chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Decreased eye contact, Fine motor skill dysfunction, Gait disturbance, Peripheral swelling, Regressive behaviour
Clinical narrative: The whole entire leg from top of the thigh to his foot was swollen, he wore a pair of sweat pants the day after the injection and we had a hard time taking the sweats off of him his leg was so huge. He refused to walk on his leg, only wanted to be held. On 01/08/2015 I did call the Hospital nurse hotline to talk to somebody, his leg was so swollen I didn't know if he needed to be taken to the Emergency Room or not. She said to take him back to the Drs the next day to report the reaction. I did take him back to the office on 01/09/2015 to report the swelling. They said there was nothing to do about it, just give it time and it would go away on its own. It eventually did go away but took 7-10 days for it to completely go away. Also he started doing this thing where he would just stare off into space but he wouldn't hear me, look at me, talk back to me. I would snap my fingers in front of him, try to get his attention and nothing, no response from him. It would last for 30 seconds to a minute and I couldn't get him to snap out of it and come back to me. Then he would start blinking and see me again, after doing more research I know now that what he was having is seizures (staring) due to the 4th dose of the DTaP vaccine. It seemed like he started to regress after this, his fine motor skills were not as keen and his speech was delayed. It seemed like his mind froze for a year or more. As a baby/infant he was taking in so much new information and was learning so quickly and then stopped taking in new information or took it in very slowly. Now going from 3 years old to 4 years old we are working with an occupational therapist and speech therapist and he is VERY slowly starting to write, hold a spoon/fork and we are just now starting to talk more. My intuition and heart know that it was the DTaP vaccine that did this. I'm his mother, even if I can't provide scientific evidence, I just know with my heart, this changed my child.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Seizure, Speech disorder developmental, Staring, Unresponsive to stimuli
Clinical narrative: The whole entire leg from top of the thigh to his foot was swollen, he wore a pair of sweat pants the day after the injection and we had a hard time taking the sweats off of him his leg was so huge. He refused to walk on his leg, only wanted to be held. On 01/08/2015 I did call the Hospital nurse hotline to talk to somebody, his leg was so swollen I didn't know if he needed to be taken to the Emergency Room or not. She said to take him back to the Drs the next day to report the reaction. I did take him back to the office on 01/09/2015 to report the swelling. They said there was nothing to do about it, just give it time and it would go away on its own. It eventually did go away but took 7-10 days for it to completely go away. Also he started doing this thing where he would just stare off into space but he wouldn't hear me, look at me, talk back to me. I would snap my fingers in front of him, try to get his attention and nothing, no response from him. It would last for 30 seconds to a minute and I couldn't get him to snap out of it and come back to me. Then he would start blinking and see me again, after doing more research I know now that what he was having is seizures (staring) due to the 4th dose of the DTaP vaccine. It seemed like he started to regress after this, his fine motor skills were not as keen and his speech was delayed. It seemed like his mind froze for a year or more. As a baby/infant he was taking in so much new information and was learning so quickly and then stopped taking in new information or took it in very slowly. Now going from 3 years old to 4 years old we are working with an occupational therapist and speech therapist and he is VERY slowly starting to write, hold a spoon/fork and we are just now starting to talk more. My intuition and heart know that it was the DTaP vaccine that did this. I'm his mother, even if I can't provide scientific evidence, I just know with my heart, this changed my child.
Age: 26.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Fear of injection, Syncope
Clinical narrative: After administering both immunizations, patient fainted due to fear of needles.
Age: 52.0
Sex: F
Vaccine: TYP
Symptoms: Blood electrolytes, Delirium, Diarrhoea, Dyspepsia, Fatigue
Clinical narrative: Experience growing fatigue over course of oral vaccines (8/16,18,20,22). Started experiencing severe nausea and headache on 8/21. Spiked a fever - temperature unknown - but experienced delirious state. Also experience muscle aches, severe cramps and diarrhea. By Friday (8/25) had developed a mild rash, and also had heartburn and numbness in the face. Went to see my physician on Friday. Unable to sleep much during this period of time. Monday (8/28) doctor prescribed anti-nausea and diarrhea medication. Symptoms seem to be subsiding at this point in time (8/30).
Age: 52.0
Sex: F
Vaccine: TYP
Symptoms: Headache, Insomnia, Muscle spasms, Myalgia, Nausea
Clinical narrative: Experience growing fatigue over course of oral vaccines (8/16,18,20,22). Started experiencing severe nausea and headache on 8/21. Spiked a fever - temperature unknown - but experienced delirious state. Also experience muscle aches, severe cramps and diarrhea. By Friday (8/25) had developed a mild rash, and also had heartburn and numbness in the face. Went to see my physician on Friday. Unable to sleep much during this period of time. Monday (8/28) doctor prescribed anti-nausea and diarrhea medication. Symptoms seem to be subsiding at this point in time (8/30).
