chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Erythema 100mmx50mms area inferior to injection site, trace pruritus Treatment: cold compresses
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: Vertigo on following day. From sitting to standing
Age: 89.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Asthenia, Dyspnoea, Heart rate decreased, Malaise
Clinical narrative: Patient got all three of the vaccines and within the next 4 days patient was not feeling well they were short of breath and were having a low heart rate. Patient was taken and admitted into the hospital for 12 to 13 days. Patient was also feeling weak. Patient is still in the hospital and the patient can't return home and is instead going to a nursing home  so the patient can help recover.
Age: 36.0
Sex: M
Vaccine: MMR, TD
Symptoms: Extremity contracture, Malaise, Muscle rigidity
Clinical narrative: Patient here for lab follow up and vaccines. Patient has history of seizures. Last seizure over two years ago. NP on call made aware of patient history and stated it is ok to vaccinate patient today. Td and MMR administered to patient. Patient stated he did not feel well after the vaccines were administered and put his head down and leaned over into his lap. Patient became rigid and arms and legs contracted and extended. He was lowered safely to the floor by two RNs. Patients head kept safe. Episode lasted approximately 30 seconds. Patient sustained no injuries. Patient sat up and had normal mental status, drank water, and had reactive pupils. Prior to episode, patient denied reactions to vaccines and faiting when getting vaccines. He stated that he had recieved many vaccines with no issues. After episode on 10/31/23, patient reported that he had fainted the last time he had his blood drawn. Patient able to hold conversation and reply appropriately. Vital signs re-checked. BP 133/90 HR 70. Patient advised not to drive. Patient insisted upon leaving clinic and stated "I am fine." Left ambulatory escorted by RN to exit window. No distress noted.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient states vaccine given to her on 10/15- arm was sore that day and pain became more severe. Patient lost mobility and it has been 2 weeks , her mobility has yet to be regained. Patient has a referral to  see orthopedic specilist. Patient states immunization was given to high up
Age: 92.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Asthenia, Dyspnoea
Clinical narrative: Patient after a few days of getting the vaccine was reporting that they felt weak and were having a hard time breathing. Patient  has oxygen at home to use as needed and patient needed to use this to help with his symptoms. Patient ended up in the hospital and did recover, but is needing to go into a nursing home since he is still weak and short of breath.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Brain natriuretic peptide, Chills, Echocardiogram, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: 8 hour after administration began to have symptoms of possible viral illness including sore throat, fever, night sweats, chills. Presented to ED, found to have elevated troponins. Admitted for myocarditis. Suspect viral etiology but due to timing of his flu vaccine, cannot rule out vaccination causing myocarditis.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Night sweats, Oropharyngeal pain, Pyrexia, Troponin increased, Viral infection
Clinical narrative: 8 hour after administration began to have symptoms of possible viral illness including sore throat, fever, night sweats, chills. Presented to ED, found to have elevated troponins. Admitted for myocarditis. Suspect viral etiology but due to timing of his flu vaccine, cannot rule out vaccination causing myocarditis.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site infection
Clinical narrative: infection at injection site; tx with abx
Age: 43.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Blood glucose, Blood pressure increased, Dizziness, Fall, Head injury
Clinical narrative: Right after the technician administered both vaccines the patient reported he felt woozy and tried to put his head in-between his arms.  Patient lost consciousness for about two to three seconds and regained consciousness on his own. When the patient lost consciousness, his body slid to the right side of the seat and the patient hit his head on the cabinet next to the chair. The patient did not fall onto the ground. 911 was called. Patient was monitored the entire time until EMS showed up. Patient denied any trouble breathing or swallowing or any pain. After the fact the patient told the pharmacy team that he normally passes out when he gets his blood drawn but he has never had a reaction or felt dizzy or fainted after a vaccine, so he did not mark that on his VAR form or mention anything ahead of time to the pharmacy team members. 911 was called a second time after they did not show up after about 15 minutes. Eventually about 45 to 60 minutes after the initial 911 call EMS showed up to the pharmacy. The patient was checked out by EMS. They checked his blood pressure and heart rate while sitting and standing, had his blood sugar checked and EMS manually checked the patient's head. EMS warned the patient about potential risks after passing out from a vaccine and from hitting his head. The patient declined transport to the emergency department. EMS recommended that the patient notify his doctor that his blood pressure was slightly elevated but not to the point that he needed to be transported immediately to the emergency room. The patient left on his own. The patient's healthcare provider office of  DO was notified on Monday, 10/23/2023. The nursing staff stated that they would reach out to the patient as follow up to see how he is doing.
