chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Laboratory test, Mechanical urticaria, Urticaria
Clinical narrative: Hives all over my body when itched or scratched. Diagnosed as Dermatographia from dermatologist. Treating with two Claritin once a day. Symptoms have remained the same since first occurring.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Acute kidney injury, Sleep disorder
Clinical narrative: I awoke at about 5:00 am with severe abdominal pain.  I was hospitalized for several days with a working diagnosis of acute kidney injury with unknown cause. Upon my release, I awoke the next morning with the same symptoms.  I was hospitalized again for several days with the same diagnosis.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Acute respiratory failure, COVID-19 pneumonia, Chronic kidney disease, SARS-CoV-2 test positive
Clinical narrative: Patient received Pfizer COVID vaccine on 3/5/21 (lot # EN6204), 3/30/21 (lot # ER8732), and 1/3/22 (lot # FJ1611).  On 1/22/23, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia, Covid-19 pneumonia with possible superimposed bacterial pneumonia, syncope, and AKI on CKD3. Patient discharged home on 1/26/23.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient received Pfizer COVID vaccine on 3/5/21 (lot # EN6204), 3/30/21 (lot # ER8732), and 1/3/22 (lot # FJ1611).  On 1/22/23, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia, Covid-19 pneumonia with possible superimposed bacterial pneumonia, syncope, and AKI on CKD3. Patient discharged home on 1/26/23.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Syncope
Clinical narrative: Patient fainted but regained consciousness within 5 seconds, EMS was immediately called and monitored her symptoms and took her to hospital as she was still reporting light-headedness. Unkown what happened after that.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, COVID-19, Palpitations, Pulmonary fibrosis, Respiratory failure
Clinical narrative: Patient received Pfizer COVID vaccine on 2/9/21, 3/9/21, 8/16/21, 1/24/22, 5/28/22, and Moderna Bivalent COVID vaccine on 9/28/22. On 1/22/23, patient admitted to our inpatient facility (med/surg unit) with acute on chronic hypoxic respiratory failure likely secondary to COVID-19 infection in addition to pulmonary fibrosis in the right lung/left lung transplant, and sinus tachycardia with palpitations. Patient discharged home on 1/24/23.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive, Sinus tachycardia
Clinical narrative: Patient received Pfizer COVID vaccine on 2/9/21, 3/9/21, 8/16/21, 1/24/22, 5/28/22, and Moderna Bivalent COVID vaccine on 9/28/22. On 1/22/23, patient admitted to our inpatient facility (med/surg unit) with acute on chronic hypoxic respiratory failure likely secondary to COVID-19 infection in addition to pulmonary fibrosis in the right lung/left lung transplant, and sinus tachycardia with palpitations. Patient discharged home on 1/24/23.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: The patient did not remember receiving 2 previous doses of this vaccine. He requested the dose / vaccine and came back a day later stating that his wife told him he had already completed the series.
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer Bivalent but was in need of the  Pfizer Primary dose.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Rash
Clinical narrative: A terrible rash that traveled my entire body, starting from my neck, all the way down my legs, arms, stomach , breasts, and finally ending on my back. The rash lasted six months had to go to the doctor and was put on prednisone. It helped for a short time and then had to use Cortizone topicals to relieve itch until it went away . The rash was so bad. That bruising started happening. It was a very difficult six months.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arteriogram carotid, Blood test, Cerebellar stroke, Computerised tomogram head normal, Dizziness
Clinical narrative: BILATERAL CEREBELLAR STROKES I received the second shot of Pfizer MRNA on Nov 7, 2021. On Nov 29th, ,at the age of 59, I suffered the first of two strokes. Early that morning I woke up at approximately 1 am dizzy, throwing up and having some difficulty when moving my legs. My wife took me to a local emergency hospital. They did a CT scan of my head and said it was clear, no sign of a stroke. I was diagnosed with vertigo, given anti-nausea prescriptions and sent home that morning feeling ok. The following morning it happened again so we went back to the same emergency hospital and they wanted to transport me by ambulance  (See continuation pg)
