chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Acute kidney injury, Anaemia, Blood creatinine increased, Epistaxis, Eye pain
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Haemoglobin decreased, Headache, Immune thrombocytopenia, Immunoglobulin therapy, Injection site bruising
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Magnetic resonance imaging abnormal, Myalgia, Myofascitis
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Ocular hyperaemia, Oral disorder, Oral mucosal blistering, Peripheral swelling, Petechiae
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Platelet count decreased, Purpura, Rash, Retinal haemorrhage, Transfusion
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Ultrasound Doppler normal, Vitreous floaters, Vitreous haemorrhage
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Anaemia, Blindness unilateral, Compartment syndrome, Computerised tomogram, Fasciitis
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Headache, Imaging procedure, Immunoglobulin therapy, Injection site bruising, Injection site pain
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Injection site swelling, Magnetic resonance imaging head, Platelet count decreased, Product use in unapproved indication, Retinal haemorrhage
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 16.0
Sex: F
Vaccine: UNK, PPV, PPV
Symptoms: Transfusion, Ultrasound scan, Vision blurred, X-ray
Clinical narrative: Around 3 hours after the vaccination, the patient contacted my office due to severe pain, swelling, and bruising at the local site.  She had substantial swelling  (right arm was swollen twice the size of the left arm). She experienced progressive swelling, bruising, and then developed a progressive rash on her face, neck, hands and feet, significant epistaxis, myalgias, blistering lesions in oral mucosa, eye pain and redness with floaters, and headaches. She was admitted to the hospital 3/10/2024 - 3/14/2024 and was diagnosed with myofasciitis and severe ITP (immune thrombocytopenic purpura). She had critically low platelets of 2, anemia (hemoglobin dropped to 7.3), as well as acute on chronic kidney injury (Cr 1.25, up from 0.89), and vitreal and subhyaloid eye hemorrhages. Orthopedics consulted to rule out compartment syndrome - but MRI showed severe myofasciitis but no compartment syndrome. She required IVIG, blood transfusion, and prednisone x 5 day course. She had repeat labs yesterday with improvement in her kidney function to baseline but her platelets are still 2. She continues to have significant petechiae with improved wet purpura, ongoing epistaxis. She will have ongoing followup with Heme-Onc, Ophthalmology, Immunology clinics.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Blood cortisol, Blood sodium decreased, Blood uric acid, Computerised tomogram head, Computerised tomogram thorax
Clinical narrative: sodium level was low/ idiopathic drop in sodium; confusion; dizziness; This is a spontaneous report received from a Pharmacist.  A 67-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Dec2023 as dose 1, single (Lot number: HF5522, Expiration Date: 10Dec2024) at the age of 67 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: diagnosed several years ago. The patient took concomitant medications. Vaccination history included: Moderna covid vaccine (DOSE NUMBER UNKNOWN), administration date: Oct2023, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: CONFUSIONAL STATE (medically significant) with onset 2024, outcome "unknown", described as "confusion"; DIZZINESS (medically significant) with onset 2024, outcome "unknown"; BLOOD SODIUM DECREASED (medically significant) with onset 2024, outcome "recovering", described as "sodium level was low/ idiopathic drop in sodium". The events "sodium level was low/ idiopathic drop in sodium", "confusion" and "dizziness" required physician office visit. The clinical course was reported as follows: The patient happened to had bloodwork drawn and her sodium level was low. They repeated the sodium level, and it went lower. Then, when sodium level hit 130 patient got symptoms of confusion and dizziness. The reporter was assuming the blood work was six weeks after the vaccine because patient said something about six weeks after the vaccine, also stated all of this happened pretty recently. The patient saw a nephrologist and went to see an ear, nose and throat (ENT) to check about the confusion and to make sure it wasn't anything else. The patient had Computerised tomogram (CT) scan done on 14Mar2024 by ENT to rule out anything related because the patient was confused and dizzy. The patient had been to gastroenterologist and pulmonologist and nephrologist, and they all think it is an idiopathic drop in sodium. The low sodium has not resolved but is getting better. The patient is a retired physician. The patient underwent the laboratory tests and procedures as aforementioned.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Electrophoresis protein, Endoscopy, Full blood count, Hyponatraemia, Metabolic function test
