chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Brain injury, Cerebral artery occlusion, Computerised tomogram head abnormal, Dysarthria, Echocardiogram abnormal
Clinical narrative: 11-11-24     Acute Right MCA ischemic stroke.   Near syncopal episode with left facial droop and dysarthria.  NIHSS 2; CT showed Right M2 branch occlusion.  IV TNK at 1601 and life flight transfer to hospital for stroke evaluation and treatment.   Echo showed pulmonary shunt and mitral valve regurgitation and prolapse.   ESUS suspected from COVID vaccine - patient had 3 doses give in the 4 years
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Ischaemic stroke, Laboratory test abnormal, Middle cerebral artery stroke, Mitral valve incompetence
Clinical narrative: 11-11-24     Acute Right MCA ischemic stroke.   Near syncopal episode with left facial droop and dysarthria.  NIHSS 2; CT showed Right M2 branch occlusion.  IV TNK at 1601 and life flight transfer to hospital for stroke evaluation and treatment.   Echo showed pulmonary shunt and mitral valve regurgitation and prolapse.   ESUS suspected from COVID vaccine - patient had 3 doses give in the 4 years
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Mitral valve prolapse, NIH stroke scale abnormal, Presyncope, Ventilation perfusion mismatch
Clinical narrative: 11-11-24     Acute Right MCA ischemic stroke.   Near syncopal episode with left facial droop and dysarthria.  NIHSS 2; CT showed Right M2 branch occlusion.  IV TNK at 1601 and life flight transfer to hospital for stroke evaluation and treatment.   Echo showed pulmonary shunt and mitral valve regurgitation and prolapse.   ESUS suspected from COVID vaccine - patient had 3 doses give in the 4 years
Age: 68.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, pain and swelling around the injection site. Patient went to the urgent care and the Doctor suspected infection so started her on Cephalexin 500mg capsules. Duration: 3 days
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received second dose of Arexvy.
Age: 43.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient reports having left arm pain, red circular area that has been spreading after having shingrix and prevnar vaccinations on left deltoid. During clinic visit, site measured 9 cm by 6 cm in diameter, warm to touch. Reports left shoulder pain and entire body feels "angry". She applied cool compresses but site is still painful and got, and had ibuprofen as well. Reports she has had bone marrow biopsies in the past and this pain is worse.  Advised follow up with urgent care. Medrol pak prescribed  in clinic today.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Blood test, Carpal tunnel decompression, Carpal tunnel syndrome
Clinical narrative: Started with tingling in hands and later in feet. Has become more progressed into loss of strength, balance issues and muscle wasting.  Has had multiple nerve conduction test with abnormal results. Carpal Tunnel surgery on both hands without relief on 5/31/23 other 8/25/23 Multiple blood test Gabapentin started by Heart Clinic 300mg 3X day then 900mg 3X day. Without any relief. Referred to Neurologist. in the past and has been re-referred but haven't heard back. Is seeing physical therapist at hospital. Has done muscle and nerve testing found his balance major issue referred and is working with Dr.. Dr. has ordered new neck MRI and EMG.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Facet joint syndrome, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Muscle atrophy, Nerve conduction studies abnormal
Clinical narrative: Started with tingling in hands and later in feet. Has become more progressed into loss of strength, balance issues and muscle wasting.  Has had multiple nerve conduction test with abnormal results. Carpal Tunnel surgery on both hands without relief on 5/31/23 other 8/25/23 Multiple blood test Gabapentin started by Heart Clinic 300mg 3X day then 900mg 3X day. Without any relief. Referred to Neurologist. in the past and has been re-referred but haven't heard back. Is seeing physical therapist at hospital. Has done muscle and nerve testing found his balance major issue referred and is working with Dr.. Dr. has ordered new neck MRI and EMG.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vertebral foraminal stenosis