Age: 43.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Right after the technician administered both vaccines the patient reported he felt woozy and tried to put his head in-between his arms.  Patient lost consciousness for about two to three seconds and regained consciousness on his own. When the patient lost consciousness, his body slid to the right side of the seat and the patient hit his head on the cabinet next to the chair. The patient did not fall onto the ground. 911 was called. Patient was monitored the entire time until EMS showed up. Patient denied any trouble breathing or swallowing or any pain. After the fact the patient told the pharmacy team that he normally passes out when he gets his blood drawn but he has never had a reaction or felt dizzy or fainted after a vaccine, so he did not mark that on his VAR form or mention anything ahead of time to the pharmacy team members. 911 was called a second time after they did not show up after about 15 minutes. Eventually about 45 to 60 minutes after the initial 911 call EMS showed up to the pharmacy. The patient was checked out by EMS. They checked his blood pressure and heart rate while sitting and standing, had his blood sugar checked and EMS manually checked the patient's head. EMS warned the patient about potential risks after passing out from a vaccine and from hitting his head. The patient declined transport to the emergency department. EMS recommended that the patient notify his doctor that his blood pressure was slightly elevated but not to the point that he needed to be transported immediately to the emergency room. The patient left on his own. The patient's healthcare provider office of  DO was notified on Monday, 10/23/2023. The nursing staff stated that they would reach out to the patient as follow up to see how he is doing.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Fever (101F max), vomiting, body aches.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: Patient is 35 weeks pregnant and was recommended to get the RSV vaccine by her OB-Gyn. Patient received one dose of Arexvy's RSV vaccine. She should have received Abrysvo, which is approved for those under 60 years old.   Patient had no adverse reaction to the vaccine.
Age: 59.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction/adverse, patient is not quite 60 years old.
Age: 61.0
Sex: F
Vaccine: FLUR4, RSV
Symptoms: Loss of consciousness, Syncope
Clinical narrative: FAINTED FOR FEW MINUTES UNTIL THE AMBULANCE CAME TO REVIVE HER
Age: 8.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: PATIENT HAD NAUSEA, FEVER, VOMITING WAS TAKEN TO URGENT CARE 2 TIMES
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Dyspnoea, Respiratory tract congestion
Clinical narrative: Shortness of breath and congestion
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: Tinnitus. Every Covid vaccine I have received my tinnitus gets a little worse. Tut happens pretty quick, too. Usually the day I receive the vaccine
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: none
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Blood gases, Chest discomfort, Electroencephalogram, Fatigue, Headache
Clinical narrative: Body aches, fatigue, malaise,  headache,  nausea, and vomiting the first day after the shot. symptoms continued after two weeks, was seen in the clinic; labs were done and sent home. More symptoms of fatigue headache, pain, diaphoresis, fainting , chest tightness ended up in the ED
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperhidrosis, Laboratory test, Malaise, Nausea, Pain
Clinical narrative: Body aches, fatigue, malaise,  headache,  nausea, and vomiting the first day after the shot. symptoms continued after two weeks, was seen in the clinic; labs were done and sent home. More symptoms of fatigue headache, pain, diaphoresis, fainting , chest tightness ended up in the ED
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vomiting, X-ray
Clinical narrative: Body aches, fatigue, malaise,  headache,  nausea, and vomiting the first day after the shot. symptoms continued after two weeks, was seen in the clinic; labs were done and sent home. More symptoms of fatigue headache, pain, diaphoresis, fainting , chest tightness ended up in the ED
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 5.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: Rashes started to develop on right side of lower abdomen, under arms and left leg. I applied cortisone 2.5 mg and gave Patient 10 ML of Benadryl allergy after her bath before bed when I saw the rashes.  Same this morning  but by the end of the day today she como long that other parts of her body were itching and when we took a bath around 9 pm before bed the rashes have spread to her bottom and back of her legs, the abdomen rash is bigger , on her left thigh, under her arm and sporadic bumps on torso and back.  Repeated same treatment as last evening/this morning. Wrote her doctor again (I had written in the morning) that if she doesn?t get better or if the rashes keep on spreading that I?ll take patient to be seen.
