chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Streptococcus test, Streptococcus test negative, Vomiting
Clinical narrative: 04/05/2023 began having a cold with runny nose and decreased energy 04/17/2023 vomiting malaise, socially withdrawn, less engaged, quieter 04/23/2023 taken to ER in the afternoon for several days of poor limb movement, inability to hod a bottle, decreased strength about 20% decreased from baseline, never had a fever, rapid strep negative, decreased muscle tone began in his legs when he stopped walking and crawling 04/25/2023 could not hold a fork or spoon 04/26/2023 minimal fine motor skills in fingers, lazy eyes; described as a "newborn" in terms of mobility and language 04/28/2023 admitted to PICU at Hospital; MRI, spinal tap, blood work, tentatively diagnosed with Guillan-Barre  04/31/2023 got feeding tube placed, nasal oxygen; given two round of IVIG, began to notice signs of improvement  05/15/2023 now speaking again
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Dehydration, Guillain-Barre syndrome, Intensive care, Listless
Clinical narrative: 04/05/2023 began having a cold with runny nose and decreased energy 04/17/2023 vomiting malaise, socially withdrawn, less engaged, quieter 04/23/2023 taken to ER in the afternoon for several days of poor limb movement, inability to hod a bottle, decreased strength about 20% decreased from baseline, never had a fever, rapid strep negative, decreased muscle tone began in his legs when he stopped walking and crawling 04/25/2023 could not hold a fork or spoon 04/26/2023 minimal fine motor skills in fingers, lazy eyes; described as a "newborn" in terms of mobility and language 04/28/2023 admitted to PICU at Hospital; MRI, spinal tap, blood work, tentatively diagnosed with Guillan-Barre  04/31/2023 got feeding tube placed, nasal oxygen; given two round of IVIG, began to notice signs of improvement  05/15/2023 now speaking again
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Otitis media, Pneumonia, Vomiting
Clinical narrative: 04/05/2023 began having a cold with runny nose and decreased energy 04/17/2023 vomiting malaise, socially withdrawn, less engaged, quieter 04/23/2023 taken to ER in the afternoon for several days of poor limb movement, inability to hod a bottle, decreased strength about 20% decreased from baseline, never had a fever, rapid strep negative, decreased muscle tone began in his legs when he stopped walking and crawling 04/25/2023 could not hold a fork or spoon 04/26/2023 minimal fine motor skills in fingers, lazy eyes; described as a "newborn" in terms of mobility and language 04/28/2023 admitted to PICU at Hospital; MRI, spinal tap, blood work, tentatively diagnosed with Guillan-Barre  04/31/2023 got feeding tube placed, nasal oxygen; given two round of IVIG, began to notice signs of improvement  05/15/2023 now speaking again
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: patient called to report her arm being very sore and tender with a half-dollar sized red circle at the site of injection. She said it was tender and hot to the touch. Patient iced and monitored arm
Age: 15.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event reported from patient. Patient was 15 years at time of vaccination and was given 2 doses of twinrix (Hep A/B) adult formulation 1st was given on 10/24/2023 and second dose was given on 11/27/2023
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; A HCP called to report a TE for MMR II, PROQUAD, and VARIVAX with 16 different current excursions beginning 04/22/2024 and were identified "sometime last week" (06/10/2024-06/14/2024).  Some vaccines have been administered to patients and the remaini; This spontaneous report was received from an other healthcare professional, referring to a 4 year-old female patient. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. Concomitant medications included sterile diluent(STERILE DILUENT). It was reported that the patient had two brothers.        On 24-APR-2024, the patient was vaccinated with an improperly stored first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Albumin status: rHA lot # W035041 with expiration date 24-MAY-2024 in the left thigh (exact dose, dose number, and route of administration were not provided); the patient was also vaccinated with an improperly stored first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # X010531 with expiration date 11-APR-2025 in the left thigh (exact dose, dose number, and route of administration were not provided).  No additional adverse event (AE) was reported and with a first dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), unk, lot #5AY2J, expiration date: 10-JUN-2024, administered for prophylaxis (strength, formulation, and route of administration were not provided). All the vaccines were administered in a private doctor's office/hospital and purchased with public funds.  