reports from the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccine was not that effective/suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past). Previously administered products included shingles vaccine (received first shingles vaccine when it was first out).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: vaccine was not that effective/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023  The case was received form the patient via interactive digital media. The patient's physician said that the vaccine was not that effective and not to get anymore if offered.  The patient had the other 2 vaccines several years ago and just got over the shingles. The patient did not understand why physician keep pushing to get it. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Blepharitis, Eye disorder, Graves' disease, Swelling of eyelid
Clinical narrative: eyelids became swollen; Eyelid inflammation; system was rejecting her eyes; Graves Disease; This serious case was reported by a consumer via interactive digital media and described the occurrence of graves' disease in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. In OCT-2021, an unknown time after receiving Shingles vaccine, the patient experienced graves' disease (Verbatim: Graves Disease) (serious criteria GSK medically significant). On an unknown date, the patient experienced swelling of eyelid (Verbatim: eyelids became swollen), inflammation of eyelids (Verbatim: Eyelid inflammation) and eye disorder (Verbatim: system was rejecting her eyes).  The outcome of the graves' disease, swelling of eyelid, inflammation of eyelids and eye disorder were not reported.   It was unknown if the reporter considered the graves' disease, swelling of eyelid, inflammation of eyelids and eye disorder to be related to Shingles vaccine.     It was unknown if the company considered the graves' disease, swelling of eyelid, inflammation of eyelids and eye disorder to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-SEP-2022 The case was received from the patient's sister interactive digital media. The patient had a reaction to the vaccine.  Two days after the second dose, her eyelids became swollen (eyelid inflammation).  After that, she was diagnosed with an autoimmune disease.  Her system was rejecting her eyes and she was diagnosed with Graves Disease.  This was in October 2021.  The problem persists on the day 10th September 2023. It was all unfortunate.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got Shingles vaccine,gotShingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got Shingles vaccine,gotShingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported via interactive digital media. It was reported that patient took Shingles vaccine and broke out with bad case of shingles. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got all shots still got shingles/Suspected vaccination failure; Shingles; Painful; 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.   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: got all shots still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful).  The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported via interactive digital media. It was reported that the patient had shingles for 30 years had received all the shots still got the shingles and they were extremely painful. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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) and shingles (Verbatim: got the shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient's wife via interactive digital media. The reporter stated that the vaccine probably helped to not get a bad case of shingles. The reporter's husband received Shingles vaccine and when he got shingles it was a very mild case. Follow-up was not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient received the vaccine and 2 years later got the shingles. Follow-up was not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes virus infection, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/The immunization causes herpes breakouts often; herpes breakouts; 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/The immunization causes herpes breakouts often) (serious criteria GSK medically significant) and shingles (Verbatim: herpes breakouts).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported the patient via interactive digital media. The patient reported that immunization caused herpes breakouts often. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: one nearly killed him; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: one nearly killed him) (serious criteria GSK medically significant).The outcome of the near death experience was not reported.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.   It was unknown if the company considered the near death experience to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a consumer via interactive digital media. The reporter said that not to get the shingles vaccine. The reporter stated that two must be taken. The reporter stated that first one nearly killed him. The reporter further stated that it was nice to have an honest man.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Drug ineffective, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included lysine.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In FEB-2023, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 The patient was diagnosed with internal shingles in February. The patient did not felt any better until May. The patient had both shingles injections. The physician shrugged his shoulders, only 90 percent effective. The physician asked about the way to knew about the lysine and how much did receive. The patient did not ever wanted to get that again. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient via interactive digital media. The patient stated that, he/she had shingles now (at the time of reporting). The reporter stated that, 14 months after 7 injections still no results, do not miss being vaccinated. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Impaired quality of life, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; having the horrible neuralgia; 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. Concurrent medical conditions included immunodeficiency.   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: Shingles) and post herpetic neuralgia (Verbatim: having the horrible neuralgia).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK receipt date: 17-SEP-2023 This case was reported the patient via interactive digital media. The patient had 2 bouts of Shingles and as the patient was immune compromised. The patient told it could possibly got it again even though had vaccinations after the 1st breakout. 2nd time the patient only had 2 pots but the arm still having the horrible neuralgia that followed it, going on 5 months and it was still making the life a living hell. The patient going to pain management for treatment but wondering what else was out there to help him/ her. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  Follow-up not possible as no contact details provided.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: experienced high Fever; chills; This non-serious case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: experienced high Fever) and chills (Verbatim: chills).  The outcome of the fever and chills were not reported.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.     It was unknown if the company considered the fever and chills to be related to Shingrix.   Additional Information: GSK receipt date: 14-Sept-2023 The patient received a dose of Shingrix and experienced high fever and chills. Rest unknown. The reporter did not consent to follow-up. The case was linked with case US2023AMR128148, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR128148:same reporter, same drug
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: experienced high Fever; chills; This non-serious case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: experienced high Fever) and chills (Verbatim: chills).  The outcome of the fever and chills were not reported.   It was unknown if the reporter considered the fever and chills to be related to Shingrix.     It was unknown if the company considered the fever and chills to be related to Shingrix.   Additional Information: GSK receipt date: 14-Sept-2023 The patient received a dose of Shingrix and experienced high fever and chills. Rest unknown. The reporter did not consent to follow-up. The case was linked with case US2023AMR128148, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR128148:same reporter, same drug