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Laboratory test, Magnetic resonance imaging, Musculoskeletal disorder
Clinical narrative: BILATERAL CEREBELLAR STROKES I received the second shot of Pfizer MRNA on Nov 7, 2021. On Nov 29th, ,at the age of 59, I suffered the first of two strokes. Early that morning I woke up at approximately 1 am dizzy, throwing up and having some difficulty when moving my legs. My wife took me to a local emergency hospital. They did a CT scan of my head and said it was clear, no sign of a stroke. I was diagnosed with vertigo, given anti-nausea prescriptions and sent home that morning feeling ok. The following morning it happened again so we went back to the same emergency hospital and they wanted to transport me by ambulance  (See continuation pg)
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler, Vertigo, Vomiting
Clinical narrative: BILATERAL CEREBELLAR STROKES I received the second shot of Pfizer MRNA on Nov 7, 2021. On Nov 29th, ,at the age of 59, I suffered the first of two strokes. Early that morning I woke up at approximately 1 am dizzy, throwing up and having some difficulty when moving my legs. My wife took me to a local emergency hospital. They did a CT scan of my head and said it was clear, no sign of a stroke. I was diagnosed with vertigo, given anti-nausea prescriptions and sent home that morning feeling ok. The following morning it happened again so we went back to the same emergency hospital and they wanted to transport me by ambulance  (See continuation pg)
Age: 16.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Abdominal pain, Back pain, Bone pain, Culture throat, Dyspnoea
Clinical narrative: Compromised his respiratory system. Developed a moderate respiratory reaction causing shortness of breath that worsened over the following days, caused high fever of 102 for 4 days, moderate to severe abdominal cramping, severe congestion,  back pain as well as panic attacks as he was unable to breathe. Patient was tested for viral infection including covid and strep and all exams were negative. He required urgent care visit which is where the test were ran. He required prescribed steroid medication and an oral suspension for minimum of 5 days. He did require to miss school for 1 week total and he was left with pain in the bony areas such as his knees and suffered from insomnia during and after the events.
Age: 16.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Hypertension, Insomnia, Loss of personal independence in daily activities, Panic attack, Pyrexia
Clinical narrative: Compromised his respiratory system. Developed a moderate respiratory reaction causing shortness of breath that worsened over the following days, caused high fever of 102 for 4 days, moderate to severe abdominal cramping, severe congestion,  back pain as well as panic attacks as he was unable to breathe. Patient was tested for viral infection including covid and strep and all exams were negative. He required urgent care visit which is where the test were ran. He required prescribed steroid medication and an oral suspension for minimum of 5 days. He did require to miss school for 1 week total and he was left with pain in the bony areas such as his knees and suffered from insomnia during and after the events.
Age: 16.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Respiratory disorder, Respiratory tract congestion, SARS-CoV-2 test negative, Streptococcus test negative, Tachycardia
Clinical narrative: Compromised his respiratory system. Developed a moderate respiratory reaction causing shortness of breath that worsened over the following days, caused high fever of 102 for 4 days, moderate to severe abdominal cramping, severe congestion,  back pain as well as panic attacks as he was unable to breathe. Patient was tested for viral infection including covid and strep and all exams were negative. He required urgent care visit which is where the test were ran. He required prescribed steroid medication and an oral suspension for minimum of 5 days. He did require to miss school for 1 week total and he was left with pain in the bony areas such as his knees and suffered from insomnia during and after the events.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Cellulitis, Pain in extremity, Peripheral swelling
Clinical narrative: 11/16/22 PT reported (L) arm swelling pain after vaccination on 11/2/22. Dx'd with cellulitis, Tx'd with cephalexin
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Dizziness, Headache, Muscular weakness
Clinical narrative: 1/25/23 @ 11:00pm Pt felt lightheaded w/ severe headache. She said her legs felt like they would give out. She felt weak w/ low energy on 1/26/23. All symptoms resolved by 1/27/23 w/ no treatment.