It was reported that the temperature excursion occur as a result of a reading from a digital data logger.; Sender's Comments:  US-009507513-2406USA005882:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported.; HCP called for TE for ROTATEQ . Products were administered 6/28/2024; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 20-JUN-2024, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1989398, expiration date: 25-NOV-2024 underwent a temperature excursion (TE) at a temperature of 51 F for time frame of 240 hours. On 26-JUN-2024, on 27-JUN-2024 and on 28-JUN-2024, the patient (s) was/were vaccinated with improperly stored vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1989398, expiration date reported and confirmed as 25-NOV-2024, administered orally for prophylaxis (strength and exact dose were not provided) (Product storage error). The healthcare professional did not have patient information or at the time of the call. No adverse side effects were reported. Escalated to team due to Not supported outcome. No additional adverse event or product quality complaint.  Follow up information has been received from the reporter on 30-JUL-2024.   The reporter confirmed that, on 28-JUN-2024, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid. The TE was of 446 hours.   This case was previously considered as non-valid since no patient's identifiers were reported, upon follow up information patient's information was updated.    This is one of several reports that were received from the same reporter.; Sender's Comments:  US-009507513-2407USA010431: US-009507513-2407USA015892: US-009507513-2407USA015881:
Age: 30.0
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No symptoms reported. No additional AE/No PQC.; Pharmacist called to report that she administered VARIVAX to a patient who had already received a VARIVAX dose the day prior at another pharmacy.; This spontaneous report was received from a pharmacist and refers to a 30-year-old patient of unreported gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JUL-2024, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 17-JUL-2024, the patient was vaccinated with another dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 mL, lot# X026325, (expiration date: 07-NOV-2025) administered for prophylaxis (strength and route of administration were not provided). Consequently, this dose had been administered to this patient who had already received a varicella virus vaccine live (oka/merck) (VARIVAX) dose the day prior at another pharmacy (Inappropriate schedule of product administration). The patient initially thought they received a polio vaccine the day prior, however it was in fact varicella virus vaccine live (oka/merck) (VARIVAX). No symptoms reported. No additional adverse event (AE)/No product quality complaint (PQC) (No adverse event).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse side effects were reported.; HCP called for TE for ROTATEQ . Products were administered 6/26/2024; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 20-JUN-2024, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1989398, expiration date: 25-NOV-2024 underwent a temperature excursion (TE) at a temperature of 51 F for time frame of 240 hours. On 26-JUN-2024, on 27-JUN-2024 and on 28-JUN-2024, the patient (s) was/were vaccinated with improperly stored vaccine of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1989398, expiration date reported and confirmed as 25-NOV-2024, administered orally for prophylaxis (strength and exact dose were not provided) (Product storage error). The healthcare professional did not have patient information or at the time of the call. No adverse side effects were reported. Escalated to team due to Not supported outcome. No additional adverse event or product quality complaint.  This is a non-valid case due to lack patient's identifiers and unknown number of patients.  Follow up information has been received from the reporter on 30-JUL-2024.   The reporter confirmed that, on 17-JUN-2024, the patient was vaccinated with an improper stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid. The temperature excursion (TE) was of 446 hours.   This case was previously considered as non-valid since no patient's identifiers were reported, upon follow up information patient's information was updated.    This is one of several reports that were received from the same reporter.; Sender Comments: Keywords :  US-009507513-2407USA010431: US-009507513-2407USA015881: US-009507513-2407USA015892:
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events reported; HCP called to report a patient received two doses of PROQUAD "within about one week".; This spontaneous report was received from a nurse and refers to a 5-year-old patient of unknown gender and race. The patient's medical history, and concurrent conditions were not reported. The patient's historical vaccines included Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX). Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown)   On 24-JUL-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, dose, lot number, expiration date, and route of administration were not provided). On 01-AUG-2024, the patient was vaccinated with another dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, dose, lot number, expiration date, and route of administration were not provided) (inappropriate schedule of product administered). No adverse event nor PQC reported.   Lot number is being requested and will be submitted if received.