Age: 94.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Arthralgia, Gait disturbance, Pain in extremity, Walking aid user
Clinical narrative: Pt went from walking without aids to requiring cane or walker and having severe  pain that started in his feet and ascended to his knees and sometimes to his thighs and hands.  Unable to walk more than 10 feet without sx.  Once sx start it can take an hour or more for them to resolve while lying down.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given second havrix today, however was within 6 month minimum dosing window as last vaccine at 1y3mo
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Pain
Clinical narrative: There was a soreness and then over to the side of the shot I noticed my arm was sore and on Monday evening, it was a little pink and on Tuesday morning, Oct 31, it was a darker pink, about the size of an egg. Itches. Still a pink tonight. Haven't done anything yet as I'm waiting to see if it disappears in the next day or so.
Age: 76.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Injection site erythema, Injection site papule, Irritability, Otitis media
Clinical narrative: Symptoms of increased fussiness started on the day of the vaccination and persisted for the next 10 days beyond what one would expect, per Mom report. On day 10 Mom brought the child to Urgent Care with concern for vaccine rx. /fussiness/pulling on ears. There were four small erythematous papules on the upper/outer aspect of the thigh that had cropped up a few days prior that Mom was concerned may represent a rash/reaction. The papules were not in the immediate area of the injection site. They were more posterior/lateral in respect to  where one would expect the injection site to have been and had the appearance of insect bites. The child also was pulling on ears and was found to have an otitis media at the UC visit on 10/26/2023.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Electrocardiogram, Intensive care, Laboratory test
Clinical narrative: 10/11 - Evaluated in Immediate Care one hour after vaccine. Tx: zyrtec, pepcid, decadron. 10/16 - Rebound Rx - Immediate Care - epi-pen then transferred to hospital overnight epi drip/icu. 10/21 - 10/23 ED then hospitalization for rebound anaphylactic Rx
Age: 64.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: On 10-7-2023 pt received Fluzone HD in error instead of Fluzone. Pt. not yet 65, will turn 65 on 12-10-2023. No adverse effects/symptoms reported on 10-7-23 day of administration. 10-26-27 - Called pt. for follow up, no answer left message to contact clinic. 10-27-23 - Called pt., no answer left message to contact clinic. 10-30-23 Called and spoke with pt. , he reports pain at injection site for 3 days after receiving. Reports some redness at site, no discharge, or swelling, headaches, dizziness.  Reports shortness of breath but states he had this prior to Flu shot and is currently waiting to be evaluated with further diagnostic testing.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against and then tested positive for COVID19
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: neurological pain in my right side of my head disabling me with immense pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received bnt162b2 (BNT162B2), in 2020 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEURALGIA (disability), outcome "not recovered", described as "neurological pain in my right side of my head disabling me with immense pain". Clinical course: Patient was a 63 year old male. He took Covid vaccine in 2020. He received neurological pain in his right side of his head disabling him with immense pain. He had no relief to this day.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Ascending flaccid paralysis, Gastrostomy, Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation
Clinical narrative: meets Brighton level 2 GBS but outside 42 window of biologic plaus; ascending paralysis; LP with elevated protein (cytoalbuminologic dissociation); back pain; inability to walk; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 55 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: meets Brighton level 2 GBS but outside 42 window of biologic plaus) (serious criteria GSK medically significant), paralysis ascending (Verbatim: ascending paralysis) (serious criteria GSK medically significant), cerebrospinal fluid protein increased (Verbatim: LP with elevated protein (cytoalbuminologic dissociation)) (serious criteria GSK medically significant), back pain (Verbatim: back pain) and unable to walk (Verbatim: inability to walk). The outcome of the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.  Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced back pain, inability to walk, ascending paralysis, LP (lumbar puncture) with elevated protein (cytoalbuminologic dissociation). The patient was on mechanical ventilation. The patient meets Brighton level 2 GBS (guillain barre syndrome) but outside 42 window of biologic plaus.  No confounding but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149534, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149534:Same reporter
