chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Burning sensation, Depressed mood, Emotional distress, Facial pain
Clinical narrative: My chronic pain started suddenly in the right side of my penis, but it was so intense that it felt like it was affecting both sides. This initial pain was accompanied by discomfort in my upper right thigh. At work, where I sit a lot, I noticed my right groin was also being affected, experiencing a burning sensation and an occasional pulling feeling. To address these symptoms, I underwent surgery for a hernia on my right side, where they removed a 7.3 x 2.2 x 0.6 cm unoriented, focally lobulated, circumscribed piece of fatty tissue.  A month into my recovery, I began to experience altered sensations in my abdomen that came and went, along with severe neck stiffness. This pain, which worsened in the cold, was similar to the pain in my right upper thigh. Eventually, the pain and sensitivity spread to my entire right side, from head to toe, making me extremely sensitive to cold air. I had a brain MRI and my entire spine checked, but everything was completely unremarkable, which is typical for severe vaccine injuries. Despite testing negative for major autoimmune diseases like lupus and Sjögren's, I believe I suffered a major immune response.  Currently, I am discussing with my surgeon the possibility of removing the mesh and avoiding any permanent materials such as sutures or meshes. We are also considering bilateral Shouldice repair, although I have not yet received confirmation from the doctor. The burning pain in my upper thigh, which worsens with cold, is now a persistent issue affecting my entire right side, suggesting that it might be immune-related rather than caused by the hernia itself.  Emotionally, this situation has been incredibly distressing. The ongoing pain and uncertainty have significantly impacted my mental health, making me feel heartbroken and desperate. My quality of life has deteriorated to the point where I feel I cannot continue living like this. I am now exploring all possible options to alleviate my symptoms and improve my condition, hoping that the mesh removal and alternative hernia repair methods will offer some relief.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of despair, Groin pain, Hernia, Hernia repair, Impaired quality of life
Clinical narrative: My chronic pain started suddenly in the right side of my penis, but it was so intense that it felt like it was affecting both sides. This initial pain was accompanied by discomfort in my upper right thigh. At work, where I sit a lot, I noticed my right groin was also being affected, experiencing a burning sensation and an occasional pulling feeling. To address these symptoms, I underwent surgery for a hernia on my right side, where they removed a 7.3 x 2.2 x 0.6 cm unoriented, focally lobulated, circumscribed piece of fatty tissue.  A month into my recovery, I began to experience altered sensations in my abdomen that came and went, along with severe neck stiffness. This pain, which worsened in the cold, was similar to the pain in my right upper thigh. Eventually, the pain and sensitivity spread to my entire right side, from head to toe, making me extremely sensitive to cold air. I had a brain MRI and my entire spine checked, but everything was completely unremarkable, which is typical for severe vaccine injuries. Despite testing negative for major autoimmune diseases like lupus and Sjögren's, I believe I suffered a major immune response.  Currently, I am discussing with my surgeon the possibility of removing the mesh and avoiding any permanent materials such as sutures or meshes. We are also considering bilateral Shouldice repair, although I have not yet received confirmation from the doctor. The burning pain in my upper thigh, which worsens with cold, is now a persistent issue affecting my entire right side, suggesting that it might be immune-related rather than caused by the hernia itself.  Emotionally, this situation has been incredibly distressing. The ongoing pain and uncertainty have significantly impacted my mental health, making me feel heartbroken and desperate. My quality of life has deteriorated to the point where I feel I cannot continue living like this. I am now exploring all possible options to alleviate my symptoms and improve my condition, hoping that the mesh removal and alternative hernia repair methods will offer some relief.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Limb discomfort, Magnetic resonance imaging head normal, Mental disorder, Musculoskeletal discomfort
Clinical narrative: My chronic pain started suddenly in the right side of my penis, but it was so intense that it felt like it was affecting both sides. This initial pain was accompanied by discomfort in my upper right thigh. At work, where I sit a lot, I noticed my right groin was also being affected, experiencing a burning sensation and an occasional pulling feeling. To address these symptoms, I underwent surgery for a hernia on my right side, where they removed a 7.3 x 2.2 x 0.6 cm unoriented, focally lobulated, circumscribed piece of fatty tissue.  A month into my recovery, I began to experience altered sensations in my abdomen that came and went, along with severe neck stiffness. This pain, which worsened in the cold, was similar to the pain in my right upper thigh. Eventually, the pain and sensitivity spread to my entire right side, from head to toe, making me extremely sensitive to cold air. I had a brain MRI and my entire spine checked, but everything was completely unremarkable, which is typical for severe vaccine injuries. Despite testing negative for major autoimmune diseases like lupus and Sjögren's, I believe I suffered a major immune response.  