chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hyperhidrosis, Malaise, Pyrexia, Vomiting
Clinical narrative: PATIENT CALLED THE OFFICE THIS MORNING AROUND 10AM STATING SHE STARTED TO FEEL SICK ON THE EVENING OF 9/10/11  AND THOUGHT THIS WAS A REACTION TOWARDS THE FLU SHOT. SHE SPOKE WITH THE NURSE PRACTITIONER AND TOLD THE PT TO TALK TO ME, THE MEDICAL ASSISTANT TO GET ALL DETAILS, AND ALL SYMPTOMS SO WE CAN REPORT THIS TO VAERS.  SHE VOMIT FOR 2 STRAIGHT DAYS, SOME SWEATS, WEAKNESS, FEVER, BUT NO OTHER SYMPTOMS. TODAY SHE ONLY FEELS SOME WEAKNESS AND HAS NOT VOMIT ANYTHING ELSE.  WE WILL CALL PT TOMORROW TO SEE HOW SHE IS DOING.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Tenderness
Clinical narrative: On 11/11/2011 at 7:45 PM, Pt came to the pharmacy, complained that 2 days after the shot, she had noticed redness, tenderness, and pain. I noticed the redness, and it was pianful to touch. On 11/14/11, I called her, she came to the pharmacy again, I have noticed that is getting much better, but it is still some redness. She was ok.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Injection site swelling, Irritability, Lethargy, Pain
Clinical narrative: Almost immediately there was swelling at the site of the injection followed by fever, lethargy, body aches and irritability which lasted well into the night.  She just went to sleep having the chills.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Almost immediately there was swelling at the site of the injection followed by fever, lethargy, body aches and irritability which lasted well into the night.  She just went to sleep having the chills.
Age: 1.51
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Hypophagia, Otitis media, Rhinorrhoea, Viral infection
Clinical narrative: Temp at home to 104.7, runny nose, decreased oral intake for 2 days prior; temp 105.7 at ED on 10/09, dx'd with bilateral otitis media, tx'd with antibiotics. Clinic visit on 10/11 with persistent symptoms, temps to 102, dx'd with viral syndrome.  Further follow up after this not available at the present time.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood culture negative, Blood sodium decreased, CSF culture negative
Clinical narrative: Evening of vaccine: fussy, fever to 100.5, lethargic - fever to 102 F next day. Periodic cyanosis, rigidity, posturing, poor feeding, irritable, very uncomfortable to being touched/moved. Diarrhea & emesis on D #3 post vaccine. Hosp x2d, r/o sepsis, IV fluid.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Culture urine negative, Cyanosis, Diarrhoea, Feeding disorder of infancy or early childhood, Hyperaesthesia
Clinical narrative: Evening of vaccine: fussy, fever to 100.5, lethargic - fever to 102 F next day. Periodic cyanosis, rigidity, posturing, poor feeding, irritable, very uncomfortable to being touched/moved. Diarrhea & emesis on D #3 post vaccine. Hosp x2d, r/o sepsis, IV fluid.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Irritability, Lethargy, Liver function test abnormal, Muscle rigidity, Posturing
Clinical narrative: Evening of vaccine: fussy, fever to 100.5, lethargic - fever to 102 F next day. Periodic cyanosis, rigidity, posturing, poor feeding, irritable, very uncomfortable to being touched/moved. Diarrhea & emesis on D #3 post vaccine. Hosp x2d, r/o sepsis, IV fluid.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Pyrexia, Vomiting
Clinical narrative: Evening of vaccine: fussy, fever to 100.5, lethargic - fever to 102 F next day. Periodic cyanosis, rigidity, posturing, poor feeding, irritable, very uncomfortable to being touched/moved. Diarrhea & emesis on D #3 post vaccine. Hosp x2d, r/o sepsis, IV fluid.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Blindness, Depression, Syncope, Visual impairment
Clinical narrative: Information has been received from a consumer concerning her niece with migraine who in 2009 was vaccinated with 3 doses of GARDASIL (lot # not provided). On an unspecified day the patient experienced a syncopal episode, the patient reported that she was seeing white spots and she could not see her. The consumer added "she could not see me and I was standing right next to her". Consumer reported that since receiving GARDASIL series the patient had experienced "severe" abdominal cramping. The patient was given a birth control pill (name unspecified) to treat the "severe" abdominal cramping but the "birth control pill" (name unspecified) had to be discontinued because the "birth control pill" caused the patient to become depressed and as a result of this depression she was admitted to a mental health hospital (name of hospital unspecified) for 3 days and was being followed by a psychiatrist and therapist (name unspecified). Consumer reported that the patient had been seen by a physician (address and phone number unspecified). At the reporting time, the patient had not recovered from the events. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red warm swollen areas at injection site (B) upper lateral arms.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose, Convulsion, Fall, Head injury, Hypotension
