chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Herpes simplex, Neck pain, Pyrexia
Clinical narrative: 2/22/2024: RSV vax. Week following: observed fatigue, apathy, no appetite, chills, 2/29/2024: HSV2 lesion, dormant for well over a year. Slight fever. 3/2/2024: overwhelming pain up neck/shoulders recognized as same as during severe bout of shingles 4/2024 to 7/2024 following covid booster. Started Valtrex 500mg TID; pain is finally resolving as of today. Schedule of vax thru winter: Shingrix #1: 10/11/23; Flu: 11/18/23; Covid: 11/29/2023; Shingrix#2: 1/10/2024; RSV: 2/22/24.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The injection site became red, swollen, sore, and itchy immediately after the injection.  A raised red circle formed around the injection site and the entire circle was swollen and itchy and very sore to the touch.  The area looked like the "covid arm" photos posted online.  The site went back to normal after five days.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Large red swollen circular area, hurts when pressed on
Age: 27.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Patient sent email on 3/13/24 to clinic to report sore arm and extreme, intolerable fatigue for over 5 days post vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Cardiac electrophysiologic study, Echocardiogram, Electrocardiogram
Clinical narrative: SEVERE REACTION INCLUDING FEVER, MALAISE, SECOND SUSTAINED EPISODE OF AFIB REQUIRING ABLATION.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise, Pyrexia
Clinical narrative: SEVERE REACTION INCLUDING FEVER, MALAISE, SECOND SUSTAINED EPISODE OF AFIB REQUIRING ABLATION.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Blood pressure decreased, Dizziness, Syncope
Clinical narrative: 2-3 MINS AFTER ADMINISTRATION TEENAGER FELT FAINT AND COLLAPSED WHILE WAITING TO BE CHECKED OUT. SHE WAS FULLY CONSCIOUS BUT MADE TO LIE SUPINE UNTIL BP AND PULSE WERE RECORDED. BP AND PULSE WERE SOMEWHAT LOW BUT WITHIN 5-10 MINS FOLLOWING OBSERVATION HR AND BP IMPROVED. SHE WAS SENT HOME WITHIN 15 MINUTES AS SHE WAS FEELING MUCH BETTER.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site paraesthesia, Pain in extremity
Clinical narrative: Left arm numbness and tingeling that radiated from injection site down to finger tips, fever, arm pain, and limited ROM- difficulty raising L arm above head. fever has resolved 2 days after admonstration. four days after admin. pt reports improvemnt in numbess, now locatlized to upper arm only.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Left arm numbness and tingeling that radiated from injection site down to finger tips, fever, arm pain, and limited ROM- difficulty raising L arm above head. fever has resolved 2 days after admonstration. four days after admin. pt reports improvemnt in numbess, now locatlized to upper arm only.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Wrong dose given for patients age group, No adverse reactions or symptoms documented.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Immediate post-injection reaction, Injection site pain, Magnetic resonance imaging abnormal, Mobility decreased
Clinical narrative: I started to feel immediate pain in my left arm at injection site.  After a couple weeks of feeling intense pain/limited mobility/limited strength I visited my primary care doctor.   Primary Care doctor referred me to receive an MRI.  The results of the MRI showed a partial tear of my rotator cuff with tendonitis.  I then was referred to physical therapy were I conducted a number of appointments.  After PT was unsuccessful Doctor has now referred me to Ortho for an appointment.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Rotator cuff syndrome, Tendonitis
Clinical narrative: I started to feel immediate pain in my left arm at injection site.  After a couple weeks of feeling intense pain/limited mobility/limited strength I visited my primary care doctor.   Primary Care doctor referred me to receive an MRI.  The results of the MRI showed a partial tear of my rotator cuff with tendonitis.  I then was referred to physical therapy were I conducted a number of appointments.  After PT was unsuccessful Doctor has now referred me to Ortho for an appointment.