Currently, I am discussing with my surgeon the possibility of removing the mesh and avoiding any permanent materials such as sutures or meshes. We are also considering bilateral Shouldice repair, although I have not yet received confirmation from the doctor. The burning pain in my upper thigh, which worsens with cold, is now a persistent issue affecting my entire right side, suggesting that it might be immune-related rather than caused by the hernia itself.  Emotionally, this situation has been incredibly distressing. The ongoing pain and uncertainty have significantly impacted my mental health, making me feel heartbroken and desperate. My quality of life has deteriorated to the point where I feel I cannot continue living like this. I am now exploring all possible options to alleviate my symptoms and improve my condition, hoping that the mesh removal and alternative hernia repair methods will offer some relief.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Nervous system disorder, Pain, Pain in extremity, Penile pain
Clinical narrative: My chronic pain started suddenly in the right side of my penis, but it was so intense that it felt like it was affecting both sides. This initial pain was accompanied by discomfort in my upper right thigh. At work, where I sit a lot, I noticed my right groin was also being affected, experiencing a burning sensation and an occasional pulling feeling. To address these symptoms, I underwent surgery for a hernia on my right side, where they removed a 7.3 x 2.2 x 0.6 cm unoriented, focally lobulated, circumscribed piece of fatty tissue.  A month into my recovery, I began to experience altered sensations in my abdomen that came and went, along with severe neck stiffness. This pain, which worsened in the cold, was similar to the pain in my right upper thigh. Eventually, the pain and sensitivity spread to my entire right side, from head to toe, making me extremely sensitive to cold air. I had a brain MRI and my entire spine checked, but everything was completely unremarkable, which is typical for severe vaccine injuries. Despite testing negative for major autoimmune diseases like lupus and Sjögren's, I believe I suffered a major immune response.  Currently, I am discussing with my surgeon the possibility of removing the mesh and avoiding any permanent materials such as sutures or meshes. We are also considering bilateral Shouldice repair, although I have not yet received confirmation from the doctor. The burning pain in my upper thigh, which worsens with cold, is now a persistent issue affecting my entire right side, suggesting that it might be immune-related rather than caused by the hernia itself.  Emotionally, this situation has been incredibly distressing. The ongoing pain and uncertainty have significantly impacted my mental health, making me feel heartbroken and desperate. My quality of life has deteriorated to the point where I feel I cannot continue living like this. I am now exploring all possible options to alleviate my symptoms and improve my condition, hoping that the mesh removal and alternative hernia repair methods will offer some relief.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance, Temperature intolerance
Clinical narrative: My chronic pain started suddenly in the right side of my penis, but it was so intense that it felt like it was affecting both sides. This initial pain was accompanied by discomfort in my upper right thigh. At work, where I sit a lot, I noticed my right groin was also being affected, experiencing a burning sensation and an occasional pulling feeling. To address these symptoms, I underwent surgery for a hernia on my right side, where they removed a 7.3 x 2.2 x 0.6 cm unoriented, focally lobulated, circumscribed piece of fatty tissue.  A month into my recovery, I began to experience altered sensations in my abdomen that came and went, along with severe neck stiffness. This pain, which worsened in the cold, was similar to the pain in my right upper thigh. Eventually, the pain and sensitivity spread to my entire right side, from head to toe, making me extremely sensitive to cold air. I had a brain MRI and my entire spine checked, but everything was completely unremarkable, which is typical for severe vaccine injuries. Despite testing negative for major autoimmune diseases like lupus and Sjögren's, I believe I suffered a major immune response.  Currently, I am discussing with my surgeon the possibility of removing the mesh and avoiding any permanent materials such as sutures or meshes. We are also considering bilateral Shouldice repair, although I have not yet received confirmation from the doctor. The burning pain in my upper thigh, which worsens with cold, is now a persistent issue affecting my entire right side, suggesting that it might be immune-related rather than caused by the hernia itself.  Emotionally, this situation has been incredibly distressing. The ongoing pain and uncertainty have significantly impacted my mental health, making me feel heartbroken and desperate. My quality of life has deteriorated to the point where I feel I cannot continue living like this. I am now exploring all possible options to alleviate my symptoms and improve my condition, hoping that the mesh removal and alternative hernia repair methods will offer some relief.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Dysphagia, Myalgia
Clinical narrative: Death