Sex: F
Vaccine: HEP
Symptoms: Abortion spontaneous, Antibody test abnormal, Exposure during pregnancy
Clinical narrative: Miscarriage; HEPLISAV-B Given When Pregnant; Titers Came Back Low; Initial report received on 01-Aug-2024.  A nurse reported that a 25-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant and miscarried.  No relevant medical history or concomitant medications were reported.    On 20-Mar-2024, the patient received the first dose of HEPLISAV-B (Lot # 943193, expiration date 12-Mar-2026, NDC # 43528-003-01) intramuscularly in the right deltoid.   The patient was not pregnant at the time of that injection.  On an unspecified date in May-2024, the patient's titers came back low.  On 17-May-2024, the patient received the second dose of HEPLISAV-B (Lot # 943193, expiration date 12-Mar-2026, NDC # 43528-003-01) intramuscularly in the left deltoid.  The patient was in the first trimester of her pregnancy at the time the second dose was given.  On 20-May-2024, three days after receiving the second dose of HEPLISAV-B, the patient experienced a miscarriage of the pregnancy.   The patient believes that the vaccine caused her to "lose her pregnancy."  The reporter stated no other side effects were reported to her.  No other information was reported.   The event of miscarriage was considered medically significant.   Company Comment: The event of miscarriage is assessed as serious (medically significant, EMA) and unlikely related to HEPLISAV-B. The event of miscarriage is considered Level 4 based on insufficient evidence to meet the Brighton Collaboration case definition of spontaneous abortion. The incidence rate of spontaneous abortion per 100 pregnancies is 17.4%. Approximately 50% of spontaneous abortions are associated with fetal chromosomal abnormalities. There is insufficient information in the present case to assess other risk factors of spontaneous abortion such as previous pregnancy loss, smoking, alcohol use. The event of miscarriage is unlisted, and the event of low titer is considered non-serious and listed per HEPLISAV-B IB, PI, SmPC and SPC.; Sender's Comments: The event of miscarriage is assessed as serious (medically significant, EMA) and unlikely related to HEPLISAV-B. The event of miscarriage is considered Level 4 based on insufficient evidence to meet the Brighton Collaboration case definition of spontaneous abortion. The incidence rate of spontaneous abortion per 100 pregnancies is 17.4%. Approximately 50% of spontaneous abortions are associated with fetal chromosomal abnormalities. There is insufficient information in the present case to assess other risk factors of spontaneous abortion such as previous pregnancy loss, smoking, alcohol use. The event of miscarriage is unlisted, and the event of low titer is considered non-serious and listed per HEPLISAV-B IB, PI, SmPC and SPC.
Age: 44.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Dizziness, Feeling abnormal, Hyperhidrosis, Immediate post-injection reaction, Skin discolouration
Clinical narrative: The patient was given 4 vaccines and immediately began to feel bad, to faint, sweating, change of skin color, tremor. We called 911 and they took him away.
Age: 44.0
Sex: M
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Tremor
Clinical narrative: The patient was given 4 vaccines and immediately began to feel bad, to faint, sweating, change of skin color, tremor. We called 911 and they took him away.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Eye irritation, Neck pain, Rash
Clinical narrative: Woke up Sunday with neck pain, then developed a rash and difficulty breathing and eyes burned.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Dizziness, Malaise
Clinical narrative: after giving the shot, patient said she reported felling fine, after a few minutes standing in line to pick up her med, P.T went and sat down near the waiting area bench. she started laying down and  at this time the clerk noticed that the patient was not feeling well and called over the pharmacist. RPH tired to check P.T blood pressure but P.T said that she felt dizzy when she stood upright. The P.T said she suffers from anxiety and that she was feeling dizzy because of anxiety. She reported having similar episodes when she does other activities that cause her anxiety. RPH offered to call an ambulance but pt refused stating that she felt fine. When p.t got up to leave, I asked p.t to stay a little longer so that we can monitor her blood pressure, but she refused and said she had to go. she reported felling fine and thanked pharmacist for their assistance. We made multiple attempts to take care of p.t but she refused all services. she reported felling fine and that it was just her anxiety
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute myeloid leukaemia, Allogenic bone marrow transplantation therapy, Aspiration bone marrow abnormal, Biopsy bone marrow abnormal, Blast cell count increased
