chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Nausea, Polydipsia, Polyuria, Sleep study, Sphingomonas paucimobilis infection
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Patient was in his usual state of good health prior to Dec 2010. Looking back, patient recalls developing symptoms of hyperglycemia sometime around November 2010 while stationed. He experienced symptoms of polyuria, polydipsia, fatigue, polyphagia and an approximately 15-pound weight loss over -30-day period. Around 10 Dec 2010, patient also began experiencing nausea and vomiting which gradually increased to the point of not being able to keep anything down by 18 Dec and led him to seek evaluation. At that time, a glucose level of 327, positive urine ketones and ketoacidosis led to his diagnosis of T1DM and he was hospitalized in the ICU for 3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG. Since diagnosis, patient has been followed through a local Endocrinologist, as well as local medical providers. Patient received FLUMIST on Oct 2010 and H1N1 vaccine in Aug 2010, and his most recent Anthrax vaccine was received in Dec 2009. He denies any unusual or prolonged reactions within the first week following vaccine receipt. Patient does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Patient does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis of T1DM. Patient reports a history of a glucose in the 200s prior to his arthroscopic knee surgery in late Oct. He denies a previous history of elevated glucose or blood pressure levels or history of hypertension. He was had not been as active over the past year due to knee pain and surgery. He has no family Hx of T1DM."
Age: 23.0
Sex: M
Vaccine: FLUN3
Symptoms: Type 1 diabetes mellitus, Urine ketone body present, Vomiting, Weight decreased
Clinical narrative: This is a verbatim narrative as reported to the FDA VAERS: "Patient was in his usual state of good health prior to Dec 2010. Looking back, patient recalls developing symptoms of hyperglycemia sometime around November 2010 while stationed. He experienced symptoms of polyuria, polydipsia, fatigue, polyphagia and an approximately 15-pound weight loss over -30-day period. Around 10 Dec 2010, patient also began experiencing nausea and vomiting which gradually increased to the point of not being able to keep anything down by 18 Dec and led him to seek evaluation. At that time, a glucose level of 327, positive urine ketones and ketoacidosis led to his diagnosis of T1DM and he was hospitalized in the ICU for 3 days. During his admission, insulin was initiated, as well as diabetes self management training. He was discharged on once daily LANTUS with additional premeal NOVOLOG and supplementation for hyperglycemia using NOVOLOG. Since diagnosis, patient has been followed through a local Endocrinologist, as well as local medical providers. Patient received FLUMIST on Oct 2010 and H1N1 vaccine in Aug 2010, and his most recent Anthrax vaccine was received in Dec 2009. He denies any unusual or prolonged reactions within the first week following vaccine receipt. Patient does not recall any viral-type symptoms just prior to or on the days of vaccine receipt. Patient does not recall a history of infection or symptoms of cough, fever, sinus symptoms, congestion or diarrhea prior to his diagnosis of T1DM. Patient reports a history of a glucose in the 200s prior to his arthroscopic knee surgery in late Oct. He denies a previous history of elevated glucose or blood pressure levels or history of hypertension. He was had not been as active over the past year due to knee pain and surgery. He has no family Hx of T1DM."
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Cataplexy, Fall, Lumbar puncture, Narcolepsy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Patient is an 8 yo F, who presented in Dec 2010 with abrupt increased daytime sleepiness and falling. After a sleep study and work up including MRI and 2 LPs she was diagnosed with narcolepsy and cataplexy. Of note her onset of symptoms were within 2 months of receiving the H1N1 nasal mist vaccine. Patient also has a history ataxia, slurred speech, and uncontrolled bowel movements and urination since December as well as migraines since age 5 1/2 yrs."
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Sleep study abnormal, Somnolence
Clinical narrative: "This is a verbatim narrative as reported to the FDA VAERS:" "Patient is an 8 yo F, who presented in Dec 2010 with abrupt increased daytime sleepiness and falling. After a sleep study and work up including MRI and 2 LPs she was diagnosed with narcolepsy and cataplexy. Of note her onset of symptoms were within 2 months of receiving the H1N1 nasal mist vaccine. Patient also has a history ataxia, slurred speech, and uncontrolled bowel movements and urination since December as well as migraines since age 5 1/2 yrs."
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Speech disorder
Clinical narrative: A non-serious spontaneous report of lisp has been received from a health professional concerning a six-year-old female, subsequent to FLUMIST. The patient's medical history included ear infections. The patient was on no concomitant medications. The patient received FLUMIST on 27-Sep-2011. The patient had a lisping in her talk about three to four hours after receiving FLUMIST. The patient received no other vaccines at the time she got FLUMIST. The patient was treated with diphenhydramine. The patient did not receive any other medical treatment after experiencing the lisp. The outcome of the event of lisp was recovered. Additional information was received on 06-Oct-2011 and incorporated in the narrative; medical history and concomitant medications. Other additional information received was: reporter information. Additional information was received on 28-Oct-2011 and incorporated in the narrative: outcome of the event and treatment of the patient.