Age: 52.0
Sex: F
Vaccine: TYP
Symptoms: Pyrexia, Rash
Clinical narrative: Experience growing fatigue over course of oral vaccines (8/16,18,20,22). Started experiencing severe nausea and headache on 8/21. Spiked a fever - temperature unknown - but experienced delirious state. Also experience muscle aches, severe cramps and diarrhea. By Friday (8/25) had developed a mild rash, and also had heartburn and numbness in the face. Went to see my physician on Friday. Unable to sleep much during this period of time. Monday (8/28) doctor prescribed anti-nausea and diarrhea medication. Symptoms seem to be subsiding at this point in time (8/30).
Age: 36.0
Sex: M
Vaccine: HEPA
Symptoms: Abdominal distension, Diarrhoea, Flatulence, Inflammatory bowel disease
Clinical narrative: I was given the vaccine and a few hours later experienced an inflammatory bowel response which looked like diarrhea, bloating, and gas which is uncommon for me. A bowel movement occured a few hours earlier, around 9am, and was a normal experience. I am unsure what manufacturer produced the vaccination but it was administered by local HHS.
Age: 1.5
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Head banging, Irritability, Mania, Nasal congestion
Clinical narrative: Within 24 hours, child became extremely congested in nose. Difficulty breathing while laying down and sometimes when upright. Engaged in new sensory seeking behaviors like biting, head banging. Irritable and almost manic. Has continued since then.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Hypoacusis, Injection site pain, Muscular weakness, Pallor, Tension
Clinical narrative: Father of child stated child developed sweaty palms prior to vaccine administration because he was worked up over getting shots. Hep A given at 1:15pm. HPV given at 1:16pm. Child was tense during vaccine administration. Complained right shot hurt a lot. I gently massaged right deltoid while talking to child about school. Child then wanted to see how tall he was; got up from chair; stood at the length board; measurement completed. Noted child turned pale; requested he sit down in nearby chair and put his head between his legs; gave him a glass of water and 2 crackers. He took a drink, stated he was fine and stood up. He turned pale; started to get weak at the knees. Father of child and I lowered him to the floor. Requested child lay down; elevated lower extremities. 1:20pm: B/P: 100/52; P: 60; R: 16. Child states our voices are muffled. Continued to lay on the floor for another 10 minutes. Color improved; states voices no longer muffled. 1:30pm: child states he feels fine; assisted to sitting position; drank a glass of water and ate 2 crackers. Assisted to nearby chair. B/P: 108/54; P: 60; R: 16. Child continues to state he is fine. Obtained VAERS information from father. Father and child left office at 1:40pm. Will follow up tomorrow.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Dysgeusia, Dyspnoea, Fatigue, Nausea, Pain
Clinical narrative: As reported by PCP, "Pt stated that within four hour of vaccine, he began to have symptoms of fatigue, nausea, palpitations, shortness of breath, fever, body aches and a metallic taste in mouth. Pt reported that symptoms persisted for 2 days."
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Palpitations, Pyrexia
Clinical narrative: As reported by PCP, "Pt stated that within four hour of vaccine, he began to have symptoms of fatigue, nausea, palpitations, shortness of breath, fever, body aches and a metallic taste in mouth. Pt reported that symptoms persisted for 2 days."
Age: 32.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: ON 8/30/2017 AT 4 AM THE SITE OF INJECTION BEGAN ITCHING. THE INJECTION SITE BECAME RED AND SWOLLEN AROUND 0830. THE ITCHING BEGAN TO SPREAD AND THE SITE OF INJECTION FELT WARM TO TOUCH AROUND 1000. THE SITE OF INJECTION IS CURRENTLY SLIGHTLY PAINFUL 2/10 AT 2PM.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Pyrexia, Skin warm
Clinical narrative: He was sore the first night but last night his arm turned bright red. When he came to the pharmacy today there was a bright red area that was warm to the touch. He also reported a low fever.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a multiple patients of unknown age. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis. Concomitant therapies included sterile diluent. No adverse event. Sender's Comments: US-009507513-1708USA012505: Original Case: 1708USA012451.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. On 28-AUG-2017, the patient was vaccinated with PROQUAD lot # N014759 for prophylaxis. Other suspect therapies included VARIVAX, M049126, 15-DEC-2018 and  sterile diluent for prophylaxis. On 28-AUG-2017, the patient experienced overdose and no adverse event. The outcome of overdose and no adverse event was unknown. The reporter considered overdose to be not related to PROQUAD and VARIVAX. The reporter considered no adverse event to be not related to VARIVAX and PROQUAD.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Started as Red Ring above elbow later yesterday afternoon. As day progressed upper arm completely became red, hot and swollen.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Bursitis, Injection site erythema, Injection site warmth, Limb injury, Musculoskeletal pain
Clinical narrative: Within 24 hours, developed severe shoulder pain, subjective fevers with redness and warmth around the injection site. Pain inhibited sleep. Was treated with NSAIDS and ice. Suspect bursitis or other shoulder injury. Pain is only slowly improved on day 5 after the vaccine.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Within 24 hours, developed severe shoulder pain, subjective fevers with redness and warmth around the injection site. Pain inhibited sleep. Was treated with NSAIDS and ice. Suspect bursitis or other shoulder injury. Pain is only slowly improved on day 5 after the vaccine.