Sex: M
Vaccine: UNK
Symptoms: Electrocardiogram, Laboratory test, Syncope
Clinical narrative: he fainted at school for no apparent reason; This case was reported by a consumer and described the occurrence of fainting in a 10-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 14th October 2022, 1 days after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced fainting (serious criteria GSK medically significant and clinically significant/intervention required). On 14th December 2022, the outcome of the fainting was recovered/resolved.   It was unknown if the reporter considered the fainting to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval 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: 20-JAN-2023 Reporter's comments: The reporter was patient's parent. The reporter had stated that the patient had received flu vaccine from GSK (influenza, injectable quadrivalent pf, Flulaval 6 months or elder). The following day, he had fainted at school for no apparent reason. He had never fainted before or since. Because of the fainting event, he was taken to see the physician, which had resulted in medical bills, for which the reporter would like to receive a reimbursement from GlaxoSmithKline (GSK).  The reporter had consented to follow-up. Additional supportive information: This case was linked with US2023AMR009365 which was reported by same reporter. The dose description was mentioned as 1 vaccination. The outcome was captured as recovered/resolved conservatively as the event end date was provided and AI was raised to confirm the same.; Sender's Comments:  US-GSK-US2023AMR009365:same reporter - reporter case
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Orthostatic intolerance, Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Autonomic Dysfunction; Orthostatic Intolerence; Small fiber Neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 32-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), small fibre neuropathy, orthostatic intolerance, autonomic nervous system imbalance, dizziness and fatigue. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007498: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4
Symptoms: Small fibre neuropathy
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Autonomic Dysfunction; Orthostatic Intolerence; Small fiber Neuropathy; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 32-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), small fibre neuropathy, orthostatic intolerance, autonomic nervous system imbalance, dizziness and fatigue. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007498: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Dizziness, Fatigue, Headache, Orthostatic intolerance
Clinical narrative: Bordeline Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Orthostatic Intolerence; Autonomic Dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 36-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), autonomic nervous system imbalance, orthostatic intolerance, headache, dizziness and fatigue. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007498: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: Bordeline Postural orthostatic tachycardia syndrome (POTS); Fatigue; Dizziness; Headache; Orthostatic Intolerence; Autonomic Dysfunction; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 36-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), autonomic nervous system imbalance, orthostatic intolerance, headache, dizziness and fatigue. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007498: US-009507513-2301USA007598: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Dizziness, Fatigue, Headache, Orthostatic intolerance, Postural orthostatic tachycardia syndrome
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Presyncope; Fatigue; Dizziness; Headache; Orthostatic Intolerance; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 39-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. Additionally it was reported that the pt received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (SLIGARD)  (lot#, expiration date, dose, route of administration and anatomical location were not reported).  On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, headache, dizziness, fatigue and presyncope. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007498: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Presyncope
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Presyncope; Fatigue; Dizziness; Headache; Orthostatic Intolerance; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 39-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. Additionally it was reported that the pt received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (SLIGARD)  (lot#, expiration date, dose, route of administration and anatomical location were not reported).  On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), orthostatic intolerance, headache, dizziness, fatigue and presyncope. The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007498: US-009507513-2301USA007599: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Headache, Postural orthostatic tachycardia syndrome, Presyncope
Clinical narrative: Postural orthostatic tachycardia syndrome (POTS); Presyncope; Fatigue; Dizziness; Headache; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 42-year-old female patient (pt). Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unspecified date, the pt was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (lot#, expiration date, dose, route of administration and anatomical location were not reported) as prophylaxis. On an unspecified date in 2013, the pt experienced following vaccination, postural orthostatic tachycardia syndrome (POTS), headache, dizziness, fatigue and presyncope.  The outcome of all the events was not provided. The reporter considered all events to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA007523: US-009507513-2301USA007524: US-009507513-2301USA007593: US-009507513-2301USA007602: US-009507513-2301USA007595: US-009507513-2301USA007596: US-009507513-2301USA007597: US-009507513-2301USA007598: US-009507513-2301USA007498: US-009507513-2301USA007600: US-009507513-2301USA007601: US-009507513-2301USA007522: US-009507513-2301USA007521: US-009507513-2301USA007594:
