chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Menactra administered to pregnant patient/no AE symptoms; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a non-health professional.   This case involves a 16 years old female patient who was exposed to vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] while she was pregnant.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Menactra administered to pregnant patient/no AE symptoms occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date is 02-Feb-2020.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy was reported.   On 25-Jun-2019, the patient received a 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6207AA via intramuscular route in the left deltoid.  Patient did not experience any adverse event.  Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as Unknown and fetal outcome was reported as Unknown.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Chest X-ray normal, Dysphagia, Dyspnoea, Hypersensitivity, Malaise
Clinical narrative: General malaise, low grade fever the night of the 7th, woke up on the 9th and was having trouble breathing and swallowing, she was taken to the ER.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: General malaise, low grade fever the night of the 7th, woke up on the 9th and was having trouble breathing and swallowing, she was taken to the ER.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Pt received 2nd Shingrix vaccine on 7/19/19. On 7/20/19 developed rash on arms and trunk. The pt also had a fever. The pt was seen in the office by Dr on 7/22/19. He determined the rash and fever were from the Shingrix vaccine. When the pt received her first Shingrix vaccine on 5/4/19 she ended up with pain and rash under her breast. She was seen in our office by NP on 5/6/19. NP stated it was contact dermatitis.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient came in 11 days after immunization and said her arm was "so sore she couldn't lift it" and it started swelling and burning immediately after immunization. She went to her PCP who said it was warm and swollen. We did not witness the swelling and warmness as it was now gone. Patient still complains of severe soreness at this time. PCP told patient to take ibuprofen and use ice.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Patient came in 11 days after immunization and said her arm was "so sore she couldn't lift it" and it started swelling and burning immediately after immunization. She went to her PCP who said it was warm and swollen. We did not witness the swelling and warmness as it was now gone. Patient still complains of severe soreness at this time. PCP told patient to take ibuprofen and use ice.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site oedema, Oropharyngeal pain, Pain in extremity, Pruritus
Clinical narrative: Per patient "excruciating" pain in arm 3 hours post administration.  + Edema at injections site.   + fever.  Reported 100.0 F fever despite taking acetaminophen.   Reported fever broke on 8/11/19.   She reported sore throat on left side on Sunday. 8/12/19:  she reports edema resolved.  Fever is resolved.   She reports 3 red, raised areas on her legs that are itchy.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Per patient "excruciating" pain in arm 3 hours post administration.  + Edema at injections site.   + fever.  Reported 100.0 F fever despite taking acetaminophen.   Reported fever broke on 8/11/19.   She reported sore throat on left side on Sunday. 8/12/19:  she reports edema resolved.  Fever is resolved.   She reports 3 red, raised areas on her legs that are itchy.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Headache, Malaise, Pyrexia
Clinical narrative: Per patient "excruciating" pain in arm 3 hours post administration.  + Edema at injections site.   + fever.  Reported 100.0 F fever despite taking acetaminophen.   Reported fever broke on 8/11/19.   She reported sore throat on left side on Sunday. 8/12/19:  she reports edema resolved.  Fever is resolved.   She reports 3 red, raised areas on her legs that are itchy.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 2 y/o girl with hx of allergic rhinitis who was update inmunized yesterday who developed erythema, swelling and tenderness over left thigh area reason for which was brought for evaluation
Age: 42.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: per pt states red hard, warm to the touch and itchy at the site of injection. Prednisone 20mg tab- take 1 po bid with food Diphenhydramine 25mg cap- Take 1 cap po qd 6-8 hrs prn
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: swollen under arm lymph nodes
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Patient is 45 y/o. Based on lot number she received a pediatric dose in error, not the reccomended/needed adult dose.