Clinical narrative: I visited my PCP on 8/16/2022 for my yearly well visit, where he advised me I had an elevated WBC of 15,700 and suggested that I consult with an oncologist.  Since I felt fine at the time I did not follow through.  Over the following 6 months, I experienced night sweats, difficulty sleeping, central serrous retinopathy, plantar fasciitus, and lower leg pain with increasing frequency.  On 2/14/2023 I went to Hospital ER with chest pain that had persisted 2/13/2023 all day and into the night.  They diagnosed me with Leukemia and admitted me to hospital main campus where I had my first bone marrow biopsy and was diagnosed with Acute Myloid Leukemia.  After one chemo treatment, they did another bone marrow biopsy which showed that the cancerous cells were still there, so they referred me to second hospital.  Upon arrival at the second hospital on 3/05/2023, they did another bone marrow biopsy which revealed that I had Mixed phenotype acute leukemia with Philadelphia chromosome.  I received numerous lab tests and chemotherapy HyperCVAD treatments and was released to go home 4/05/2023.  They suggested that I have a bone marrow transplant since relapse occurrence was very high.  Since it is necessary to be within 45 minutes from the hospital doing the transplant, I transferred my care to the third Hospital where I received my bone marrow transplant on 8/01/2023.  I am now 1 year out from transplant and still on some drugs to keep viruses at bay and also keep my body from rejecting the new T-cells from allogenic donor.  I will have to deal with the donor cells for the rest of my life, I also suffer from nerve damage throughout my body and neuropathy.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test abnormal, Bone marrow disorder, Bone marrow failure, Cancer cells present, Central serous chorioretinopathy
Clinical narrative: I visited my PCP on 8/16/2022 for my yearly well visit, where he advised me I had an elevated WBC of 15,700 and suggested that I consult with an oncologist.  Since I felt fine at the time I did not follow through.  Over the following 6 months, I experienced night sweats, difficulty sleeping, central serrous retinopathy, plantar fasciitus, and lower leg pain with increasing frequency.  On 2/14/2023 I went to Hospital ER with chest pain that had persisted 2/13/2023 all day and into the night.  They diagnosed me with Leukemia and admitted me to hospital main campus where I had my first bone marrow biopsy and was diagnosed with Acute Myloid Leukemia.  After one chemo treatment, they did another bone marrow biopsy which showed that the cancerous cells were still there, so they referred me to second hospital.  Upon arrival at the second hospital on 3/05/2023, they did another bone marrow biopsy which revealed that I had Mixed phenotype acute leukemia with Philadelphia chromosome.  I received numerous lab tests and chemotherapy HyperCVAD treatments and was released to go home 4/05/2023.  They suggested that I have a bone marrow transplant since relapse occurrence was very high.  Since it is necessary to be within 45 minutes from the hospital doing the transplant, I transferred my care to the third Hospital where I received my bone marrow transplant on 8/01/2023.  I am now 1 year out from transplant and still on some drugs to keep viruses at bay and also keep my body from rejecting the new T-cells from allogenic donor.  I will have to deal with the donor cells for the rest of my life, I also suffer from nerve damage throughout my body and neuropathy.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chemotherapy, Chest pain, Dysmegakaryopoiesis, Fluorescent in situ hybridisation, Immunohistochemistry
Clinical narrative: I visited my PCP on 8/16/2022 for my yearly well visit, where he advised me I had an elevated WBC of 15,700 and suggested that I consult with an oncologist.  Since I felt fine at the time I did not follow through.  Over the following 6 months, I experienced night sweats, difficulty sleeping, central serrous retinopathy, plantar fasciitus, and lower leg pain with increasing frequency.  On 2/14/2023 I went to Hospital ER with chest pain that had persisted 2/13/2023 all day and into the night.  They diagnosed me with Leukemia and admitted me to hospital main campus where I had my first bone marrow biopsy and was diagnosed with Acute Myloid Leukemia.  After one chemo treatment, they did another bone marrow biopsy which showed that the cancerous cells were still there, so they referred me to second hospital.  Upon arrival at the second hospital on 3/05/2023, they did another bone marrow biopsy which revealed that I had Mixed phenotype acute leukemia with Philadelphia chromosome.  I received numerous lab tests and chemotherapy HyperCVAD treatments and was released to go home 4/05/2023.  They suggested that I have a bone marrow transplant since relapse occurrence was very high.  Since it is necessary to be within 45 minutes from the hospital doing the transplant, I transferred my care to the third Hospital where I received my bone marrow transplant on 8/01/2023.  I am now 1 year out from transplant and still on some drugs to keep viruses at bay and also keep my body from rejecting the new T-cells from allogenic donor.  I will have to deal with the donor cells for the rest of my life, I also suffer from nerve damage throughout my body and neuropathy.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunophenotyping, Insomnia, Laboratory test, Lymphoblast count, Myelodysplastic syndrome