Clinical narrative: Started with tingling in hands and later in feet. Has become more progressed into loss of strength, balance issues and muscle wasting.  Has had multiple nerve conduction test with abnormal results. Carpal Tunnel surgery on both hands without relief on 5/31/23 other 8/25/23 Multiple blood test Gabapentin started by Heart Clinic 300mg 3X day then 900mg 3X day. Without any relief. Referred to Neurologist. in the past and has been re-referred but haven't heard back. Is seeing physical therapist at hospital. Has done muscle and nerve testing found his balance major issue referred and is working with Dr.. Dr. has ordered new neck MRI and EMG.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received one dose on 12/27/2023 and received another dose on 08/16/2024.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Benign fasciculation syndrome, Blood test, COVID-19, Cervical spinal stenosis
Clinical narrative: Onset of extreme pain in left brachial plexus. PT and chiropractor care didn?t resolve it for months. My strength was leaving quickly and MRI of neck showed stenosis so artificial disc replacement was done in C5-C7. Recovery was minimal. Pain improved but weakness and muscle twitching remained. In 2022 I caught Covid 19 for my first time. Within two months I had muscle twitching through my whole body. They did an EMG and it showed signs of Parsonage Turner Syndrome, which is an autoimmune attack of the brachial plexus, one of the causes being from vaccines. It also said it looked like BFS from Covid infection. My immune system continued to weaken until I nearly died in spring of 2024. It was then that a retired pharmacist now practicing functional medicine put me on a strict routine of ivermectin, immune supplementation and detoxes. My health turned around in 30 days of treatment.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram abnormal, Immune system disorder, Intervertebral disc operation, Magnetic resonance imaging neck abnormal, Muscle twitching
Clinical narrative: Onset of extreme pain in left brachial plexus. PT and chiropractor care didn?t resolve it for months. My strength was leaving quickly and MRI of neck showed stenosis so artificial disc replacement was done in C5-C7. Recovery was minimal. Pain improved but weakness and muscle twitching remained. In 2022 I caught Covid 19 for my first time. Within two months I had muscle twitching through my whole body. They did an EMG and it showed signs of Parsonage Turner Syndrome, which is an autoimmune attack of the brachial plexus, one of the causes being from vaccines. It also said it looked like BFS from Covid infection. My immune system continued to weaken until I nearly died in spring of 2024. It was then that a retired pharmacist now practicing functional medicine put me on a strict routine of ivermectin, immune supplementation and detoxes. My health turned around in 30 days of treatment.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Neuralgic amyotrophy
Clinical narrative: Onset of extreme pain in left brachial plexus. PT and chiropractor care didn?t resolve it for months. My strength was leaving quickly and MRI of neck showed stenosis so artificial disc replacement was done in C5-C7. Recovery was minimal. Pain improved but weakness and muscle twitching remained. In 2022 I caught Covid 19 for my first time. Within two months I had muscle twitching through my whole body. They did an EMG and it showed signs of Parsonage Turner Syndrome, which is an autoimmune attack of the brachial plexus, one of the causes being from vaccines. It also said it looked like BFS from Covid infection. My immune system continued to weaken until I nearly died in spring of 2024. It was then that a retired pharmacist now practicing functional medicine put me on a strict routine of ivermectin, immune supplementation and detoxes. My health turned around in 30 days of treatment.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Swelling
Clinical narrative: patient noticed red swelling second day after the vaccine (2/15/25) and it's gotten larger since then. patient describes as the size of the fist
Age: 86.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had previously received this same vaccine on 12/22/2023. Reporting this event as per the guidelines it is not recommended to receive a second dose of the RSV at this time. No adverse reactions were reported by that patient from the vaccine.
Age: 92.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Confusional state, Disorientation, Mental status changes
Clinical narrative: Patient experienced a change in mental status, became confused and disoriented within hours of receiving the vaccines.  Patient was hospitalized and remains there as of this filing.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: localized reaction at injection site.  redness, itchiness, induration starting at 24 hours after injection.  cool packs to site, benadryl, OTC steroid cream
Age: 67.0
Sex: M
Vaccine: COVID19, FLU3, PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt received a second dose of Prevnar 20 when he had already completed the series. Pt has not reported any adverse effects at this time.