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Got 3 vax for shingles, got shingles/Suspected vaccination failure; Shingles in eye; Got 3 vax for shingles; This 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and extra dose administered. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and extra dose administered were unknown.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Dec-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient's friend reported that the patient got 3 vaccine for shingles then got shingles in his eye. The reporter stated no thanks. Additional supportive information: The patient received 3 shingles vaccines, which led to extra dose administered. 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. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye operation, Injection site pain, Laboratory test, Ophthalmic herpes zoster
Clinical narrative: injection site pain; chills; fever; shingles in eye / did a procedure on eye / reaction; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (especially the right eye, numerous times years ago from reporting). Previously administered products included Shingles vaccine with an associated reaction of no adverse event (original Shingles vaccines a few years ago and did not experience any side effects not did I get shingles again) and Shingrix with an associated reaction of ophthalmic herpes zoster (first dose received on 15th June 2022 and also experienced injection site pain, chills and pyrexia, refer case US2023008656). Concurrent medical conditions included blood cholesterol increased. Concomitant products included metoprolol succinate and lovastatin.   On 6th December 2022, the patient received the 2nd dose of Shingrix. On 6th December 2022, less than a day after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced injection site pain, chills and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved and the outcome of the injection site pain, chills and fever were unknown.   The reporter considered the ophthalmic herpes zoster to be related to Shingrix. It was unknown if the reporter considered the injection site pain, chills and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2023008656   Additional Information: GSK receipt date: 20-Jan-2023 Reporter's Comments: The patient self-reported this case. The patient received second Shingrix vaccination and experienced both the injection site pain and the chills or fever like with the initial vaccination; however, she had now had Shingles in her right eye since 6th December 2022.  The patient had now spent over 1,000 dollars out of pocket for doctor visits, prescription, lab work, and treatments.  She had been to an urgent care clinic run by her PCP (primary care physician) practice, been to the eye doctor at least 5 times, and her PCP once.  The patient now being treated by a cornea specialist who did a procedure on her eye and who she had to go back to next week. The patient still had the shingles and it was directly related to getting the 2nd vaccination of Shingrix.  All of the health care providers she had seen said that none of the literature on the vaccine lists this as a possible reaction. If nothing else, she was letting GSK know so GSK could rectify that. The adverse event shingles in my right eye symptoms were treated. The reporter gave permission to contact.; Sender's Comments:  US-GSK-US2023008656:same reporter - 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: injection site pain; chills; fever; shingles in eye / did a procedure on eye / reaction; This case was reported by a consumer and described the occurrence of ophthalmic herpes zoster in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (especially the right eye, numerous times years ago from reporting). Previously administered products included Shingles vaccine with an associated reaction of no adverse event (original Shingles vaccines a few years ago and did not experience any side effects not did I get shingles again) and Shingrix with an associated reaction of ophthalmic herpes zoster (first dose received on 15th June 2022 and also experienced injection site pain, chills and pyrexia, refer case US2023008656). Concurrent medical conditions included blood cholesterol increased. Concomitant products included metoprolol succinate and lovastatin.   On 6th December 2022, the patient received the 2nd dose of Shingrix. On 6th December 2022, less than a day after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the patient experienced injection site pain, chills and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the ophthalmic herpes zoster was not recovered/not resolved and the outcome of the injection site pain, chills and fever were unknown.   The reporter considered the ophthalmic herpes zoster to be related to Shingrix. It was unknown if the reporter considered the injection site pain, chills and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2023008656   Additional Information: GSK receipt date: 20-Jan-2023 Reporter's Comments: The patient self-reported this case. The patient received second Shingrix vaccination and experienced both the injection site pain and the chills or fever like with the initial vaccination; however, she had now had Shingles in her right eye since 6th December 2022.  The patient had now spent over 1,000 dollars out of pocket for doctor visits, prescription, lab work, and treatments.  She had been to an urgent care clinic run by her PCP (primary care physician) practice, been to the eye doctor at least 5 times, and her PCP once.  The patient now being treated by a cornea specialist who did a procedure on her eye and who she had to go back to next week. The patient still had the shingles and it was directly related to getting the 2nd vaccination of Shingrix.  All of the health care providers she had seen said that none of the literature on the vaccine lists this as a possible reaction. If nothing else, she was letting GSK know so GSK could rectify that. The adverse event shingles in my right eye symptoms were treated. The reporter gave permission to contact.; Sender's Comments:  US-GSK-US2023008656:same reporter - 1st dose