Age: 56.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Influenza like illness, Injection site rash, Peripheral swelling
Clinical narrative: Developed rash around injection site. Patient's arm swelled and flu-like symptoms. Patient went to ER for treatment.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain, Pyrexia
Clinical narrative: HIGH TEMPERATURE (2 DEGREES HIGHER THAN PATIENT NORMAL). IT WAS 100.6 DEGREES FOR 2 DAYS  ATARTING DAY AFTER VACCINE ADMINISTRATION.  ALSO HAD SORE LYMPH NODES UNDER  ARMS.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Feeling abnormal, Lethargy, Pain
Clinical narrative: Eight hours after the vaccine, I had diarrhea.  Three hours later, I was vomiting.  Three hours after that, I had aches, pains, stomach pains, and lethargy.  By that night, I was trying to drink water, and take clear broth.  The next day, I still felt bad, but was able to drink some tea and eat bland foods.  Within about 40 hours of the vaccine, I started feeling alright.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC13
Symptoms: Diarrhoea, Pyrexia, Rash, Rash erythematous
Clinical narrative: fever, red rash head to toe, diarrhea
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Headache, Hot flush
Clinical narrative: Employee state she felt hot flashes, diarrhea and headache. Removed from working area, increased oral fluid ,self-care recommended. Diarrhea  and OTC medications recommended. Employee state diarrhea and hot flashes are gone but still complain of headache.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Balance disorder, Chest pain, Coordination abnormal, Fatigue, Feeling abnormal
Clinical narrative: Moments following receiving the vaccination, I stated that I really didn?t feel well and then proceeded to have lose consciousness (vasovagal syncope). Less than a year later I became very sick with neurological health issues (I had brain fog 24/7, nausea, weight loss, chest pain, erratic heart rate - it would get very low and then jump very high, I continued to have episodes of syncope, could barely walk for many months - my neurologist describes it as my muscles wouldn?t coordinate to walk properly, headaches, pain all throughout my body, arms would go numb, my body would sway when I was trying to stand still, I would have episodes of my head and neck falling in a direction and being unable to lift it, exhaustion and many other symptoms. These persisted for 2 years and the only way I got better was through treatment with a functional neurologist. I feel that the neurological health issues are in the background of my health for the  most part until I or my body becomes stressed. Which happens about once a month or so considering stress and stressors are a part of everyone?s life, mine included. So basically I live with the remnants of this and expect myself to for the rest of my life at this point. I feel the neurological symptoms are linked to the vaccine reaction/injury because I never experienced a time of losing consciousness in my entire life until I received the menactra vaccine, and syncope is one of the neurological symptoms I experience.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Gait disturbance, Headache, Heart rate decreased, Heart rate increased, Hypoaesthesia
Clinical narrative: Moments following receiving the vaccination, I stated that I really didn?t feel well and then proceeded to have lose consciousness (vasovagal syncope). Less than a year later I became very sick with neurological health issues (I had brain fog 24/7, nausea, weight loss, chest pain, erratic heart rate - it would get very low and then jump very high, I continued to have episodes of syncope, could barely walk for many months - my neurologist describes it as my muscles wouldn?t coordinate to walk properly, headaches, pain all throughout my body, arms would go numb, my body would sway when I was trying to stand still, I would have episodes of my head and neck falling in a direction and being unable to lift it, exhaustion and many other symptoms. These persisted for 2 years and the only way I got better was through treatment with a functional neurologist. I feel that the neurological health issues are in the background of my health for the  most part until I or my body becomes stressed. Which happens about once a month or so considering stress and stressors are a part of everyone?s life, mine included. So basically I live with the remnants of this and expect myself to for the rest of my life at this point. I feel the neurological symptoms are linked to the vaccine reaction/injury because I never experienced a time of losing consciousness in my entire life until I received the menactra vaccine, and syncope is one of the neurological symptoms I experience.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Malaise, Nausea, Neurological symptom, Pain