Age: 45.0
Sex: M
Vaccine: PNC20
Symptoms: Echocardiogram, Electrocardiogram T wave abnormal, Injection site reaction, Sinus arrhythmia
Clinical narrative: 2/23/2024 Local site reaction. 2/26/24 Sinus Arrhythmia, T wave abnormality.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Pulmonary thrombosis
Clinical narrative: Multiple Blood clot in both lungs
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder cancer, Blood test, Blood urine present, Cystoscopy, Laboratory test
Clinical narrative: On December 3, 2022 I started urinating blood. After two emergency room visits, a multitude of tests, and seeing a urologist I was diagnosed with bladder cancer. I have no family history of bladder cancer and I had no symptoms prior to being vaccinated to suspect that I had bladder cancer.  Based on the size and type of tumor my urologist estimated that it would that type of cancer one year to one year and a half to grow to the size it was.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm, Urine analysis
Clinical narrative: On December 3, 2022 I started urinating blood. After two emergency room visits, a multitude of tests, and seeing a urologist I was diagnosed with bladder cancer. I have no family history of bladder cancer and I had no symptoms prior to being vaccinated to suspect that I had bladder cancer.  Based on the size and type of tumor my urologist estimated that it would that type of cancer one year to one year and a half to grow to the size it was.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC20
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Right thigh red, swollen and had rash going down right leg.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site pain, Injection site scab
Clinical narrative: Skin is black thought it was a bruise but was not.  Skin did burn at the vaccine site & scab appeared & new pink skin showing.  I had the RSV a month ago today & it?s still trying to heal from the burnt skin from the vaccine.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Hypopnoea, Pain in extremity, Painful respiration, Peripheral swelling
Clinical narrative: Patient is c/o left arm pain 10/10, redness and swelling the size of her hand. Patient also c/o pain to left back lung 8/10 at rest and 10/10 when she takes a deep breath. Patient denies shortness of breath, wheezing or tightness in chest but states that she is taking shallow breaths due to pain.
Age: 26.0
Sex: F
Vaccine: MNQ
Symptoms: Pulmonary pain
Clinical narrative: Patient is c/o left arm pain 10/10, redness and swelling the size of her hand. Patient also c/o pain to left back lung 8/10 at rest and 10/10 when she takes a deep breath. Patient denies shortness of breath, wheezing or tightness in chest but states that she is taking shallow breaths due to pain.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given a vaccine out of her age range. Patient was given moderna ages 6 mos-11years; patient should have received moderna for ages 12+
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Antinuclear antibody negative, Blood copper normal, Blood creatinine increased, Blood lactate dehydrogenase normal, Chest pain
Clinical narrative: Recently received covid (Moderna ? Spikevax) vaccine on Monday, 3/4/24. Fevers and muscle aches started after. Also reports nausea and non-bloody emesis. She also reports pain in her chest and this is why she called EMS. Pain in chest has since resolved. Chest pain was at its worse when her fever was 104-106F. She frequently has leukopenia with vaccines. A similar reaction occurred when she received an influenza vaccine before (10/31/2019). She did not have prior severe reactions to past covid vaccines (received Pfizer x3). She reports the muscle pain. She denies any further fevers/chills after arriving to the clinic.  