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Muscular weakness, Pain in extremity, Tracheostomy
Clinical narrative: meets Brighton level 2 GBS but outside 42 window of biologic plaus; ascending paralysis; LP with elevated protein (cytoalbuminologic dissociation); back pain; inability to walk; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 55 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: meets Brighton level 2 GBS but outside 42 window of biologic plaus) (serious criteria GSK medically significant), paralysis ascending (Verbatim: ascending paralysis) (serious criteria GSK medically significant), cerebrospinal fluid protein increased (Verbatim: LP with elevated protein (cytoalbuminologic dissociation)) (serious criteria GSK medically significant), back pain (Verbatim: back pain) and unable to walk (Verbatim: inability to walk). The outcome of the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.  Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced back pain, inability to walk, ascending paralysis, LP (lumbar puncture) with elevated protein (cytoalbuminologic dissociation). The patient was on mechanical ventilation. The patient meets Brighton level 2 GBS (guillain barre syndrome) but outside 42 window of biologic plaus.  No confounding but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149534, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149534:Same reporter
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: meets Brighton level 2 GBS but outside 42 window of biologic plaus; ascending paralysis; LP with elevated protein (cytoalbuminologic dissociation); back pain; inability to walk; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 55 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: meets Brighton level 2 GBS but outside 42 window of biologic plaus) (serious criteria GSK medically significant), paralysis ascending (Verbatim: ascending paralysis) (serious criteria GSK medically significant), cerebrospinal fluid protein increased (Verbatim: LP with elevated protein (cytoalbuminologic dissociation)) (serious criteria GSK medically significant), back pain (Verbatim: back pain) and unable to walk (Verbatim: inability to walk). The outcome of the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.  Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced back pain, inability to walk, ascending paralysis, LP (lumbar puncture) with elevated protein (cytoalbuminologic dissociation). The patient was on mechanical ventilation. The patient meets Brighton level 2 GBS (guillain barre syndrome) but outside 42 window of biologic plaus.  No confounding but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149534, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149534:Same reporter
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Dizziness, Guillain-Barre syndrome, Influenza like illness, Injection site pain, Lumbar puncture
Clinical narrative: meets Brighton level 2 GBS but outside 42 window of biologic plaus; ascending paralysis; LP with elevated protein (cytoalbuminologic dissociation); back pain; inability to walk; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 55 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: meets Brighton level 2 GBS but outside 42 window of biologic plaus) (serious criteria GSK medically significant), paralysis ascending (Verbatim: ascending paralysis) (serious criteria GSK medically significant), cerebrospinal fluid protein increased (Verbatim: LP with elevated protein (cytoalbuminologic dissociation)) (serious criteria GSK medically significant), back pain (Verbatim: back pain) and unable to walk (Verbatim: inability to walk). The outcome of the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.  Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced back pain, inability to walk, ascending paralysis, LP (lumbar puncture) with elevated protein (cytoalbuminologic dissociation). The patient was on mechanical ventilation. The patient meets Brighton level 2 GBS (guillain barre syndrome) but outside 42 window of biologic plaus.  No confounding but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149534, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149534:Same reporter
