chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Neuralgia, Neuropathy peripheral, Plastic surgery
Clinical narrative: right after vaccine, chest pain. Then patient became anemic, hair loss, and fatigued. Couple month slater, bloody diarrhea for 3 weeks. Another flare up of bloody diarrhea in April. Another flare up of bloody diarrhea in May, ended up being hospitalized for 6 days for fever, dehydration. fever, bloody diarrhea. Found out she had microscopic colitis. September she had another flare up, and neuropathy in feet. screamign in pain all night long. took her to hospital, she was admitted for 2 months. 5 surgeries in foot to debride "pus" all labs and pathogens came back negative for any bacterial infection, instead only inflammation. Full body MRI showed abscesses in spleen, backed up liver, lesions in lower extremities, pus continue to drain from foot after plastic surgery closed incision with donor skin graph, fevers for 2 months. No drs can figure out pt's health. Calling pt a mystery. She is currently wheelchair bound. Foot drained again after getting PM23 vaccine couple weeks ago. This proves vacinnes is causing her inflammation. She's a thriving 3 grader, and had to remove her from school over this mess. Robbed her of her childhood. shame!
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pustule, Pyrexia, Screaming, Skin lesion, Splenic abscess
Clinical narrative: right after vaccine, chest pain. Then patient became anemic, hair loss, and fatigued. Couple month slater, bloody diarrhea for 3 weeks. Another flare up of bloody diarrhea in April. Another flare up of bloody diarrhea in May, ended up being hospitalized for 6 days for fever, dehydration. fever, bloody diarrhea. Found out she had microscopic colitis. September she had another flare up, and neuropathy in feet. screamign in pain all night long. took her to hospital, she was admitted for 2 months. 5 surgeries in foot to debride "pus" all labs and pathogens came back negative for any bacterial infection, instead only inflammation. Full body MRI showed abscesses in spleen, backed up liver, lesions in lower extremities, pus continue to drain from foot after plastic surgery closed incision with donor skin graph, fevers for 2 months. No drs can figure out pt's health. Calling pt a mystery. She is currently wheelchair bound. Foot drained again after getting PM23 vaccine couple weeks ago. This proves vacinnes is causing her inflammation. She's a thriving 3 grader, and had to remove her from school over this mess. Robbed her of her childhood. shame!
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheelchair user, X-ray
Clinical narrative: right after vaccine, chest pain. Then patient became anemic, hair loss, and fatigued. Couple month slater, bloody diarrhea for 3 weeks. Another flare up of bloody diarrhea in April. Another flare up of bloody diarrhea in May, ended up being hospitalized for 6 days for fever, dehydration. fever, bloody diarrhea. Found out she had microscopic colitis. September she had another flare up, and neuropathy in feet. screamign in pain all night long. took her to hospital, she was admitted for 2 months. 5 surgeries in foot to debride "pus" all labs and pathogens came back negative for any bacterial infection, instead only inflammation. Full body MRI showed abscesses in spleen, backed up liver, lesions in lower extremities, pus continue to drain from foot after plastic surgery closed incision with donor skin graph, fevers for 2 months. No drs can figure out pt's health. Calling pt a mystery. She is currently wheelchair bound. Foot drained again after getting PM23 vaccine couple weeks ago. This proves vacinnes is causing her inflammation. She's a thriving 3 grader, and had to remove her from school over this mess. Robbed her of her childhood. shame!
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Patient uncooperative, Product administration interrupted, Underdose
Clinical narrative: Patient laying on clinic table with father hugging him, staff injecting the vaccine into left thiegh, patient reached down between fathers arm and grabbed syringe and pulled needle out of leg, injection was half dose given. No completion to vaccine accomplished at this time.
Age: 59.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Erythema, Injection site pruritus, Pain in extremity, Pruritus
Clinical narrative: Rightside of back started itching then whipped up. Pain in left arm got worse and a big red circle is present after one week injection site started itching having to use Cortizone-10 to stop itching
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pain in extremity
Clinical narrative: shivering, sore arm, lethargic
Age: 10.0
Sex: F
Vaccine: DTAP, HEP, IPV, VARCEL
Symptoms: Confusional state, Diarrhoea, Lethargy, Nausea, Pyrexia
Clinical narrative: Fever, lethargy, confusion, nausea, vomiting, diarrhea.