Age: 46.0
Sex: F
Vaccine: FLUN3
Symptoms: Accidental exposure, No adverse event
Clinical narrative: A non-serious spontaneous report of squirting of FLUMIST over face and eye was received from a health professional concerning a 46-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 04-Oct-2011, the second half of FLUMIST was squirted on the patient's face and into her eye. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 32.0
Sex: F
Vaccine: FLUN3
Symptoms: Rash, Vomiting
Clinical narrative: A non-serious spontaneous report of FLUMIST was administered to a patient with a mild egg allergy, vomiting and rash on face and neck has been received from a health professional concerning an 32-year-old female, subsequent to FLUMIST. The patient had a history of mild allergy to egg. Concomitant medications have not been reported for this patient. The patient received FLUMIST in Nov 2011. On 11-Nov-2011, the patient had rash on her face and neck and vomiting after receiving FLUMIST. The reporter also reported that although the patient marked that she did not have an allergy on the patient consent form, she indicated on the consent form that she had a mild egg allergy. Reporter stated that she had already reported to VAERS. The outcome of the events FLUMIST was administered to patient with a mild egg allergy was resolved, rash on face and neck and vomiting was unknown.
Age: 14.0
Sex: M
Vaccine: FLUN3
Symptoms: Tic
Clinical narrative: A non-serious spontaneous report of tick [sic] has been received from a registered nurse concerning a 14-year-old male, subsequent to FLUMIST. The patient's medical history included kidney disease. No concomitant medications have been reported for this patient. The patient received FLUMIST on 12-Sep-2011. On 21-Oct-2011, the patient started to get a tic. The outcome of the event tic was unknown.
Age: 49.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Decreased appetite, Exposure to communicable disease, Eye pruritus, Fatigue, Multiple sclerosis
Clinical narrative: Patient - 12/5/1993 (daughter) received varicella vaccine 1/27/2012. Mother changed band-aids/upon daughter return home 1/29/2012 mother noticed rash on chest Weds-Thurs 2/8/12 to back & spread. ? daughter had sm. bumps on neck. 2/13/12 remain with vesicles over entire body. Sm. amt scabbed over; did not seek medical attention. Talked with Merck and filled out ? VAERS.
Age: 49.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Nausea, Ocular hyperaemia, Rash erythematous, Rash maculo-papular, Rash pruritic
Clinical narrative: Patient - 12/5/1993 (daughter) received varicella vaccine 1/27/2012. Mother changed band-aids/upon daughter return home 1/29/2012 mother noticed rash on chest Weds-Thurs 2/8/12 to back & spread. ? daughter had sm. bumps on neck. 2/13/12 remain with vesicles over entire body. Sm. amt scabbed over; did not seek medical attention. Talked with Merck and filled out ? VAERS.
Age: 49.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Scab, Secondary transmission, Varicella
Clinical narrative: Patient - 12/5/1993 (daughter) received varicella vaccine 1/27/2012. Mother changed band-aids/upon daughter return home 1/29/2012 mother noticed rash on chest Weds-Thurs 2/8/12 to back & spread. ? daughter had sm. bumps on neck. 2/13/12 remain with vesicles over entire body. Sm. amt scabbed over; did not seek medical attention. Talked with Merck and filled out ? VAERS.
Age: 49.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Papule, Rash, Scab
Clinical narrative: Patient - 12/5/1993 (daughter) received varicella vaccine 1/27/2012. Mother changed band-aids/upon daughter return home 1/29/2012 mother noticed rash on chest Weds-Thurs 2/8/12 to back & spread. ? daughter had sm. bumps on neck. 2/13/12 remain with vesicles over entire body. Sm. amt scabbed over; did not seek medical attention. Talked with Merck and filled out ? VAERS.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Lethargy, Pyrexia, Rash generalised, Rash vesicular
Clinical narrative: Became lethargic, and spiked a fever about two hours later. Had pox like rash over his body, ongoing to at least the next day.
Age: 10.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Rash erythematous, Rash generalised, Rash macular
Clinical narrative: Child woke up covered with red rash from head to toe.  Some red blotchy areas per dad.
Age: 19.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Rash erythematous, Rash generalised, Rash papular, Rash pruritic, Skin plaque
Clinical narrative: Numerous small scattered erythematous papules, many with vesicles - spread across entire body, pruritic, some coalescing on the hands, and large erythematous almost purple plaques on both heels.