Clinical narrative: Information has been received from a registered nurse concerning her 12 year old son with no pertinent medical history, drug reactions or allergies who in September or October 2010, was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot number not reported) and on 21-OCT-2011 was vaccinated intramuscularly with a second 0.5 ml dose of GARDASIL (lot number not reported). There was no concomitant medication. The registered nurse reported that her son received the first dose of the vaccine without incident. The patient received the second dose of the vaccine from his pediatrician on 21-OCT-2011, and within 3 minutes of receiving the vaccine he grabbed his head and passed out. The registered nurse stated that her son began to fall, he hit his head on the wall and then had seizures. The seizures lasted about 15 seconds. The registered nurse reported that 911 was called, while still in the pediatricians office and while waiting for 911 to arrive they monitored her son's vital signs and he was hypotensive. They also monitored his blood sugar (result not reported) and oxygen was applied. The Registered nurse reported that 911 staff arrived and transported her son to the emergency room, while in the ER they inserted a hep-lock, provided fluids by mouth and observed her son. The registered nurse reported that the ER physician recommended an EEG but her husband who was a neurologist spoke to the physician in the ER and the EEG was not done. The registered nurse reported that several hours later her son was discharged home directly from the ER and he was not admitted to the hospital. Subsequently on 21-OCT-2011, the patient recovered from the events. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a registered nurse concerning her 12 year old son with no pertinent medical history, drug reactions or allergies who in September or October 2010, was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (lot number not reported) and on 21-OCT-2011 was vaccinated intramuscularly with a second 0.5 ml dose of GARDASIL (lot number not reported). There was no concomitant medication. The registered nurse reported that her son received the first dose of the vaccine without incident. The patient received the second dose of the vaccine from his pediatrician on 21-OCT-2011, and within 3 minutes of receiving the vaccine he grabbed his head and passed out. The registered nurse stated that her son began to fall, he hit his head on the wall and then had seizures. The seizures lasted about 15 seconds. The registered nurse reported that 911 was called, while still in the pediatricians office and while waiting for 911 to arrive they monitored her son's vital signs and he was hypotensive. They also monitored his blood sugar (result not reported) and oxygen was applied. The Registered nurse reported that 911 staff arrived and transported her son to the emergency room, while in the ER they inserted a hep-lock, provided fluids by mouth and observed her son. The registered nurse reported that the ER physician recommended an EEG but her husband who was a neurologist spoke to the physician in the ER and the EEG was not done. The registered nurse reported that several hours later her son was discharged home directly from the ER and he was not admitted to the hospital. Subsequently on 21-OCT-2011, the patient recovered from the events. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Renal failure acute, Tubulointerstitial nephritis, Weight decreased
Clinical narrative: Information has been received from a physician concerning a healthy 78 year old female patient with no pertinent medical history and no known drug reactions/allergies who about three weeks ago, on approximately 14-OCT-2011, was vaccinated SQ with a 0.5 ml dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included aspirin and metoprolol (strength and manufacturer unspecified) and unspecified herbal medication. The physician reported that, about three weeks ago, on approximately 14-OCT-2011, after receiving ZOSTAVAX (Merck), the patient experienced acute renal failure and interstitial nephritis and was hospitalized for three days. It was also stated that the patient had lost 20 pounds since the injection. The events did not improve and at the time of the report the patient had not recovered. The patient was seeing her physician and nephrologist on 04-NOV-2011. Acute renal failure, interstitial nephritis and weight decrease were considered to be immediately life-threatening and disabling by the reporting physician. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: PNEUMOVAX given 8-24-11 - L.D. - left arm started getting painful 8-25-11. Site red + swollen. Chilling.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Balance disorder, Joint swelling, Laboratory test, Musculoskeletal pain
Clinical narrative: Extreme swelling and soreness of left shoulder, tongue swelled - extreme thirst, loss of balance - couldn't walk. Called paramedics Nov 2 and admitted to hospital.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue, Thirst
Clinical narrative: Extreme swelling and soreness of left shoulder, tongue swelled - extreme thirst, loss of balance - couldn't walk. Called paramedics Nov 2 and admitted to hospital.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Ear pain, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Left arm pain - below injection site to hand - 24 hours after inj. fever - 100 degrees - sore throat, right ear ache. 48 hours after inj.