Age: 10.0
Sex: F
Vaccine: DTAP, HEP, IPV, VARCEL
Symptoms: Vomiting
Clinical narrative: Fever, lethargy, confusion, nausea, vomiting, diarrhea.
Age: 31.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Face injury, Loss of consciousness, Syncope
Clinical narrative: Patient lost consciousness while sitting, fainting forward and hit face against wall then slid down to floor.
Age: 68.0
Sex: F
Vaccine: PNC20, VARZOS
Symptoms: Chest pain, Hypersensitivity, Injection site pain, Neck pain
Clinical narrative: Patient complained of pain up left arm into neck and chest area.  Advised to go to ER.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: The patient has had arm pain and swelling for 3 months after the vaccination. She describes the pain as "radiating."
Age: 38.0
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Recieved 2nd dose of shingrix vaccine.  Left clinic .  Blurry vision to both eyes  post administration of vaccine .  It happened about 10 -15 min after receiving  the vaccine .  Returned to clinic .  VSS.  Vision returned to baseline.
Age: 37.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature labour, Preterm premature rupture of membranes
Clinical narrative: delivered on early; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2712004-1 (VAERS ID).  A 37-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: 6215364 N) at the age of 37 years intramuscular, in right arm for immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "PPROM", start date: 19Dec2020, stop date:; "Premature 33 w delivery", start date:, stop date:, notes: received the covid vaccine at 32 weeks 5 days and water broke the day after receiving the covid vaccine. The patient was 37 weeks pregnant at the event onset. The patient is expected to deliver one baby(s) on 10Nov2023. Concomitant medication(s) included: LEVOTHYROXINE; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; ASPIRIN [ACETYLSALICYLIC ACID]; IRON. Vaccination history included: COVID vaccine (received the covid vaccine at 32 weeks 5 days and water broke the day after receiving the covid vaccine), administration date:, for Immunization. The following information was reported: PREMATURE DELIVERY (hospitalization) with onset, outcome "recovered" (13Oct2023), described as "delivered on early". The patient was hospitalized for premature delivery (start date:, discharge date:, hospitalization duration: 2 day(s)). The baby was delivered premature. The baby weighed 2777.687 grams. Clinical course: The patient was vaccinated, the mother was 36 weeks 6 days pregnant. The following day, she started with contractions and delivered on early (day after receiving vaccine), at 36 weeks 7 days. Birth weight 6 lbs 2 oz. Estimated date of delivery was 10Nov2023. It was assessed as serious. Patient was hospitalized for 2 days. The patient had prior history of prematurity. Last delivery was 33 weeks. The patient had received the covid vaccine at 32 weeks 5 days and her water broke the day after receiving the covid vaccine.  No follow-up attempts are possible.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted event Maternal exposure during pregnancy, third trimester.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400003515 baby case;
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Haemorrhage in pregnancy, Muscle spasms, Nasopharyngitis, Premature delivery
Clinical narrative: cramping; bleeding; pre term labor and delivered; pre term labor and delivered; Cold; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2718314-1 (VAERS ID).  A 36-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies: sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ADVAIR; VITAMIN D NOS; FISH OIL. The patient also took other concomitant therapy. Past drug history included: Allergies: erythromycin, reaction(s): "Allergies: Erythromycin". The following information was reported: HAEMORRHAGE (hospitalization) with onset, outcome "recovered", described as "bleeding"; MUSCLE SPASMS (hospitalization) with onset, outcome "recovered", described as "cramping"; PREMATURE LABOUR (hospitalization), PREMATURE DELIVERY (hospitalization) all with onset, outcome "recovered" and all described as "pre term labor and delivered"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Cold". The patient was hospitalized for muscle spasms, haemorrhage, premature labour, premature delivery (hospitalization duration: 3 day(s)). The baby was delivered premature.  Additional information: It was reported that "35 weeks, approximately 5 hours after receiving the vaccine I experienced cramping and bleeding. I was admitted to hospital where they confirmed spontaneous pre term labor and delivered in less than 24 hours from receiving the vaccine"  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Deleted event coded to Maternal exposure during pregnancy, third trimester.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400006407 baby case;
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Premature labour