Age: 18.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Underdose
Clinical narrative: Mother brought patient in to have her school vaccinations updated. Per the school form the patient needed; HPV, Meningoccal and Dtap. On said date I administered the 3 vaccinations without incident. On 8/30/17 a billing issues came up for the Dtap vaccination due to the patients age. I consulted with Health dept to confirm which vaccination the patient should have recieved. Per HD patient should have recieved Tdap which is an adult dose vs Dtap which is a pediatric dose. No harm has come to the patient, the vaccination simply is a lower dose and patient does require an adult dose for the vaccination to be effective.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Biopsy bone marrow normal, Immune thrombocytopenic purpura, Increased tendency to bruise, Petechiae, Platelet count decreased
Clinical narrative: She developed thrombocytopenia - platelets dropped from normal of 255k 12/2016 to 115k on 4/26/17, which is a few weeks after the MMRV. Counts have remained between 18k and 50k since then and she has been diagnosed with ITP. She has not had any bleeding, but has had some increased bruising and petechiae.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Thrombocytopenia
Clinical narrative: She developed thrombocytopenia - platelets dropped from normal of 255k 12/2016 to 115k on 4/26/17, which is a few weeks after the MMRV. Counts have remained between 18k and 50k since then and she has been diagnosed with ITP. She has not had any bleeding, but has had some increased bruising and petechiae.
Age: 28.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injection site rash, Lip swelling, Pruritus, Rash
Clinical narrative: Patient called and advised she is itchy and began to have a rash that emanated from her right shoulder today after vaccine injections and has begun to spread to her abdomen and face. Patient was advised to go to the nearest emergency department and to call 911 if she began to have any trouble breathing, which she denied at the time of the call. Speaking in full sentences and without any distress in her voice. Patient went to the ED twice. The first time she received an EPIPEN injection, went home and her lips began to swell so she went back and received a BENADRYL injection, and is resting at home on steroids and oral BENADRYL now.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Hypoaesthesia, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported numbness, pain, redness and swelling in the right arm.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Feeling hot, Visual impairment
Clinical narrative: Patient received the Tdap and Meningitis in the right arm. Reported to troubles.  HPV given in the left arm. Patient reports feeling warm, dizzy and seeing spots. No LOC. Food, Water and cold pack given.  Puts head down on head rest. After 30 minutes patient reports no issues.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Head discomfort, Immediate post-injection reaction, Nausea, Pallor, Skin warm
Clinical narrative: Patient given Hep A #1 dose in the left deltoid. Immediately after giving vaccine patient becomes pale, warm to touch, and reports feeling nauseated. States that his head feels heavy and feels like he can't see. Drink, food and cold pack provided. Encouraged to rest head on arm rest of chair. After 30 minutes of receiving vaccination, patient receives HPV #3.  Becomes pale again but denies N/V. Make patient wait 30 more minutes. Patient verbalizes he's fine after wait.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Visual impairment
Clinical narrative: Patient given Hep A #1 dose in the left deltoid. Immediately after giving vaccine patient becomes pale, warm to touch, and reports feeling nauseated. States that his head feels heavy and feels like he can't see. Drink, food and cold pack provided. Encouraged to rest head on arm rest of chair. After 30 minutes of receiving vaccination, patient receives HPV #3.  Becomes pale again but denies N/V. Make patient wait 30 more minutes. Patient verbalizes he's fine after wait.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: Slight swelling and soreness next day. The next day day after that, swelling increased to size of 16 x 7 cm, raised, hot. Arm very sore and hard to use.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood glucose normal, Body temperature increased, Full blood count normal, Lethargy, Loss of consciousness