Age: 19.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Rash generalised, Rash papular, Rash pruritic, Rash vesicular, Skin plaque
Clinical narrative: Numerous small scattered erythematous papules, many with vesicles - spread across entire body, pruritic, some coalescing on the hands, and large erythematous almost purple plaques on both heels.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Fatigue, Headache, Night sweats, Oropharyngeal pain
Clinical narrative: Dizziness, Headache, Sore Throat, Night Sweats, Fatigue.
Age: 35.0
Sex: F
Vaccine: TTOX
Symptoms: Rash
Clinical narrative: Rash.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Blindness, Eye movement disorder, Nuclear magnetic resonance imaging brain normal, Visual acuity reduced
Clinical narrative: Pt sitting in waiting room after vaccine administration waiting for Mom. He began to notice the he could not see well to his right side. He then realized that he could not move his eyes to the right. Symptoms continued and he was seen in the office on 7/27/11 pt was then referred to ER for loss of vision where an MRI of Brain was done (Negative) and was later referred to pediatric neurologist and pediatric ophthalmologist.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Rash
Clinical narrative: Pt was given vaccines 2/20/12 & started with a rash a few hours after administration. Rash was on arms & legs. Rash was for two days.
Age: 1.97
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pyrexia
Clinical narrative: 99-101 fever, blisters.
Age: 1.27
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Decreased appetite, Fatigue, Fluid intake reduced, Pyrexia
Clinical narrative: Fever up to 101. Blisters on leg. Not eating/drinking. Fatigue.
Age: 17.0
Sex: M
Vaccine: FLUN3, HEPA, HPV4, MNQ
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: 2 vaccines. Syncope episode in office with some tonic-clonic movements 20-30 seconds sent to ER. Full work up done and released.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Dizziness, Nausea
Clinical narrative: Physician received 1st flu shot ever. He states he experienced dizziness & faintness at 3:30 pm & 5pm developed 100.5 temp, nausea, chills, faintness x 2-3 hrs  then resolved.
Age: 1.02
Sex: F
Vaccine: MMR, PNC13
Symptoms: Pain, Pyrexia, Salivary gland enlargement, White blood cell count increased
Clinical narrative: Swelling of the salivary glands. High fever and white count. Very painful.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ataxia, CSF test normal, Drug screen negative, Hypoaesthesia, Muscle twitching
Clinical narrative: Diffuse numbness, muscle twitches, ataxia.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid factor negative
Clinical narrative: Diffuse numbness, muscle twitches, ataxia.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness & swelling on the right arm.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Activated partial thromboplastin time, Contusion, Full blood count, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: 10 days after vaccination, pt presented with multiple bruises on body. Platelet count - 0. Admitted at hosp. Treated with IVIG x 2 - Dx: ITP. Responded well. Plat count 236K 1/26/12.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: International normalised ratio, Metabolic function test, Platelet count decreased, Prothrombin time
Clinical narrative: 10 days after vaccination, pt presented with multiple bruises on body. Platelet count - 0. Admitted at hosp. Treated with IVIG x 2 - Dx: ITP. Responded well. Plat count 236K 1/26/12.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Convulsion
Clinical narrative: A serious spontaneous report of seizures has been received from a non-health professional concerning a seven-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 28-Nov-2011. Two days after receiving FLUMIST, on 30-Nov-2011, the patient had seizures and then two weeks later he experienced seizures again. The outcome of the event seizures was unknown.
Age: 7.0
Sex: M
Vaccine: FLUN3, FLUN3
Symptoms: Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: A serious spontaneous report of seizures has been received from a non-health professional concerning a seven-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 28-Nov-2011. Two days after receiving FLUMIST, on 30-Nov-2011, the patient had seizures and then two weeks later he experienced seizures again. The outcome of the event seizures was unknown.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cyanosis, Dyspnoea
Clinical narrative: Parent reports child had trouble breathing for 10-15 minutes with cyanosis, 2 hrs. post receiving vaccines. Told by phone by PP to go to Emergency. When they arrived child was better, and was discharged without treatment. Parent denies child had a rash, swelling or fever.
Age: 1.68
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Pyrexia, Tremor, Urticaria
Clinical narrative: 4 hr. post inj. hives, fever 103, shaking.