Clinical narrative: Moments following receiving the vaccination, I stated that I really didn?t feel well and then proceeded to have lose consciousness (vasovagal syncope). Less than a year later I became very sick with neurological health issues (I had brain fog 24/7, nausea, weight loss, chest pain, erratic heart rate - it would get very low and then jump very high, I continued to have episodes of syncope, could barely walk for many months - my neurologist describes it as my muscles wouldn?t coordinate to walk properly, headaches, pain all throughout my body, arms would go numb, my body would sway when I was trying to stand still, I would have episodes of my head and neck falling in a direction and being unable to lift it, exhaustion and many other symptoms. These persisted for 2 years and the only way I got better was through treatment with a functional neurologist. I feel that the neurological health issues are in the background of my health for the  most part until I or my body becomes stressed. Which happens about once a month or so considering stress and stressors are a part of everyone?s life, mine included. So basically I live with the remnants of this and expect myself to for the rest of my life at this point. I feel the neurological symptoms are linked to the vaccine reaction/injury because I never experienced a time of losing consciousness in my entire life until I received the menactra vaccine, and syncope is one of the neurological symptoms I experience.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Posture abnormal, Syncope, Weight decreased
Clinical narrative: Moments following receiving the vaccination, I stated that I really didn?t feel well and then proceeded to have lose consciousness (vasovagal syncope). Less than a year later I became very sick with neurological health issues (I had brain fog 24/7, nausea, weight loss, chest pain, erratic heart rate - it would get very low and then jump very high, I continued to have episodes of syncope, could barely walk for many months - my neurologist describes it as my muscles wouldn?t coordinate to walk properly, headaches, pain all throughout my body, arms would go numb, my body would sway when I was trying to stand still, I would have episodes of my head and neck falling in a direction and being unable to lift it, exhaustion and many other symptoms. These persisted for 2 years and the only way I got better was through treatment with a functional neurologist. I feel that the neurological health issues are in the background of my health for the  most part until I or my body becomes stressed. Which happens about once a month or so considering stress and stressors are a part of everyone?s life, mine included. So basically I live with the remnants of this and expect myself to for the rest of my life at this point. I feel the neurological symptoms are linked to the vaccine reaction/injury because I never experienced a time of losing consciousness in my entire life until I received the menactra vaccine, and syncope is one of the neurological symptoms I experience.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Papule, Rash, Rash pustular
Clinical narrative: Start to have extreme chills the night of immunization. Pt states extreme fatigue for 1 month and developed a rash on both lower extremities. Pt states after scratching one leg it developed into open pustule and now after 3 months started to develop papules near eye and ear.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Patient received the Shingrix vaccine, and approximately at 12 hours later, she developed red lumps around the injection site. Since then, it has gotten worse to a section of her upper left arm is now itching, inflamed, and very warm to touch. The patient is not in pain other than the site itching. She is also not experiencing a fever. She has used cortisone cream for the itching.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Fatigue, Headache, Myalgia
Clinical narrative: Sore arm and head first 6-8 hours  Myalgia major muscles, headache - head and through eyes, chills, tired
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm and head first 6-8 hours  Myalgia major muscles, headache - head and through eyes, chills, tired
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Hard lump became apparent the day after the injection. Lump and surrounding area were red and warm to the touch. Redness and pain receded after 3 days. Lump remains at 7 days, and pain is present if the lump or surrounding area is touched.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: Day1-5 Redness, hard lump size of a half dollar, warm to the touch, very painful to the touch Day 6 large raised rash like redness 2? wide by 2? high, all around injection site.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: Day1-5 Redness, hard lump size of a half dollar, warm to the touch, very painful to the touch Day 6 large raised rash like redness 2? wide by 2? high, all around injection site.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Confusional state, Headache, Pallor, Presyncope
Clinical narrative: Patient felt ok for a few minutes and then suddenly she turned white as a ghost and started screaming about her head hurting and nearly passed out.  I grabbed onto her as she was screaming and she projectile vomited all over herself and the floor.  She vomited one more time and said she was going to pass out so I quickly laid her down on a lunch table bench and lifted her feet above her heart.  She stayed very pale for 30 minutes and seemed extremely confused.  She said things that didn't make sense at all when she would speak.  I finally was able to get her home where I continued to monitor her as she laid in the living room unable to hold anything down.  She had severe child's and needed to be wrapped in blankets to keep warm.