Clinical narrative: 15 month old child was brought in urgently by his grandmother for the acute onset of unresponsiveness after collapsing to the floor while she was watching him about 15 minutes prior to being seen. When she received him from his parents earlier this morning, he seem fine except for seeming a little lethargic. He demonstrated mild shaking of his arms but no obvious tonic-clonic movements. He was seen in the office last evening for his routine 15 month exam at which time he appeared well and had a normal exam. He received his PENTACEL and PREVNAR vaccines. In the office today, he appeared unconscious, with slight response to painful stimuli. His temperature was 102.7. He was transported to the ER by ambulance.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: 15 month old child was brought in urgently by his grandmother for the acute onset of unresponsiveness after collapsing to the floor while she was watching him about 15 minutes prior to being seen. When she received him from his parents earlier this morning, he seem fine except for seeming a little lethargic. He demonstrated mild shaking of his arms but no obvious tonic-clonic movements. He was seen in the office last evening for his routine 15 month exam at which time he appeared well and had a normal exam. He received his PENTACEL and PREVNAR vaccines. In the office today, he appeared unconscious, with slight response to painful stimuli. His temperature was 102.7. He was transported to the ER by ambulance.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Adverse reaction
Clinical narrative: Dr.'s office records indicate they failed to properly report administered vaccines causes health department to have inaccurate information and re-vaccinate patient 4 months later thinking he was missing vaccines. As a result he is having more than normal adverse reactions.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Swelling
Clinical narrative: The patient noticed redness and swelling which grew significantly over the two days following receiving the vaccination. She went to her primary care provider and they gave the patient a prescription for a methylprednisolone dose pack to decrease the inflammation. They did not believe there was a secondary infection at this time. The event was brought to our attention immediately after the doctor's appointment today.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Two days after injection patient reported redness, swelling, and itching at the injection site about 2 inches in diameter. She said it got a little worse but then got better.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: The patient called for an appointment complaining of pain, itching, and welts on right deltoid are where the PNEUMOVAX shot was given.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Erythema, Injection site rash, Irritability, Pallor, Peripheral swelling
Clinical narrative: Patient developed rash 33 hours after vaccines were administered. Rash started on bilateral thighs and spread to trunk, arms, and down legs.  No difficulty breathing, vomiting, or diarrhea.  Patient was also fussier than normal, per Mom. Exam in office reassuring except for rash; notable blanching erythematous plaques with areas of confluence on trunk, arms, and legs, as well as swelling of bilateral feet.  Vital signs were reassuring and normal.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Rash, Skin plaque
Clinical narrative: Patient developed rash 33 hours after vaccines were administered. Rash started on bilateral thighs and spread to trunk, arms, and down legs.  No difficulty breathing, vomiting, or diarrhea.  Patient was also fussier than normal, per Mom. Exam in office reassuring except for rash; notable blanching erythematous plaques with areas of confluence on trunk, arms, and legs, as well as swelling of bilateral feet.  Vital signs were reassuring and normal.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Nodule, Peripheral swelling, Skin warm
Clinical narrative: Patient's daughter called and said her mother's arm was red and swollen from the shot she received.  I checked with her again today and she states her mother's arm is not as red but still has a "knot" and it's hot and a little swollen.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingle outbreak on forehead more frequent after vaccine.
Age: 13.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: NO ADVERSE REACTION. BUT THERE IS A HIGH CHANCE THAT THE PATIENT RECEIVED ZOSTAVAX INSTEAD OF VARICELLA. PATIENT DID NOT HAVE AN ADVERSE REACTION.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Vaccination site induration
Clinical narrative: Patient with induration at the site of vaccination as well as redness and warmth over the entire arm above elbow.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Pt reported to us that 3 hours after injection she developed pain and redness at the site. By the next morning she stated her arm was swollen down to her elbow and red and warm. Symptoms resolved after three days. She went out of state after the injection so did not report this to us until 8/28. She did not receive medical attention. She placed ice on it during the three days as she was directed by a friend who was a nurse. When she called us, all symptoms were resolved.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Patient went to medical office, where they stated her the back of her right arm is red, swollen and looks like cellulitis. I will report it to VAERS but I also advised the triage nurse to advise patient to seek urgent care. Nurse verbalized understanding.