Age: 1.82
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, erythema, left deltoid.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt claims there is redness and swelling at the injection site and it itches.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Around 8:30 pm on 02/20/2012, Pt's mom states the pt c/o her leg being very sore and not wanting to bear weight on the R leg. Mom states she give the pt Tylenol and placed warm compresses on the pt's R thigh, which mom described a being red and swollen and painful to the touch. On 02/22/2012 at 3:15PM, Pt was brought in to the Health Dept. It was noted that pt had a large red raised area to upper R thigh, measuring approx 3in x 3in. The area was warm to the touch and painful to the touch. Pt was able to bearing weight on the leg and walked fine on that leg. This was observed by 2 RN's. Mom states that the pt has not had any fever or unconsolible crying since being vaccinated. Instructed mom to take pt to see her PMD for further evaluation on the R thigh.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Pain in extremity, Weight bearing difficulty
Clinical narrative: Around 8:30 pm on 02/20/2012, Pt's mom states the pt c/o her leg being very sore and not wanting to bear weight on the R leg. Mom states she give the pt Tylenol and placed warm compresses on the pt's R thigh, which mom described a being red and swollen and painful to the touch. On 02/22/2012 at 3:15PM, Pt was brought in to the Health Dept. It was noted that pt had a large red raised area to upper R thigh, measuring approx 3in x 3in. The area was warm to the touch and painful to the touch. Pt was able to bearing weight on the leg and walked fine on that leg. This was observed by 2 RN's. Mom states that the pt has not had any fever or unconsolible crying since being vaccinated. Instructed mom to take pt to see her PMD for further evaluation on the R thigh.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: High fever, 102.2, and overall ache.  Extremely tired.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Condition aggravated, Dyskinesia, Induration, Muscular weakness
Clinical narrative: Nothing noticed right away. Hard muscle knot upper left arm, lasted weeks, maybe more. Distinct worsening of L hand dyskinesia. New symptom (worst) Parkinson-like tremor of L hand, not improving. Weakness and tremor noticed within a couple weeks (?) of shot, continues now three months later.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Subcutaneous nodule, Tremor
Clinical narrative: Nothing noticed right away. Hard muscle knot upper left arm, lasted weeks, maybe more. Distinct worsening of L hand dyskinesia. New symptom (worst) Parkinson-like tremor of L hand, not improving. Weakness and tremor noticed within a couple weeks (?) of shot, continues now three months later.
Age: 1.49
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Blood culture, Chest X-ray, Culture urine, Febrile convulsion, Full blood count
Clinical narrative: Febrile seizure.
Age: 1.49
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13
Symptoms: Urine analysis
Clinical narrative: Febrile seizure.
Age: 15.0
Sex: F
Vaccine: HPV2
Symptoms: Abdominal discomfort, Headache, Influenza like illness, Nausea, Pyrexia
Clinical narrative: 02-13-12, approx. 10 hrs after HPV injection, client c/o nausea, abd. discomfort. Sl. fever & headache. Mom took child to urgent care on 02-14-12 (evening) she was told to take child to DCP the following morning. 02-15-12 mom states child is no better and now has "flu like symptoms". Advised to take child to PCP.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Diagnosed as shingles illness by Dr.. Rash on right side of face & scalp. Medications prescribed: Methylpred 4 mg Dosepak, & Valacyclovir 1gram, 21 tabs. Course: 12 days.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Marked erythema and induration developed at the injection site. At its worst 3-4 days after took two weeks to completely resolve. Recommended cold packs, ibuprofen. Treated with course of KEFLEX in case cellulitis component.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Groin pain, Influenza like illness, Joint injury, Laboratory test normal
Clinical narrative: Mother calls with concerns about her daughter who, after completing GARDASIL series, seemed to have flu like symptoms, achiness and then hip joint injury requiring P.T. that she was concerned due to some type of joint effect from vaccine.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, X-ray of pelvis and hip normal
Clinical narrative: Mother calls with concerns about her daughter who, after completing GARDASIL series, seemed to have flu like symptoms, achiness and then hip joint injury requiring P.T. that she was concerned due to some type of joint effect from vaccine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Confusional state, Fatigue, Headache, Malaise, Rhinorrhoea
Clinical narrative: Fatigue, malaise, headache, confusion, copious rhinorrhea, somnolence. "3 days not fit for duty".
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Fatigue, malaise, headache, confusion, copious rhinorrhea, somnolence. "3 days not fit for duty".
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Injection site reaction, Malaise, Rash vesicular
Clinical narrative: Vesicular rash w/ mild illness on buttocks and upper thigh.