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: experienced fever; chills; body aches; This non-serious case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: experienced fever), chills (Verbatim: chills) and general body pain (Verbatim: body aches).  The outcome of the fever, chills and general body pain were not reported.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.     It was unknown if the company considered the fever, chills and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 14-Sept-2023 The patient received a dose of Shingrix and experienced fever, chills and body aches. Rest unknown. The reporter did not consent to follow-up. The case was linked with case US2023AMR128117, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR128117:same reporter, same drug
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: experienced fever; chills; body aches; This non-serious case was reported by a other health professional via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: experienced fever), chills (Verbatim: chills) and general body pain (Verbatim: body aches).  The outcome of the fever, chills and general body pain were not reported.   It was unknown if the reporter considered the fever, chills and general body pain to be related to Shingrix.     It was unknown if the company considered the fever, chills and general body pain to be related to Shingrix.   Additional Information: GSK receipt date: 14-Sept-2023 The patient received a dose of Shingrix and experienced fever, chills and body aches. Rest unknown. The reporter did not consent to follow-up. The case was linked with case US2023AMR128117, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR128117:same reporter, same drug
Sex: U
Vaccine: FLUX, RVX
Symptoms: Headache, Pain in extremity
Clinical narrative: Have sore arm; headche; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 14-SEP-2023, the patient received RSV vaccine and INFLUENZA VACCINE. On 14-SEP-2023, less than a day after receiving RSV vaccine and an unknown time after receiving INFLUENZA VACCINE, the patient experienced pain in arm (Verbatim: Have sore arm) and headache (Verbatim: headche).  The patient was treated with paracetamol (Tylenol). The outcome of the pain in arm and headache were not resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to RSV vaccine.     It was unknown if the company considered the pain in arm and headache to be related to RSV vaccine.   Additional Information: GSK receipt date: 14-Sept-2023 The case was received from the patient via  interactive digital media. The patient got the flu and RSV vaccines on the day of reporting and less than a day after vaccination, had sore arm and a headache right now but nothing he or she can not live with.  The patient took Tylenol and should be good by tomorrow. It was unknown if the reporter considered the pain in arm and headache to be related to flu vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Shingles; nerve endings still active on left hip area; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and post herpetic neuralgia (Verbatim: nerve endings still active on left hip area).  The outcome of the shingles was not reported and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported via interactive digital media. It was reported that two weeks after receiving his/her first shot, the patient experienced Shingles for the first time and as of now that is 1 year 33 weeks later (yes you read it correctly), the patient still had the nerve endings still active on his/her left hip area. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pruritus
Clinical narrative: Sick; itchy all over my body; 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: Sick) and generalized pruritus (Verbatim: itchy all over my body).  The outcome of the sickness and generalized pruritus were not reported.   It was unknown if the reporter considered the sickness and generalized pruritus to be related to Shingles vaccine.     It was unknown if the company considered the sickness and generalized pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2022 The case was received from the patient interactive digital media. The patient reported that he/she got vaccinated and got sick and itchy all over his/her body. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Injection site pain
Clinical narrative: only experienced soreness at the site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included Flu shot with an associated reaction of injection site pain.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: only experienced soreness at the site).The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to RSV vaccine.  It was unknown if the company considered the injection site pain to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 15-SEP-2023 This case was reported by a patient via interactive digital media. The patient got his/her RSV vaccine and only experienced soreness at the site just like with the flu shot.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Limb discomfort
Clinical narrative: felt like arm was going to fall off; Swelling where got the shot; Redness where got the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site swelling (Verbatim: Swelling where got the shot), injection site erythema (Verbatim: Redness where got the shot) and arm discomfort (Verbatim: felt like arm was going to fall off).  The outcome of the injection site swelling and injection site erythema were resolved (duration 10 days) and the outcome of the arm discomfort was not reported.   It was unknown if the reporter considered the injection site swelling, injection site erythema and arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the injection site swelling, injection site erythema and arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported via interactive digital media. Th patient reported that the shot did not hurt but he/she had swelling and redness where he/she got shot for 10 days and felt like his/her arm was going to fall off. The patient got second shot on another arm and had no problem. The had got shingles before he/she got shots which were painful. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Muscular weakness, Peripheral swelling, Pyrexia, Tenderness
Clinical narrative: she spiked a fever; lost grip in her hand; arm had swelling; arm was warm; tender to touch; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   On 12-SEP-2023, the patient received Fluarix Quadrivalent 2022-2023 season. In SEP-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced swelling arm (Verbatim: arm had swelling), extremities hot feeling of (Verbatim: arm was warm), pain in arm (Verbatim: tender to touch), fever (Verbatim: she spiked a fever) and grip strength decreased (Verbatim: lost grip in her hand).  The patient was treated with paracetamol (Tylenol). In SEP-2023, the outcome of the fever and grip strength decreased were resolved. The outcome of the swelling arm, extremities hot feeling of and pain in arm were unknown.   It was unknown if the reporter considered the swelling arm, extremities hot feeling of, pain in arm, fever and grip strength decreased to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the swelling arm, extremities hot feeling of, pain in arm, fever and grip strength decreased to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra 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: 14-SEP-2023 The pharmacist reported an patient received Fluarix and after her arm had swelling, was warm and tender to touch. She spoke a fever which resolved with Tylenol.  She also temporarily lost grip in her hand but that has returned.  The patient thought it may have not been given in the right location but health care professional (HCP) stated there was no evidence of that. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Maldaministration of two Fluarix QIV doses on the same clinic day; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 14-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number AF749, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLUARIX).   On 13-SEP-2023, the patient received the 2nd dose of Fluarix Quadrivalent 2022-2023 season. On 13-SEP-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced accidental overdose (Verbatim: Maldaministration of two Fluarix QIV doses on the same clinic day).  The outcome of the accidental overdose 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: 14-SEP-2023 The nurse reported that a patient received by error two Fluarix QIV vaccines, which led to accidental overdose. The reporter did not consent to follow-up.