Age: 5.0
Sex: F
Vaccine: UNK
Symptoms: Screaming, Vomiting projectile
Clinical narrative: Patient felt ok for a few minutes and then suddenly she turned white as a ghost and started screaming about her head hurting and nearly passed out.  I grabbed onto her as she was screaming and she projectile vomited all over herself and the floor.  She vomited one more time and said she was going to pass out so I quickly laid her down on a lunch table bench and lifted her feet above her heart.  She stayed very pale for 30 minutes and seemed extremely confused.  She said things that didn't make sense at all when she would speak.  I finally was able to get her home where I continued to monitor her as she laid in the living room unable to hold anything down.  She had severe child's and needed to be wrapped in blankets to keep warm.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: After giving the patient a Shingrix shot that he asked about getting, I saw that the patient, had already gotten 2 shingrix. I called him a few days later and he said he had no problems. Some got 3 shingrix doses
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling cold, Headache, Insomnia
Clinical narrative: Shivering on a hot night - 10:00 pm unable to get warm although body skin hot, hands like ice loss of energy, headache  unable to sleep, called advice nurse at 6:30 a.m.  slept, no energy for 3 days
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral coldness, Skin warm
Clinical narrative: Shivering on a hot night - 10:00 pm unable to get warm although body skin hot, hands like ice loss of energy, headache  unable to sleep, called advice nurse at 6:30 a.m.  slept, no energy for 3 days
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Unevaluable event
Clinical narrative: Pt received MMRV and DTAP-IPV Monday 7-29. Returned to clinic on Wednesday 7/31. Rt upper arm @ injection sites. Referred to physician. Mom said she would take to local physician
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Heart rate increased, Vitreous floaters
Clinical narrative: Patient was given dose 2 of Shingrix in left arm. She reported no illness or adverse reaction to dose one, she returned to the pharmacy approximately 15-20 min after the shot reporting floaters in the periphery of her right eye. She also reported feeling like she was going to faint and rapid heart rate. I had her remain seated and gave her a bottle of orange juice. The patient reported only having toast this morning. She declined needing 911 and I sat with her for observation until she was confident with getting up and walking around. An employee who is a Tech here and also family walked her around outside to get fresh air. Her husband arrived and by this time the patient was feeling almost all the way normal. I called and informed her PCP of reported adverse reaction on 6-12-2019 at 3:00, I have tried to follow up with the patient several times today but I have been unsuccessful contacting them. I will continue to call patient in hopes to confirm she has had no further reactions and is fully recovered.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: Patient came into office 8/9/19 at 345pm for the varicella vaccine per Dr Patient at 4pm went stiff & turned pale per mom 911 was called v/s done prior to EMS 99% RA 53 bpm
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Red, hot, swollen and a hard lump at  injection sites 3 to 4 inches in diameter in  left arm. Same on right arm but 5 inches  in diameter.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pyrexia, Skin warm, Swelling
Clinical narrative: Swelling, raised area 6x5 hot to the touch, "felt sick" fever.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Peripheral swelling
Clinical narrative: Swelling Lt arm
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Chills, Fatigue, Feeling hot
Clinical narrative: Several hours of extreme chills, which occurred within 6 hours of receiving shot, followed by fever for about 4 hours. Now, the following day, am experiencing weakness, tiredness, some muscle discomfort and off and on chills and overheating and some stomach pain.
Sex: M
Vaccine: VARZOS
Symptoms: Muscle discomfort, Pyrexia
Clinical narrative: Several hours of extreme chills, which occurred within 6 hours of receiving shot, followed by fever for about 4 hours. Now, the following day, am experiencing weakness, tiredness, some muscle discomfort and off and on chills and overheating and some stomach pain.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Blood test, Feeling abnormal, Feeling of body temperature change, Laboratory test