Age: 14.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: NO ADVERSE REACTION. BUT THERE IS A HIGH CHANCE PATIENT WAS GIVEN ZOSTAVAX INSTEAD OF VARICELLA NO ADVERSE REACTION.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: PATIENT STATED THAT SHE STARTED FEELING DIZZY, LIGHTHEADEDNESS , AND FAINT AFTER GETTING THE HIGH DOSE FLU SHOT. WE CALLED THE PATIENT'S PCP AND SHE ADVISED US TO RE-CHECK HER BLOOD PRESSURE 30 MIN AFTER THE SHOT AND HAVE HER TAKE A CLONIDINE BEFORE. SHE DIDN'T FEEL BETTER AND HER BLOOD PRESSURE WAS STILL HIGH, SO WE CALLED 911. SHE LEFT THE STORE WITH HER BP ALOT LOWER AND NOT AS DIZZY. SHE WAS TAKEN TO THE HOSPITAL BY THE PARAMEDICS.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Patient presented with significant redness and swelling at the injection site (about 5 inches in diameter) He complained of tenderness. Outcome unknown.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Burning sensation, Dizziness, Headache, Nausea
Clinical narrative: Acute burning rash on stomach and back, severe itching, nausea, light-headedness, all joints ached severely, and headaches.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Acute burning rash on stomach and back, severe itching, nausea, light-headedness, all joints ached severely, and headaches.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt came in to the pharmacy on 8/29 and stated his arm still hurt after his shot on 8/27. He said the shot was very painful and the pain continued to get worse over the next couple days. It hurt to lift his arm. When he was called on 8/30, he stated it was somewhat better, and that it still hurt in the muscle where the shot was given (was questioned about it hurting in his shoulder area but he said no, in the muscle where the shot was given). He was counseled to take anti-inflammatories and put ice on his shoulder and seek medical attention if it did not get better in a couple days.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Pain in extremity, Rash
Clinical narrative: Pain in arm greater than 10 days, rash on shoulder.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Malaise, Nausea, Pallor, Presyncope
Clinical narrative: I give 3 shot to patient by parent request states need for school entry Tdap, HPV, MCV-4 patient was anxious and crying she wait 10 minutes in the room I was printing shots records and after parents and pt walk to the front desk to finish paperwork, patient start telling sick was assisted by RN. Triage for pt found sitting on floor, c/o nausea and syncope observed very pale. Pt's father reports pt assisted to sitting position secondary onset syncope. VS: BP 116/67 T 97.4 HR 46. Pt assisted to triage exam rm, pt cont. c/o dizziness speech clear, not slurred, but answers vague. Started O2 2L mask, pt cont. pale, increased syncope w/near fainting. Pt assisted to prone position w/LE's elevated, O2 increased 6L mask O2 Sat 100%, PCP notified, 911 called. EMT's arrived < 10 min while pt examined by PCP. VSS, HR 107.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Speech disorder, Syncope
Clinical narrative: I give 3 shot to patient by parent request states need for school entry Tdap, HPV, MCV-4 patient was anxious and crying she wait 10 minutes in the room I was printing shots records and after parents and pt walk to the front desk to finish paperwork, patient start telling sick was assisted by RN. Triage for pt found sitting on floor, c/o nausea and syncope observed very pale. Pt's father reports pt assisted to sitting position secondary onset syncope. VS: BP 116/67 T 97.4 HR 46. Pt assisted to triage exam rm, pt cont. c/o dizziness speech clear, not slurred, but answers vague. Started O2 2L mask, pt cont. pale, increased syncope w/near fainting. Pt assisted to prone position w/LE's elevated, O2 increased 6L mask O2 Sat 100%, PCP notified, 911 called. EMT's arrived < 10 min while pt examined by PCP. VSS, HR 107.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO. On 17th August 2017, the patient received the 2nd dose of BEXSERO. On 17th August 2017, less than a day after receiving BEXSERO, the patient experienced injection site erythema. On 18th August 2017, the patient experienced nausea. On an unknown date, the outcome of the injection site erythema and nausea were unknown. It was unknown if the reporter considered the injection site erythema and nausea to be related to BEXSERO. Additional details were provided as follows: The patient reported redness at the injection site and nausea, which began one day after vaccination with BEXSERO. The report was received from the patient's mother. It was reported that, she was not happy that she could not tell her how long nausea lasts and was referred to her healthcare professional.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Asthma, Autoimmune dermatitis, Autonomic nervous system imbalance, Bedridden
Clinical narrative: Patient was never evaluated by our office. Was admitted and evaluated in patient at hospital. 2014 healthy 15 year old girl. Cheerleader, tumble classes, normal social activity and average student. 11/2014 First HPV injection-became dizzy and nauseated within an hour afterward. Called doctor, they said it can happen to get her from school and let her wait it out. 12/2014 Began to complain about leg pain constantly. Missed tumble classes several times that month. 01/2015 First sign of tremors. Was at a New Years' party and dropped food because she couldn't hold it. Humiliated. Started to hide hand tremors due to embarrassment. Received the second injection of the HPV that month. Again it made her sick and very dizzy. Called the doctor and they said it was normal. 06/2015 Received third injection of HPV. Once again, made her feel horrible for two days. Continued to complain of pain and not feeling good throughout the year. Had to stop tumble classes. No energy. Never felt well. Never slept. 07/2015 On family vacation and tremors were very bad. We called her pediatrician and made an appointment for when we returned in the first week of August. 