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Eye irritation, Headache, Ocular hyperaemia, Pyrexia
Clinical narrative: Burning eyes; Redness in eyes; Fever; Headache; Upset stomach; This case was reported by a consumer and described the occurrence of burning in eyes in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2023, the patient received the 2nd dose of Shingrix. On 14th January 2023, 1 days after receiving Shingrix, the patient experienced burning in eyes, eye red, fever, headache and upset stomach. The patient was treated with ibuprofen and ophthalmologicals (nos) (Gentle Tears). On an unknown date, the outcome of the burning in eyes and eye red were recovering/resolving and the outcome of the fever, headache and upset stomach were recovered/resolved.   It was unknown if the reporter considered the burning in eyes, eye red, fever, headache and upset stomach to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-Jan-2023 and 18-Jan-2023  Reporter's Comments: The reporter reported that the patient received second dose Shingrix vaccine on the left arm.  The reporter reported that on next day am the patient experienced fever, headache, upset stomach in addition to the burning and redness in eyes.  The fever, headache and upset stomach had resolved.  The burning and redness in eyes were better.  The patient was using Ibuprofen and Gentle Tears for eyes.  The reporter gave permission for GSK to contact physician.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: More than 6 months since 1st dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient had the first injection but it had been greater than 6 months).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date: 20-JAN-2023 Reporter's comment: The reporter had asked that, if the patient had the first injection, but it had been greater than 6 months, so do they need to start the series over. The reporter had consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the second dose of Shingrix, which had led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain at injection site; This case was reported by a consumer and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 20-JAN-2023 Reporter's comment: This report was submitted by public reporting reference via the online reporting system. The patient had asked that, what he could do for the pain (Pain at injection site). The patient had stated that the symptoms were not treated at the time of reporting. The reporter had denied to provide further contact details. Additional supportive information : The dosage text was mentioned as 2 which was not captured in the case and was mentioned into the narrative only.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Dizziness, Fall, Malaise
Clinical narrative: Slight Fever; she is in bed shivering; feeling lightheaded; Fell to the floor twice; Feeling sick; stayed in bed all day; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2023, the patient received the 1st dose of Shingrix (intramuscular). On 15th January 2023, 1 days after receiving Shingrix, the patient experienced feeling unwell. In January 2023, the patient experienced bedridden. On 16th January 2023, the patient experienced shivering, light headedness and fall. On 17th January 2023, the patient experienced fever. On 17th January 2023, the outcome of the fall was recovered/resolved. On an unknown date, the outcome of the feeling unwell, fever and shivering were not recovered/not resolved and the outcome of the bedridden and light headedness were unknown.   It was unknown if the reporter considered the feeling unwell, fever, shivering, bedridden, light headedness and fall to be related to Shingrix.     Additional Information: GSK receipt date: 17-JAN-2023 Reporter comment: Reporter was the patient's grandson. The reporter states that the patient received her first Shingrix dose on Saturday morning and that she started feeling sick Sunday night.  The reporter stated that the patient had a slight fever and she was in bed shivering right now despite having 6 blankets on and with the heat up in the house and that the shivering started yesterday (16th January 2023) and stayed in bed all day.  The reporter also stated that the patient felt lightheaded yesterday (16th January 2023) and that she fell to the floor twice and that he helped her back up to get to her bed, but he was not sure if she was still feeling lightheaded at this time. The grandson did not consent for safety follow-up with HCP (healthcare professional) and HCP's information were not provided.  The reporter did not consent to follow up. Additional Supportive Information: Outcome date was reporter for event feeling unwell, fever, shivering, light headedness as 17th January 2023, but the outcome was given as not recovered and not resolved for event feeling unwell, fever and shivering and lightheaded outcome given unknown. Outcome was conservatively captured as per description and clarification has been raised.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: injection site is painful; injection site is hot; injection site is red, redness; injection site is swollen, swelling; injection site is hard, hard to touch; didn't shake vigorousl,  no white appearance achieved; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th January 2023, less than a day after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site swelling, injection site induration and wrong technique in product usage process. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site swelling and injection site induration were not recovered/not resolved and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, injection site swelling and injection site induration to be related to Kinrix and Kinrix 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: 17-JAN-2023 Reporter's Comment: The mother was calling on behalf of her son who was the consumer.  