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Atypical pneumonia, COVID-19, Hyperglycaemia, Hyponatraemia, Physical deconditioning
Clinical narrative: Hospitalization for atypical pneumonia, COVID-19 infection, elevated troponin level, hyponatremia, hyperglycemia, physical deconditioning on dates 7/10/24- 7/15/24. Treated with dexamethasone, baricitinib, Remdesivir.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Hospitalization for atypical pneumonia, COVID-19 infection, elevated troponin level, hyponatremia, hyperglycemia, physical deconditioning on dates 7/10/24- 7/15/24. Treated with dexamethasone, baricitinib, Remdesivir.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, COVID-19, Normocytic anaemia, Physical deconditioning
Clinical narrative: Hospitalization for COVID-19 infection, acute renal failure, normocytic anemia, physical deconditioning on dates 7/11/24- 7/13/24. Treated with  vitamin C 500 mg PO daily, zinc 50 mg PO daily.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure congestive, Chronic kidney disease, Chronic obstructive pulmonary disease, Coronary artery disease
Clinical narrative: Hospitalization for COVID-19, H. influenzae infection, pleural effusion, CHF, CKD, COPD, coronary artery disease, dyspnea on dates 7/26/24- 7/29/24. Treated with no COVID-19 related medications.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Haemophilus infection, Pleural effusion
Clinical narrative: Hospitalization for COVID-19, H. influenzae infection, pleural effusion, CHF, CKD, COPD, coronary artery disease, dyspnea on dates 7/26/24- 7/29/24. Treated with no COVID-19 related medications.
Age: 9.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Varicella vaccination was administered at the same date/time as MMRV vaccination.  No adverse effects were noted at the time of administration.  Per guardian: no adverse effects noted days 0-11.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Pt reports that shortly after receiving Arexvy he had a lot of soreness in his upper arm muscle that has not since gone away. He reports that it is contained to his upper arm muscle. He reports that it hasn't worsened or improved since the first day. He reported no issues upon injection, and cannot physically see any changes on his arm.
Age: 25.0
Sex: M
Vaccine: EBZR
Symptoms: Chest discomfort, Full blood count, Metabolic function test, Nervousness, Throat irritation
Clinical narrative: Received vaccine at 0831, stayed in clinic for 15 minutes to monitor, no signs or symptoms of adverse reaction prior to leaving clinic. At 0930 while at work start feeling shaky legs, chest tightness and throat itchy. He reported to ER for evaluation and treatment. Received IV Benadryl, IV Solu-Medrol, IV Pepcid. Patient refused IM epinephrine. He was monitored in ER for 2 hours, he improved was discharged home. He received outpatient Pepcid for 5 days and Prednisone for 5 days.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Headache, Immunisation reaction, Pain, Rash, Rash pruritic
Clinical narrative: Pt called clinic today because she is concerned that she got chicken pox from her recent varicella vaccine on 7/17/24. She states that on Saturday, 8/3/24, she started getting red bumps "all over her body" that develop blisters on top of the bumps. She states the bumps are mostly on her torso and arms, with a few on her face and legs as well. She estimates that there are less than 50 bumps on her body overall. She says that as of today she is still developing new bumps. The bumps are itchy and she has been using calamine lotion for symptom management.  She states that on Friday, she developed headache and body aches which are mostly resolved today (Tuesday). She was afebrile.  On Sunday, she went to a walk-in clinic. She states the provider said that it "looks like chicken pox", but that they did not do any other testing or recommend additional treatment.   Discussed with the patient that she may be experiencing an uncommon varicella vaccine side effect where she has essentially developed a very mild case of vaccine-related varicella. Educated the patient that this is typically not infectious to the general public, but that she should avoid physical contact with people who are immunocompromised until her rash is better.   The patient states that she will need a doctor's note to return to work. In consultation with the local and state health department, this is not considered a case of varicella. It is considered a vaccine reaction. She is not considered contagious, except to people who are immune compromised until her rash is completely crusted over. She is not contraindicated from getting a second dose of the varicella vaccine. Because this is not a case, she is not considered immune to varicella and will likely not have a positive titer. She should get the second dose of the varicella vaccine when she is due (mid-August). This vaccine reaction is less likely to occur after the second dose of the vaccine. As of Wednesday, the patient is feeling better but still has some bumps on her body.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Rash vesicular, Varicella post vaccine