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Magnetic resonance imaging spinal, Muscular weakness, Paraesthesia
Clinical narrative: meets Brighton level 2 GBS but outside 42 window of biologic plaus; ascending paralysis; LP with elevated protein (cytoalbuminologic dissociation); back pain; inability to walk; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 55 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: meets Brighton level 2 GBS but outside 42 window of biologic plaus) (serious criteria GSK medically significant), paralysis ascending (Verbatim: ascending paralysis) (serious criteria GSK medically significant), cerebrospinal fluid protein increased (Verbatim: LP with elevated protein (cytoalbuminologic dissociation)) (serious criteria GSK medically significant), back pain (Verbatim: back pain) and unable to walk (Verbatim: inability to walk). The outcome of the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.  Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced back pain, inability to walk, ascending paralysis, LP (lumbar puncture) with elevated protein (cytoalbuminologic dissociation). The patient was on mechanical ventilation. The patient meets Brighton level 2 GBS (guillain barre syndrome) but outside 42 window of biologic plaus.  No confounding but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149534, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149534:Same reporter
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Ascending flaccid paralysis, Back pain, CSF protein increased, CSF white blood cell count negative, Gait inability
Clinical narrative: meets Brighton level 2 GBS but outside 42 window of biologic plaus; ascending paralysis; LP with elevated protein (cytoalbuminologic dissociation); back pain; inability to walk; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 55 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: meets Brighton level 2 GBS but outside 42 window of biologic plaus) (serious criteria GSK medically significant), paralysis ascending (Verbatim: ascending paralysis) (serious criteria GSK medically significant), cerebrospinal fluid protein increased (Verbatim: LP with elevated protein (cytoalbuminologic dissociation)) (serious criteria GSK medically significant), back pain (Verbatim: back pain) and unable to walk (Verbatim: inability to walk). The outcome of the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.  Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced back pain, inability to walk, ascending paralysis, LP (lumbar puncture) with elevated protein (cytoalbuminologic dissociation). The patient was on mechanical ventilation. The patient meets Brighton level 2 GBS (guillain barre syndrome) but outside 42 window of biologic plaus.  No confounding but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149534, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149534:Same reporter
Sex: M
Vaccine: RSV, RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Mechanical ventilation
Clinical narrative: meets Brighton level 2 GBS but outside 42 window of biologic plaus; ascending paralysis; LP with elevated protein (cytoalbuminologic dissociation); back pain; inability to walk; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 55 days after receiving Arexvy, the patient experienced guillain barre syndrome (Verbatim: meets Brighton level 2 GBS but outside 42 window of biologic plaus) (serious criteria GSK medically significant), paralysis ascending (Verbatim: ascending paralysis) (serious criteria GSK medically significant), cerebrospinal fluid protein increased (Verbatim: LP with elevated protein (cytoalbuminologic dissociation)) (serious criteria GSK medically significant), back pain (Verbatim: back pain) and unable to walk (Verbatim: inability to walk). The outcome of the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.     It was unknown if the company considered the guillain barre syndrome, paralysis ascending, cerebrospinal fluid protein increased, back pain and unable to walk to be related to Arexvy.  Additional Information: GSK Receipt Date: 24-OCT-2023 The patient experienced back pain, inability to walk, ascending paralysis, LP (lumbar puncture) with elevated protein (cytoalbuminologic dissociation). The patient was on mechanical ventilation. The patient meets Brighton level 2 GBS (guillain barre syndrome) but outside 42 window of biologic plaus.  No confounding but need to look deeper into records. The follow-up could not be possible as no contact details were available. This case had been link with US2023AMR149528 and US2023AMR149534, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR149528:Same reporter US-GSK-US2023AMR149534:Same reporter