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Tinnitus
Clinical narrative: Tittinus developed from vaccine
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose abnormal, Type 1 diabetes mellitus, Urine ketone body present
Clinical narrative: I was diagnosed with type 1 diabetes post covid vaccine. I had no prior findings of this and no family history of this chronic illness. The urgent care I was diagnosed at mentioned it was most likely due to the Covid-19 vaccine
Age: 70.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Warm, itchy, inflamed skin at vaccination site. Per pt. she can't use antihistamines or analgesics by mouth. Using cold compresses she got the inflammation and other symptoms to subside almost completely.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered, Pain in extremity
Clinical narrative: Patient given RSV vaccine twice: first dose on 6/3/24 and second dose on 1/27/25. She stated no problems other than sore arm
Age: 24.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Fall, Gaze palsy, Seizure, Syncope
Clinical narrative: Pt was administered the Heplisav-b  followed by the MMR vaccine. PT eyes rolled back, he fainted, fell out of his chair face down and begun to seize. 1 dose of epi 0.3mg was administered; he recovered immediately. EMS was activated; they came and assessed the pt; they released the pt home with family.
Age: 36.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Fever ranging between 100 and 102.2 degrees Fahrenheit for two days, swollen left shoulder, pins and needles feeling down left arm and hand
Age: 1.25
Sex: M
Vaccine: UNK, UNK
Symptoms: Febrile convulsion
Clinical narrative: 8 days after the vaccine, he had a febrile seizure. He had never had a seizure before and has never had one since. All the research I?ve done shows that a delayed response within the 8 day time frame is normal for the MMR vaccine. Seizures are also a possible side effect of the MMR vaccine.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ataxia, Chronic inflammatory demyelinating polyradiculoneuropathy, Cognitive disorder, Constipation, Fall
Clinical narrative: Post vaccine:  CIDP - ongoing, treated with monthly IVIG, inappropriate tachycardia - treated with Atenolol 25mg qD, POTS - treated with 3 - 4L fluid a day with electrolytes added, SFN - treated with IVIG - ongoing, tinnitus - no treatment, ongoing, MCI, gastroparesis with upper GI bleed, slow gut transit, ataxic gait, LE weakness, falls - weekly PT
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Impaired gastric emptying, Laboratory test, Muscular weakness, Postural orthostatic tachycardia syndrome
Clinical narrative: Post vaccine:  CIDP - ongoing, treated with monthly IVIG, inappropriate tachycardia - treated with Atenolol 25mg qD, POTS - treated with 3 - 4L fluid a day with electrolytes added, SFN - treated with IVIG - ongoing, tinnitus - no treatment, ongoing, MCI, gastroparesis with upper GI bleed, slow gut transit, ataxic gait, LE weakness, falls - weekly PT
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Small fibre neuropathy, Tachycardia, Tinnitus, Upper gastrointestinal haemorrhage
Clinical narrative: Post vaccine:  CIDP - ongoing, treated with monthly IVIG, inappropriate tachycardia - treated with Atenolol 25mg qD, POTS - treated with 3 - 4L fluid a day with electrolytes added, SFN - treated with IVIG - ongoing, tinnitus - no treatment, ongoing, MCI, gastroparesis with upper GI bleed, slow gut transit, ataxic gait, LE weakness, falls - weekly PT
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Tinnitus
Clinical narrative: Tinnitus - ringing in both of my ears. A constant hissing.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 60.0
Sex: M
Vaccine: FLUC4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: severe arm pain at injection site months after getting vaccine to the point she cannot move her arm and already had an xray and scheduled mri.-Severe, Additional Details: Patient stated that the day of the injection there was an issue with the vaccination and that the vaccine splashed herself and the pharmacist when the needle was in her arm and pushed the stopper on the vaccine to give the dose leaving half dose in syringe. Patient states she has had severe arm pain since the incident to the point she cannot move her arm to work and got an xray and is getting mri to look for muscle damage, Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: gsk; LotNumber: a5n4z; Route: im; BodySite: right deltoid; Dose: 1; VaxDate: 10/05/2024
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Underdose, X-ray
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: severe arm pain at injection site months after getting vaccine to the point she cannot move her arm and already had an xray and scheduled mri.-Severe, Additional Details: Patient stated that the day of the injection there was an issue with the vaccination and that the vaccine splashed herself and the pharmacist when the needle was in her arm and pushed the stopper on the vaccine to give the dose leaving half dose in syringe. Patient states she has had severe arm pain since the incident to the point she cannot move her arm to work and got an xray and is getting mri to look for muscle damage, Other Vaccines:  VaccineTypeBrand: shingrix; Manufacturer: gsk; LotNumber: a5n4z; Route: im; BodySite: right deltoid; Dose: 1; VaxDate: 10/05/2024