Clinical narrative: Pt called clinic today because she is concerned that she got chicken pox from her recent varicella vaccine on 7/17/24. She states that on Saturday, 8/3/24, she started getting red bumps "all over her body" that develop blisters on top of the bumps. She states the bumps are mostly on her torso and arms, with a few on her face and legs as well. She estimates that there are less than 50 bumps on her body overall. She says that as of today she is still developing new bumps. The bumps are itchy and she has been using calamine lotion for symptom management.  She states that on Friday, she developed headache and body aches which are mostly resolved today (Tuesday). She was afebrile.  On Sunday, she went to a walk-in clinic. She states the provider said that it "looks like chicken pox", but that they did not do any other testing or recommend additional treatment.   Discussed with the patient that she may be experiencing an uncommon varicella vaccine side effect where she has essentially developed a very mild case of vaccine-related varicella. Educated the patient that this is typically not infectious to the general public, but that she should avoid physical contact with people who are immunocompromised until her rash is better.   The patient states that she will need a doctor's note to return to work. In consultation with the local and state health department, this is not considered a case of varicella. It is considered a vaccine reaction. She is not considered contagious, except to people who are immune compromised until her rash is completely crusted over. She is not contraindicated from getting a second dose of the varicella vaccine. Because this is not a case, she is not considered immune to varicella and will likely not have a positive titer. She should get the second dose of the varicella vaccine when she is due (mid-August). This vaccine reaction is less likely to occur after the second dose of the vaccine. As of Wednesday, the patient is feeling better but still has some bumps on her body.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Hypoaesthesia, Inflammation, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal
Clinical narrative: Sudden tingling & then numbness in lower right back/hip area, then numbness in right leg? within 10 minutes more right leg was limp .. called 911 & was transported to hospital. By the time I was brought into ER, lower right side and leg were paralyzed. I was in the hospital until my release on June 5, 20w4, to a rehab facility. I was released from that facility on June 20. 2024 to begin out patient rehab from home.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Monoplegia, Paraesthesia, Spinal cord disorder, Vascular test normal
Clinical narrative: Sudden tingling & then numbness in lower right back/hip area, then numbness in right leg? within 10 minutes more right leg was limp .. called 911 & was transported to hospital. By the time I was brought into ER, lower right side and leg were paralyzed. I was in the hospital until my release on June 5, 20w4, to a rehab facility. I was released from that facility on June 20. 2024 to begin out patient rehab from home.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: Patient given Adult hep B
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Wrong product administered
Clinical narrative: RN mistakenly administered Meningococcal Conjugate, instead of Meningococcal B (Bexsero), due to RN misinterpretation of "due now" vaccines shown in system. RN shared the error with the family, with help of translator. Parent acknowledge and asked questions about receiving a second dose of meningitis vaccine. Parents educated on the different types of meningitis vaccines. RN reassured family that it is okay to receive an extra dose and sign effects can happen but are not common. RN educated family on after vaccination instructions, such as moving arm, cold compress for soreness and Tylenol for fever, prior to providing the correct vaccine-- Bexsero.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Flushing, Pyrexia
Clinical narrative: Patient came in today 8/7/24 to inform me she had an adverse reaction to her shingles shot three months ago and she suffered from a slight fever, flushed face, chills, covid like symptoms, tired, and dizzy for 10 days after the vaccination. Did not seek medical help, did not inform MD office.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypertension, Injection site hypoaesthesia, Peripheral swelling
Clinical narrative: NUMBNESS OF ARM ( INJECTION SITE ) HTN DIZZINESS SWELLING- LEGS SHORTNESS OF BREATH. No additional information from EMR available.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Grunting, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Pt started to feel dizzy 2min after vaccine administration; Eyes rolled back and started grunting having tonic clonic movements and loss of bladder control; Unresponsive for about 45 seconds; 911 was immediately called and patient was taken to a local hospital, Hospital. NP spoke with ED physician and pt is not to receive any more vaccines until cleared by Neuro. Chart updated with this information.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Urinary incontinence
Clinical narrative: Pt started to feel dizzy 2min after vaccine administration; Eyes rolled back and started grunting having tonic clonic movements and loss of bladder control; Unresponsive for about 45 seconds; 911 was immediately called and patient was taken to a local hospital, Hospital. NP spoke with ED physician and pt is not to receive any more vaccines until cleared by Neuro. Chart updated with this information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth, Skin discolouration
Clinical narrative: Injection site looked like a bullseye with a pale white circle in the center surrounded by redness, warmth, mild discomfort and mild swelling.It lasted several days and I still have discoloration on my upper arm almost 4 weeks later.