Clinical narrative: cramping; bleeding; pre term labor and delivered; pre term labor and delivered; Cold; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2718314-1 (VAERS ID).  A 36-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies: sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; ADVAIR; VITAMIN D NOS; FISH OIL. The patient also took other concomitant therapy. Past drug history included: Allergies: erythromycin, reaction(s): "Allergies: Erythromycin". The following information was reported: HAEMORRHAGE (hospitalization) with onset, outcome "recovered", described as "bleeding"; MUSCLE SPASMS (hospitalization) with onset, outcome "recovered", described as "cramping"; PREMATURE LABOUR (hospitalization), PREMATURE DELIVERY (hospitalization) all with onset, outcome "recovered" and all described as "pre term labor and delivered"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Cold". The patient was hospitalized for muscle spasms, haemorrhage, premature labour, premature delivery (hospitalization duration: 3 day(s)). The baby was delivered premature.  Additional information: It was reported that "35 weeks, approximately 5 hours after receiving the vaccine I experienced cramping and bleeding. I was admitted to hospital where they confirmed spontaneous pre term labor and delivered in less than 24 hours from receiving the vaccine"  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Deleted event coded to Maternal exposure during pregnancy, third trimester.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400006407 baby case;
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Foetal growth restriction, Laboratory test normal, Premature delivery, Premature labour
Clinical narrative: her due date was 04Jan2024; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2722480-1 (VAERS ID). A 32-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 17Nov2023 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in right arm for maternal exposure timing unspecified. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient is expected to deliver a baby(s) on 04Jan2024. Concomitant medications included: CONCERTA; CELEXA [CELECOXIB]; ASPIRIN [ACETYLSALICYLIC ACID]. The patient also took other concomitant therapy. The following information was reported: PREMATURE DELIVERY (hospitalization), outcome "unknown", described as "her due date was 04Jan2024". The patient was hospitalized for premature delivery (hospitalization duration: 1 days). The event "her due date was 04jan2024" required emergency room visit. The baby was delivered premature. The baby weighed 2437.562 grams. The patient underwent the following laboratory tests and procedures: Laboratory Test: Normal. Additional information: The patient went into labor and she had her baby. Her due date was 04Jan2024. A week before delivery she was diagnosed with IUGR because she measured 6th percentile during a growth ultrasound. All other tests were normal. She was 27th percentile when she was born. Birth weight was 5 lb. 6 oz.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted the event Maternal exposure during pregnancy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400005963 mother-baby case;
Sex: F
Vaccine: RSV, RSV
Symptoms: Ultrasound antenatal screen abnormal
Clinical narrative: her due date was 04Jan2024; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2722480-1 (VAERS ID). A 32-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 17Nov2023 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in right arm for maternal exposure timing unspecified. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient is expected to deliver a baby(s) on 04Jan2024. Concomitant medications included: CONCERTA; CELEXA [CELECOXIB]; ASPIRIN [ACETYLSALICYLIC ACID]. The patient also took other concomitant therapy. The following information was reported: PREMATURE DELIVERY (hospitalization), outcome "unknown", described as "her due date was 04Jan2024". The patient was hospitalized for premature delivery (hospitalization duration: 1 days). The event "her due date was 04jan2024" required emergency room visit. The baby was delivered premature. The baby weighed 2437.562 grams. The patient underwent the following laboratory tests and procedures: Laboratory Test: Normal. Additional information: The patient went into labor and she had her baby. Her due date was 04Jan2024. A week before delivery she was diagnosed with IUGR because she measured 6th percentile during a growth ultrasound. All other tests were normal. She was 27th percentile when she was born. Birth weight was 5 lb. 6 oz.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted the event Maternal exposure during pregnancy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400005963 mother-baby case;
Sex: F
Vaccine: RSV, RSV
Symptoms: Foetal exposure during pregnancy, Foetal growth restriction, Premature baby