The patient initially presented to clinic for complaints of myalgias and fevers in the setting of recent vaccination and PMHx of leukopenias with vaccinations. The patient was febrile to 38.9 tachycardic and hemodynamically stable. The patient was noted to have leukopenia 610 with no neutrophils as well as elevation in Cr to 4.32. The patient was started on broad spectrum antibiotics (Cefepime/Vanc) and admitted to the hospital for further diagnostic evaluation and management. The patient had a broad differential regarding her neutropenia with viral studies negative (EBV, CMV, ParvoB19, HIV, Hepatitis B/C, Respiratory viral panel), Negative hemolysis labs (Direct antiglobulin, LDH, haptoglobin), Negative nutritional studies B12, B9, Copper with mild deficiency in Zn which was supplemented. Patient was evaluated with Flow cytometry with negative clonal population with anti neutrophil antibodies send out IP (surface not ANCA Igs). Patient had negative autoimmune panel (ANA, RF). The patient was further noted to have abnormalities in her PT/INR and was treated with Vit K with normal TEG study and normal Coag Factor levels. The patient had an uncomplicated stay with slow recovery of neutrophils to 620 and no further episodes of fever. The patient was evaluated by the transplant nephrology team with adjustments of immunosuppression and mycophenolate held initially due to concern for leukopenia and restarted at a lower dose on discharge with planned outpatient adjustment. The patient was discharged on good condition with follow up outpatient consultations with PCP, hematology, and transplant nephrology
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Coagulation factor level normal, Coombs direct test, Cytomegalovirus test negative, Epstein-Barr virus test negative, Flow cytometry
Clinical narrative: Recently received covid (Moderna ? Spikevax) vaccine on Monday, 3/4/24. Fevers and muscle aches started after. Also reports nausea and non-bloody emesis. She also reports pain in her chest and this is why she called EMS. Pain in chest has since resolved. Chest pain was at its worse when her fever was 104-106F. She frequently has leukopenia with vaccines. A similar reaction occurred when she received an influenza vaccine before (10/31/2019). She did not have prior severe reactions to past covid vaccines (received Pfizer x3). She reports the muscle pain. She denies any further fevers/chills after arriving to the clinic.  The patient initially presented to clinic for complaints of myalgias and fevers in the setting of recent vaccination and PMHx of leukopenias with vaccinations. The patient was febrile to 38.9 tachycardic and hemodynamically stable. The patient was noted to have leukopenia 610 with no neutrophils as well as elevation in Cr to 4.32. The patient was started on broad spectrum antibiotics (Cefepime/Vanc) and admitted to the hospital for further diagnostic evaluation and management. The patient had a broad differential regarding her neutropenia with viral studies negative (EBV, CMV, ParvoB19, HIV, Hepatitis B/C, Respiratory viral panel), Negative hemolysis labs (Direct antiglobulin, LDH, haptoglobin), Negative nutritional studies B12, B9, Copper with mild deficiency in Zn which was supplemented. Patient was evaluated with Flow cytometry with negative clonal population with anti neutrophil antibodies send out IP (surface not ANCA Igs). Patient had negative autoimmune panel (ANA, RF). The patient was further noted to have abnormalities in her PT/INR and was treated with Vit K with normal TEG study and normal Coag Factor levels. The patient had an uncomplicated stay with slow recovery of neutrophils to 620 and no further episodes of fever. The patient was evaluated by the transplant nephrology team with adjustments of immunosuppression and mycophenolate held initially due to concern for leukopenia and restarted at a lower dose on discharge with planned outpatient adjustment. The patient was discharged on good condition with follow up outpatient consultations with PCP, hematology, and transplant nephrology
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: HIV test negative, Haptoglobin normal, Hepatitis B test negative, Hepatitis C test negative, Immunosuppression
Clinical narrative: Recently received covid (Moderna ? Spikevax) vaccine on Monday, 3/4/24. Fevers and muscle aches started after. Also reports nausea and non-bloody emesis. She also reports pain in her chest and this is why she called EMS. Pain in chest has since resolved. Chest pain was at its worse when her fever was 104-106F. She frequently has leukopenia with vaccines. A similar reaction occurred when she received an influenza vaccine before (10/31/2019). She did not have prior severe reactions to past covid vaccines (received Pfizer x3). She reports the muscle pain. She denies any further fevers/chills after arriving to the clinic.  