Age: 1.08
Sex: M
Vaccine: DTAPIPVHIB, MMR, PNC20
Symptoms: Rash
Clinical narrative: Rash on chin, neck, ears, chest lasting 7-10 days. Full recovery
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Sleep disorder
Clinical narrative: He reports that night while sleeping, he woke to a pain in his left chest that travelled to his rt chest. He states that this lasted seconds but felt as though his heart stopped. I concerned him that he wanted to stay near a phone. He denies further symptoms.
Age: 55.0
Sex: F
Vaccine: HEP, MMRV, TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Proquad was given to a 55 year old.  Proquad is not supposed to be given after age 12.
Age: 6.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given a 3rd dose of M-M-R. No adverse effects reported at time of vaccination
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash
Clinical narrative: PATIENT HAD RASHES COUPLE OF DAYS LATER AFTER THE INJECTION. 7 DAYS LATER  THE INJECTION SITE WAS SWOLLEN LIKE A SOFT BALL.
Age: 78.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Asthenia
Clinical narrative: Pt presented to clinic with CC of left shoulder pain and weakness beginning 8/1/24 after receiving Prevnar 20 vaccination earlier that day. Patient was recommended to rest affected arm, Ice affected arm, elevate affected arm and take OTC ibuprofen for pain. Contacted pharmacy 8/7/24 and verified information for vaccine as provided with staff.
Age: 80.0
Sex: F
Vaccine: HEPAB, RSV, VARZOS
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Patient called today saying she is experiencing swelling, redness, heat in right shoulder.  Treating at home with pain/fever reducer, ice, and benadryl.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Vomiting
Clinical narrative: Patient threw up and started feeling clamy
Age: 8.0
Sex: M
Vaccine: IPV, MMR, TDAP
Symptoms: Apnoea, Electrocardiogram, Seizure
Clinical narrative: Seizure activity with prolonged apnea, denied fever and any other symptoms. Mom reported using onions as a home remedy.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA, SARS-CoV-2 test positive
Clinical narrative: HOSPITALIZATION RELATED TO COVID-19 FOLLOWING COMPLETION OF PRIMARY COVID VACCINE SERIES 7/5/24
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Cough, Diarrhoea, Nausea, Throat irritation, Vomiting
Clinical narrative: Within one hour of receiving the vaccine the patient had nausea, vomiting, diarrhea, cough and itchy throat that continued for several hours. Patient had no symptoms of illness at time of vaccination.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no symptoms after event
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: no effect
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Local reaction, Malaise, Pyrexia
Clinical narrative: Within 24 hours of receiving the vaccine the patient developed a very large local reaction approximate size 20in by 5in and fever and felt physically ill.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose normal, Blood pressure increased, Electrocardiogram, Extra dose administered, Presyncope
Clinical narrative: Patient received 4 doses of HPV vaccine, due to following the incorrect Suggested Tracking Schedule of system.  Although patient's HPV vaccination series was complete, system flagged patient as needing another dose.  Patient had received 3 doses for HPV in 2015 and 2016, before the CDC changed the recommendation from 3 doses to 2 doses. System flagged doses 2 and 3 as invalid for this patient because they did not fit the time period currently required by the 2-dose series.   However, the HPV vaccine did coincide with the recommendations at the time they were given.  Therefore, the patient s vaccination series was complete.  On 8/2/24, 18 year old patient was administered Gardasil (Merck) 0.5mL, IM, Lot X024650 at 9:45am. Patient had vasovagal response in the lab at 11:27am, which prompted our investigation.  Patient's response was significant; he required transport by EMS to Emergency Department, after failing to rouse and failing to respond to verbal commands.  Previous doses for patient were 1) on 12/15/2015, Gardasil (Merck), 0.5mL, IM, Lot: L020015, 2) on 3/7/16, 0.5ml, Gardasil (Merck), IM, Lot: L020015, and 3) on 7/13/2016, Gardasil (Merck), 0.5mL, IM, Lot: L035105. As for error prevention in the future, staff need to be educated on prior vaccination schedules, and those appropriate for particular patients, and understand that the computer program s Suggested Tracking Schedule is not binding nor necessarily correct.  In addition, staff now have a nurse number to contact at system for questions or concerns on vaccination recommendations.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient received 4 doses of HPV vaccine, due to following the incorrect Suggested Tracking Schedule of system.  Although patient's HPV vaccination series was complete, system flagged patient as needing another dose.  