Clinical narrative: I went to my doctor on July 9 appointment time was around 10:15 am She said it was time for my neumoccal shot I told her I had one in January & the flue shot She said I needed this pneumococcal polysaccharide vaccine so she gave it to me. I was ok when I left her office around about 10:30 AM that day around about twenty minnuts later I started not feeling right I was starting not to see to good and could not talk to good I went to pay my phone bill & my electric bill. The girl at the window could unstand what I was saying I told here that I would pray to God so he wold help me get home So when I got home I was shaking all over plus I was fezzing and buring up at same time. I felt like Ice water was running all over me. I thought that I was dieing. So I manged to call 911. They could not unstand what I was saying our could not make out while I lived. I cant harley rember all of what happen to me You can see from my writting and spelling is not very good now. I am still very weak and cant see to good, and I am hurting real bad. I cant harley tell you everthing right now. All I know this shot really did a number on me. Dont wont it every again. I cant harley think right now I am sorry for taking so long to finish all of the questions I am tring to remember everthing I have had other adverse event to other shots Dont know if I am spelling them right
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Speech disorder, Thinking abnormal, Tremor, Visual impairment
Clinical narrative: I went to my doctor on July 9 appointment time was around 10:15 am She said it was time for my neumoccal shot I told her I had one in January & the flue shot She said I needed this pneumococcal polysaccharide vaccine so she gave it to me. I was ok when I left her office around about 10:30 AM that day around about twenty minnuts later I started not feeling right I was starting not to see to good and could not talk to good I went to pay my phone bill & my electric bill. The girl at the window could unstand what I was saying I told here that I would pray to God so he wold help me get home So when I got home I was shaking all over plus I was fezzing and buring up at same time. I felt like Ice water was running all over me. I thought that I was dieing. So I manged to call 911. They could not unstand what I was saying our could not make out while I lived. I cant harley rember all of what happen to me You can see from my writting and spelling is not very good now. I am still very weak and cant see to good, and I am hurting real bad. I cant harley tell you everthing right now. All I know this shot really did a number on me. Dont wont it every again. I cant harley think right now I am sorry for taking so long to finish all of the questions I am tring to remember everthing I have had other adverse event to other shots Dont know if I am spelling them right
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Received the Recombinant shot and that night had very severe headache for 36 hours chills and tiredness. Also very sore and red at injection site. Still sore and red at injection site
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash vesicular, Scab
Clinical narrative: I had the Shingrix vaccine on 8/5/19. On 8/10/19, I developed a chicken-pox like rash across the back of both shoulders. They were in a thin strip all the way across from one shoulder to the other. They were tiny little bumps that turned scabby over night. They were very itchy. I took antihistamines which helped.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Nausea
Clinical narrative: Two hours after vaccination - very sick, nausea + flu like symptoms for 30 hours (in bed)  I had to pay $163.09 out of pocket because my insurance would not cover SHiNGRiX shot. I am suppose to have another shot and another $163.09 for the follow-up shot. I am afraid to do it. I have insurance. Not happy.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea, Pyrexia, Vomiting projectile
Clinical narrative: At 8pm day of the vaccine patient starting running low grade fever (100.5) and had a headache and nausea. At 5am 7/11/19 she started projectile vomiting. Her mom gave her Phenergan and it helped until 8am when she woke up and continued to projectile vomit. She still had the headache. Mom said she could not stop the vomiting. She called to ask us about side effects and we discussed them, but hers were not just mild problems. Mom was concerned about her becoming dehydrated. She took her to the E.R where they gave her fluids, Zofran and put her on a clear liquid diet for a day. The next day she was feeling better.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Dizziness, headache
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness + arm swelling starting the day after vaccination
Age: 21.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, Syncope
Clinical narrative: Shot Given + 5 min after given, pt had LOC witnessed with jerky movement of extremities. Pt then stood + collapsed while walking. Remained dizzy after she was arousable.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hallucination, visual
Clinical narrative: visual hallucinations following Shingrix vaccine
Age: 17.0
Sex: M
Vaccine: HEPA, IPV, MENB, MMR, MNQ
Symptoms: Grunting, Hyperhidrosis, Pallor, Presyncope, Somnolence
Clinical narrative: Had a vasoresponse after receiving Hepatitis A, MCV4, MenB, IPV, and MMR. On August 6th, 2019. He became extremely diaphoretic, extremely pale, made grunting noises, blurry vision, vomiting. Very difficult to wake up. Blood pressure at 1155AM- 98/48. Constantly stimulating to keep awake. - Placed on floor and elevate feet. Color instantly returned. He ate a cookie and without difficulty. Declined water - and stated he felt like himself. B/P 102/60 when left clinic at 1215 pm.