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Other Vaccines:  VaccineTypeBrand: Flucelvax; Manufacturer: ; LotNumber: 946618; Route: IM - Deltoid; BodySite: (L) Arm; Dose: ; VaxDate: UNKNOWN
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Pain, Periarthritis, Product administered at inappropriate site
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint injury
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Pain in extremity, Tenderness
Clinical narrative: still has no energy; right arm was very swollen; right arm was about to "kill her" from the pain that she reports felt "like a baseball hit (her arm) at 100 miles per hour; pain caused her to start crying in the middle of the night; she is getting over the flu; she started not feeling good, feeling off; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-FEB-2025 12:30, the patient received the 1st dose of Shingrix (right arm). On 08-FEB-2025, less than a day after receiving Shingrix, the patient experienced swelling arm (Verbatim: right arm was very swollen) and pain in arm (Verbatim: right arm was about to "kill her" from the pain that she reports felt "like a baseball hit (her arm) at 100 miles per hour). On 10-FEB-2025, the patient experienced loss of energy (Verbatim: still has no energy). In FEB-2025, the patient experienced feeling unwell (Verbatim: she started not feeling good, feeling off), crying (Verbatim: pain caused her to start crying in the middle of the night) and influenza-like symptoms (Verbatim: she is getting over the flu). The outcome of the loss of energy, feeling unwell, swelling arm and pain in arm were not resolved and the outcome of the crying was unknown and the outcome of the influenza-like symptoms was not reported.   It was unknown if the reporter considered the loss of energy, feeling unwell, swelling arm, pain in arm, crying and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the loss of energy, feeling unwell, swelling arm, pain in arm, crying and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-FEB-2025 The patient received Shingrix and reported that by 6:30 to 7 PM that evening, her right arm was about to kill her from the pain that she reports felt like a baseball hit (her arm) at 100 miles per hour.  The patient reports that she could not touch her right arm or lie on her right side, and still cannot lie on her right side today, 10-FEB-2025 because of the pain.  This pain caused her to start crying in the middle of the night. The patient reports that the pain was not as bad on, 10-FEB-2025, as it was the first two nights. The patient also reports that her right arm was very swollen starting the day she received the Shingrix vaccine. The patient reports that she started not feeling good, feeling off.  The patient reports it was day three after receiving the Shingrix first dose and she still has no energy like she was getting over the flu. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Crying, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: still has no energy; right arm was very swollen; right arm was about to "kill her" from the pain that she reports felt "like a baseball hit (her arm) at 100 miles per hour; pain caused her to start crying in the middle of the night; she is getting over the flu; she started not feeling good, feeling off; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-FEB-2025 12:30, the patient received the 1st dose of Shingrix (right arm). On 08-FEB-2025, less than a day after receiving Shingrix, the patient experienced swelling arm (Verbatim: right arm was very swollen) and pain in arm (Verbatim: right arm was about to "kill her" from the pain that she reports felt "like a baseball hit (her arm) at 100 miles per hour). On 10-FEB-2025, the patient experienced loss of energy (Verbatim: still has no energy). In FEB-2025, the patient experienced feeling unwell (Verbatim: she started not feeling good, feeling off), crying (Verbatim: pain caused her to start crying in the middle of the night) and influenza-like symptoms (Verbatim: she is getting over the flu). The outcome of the loss of energy, feeling unwell, swelling arm and pain in arm were not resolved and the outcome of the crying was unknown and the outcome of the influenza-like symptoms was not reported.   It was unknown if the reporter considered the loss of energy, feeling unwell, swelling arm, pain in arm, crying and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the loss of energy, feeling unwell, swelling arm, pain in arm, crying and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-FEB-2025 The patient received Shingrix and reported that by 6:30 to 7 PM that evening, her right arm was about to kill her from the pain that she reports felt like a baseball hit (her arm) at 100 miles per hour.  The patient reports that she could not touch her right arm or lie on her right side, and still cannot lie on her right side today, 10-FEB-2025 because of the pain.  This pain caused her to start crying in the middle of the night. The patient reports that the pain was not as bad on, 10-FEB-2025, as it was the first two nights. The patient also reports that her right arm was very swollen starting the day she received the Shingrix vaccine. The patient reports that she started not feeling good, feeling off.  The patient reports it was day three after receiving the Shingrix first dose and she still has no energy like she was getting over the flu. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Sleep disorder