Clinical narrative: her due date was 04Jan2024; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2722480-1 (VAERS ID). A 32-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 17Nov2023 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in right arm for maternal exposure timing unspecified. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient is expected to deliver a baby(s) on 04Jan2024. Concomitant medications included: CONCERTA; CELEXA [CELECOXIB]; ASPIRIN [ACETYLSALICYLIC ACID]. The patient also took other concomitant therapy. The following information was reported: PREMATURE DELIVERY (hospitalization), outcome "unknown", described as "her due date was 04Jan2024". The patient was hospitalized for premature delivery (hospitalization duration: 1 days). The event "her due date was 04jan2024" required emergency room visit. The baby was delivered premature. The baby weighed 2437.562 grams. The patient underwent the following laboratory tests and procedures: Laboratory Test: Normal. Additional information: The patient went into labor and she had her baby. Her due date was 04Jan2024. A week before delivery she was diagnosed with IUGR because she measured 6th percentile during a growth ultrasound. All other tests were normal. She was 27th percentile when she was born. Birth weight was 5 lb. 6 oz.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted the event Maternal exposure during pregnancy.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400005963 mother-baby case;
Sex: F
Vaccine: COVID19, RSV
Symptoms: Premature delivery, Premature separation of placenta
Clinical narrative: Partial placental abruption resulting in preterm birth. Delivered at 36 weeks via emergency; Partial placental abruption resulting in preterm birth. Delivered at 36 weeks via emergency; This is a spontaneous report received from an Other HCP from Regulatory Authority. Regulatory number: 2722920-1 (VAERS ID). A 32-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 04Nov2023 as dose 1, single (Batch/Lot number: unknown) for maternal exposure timing unspecified; elasomeran (MODERNA COVID-19 VACCINE), on 04Nov2023 as dose 4, single) for immunisation. The patient's relevant medical history included: "Hyperemesis gravidarum" (unspecified if ongoing). The patient was 36 weeks pregnant at the event onset. Concomitant medication(s) included: UNISOM [DOXYLAMINE SUCCINATE]; SERTRALINE; ZOFRAN [ONDANSETRON]. The patient also took other concomitant therapy. The following information was reported: PREMATURE SEPARATION OF PLACENTA (hospitalization), PREMATURE DELIVERY (hospitalization) all with onset XXNov2023, outcome "unknown" and all described as "Partial placental abruption resulting in preterm birth. Delivered at 36 weeks via emergency". The patient was hospitalized for premature separation of placenta, premature delivery (hospitalization duration: 3 day(s)). The baby was delivered premature, via cesarean route, delivery date XXNov2023. Additional information: Partial placental abruption resulting in preterm birth. Delivered at 36 weeks via emergency c section. Lab data: c section confirmed.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: deleted the event Maternal exposure during pregnancy; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400005831 mother-baby cases;
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Caesarean section, Exposure during pregnancy, Gestational hypertension, Headache, Pre-eclampsia
Clinical narrative: preelcampsia; gestational hypertension; protein in urine; severe headache; vomiting; preterm delivery; This is a spontaneous report received from an Other HCP from Regulatory Authority. Regulatory number: 2723562-1 (VAERS ID).  A 36-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 22Nov2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for maternal exposure timing unspecified. The patient's relevant medical history included: "pregnancy" (unspecified if ongoing), notes: previous two pregnancies. The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver one baby(s) on 09Jan2024. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; BABY ASPIRIN. Past drug history included: Tetracycline, reaction(s): "Allergies: Tetracycline". The following information was reported: GESTATIONAL HYPERTENSION (hospitalization) with onset 01Dec2023, outcome "not recovered"; PREMATURE DELIVERY (hospitalization) with onset 01Dec2023, outcome "not recovered", described as "preterm delivery"; PROTEINURIA (hospitalization) with onset 01Dec2023, outcome "not recovered", described as "protein in urine"; HEADACHE (hospitalization) with onset 01Dec2023, outcome "not recovered", described as "severe headache"; VOMITING (hospitalization) with onset 01Dec2023, outcome "not recovered"; PRE-ECLAMPSIA (hospitalization) with onset 07Dec2023, outcome "not recovered", described as "preelcampsia". The patient was hospitalized for premature delivery, pre-eclampsia, gestational hypertension, protein urine, headache, vomiting (hospitalization duration: 5 day(s)). The baby was delivered premature, via cesarean route, delivery date unknown. The baby weighed 2635.968 grams. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high; Protein urine: present.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Deleted event coded to Maternal exposure during pregnancy, third trimester.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400006297 mother-baby case;
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Premature delivery, Protein urine present, Proteinuria, Vomiting