Sex: F
Vaccine: COVID19-2, FLU4, PNC20, RSV, COVID19, FLU3, RSV, UNK
Symptoms: Computerised tomogram abdomen normal, Computerised tomogram head, Computerised tomogram spine normal, Computerised tomogram thorax normal, Fall
Clinical narrative: Guillain; difficulty walking; weakness in LE/ progressive weakness; loss of reflexes; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE HD) for prophylaxis, COVID-19 MRNA BIVALENT for prophylaxis and PCV20 for prophylaxis.   On an unknown date, the patient received Arexvy, FLUZONE HD, COVID-19 MRNA BIVALENT and PCV20. On an unknown date, 10 days after receiving Arexvy and an unknown time after receiving COVID-19 MRNA BIVALENT and PCV20, the patient experienced atrial fibrillation (Verbatim: atrial fibrilation) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain) (serious criteria GSK medically significant), walking difficulty (Verbatim: difficulty walking), lower extremities weakness of (Verbatim: weakness in LE/ progressive weakness) and reflex loss (Verbatim: loss of reflexes). The patient was treated with anticoagulant (nos) (Anticoagulant) and immunoglobulins nos (Ivig). The outcome of the atrial fibrillation, walking difficulty, lower extremities weakness of and reflex loss were not reported and the outcome of the guillain barre syndrome was not resolved.   It was unknown if the reporter considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy.   It was unknown if the company considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy.   Additional Information: GSK receipt date: 24-OCT-2023 The patient had difficulty walking, weakness in LE, progressive weakness and loss of reflexes, no LP because had atrial fibrillation (afib) and was on anticoagulant. The patient was diagnosed with Guillain Barre syndrome (GBS) with treatment IVIG for 5 days with no improvement and no worsening. The patient met Brighton level 3 and was discharged to rehabilitation. The confounding factors such as multiple co-ad vaccines like fulsome HD, bivalent mRNA COVID and PCV 20. 10 days after receiving Arexvy, the patient experienced guillain barre syndrome, walking difficulty, weakness and reflex loss. It was unknown if the reporter considered the guillain barre syndrome, walking difficulty, weakness and reflex loss to be related to fulsome HD, bivalent mRNA COVID and PCV 20.; Sender's Comments:  US-GSK-US2023AMR149534:Same reporter US-GSK-US2023AMR149213:Same reporter
Sex: F
Vaccine: COVID19-2, FLU4, PNC20, RSV, COVID19, FLU3, RSV, UNK
Symptoms: Gait disturbance, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Guillain; difficulty walking; weakness in LE/ progressive weakness; loss of reflexes; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE HD) for prophylaxis, COVID-19 MRNA BIVALENT for prophylaxis and PCV20 for prophylaxis.   On an unknown date, the patient received Arexvy, FLUZONE HD, COVID-19 MRNA BIVALENT and PCV20. On an unknown date, 10 days after receiving Arexvy and an unknown time after receiving COVID-19 MRNA BIVALENT and PCV20, the patient experienced atrial fibrillation (Verbatim: atrial fibrilation) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain) (serious criteria GSK medically significant), walking difficulty (Verbatim: difficulty walking), lower extremities weakness of (Verbatim: weakness in LE/ progressive weakness) and reflex loss (Verbatim: loss of reflexes). The patient was treated with anticoagulant (nos) (Anticoagulant) and immunoglobulins nos (Ivig). The outcome of the atrial fibrillation, walking difficulty, lower extremities weakness of and reflex loss were not reported and the outcome of the guillain barre syndrome was not resolved.   It was unknown if the reporter considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy.   It was unknown if the company considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy.   Additional Information: GSK receipt date: 24-OCT-2023 The patient had difficulty walking, weakness in LE, progressive weakness and loss of reflexes, no LP because had atrial fibrillation (afib) and was on anticoagulant. The patient was diagnosed with Guillain Barre syndrome (GBS) with treatment IVIG for 5 days with no improvement and no worsening. The patient met Brighton level 3 and was discharged to rehabilitation. The confounding factors such as multiple co-ad vaccines like fulsome HD, bivalent mRNA COVID and PCV 20. 10 days after receiving Arexvy, the patient experienced guillain barre syndrome, walking difficulty, weakness and reflex loss. It was unknown if the reporter considered the guillain barre syndrome, walking difficulty, weakness and reflex loss to be related to fulsome HD, bivalent mRNA COVID and PCV 20.; Sender's Comments:  US-GSK-US2023AMR149534:Same reporter US-GSK-US2023AMR149213:Same reporter