Clinical narrative: still has no energy; right arm was very swollen; right arm was about to "kill her" from the pain that she reports felt "like a baseball hit (her arm) at 100 miles per hour; pain caused her to start crying in the middle of the night; she is getting over the flu; she started not feeling good, feeling off; This non-serious case was reported by a consumer via call center representative and described the occurrence of loss of energy in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-FEB-2025 12:30, the patient received the 1st dose of Shingrix (right arm). On 08-FEB-2025, less than a day after receiving Shingrix, the patient experienced swelling arm (Verbatim: right arm was very swollen) and pain in arm (Verbatim: right arm was about to "kill her" from the pain that she reports felt "like a baseball hit (her arm) at 100 miles per hour). On 10-FEB-2025, the patient experienced loss of energy (Verbatim: still has no energy). In FEB-2025, the patient experienced feeling unwell (Verbatim: she started not feeling good, feeling off), crying (Verbatim: pain caused her to start crying in the middle of the night) and influenza-like symptoms (Verbatim: she is getting over the flu). The outcome of the loss of energy, feeling unwell, swelling arm and pain in arm were not resolved and the outcome of the crying was unknown and the outcome of the influenza-like symptoms was not reported.   It was unknown if the reporter considered the loss of energy, feeling unwell, swelling arm, pain in arm, crying and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the loss of energy, feeling unwell, swelling arm, pain in arm, crying and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-FEB-2025 The patient received Shingrix and reported that by 6:30 to 7 PM that evening, her right arm was about to kill her from the pain that she reports felt like a baseball hit (her arm) at 100 miles per hour.  The patient reports that she could not touch her right arm or lie on her right side, and still cannot lie on her right side today, 10-FEB-2025 because of the pain.  This pain caused her to start crying in the middle of the night. The patient reports that the pain was not as bad on, 10-FEB-2025, as it was the first two nights. The patient also reports that her right arm was very swollen starting the day she received the Shingrix vaccine. The patient reports that she started not feeling good, feeling off.  The patient reports it was day three after receiving the Shingrix first dose and she still has no energy like she was getting over the flu. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Pyrexia, Swelling
Clinical narrative: fever; swelling; freezing to death; head hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of pain in extremity (Patient received first dose on an unknown date).   On 17-JAN-2025, the patient received the 2nd dose of Shingles vaccine. In JAN-2025, less than a week after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever), swelling (Verbatim: swelling), feeling cold (Verbatim: freezing to death) and headache (Verbatim: head hurts). The outcome of the fever, swelling, feeling cold and headache were not resolved.   It was unknown if the reporter considered the fever, swelling, feeling cold and headache to be related to Shingles vaccine.     It was unknown if the company considered the fever, swelling, feeling cold and headache to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The follow-up could not be possible as no contact details were available. Patient received second one dose of vaccine and got a fever, swelling, and stated that he/she was freezing to death, head was hurting, also said that he/she was warned about this.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm is still a bit sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-JAN-2025, the patient received the 1st dose of Shingrix. In JAN-2025, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Arm is still a bit sore). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she received Shingrix vaccine and after vaccination the arm was still a bit sore but no other issues.  The patient was now worried about the second one, but he/she would did it.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: second dose felt worse than the first/felt bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of feeling abnormal (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: second dose felt worse than the first/felt bad). Rechallenge with Shingrix was positive. The outcome of the feeling bad was resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by patient itself. The patient felt bad on both shots of Shingrix. The patient stated the second dose felt worse than the first.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I had the shingles shot and my arm is still sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: I had the shingles shot and my arm is still sore). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that patient received the shingles vaccine and patient arm was still sore.