08/2015 First doctor's visit for symptoms. After a very extensive exam, pediatrician very concerned. Referred to a neurologist. 09/2015 First Neuro. appointment. Scheduled a sleep study. Initial diagnosis was Essential Tremor. Normally not showing in a person until after 40 years of age. Neurologist stated that something brought it out early in life. No sign of tremor in mother or father. Sleep study showed Sleep Myoclonus in head. 10/2016 Tremor episodes began daily. Had to stop driving, had to quit job and school. Became a homebound student for remainder of her junior year. Episodes so severe, went to ER and was admitted. After returning home, pain in legs increased. Became confined to bed. Could not walk without assistance. Has to use a wheelchair when going out. 01/2016 Tremor seizure like episodes stopped but leg pain and normal tremors continued. Had to keep increasing meds, which caused a lot of side effects. 03/2017 Diagnosed with Dysautonomia (POTS) by Primary Care Physician. Up to present: Pain is manageable but still all symptoms and randomly has other symptoms and problems arise, acute asthma, rare skin autoimmune disorder and the list goes on. Patient has been a patient of mine for the last two and a half years. Patient has recently been under my care and has been diagnosed with POTS Syndrome and Essential Tremors that began after receiving the GARDASIL shot.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Dizziness, Emotional distress, Essential tremor, Feeling abnormal
Clinical narrative: Patient was never evaluated by our office. Was admitted and evaluated in patient at hospital. 2014 healthy 15 year old girl. Cheerleader, tumble classes, normal social activity and average student. 11/2014 First HPV injection-became dizzy and nauseated within an hour afterward. Called doctor, they said it can happen to get her from school and let her wait it out. 12/2014 Began to complain about leg pain constantly. Missed tumble classes several times that month. 01/2015 First sign of tremors. Was at a New Years' party and dropped food because she couldn't hold it. Humiliated. Started to hide hand tremors due to embarrassment. Received the second injection of the HPV that month. Again it made her sick and very dizzy. Called the doctor and they said it was normal. 06/2015 Received third injection of HPV. Once again, made her feel horrible for two days. Continued to complain of pain and not feeling good throughout the year. Had to stop tumble classes. No energy. Never felt well. Never slept. 07/2015 On family vacation and tremors were very bad. We called her pediatrician and made an appointment for when we returned in the first week of August. 08/2015 First doctor's visit for symptoms. After a very extensive exam, pediatrician very concerned. Referred to a neurologist. 09/2015 First Neuro. appointment. Scheduled a sleep study. Initial diagnosis was Essential Tremor. Normally not showing in a person until after 40 years of age. Neurologist stated that something brought it out early in life. No sign of tremor in mother or father. Sleep study showed Sleep Myoclonus in head. 10/2016 Tremor episodes began daily. Had to stop driving, had to quit job and school. Became a homebound student for remainder of her junior year. Episodes so severe, went to ER and was admitted. After returning home, pain in legs increased. Became confined to bed. Could not walk without assistance. Has to use a wheelchair when going out. 01/2016 Tremor seizure like episodes stopped but leg pain and normal tremors continued. Had to keep increasing meds, which caused a lot of side effects. 03/2017 Diagnosed with Dysautonomia (POTS) by Primary Care Physician. Up to present: Pain is manageable but still all symptoms and randomly has other symptoms and problems arise, acute asthma, rare skin autoimmune disorder and the list goes on. Patient has been a patient of mine for the last two and a half years. Patient has recently been under my care and has been diagnosed with POTS Syndrome and Essential Tremors that began after receiving the GARDASIL shot.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Impaired driving ability, Impaired work ability, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Patient was never evaluated by our office. Was admitted and evaluated in patient at hospital. 2014 healthy 15 year old girl. Cheerleader, tumble classes, normal social activity and average student. 11/2014 First HPV injection-became dizzy and nauseated within an hour afterward. Called doctor, they said it can happen to get her from school and let her wait it out. 12/2014 Began to complain about leg pain constantly. Missed tumble classes several times that month. 01/2015 First sign of tremors. Was at a New Years' party and dropped food because she couldn't hold it. Humiliated. Started to hide hand tremors due to embarrassment. Received the second injection of the HPV that month. Again it made her sick and very dizzy. Called the doctor and they said it was normal. 06/2015 Received third injection of HPV. Once again, made her feel horrible for two days. Continued to complain of pain and not feeling good throughout the year. Had to stop tumble classes. No energy. Never felt well. Never slept. 07/2015 On family vacation and tremors were very bad. We called her pediatrician and made an appointment for when we returned in the first week of August. 08/2015 First doctor's visit for symptoms. After a very extensive exam, pediatrician very concerned. Referred to a neurologist. 09/2015 First Neuro. appointment. Scheduled a sleep study. Initial diagnosis was Essential Tremor. Normally not showing in a person until after 40 years of age. Neurologist stated that something brought it out early in life. No sign of tremor in mother or father. Sleep study showed Sleep Myoclonus in head. 10/2016 Tremor episodes began daily. Had to stop driving, had to quit job and school. Became a homebound student for remainder of her junior year. Episodes so severe, went to ER and was admitted. After returning home, pain in legs increased. Became confined to bed. Could not walk without assistance. Has to use a wheelchair when going out. 01/2016 Tremor seizure like episodes stopped but leg pain and normal tremors continued. Had to keep increasing meds, which caused a lot of side effects. 03/2017 Diagnosed with Dysautonomia (POTS) by Primary Care Physician. Up to present: Pain is manageable but still all symptoms and randomly has other symptoms and problems arise, acute asthma, rare skin autoimmune disorder and the list goes on. Patient has been a patient of mine for the last two and a half years. Patient has recently been under my care and has been diagnosed with POTS Syndrome and Essential Tremors that began after receiving the GARDASIL shot.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Malaise, Myoclonus, Nausea, Pain in extremity, Postural orthostatic tachycardia syndrome