Clinical narrative: I visited my PCP on 8/16/2022 for my yearly well visit, where he advised me I had an elevated WBC of 15,700 and suggested that I consult with an oncologist.  Since I felt fine at the time I did not follow through.  Over the following 6 months, I experienced night sweats, difficulty sleeping, central serrous retinopathy, plantar fasciitus, and lower leg pain with increasing frequency.  On 2/14/2023 I went to Hospital ER with chest pain that had persisted 2/13/2023 all day and into the night.  They diagnosed me with Leukemia and admitted me to hospital main campus where I had my first bone marrow biopsy and was diagnosed with Acute Myloid Leukemia.  After one chemo treatment, they did another bone marrow biopsy which showed that the cancerous cells were still there, so they referred me to second hospital.  Upon arrival at the second hospital on 3/05/2023, they did another bone marrow biopsy which revealed that I had Mixed phenotype acute leukemia with Philadelphia chromosome.  I received numerous lab tests and chemotherapy HyperCVAD treatments and was released to go home 4/05/2023.  They suggested that I have a bone marrow transplant since relapse occurrence was very high.  Since it is necessary to be within 45 minutes from the hospital doing the transplant, I transferred my care to the third Hospital where I received my bone marrow transplant on 8/01/2023.  I am now 1 year out from transplant and still on some drugs to keep viruses at bay and also keep my body from rejecting the new T-cells from allogenic donor.  I will have to deal with the donor cells for the rest of my life, I also suffer from nerve damage throughout my body and neuropathy.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nerve injury, Neuropathy peripheral, Night sweats, Pain in extremity, Pancytopenia
Clinical narrative: I visited my PCP on 8/16/2022 for my yearly well visit, where he advised me I had an elevated WBC of 15,700 and suggested that I consult with an oncologist.  Since I felt fine at the time I did not follow through.  Over the following 6 months, I experienced night sweats, difficulty sleeping, central serrous retinopathy, plantar fasciitus, and lower leg pain with increasing frequency.  On 2/14/2023 I went to Hospital ER with chest pain that had persisted 2/13/2023 all day and into the night.  They diagnosed me with Leukemia and admitted me to hospital main campus where I had my first bone marrow biopsy and was diagnosed with Acute Myloid Leukemia.  After one chemo treatment, they did another bone marrow biopsy which showed that the cancerous cells were still there, so they referred me to second hospital.  Upon arrival at the second hospital on 3/05/2023, they did another bone marrow biopsy which revealed that I had Mixed phenotype acute leukemia with Philadelphia chromosome.  I received numerous lab tests and chemotherapy HyperCVAD treatments and was released to go home 4/05/2023.  They suggested that I have a bone marrow transplant since relapse occurrence was very high.  Since it is necessary to be within 45 minutes from the hospital doing the transplant, I transferred my care to the third Hospital where I received my bone marrow transplant on 8/01/2023.  I am now 1 year out from transplant and still on some drugs to keep viruses at bay and also keep my body from rejecting the new T-cells from allogenic donor.  I will have to deal with the donor cells for the rest of my life, I also suffer from nerve damage throughout my body and neuropathy.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pathology test, Philadelphia chromosome positive, Philadelphia chromosome test, Plantar fasciitis, Thrombosis
Clinical narrative: I visited my PCP on 8/16/2022 for my yearly well visit, where he advised me I had an elevated WBC of 15,700 and suggested that I consult with an oncologist.  Since I felt fine at the time I did not follow through.  Over the following 6 months, I experienced night sweats, difficulty sleeping, central serrous retinopathy, plantar fasciitus, and lower leg pain with increasing frequency.  On 2/14/2023 I went to Hospital ER with chest pain that had persisted 2/13/2023 all day and into the night.  They diagnosed me with Leukemia and admitted me to hospital main campus where I had my first bone marrow biopsy and was diagnosed with Acute Myloid Leukemia.  After one chemo treatment, they did another bone marrow biopsy which showed that the cancerous cells were still there, so they referred me to second hospital.  Upon arrival at the second hospital on 3/05/2023, they did another bone marrow biopsy which revealed that I had Mixed phenotype acute leukemia with Philadelphia chromosome.  I received numerous lab tests and chemotherapy HyperCVAD treatments and was released to go home 4/05/2023.  They suggested that I have a bone marrow transplant since relapse occurrence was very high.  Since it is necessary to be within 45 minutes from the hospital doing the transplant, I transferred my care to the third Hospital where I received my bone marrow transplant on 8/01/2023.  I am now 1 year out from transplant and still on some drugs to keep viruses at bay and also keep my body from rejecting the new T-cells from allogenic donor.  I will have to deal with the donor cells for the rest of my life, I also suffer from nerve damage throughout my body and neuropathy.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: White blood cell count increased