The patient initially presented to clinic for complaints of myalgias and fevers in the setting of recent vaccination and PMHx of leukopenias with vaccinations. The patient was febrile to 38.9 tachycardic and hemodynamically stable. The patient was noted to have leukopenia 610 with no neutrophils as well as elevation in Cr to 4.32. The patient was started on broad spectrum antibiotics (Cefepime/Vanc) and admitted to the hospital for further diagnostic evaluation and management. The patient had a broad differential regarding her neutropenia with viral studies negative (EBV, CMV, ParvoB19, HIV, Hepatitis B/C, Respiratory viral panel), Negative hemolysis labs (Direct antiglobulin, LDH, haptoglobin), Negative nutritional studies B12, B9, Copper with mild deficiency in Zn which was supplemented. Patient was evaluated with Flow cytometry with negative clonal population with anti neutrophil antibodies send out IP (surface not ANCA Igs). Patient had negative autoimmune panel (ANA, RF). The patient was further noted to have abnormalities in her PT/INR and was treated with Vit K with normal TEG study and normal Coag Factor levels. The patient had an uncomplicated stay with slow recovery of neutrophils to 620 and no further episodes of fever. The patient was evaluated by the transplant nephrology team with adjustments of immunosuppression and mycophenolate held initially due to concern for leukopenia and restarted at a lower dose on discharge with planned outpatient adjustment. The patient was discharged on good condition with follow up outpatient consultations with PCP, hematology, and transplant nephrology
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: International normalised ratio normal, Laboratory test normal, Leukopenia, Myalgia, Nausea
Clinical narrative: Recently received covid (Moderna ? Spikevax) vaccine on Monday, 3/4/24. Fevers and muscle aches started after. Also reports nausea and non-bloody emesis. She also reports pain in her chest and this is why she called EMS. Pain in chest has since resolved. Chest pain was at its worse when her fever was 104-106F. She frequently has leukopenia with vaccines. A similar reaction occurred when she received an influenza vaccine before (10/31/2019). She did not have prior severe reactions to past covid vaccines (received Pfizer x3). She reports the muscle pain. She denies any further fevers/chills after arriving to the clinic.  The patient initially presented to clinic for complaints of myalgias and fevers in the setting of recent vaccination and PMHx of leukopenias with vaccinations. The patient was febrile to 38.9 tachycardic and hemodynamically stable. The patient was noted to have leukopenia 610 with no neutrophils as well as elevation in Cr to 4.32. The patient was started on broad spectrum antibiotics (Cefepime/Vanc) and admitted to the hospital for further diagnostic evaluation and management. The patient had a broad differential regarding her neutropenia with viral studies negative (EBV, CMV, ParvoB19, HIV, Hepatitis B/C, Respiratory viral panel), Negative hemolysis labs (Direct antiglobulin, LDH, haptoglobin), Negative nutritional studies B12, B9, Copper with mild deficiency in Zn which was supplemented. Patient was evaluated with Flow cytometry with negative clonal population with anti neutrophil antibodies send out IP (surface not ANCA Igs). Patient had negative autoimmune panel (ANA, RF). The patient was further noted to have abnormalities in her PT/INR and was treated with Vit K with normal TEG study and normal Coag Factor levels. The patient had an uncomplicated stay with slow recovery of neutrophils to 620 and no further episodes of fever. The patient was evaluated by the transplant nephrology team with adjustments of immunosuppression and mycophenolate held initially due to concern for leukopenia and restarted at a lower dose on discharge with planned outpatient adjustment. The patient was discharged on good condition with follow up outpatient consultations with PCP, hematology, and transplant nephrology
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neutrophil count decreased, Parvovirus B19 test negative, Prothrombin time normal, Pyrexia, Respiratory viral panel
