chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Acute kidney injury, Altered state of consciousness, Asthenia, Atrial fibrillation, Biopsy brain abnormal
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Blood immunoglobulin G increased, CSF protein increased, Cerebral disorder, Depressed level of consciousness, Electroencephalogram normal
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Endotracheal intubation, Fatigue, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Intensive care, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal, Paraesthesia, Partial seizures
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Plasmapheresis, Pneumonia staphylococcal, Positron emission tomogram, Rash erythematous, Respiratory failure
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 68.0
Sex: M
Vaccine: COVID19, RSV, COVID19, RVX, COVID19, RVX, COVID19, RSV, COVID19, RSV
Symptoms: Spinal cord disorder, Splenomegaly, Unresponsive to stimuli
Clinical narrative: Patient received Moderna COVID19 booster and  GSK RSV vaccines on 11/24/2023. He felt fatigued shortly after receiving the vaccines and this fluctuated over a few days. He then developed tingling in his left leg up to his thigh and patchy distribution in his right leg. On 12/8/2023 he was given prednisone 40mg x 4 days which did not improve symptoms. He began to have weakness when walking and used walking sticks for better stability when ambulating. About this time, he developed a non-pruritic diffuse erythematous rash. He continued to worsen and was advised by his oncologist to be admitted for additional workup which occurred on 12/15/2023-12/22/2023. MRIs of the brain and spine demonstrated multifocal T2 lesions, dozens with enhancement including a C-spine lesion likely driving his motor symptoms. CSF was notable for elevated protein. He had been treated with IVIg (for presumed Guillain-Barre syndrome, which was fully consistent with clinical picture) and then steroids for demyelinating disease. These resulted in modest improvements. He re-presented to the hospital on 1/12/2023 while still on oral prednisone taper due to transient loss of awareness concerning for syncope, seizure, or vascular etiology.   Repeat MRIs on 1/19/2023 demonstrated improvement of prior demyelinating lesions, but with new foci of restricted diffusion in the basal ganglia and bilateral temporal lobes concerning for acute infarcts or inflammatory foci. EEG monitoring was unremarkable. On 1/21/2023 he had episode of unresponsiveness and R gaze deviation consistent with focal seizure (not on EEG at the time). On 1/22/2023 was found unresponsive and intubated for hypoxemic respiratory failure. CT/CTA were stable, remained obtunded without ongoing seizure activity on EEG. Repeat CSF studies notable for protein elevated to 131 and elevated IgG index. Repeat MRI brain 1/23/2023 with new periventricular and cortical areas of diffusion restriction as well as diffuse susceptibility throughout white matter, especially involving corpus callosum. No significant contrast enhancement. Body FDG-PET scan 1/25/2023 with splenomegaly with FDG uptake greater than liver, suspicious for lymphomatosis infiltration. Brain biopsy without evidence of vasculitis or malignancy but findings potentially consistent with ADEM. Treated with steroids and then plasma exchange. While in ICU developed AKI, MSSA pneumonia, atrial fibrillation with RVR, and ultimately requiring vasopressors. Transitioned to comfort care given poor prognosis in line with stated goals of care.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Expired product administered
Clinical narrative: This was a vaccine error that happened Pediatrics. The parent of this child phoned this RN at the clinic to report that Pediatrics RN gave her 15 month old child an expired dose of HIB. The child did not have an adverse reaction. The parent is alarmed and concerned and wants to make sure this error is reported.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC20
Symptoms: Expired product administered, No adverse event
Clinical narrative: This was a vaccine error that happened Pediatrics. The parent of this child phoned this RN at the clinic to report that Pediatrics RN gave her 15 month old child an expired dose of HIB. The child did not have an adverse reaction. The parent is alarmed and concerned and wants to make sure this error is reported.