Clinical narrative: I visited my PCP on 8/16/2022 for my yearly well visit, where he advised me I had an elevated WBC of 15,700 and suggested that I consult with an oncologist.  Since I felt fine at the time I did not follow through.  Over the following 6 months, I experienced night sweats, difficulty sleeping, central serrous retinopathy, plantar fasciitus, and lower leg pain with increasing frequency.  On 2/14/2023 I went to Hospital ER with chest pain that had persisted 2/13/2023 all day and into the night.  They diagnosed me with Leukemia and admitted me to hospital main campus where I had my first bone marrow biopsy and was diagnosed with Acute Myloid Leukemia.  After one chemo treatment, they did another bone marrow biopsy which showed that the cancerous cells were still there, so they referred me to second hospital.  Upon arrival at the second hospital on 3/05/2023, they did another bone marrow biopsy which revealed that I had Mixed phenotype acute leukemia with Philadelphia chromosome.  I received numerous lab tests and chemotherapy HyperCVAD treatments and was released to go home 4/05/2023.  They suggested that I have a bone marrow transplant since relapse occurrence was very high.  Since it is necessary to be within 45 minutes from the hospital doing the transplant, I transferred my care to the third Hospital where I received my bone marrow transplant on 8/01/2023.  I am now 1 year out from transplant and still on some drugs to keep viruses at bay and also keep my body from rejecting the new T-cells from allogenic donor.  I will have to deal with the donor cells for the rest of my life, I also suffer from nerve damage throughout my body and neuropathy.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: No adverse event
Clinical narrative: No adverse treatment needed.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin G, Epstein-Barr virus infection
Clinical narrative: Dormant Epstein Barr virus emerged.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney abnormal, Dialysis, Focal segmental glomerulosclerosis, Renal failure, Renal transplant
Clinical narrative: Kidney failure/ dialysis/transplant / continued treatments
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was administered a third dose of Shingrix
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Pain
Clinical narrative: Fatigue. Bodyaches. Discussed with patient this is a normal vaccine response.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling around vaccine site
Age: 76.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Chills, Erythema, Skin warm
Clinical narrative: Patient called today to report a 4-inch area of redness which was warm to touch following his immunization, coupled with chills that had subsided. He was advised to use antihistamines, anti-inflammatories and cold compresses and follow up with his doctor if there was no improvement. Report and VAERS were submitted. Pharmacy Manager, Market Leader and prescriber made aware.
Age: 1.67
Sex: M
Vaccine: PNC13, PNC15
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 20 month old patient has received two prior vaccinations, one with Prevnar-13 and the other with the pneumococcal 15 vaccine. PCV-13 03APR2023 Pneumoccal-15 07MAY2024/Patient is behind regularly scheduled dosing guidelines; 20 month old patient has received two prior vaccinations, one with Prevnar-13 and the other with the pneumococcal 15 vaccine. PCV-13 03APR2023 Pneumoccal-15 07MAY2024; This spontaneous report was received from a nurse, via partner, referring to a 20-month-old male patient.    The patient's concurrent conditions, medical history and concomitant medications were not provided.  The patient had not followed the labeled dosing guidelines for pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), The patient had received two prior vaccinations: one on 23-APR-2024 (also reported as last April 15 and 03-APR-2023, conflicting information), with pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) (also reported as pneumococcal conjugate vaccine [PCV13]) (strength, formulation, dose, lot #, expiry date, route of administration, and indication were not provided) and the other on 07-MAY-2024, with pneumococcal 15v conj vaccine (crm197) (manufacturer unknown) (reported as PCV 15) administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). She mentioned he was behind on his pneumococcal vaccines (Product administered to patient of inappropriate age, Inappropriate schedule of product administration). The patient was about to get a cochlear implant on 23-SEP-2024 (also reported as the patient had surgery for cochlear implant September 2023, conflicting information). Moreover, it was stated that the patient needed two more doses, the reporting nurse was asking how often they could get the vaccine pneumococcal vaccine conj 13v (crm197) (PREVNAR 13).
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: No additional AE/No reported signs/symptoms of adverse events; HCP called regarding PROQUAD and VARIVAX. HCP stated that both were inadvertently administered concomitantly to a 5 year old patient today (07/09/2024) No reported signs/symptoms of adverse events. Limited information was provided. Permission to cont; This spontaneous report was received from a Medical Assistant and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 09-JUL-2024, the patient was inadvertently vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis (Accidental overdose). No additional signs/ symptoms of adverse events was reported.  Lot # is being requested and will be submitted if received.