Age: 1.28
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Cough, Crying, Hypotonia, Stridor, Vomiting projectile
Clinical narrative: Child was in car seat leaving from office visit. Child had stridorous cough followed by projectile vomiting thru Nissen. Then cried and went limp for a few seconds then cried normally.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Right arm red 2 1/4 x 3 1/2, slight swelling, warm to touch, during injection notation made of patient moved around.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt. deltoid muscle swelled immediately after Tdap injected to approximately 50 mm in diameter. Deltoid muscle was red. Ice was applied. Pt. reported no pain, 50mg oral BENADRYL given. Dr. evaluated pt.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Day of vaccination - post, mild pain to site (L) deltoid, at night time pain increased "took ibuprofen, next day mild swelling with tenderness, mild to moderate pain, took ibuprofen 2 x day, 3rd day minimal redness below injection site at least 2-3 fingers below, minimal to mild tenderness, redness is getting bigger, pain minimal. No fever noted.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site joint pain, Mobility decreased, Pain, Rotator cuff syndrome
Clinical narrative: Began to have significant pain in Lt shoulder within seconds of vaccine being given. Took ibuprofen intermittently to decrease pain with minimal relief. Unable to put arm behind back, left self from recumbent to sitting position off bed or raise arm above head without significant pain. Dr dx'd tendonitis of Lt shoulder: 2/7/12 tx'd with FLEXOR patches & VICODEN. No injection site mark seen by PMD.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral, Pain
Clinical narrative: Patient came back on day after vaccination. She reported abnormal soreness & swelling. Upon exam her arm was red & warm to touch from inj site down to elbow. Arm also appeared slightly swollen. Patient advised to use diphenhydramine & follow if with MD if no resolution.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Enema administration, Intestinal obstruction, Intussusception
Clinical narrative: A serious spontaneous report of intussusception has been received from a health professional concerning a two-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 21-Sep-2011. On 23-Sep-2011, the patient experienced abdominal pain and was admitted to hospital and was diagnosed with intussusception. The patient spent one night at the hospital, was NPO and an enema was administered. The abdominal pain resolved and patient was released from the hospital. The outcome of event intussusception was resolved on 24-Sep-2011.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Maternal exposure during pregnancy
Clinical narrative: None stated.
Age: 26.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Periorbital oedema, Sensation of foreign body, Urticaria
Clinical narrative: Approximately 2 hours after receiving Hepatitis A/Typhoid Vi/ IPV vaccines for travel to foreign country, pt. developed sudden, rapidly enlarging hives in both eyes, expanding to include periorbital area, upper nose & cheeks and a feeling of a lump in her throat. Provider at home thru the emergency service. Pt. did not report swelling to tongue/lips/airway or difficulty with breathing/swallowing when she called the provider on-call (me). She was advised to go to ER & since she called from Pharmacy to my home, I advised her to take BENADRYL 25mg X 2 STAT & have parents drive to ER, (They were with her at time) Pt. ended up not going to ER, but taking the BENADRYL "two or three tablets" and sitting at home with her parents, until symptoms mostly resolved (around 10 pm the same night). Today (2/21) I called pt. for update around 11:45 am. She still has some puffiness around her eyes but otherwise, symptoms have mostly resolved.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Pain, Pruritus, Skin warm
Clinical narrative: Immediate itching. 24 hours after: swelling, hot, redness, soreness. 36 hours after: swelling down arm to below elbow, hot, red, sore, still itching.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Immediate itching. 24 hours after: swelling, hot, redness, soreness. 36 hours after: swelling down arm to below elbow, hot, red, sore, still itching.
Age: 60.0
Sex: F
Vaccine: HEPAB, TDAP, TYP, YF
Symptoms: Rash pruritic
Clinical narrative: Pt. phoned 2/15/12 to schedule next in series of travel vaccines. Reported "itchy rash" on "back" of (R) arm "between shoulder and elbow" & using OTC "hydrocortisone cream" for relief. Said rash persisting over past "2 weeks".
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Dysstasia
Clinical narrative: 24 hrs after shot - extremely dizzy, couldn't stand without help. Spouse gave lg glass water, 1/2 banana, few pretzels. Was a little dizzy till bedtime, was ok next morning & ever since. Was not sick at all before & no vaccines prior to shot. Blood pressure was fine.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Screaming
Clinical narrative: Infant screamed for 9 hours starting 1 1/2 hrs. after receiving 4 mo. immunizations.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: (R) arm cellulitis. KEFLEX, BENADRYL & cool compresses.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abdominal pain, Endoscopy gastrointestinal
Clinical narrative: Chronic abd pain.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Face oedema, Oedema peripheral, Urticaria
Clinical narrative: Edema to hands and feet, face. Hives under arms (per mother). Was seen and released at emergency room. Oral steroids given. To use OTC, BENADRYL, at home, as needed.