Age: 9.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Warm. Reddened area on back of LA at injection site 13 x 14 in. Seen at clinic. Dx'd with cellulitis. Started on KEFLEX 500mg PO TID. Temp. 99.8 degrees F.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever T-max 100.7. Bilateral leg (thigh) pain. Left thumb intermittently could not raise it.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Eye irritation, Eye pruritus, Sinus disorder
Clinical narrative: Burning, itching eyes, sinus irritation.
Age: 68.0
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Pain in extremity, Restlessness
Clinical narrative: Pain - running down my arm - left/don't have strength restless at time. Pain killer will not take the pain away.
Age: 1.25
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Body temperature increased, Crying, Hypotonia, Irritability
Clinical narrative: Change in consciousness. 1 y/o female presents with several episodes of altered consciousness today. Seen by PCP this am for 15 mo well child check & received 1st flu shot. This afternoon had an episode where she stopped crying, looked limp, & stared into space, lasted 2-3 minutes. No nystagmus - eyes were tracking OFC dunning episode. No stiffening/shaking of extremities. Afterward returned to baseline except increased pus. 2 more identical episodes. HEENT (-) resp (-) later in the day which self recovered. Was sitting upright during 1 episode Temp 99-100 today. Emesis x 3, NBNB after giving TYLENOL. Tolerating PO now. Normal stool & WOP today.
Age: 1.25
Sex: F
Vaccine: FLU3
Symptoms: Staring, Vomiting
Clinical narrative: Change in consciousness. 1 y/o female presents with several episodes of altered consciousness today. Seen by PCP this am for 15 mo well child check & received 1st flu shot. This afternoon had an episode where she stopped crying, looked limp, & stared into space, lasted 2-3 minutes. No nystagmus - eyes were tracking OFC dunning episode. No stiffening/shaking of extremities. Afterward returned to baseline except increased pus. 2 more identical episodes. HEENT (-) resp (-) later in the day which self recovered. Was sitting upright during 1 episode Temp 99-100 today. Emesis x 3, NBNB after giving TYLENOL. Tolerating PO now. Normal stool & WOP today.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Palpitations
Clinical narrative: The purpose of this email is to recount the events surrounding patient: Patient is a 15y/o girl, who arrived at the building during the hour of 3:30-4:30pm, accompanied by her mother and sister. She received 0.5ml of FLUZONE vial (lot#UH476AB) to her Left Deltoid as documented by LVN. It was LVN who had administered the injection. Patient voiced no complaints after the injection, and her mother stated that her family receives flu shots every year. Patient returned to the building prior to the 5pm closing time. Patient had reported feeling "dizzy" and experiencing her "heart racing." RN evaluated her in her vehicle and reported patient had a pulse rate of 70/min. RN also administered nasal ammonia which resulted in no change in patient's condition. Patient was also given fluids to drink which had no effect on her presenting complaints. I contacted Assistant Manager, and I was advised to send patient to the Emergency department for further evaluation. As instructed I passed that advisement along to patient's mother. I obtained patient medical record and spoke to the Emergency Department to inform her that patient was en route. The above is an accurate account of the events surrounding patient's flu shot administration to the best of my recollection. If you have any further questions you can contact me. Thank you for allowing me the opportunity to be of assistance in this matter.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Fatigue, Flushing, Hypersomnia, Lethargy
Clinical narrative: Client received the vaccinations. Her father said following the shots she began to feel alot more tired. (The next day). He said since then there has been an increase in sleeping. She has been following asleep in class. Also she has flushed cheeks. He planned to take her to the doctors for her lethargy.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt seen with complaints of arm pain since receiving flu vaccine 1 month ago.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Dysstasia, Endotracheal intubation, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Total paralysis from Guillain-Barre syndrome requiring intubation, tracheostomy, ventilator for 60 + days, extreme pain. Received IV/IG transfusions. Can now move & walk, but legs & feet remain weak & painful. Left side of face droops, left eye is blurry. Cannot walk or stand for extended periods.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Mechanical ventilation, Muscular weakness, Pain, Pain in extremity, Paralysis