Clinical narrative: sodium level was low/ idiopathic drop in sodium; confusion; dizziness; This is a spontaneous report received from a Pharmacist.  A 67-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Dec2023 as dose 1, single (Lot number: HF5522, Expiration Date: 10Dec2024) at the age of 67 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: diagnosed several years ago. The patient took concomitant medications. Vaccination history included: Moderna covid vaccine (DOSE NUMBER UNKNOWN), administration date: Oct2023, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: CONFUSIONAL STATE (medically significant) with onset 2024, outcome "unknown", described as "confusion"; DIZZINESS (medically significant) with onset 2024, outcome "unknown"; BLOOD SODIUM DECREASED (medically significant) with onset 2024, outcome "recovering", described as "sodium level was low/ idiopathic drop in sodium". The events "sodium level was low/ idiopathic drop in sodium", "confusion" and "dizziness" required physician office visit. The clinical course was reported as follows: The patient happened to had bloodwork drawn and her sodium level was low. They repeated the sodium level, and it went lower. Then, when sodium level hit 130 patient got symptoms of confusion and dizziness. The reporter was assuming the blood work was six weeks after the vaccine because patient said something about six weeks after the vaccine, also stated all of this happened pretty recently. The patient saw a nephrologist and went to see an ear, nose and throat (ENT) to check about the confusion and to make sure it wasn't anything else. The patient had Computerised tomogram (CT) scan done on 14Mar2024 by ENT to rule out anything related because the patient was confused and dizzy. The patient had been to gastroenterologist and pulmonologist and nephrologist, and they all think it is an idiopathic drop in sodium. The low sodium has not resolved but is getting better. The patient is a retired physician. The patient underwent the laboratory tests and procedures as aforementioned.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Thyroid function test, Urine analysis, Urine potassium, Urine sodium
Clinical narrative: sodium level was low/ idiopathic drop in sodium; confusion; dizziness; This is a spontaneous report received from a Pharmacist.  A 67-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Dec2023 as dose 1, single (Lot number: HF5522, Expiration Date: 10Dec2024) at the age of 67 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: diagnosed several years ago. The patient took concomitant medications. Vaccination history included: Moderna covid vaccine (DOSE NUMBER UNKNOWN), administration date: Oct2023, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: CONFUSIONAL STATE (medically significant) with onset 2024, outcome "unknown", described as "confusion"; DIZZINESS (medically significant) with onset 2024, outcome "unknown"; BLOOD SODIUM DECREASED (medically significant) with onset 2024, outcome "recovering", described as "sodium level was low/ idiopathic drop in sodium". The events "sodium level was low/ idiopathic drop in sodium", "confusion" and "dizziness" required physician office visit. The clinical course was reported as follows: The patient happened to had bloodwork drawn and her sodium level was low. They repeated the sodium level, and it went lower. Then, when sodium level hit 130 patient got symptoms of confusion and dizziness. The reporter was assuming the blood work was six weeks after the vaccine because patient said something about six weeks after the vaccine, also stated all of this happened pretty recently. The patient saw a nephrologist and went to see an ear, nose and throat (ENT) to check about the confusion and to make sure it wasn't anything else. The patient had Computerised tomogram (CT) scan done on 14Mar2024 by ENT to rule out anything related because the patient was confused and dizzy. The patient had been to gastroenterologist and pulmonologist and nephrologist, and they all think it is an idiopathic drop in sodium. The low sodium has not resolved but is getting better. The patient is a retired physician. The patient underwent the laboratory tests and procedures as aforementioned.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Age: 67.0
Sex: F
Vaccine: RSV, RSV
Symptoms: Blood sodium decreased, Computerised tomogram, Confusional state, Dizziness
Clinical narrative: sodium level was low/ idiopathic drop in sodium; confusion; dizziness; This is a spontaneous report received from a Pharmacist.  A 67-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 11Dec2023 as dose 1, single (Lot number: HF5522, Expiration Date: 10Dec2024) at the age of 67 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: diagnosed several years ago. The patient took concomitant medications. Vaccination history included: Moderna covid vaccine (DOSE NUMBER UNKNOWN), administration date: Oct2023, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: CONFUSIONAL STATE (medically significant) with onset 2024, outcome "unknown", described as "confusion"; DIZZINESS (medically significant) with onset 2024, outcome "unknown"; BLOOD SODIUM DECREASED (medically significant) with onset 2024, outcome "recovering", described as "sodium level was low/ idiopathic drop in sodium". The events "sodium level was low/ idiopathic drop in sodium", "confusion" and "dizziness" required physician office visit. The clinical course was reported as follows: The patient happened to had bloodwork drawn and her sodium level was low. They repeated the sodium level, and it went lower. Then, when sodium level hit 130 patient got symptoms of confusion and dizziness. The reporter was assuming the blood work was six weeks after the vaccine because patient said something about six weeks after the vaccine, also stated all of this happened pretty recently. The patient saw a nephrologist and went to see an ear, nose and throat (ENT) to check about the confusion and to make sure it wasn't anything else. The patient had Computerised tomogram (CT) scan done on 14Mar2024 by ENT to rule out anything related because the patient was confused and dizzy. The patient had been to gastroenterologist and pulmonologist and nephrologist, and they all think it is an idiopathic drop in sodium. The low sodium has not resolved but is getting better. The patient is a retired physician. The patient underwent the laboratory tests and procedures as aforementioned.; Sender's Comments: There is not a reasonable possibility that the reported event related to the suspect product event most likely due to patient underlying contributory factors.