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles outbreak; 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 outbreak). The patient was treated with lysine. The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-FEB-2025 This case was reported by a patient via interactive digital media. The reporter reported that supplement of lysine prevented Shingles outbreaks. The reporter mentioned that he/she had 3 outbreaks even with the vaccine. The reporter mentioned that he/she took Lysine daily. During one outbreak, he/she took 7 grams at once, which shrank the shingles. He/she took 1 to 2 grams daily, mine were caused by arginine, not by stress. This case was considered as suspected vaccination failure since the details regarding 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 the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I still have shingles outbreaks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I still have shingles outbreaks). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 08-FEB-2025 This case was reported by a patient via interactive digital media. The patient reported that the Shingles shot only had about 50 percent efficacy. Take the second shot, only about 70 percent efficacy.  The patient did both Shingles shots, and he/she still had shingles outbreaks.  Th patient thought he/she would never suffer again. Then patient read up on it and further he/she stated if you have had chicken pox, you would get shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: accidental administration of a dose of Kinrix to a 2 month old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   On 23-JAN-2025, the patient received the 1st dose of Kinrix. On 23-JAN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: accidental administration of a dose of Kinrix to a 2 month old patient). The outcome of the inappropriate age at vaccine administration 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: 23-JAN-2025 A nurse reported that there was accidental administration of a dose of Kinrix to a 2 month old patient, which led to inappropriate age at vaccine administration. The Vaccine Administration Facility is the same as Primary Reporter.
Sex: U
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose of Menveo  administered to a patient.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA987A, expiry date 31-OCT-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of Menveo  administered to a patient.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 23-JAN-2025 Other HCP reported that in the clinic an expired dose of a Menveo two vial dose that was administered to a patient, which led to expired vaccine used. Reporter wanted to receive guidance on this topic. No vaccination date or patient demographics were provided.
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient got her 2nd dose of Havrix too early; 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 short in a 11-year-old female patient who received HAV (Havrix 720) (batch number 423nl, expiry date 16-NOV-2025) for prophylaxis.   Previously administered products included Havrix 720 (received 1st dose of Havrix vaccine on 16-OCT-2024).   On 22-JAN-2025, the patient received the 2nd dose of Havrix 720. On 22-JAN-2025, an unknown time after receiving Havrix 720, the patient experienced drug dose administration interval too short (Verbatim: patient got her 2nd dose of Havrix too early). The outcome of the drug dose administration interval too short 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: 23-JAN-2025 The reporter reported that patient got her 2nd dose of Havrix too early, which led to drug dose administration interval too short. 1st dose was administered on 16-OCT-2024.  Second dose was administered 22-JAN-2025.
Age: 0.67
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received an Adult Hep B vaccine instead of the pediatric dosage; received an Adult Hep B vaccine instead of the pediatric dosage; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 8-month-old female patient who received HBV (Engerix B adult) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis.   Previously administered products included Engerix B adult (received 1st dose of Engerix B adult on unknown date) and Engerix B adult (received 2nd dose of Engerix B adult on unknown date).   On 23-JAN-2025, the patient received the 3rd dose of Engerix B adult. On 23-JAN-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: received an Adult Hep B vaccine instead of the pediatric dosage) and overdose (Verbatim: received an Adult Hep B vaccine instead of the pediatric dosage). The outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JAN-2025 The reporter reported that a patient received an Adult Hepatitis B vaccine instead of the pediatric dosage, which led to adult product administered to child and overdose. Consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Possible late second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on 02-FEB-2024 with batch number J294K).   On 23-JAN-2025, the patient received the 2nd dose of Shingrix. On 23-JAN-2025, 356 days after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Possible late second dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-JAN-2025 The reporter reported that the possible administration of a 3rd dose of Shingrix to a patient who does not remember receiving a 2nd dose of Shingrix, which led to extra dose administered.  The manager stated that they needed data about the indication from GlaxoSmithKline.  After the call, they stated that if the second dose had not been given, this would possibly qualify as a late second dose.  As neither the patient nor the healthcare professional can clarify if the dose was given or not, a possible.