Clinical narrative: Recently received covid (Moderna ? Spikevax) vaccine on Monday, 3/4/24. Fevers and muscle aches started after. Also reports nausea and non-bloody emesis. She also reports pain in her chest and this is why she called EMS. Pain in chest has since resolved. Chest pain was at its worse when her fever was 104-106F. She frequently has leukopenia with vaccines. A similar reaction occurred when she received an influenza vaccine before (10/31/2019). She did not have prior severe reactions to past covid vaccines (received Pfizer x3). She reports the muscle pain. She denies any further fevers/chills after arriving to the clinic.  The patient initially presented to clinic for complaints of myalgias and fevers in the setting of recent vaccination and PMHx of leukopenias with vaccinations. The patient was febrile to 38.9 tachycardic and hemodynamically stable. The patient was noted to have leukopenia 610 with no neutrophils as well as elevation in Cr to 4.32. The patient was started on broad spectrum antibiotics (Cefepime/Vanc) and admitted to the hospital for further diagnostic evaluation and management. The patient had a broad differential regarding her neutropenia with viral studies negative (EBV, CMV, ParvoB19, HIV, Hepatitis B/C, Respiratory viral panel), Negative hemolysis labs (Direct antiglobulin, LDH, haptoglobin), Negative nutritional studies B12, B9, Copper with mild deficiency in Zn which was supplemented. Patient was evaluated with Flow cytometry with negative clonal population with anti neutrophil antibodies send out IP (surface not ANCA Igs). Patient had negative autoimmune panel (ANA, RF). The patient was further noted to have abnormalities in her PT/INR and was treated with Vit K with normal TEG study and normal Coag Factor levels. The patient had an uncomplicated stay with slow recovery of neutrophils to 620 and no further episodes of fever. The patient was evaluated by the transplant nephrology team with adjustments of immunosuppression and mycophenolate held initially due to concern for leukopenia and restarted at a lower dose on discharge with planned outpatient adjustment. The patient was discharged on good condition with follow up outpatient consultations with PCP, hematology, and transplant nephrology
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rheumatoid factor negative, Tachycardia, Thromboelastogram, Vitamin B12 normal, Vomiting
Clinical narrative: Recently received covid (Moderna ? Spikevax) vaccine on Monday, 3/4/24. Fevers and muscle aches started after. Also reports nausea and non-bloody emesis. She also reports pain in her chest and this is why she called EMS. Pain in chest has since resolved. Chest pain was at its worse when her fever was 104-106F. She frequently has leukopenia with vaccines. A similar reaction occurred when she received an influenza vaccine before (10/31/2019). She did not have prior severe reactions to past covid vaccines (received Pfizer x3). She reports the muscle pain. She denies any further fevers/chills after arriving to the clinic.  The patient initially presented to clinic for complaints of myalgias and fevers in the setting of recent vaccination and PMHx of leukopenias with vaccinations. The patient was febrile to 38.9 tachycardic and hemodynamically stable. The patient was noted to have leukopenia 610 with no neutrophils as well as elevation in Cr to 4.32. The patient was started on broad spectrum antibiotics (Cefepime/Vanc) and admitted to the hospital for further diagnostic evaluation and management. The patient had a broad differential regarding her neutropenia with viral studies negative (EBV, CMV, ParvoB19, HIV, Hepatitis B/C, Respiratory viral panel), Negative hemolysis labs (Direct antiglobulin, LDH, haptoglobin), Negative nutritional studies B12, B9, Copper with mild deficiency in Zn which was supplemented. Patient was evaluated with Flow cytometry with negative clonal population with anti neutrophil antibodies send out IP (surface not ANCA Igs). Patient had negative autoimmune panel (ANA, RF). The patient was further noted to have abnormalities in her PT/INR and was treated with Vit K with normal TEG study and normal Coag Factor levels. The patient had an uncomplicated stay with slow recovery of neutrophils to 620 and no further episodes of fever. The patient was evaluated by the transplant nephrology team with adjustments of immunosuppression and mycophenolate held initially due to concern for leukopenia and restarted at a lower dose on discharge with planned outpatient adjustment. The patient was discharged on good condition with follow up outpatient consultations with PCP, hematology, and transplant nephrology
Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: White blood cell count decreased