Age: 17.0
Sex: M
Vaccine: HEPA, IPV, MENB, MMR, MNQ
Symptoms: Vision blurred, Vomiting
Clinical narrative: Had a vasoresponse after receiving Hepatitis A, MCV4, MenB, IPV, and MMR. On August 6th, 2019. He became extremely diaphoretic, extremely pale, made grunting noises, blurry vision, vomiting. Very difficult to wake up. Blood pressure at 1155AM- 98/48. Constantly stimulating to keep awake. - Placed on floor and elevate feet. Color instantly returned. He ate a cookie and without difficulty. Declined water - and stated he felt like himself. B/P 102/60 when left clinic at 1215 pm.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Hives to left arm, chest, neck, upper back given children's chewable claritin while at office. Pt was monitored for 1 hr 30mins.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain in extremity
Clinical narrative: 3" area around inj site red, hot, hard. PAIN IN RT. ARM - STILL THE SAME 3 DAYS AFTER INJ. ADM. ALTHOUGH SYMPTOMS REDUCED
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: PATIENT STATED THAT WHEN SHE LEFT PHARMACY AND WAS ON THE WAY HOME, HER VISION IN HER LEFT EYE WHEN COMPLETELY BRIGHT WHITE. THE SYMPTOMS OCCURED AFTER ABOUT 30 MINUTES AND LASTED FOR SEVERAL WEEKS.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Body temperature, Rash
Clinical narrative: SYMPTOMS: Rash on face, arms, and legs that lasted from friday to sunday after immunizations were given. Pt had temp on friday and saturday.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Patient claimed got sore at the injection site the first day and next day red and inflamed and it kept on increasing the size. The patient called me on Sunday evening, recommended take Benadryl and if still no relief to go the Prescriber
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Injection site urticaria; Injection site erythema; njection site swelling; Information was received from the Vaccine Adverse Event Reporting System (VAERS) (Agency Number 796363) concerning a 11 years old female patient. The patient had no other medications or lab date. Information about current illnesses and history prior vaccinations were not provided.  On 15-JAN-2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) dose 1, intramuscular in the left arm for prophylaxis by public (PUB) (lot number R06970). Other suspect therapies included diphtheria toxoid, pertussis acellular 5-component vaccine, tetanus toxoid (ADACEL) and meningococcal acyw conj vaccine (crm197) (MENVEO).      On 16-JAN-2019, the patient experienced injection site erythema, injection site urticaria and injection site swelling. Swelling was reported to left upper arm and red whelps left upper arm. It was reported to health department after school the day following vaccinations.    The outcome of injection site erythema, injection site urticaria and injection site swelling was reported as recovery unknown. The causality assessment between all the event and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) therapy was not provided by the Agency.  Follow-up information was received from a healthcare professional/staff on 03-JUL-2019. The patient was 11 years and 1 month. The patient had no allergies to food, or other products. The patient was not pregnant at the time of vaccination and the patient has none other illnesses at the time of vaccination and up to one month prior. The patient has none chronic or longstanding health conditions. It was reported that the time of vaccination was on 15-JAN-2019 at 11:00 and adverse events occurred on 16-JAN-2019 at 07:00. Information about the facility where the vaccine was given was updated.  Follow up information was received from the health care professional on 09-AUG-2019.  The reporter stated that nothing happened immediately after the vaccination prior the patient leaved the clinic. The reporter did not have enough information about the patient.
Age: 78.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: pain and inflammation left upper arm
Age: 0.17
Sex: M
Vaccine: IPV
Symptoms: Extra dose administered
Clinical narrative: Parent came in reporting that previous facility was "out of the polio vaccine" and she just came in to get the patient his polio vaccine.  After Polio vaccine was given it was discovered in previous records that pt had in fact received the polio vaccine at previous well child visit and was in fact missing the rotavirus vaccine.  Pt was then given rotavax and told to monitor pt for any side effects.