Sex: F
Vaccine: COVID19-2, FLU4, PNC20, RSV, COVID19, FLU3, RSV, UNK
Symptoms: Areflexia, Gait disturbance, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Guillain; difficulty walking; weakness in LE/ progressive weakness; loss of reflexes; This serious case was reported by a consumer and described the occurrence of atrial fibrillation in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE INACT (FLUZONE HD) for prophylaxis, COVID-19 MRNA BIVALENT for prophylaxis and PCV20 for prophylaxis.   On an unknown date, the patient received Arexvy, FLUZONE HD, COVID-19 MRNA BIVALENT and PCV20. On an unknown date, 10 days after receiving Arexvy and an unknown time after receiving COVID-19 MRNA BIVALENT and PCV20, the patient experienced atrial fibrillation (Verbatim: atrial fibrilation) (serious criteria GSK medically significant), guillain barre syndrome (Verbatim: Guillain) (serious criteria GSK medically significant), walking difficulty (Verbatim: difficulty walking), lower extremities weakness of (Verbatim: weakness in LE/ progressive weakness) and reflex loss (Verbatim: loss of reflexes). The patient was treated with anticoagulant (nos) (Anticoagulant) and immunoglobulins nos (Ivig). The outcome of the atrial fibrillation, walking difficulty, lower extremities weakness of and reflex loss were not reported and the outcome of the guillain barre syndrome was not resolved.   It was unknown if the reporter considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy.   It was unknown if the company considered the atrial fibrillation, guillain barre syndrome, walking difficulty, lower extremities weakness of and reflex loss to be related to Arexvy.   Additional Information: GSK receipt date: 24-OCT-2023 The patient had difficulty walking, weakness in LE, progressive weakness and loss of reflexes, no LP because had atrial fibrillation (afib) and was on anticoagulant. The patient was diagnosed with Guillain Barre syndrome (GBS) with treatment IVIG for 5 days with no improvement and no worsening. The patient met Brighton level 3 and was discharged to rehabilitation. The confounding factors such as multiple co-ad vaccines like fulsome HD, bivalent mRNA COVID and PCV 20. 10 days after receiving Arexvy, the patient experienced guillain barre syndrome, walking difficulty, weakness and reflex loss. It was unknown if the reporter considered the guillain barre syndrome, walking difficulty, weakness and reflex loss to be related to fulsome HD, bivalent mRNA COVID and PCV 20.; Sender's Comments:  US-GSK-US2023AMR149534:Same reporter US-GSK-US2023AMR149213:Same reporter
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTERED AFTER BUD
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AFTER BUD
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTERED AFTER BUD
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AFTER BUD
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Product storage error
Clinical narrative: ADMINISTERED AFTER BUD
Age: 36.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AFTER BUD
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: ADMINISTERED AFTER BUD
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED AFTER BUD
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Keratitis, Oral herpes