Patient had received 3 doses for HPV in 2015 and 2016, before the CDC changed the recommendation from 3 doses to 2 doses. System flagged doses 2 and 3 as invalid for this patient because they did not fit the time period currently required by the 2-dose series.   However, the HPV vaccine did coincide with the recommendations at the time they were given.  Therefore, the patient s vaccination series was complete.  On 8/2/24, 18 year old patient was administered Gardasil (Merck) 0.5mL, IM, Lot X024650 at 9:45am. Patient had vasovagal response in the lab at 11:27am, which prompted our investigation.  Patient's response was significant; he required transport by EMS to Emergency Department, after failing to rouse and failing to respond to verbal commands.  Previous doses for patient were 1) on 12/15/2015, Gardasil (Merck), 0.5mL, IM, Lot: L020015, 2) on 3/7/16, 0.5ml, Gardasil (Merck), IM, Lot: L020015, and 3) on 7/13/2016, Gardasil (Merck), 0.5mL, IM, Lot: L035105. As for error prevention in the future, staff need to be educated on prior vaccination schedules, and those appropriate for particular patients, and understand that the computer program s Suggested Tracking Schedule is not binding nor necessarily correct.  In addition, staff now have a nurse number to contact at system for questions or concerns on vaccination recommendations.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Gait disturbance, Laboratory test, Pain
Clinical narrative: Pt reports bilateral wrist and ankle pain and weakness started 3-4 days after TDaP vaccination. Tactile fever. Parents report trouble ambulating and decreased energy. Has to be carried around the house as pt c/o pain and unable to walk. Ibuprofen not helping with pain.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Pt reports bilateral wrist and ankle pain and weakness started 3-4 days after TDaP vaccination. Tactile fever. Parents report trouble ambulating and decreased energy. Has to be carried around the house as pt c/o pain and unable to walk. Ibuprofen not helping with pain.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling
Clinical narrative: Patient experienced redness, swelling, and irritation below the injection site the day after administration and has been experiencing this for 3 days now.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: SARS-CoV-2 test, Sinus pain
Clinical narrative: Sinus pain
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site papule, Injection site rash, Product administered at inappropriate site
Clinical narrative: Rash with small papules developed on both legs approximately 24 hours after administration of vaccines.
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 1) Numbness in the Toe 2) Tingling Sensation in finger
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nausea, Throat tightness
Clinical narrative: This patient walked in for her vaccines.  She was given the vaccines and asked to wait for 15 min or so to make sure that she didn't have any reactions to the vaccines.  Patient and her mom waiting in the lobby and notified nursing 35min after vaccines was given that she was having nausea and tightness in the throat.  Dr. was called into the room for assessment.  She decided to send the patient down to the ED for evaluation.
Age: 27.0
Sex: M
Vaccine: HEP, MENB, TDAP
Symptoms: Dizziness, Fall, Feeling hot, Nausea, Syncope
Clinical narrative: After received these 3 vaccines, Patient fainted and fell off the chair.  Patient stood up right at the moment he fell off.  I (pharmacist) asked him to sit down on the chair.  He started felling dizzy and vomited.   He complained of felling very hot.  He was alert, answer all the questions correctly.  There was no rash, or sign  of anaphylaxis.  Th ambulance came and asked questions.  He answer all the question with no problem.  He still feeling dizzy and nausea so they took him away.
Age: 27.0
Sex: M
Vaccine: HEP, MENB, TDAP
Symptoms: Vomiting
Clinical narrative: After received these 3 vaccines, Patient fainted and fell off the chair.  Patient stood up right at the moment he fell off.  I (pharmacist) asked him to sit down on the chair.  He started felling dizzy and vomited.   He complained of felling very hot.  He was alert, answer all the questions correctly.  There was no rash, or sign  of anaphylaxis.  Th ambulance came and asked questions.  He answer all the question with no problem.  He still feeling dizzy and nausea so they took him away.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Parent gave incorrect birthday. Child was 6 days too young to receive adult formulation.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Injection site pain, Joint stiffness, Pain
Clinical narrative: On 07/03/24 I went to the Occupational health at work to get a Hep B vaccine on my right arm. from that day into the present time, I Experience a shooting pain, Stiffness and burning sensation on my joints from the injection site through my elbow and hand.