Age: 27.0
Sex: M
Vaccine: FLU3, HEP, MMR
Symptoms: Chills, Influenza, Pain, Similar reaction on previous exposure to drug, Upper respiratory tract congestion
Clinical narrative: Pt came in for hepatitis B #2 vaccine. He states that he believes that the flu vaccine caused flu symptoms after shots 1/17/2012. He received flu vaccine, hep B & MMR vaccine 1/17/2012. Day after had aching in legs - 2 days later he had body aches, chills & head congestion. Symptoms lasted 2-3 days. He said he felt similar symptoms after last flu vaccine 3-4 years ago.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: Patient came to pharmacy on 2-10-12 says her left shoulder still hurts from flu shot. She claims she has loss of mobility in that arm and she can not raise it. Pt. has been to family physician for this and has had MRI done on shoulder, but did not discuss details.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Blood test, Cellulitis streptococcal, Chest X-ray, Connective tissue disorder, Culture
Clinical narrative: Strep cellulitis that began (appeared) on 10/25/11 resulted in hospitalization, an open wound that required weeks of care, treatment by an infectious disease specialist, in-home IV antibiotics, damage to connective tissue in shoulder that is requiring ongoing physical therapy, treatment by an orthop specialist for shoulder. All in right arm.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site reaction, Nuclear magnetic resonance imaging, Open wound
Clinical narrative: Strep cellulitis that began (appeared) on 10/25/11 resulted in hospitalization, an open wound that required weeks of care, treatment by an infectious disease specialist, in-home IV antibiotics, damage to connective tissue in shoulder that is requiring ongoing physical therapy, treatment by an orthop specialist for shoulder. All in right arm.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Blood electrolytes, Blood sodium decreased, Computerised tomogram, Immunoglobulin therapy, Laboratory test
Clinical narrative: Tingling in hands and feet - severe pain throughout body.  Treatment was 5 days of IV IgG administration.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Pain, Paraesthesia, Ultrasound scan
Clinical narrative: Tingling in hands and feet - severe pain throughout body.  Treatment was 5 days of IV IgG administration.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Viral test
Clinical narrative: Tingling in hands and feet - severe pain throughout body.  Treatment was 5 days of IV IgG administration.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Injection site erythema, Injection site vesicles
Clinical narrative: My left arm at vaccination site began to swell and become extremely hot.  It blew up to about 2x its size and was so hot it blistered.  The redness and heat extended to my shoulder and almost to my elbow.  I developed a low grade fever 94 and became very weak and dizzy.  I then broke out on the left side of my mouth with fever blisters.  I could not get out of bed the next day and was extremely weak.  My back broke out in little itchy bumps.  My arm continued to blister and I became more weak.  I called the clinic and they said to go to emergent care immediately.  I called my doctor Dr. and he got me into his office immediately.  He said I should have never been given the Tdap that a tetanus was all I needed.  He gave me two shots in my thigh and the next day I began to feel relief.  Up to and including today my arm still has a large knot, it is now peeling and my back still itches.  The fever blisters are healing.  I have never felt so sick in my entire life.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Malaise, Oral herpes, Pyrexia, Rash pruritic, Skin exfoliation
Clinical narrative: My left arm at vaccination site began to swell and become extremely hot.  It blew up to about 2x its size and was so hot it blistered.  The redness and heat extended to my shoulder and almost to my elbow.  I developed a low grade fever 94 and became very weak and dizzy.  I then broke out on the left side of my mouth with fever blisters.  I could not get out of bed the next day and was extremely weak.  My back broke out in little itchy bumps.  My arm continued to blister and I became more weak.  I called the clinic and they said to go to emergent care immediately.  I called my doctor Dr. and he got me into his office immediately.  He said I should have never been given the Tdap that a tetanus was all I needed.  He gave me two shots in my thigh and the next day I began to feel relief.  Up to and including today my arm still has a large knot, it is now peeling and my back still itches.  The fever blisters are healing.  I have never felt so sick in my entire life.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Upper extremity mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: My left arm at vaccination site began to swell and become extremely hot.  It blew up to about 2x its size and was so hot it blistered.  The redness and heat extended to my shoulder and almost to my elbow.  I developed a low grade fever 94 and became very weak and dizzy.  I then broke out on the left side of my mouth with fever blisters.  I could not get out of bed the next day and was extremely weak.  My back broke out in little itchy bumps.  My arm continued to blister and I became more weak.  I called the clinic and they said to go to emergent care immediately.  I called my doctor Dr. and he got me into his office immediately.  He said I should have never been given the Tdap that a tetanus was all I needed.  He gave me two shots in my thigh and the next day I began to feel relief.  Up to and including today my arm still has a large knot, it is now peeling and my back still itches.  The fever blisters are healing.  I have never felt so sick in my entire life.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever 103.8.