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Attributes this to dehydration/fluid loss as he states cannot drink enough to keep up with diarrhea.; burning sensation in bilateral upper extremities; Pt reports developing explosive diarrhea yesterday evening with >10 episodes; With diarrhea, patient also notes onset of lighheadedness; a diffuse skin rash/skin rash is mildly pruritic; This spontaneous case was reported by a patient and describes the occurrence of DEHYDRATION (Attributes this to dehydration/fluid loss as he states cannot drink enough to keep up with diarrhea.), BURNING SENSATION (burning sensation in bilateral upper extremities), DIARRHOEA (Pt reports developing explosive diarrhea yesterday evening with >10 episodes), DIZZINESS (With diarrhea, patient also notes onset of lighheadedness) and RASH PRURITIC (a diffuse skin rash/skin rash is mildly pruritic) in a 77-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-93) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 14-Mar-2024, the patient experienced DEHYDRATION (Attributes this to dehydration/fluid loss as he states cannot drink enough to keep up with diarrhea.), BURNING SENSATION (burning sensation in bilateral upper extremities), DIARRHOEA (Pt reports developing explosive diarrhea yesterday evening with >10 episodes), DIZZINESS (With diarrhea, patient also notes onset of lighheadedness) and RASH PRURITIC (a diffuse skin rash/skin rash is mildly pruritic). At the time of the report, DEHYDRATION (Attributes this to dehydration/fluid loss as he states cannot drink enough to keep up with diarrhea.), BURNING SENSATION (burning sensation in bilateral upper extremities), DIARRHOEA (Pt reports developing explosive diarrhea yesterday evening with >10 episodes), DIZZINESS (With diarrhea, patient also notes onset of lighheadedness) and RASH PRURITIC (a diffuse skin rash/skin rash is mildly pruritic) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient had onset of lightheadedness, worse with moving from lying down to sitting or standing.
Age: 77.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Burning sensation, Dehydration, Diarrhoea, Dizziness, Rash pruritic
Clinical narrative: Attributes this to dehydration/fluid loss as he states cannot drink enough to keep up with diarrhea.; burning sensation in bilateral upper extremities; Pt reports developing explosive diarrhea yesterday evening with >10 episodes; With diarrhea, patient also notes onset of lighheadedness; a diffuse skin rash/skin rash is mildly pruritic; This spontaneous case was reported by a patient and describes the occurrence of DEHYDRATION (Attributes this to dehydration/fluid loss as he states cannot drink enough to keep up with diarrhea.), BURNING SENSATION (burning sensation in bilateral upper extremities), DIARRHOEA (Pt reports developing explosive diarrhea yesterday evening with >10 episodes), DIZZINESS (With diarrhea, patient also notes onset of lighheadedness) and RASH PRURITIC (a diffuse skin rash/skin rash is mildly pruritic) in a 77-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-93) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 14-Mar-2024, the patient experienced DEHYDRATION (Attributes this to dehydration/fluid loss as he states cannot drink enough to keep up with diarrhea.), BURNING SENSATION (burning sensation in bilateral upper extremities), DIARRHOEA (Pt reports developing explosive diarrhea yesterday evening with >10 episodes), DIZZINESS (With diarrhea, patient also notes onset of lighheadedness) and RASH PRURITIC (a diffuse skin rash/skin rash is mildly pruritic). At the time of the report, DEHYDRATION (Attributes this to dehydration/fluid loss as he states cannot drink enough to keep up with diarrhea.), BURNING SENSATION (burning sensation in bilateral upper extremities), DIARRHOEA (Pt reports developing explosive diarrhea yesterday evening with >10 episodes), DIZZINESS (With diarrhea, patient also notes onset of lighheadedness) and RASH PRURITIC (a diffuse skin rash/skin rash is mildly pruritic) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient had onset of lightheadedness, worse with moving from lying down to sitting or standing.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP calling to report an AE regarding the MMR II vaccine. HCP reported that an expired dose of the MMR II vaccine was inadverntly administered to a patient. HCP reported no prior T.Es for the MMR II vaccine and was provided the supported disclaimer.; This spontaneous report was received from a nurse and refers to a patient of unspecified age or gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 05-MAR-2024, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # U039549, expiration date: 14-DEC-2023, albumin status validated as rHA (strength, route of administration, anatomical location not provided) as prophylaxis.  No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Influenza like illness