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Antineutrophil cytoplasmic antibody positive
Clinical narrative: no discernible antibody response to pneumococcal vaccine;   This literature marketed report has been received from the authors of a published literature article, and refers to 2 female patients of an unknown age. The retrospective study of 136 patients in antineutrophil cytoplasmic antibodies (ANCA) database was conducted to identify patients with recurrent infections and hypogammaglobinemia who were subsequently treated with the novel subcutaneous IgG SQIG. Of the 136 patients, 4 were treated with SQIG.    On unknown dates, the patients had proteinase 3 (PR3) antibody positive and immunoglobulin (Ig) levels (G and M) were reduced. CD19/20 cells were depleted and CD3/4/8/ natural killer (NK) cells were preserved in all patients.   On unknown dates, the patients were vaccinated with pneumococcal vaccine (manufacturer unknown) (exact dose, route of administration, lot# and expiration date were not provided) for prophylaxis.  On unknown dates, the patients had no discernible antibody response to pneumococcal vaccine (specific pneumococcal serotypes measured pre and post vaccine). The outcome of the event was unknown.  The authors of a published literature article considered the event of no discernible antibody response to pneumococcal vaccine to be related to the suspect vaccine.  A copy of the published article is attached as further documentation of the patients' experience.  This is one of two reports derived from the same literature article (cross referenced with # 1908USA004919).; Sender's Comments:  US-009507513-1908USA004919:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effect reported; the patient was inadvertently administered a  dose of MMR II (Lot#R031636/Exp:11/1/2020)  by the intramuscular route, instead of the subcutaneous route; Information has been received from a medical assistant, referring to a patient of unknown age or gender. Information of concurrent condition, medical history and concomitant therapy was not provided.     On 15-JUL-2019, the patient inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (recombinant Human albumin (rHA)) (strength unknown; lot# R031636 and expiration date 11-JAN-2020) by the intramuscular route, instead of the subcutaneous route for prophylaxis (incorrect route of product administration). No adverse effect reported.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: patient developed swelling "across her shoulders to her shoulder blades"; This spontaneous report was received from a nurse referring to a 41 years old female patient. The patient's medical history included severe asthma. The patient's concomitant therapies included losartan potassium (+) hydrochlorothiazide(HYZAAR); albuterol(manufacture unknown); azathioprine(IMURAN); dupilumab(DUPIXENT); fluticasone furoate(+)vilanterol trifenatate(BREO); mycophenolate sodium(MYFORTIC); prednisone; venlafaxine hydrochloride(EFFEXOR); alprazolam(XANAX). The patient was allergic to levofloxacin (LEVAQUIN). On 03-JUL-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(lot# R031810,expiration date not reported, but upon internal validation established as 02-SEP-2020, intramuscular, dose and location were not reported)for prophylaxis. On the same day the patient developed swelling across her shoulders to her shoulder blades following vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). The patient called physician's office to seek medical attention.There were no treatment or lab diagnostics given for the event. The patient recovered from swelling on 15-JUL-2019. The causality between the event and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Age: 1.67
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported.; a patient received one dose of MMR II on 3/6/2019 and then one dose of VARIVAX on 3/26/2019.; This spontaneous report was received from a nurse referring to a 20 months old patient with unknown gender. Information about medical history and concurrent conditions was not provided. Concomitant therapy included sterile diluent. On 06-MAR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (recombinant Human albumin (rHA)) (lot # R020831, expiration date 19-JUL-2020, dose and route were not reported) for prophylaxis.  On 26-MAR-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R023735, expiration date 20-AUG-2020, dose and route were not reported) for prophylaxis (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1907USA012991:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and/or zoster-related conditions by the pharmacist. On an unspecified date, subsequent to patient's inoculation, the patient was treated by healthcare provider for shingles. The outcome of shingles was not provided. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; Improperly stored; This spontaneous report was received from a physician, referring to a patient of unknown age and gender: The patient's pertinent medical history, drug reactions, allergies, current conditions and concomitant medication were not reported.  On 12-JUN-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (Schedule, route and anatomical location of vaccination were not reported; lot # R035223, expiration date: 04-DEC-2019), as prophylaxis; concomitantly administered with one dose of Merck sterile diluent solution for injection.  According to the physician, the varicella virus vaccine live (oka/merck)(VARIVAX) underwent a temperature excursion of -9 to 8 degrees Celsius (°C) for 15 minutes and from -14 to -10 °C for 4 hours and 45 minutes on that day, which was detected by a digital data logger. No previous temperature excursions were reported. No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient may have been administered an improperly stored GARDASIL 9; This spontaneous report has been received from a registered nurse refers to an 11 years old patient whose gender was not provided. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported.     