Age: 5.0
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/No reported signs/symptoms of adverse events; HCP called regarding PROQUAD and VARIVAX. HCP stated that both were inadvertently administered concomitantly to a 5 year old patient today (07/09/2024) No reported signs/symptoms of adverse events. Limited information was provided. Permission to cont; This spontaneous report was received from a Medical Assistant and refers to a 5-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 09-JUL-2024, the patient was inadvertently vaccinated with both measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection (strength, lot #, expiry date, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis (Accidental overdose). No additional signs/ symptoms of adverse events was reported.  Lot # is being requested and will be submitted if received.
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Delirium, Dementia, Herpes zoster, Impaired work ability
Clinical narrative: shingles; his pain was extreme; dizziness; lethargy; unable to work; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of back pain (received his first dose two months ago and experienced lesions and back pain; reference case US2024093766).   On 21-JUL-2024, the patient received the 2nd dose of Shingrix. In JUL-2024, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: dizziness), lethargy (Verbatim: lethargy) and inability to work (Verbatim: unable to work). On 21-JUL-2024, the patient experienced shingles (Verbatim: shingles) and pain (Verbatim: his pain was extreme). The outcome of the shingles, pain, dizziness and lethargy were unknown and the outcome of the inability to work was not reported.   It was unknown if the reporter considered the shingles, pain, dizziness, lethargy and inability to work to be related to Shingrix.     It was unknown if the company considered the shingles, pain, dizziness, lethargy and inability to work to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR094589   Additional Information: GSK receipt date: 25-JUL-2024 The patient received his 2nd dose and that same day his pain was extreme and he went to an urgent care center, where he was diagnosed with shingles.  He states that his pain was severe, he was dizzy and lethargic, and he was unable to work.  He also stated that he has reported this event to VAERS.; Sender's Comments:  US-GSK-US2024AMR094589:Original Case : US2024093766
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Tenderness, Tremor, Vomiting
Clinical narrative: shingles; his pain was extreme; dizziness; lethargy; unable to work; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of back pain (received his first dose two months ago and experienced lesions and back pain; reference case US2024093766).   On 21-JUL-2024, the patient received the 2nd dose of Shingrix. In JUL-2024, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: dizziness), lethargy (Verbatim: lethargy) and inability to work (Verbatim: unable to work). On 21-JUL-2024, the patient experienced shingles (Verbatim: shingles) and pain (Verbatim: his pain was extreme). The outcome of the shingles, pain, dizziness and lethargy were unknown and the outcome of the inability to work was not reported.   It was unknown if the reporter considered the shingles, pain, dizziness, lethargy and inability to work to be related to Shingrix.     It was unknown if the company considered the shingles, pain, dizziness, lethargy and inability to work to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR094589   Additional Information: GSK receipt date: 25-JUL-2024 The patient received his 2nd dose and that same day his pain was extreme and he went to an urgent care center, where he was diagnosed with shingles.  He states that his pain was severe, he was dizzy and lethargic, and he was unable to work.  He also stated that he has reported this event to VAERS.; Sender's Comments:  US-GSK-US2024AMR094589:Original Case : US2024093766
Age: 51.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Herpes zoster, Impaired work ability, Lethargy, Pain
Clinical narrative: shingles; his pain was extreme; dizziness; lethargy; unable to work; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of back pain (received his first dose two months ago and experienced lesions and back pain; reference case US2024093766).   On 21-JUL-2024, the patient received the 2nd dose of Shingrix. In JUL-2024, an unknown time after receiving Shingrix, the patient experienced dizziness (Verbatim: dizziness), lethargy (Verbatim: lethargy) and inability to work (Verbatim: unable to work). On 21-JUL-2024, the patient experienced shingles (Verbatim: shingles) and pain (Verbatim: his pain was extreme). The outcome of the shingles, pain, dizziness and lethargy were unknown and the outcome of the inability to work was not reported.   It was unknown if the reporter considered the shingles, pain, dizziness, lethargy and inability to work to be related to Shingrix.     It was unknown if the company considered the shingles, pain, dizziness, lethargy and inability to work to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR094589   Additional Information: GSK receipt date: 25-JUL-2024 The patient received his 2nd dose and that same day his pain was extreme and he went to an urgent care center, where he was diagnosed with shingles.  He states that his pain was severe, he was dizzy and lethargic, and he was unable to work.  He also stated that he has reported this event to VAERS.; Sender's Comments:  US-GSK-US2024AMR094589:Original Case : US2024093766
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Axillary mass, Axillary pain, Injection site pain, Pain