Clinical narrative: preelcampsia; gestational hypertension; protein in urine; severe headache; vomiting; preterm delivery; This is a spontaneous report received from an Other HCP from Regulatory Authority. Regulatory number: 2723562-1 (VAERS ID).  A 36-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 22Nov2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in right arm for maternal exposure timing unspecified. The patient's relevant medical history included: "pregnancy" (unspecified if ongoing), notes: previous two pregnancies. The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver one baby(s) on 09Jan2024. Concomitant medication(s) included: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; BABY ASPIRIN. Past drug history included: Tetracycline, reaction(s): "Allergies: Tetracycline". The following information was reported: GESTATIONAL HYPERTENSION (hospitalization) with onset 01Dec2023, outcome "not recovered"; PREMATURE DELIVERY (hospitalization) with onset 01Dec2023, outcome "not recovered", described as "preterm delivery"; PROTEINURIA (hospitalization) with onset 01Dec2023, outcome "not recovered", described as "protein in urine"; HEADACHE (hospitalization) with onset 01Dec2023, outcome "not recovered", described as "severe headache"; VOMITING (hospitalization) with onset 01Dec2023, outcome "not recovered"; PRE-ECLAMPSIA (hospitalization) with onset 07Dec2023, outcome "not recovered", described as "preelcampsia". The patient was hospitalized for premature delivery, pre-eclampsia, gestational hypertension, protein urine, headache, vomiting (hospitalization duration: 5 day(s)). The baby was delivered premature, via cesarean route, delivery date unknown. The baby weighed 2635.968 grams. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: high; Protein urine: present.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Deleted event coded to Maternal exposure during pregnancy, third trimester.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400006297 mother-baby case;
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blister, Globulin, Lymphadenopathy, Neoplasm malignant, Platelet disorder
Clinical narrative: (Shot 3-4-21) 3-25-2021 squamous cell cancer on Left leg (shot 3-5-2021) 3-31-2021 Thrompopenia (Low platelets) (shot 11-3-2021 Blisters on hand, back, legs, forehead 9-23-2023 Thrompenia again 9-26-2023 Diagnosed waldenstrom macroglobulinemia Lymphoplasmacytic Lymphoma
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Splenomegaly, Thrombocytopenia, Waldenstrom's macroglobulinaemia
Clinical narrative: (Shot 3-4-21) 3-25-2021 squamous cell cancer on Left leg (shot 3-5-2021) 3-31-2021 Thrompopenia (Low platelets) (shot 11-3-2021 Blisters on hand, back, legs, forehead 9-23-2023 Thrompenia again 9-26-2023 Diagnosed waldenstrom macroglobulinemia Lymphoplasmacytic Lymphoma
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis, Hypoaesthesia, Injection site bruising, Injection site pain, Rash
Clinical narrative: Redness/pain @ site/numbness/severe hives/pruritis throughout core/neck/all extremities
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic
Clinical narrative: Redness/pain @ site/numbness/severe hives/pruritis throughout core/neck/all extremities
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site urticaria, Pruritus
Clinical narrative: Redness/pain @ site/numbness/severe hives/pruritis throughout core/neck/all extremities
Age: 45.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no symptomatic adverse events were reported.; HCP called to report that the patient was inadvertently administered their third dose of GARDASIL 9 three months early. No symptomatic adverse events were reported. No additional information provided. No additional AE/ no PQC.   Operator of device =; The patient turned 46 years old and 9 days before third dose; This spontaneous report was received from a pharmacist and refers to a 46-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 21-AUG-2023, the patient was vaccinated with the first does of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On 11-OCT-2023, the patient was vaccinated with the second does of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On 13-NOV-2023, the patient was inadvertently vaccinated with the third does of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection three months early, 0.5 milliliter, lot #X002626, expiration date: 12-FEB-2025, administered for prophylaxis (strength, and route of administration were not provided) (Inappropriate schedule of product administration). The patient was 45 years-old when series was started, turned 46 years old 9 days before that third dose (Product administered to patient of inappropriate age). No symptomatic adverse events were reported.  Lot# for first and second doses are being requested and will be submitted if received.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP has no additional AE details; A single dose of VARIVAX was given to a single patient after it underwent a TE.; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-MAR-2024, the patient was vaccinated with a single dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X006980, (expiration date: 07-MAR-2025), administered for prophylaxis (strength, and route of administration were not provided), after it underwent a temperature excursion (TE) reaching 15 degree Fahrenheit (F) during 5 Hours 0 Minutes 0 Seconds (Product storage error). No Previous temperature excursion was reported. The health care professional (HCP) had no additional adverse events (AE) details (No adverse event).