Age: 15.0
Sex: F
Vaccine: HEPAB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: PT WAS NEEDING BOTH HEPATITIS A  (HAVRIX) AND B (ENGERIX-B) BUT INSTEAD WAS GIVEN HEPATITIS A/B (TWINRIX), CALLED PT TO SEE HOW SHES DOING BUT NO SYMPTOMS,FEVERS ,RASHES, OR OTHER UNUSUAL SYMPTOMS HAVE BEEN SHOWN. AS PER PT MOM "SHE IS DOING WELL AND I HAVE NOT NOTICED ANY SYMPOTMS"
Age: 42.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Complains of redness, swelling,  and raised area at sites of injections and getting worse. Educated on side effects of the vaccinations she received 8/5/24. Patient states she is going to walk in clinic.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: My son all of sudden passed out in my kitchen floor for no reason the first time. It happened again  and I took him to the emergency room.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE reported. No PQC.; Caller is a nurse who reports pediatric VAQTA was administered to an adult patient. Date of administration was 7/5/2024. No additional AE details. Nurse consents to follow-up. No additional AE reported. No PQC.; This spontaneous report was received from a nurse regarding an adult patient of unspecified age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not reported.   On 05-JUL-2024, the patient received a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA), 0.5 ml as prophylaxis (lot number 1971512 and expiration date 23-AUG-2024 were confirmed as valid) (strength, vaccination scheme, anatomical location and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event (AE) was reported, no product quality complaint (PQC).
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Patient reported that she has a lesion coming as of 07/16/2024; This spontaneous report was received from a nurse and refers to a 37-year-old female patient.  The patient's medical history included herpes. The patient's concurrent conditions were not reported. Historical drug included valaciclovir hydrochloride (VALTREX). Concomitant therapies were not reported.  On 15-JUL-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (1 dose, exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis.  On 16-JUL-2024, the patient experienced a lesion. Sought medical attention. At the time of reporting, the patient had not recovered from the event. The action taken with suspect vaccine regarding the event was not applicable.  The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided.  Lot # is being requested and will be submitted if received.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; Improper storage of product in use; This spontaneous report was received from a medical assistant, referring to a 4-year-old male patient. The patient's pertinent medical history, drug reactions/allergies, and concurrent condition were not provided. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine acellular 3-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (KINRIX) (Lot# 54Y2J, expiration date 10-JUN-2024, site: left thigh).   On 07-MAY-2024, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (therapy type: recombinant Human albumin/ rHA for V205C/V221) (M-M-R II) injection, lot #W035041, expiration date: 24-MAY-2024, administered in the right thigh for prophylaxis (strength, dose and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X010531, expiration date: 11-APR-2025, administered in the right thigh for prophylaxis (strength, dose and route of administration were not provided) after excursions on 22-APR-2024 (through approximately 14-JUN-2024) (product storage error). Temperature excursions were identified some time last week (reported as from 10-JUN-2024 to 14-JUN-2024). The vaccines were occurred temperature excursion as a result of a reading from a digital data logger. The vaccines were back in range. There was no previous excursions. The vaccines were used according to the instruction leafletNo additional adverse event (AE) (no adverse event).
Age: 1.0
Sex: F
Vaccine: MMR, PNC20, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a medical assistance (M.A) concerning a 1-year-old female patient.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter. The patient had only 1 brother.  The patient received previously one dose of pneumococcal vaccine conj 13V(CRM197) (PREVNAR 13) and two doses of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20).  On 11-JUN-2024, the patient was vaccinated with improperly doses (product storage error) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, Lot # W028734, Expiration date: 08-SEP-2024 in the right thigh, (route was not reported) for prophylaxis.  Other suspect therapies included varicella virus vaccine live (oka/merck)(VARIVAX) Lot# X018954, Expiration date: 13-JUL-2025 in the right thigh, (route was not reported) for prophylaxis and pneumococcal vaccine conj 20v (crm197)(PREVNAR 20) Lot# HL3889, Expiration date: 31-MAY-2025 in the left thigh, (route was not reported) for prophylaxis.    None adverse event following a prior vaccination (No adverse event). The temperature excursion occurred as a result of a reading from a Digital Data Logger.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller reported VARIVAX administered after temperature excursion.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 22-JUL-2024, the patient was vaccinated with improperly stored with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #Y004555, expiration date: 20-FEB-2026, (strength, exact dose, dose#, anatomical site of vaccination and route of administration were not provided) for prophylaxis (product storage error). The suspect vaccine underwent a temperature excursion of 9.9 Fahrenheit (F) degrees for 1 hour and 9 minutes. There was no previous temperature excursion.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE; HCP called to report that an expired dose of PROQUAD was inadvertently administered to the patient.; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported.   On 22-JUL-2024, the patient was vaccinated with an expired dose of a measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHa) (PROQUAD) injection, 0.5ml/ series, lot #x011980, expiration date: 19-JUL-2024, (strength, dose#, anatomical site of vaccination and route of administration were not provided) for prophylaxis (expired product administered). No additional adverse event (AE) was reported (no adverse event).