Clinical narrative: patient is experiencing injection site soreness and reports her armpit is swollen and it hurts to lift her arm after receiving a GARDASIL 9 vaccination; patient is experiencing injection site soreness and reports her armpit is swollen and it hurts to lift her arm after receiving a GARDASIL 9 vaccination; This spontaneous report was received from Pharmacist and refers to a female patient of unspecified age.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were unknown by reporter.  On 26-JUL-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1967338, expiration date: 26-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided).  On 30-JUL-2024, the patient experienced injection site soreness and reports her armpit was swollen and it hurt to lift her arm (Vaccination site pain and swelling). Pharmacist reports she was going to refer this patient to her healthcare professional (HCP). At the reporting time, the outcome of the events, as well as, if patient sought medical attention, or if treatment was given for the adverse events were unknown.   The causal relationship between vaccination site pain and swelling with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain, Oedema peripheral, Pain
Clinical narrative: patient is experiencing injection site soreness and reports her armpit is swollen and it hurts to lift her arm after receiving a GARDASIL 9 vaccination; patient is experiencing injection site soreness and reports her armpit is swollen and it hurts to lift her arm after receiving a GARDASIL 9 vaccination; This spontaneous report was received from Pharmacist and refers to a female patient of unspecified age.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were unknown by reporter.  On 26-JUL-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #1967338, expiration date: 26-JAN-2026, administered for prophylaxis (strength, and route of administration were not provided).  On 30-JUL-2024, the patient experienced injection site soreness and reports her armpit was swollen and it hurt to lift her arm (Vaccination site pain and swelling). Pharmacist reports she was going to refer this patient to her healthcare professional (HCP). At the reporting time, the outcome of the events, as well as, if patient sought medical attention, or if treatment was given for the adverse events were unknown.   The causal relationship between vaccination site pain and swelling with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 1.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: His 12-month-old daughter was given the GARDASIL 9 vaccine. It's been 25 hours since she received the vaccine, and he has not noticed any side effects yet.; His 12-month-old daughter was given the GARDASIL 9 vaccine. It's been 25 hours since she received the vaccine, and he has not noticed any side effects yet.; This spontaneous report was received from the patient's father and refers to his 12-month-old daughter. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.      On 15-JUL-2024, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (quantity dose, lot #, expiration date and route were not reported) (product administered to patient of inappropriate age). It had been 25 hours since she received the vaccine, and he had not noticed any side effects yet (no adverse event).   Caller wanted to inquire from the company about if she would be okay and what side effects to look out for.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; ROTATEQ was inadvertently administered after its labeled expiry date to a patient on 7/24/2024; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 24-JUL-2024, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dose (lot number 1947648 was verified to be valid, expiration date was reported and confirmed as 21-JUN-2024), administered orally as prophylaxis by a health professional (dose number was not provided). The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was inadvertently administered after its labeled expiry date (Expired product administered). The healthcare professional (HCP) confirmed that there was no temperature excursion (T/E). Provided outcome based on "Vaccines and Biologics Administered Post Expiry" as supported. No additional adverse event (AE) was reported.  No other information was given or requested by the HCP and permission was given to contact for further information.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Scratch, Skin lesion
Clinical narrative: lesions on his back; scrapes which never healed; pain reported to be deep into his back muscles; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin lesion in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced skin lesion (Verbatim: lesions on his back), skin abrasion (Verbatim: scrapes which never healed) and muscular back pain (Verbatim: pain reported to be deep into his back muscles). The outcome of the skin lesion, skin abrasion and muscular back pain were not resolved.   It was unknown if the reporter considered the skin lesion, skin abrasion and muscular back pain to be related to Shingrix.     It was unknown if the company considered the skin lesion, skin abrasion and muscular back pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024093766   Additional Information: GSK Receipt Date: 25-JUL-2024 The patient reported that he received his first dose of Shingrix two months ago. He then began experiencing lesions on his back similar to scrapes which never healed, along with pain reported to be deep into his back muscles. The pain continued to current day. He did not report seeking medical care at that time. He also stated that he had reported this event to VAERS.; Sender's Comments:  US-GSK-US2024093766:same patient, different dose