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise
Clinical narrative: did not feel well; This spontaneous report has been received from a consumer via a company representative and referred to a 16-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were unknown.   On 08-MAR-2024 at office the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose, strength, lot# and expiration date were not provide) via intramuscular for prophylaxis. The patient did not eat breakfast.   Before leaving room, the patient was asked by office to wait for 15 mins. The patient went to waiting room to wait. Her mom noticed she did not feel well (malaise) in waiting room. The patient was placed on floor in hallway. She felt better, had recovered and left office. The patient had sought medical attention. The relationship between malaise and vaccine was unknown.   The reporter considered the event malaise to be serious due to medically significant.        Additional information is not expected.
Age: 3.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE occurred and the product did not have a prior excursion; The caller said an expired dose was administered on 04-MAR-2024.; This spontaneous report has been received from other health professional, referring to a 3-year-old patient of an unknown gender and ethnicity.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 04-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) injection, 1 dose, administered as prophylaxis (lot # reported as w007182, which is a valid lot # for this vaccine, expiration date reported and validated to be on 01-MAR-2024; strength, route and anatomical location of administration were not provided) (expired product administered). No other adverse event (AE) occurred, and the product did not have a prior excursion (no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Insurance issue, No adverse event, Product dose omission issue
Clinical narrative: Patient had a change of insurance and the pharmacy advised his insurance would not cover the GARDASIL 9 shot so he missed the dose. Patient is planning to get the third dose of GARDASIL 9 but looking for financial assistance.; Patient had a change of insurance and the pharmacy advised his insurance would not cover the GARDASIL 9 shot so he missed the dose. Patient is planning to get the third dose of GARDASIL 9 but looking for financial assistance.; No additional AE/PQC.; This spontaneous report was received from a consumer, referring to a male patient of an unknown age and ethnicity.   The patient's pertinent medical history, previous drug reactions or allergies and concomitant therapies were not reported.  On 26-SEP-2023, he was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prophylaxis (strength, dose, lot #, expiration date, route and anatomical location of administration were not provided). On an unknown date in December 2023, he was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prophylaxis (strength, dose, lot #, expiration date, route and anatomical location of administration were not provided). His third dose was scheduled for 03-MAR-2024; nevertheless, the patient had a change of insurance, and the pharmacy advised his insurance would not cover the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) shot, so he missed the dose. He was planning to get the third dose of  the vaccine but was looking for financial assistance (product dose omission issue, insurance issue). The patient experienced no additional adverse event (AE) or product quality complaint (PQC) (no adverse event).
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Asthenia, Myalgia
Clinical narrative: shoulders pain at the Joint; astenia; myalgia; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in joint involving shoulder region 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 pain in joint involving shoulder region (Verbatim: shoulders pain at the Joint), asthenia (Verbatim: astenia) and myalgia (Verbatim: myalgia). The outcome of the pain in joint involving shoulder region, asthenia and myalgia were not reported.   It was unknown if the reporter considered the pain in joint involving shoulder region, asthenia and myalgia to be related to Arexvy.     It was unknown if the company considered the pain in joint involving shoulder region, asthenia and myalgia to be related to Arexvy.   Additional Information: GSK Receipt Date: 04-MAR-2024 This case was reported by patient via (Open field AE monitoring) interactive digital media. The patient had severe shoulders pain at the joints, asthenia and myalgia.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Syringe issue, Underdose
Clinical narrative: administration of less than a half of the Shingrix dose to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 4J2NK, expiry date 25-JAN-2026) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: administration of less than a half of the Shingrix dose to a patient). The outcome of the accidental underdose was unknown.   Additional Information: GSK Receipt Date: 04-MAR-2024 The pharmacist reported that the administration of less than a half of the Shingrix dose to a patient due to the malfunction of the syringe, which led to an accidental underdose. No PQC (product quality complaint) reported. The HCP (health care professional) was concerned about the recommended interval to repeat the dose. HCP mentioned this event was reported in VAERS.