Clinical narrative: Recently received covid (Moderna ? Spikevax) vaccine on Monday, 3/4/24. Fevers and muscle aches started after. Also reports nausea and non-bloody emesis. She also reports pain in her chest and this is why she called EMS. Pain in chest has since resolved. Chest pain was at its worse when her fever was 104-106F. She frequently has leukopenia with vaccines. A similar reaction occurred when she received an influenza vaccine before (10/31/2019). She did not have prior severe reactions to past covid vaccines (received Pfizer x3). She reports the muscle pain. She denies any further fevers/chills after arriving to the clinic.  The patient initially presented to clinic for complaints of myalgias and fevers in the setting of recent vaccination and PMHx of leukopenias with vaccinations. The patient was febrile to 38.9 tachycardic and hemodynamically stable. The patient was noted to have leukopenia 610 with no neutrophils as well as elevation in Cr to 4.32. The patient was started on broad spectrum antibiotics (Cefepime/Vanc) and admitted to the hospital for further diagnostic evaluation and management. The patient had a broad differential regarding her neutropenia with viral studies negative (EBV, CMV, ParvoB19, HIV, Hepatitis B/C, Respiratory viral panel), Negative hemolysis labs (Direct antiglobulin, LDH, haptoglobin), Negative nutritional studies B12, B9, Copper with mild deficiency in Zn which was supplemented. Patient was evaluated with Flow cytometry with negative clonal population with anti neutrophil antibodies send out IP (surface not ANCA Igs). Patient had negative autoimmune panel (ANA, RF). The patient was further noted to have abnormalities in her PT/INR and was treated with Vit K with normal TEG study and normal Coag Factor levels. The patient had an uncomplicated stay with slow recovery of neutrophils to 620 and no further episodes of fever. The patient was evaluated by the transplant nephrology team with adjustments of immunosuppression and mycophenolate held initially due to concern for leukopenia and restarted at a lower dose on discharge with planned outpatient adjustment. The patient was discharged on good condition with follow up outpatient consultations with PCP, hematology, and transplant nephrology
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Rash, Rash erythematous, Tinnitus
Clinical narrative: first noticed ringing in both ears along with dizziness for a few days,  dizziness went away but ringing in both ears has continued, also have a red rash around front of neck area, also small red bumps on stomach
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Pain, Productive cough, Pyrexia
Clinical narrative: Body aches, fever, coughing up clear sputum
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: no symptomatic adverse events were reported; patient had both VARIVAX and MMR-II administered intramuscularly into the glute; This spontaneous report was received from a Health Professional and refers to a 7-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 04-MAR-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection; and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, both vaccines administered intramuscularly into the glute as prophylaxis (strengths, doses. schemes, lot #s, and expiry date were not provided) (Product administered at inappropriate site). No adverse events were reproted.
Sex: F
Vaccine: PNC20, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient went to see 2 different Doctors and one gave the patient a dose of Prevnar 20 on 26-JAN, and than 3 weeks later, another doctor gave the patient a dose of pneumovax 23 on 12FEB; This spontaneous report was received from other health professional and refers to a female.  The patient's medical history and concomitant therapies were not reported. The patient current condition was reported as immunocompromising conditions.  On 26 January of unknown year, the patient was vaccinated with pneumococcal vaccine conj 20v (crm197) (PREVNAR 20), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided). On 12 February of unknown year, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The patient went to two fiffrient doctors and one gave patient a dose of Prevenar 20 and then 3 weeks later antother doctor gave patient a dose of Pneumovax 23 (Inappropriate schedule of product administration). Caller stated on their immunization table it is confusing and the doctor probably looked at that and thought the patient had not administered since 2013.