Age: 6.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Reported the consumer had swelling at the injection site, it was hot to the touch, and there was a circle around the injection site; Reported the consumer had swelling at the injection site, it was hot to the touch, and there was a circle around the injection site; This spontaneous report was received from a Consumer regarding her daughter to a 6-year-old female.  The patient's medical history, concurrent conditions and Concomitant therapies were not reported.  On an unknown date in 2024, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose description, lot #, expiry date, and route of administration were not provided), subcutaneous injection; along with diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP); both administered for prophylaxis.  On unspecified date in 2024, the patient presented swelling at the injection site, it was hot to the touch, and there was a circle around the injection site. At the reporting time, the outcome of the events was not reported.  The causality assessment between the events and varicella virus vaccine live (oka/merck) (VARIVAX) was not reported. It was believed to have been caused by the diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) vaccine.   Lot Number is being requested and will be submitted if received.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Erythema, Fall, Influenza, Influenza like illness
Clinical narrative: Flu; body aches; migraines; balance,/ balance falling; arm red; arm double size red super hot swollen double size/ swollen double size; arm hot/ super hot; Extreme flu like symptoms; This non-serious case was reported by a consumer and described the occurrence of influenza in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included anxiety, depression and stroke. Concomitant products included fluoxetine hydrochloride (Prozac).   On 22-JAN-2024, the patient received Shingrix. On 25-FEB-2024, 34 days after receiving Shingrix, the patient experienced influenza (Verbatim: Flu), general body pain (Verbatim: body aches), migraine (Verbatim: migraines), balance disorder (Verbatim: balance,/ balance falling), erythema of extremities (Verbatim: arm red), swelling arm (Verbatim: arm double size red super hot swollen double size/ swollen double size), extremities hot feeling of (Verbatim: arm hot/ super hot) and influenza-like symptoms (Verbatim: Extreme flu like symptoms). The outcome of the influenza, general body pain, migraine, balance disorder, erythema of extremities, swelling arm, extremities hot feeling of and influenza-like symptoms were not resolved.   It was unknown if the reporter considered the influenza, general body pain, migraine, balance disorder, erythema of extremities, swelling arm, extremities hot feeling of and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the influenza, general body pain, migraine, balance disorder, erythema of extremities, swelling arm, extremities hot feeling of and influenza-like symptoms to be related to Shingrix.   Additional Information: RA receipt date: 29-FEB-2024 The patient had flu body aches migraines, balance, arm red hot and double size arm) Were the symptoms. Extreme flu like symptoms migraines balance falling over arm double size red super hot swollen double size. The patient had Flavix listropil, as concomitant drug.
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Pain, Peripheral swelling, Skin warm
Clinical narrative: Flu; body aches; migraines; balance,/ balance falling; arm red; arm double size red super hot swollen double size/ swollen double size; arm hot/ super hot; Extreme flu like symptoms; This non-serious case was reported by a consumer and described the occurrence of influenza in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included anxiety, depression and stroke. Concomitant products included fluoxetine hydrochloride (Prozac).   On 22-JAN-2024, the patient received Shingrix. On 25-FEB-2024, 34 days after receiving Shingrix, the patient experienced influenza (Verbatim: Flu), general body pain (Verbatim: body aches), migraine (Verbatim: migraines), balance disorder (Verbatim: balance,/ balance falling), erythema of extremities (Verbatim: arm red), swelling arm (Verbatim: arm double size red super hot swollen double size/ swollen double size), extremities hot feeling of (Verbatim: arm hot/ super hot) and influenza-like symptoms (Verbatim: Extreme flu like symptoms). The outcome of the influenza, general body pain, migraine, balance disorder, erythema of extremities, swelling arm, extremities hot feeling of and influenza-like symptoms were not resolved.   It was unknown if the reporter considered the influenza, general body pain, migraine, balance disorder, erythema of extremities, swelling arm, extremities hot feeling of and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the influenza, general body pain, migraine, balance disorder, erythema of extremities, swelling arm, extremities hot feeling of and influenza-like symptoms to be related to Shingrix.   Additional Information: RA receipt date: 29-FEB-2024 The patient had flu body aches migraines, balance, arm red hot and double size arm) Were the symptoms. Extreme flu like symptoms migraines balance falling over arm double size red super hot swollen double size. The patient had Flavix listropil, as concomitant drug.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyshidrotic eczema