Clinical narrative: Total paralysis from Guillain-Barre syndrome requiring intubation, tracheostomy, ventilator for 60 + days, extreme pain. Received IV/IG transfusions. Can now move & walk, but legs & feet remain weak & painful. Left side of face droops, left eye is blurry. Cannot walk or stand for extended periods.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Tracheostomy, VIIth nerve paralysis, Vision blurred
Clinical narrative: Total paralysis from Guillain-Barre syndrome requiring intubation, tracheostomy, ventilator for 60 + days, extreme pain. Received IV/IG transfusions. Can now move & walk, but legs & feet remain weak & painful. Left side of face droops, left eye is blurry. Cannot walk or stand for extended periods.
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: C/O arm pain since receiving flu vaccine 1 month ago.
Age: 10.0
Sex: F
Vaccine: DT, HEP, IPV, MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Client was given expired dose of hep B in error. Vaccine exp 11-13-11, after 30 min. No adverse s/s observed or voiced.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Aggression, Condition aggravated, Personality change, Psychomotor hyperactivity, Speech disorder
Clinical narrative: Mother stats "patient has had personality changes since receiving Hep A vaccine. He is aggressive, hyperactive and had lost some language skills".
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Dizziness, Headache, Nausea, Vomiting
Clinical narrative: One hr after receiving flu shot in (L) deltoid, developed severe headache, nausea, and dizziness. Vomited 8 hours post injection.
Age: 0.74
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Pyrexia
Clinical narrative: Fever of 105.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Vaccine (MCV4) given at 9:30 AM in clinic and pt return to clinic after lunch at 1:30 pm with rash, mild hives, itching in her upper torso, face, arms area. Tx: Loratadine 10 mg.
Age: 13.0
Sex: M
Vaccine: DT, HEP, IPV, MMR, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Client was given expired dose of hep B in error vaccine exp 11-13-11 after 30 min. No adverse s/s observed or voiced.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Petit mal epilepsy
Clinical narrative: Pt felt sick; sat down and had an absence seizure (in my personal opinion). 911 was called; pt refused to emergency room and seen by ER physician. Mom states pt has never had any experience like this prior. This was the pt's 1st flu vaccination.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Chest pain, Cough, Hyperhidrosis, Increased upper airway secretion, Nasal congestion
Clinical narrative: Sore throat, sweats, coughing, nasal congestion, a lot of mucus build-up & chest ached.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat, sweats, coughing, nasal congestion, a lot of mucus build-up & chest ached.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Ocular hyperaemia, Rash, Rash pustular
Clinical narrative: Pt broke out with raised rash on neck, trunk & facial area. Pustules present, but not open. Eyes red & blood shot. Taken to hospital 10/24/11 - started on DURACEF & gentamycin. Patient not getting better rash getting worse & eyes not clearing. Taken to doctor, optometrist. Started on TOBRADEX. Taken to MD again started on prednisone. Rash still visible but fading with time.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity, X-ray normal
Clinical narrative: Initially ache in (L) arm escalating on pain scale to 10 by evening. Pt states she was unable to lift arm all the way up.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Patient called  provider at about 4:00 pm on 11/1/11 to state she was getting "hives" on her arms and was wondering if it was caused by FLUVIRIN given on 10/31/11. Suggested she go to "ED" but she refused and wanted to take BENADRYL.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: Patient presented to pharmacy on 11/3/11 with softball sized raised red circle at injection site. Small blisters were present in middle of reaction. Site started itching the night following injection. Continues to itch, but not worsening husband received vaccine same day from same lot & did not experience A/E. RPH contacted prescriber pt. advised to take TYLENOL or ADVIL and BENADRYL & ice if needed. Also told to follow up with MD ASAP.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure approximately 16 hours later, went to ER.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Patient received PNEUMOVAX vaccine and after 2 days has pain, spreading redness, and swelling. The reaction was caused by the PNEUMOVAX vaccine and not the FLUZONE.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Pruritus
Clinical narrative: Ill feeling, chills, itchy.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Musculoskeletal chest pain, Oesophageal spasm, Oropharyngeal pain
Clinical narrative: Within 5 min of vaccine administration pt complained of chest pain, described as spasmodic & related to chest wall, & throat pain, described as similar to esophageal spasm (previously experienced). (see over).