On 05-AUG-2019, the patient was administered an improperly stored  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9); dose as prophylaxis (number of dose in vaccination scheme), frequency, route and anatomical location of administration were not provided; (lot # 1614897, expiration date:  was reported as 10-JUL-2021, but upon internal validation has been determined as 20-SEP-2021); According to the reporter,  On 05-AUG-2019 the reported said  "a patient may have been administrated an improperly stored" (incorrect product storage); the vaccine was exposed to a temperature excursion below of  36 degress Fahrenheit (°F)/ 2 degress Celsius (°C) (-1.44 °C) for a timeframe of 35 minutes on that day, which was not recorded by a digital data logger. Previous temperature excursions and adverse effects were not reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; improperly stored vaccine was administered to patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in July 2019 (reported as between 03-JUL-2019 and 29-JUL-2019), the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S002393, expiration date 31-JAN-2021 and lot # R035225, expiration date 04-DEC-2020 (dose and route of administration were not reported) for prophylaxis and improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S003178, expiration date reported as 31-JUL-2020, but upon internal validation established as 30-JUL-2020 and lot # S008577, expiration date reported as 30-SEP-2020, but upon internal validation established as 16-SEP-2020 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of total time in range -14 degrees Celsius to -10 degrees Celsius (-12.8 degrees Celsius) for 12 hours 3 minutes. There were no previous excursions reported. The digital data logger was involved.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA000192:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Deafness unilateral, Herpes zoster
Clinical narrative: unilateral sensorineural hearing loss with unrestricted hearing on contralateral side; herpes zoster; This spontaneous report as received from a lawyer regarding a case in litigation and refers to a currently 64 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 14-JAN-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route were not reported) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster and unilateral sensorineural hearing loss with unrestricted hearing on contralateral side. On an unspecified date, the patient was treated by a nurse practitioner for herpes zoster and unilateral sensorineural hearing loss with unrestricted hearing on contralateral side.  The outcome of herpes zoster and unilateral sensorineural hearing loss with unrestricted hearing on contralateral side was unknown.    The reporter considered herpes zoster and unilateral sensorineural hearing loss with unrestricted hearing on contralateral side to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, the event unilateral sensorineural hearing loss with unrestricted hearing on contralateral side was determined to be medically significant.  Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; One patient was administered an improperly stored dose of  M-M-R II; This spontaneous report was received from a Registered Nurse referring to a  4 year old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 19-JUL-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(Strength, route, dose, frequency, and anatomical location were unknown) wit lot # R014355 and expiration date 21-MAY-2020, reconstituted with properly stored sterile diluent.   The administered dose of the vaccine experienced total time and highest temperature above 9°C (9.0°C) Celsius degrees for 65 hours and total time and highest temperature above 9°C (9.0°C) for 63 hours and 15 minutes. min. There was no a digital data logger invloved, and no previous temperature excursion. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Therapeutic response unexpected
Clinical narrative: her regular non-genital warts have cleared up, off of her hands; This spontaneous report was received from a physician who was the female patient of unknown age, via a company representative, reporting on herself. Information regarding the patient's pertinent medical history, concomitant and historical drugs was not provided. The patient's concurrent conditions included non-genital wart.  On an unknown date, the patient was self-vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot # and expiration date were not provided) for Human Papillomavirus (HPV) prophylaxis. On an unknown date, the physician reported that her "regular" non-genital warts had "cleared up, off of her hands".
Sex: F
Vaccine: PNC13, PPV
Symptoms: Wrong product administered
Clinical narrative: caller uses prevnar and pneumovax 23 interchangeably; This spontaneous report was received from a physician via Pfizer refers to a 65 year old female patient. The patient's concurrent condition, medical history and concomitant medications were unknown. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, lot#, expiry date, dosage information, route of administration and anatomical locations were unknown) for prophylaxis interchangeably with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13)  (also reported as "PREVNAR 23") (strength, lot#, expiry date, dosage information, route of administration, anatomical locations and indication were unknown, Wrong product administered). It was reported that the patient was supposed to vaccinated with pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) but she was vaccinated with pneumococcal 13v conj vaccine (PREVNAR 23) by the medical assistant. The outcome of wrong product administered was unknown.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: small rash on back; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 24th May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 25th May 2019, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right arm. After vaccination, the patient experienced rash on back. The patient consented to follow up. This case has been linked with case US2019AMR138425, reported by same reporter.