Age: 37.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site erythema, Lymphadenopathy
Clinical narrative: Regional lymphadenopathy with diffuse erythema extending from left deltoid to ant shoulder. Pt treated with ATB for poss cellulitis very robust take with daily f/u with provider.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Dizziness, Lethargy, Palpitations
Clinical narrative: Pt. mom reported called 2/8/12 daughter had received HPV4 (3rd dose) and Depo-provera inj (first time receiving) on 2/7/12. Stated pt had lethargy, dizziness, and heart palpitations.  States no previous reaction with prior HPV4 shots.  Advised to call PCP. On 2/15/12 pt mom called back stated daughter had 102*F temp. Stated gave pt ibuprof. 800mg. and pt was feeling better.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Fatigue, Laboratory test normal, Muscular weakness, Palpitations
Clinical narrative: Nighttime leg weakness only immediate symptom. Insidious onset resulting 3 months later of weight gain, increased abdominal girth, shortness of breath, palpitations, excessive tiredness.  Never before present.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Waist circumference increased, Weight increased
Clinical narrative: Nighttime leg weakness only immediate symptom. Insidious onset resulting 3 months later of weight gain, increased abdominal girth, shortness of breath, palpitations, excessive tiredness.  Never before present.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Cellulitis, Culture throat positive, Injection site erythema, Injection site warmth, Pharyngitis streptococcal
Clinical narrative: Seen 1/20/12 with 24 hours of mom noting "red, warm area (R) thigh where vaccine given". Better today but still sl erythematous (4.5 " x 3.5"). Had 1 dose of AMOXIL for suspected strep pharyngitis - later confirmed by throat culture. Antibiotic changed 1/30/12 to KEFLEX to cover cellulitis.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Blister
Clinical narrative: Pt has blisters on the same arm but not at injection site. The break out occurred on the same day as vaccination. Pt has an upcoming appt with physician.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 60 mm red area to injection site from 3 days ago. Area is warm to touch.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Autism, Condition aggravated, Disturbance in attention, Middle insomnia, Regressive behaviour
Clinical narrative: Son had regression of autism symptoms, including decreased language and eye contact, increased need for sensory stimulation, decreased attention and focus, increased night wakings.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Social avoidant behaviour, Speech disorder developmental
Clinical narrative: Son had regression of autism symptoms, including decreased language and eye contact, increased need for sensory stimulation, decreased attention and focus, increased night wakings.
Sex: U
Vaccine: FLUN3
Symptoms: Fatigue
Clinical narrative: A non serious spontaneous report of fatigue has been received from an adult consumer concerning an themself subsequent to receiving FLUMIST. No medical history or concomitant medication information was provided. The patient received a single dose of FLUMIST on 18-Oct-2011. The patient reported after receiving FLUMIST that they experienced fatigue. The outcome for fatigue is unknown.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: A non-serious spontaneous report of FLUMIST administered to a nine-year-old with diabetes was received from a physician concerning a nine-year-old female. Medical history included diabetes. No concomitant medications have been reported for this patient. On 02-Nov-2011, a nine-year-old female with diabetes received FLUMIST (LAIV) instead of TIV. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Age: 0.58
Sex: F
Vaccine: FLUN3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of oral administration of FLUMIST and inadvertent oral administration to 7 month old was received from a health professional concerning a seven-month-old female. On 12-Sep-2011, the patient received FLUMIST orally. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Lymphadenopathy
Clinical narrative: Swollen Gland (Lump) by collar Bone on the same side as the shot.  On 2/22/2012 Swollen Gland under arm on the same side as the shot.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Dizziness, Injection site haematoma, Injection site swelling, Nausea, Pain in extremity
Clinical narrative: Light headed, fever, swelling and bruising around entire area where shot was given.  Severe soreness in entire arm.  Vertigo, nausea.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vertigo
Clinical narrative: Light headed, fever, swelling and bruising around entire area where shot was given.  Severe soreness in entire arm.  Vertigo, nausea.
Age: 3.0
Sex: F
Vaccine: HIBV
Symptoms: Crying, Dyskinesia, Opisthotonus, Unresponsive to stimuli
Clinical narrative: Patient cried after vaccinated, Pt's mother picked her up and pt stopped crying, Pt was placed into a stroller. While her brother was about to be vaccinated next, Corpsman and nurse found Pt closing eyes tongue out, slowly sliding out from a stroller by stretching her back, no response to mother's call. Called 911. Nurse immediately placed Pt in prone position on floor, Pt started spastic motion. Nurse keep calling patient, and pt responded at 3:32. Pt cried and placed on bed, temperature 97.9F. ER corpsman and physician arrived and took Pt to ER @3:40.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Sensation of foreign body
Clinical narrative: Sensation of globus (lump in throat) within 10 minutes of receiving HPV#1, Meningococcal, and TdaP.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLUX, PNC
Symptoms: Diet refusal, Pyrexia, Vomiting projectile
Clinical narrative: 102.7- 103 degree fever lasting 36 hours (even with use of acetaminophen and ibuprofen), after that temperature went down to 100.3 degrees. Baby refused solid food and was not able to nurse; 48 hours after vaccinations baby exhibited profuse, projectile vomiting requiring administration of electrolyte solution via dropper. 72 hours after vaccinations all symptoms subsided.
Age: 0.18
Sex: F
Vaccine: RVX
Symptoms: No adverse event, Secondary transmission
Clinical narrative: I am patients grandmother and have intestinal problems and suffered severe diarrhea for 2 week after my granddaughter who lives with me was vaccinated.  I did ask provider it there would be a possibility of a problem for me because of medical history and was assured it would be okay.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local reaction/redness at immunization site.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site reaction, Urticaria
Clinical narrative: 2-3 cm welt that extended up thigh about 5 minutes after injection of HIBERIX & PREVNAR - has received PREVNAR before with no problems. Cold compresses & 6.25 mg BENADRYL.