Sex: U
Vaccine: COVID19-2, FLU4
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19; Initial information received on 06-Mar-2024 regarding an unsolicited valid non-serious courtesy case received from a consumer.  This case involves an adult patient of unknown gender who experienced diagnosed with COVID-19 after receiving Moderna COVID-19 vaccine, Bivalent (Original and Omicron BA.4/BA.5) and Influenza Quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past vaccination(s) included Moderna on 12-Apr-2021 with Dose:1, Lot number: 037B21A, dose: 0.5 ml, site: Left arm, Moderna on 11-May-2021 with Dose:2, Lot number: 022021A, dose: 0.5 ml, site: Left arm and Moderna on 20-Dec-2021 with Dose:3, Lot number: 069H21A, dose: 0.5 ml and site: Left arm.  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included Omeprazole for GERD; and Rosuvastatin for Hyperlipidemia.  On an unknown date, the patient received 1 DF dose of suspect Influenza Quadrival A-B vaccine suspension for injection of lot U8201FA (strength and expiry: unknown) via unknown route in unknown administration site as prophylactic vaccination (immunization).  On 14-Oct-2022 at 05:15 hours, the patient received 0.5 ml dose (dose 4) of suspect Moderna Covid-19 vaccine, Bivalent (Original and Omicron BA.4/BA.5) not produced by Sanofi Pasteur, formulation: injection of lot 053D22A via unknown route in unknown administration site as COVID-19 prophylaxis.  On 16-Nov-2023, the patient was diagnosed with COVID-19 (Covid-19) (unknown latency) following the administration of Influenza Quadrival A-B vaccine and 2 years 7 months 4 days following the first dose administration and 1 year 1 month 2 days following the last dose administration of Moderna Covid-19 vaccine and Bivalent (Original and Omicron BA.4/BA.5).  Relevant laboratory test results included: SARS-CoV-2 test - On 16-Nov-2023: Positive  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (diagnosed with COVID-19).  At time of reporting, the outcome was Unknown for the event diagnosed with COVID-19.
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: the injection was administered to patient beyond expiration date with no reported adverse event; Initial information received on 07-Mar-2024 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 2 months old male patient (P-62028451) who experienced the injection of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (vero)] was administered to patient beyond expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Mar-2024, the patient received an expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection (lot UJ805AA, Expiry: 17-Feb-2024 with unknown strength) via unknown route in unknown administration site as Prophylactic vaccination with no reported adverse event (expired product administered) (latency: same day).   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: 79.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: tenivac vaccine was given to a patient which had already expired 02mar2024. with no reported adverse event; Initial information received on 08-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 79 years old male patient who was given Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] which had already expired on 02-Mar-2024 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 08-Mar-2024at 10:08 hours, the patient was given 0.5 ml of Diphtheria-2/Tetanus-5 Adsorbed Toxoids No Preservative Adult (Suspension for injection) (lot C5965AA, strength not reported) which had already expired 02-Mar-2024 via intramuscular route in the left arm for Immunization with no reported adverse event (expired product administered) (latency: same day).   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: accidentally mixed the ACTHIB with sterile water instead of its diluent with no reported adverse event; Initial information was received on 08-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom accidentally mixed the HIB (PRP/T) vaccine [ACT-HIB] with sterile water instead of its diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Mar-2024, the patient received a 0.5 ml, (once) total (dose1) of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot UJ978AA, expiry date: 08-Nov-2024, strength: standard) via unknown route in left quadricep for Immunisation and accidentally mixed the acthib with sterile water instead of its diluent with no reported adverse event (product preparation error) (Latency: same day).  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: 31.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: dose of yf-vax was administered intramuscularly instead of subcutaneously with no reported adverse event; Initial information was received on 11-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 31 years old female patient who received dose of Yellow Fever Vaccine [YF-VAX]was administered intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On 10-Mar-2024, the patient received a dose of 0.5 ml of suspect Yellow Fever Vaccine (Solution for injection) (lot UJ966AA, Frequency : Total, Expiry date : 31-Jan-2025, strength was unknown) via intramuscular route in the left deltoid for Prophylactic vaccination (Immunization) and dose of yf-vax was administered intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration) (latency : same day).   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: 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, 2024SA08311 and 2024SA081652.  This case involves a 13 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); And Meningococcal Vaccine 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.