Clinical narrative: Patient began experiencing symptoms 3-5 days after immunization and condition has worsened; This non-serious case was reported by a other health professional via sales rep and described the occurrence of dyshidrotic eczema in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number YC5Y7, expiry date 25-OCT-2023) for prophylaxis.   On 02-MAY-2023, the patient received the 1st dose of Shingrix. On 05-MAY-2023, 3 days after receiving Shingrix, the patient experienced dyshidrotic eczema (Verbatim: Patient began experiencing symptoms 3-5 days after immunization and condition has worsened). The outcome of the dyshidrotic eczema was not resolved.   The reporter considered the dyshidrotic eczema to be related to Shingrix.     The company considered the dyshidrotic eczema to be related to Shingrix.   Additional Information: RA Receipt Date: 01-MAR-2024 This report was submitted via the online direct entry reporting system.  The reporter was practice administrator. The patient began experiencing symptoms 3-5 days after immunization and condition had worsened. The patient had been seen by three dermatologists.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The vaccine really painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: The vaccine really painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2024 The patient self reported this case. The patient stated that the vaccine was really painful, but did not want the singles pain. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity
Clinical narrative: nausea; sore arm; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nausea in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27-FEB-2024, the patient received Shingles vaccine. In FEB-2024, an unknown time after receiving Shingles vaccine, the patient experienced nausea (Verbatim: nausea), pain in arm (Verbatim: sore arm) and tiredness (Verbatim: tiredness). The outcome of the nausea, pain in arm and tiredness were not reported.   It was unknown if the reporter considered the nausea, pain in arm and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the nausea, pain in arm and tiredness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2024. This case was reported by a patient via interactive digital media. The patient received their shingles vaccine (yesterday) a day before the time of reporting and experienced nausea, sore arm and tiredness.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypersensitivity
Clinical narrative: The patient had injection site reaction and it was allergic reaction; Injection site redness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site allergic reaction (Verbatim: The patient had injection site reaction and it was allergic reaction) and injection site erythema (Verbatim: Injection site redness). The outcome of the injection site allergic reaction and injection site erythema were not reported.   It was unknown if the reporter considered the injection site allergic reaction and injection site erythema to be related to Shingles vaccine.     It was unknown if the company considered the injection site allergic reaction and injection site erythema to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 29-Feb-2024 This case was reported by the consumer via interactive digital media. The patient reported that he or she received Shingles and had a reaction at injection site.  The patient went to the physician and she stated that it was an allergic.  The physician drew a purple circle around the area and she stated that if the redness went out of that circle to come back.  The physician told him or her not to take the second shot. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: And my arm really bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27-FEB-2024, the patient received the 2nd dose of Shingles vaccine. In FEB-2024, an unknown time after receiving Shingles vaccine, the patient experienced arm discomfort (Verbatim: And my arm really bad). The outcome of the arm discomfort was not reported.   It was unknown if the reporter considered the arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-FEB-2024 This case was reported by a patient via interactive digital media. The reporter reported that the patient got the second shot a day before reporting and the arm was really bad . The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: called for excursion; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: called for excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 29-FEB-2024 The reporter called for excursion non-Novartis product Menveo, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: The vaccine has caused fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigue (Verbatim: The vaccine has caused fatigue). The outcome of the fatigue was not reported.   The reporter considered the fatigue to be related to Arexvy.     The company considered the fatigue to be related to Arexvy.   Additional Information: GSK receipt date: 01-MAR-2024 The vaccine has caused fatigue to the patient.
Sex: U
Vaccine: RSV
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: large swollen; very itchy area; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced swelling (Verbatim: large swollen) and pruritus (Verbatim: very itchy area). The outcome of the swelling and pruritus were not resolved.   It was unknown if the reporter considered the swelling and pruritus to be related to Arexvy.     It was unknown if the company considered the swelling and pruritus to be related to Arexvy.   Additional Information: GSK Receipt date: 01-MAR-2024 This case was reported by consumer via interactive digital media. Reporter reported that the reaction that patient had was a large swollen, and very itchy area about the size of a ball, about 2 inches below the injection site. It had been there for 3 days and was not getting any better and was not going away.