Clinical narrative: Illness is terrible; illness like bad flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of illness 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 illness (Verbatim: Illness is terrible) and influenza like illness (Verbatim: illness like bad flu). The outcome of the illness and influenza like illness were not reported.   It was unknown if the reporter considered the illness and influenza like illness to be related to Shingles vaccine.     It was unknown if the company considered the illness and influenza like illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2024 This case was reported by the patient via interactive digital media. The patient had illness was terrible after the shots like a bad flu.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired product used; 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 18-month-old female patient who received Hib (Hiberix) (batch number AE234, expiry date 12-DEC-2023) for prophylaxis.   On 28-FEB-2024, the patient received the 4th dose of Hiberix. On 28-FEB-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: expired product used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-MAR-2024 The medical assistant reported that an 18-month-old patient was administered a dose of Hiberix. Afterward staff realized the product had an earlier expiration date, which led to an expired vaccine used. At the time of reporting, a repeat dose has not been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: She never received her second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her 1st dose 15 months ago from the date of reporting).   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: She never received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-MAR-2024 The reporter was the patient who never received her second dose of Shingrix till the time of reporting, which led to an incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Death
Clinical narrative: DEATH; HEART ISSUES; This spontaneous report received from a consumer and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The complainants sister experienced heart issues and death after  taking the vaccine(dose series 1). On an unspecified date, the patient died from unknown cause of death. The date of death and autopsy details were not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of heart issues was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: Death, Cardiac disorder. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Biopsy brain abnormal, Contraindicated product administered, Infusion, Measles post vaccine
Clinical narrative: Developed acute vaccine-strain measles virus disease (Measles post vaccine ); Contraindicated product administered; Information has been received from Health Authority (US-MLMSERVICE-20240304-4863795-1) on 08-MAR-2024.   This literature marketed report has been received from the authors of a published literature article, titled as stated above, concerning to a 1-year-old female infant patient diagnosed with acute myeloid leukemia. Her historical medical history, previous drug reaction or allergies and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, dose, frequency, scheme, lot #, expiry date, and route of administration were not provided)(contraindicated product administered).  On an unspecifed date, the patient developed acute vaccine-strain measles virus disease, and a brain biopsy specimen was positive for vaccine-strain measles virus detected by reverse transcriptase polymerase chain reaction. She was treated with intravenous ribavirin, inosine pranobex, intrathecal interferon-alpha and donor lymphocyte infusion following measles-mumps-rubella vaccine boost. By the time of report, the ourcome of the event was not provided.   The reporter considered the event of measles post vaccine to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). Upon internal review, the event of Measles post vaccine was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 as dose 1, single (Lot number: HF9300) at the age of 64 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: both controlled; "hypothyroid" (unspecified if ongoing), notes: both controlled. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE; Lot number: GJ6665, Anatomical location: Right arm), administration date: 08Nov2022, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: FK9894, Anatomical location: Left arm), administration date: 11Apr2022, when the patient was 63-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FE3590, Anatomical location: Left arm), administration date: 15Oct2021, when the patient was 62-year-old, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EK9231, Anatomical location: Left arm), administration date: 06Jan2021, when the patient was 61-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE; Lot number: EK5730), administration date: 18Dec2020, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: previously been negative x2; Negative, notes: previously been negative x2; Positive, notes: Positive Ag test. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 04Mar2024 to 08Mar2024 with lot number: 00069532130.  Clinical course: Rebound illness 5 days following completion of full course of Paxlovid with runny nose cough sore throat and fever. Positive Ag test ( which had previously been negative x2).  No follow-up attempts are possible.