Clinical narrative: Patient was never evaluated by our office. Was admitted and evaluated in patient at hospital. 2014 healthy 15 year old girl. Cheerleader, tumble classes, normal social activity and average student. 11/2014 First HPV injection-became dizzy and nauseated within an hour afterward. Called doctor, they said it can happen to get her from school and let her wait it out. 12/2014 Began to complain about leg pain constantly. Missed tumble classes several times that month. 01/2015 First sign of tremors. Was at a New Years' party and dropped food because she couldn't hold it. Humiliated. Started to hide hand tremors due to embarrassment. Received the second injection of the HPV that month. Again it made her sick and very dizzy. Called the doctor and they said it was normal. 06/2015 Received third injection of HPV. Once again, made her feel horrible for two days. Continued to complain of pain and not feeling good throughout the year. Had to stop tumble classes. No energy. Never felt well. Never slept. 07/2015 On family vacation and tremors were very bad. We called her pediatrician and made an appointment for when we returned in the first week of August. 08/2015 First doctor's visit for symptoms. After a very extensive exam, pediatrician very concerned. Referred to a neurologist. 09/2015 First Neuro. appointment. Scheduled a sleep study. Initial diagnosis was Essential Tremor. Normally not showing in a person until after 40 years of age. Neurologist stated that something brought it out early in life. No sign of tremor in mother or father. Sleep study showed Sleep Myoclonus in head. 10/2016 Tremor episodes began daily. Had to stop driving, had to quit job and school. Became a homebound student for remainder of her junior year. Episodes so severe, went to ER and was admitted. After returning home, pain in legs increased. Became confined to bed. Could not walk without assistance. Has to use a wheelchair when going out. 01/2016 Tremor seizure like episodes stopped but leg pain and normal tremors continued. Had to keep increasing meds, which caused a lot of side effects. 03/2017 Diagnosed with Dysautonomia (POTS) by Primary Care Physician. Up to present: Pain is manageable but still all symptoms and randomly has other symptoms and problems arise, acute asthma, rare skin autoimmune disorder and the list goes on. Patient has been a patient of mine for the last two and a half years. Patient has recently been under my care and has been diagnosed with POTS Syndrome and Essential Tremors that began after receiving the GARDASIL shot.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Seizure like phenomena, Sleep study abnormal, Tremor, Wheelchair user
Clinical narrative: Patient was never evaluated by our office. Was admitted and evaluated in patient at hospital. 2014 healthy 15 year old girl. Cheerleader, tumble classes, normal social activity and average student. 11/2014 First HPV injection-became dizzy and nauseated within an hour afterward. Called doctor, they said it can happen to get her from school and let her wait it out. 12/2014 Began to complain about leg pain constantly. Missed tumble classes several times that month. 01/2015 First sign of tremors. Was at a New Years' party and dropped food because she couldn't hold it. Humiliated. Started to hide hand tremors due to embarrassment. Received the second injection of the HPV that month. Again it made her sick and very dizzy. Called the doctor and they said it was normal. 06/2015 Received third injection of HPV. Once again, made her feel horrible for two days. Continued to complain of pain and not feeling good throughout the year. Had to stop tumble classes. No energy. Never felt well. Never slept. 07/2015 On family vacation and tremors were very bad. We called her pediatrician and made an appointment for when we returned in the first week of August. 08/2015 First doctor's visit for symptoms. After a very extensive exam, pediatrician very concerned. Referred to a neurologist. 09/2015 First Neuro. appointment. Scheduled a sleep study. Initial diagnosis was Essential Tremor. Normally not showing in a person until after 40 years of age. Neurologist stated that something brought it out early in life. No sign of tremor in mother or father. Sleep study showed Sleep Myoclonus in head. 10/2016 Tremor episodes began daily. Had to stop driving, had to quit job and school. Became a homebound student for remainder of her junior year. Episodes so severe, went to ER and was admitted. After returning home, pain in legs increased. Became confined to bed. Could not walk without assistance. Has to use a wheelchair when going out. 01/2016 Tremor seizure like episodes stopped but leg pain and normal tremors continued. Had to keep increasing meds, which caused a lot of side effects. 03/2017 Diagnosed with Dysautonomia (POTS) by Primary Care Physician. Up to present: Pain is manageable but still all symptoms and randomly has other symptoms and problems arise, acute asthma, rare skin autoimmune disorder and the list goes on. Patient has been a patient of mine for the last two and a half years. Patient has recently been under my care and has been diagnosed with POTS Syndrome and Essential Tremors that began after receiving the GARDASIL shot.