Clinical narrative: blind in left eye; Fever; swollen throat; cold sores; exacerbation of stromal keratitis; feeling sick; This serious case was reported by a consumer via call center representative and described the occurrence of blind left eye in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included keratitis (Stromal Keratitis).   On 17-OCT-2023, the patient received the 2nd dose of Shingrix. On 17-OCT-2023, 5 hrs after receiving Shingrix, the patient experienced fever (Verbatim: Fever), throat swelling (Verbatim: swollen throat), cold sores (Verbatim: cold sores), keratitis (Verbatim: exacerbation of stromal keratitis) and feeling unwell (Verbatim: feeling sick). On 18-OCT-2023, the patient experienced blind left eye (Verbatim: blind in left eye) (serious criteria GSK medically significant). The outcome of the blind left eye, fever, throat swelling, cold sores, keratitis and feeling unwell were not resolved.   It was unknown if the reporter considered the blind left eye, fever, throat swelling, cold sores, keratitis and feeling unwell to be related to Shingrix.     It was unknown if the company considered the blind left eye, fever, throat swelling, cold sores, keratitis and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2023 The reporter was a patient. The patient received the Shingrix vaccine and 5 hours later the vaccination he had a fever of 101 degree Fahrenheit, swollen throat, cold sores, exacerbation of his stromal keratitis rendering him blind in the left eye at this point. Patient also complained of feeling sick ever since the shot.  Patient stated that these symptoms were still ongoing. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blindness unilateral, Condition aggravated, Keratitis, Malaise, Oral herpes
Clinical narrative: blind in left eye; Fever; swollen throat; cold sores; exacerbation of stromal keratitis; feeling sick; This serious case was reported by a consumer via call center representative and described the occurrence of blind left eye in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included keratitis (Stromal Keratitis).   On 17-OCT-2023, the patient received the 2nd dose of Shingrix. On 17-OCT-2023, 5 hrs after receiving Shingrix, the patient experienced fever (Verbatim: Fever), throat swelling (Verbatim: swollen throat), cold sores (Verbatim: cold sores), keratitis (Verbatim: exacerbation of stromal keratitis) and feeling unwell (Verbatim: feeling sick). On 18-OCT-2023, the patient experienced blind left eye (Verbatim: blind in left eye) (serious criteria GSK medically significant). The outcome of the blind left eye, fever, throat swelling, cold sores, keratitis and feeling unwell were not resolved.   It was unknown if the reporter considered the blind left eye, fever, throat swelling, cold sores, keratitis and feeling unwell to be related to Shingrix.     It was unknown if the company considered the blind left eye, fever, throat swelling, cold sores, keratitis and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2023 The reporter was a patient. The patient received the Shingrix vaccine and 5 hours later the vaccination he had a fever of 101 degree Fahrenheit, swollen throat, cold sores, exacerbation of his stromal keratitis rendering him blind in the left eye at this point. Patient also complained of feeling sick ever since the shot.  Patient stated that these symptoms were still ongoing. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pharyngeal swelling, Pyrexia
Clinical narrative: blind in left eye; Fever; swollen throat; cold sores; exacerbation of stromal keratitis; feeling sick; This serious case was reported by a consumer via call center representative and described the occurrence of blind left eye in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously experienced adverse reactions included keratitis (Stromal Keratitis).   On 17-OCT-2023, the patient received the 2nd dose of Shingrix. On 17-OCT-2023, 5 hrs after receiving Shingrix, the patient experienced fever (Verbatim: Fever), throat swelling (Verbatim: swollen throat), cold sores (Verbatim: cold sores), keratitis (Verbatim: exacerbation of stromal keratitis) and feeling unwell (Verbatim: feeling sick). On 18-OCT-2023, the patient experienced blind left eye (Verbatim: blind in left eye) (serious criteria GSK medically significant). The outcome of the blind left eye, fever, throat swelling, cold sores, keratitis and feeling unwell were not resolved.   It was unknown if the reporter considered the blind left eye, fever, throat swelling, cold sores, keratitis and feeling unwell to be related to Shingrix.     It was unknown if the company considered the blind left eye, fever, throat swelling, cold sores, keratitis and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-OCT-2023 The reporter was a patient. The patient received the Shingrix vaccine and 5 hours later the vaccination he had a fever of 101 degree Fahrenheit, swollen throat, cold sores, exacerbation of his stromal keratitis rendering him blind in the left eye at this point. Patient also complained of feeling sick ever since the shot.  Patient stated that these symptoms were still ongoing. The reporter did not consent to follow up.