Sex: F
Vaccine: VARCEL
Symptoms: Circumstance or information capable of leading to medication error, Scratch, Underdose
Clinical narrative: Patient experienced a small scratch to their upper left thigh.; The push resulted in the needle coming out which scratched her thigh and; patient receiving a smaller than recommended dose of VARIVAX on 21FEB2023.; This spontaneous report was received from an other healthcare professional referring to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant therapy and drug reactions or allergies were provided.  On 21-FEB-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U032852  and upon validation, the expiration date was reported as: 20-OCT-2023 (strength, dose number, dose, route and anatomical location were not provided).  It was reported that the patient received a smaller than recommended dose of varicella virus vaccine live (oka/merck) (VARIVAX) (underdose); the patient experienced a small scratch to their upper left thigh. It was confirmed that the scratch on the patients' upper thigh was from the needle when the patient pushed the health care professional away while getting the vaccination (injury associated with device). The push resulted in the needle coming out which scratched her thigh and therefore getting the smaller than recommended dose.  The outcome of scratch and injury associated with device was not provided.  The causal relationship between injury associated with device and therapy with varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; HBP in charge of vaccine storage reports one dose of VAQTA that experienced below excursion administered to patient. Product administered 2/14/2024. Unknown if adult or pediatric formulation.  ?    Names of vaccines involved (including lot/exp) VAQ; This spontaneous report was received from office manager and refers to a patient of unknown ae and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-FEB-2024, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #X020849, expiration date: 26-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion on the same date in 35.6 Farenheit for 1 hour. Also this vaccine undervent previous temperature exposure on 06-FEB-2024, in 35.4 Farenheit for 1 hour 15 minutes (Product storage error). It was unkown if adult or pediatric formulation was administered. No additional adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Exposure to toxic agent, Exposure via skin contact, Occupational exposure to product, Product complaint
Clinical narrative: chemical exposure of slight burn reactions to fingers from 2 nurses; chemical exposure of slight burn reactions to fingers from 2 nurses; Exposure via skin contact; Pharmaceutical product complaint; This serious case was reported by a pharmacist via sales rep and described the occurrence of burning finger in a patient who received Herpes zoster (Shingrix) (batch number D5934) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced burning finger (Verbatim: chemical exposure of slight burn reactions to fingers from 2 nurses) (serious criteria other: Serious as per reporter), occupational exposure while administering product (Verbatim: chemical exposure of slight burn reactions to fingers from 2 nurses), exposure via skin contact (Verbatim: Exposure via skin contact) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the burning finger, occupational exposure while administering product, exposure via skin contact and pharmaceutical product complaint were unknown.   The reporter considered the burning finger to be related to Shingrix.     The company considered the burning finger to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-Feb-2024 The reporter reported that they received chemical exposure of slight burn reactions to fingers from 2 nurses and it was literally back to back within 30 minutes apart when they were drawing up shingrix vaccine after reconstituting, which led to occupational exposure while administering product and exposure via skin contact. The reporter stated that the nurses did not felt any spill of medication on skin when drawing it up.  The patients felt a burning sensation on their fingers afterwards. The reporter stated that he or she had the email that he or she can forward with pics of the exposed digits. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Ophthalmic herpes zoster, Pain, Vaccination failure
Clinical narrative: Again got the shingles/Susupected vaccination failure; Shingles in the right eye and forehead; Painful; Awful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had shingles in left eye two year ago and it was horrible), loss of vision (lost sight in the eye for a month) and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Again got the shingles/Susupected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: Shingles in the right eye and forehead) (serious criteria GSK medically significant), pain (Verbatim: Painful) and feeling abnormal (Verbatim: Awful). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and pain were not reported and the outcome of the feeling abnormal was not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, pain and feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, ophthalmic herpes zoster, pain and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 06-MAR-2024 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and again got Shingles, that time in the right eye and forehead.  It was less painful after getting the vaccine, but still awful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the vaccine and still got it/Suspected vaccination failure; still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-Mar-2024 This case was reported by the patient via interactive digital media. The patient stated that he/she got vaccine and still got the shingles. The patient further expressed that pray he/she would never get it again, and asked that if you were in the sun a lot it would come back. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK received date: 07-Mar-2024 This case was reported by a reporter via interactive digital media. Reporter stated, they are absolutely horrible. Reporter knew people who have had the vaccine but still get shingles but they much lighter and is the same with covid.