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pain, Injection site erythema, Injection site warmth, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Eyes red & painful. Sore throat. Sneezes. Right deltoid - red area warm to touch.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: Eyes red & painful. Sore throat. Sneezes. Right deltoid - red area warm to touch.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Abdominal X-ray, Enema administration, Full blood count normal, Intussusception, Laboratory test normal
Clinical narrative: Pt. received vaccine(s) on 11/07/11. Pt. returned to ofc 11/11/11. Had been vomiting x 3 on 11/11/11. Had CBC in ofc. (normal) TC neg in ofc. Pt sent to hospital; 3-way Abd = positive intussusception -> air enema reduced.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting, X-ray abnormal
Clinical narrative: Pt. received vaccine(s) on 11/07/11. Pt. returned to ofc 11/11/11. Had been vomiting x 3 on 11/11/11. Had CBC in ofc. (normal) TC neg in ofc. Pt sent to hospital; 3-way Abd = positive intussusception -> air enema reduced.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Blood test, Enema administration, Full blood count, Intussusception, Ultrasound scan abnormal
Clinical narrative: Pt. received vaccine(s) on 11/07/11. Pt. returned to ofc 11/11/11. Had been vomiting x 3 on 11/11/11. Had CBC in ofc. (normal) TC neg in ofc. Pt sent to hospital; 3-way Abd = positive intussusception -> air enema reduced.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC13, RV5, DTAP, HEP, HIBV, IPV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Pt. received vaccine(s) on 11/07/11. Pt. returned to ofc 11/11/11. Had been vomiting x 3 on 11/11/11. Had CBC in ofc. (normal) TC neg in ofc. Pt sent to hospital; 3-way Abd = positive intussusception -> air enema reduced.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: 10-5-11 - mother called - states child's arm swollen told mom to bring child in - (L) arm swollen with some redness - warm to touch - no tenderness to touch - apply ice packs & give MOTRIN - encourage child to move arm.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain
Clinical narrative: Left arm at site of injection when move arm above head or behind back shooting pain normal position - no pain.
Age: 33.0
Sex: M
Vaccine: HEPAB
Symptoms: Anxiety, Chills, Confusional state, Feeling cold, Mobility decreased
Clinical narrative: Patient reports that within 10-15 min after leaving clinic he experienced some confusion and "chills". Symptoms became worse over next 2-3 hours and lasted for 48hrs. Patient reports feeling "extremely cold", anxious & confused. Patient states he was in bed for 2 days but did not seek medical treatment for symptoms.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Area of injection red and swollen put on MEDROL DOSEPAK.
Age: 16.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Chills, Cough, Full blood count, Headache, Influenza virus test
Clinical narrative: Within 24 hours - fever, headache, cough, chills lethargy, body aches - lasting 7 days.
Age: 16.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Lethargy, Mononucleosis heterophile test, Pain, Pyrexia, Streptococcus test
Clinical narrative: Within 24 hours - fever, headache, cough, chills lethargy, body aches - lasting 7 days.