Sex: U
Vaccine: RSV
Symptoms: Headache
Clinical narrative: Headache it is for me; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced headache (Verbatim: Headache it is for me). The outcome of the headache was not reported.   It was unknown if the reporter considered the headache to be related to Arexvy.     It was unknown if the company considered the headache to be related to Arexvy.   Additional Information: GSK receipt date: 01-MAR-2024 This case was reported the consumer via interactive digital media. The reporter reported it was headache for him.
Sex: U
Vaccine: RSV
Symptoms: Pain, Pruritus, Skin discolouration
Clinical narrative: arm  itch so bad; sight is still back and blue; Very little pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of itchy upper limbs in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 7 days after receiving Arexvy, the patient experienced itchy upper limbs (Verbatim: arm  itch so bad), skin discoloration (Verbatim: sight is still back and blue) and pain (Verbatim: Very little pain). The outcome of the itchy upper limbs, skin discoloration and pain were not reported.   It was unknown if the reporter considered the itchy upper limbs, skin discoloration and pain to be related to Arexvy.     It was unknown if the company considered the itchy upper limbs, skin discoloration and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 The patient self-reported this case. Patient's arm itch so bad 7 days after my RSV shot. The sight was still back and blue and had very little pain.
Sex: U
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: I'm sick from shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: I'm sick from shot). The outcome of the sickness was not reported.   The reporter considered the sickness to be related to Arexvy.     The company considered the sickness to be related to Arexvy.   Additional Information: GSK Receipt date: 01-MAR-2024 This case was reported by consumer via interactive digital media. Patient was a reporter. The patient was sick from shot.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Pain in injection area; Pain in injection area and joint; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain in injection area) and joint pain (Verbatim: Pain in injection area and joint). The outcome of the injection site pain and joint pain were not reported.   It was unknown if the reporter considered the injection site pain and joint pain to be related to Arexvy.     It was unknown if the company considered the injection site pain and joint pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a consumer via interactive digital media. The patient experienced pain in the injection area and joint.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Terrible joint ache; aches throughout body; Slight fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: Terrible joint ache), general body pain (Verbatim: aches throughout body) and fever (Verbatim: Slight fever). The outcome of the joint pain, general body pain and fever were not reported.   It was unknown if the reporter considered the joint pain, general body pain and fever to be related to Arexvy.     It was unknown if the company considered the joint pain, general body pain and fever to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient experienced terrible joint and aches throughout body and slight fever.
Sex: M
Vaccine: VARZOS
Symptoms: Giant cell arteritis, Herpes zoster
Clinical narrative: Shingles; Giant cell arteritis; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and giant cell arteritis (Verbatim: Giant cell arteritis). The outcome of the shingles and giant cell arteritis were not reported.   It was unknown if the reporter considered the shingles and giant cell arteritis to be related to Shingles vaccine.     It was unknown if the company considered the shingles and giant cell arteritis to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-FEB-2024 This case was reported by a patient via interactive digital media. The reporter stated that her husband got the first shingle shot then had shingles then later had giant cell arteritis. Neurologist said the shot probably triggered this autoimmune disease had been disabled since then.  The follow-up could not be possible as no contact details were available.