Age: 2.0
Sex: M
Vaccine: PNC, UNK
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: redness, almost like hives, in the area where the PENTACEL dose was given; redness, almost like hives, in the area where the PENTACEL dose was given; Initial information received on 08-Mar-2024 regarding an unsolicited valid  non-serious case received from a physician via call center.  This case involves a 2 years old male patient who experienced redness, almost like hives, in the area where the Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] and Pneumococcal Vaccine CONJ 7V (CRM197) [Prevnar] dose was given.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Mar-2024, the patient had received 0.5 ml (dose: 1) of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (strength unknown) (lot UJ958AB; expiry date: 02-Jun-2024  via intramuscular route in the left deltoid and on the same day the patient also received (dose and units: unknown) suspect Prevnar (Lot, expiry date, strength and formulation not reported); both for prophylactic vaccination.  On 07-Mar-2024 (Latency: 6 days) the patient had developed redness, almost like hives, in the area where the pentacel dose was given (vaccination site erythema) (vaccination site urticaria) following the administration ofDiphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine and Prevnar.  Doctor stated that usually, she sees it right away (referring to the injection site reaction), like 2, 3, or 4 days after the injection, and it is usually like with the "4-year-olds DTAP or something like that" and she has never had it happen with the Pentacel . She also mentioned that this is the patient's first time to receive the vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for both the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for both the events.
Age: 14.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered, Wrong technique in product usage process
Clinical narrative: inappropriate administration of IPOL that was no longer suitable for use to patients with no reported adverse event; Initial information received on 11-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2024SA074397, 2024SA082167, 2024SA082816, 2024SA082981, 2024SA08311 and 2024SA081652.  This case involves a 14 years old male patient who experienced inappropriate administration of IPV (Vero) [Ipol] that was no longer suitable for use to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (Tdap) Vaccination; Varicella Zoster Vaccine (Varicella Vaccine) both for Prophylactic Vaccination.  On 27-Feb-2024, the patient had inappropriate administration of 0.5 ml of IPV (Vero) (Suspension for injection) (lot W1C751M, expiry date: 18-Nov-2025, strength not reported) via intramuscular route in the right arm for Immunization that was no longer suitable for use to patient with no reported adverse event (poor quality product administered)(latency: same day).  It was reported that "The Ipol was administered to 8 patients".  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive and Regulatory Authority Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: inappropriate administration of IPOL that was no longer suitable for use to patients with no reported adverse event; Initial information received on 11-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2024SA074397, 2024SA082167, 2024SA082816, 2024SA082981, 2024SA081647 and 2024SA081652.  This case involves a 13 years and 10 months old male patient who experienced inappropriate administration of IPV (Vero) [Ipol] that was no longer suitable for use to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Tetanus Vaccine Toxoid (TD); Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR); Varicella Zoster Vaccine (Varicella Vaccine); and Hepatitis B Vaccine (HEP B Vax) all for prophylactic vaccination.  On 27-Feb-2024, the patient had inappropriate administration of 0.5 ml of IPV (Vero) (Suspension for injection) (lot W1C751M, expiry date: 18-Nov-2025, strength not reported) via intramuscular route in the right arm for Immunization that was no longer suitable for use to patient with no reported adverse event (poor quality product administered)(latency: same day).  It was reported that "The Ipol was administered to 8 patients".   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: inadvertently reconstituted with sterile water instead of the accompanying 0.4% sodium chloride ACTHIB diluent with no reported adverse event; Initial information received on 12-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced inadvertently reconstituted with sterile water instead of the accompanying 0.4% sodium chloride acthib diluent with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; Varicella Zoster Vaccine Live (OKA/MERCK) (VARIVAX II) for Prophylactic vaccination; Pneumococcal Vaccine CONJ 20V (CRM197) (PREVNAR 20) for Prophylactic vaccination; and Hepatitis A vaccine INACT (VAQTA) for Prophylactic vaccination.  On 08-Mar-2024, the patient received 0.5 ml dose (dose 4) of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of lot UJ977AA and expiry: 08-Nov-2024 via intramuscular route in the left thigh for immunization  On 08-Mar-2024 the patient was administered by inadvertently reconstituted with sterile water instead of the accompanying 0.4% sodium chloride acthib diluent with no reported adverse event (product preparation error) same day following the administration of HIB (PRP/T) vaccine.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.