Age: 0.33
Sex: F
Vaccine: HIBV, HIBV
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Sex: U
Vaccine: MNQ
Symptoms: Pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in a patient who received MENVEO. On an unknown date, the patient received MENVEO at an unknown dose. On an unknown date, unknown after receiving MENVEO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to MENVEO. Additional details were provided as follows: The reporter stated that, the patient had been offered a Medical Science Liaison (MSL) address safety concerns. This case has been linked to the US2017GSK132045 and US2017GSK132046 reported by the same reporter.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pruritus, Pyrexia, Rash generalised, Rash maculo-papular, Streptococcus test negative
Clinical narrative: The next day after vaccine administration, patient had fever of 103 F. He then broke out in a full body rash (diffuse maculopapular) 3 days after vaccine administration. (+) Pruritus. Office visits 4/3/17-UA, rapid strep were negative. Rx'd Prednisone and BENADRYL. 4/5/17-50% improvement in rash Rx'd CLARITIN x1 mo. 4/19/17-Doing well, no residual symptoms.
Age: 0.67
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration
Clinical narrative: A black mark was left at injection site after giving HIBERIX.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site, approx 2 days after receiving vaccine. 8 inch band around arm.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Product preparation error
Clinical narrative: The diluent given but not the actual vaccine of the MENVEO.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb mass
Clinical narrative: I had a shingles vaccination on Thursday 24th in my left arm - on Sunday 27th I noticed a significant lump on my right hand forearm - there is no associated pain, and the lump is still on my arm today (28th).
Age: 1.33
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: 5 x 2 local red warm tender area around vaccine site DTaP (L) thigh given yest. 8/28/17. Onset last night worse today.
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Tdap vac. 8-25 - L deltoid now red swollen area 8 cm x 8 cm. TTP and warm. Afeb. Tx-ADVIL; ZYRTEC; Cold comp
Age: 24.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Student reports having slight fever 1 day after vaccine. Then redness, pain, and warmth at site of injection 3 days after injection.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Crying, Dyskinesia, Emotional distress, Fall, Loss of consciousness
Clinical narrative: Vaccine adm. 8/20/17, 04:15 PM in right arm. Patient was standing while Dad was holding. Patient started to cry/shake (was afraid) while wiping site with alcohol pad. Shaking increased when wiping was completed and syringe was picked up for adm. Dad held tightly injection completed using a 5/8" needle (small arm). Patient was shaking and crying then Dad let go. He was very upset, crying then fell to the floor his eyes remained open and he had muscle tightness. We continued to talk to him. Patient appeared to lose consciousness for about 2 seconds and doesn't remember falling. Patient recovered and remained in store about 15 minutes. Appeared fine. (Possible seizure ?? parent observation) (syncope with muscle stiffness/jerk RPh. observation).
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Muscle tightness, Musculoskeletal stiffness, Syncope, Tremor
Clinical narrative: Vaccine adm. 8/20/17, 04:15 PM in right arm. Patient was standing while Dad was holding. Patient started to cry/shake (was afraid) while wiping site with alcohol pad. Shaking increased when wiping was completed and syringe was picked up for adm. Dad held tightly injection completed using a 5/8" needle (small arm). Patient was shaking and crying then Dad let go. He was very upset, crying then fell to the floor his eyes remained open and he had muscle tightness. We continued to talk to him. Patient appeared to lose consciousness for about 2 seconds and doesn't remember falling. Patient recovered and remained in store about 15 minutes. Appeared fine. (Possible seizure ?? parent observation) (syncope with muscle stiffness/jerk RPh. observation).
Age: 61.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema
Clinical narrative: Pt had redness extending down arm below injection site.
Age: 0.92
Sex: F
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Tremor, Wheezing
Clinical narrative: Approximately 15 minutes after the vaccines were administered the child's mouth started shaking and the child started wheezing.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site, 1.5 cm oval area, non-tender to light touch, no loss of ROM.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Red, very swelled upper arm surrounding injection site, with pain radiating in back. Area very warm.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Chills, Fatigue, Injection site swelling, Injection site warmth
Clinical narrative: Complaint of warmth and swelling of right upper arm, chills and fever, increased fatigue. Treated for cellulitis on 8-23-17 with AUGMENTIN.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Complaint of warmth and swelling of right upper arm, chills and fever, increased fatigue. Treated for cellulitis on 8-23-17 with AUGMENTIN.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Complaints of redness/tenderness/swelling/warmth to left upper arm, fatigue and nausea. Cellulitis - treated with AUGMENTIN.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Nausea
Clinical narrative: Complaints of redness/tenderness/swelling/warmth to left upper arm, fatigue and nausea. Cellulitis - treated with AUGMENTIN.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Day 2 had quarter size redness increasing to softball size redness and swelling. Typical reaction in 20% of patients. MD told pt that it was cellulitis and started BACTRIM DS.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Presyncope
Clinical narrative: Near syncope after MCV4P and HPV vaccine.