Age: 0.42
Sex: U
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration in 5 month old infant; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration in 5 month old infant). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2024 The physician reported that the 5 months old infant received the Bexsero vaccine which led to inappropriate age at vaccine administration. A physician called in requesting recommendations for the administration of Bexsero in an infant from another country.  They ended the call on their own end after saying they had found the information, so the report was filed for the possible event. The reporter consented to follow up.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: a dose of Havrix to a 1 year old patient on 26Feb2024, which had an expiration date of 06Feb2023.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old male patient who received HAV (Havrix) (batch number EP47E, expiry date 06-FEB-2023) for prophylaxis.   On 26-FEB-2024, the patient received the 1st dose of Havrix. On 26-FEB-2024, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: a dose of Havrix to a 1 year old patient on 26Feb2024, which had an expiration date of 06Feb2023.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-FEB-2024 The office manager reported that the medical assistant administered a expired dose of Havrix to a patient which led to expired vaccine used. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: HEP
Symptoms: Liquid product physical issue, Product preparation issue
Clinical narrative: previous single doses have appeared completely clear; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received HBV (Engerix B adult) (batch number 4T39P, expiry date 09-DEC-2025) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced inappropriate preparation of medication (Verbatim: previous single doses have appeared completely clear). The outcome of the inappropriate preparation of medication was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 29-FEB-2024 Reporter reported that he or she had the Engerix B 20 microgram per milliliter single dose on hand and it appears slightly cloudy which had not noticed with previous orders. Reporter asked was it supposed to be clear, reporter had a single dose of Engerix B 20 microgram per milliliter, and it appears slightly cloudy versus completely clear. Previous single doses had appeared completely clear. (After sharing information in the prescribing information with health care provider). Reporter would assume that he or she did not agitate the previous syringes and currently reporter happen to be very deliberate in doing this not for any reason, which lead to inappropriate preparation of medication. The reporter consented to follow-up.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Muscular weakness, Myalgia
Clinical narrative: Weakness in arm; lingering muscle pain in the arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of myalgia upper extremities in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number M4DY4, expiry date 04-OCT-2025) for prophylaxis.   On 14-NOV-2023, the patient received Shingrix. On 14-NOV-2023, immediately after receiving Shingrix, the patient experienced myalgia upper extremities (Verbatim: lingering muscle pain in the arm). On an unknown date, the patient experienced weakness of arms (Verbatim: Weakness in arm). The outcome of the myalgia upper extremities and weakness of arms were not resolved.   It was unknown if the reporter considered the myalgia upper extremities and weakness of arms to be related to Shingrix.     It was unknown if the company considered the myalgia upper extremities and weakness of arms to be related to Shingrix.   Additional Information: RA receipt date: 29-FEB-2024  The pharmacist called to inform that a patient that received a dose of Shingrix and reported a lingering muscle pain in the arm.  According to the reporter, the patient had experiences that since the moment of vaccination.  Also, the reported mentioned that the patient experienced weakness in the arm when putting it above his head. The Vaccine Administration Facility was the same as Primary Reporter The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Malaise, Pain, Pain in extremity
Clinical narrative: a red spot the size of a quarter; extreme soreness in her arm; body aches; chills; didn't feel well; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: a red spot the size of a quarter), pain in arm (Verbatim: extreme soreness in her arm), general body pain (Verbatim: body aches), chills (Verbatim: chills) and feeling unwell (Verbatim: didn't feel well). The outcome of the injection site erythema, pain in arm, general body pain, chills and feeling unwell were resolved.   It was unknown if the reporter considered the injection site erythema, pain in arm, general body pain, chills and feeling unwell to be related to Shingrix.     It was unknown if the company considered the injection site erythema, pain in arm, general body pain, chills and feeling unwell to be related to Shingrix.   Additional Information: RA Receipt date: 29-FEB-2024 Reporter called to patient regarding different product, they reported that the Shingrix adverse event. Patient took the Shingrix dose one or two years ago from reporting day and beginning on the day after the vaccine, they experienced extreme arm soreness, a red spot the size of a quarter (about 24 millimeter diagonal), body aches, chills and did not feel well. The symptoms lasted about 3 or 4 days. The reporter requested to consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: request information about the administration of Shingrix after the maximum recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 29th December 2021, received 1st dose with batch 7CX2C and expiry date of 10th March 2023.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: request information about the administration of Shingrix after the maximum recommended interval). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA receipt date: 29-FEB-2024 A pharmacist called in to request information about the administration of Shingrix after the maximum recommended interval.  The Vaccine Administration Facility was the same as Primary Reporter The patient did not receive the 2nd dose, which led to incomplete course of vaccination. They provided basic case details and declined follow-up.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: A CMA called to report the administration of an expired Engerix-b dose to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 57-year-old male patient who received HBV (Engerix B) (batch number 9255P, expiry date 15-FEB-2024) for prophylaxis.   On 28-FEB-2024, the patient received Engerix B. On 28-FEB-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: A CMA called to report the administration of an expired Engerix-b dose to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 29-FEB-2024 The reporter was a certified medical assistant. The healthcare professional asked for guidance on this situation.