Age: 23.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE.; expired dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant and refers to a 23-year-old patient (gender no provided)  The patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant therapies were not reported.  On 23-JUL-2024, the patient was vaccinated with  an expired varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #w022293, expiration date: 13-JUL-2024, administered for prophylaxis (strength, exact dose, and route of administration were not provided) (Expired vaccine used). It was confirmed the product did not experience any temperature excursions and no other adverse event occurred.
Age: 1.5
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: not experiencing any local or systemic side effects at this time/ No additional AE; Physician calling to report that a dose of GARDASIL 9 was accidently administered to a 18 month old male patient; This spontaneous report was received from a pediatrician and refers to an 18-month-old male. His medical history, concurrent conditions and concomitant therapies were not provided.  On 03-JUL-2024, the patient was accidently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1967338, expiration date: 26-JAN-2026, administered for prophylaxis (anatomical location, strength and route of administration were not provided) (Product administered to patient of inappropriate age). The physician assistant reported, that the patient was doing well. No additional AE, no PQC. No additional information.
Age: 33.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: patient did not report any medical symptoms; Medical Assistant calling to report adverse event regarding PROQUAD.  Medical Assistant stated that a dose of PROQUAD was administered inadvertently to a 33 year old patient today, 7/24/2024.  Medical Assistant stated that this was the first dose of; This spontaneous report was received from a medical assistant referring to a 33-year-old patient of unknown gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 24-JUL-2024, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot # Y006781, expiration date 24-SEP-2025, 0.5 milliliter (route of administration not provided) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Needle issue, No adverse event, Underdose
Clinical narrative: Caller reported no ongoing AEs or hospitalizations./No additional AE; the patient only received half the dose; the needle came off of a VARIVAX while administering the dose to a 15 month old; This spontaneous report was received from a physician via Company representative concerning to a 15-month-old patient of unspecified gender.  The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (manufacturer unknown) (it was unknown whether syringe used was a Company supplied prefilled diluent syringe).   On 25-JUL-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection (dosage regimen, lot #, expiry date, anatomical location and route of administration were not provided) administered as prophylaxis. It was reported that the needle came off while administering the dose (needle issue) and the patient only received half the dose (accidental underdose). No ongoing adverse events (AEs) or hospitalizations were reported (no adverse event). No further information was provided.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: HEP, MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE; the vaccine was reconstituted incorrectly. The MMR-II vial was reconstituted with Heplisav-B instead of sterile diluent.; This spontaneous report was received from Pharmacist and refers to a patient of unspecified age and gender.  The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported.  On 30-JUL-2024, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided); which was reconstituted incorrectly with hepatitis b vaccine rhbsag (yeast) (HEPLISAV B) instead of sterile diluent (Vaccine incorrect diluent used). No additional adverse event.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: POTS (Postural orthostatic tachycardia syndrome); This spontaneous report was received from a Physician and referred to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date at age 11, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, frequency, lot #, expiry date, and route of administration were not provided). On an unknown date at age 12, the patient was vaccinated with the second dose.  On an unknown date, the patient experienced POTS (Postural orthostatic tachycardia syndrome). The outcome of the event POTS (Postural orthostatic tachycardia syndrome) was not reported. The physician confirmed adverse event did not occur immediately after receiving vaccine and did not believe it is related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The reporter considered POTS (Postural orthostatic tachycardia syndrome) to be not related to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; Nurse stated that a 19 year old patient was administered a dose of RECOMBIVAX HB that is recommended for patients greater than 20 years of age on 7/30/2024.; This spontaneous report was received from a nurse and refers to a 19-year-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-JUL-2024, the patient was vaccinated with the first dose of adult formulation (recommended for patients greater than 20 years old of age) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 10 microgram/ 1 ml, intramuscular injection, at a dose of 1 milliliter,  three dose series which was against the recommended dose for a patient in that age group (incorrect product formulation administered), lot #X027441 which had been verified to be a valid lot number, expiration date reported and confirmed as 11-OCT-2026, administered for prophylaxis by a health care professional (route of administration and anatomical location were not provided). It was confirmed that patient had not reported any medical concerns or symptoms after the administration (no adverse event). No additional information provided.