Age: 86.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Pt states vaccine given 2-14-12 & was very painful x 2 days, then had a knot on (R) arm x 2 days, very red, warm to touch & swollen. In office 2/23/12 (R) arm red, warm, swollen (L-6 inches W-5.75 inches) at injection site.
Age: 86.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Skin warm, Upper extremity mass
Clinical narrative: Pt states vaccine given 2-14-12 & was very painful x 2 days, then had a knot on (R) arm x 2 days, very red, warm to touch & swollen. In office 2/23/12 (R) arm red, warm, swollen (L-6 inches W-5.75 inches) at injection site.
Age: 1.03
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: On 3-3-11 received immunizations --> Hep A, MMR, PENTACEL, VARIVAX. On 3-5-11 pts mom called to report mild local reaction at injection site --> red, hard, warm to touch.
Age: 8.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Rash
Clinical narrative: 2/21/12 Rash on face - fine rash. 2/23/12 Rash on stomach - fine rash.
Age: 0.22
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea explosive per mom. Started today am.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Palmar erythema, Pruritus, Respiratory disorder
Clinical narrative: C/o itching both hands and spot on right foot. Also c/o tight feeling in airway. Mild erythema on bilat palmar surfaces. Tx no further GARDASIL, return if worsens.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Underdose
Clinical narrative: A non-serious spontaneous report of received only 0.1 ml in one nostril was received from a consumer concerning a 31-month-old female. Neither relevant medical history nor concomitant medications were reported for this patient. The patient received 0.1ml of FLUMIST in one nostril on 29-Sep-2011. On 03-Oct-2011, the patient received 0.1 ml of FLUMIST in each of the nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 4.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: A non-serious spontaneous report of two doses of FLUMIST given one week apart was received from a health professional concerning a four-year-old female. Medical history and concomitant medications were not reported. The patient was vaccinated on 29-Sep-2011 and then received a second dose on 04-Oct-2011, one week later. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood culture negative, Cellulitis, Chest pain, Electrocardiogram normal, Hypersensitivity
Clinical narrative: Case number PHEH2012US003537 is an initial spontaneous report received from a consumer and a physician on 09 Feb 2012. This case refers to a 45-year-old female patient. Her medical history included ongoing headache, nerve pain, depression, spasms, tobacco abuse, chronic pain syndrome (continuing: unknown), multiple sclerosis (diagnosed in 2009) and a negative history of cellulitis. Concomitant medications included a TOPAMAX 100mg twice daily for headache, gabapentin 300mg twice daily for nerve pain, ZOLOFT 200mg daily for depression and ZANAFLEX 2mg daily for spasm. She was started therapy with REBIF 44 micrograms three times a week, subcutaneously on 24 May 2011 for multiple sclerosis and it was continuing at the time of this report. On 01 Dec 2011, she went for routine physical examination and was vaccinated with FLUVIRIN (batch number: 1102601 and expiration date: June 2012), and with PNEUMOVAX (batch number: 1138AA and expiration date: 06 Oct 2009). On 02 Dec 2011, she went to the emergency room due to allergic reaction where the arm of the patient swelled in the area of the PNEUMOVAX vaccine and it was hot, red and inflamed. She was admitted to the hospital overnight when the pain was going to her shoulder blade and in her chest. During hospitalization she had laboratory tests which were negative for cardiac issues and blood cultures were negative. She also had an ultrasound of upper right arm that was negative for blood clots. She had serial cardiac and electrocardiogram and they ruled out a myocardial infarction. The symptoms were felt to be non-cardiac in etiology and most likely musculoskeletal in relation to her recent PNEUMOVAX. She received no treatment while in the hospital. On 03 Dec 2011 she was sent back to the emergency room by the physician because the arm was getting worse. She was given intravenous vancomycin in the emergency room for right arm cellulitis. She then had an allergic reaction with hives and her whole body was itching. She was given BENADRYL and antibiotic to prevent her from getting cellulitis. Her top head became spontaneously itchy since the allergic reaction. She stated that she noticed itching of the tip of the head which began in Aug 2011, she continued administration of REBIF. She was discharged from the hospital on 03 Dec 2011 with FIOROCET 50/325 twice daily and VICODIN 10/325 daily as needed for pain. She had recovered from allergic reaction, right arm cellulitis and allergic reaction to vancomycin. The physician assessed the relationship between the allergic reaction and right arm cellulitis and REBIF as suspected and considered PNEUMOVAX vaccine as a suspect causal factor.