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR030697:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles in head; painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Family history included cancer (patient's daughter had cancer).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles in head) and pain (Verbatim: painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2024 This case was reported by a consumer via interactive digital media. The patient got the shingles vaccine and paid over dollar 300 for them and still had awful breakouts in his/her head, they were truly painful especially if he/she get stressed about anything. The shots did not do anything to stop them from acting up. The patient had those vaccines 4 or 5 years ago and they did nothing to help him/her.  The patient prayed that one day they would find a complete cure for Shingles and he/she prayed for all those who were suffering with them everyday as he/she was.  The patient's started after his/her precious youngest daughter passed away from that terrible Cancer over 7 years ago and had not let up since.  The reporter further stated that God bless everyone who were suffering from these horrible shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule , time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was vaccinated before this one/Suspected vaccination failure; was vaccinated before this one/I'm on my third time now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles twice and the first time before fifty).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: was vaccinated before this one/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: was vaccinated before this one/I'm on my third time now). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2024 This case was reported by the patient via (social media) interactive digital media. The patient was on his/her third time now and was vaccinated before this one. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Patient had ocular shingles after vaccination/Suspected vaccination failure; Ocular shingles; Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of no adverse event. Serious criteria included GSK medically significant. Additional event(s) included ophthalmic herpes zoster (Verbatim: Ocular shingles) in FEB-2023 with serious criteria of GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included ophthalmic herpes zoster (resolved).     Other possible cause(s) of the vaccination failure included Recombinant Varicella Zoster virus surface glycoproteinE. Other possible cause(s) of the ophthalmic herpes zoster included Recombinant Varicella Zoster virus surface glycoproteinE.       Additional Information: GSK Receipt Date: 07-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had both vaccines, the original one and Shingrix about 5 years ago. The patient still had ocular shingles last month. The good news was that because the patient was vaccinated and the ophthalmologist got the patient on the anti virals the same day he/she broke out, they only lasted about a week. The patient thanks goodness, he/she had no loss of vision. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Since I took the shot it happened about two times/ suspected vaccination failure; Shingles; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Since I took the shot it happened about two times/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 07-Mar-2024 This case was reported by a patient via interactive digital media. The patient reported that pharmacy gave him or her two doses of Shingles vaccine. The patient stated that since he or she received Shingles vaccine experienced shingles two times and it was not painful as before. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: DTP
Symptoms: Diplegia, Guillain-Barre syndrome, Walking aid user
Clinical narrative: developed GBS; I was paralyzed from the hips down; walk with a cane; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis.   On an unknown date, the patient received DTP (A or W not known). On an unknown date, an unknown time after receiving DTP (A or W not known), the patient experienced guillain barre syndrome (Verbatim: developed GBS) (serious criteria GSK medically significant), paralysis (Verbatim: I was paralyzed from the hips down) (serious criteria GSK medically significant) and cane user (Verbatim: walk with a cane). The outcome of the guillain barre syndrome, paralysis and cane user were not reported.   It was unknown if the reporter considered the guillain barre syndrome, paralysis and cane user to be related to DTP (A or W not known).     It was unknown if the company considered the guillain barre syndrome, paralysis and cane user to be related to DTP (A or W not known).   Linked case(s) involving the same patient:  US2024AMR031440   Additional Information: GSK Receipt Date: 07-MAR-2024 This case was reported by a patient via interactive digital media. In 2012, the patient developed Guillain Barre syndrome (GBS) after getting a TDP vaccine and then had usual flu shot. The patient was paralyzed from the hips down and it took 6 months to be able to walk with a cane.; Sender's Comments:  US-GSK-US2024AMR031440:
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: age less than approved indication age; indication is immunocompromised; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 42-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: age less than approved indication age) and drug use for unapproved indication (Verbatim: indication is immunocompromised). The outcome of the inappropriate age at vaccine administration and drug use for unapproved indication were unknown.   Additional Information: GSK Receipt Date: 07-MAR-2024 This report was submitted via the online direct entry reporting system.  The report was of less than 60 years old patient who received Arexvy off-label intended by physician decision in patient, which led to inappropriate age at vaccine administration. The indication for Arexvy was immunocompromised, which led to drug used for unapproved indication. The physician felt off-label to be appropriate in this patient at risk for severe RSV if they were infected. It was unknown if other medications were taken by the patient.