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered a dose of Havrix which had a November 2024 expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old female patient who received HAV (Havrix) (batch number 9R5LC, expiry date 02-NOV-2024) for prophylaxis.   Previously administered products included Havrix (1st dose on unknown date).   On 23-JAN-2025, the patient received the 2nd dose of Havrix. On 23-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Havrix which had a November 2024 expiration date). The outcome of the expired vaccine used 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: 24-JAN-2025 Other HCP reported that a 6 year old female patient was administered a dose of Havrix which had a November 2024 expiration date, which led to expired vaccine used. Reporter stated that this was the patient's second dose in the series. Also, at the time of reporting, a repeat dose has not been administered.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: the patient had not received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose 6 months ago).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: the patient had not received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-JAN-2025 A pharmacist called to informed that the patient got the 1st dose 6 months ago and at the moment of the call, the patient had not received the 2nd dose yet. The reporter did not agree to disclose any more information about the adverse event than the one present in this report and refused follow up by the team. Till the time of reporting, the patient did not receive 2nd dose of Twinrix which led to incomplete course of vaccination.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Underdose
Clinical narrative: they gave a dose of Infanrix to a 25 year old patient; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 25-year-old female patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis.   Previously administered products included Tetanus Diphtheria and Pertussis vaccine (received vaccine on 29-OCT-2011 with batch number AC528067BA).   On 24-JAN-2025, the patient received Infanrix. On 24-JAN-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: they gave a dose of Infanrix to a 25 year old patient). The outcome of the inappropriate age at vaccine administration 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: 24-JAN-2025 Information received via Web Chat. The physician explained they gave a dose of Infanrix to a 25 year old patient on 24th January 2025 which led to inappropriate age at vaccine administration. The reporter mentioned that patient received a shot of Tetanus, Diphtheria, and Pertussis vaccine back on 29th October 2011 (they did not know the brand name, the only information was lot AC528067BA, GlaxoSmithKline).
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given a third dose of TWINRIX too close together to second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 30-year-old male patient who received HAB (Twinrix) (batch number 2553, expiry date 25-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date). Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 09-SEP-2024, the patient received the 3rd dose of Twinrix. On 09-SEP-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: given a third dose of TWINRIX too close together to second dose). The outcome of the drug dose administration interval too short 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: 24-JAN-2025 The pharmacist reported that a patient was given a third dose of Twinrix too close together to second dose (one month apart), which led to drug dose administration interval too short. The vaccination date, vaccine detail and patient demographics were obtained during this call.  No further information was provided from the pharmacist´s end. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Product preparation issue
Clinical narrative: Administered vaccine reconstituted with sterile water; Administered vaccine reconstituted with sterile water; receveid 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number PC5Y3, expiry date 30-JAN-2027) for prophylaxis.   Previously administered products included Shingrix (received 1st on 09-MAR-2024 with expiry date 2P5E9 and expiry date 18-APR-2026).   On 24-JAN-2025, the patient received the 2nd dose of Shingrix. On 24-JAN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Administered vaccine reconstituted with sterile water), inappropriate dose of vaccine administered (Verbatim: Administered vaccine reconstituted with sterile water) and drug dose administration interval too long (Verbatim: receveid 2nd dose). The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 24-JAN-2025 The nurse explained that on 24th January 2025 they administered a dose of Shingrix but the powder was diluted with sterile water instead of the adjuvant component provided by the manufacturer which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. the patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.