The reporter stated that patient received a dose of Kinrix yesterday at the pediatricians office.  The reporter stated thate the nurse did not shake the prefilled syringe vigorously to obtain a homogeneous, turbid, white suspension prior to administration.  The reporter identified themselves as a pharmacist and the parent of the affected patient. The reporter gave details about the institution at which the dose was given and the symptoms presented. The patients arm at the injection site was hard, swollen, red, painful, and hot. The reporter also disclosed information about the patient but did not have specific information about the vaccine. The reporter consent to follow up. Additional Supportive Information: The nurse did not shake the prefilled syringe vigorously to obtain a homogeneous, turbid, white suspension, which led to wrong technique in drug usage process. The case US2023006931 is identified as duplicate of case US2023006929. All future correspondence would be added in case US2023006929, which stands as case of record for this patient and the case US2023006931 would be deleted. Note: The event onset date was captured as 16th Jan 2023 and outcome kept as not recovered based upon initial source document as all events were reported at the injection site.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong technique in product usage process
Clinical narrative: injection site is painful; injection site is hot; injection site is red, redness; injection site is swollen, swelling; injection site is hard, hard to touch; didn't shake vigorousl,  no white appearance achieved; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th January 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 16th January 2023, less than a day after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced injection site pain, injection site warmth, injection site erythema, injection site swelling, injection site induration and wrong technique in product usage process. On an unknown date, the outcome of the injection site pain, injection site warmth, injection site erythema, injection site swelling and injection site induration were not recovered/not resolved and the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth, injection site erythema, injection site swelling and injection site induration to be related to Kinrix and Kinrix 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: 17-JAN-2023 Reporter's Comment: The mother was calling on behalf of her son who was the consumer.  The reporter stated that patient received a dose of Kinrix yesterday at the pediatricians office.  The reporter stated thate the nurse did not shake the prefilled syringe vigorously to obtain a homogeneous, turbid, white suspension prior to administration.  The reporter identified themselves as a pharmacist and the parent of the affected patient. The reporter gave details about the institution at which the dose was given and the symptoms presented. The patients arm at the injection site was hard, swollen, red, painful, and hot. The reporter also disclosed information about the patient but did not have specific information about the vaccine. The reporter consent to follow up. Additional Supportive Information: The nurse did not shake the prefilled syringe vigorously to obtain a homogeneous, turbid, white suspension, which led to wrong technique in drug usage process. The case US2023006931 is identified as duplicate of case US2023006929. All future correspondence would be added in case US2023006929, which stands as case of record for this patient and the case US2023006931 would be deleted. Note: The event onset date was captured as 16th Jan 2023 and outcome kept as not recovered based upon initial source document as all events were reported at the injection site.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: Kinrix and Pediarix administered same day; 4YO received 1st Pediarix after 1st Kinrix; 1st Kinrix 07Dec2022, 2nd 16Jan2023; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date 21st October 2024) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + POLIO VACCINE + TETANUS VACCINE TOXOID (KINRIX).   On 16th January 2023, the patient received the 2nd dose of Kinrix, Kinrix Pre-Filled Syringe Device, the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 16th January 2023, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose, inappropriate schedule of vaccine administered and extra dose administered. On an unknown date, the outcome of the overdose, inappropriate schedule of vaccine administered and extra dose administered 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: 17-JAN-2023 Reporter comment: Assistant manager/medical assistant inquired that, how to proceed with patient receiving two DTaP-IPV. The assistant manager reported a 4 year old patient received both Kinrix and Pediarix on 16th January 2023. The assistant manager mentioned this was the patient's second dose of Kinrix, the first dose was administered on 7th December 2022. This was only the first dose of Pediarix patient received. The patient was playing catch up on vaccines. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Kinrix and 1st dose of Pediarix on same day, which led to overdose, extra dose administered and inappropriate schedule of vaccine administered.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the adjuvant portion of Shingrix without reconstitution; only adjuvant portion administered/ Shingrix only adjuvant administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number 2JA2N, expiry date 6th October 2023) for prophylaxis.   On 19th January 2023, the patient received the 1st dose of Shingrix. On 19th January 2023, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 19-JAN-2023 Reporter's Comments: The nurse reported that the patient received only the adjuvant portion of Shingrix without reconstitution. The reporter did not consent to follow up. Additional supportive information: The patient received only the adjuvant portion of Shingrix without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.