Age: 16.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Urine analysis
Clinical narrative: Within 24 hours - fever, headache, cough, chills lethargy, body aches - lasting 7 days.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site inflammation, Injection site pain, Pruritus
Clinical narrative: Two days after the patient received the vaccine, she had a burning sensation down the back of her neck that radiated to her lower chest. The burning sensation was accompanied by itching as well. The injection site was inflamed & sore as well. The patient went to ER for the reaction & was monitored, but no treatment was given. Dr. said it was reaction to the vaccine.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Injection site rash, red, raised, itchy > 4 days.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, PNC13
Symptoms: Hypersomnia, Irritability, Pyrexia
Clinical narrative: Seen 11/8 for 6 mo WCC, rec'd immunes. On 11/8 at 12n at her visit cranky fever 103. Decreased with TYLENOL to 101, slept most of day. Seen in our office 11/9 Dx ROM on antibiotics injection sites clear.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Injection site rash, red, raised, itchy > 4 days.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site haematoma, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Vaccinated 11/1/11 that evening noticed soreness shoulder to elbow and "started to puff". Continued with swelling and redness and heat throughout the week, starting to taper off on Saturday. Itchiness at red area on inside of forearm. Bruise at injection site half dollar size, and noticed another bruise half dollar size 6 inches down on outside forearm. No fever but warmness at site.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth
Clinical narrative: Vaccinated 11/1/11 that evening noticed soreness shoulder to elbow and "started to puff". Continued with swelling and redness and heat throughout the week, starting to taper off on Saturday. Itchiness at red area on inside of forearm. Bruise at injection site half dollar size, and noticed another bruise half dollar size 6 inches down on outside forearm. No fever but warmness at site.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash macular, Urticaria
Clinical narrative: Pt. reports that on 10/24/11, 1 wk after receiving 2nd GARDASIL vaccine she broke out in red, blotchy rash that turned into hives torso, arms & legs. Pt. started BENADRYL 10/27/11 with relief.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: 9 am HPV #3 GARDASIL vaccine given LA deltoid without diff. A few minutes after injection pt start scratching injection site. About 5 minutes later entire arm is itching per pt. BENADRYL 25mg PO given per protocol. Pt waits 20 min and itching has stopped and pt states she feels fine.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Pt stated she felt lightheaded after 3rd immunization "GARDASIL". Then she fainted for approx 4-6 seconds. Treatment included cool washcloth to forehead, crackers, water. Pt. stated no food since breakfast. Accompanied by mom. Waited 20 min. Advised ER if further complication.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure taken by EMS to ER.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Varicella
Clinical narrative: Chicken pox. Varicella. Rash despite vaccine.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Chills, Dizziness, Fatigue, Headache, Insomnia
Clinical narrative: Pt reported reactions began with headache progressed to lightheadedness, dizziness, vertigo chills, fatigue, insomnia.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Vertigo
Clinical narrative: Pt reported reactions began with headache progressed to lightheadedness, dizziness, vertigo chills, fatigue, insomnia.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Mother reports injection site from (R) elbow to (R) shoulder red, swollen and warm to touch. Symptoms reported 24 hours after injection. Does c/o itching. Mother administered BENADRYL.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) upper arm with swelling, warmth & pinkness around periphery of injection.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Blood prolactin, Differential white blood cell count, Electroencephalogram, Full blood count, Gaze palsy
Clinical narrative: Syncopal episodes. With arched back & all body stiffened. Eyes rolled up. Episode almost 15 secs. Pale & diaphoretic.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Hyperhidrosis, Metabolic function test, Musculoskeletal stiffness, Opisthotonus, Pallor
Clinical narrative: Syncopal episodes. With arched back & all body stiffened. Eyes rolled up. Episode almost 15 secs. Pale & diaphoretic.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncopal episodes. With arched back & all body stiffened. Eyes rolled up. Episode almost 15 secs. Pale & diaphoretic.
Sex: U
Vaccine: FLU3
Symptoms: Pallor, Syncope
Clinical narrative: Patient fainted and became pale. Patient sat in waiting area for 10 minutes and was provided with water.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient called stating still had arm pain 2 1/2 weeks after administration. Extremely painful for first 2-3 days - pt took OTC naproxen.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain
Clinical narrative: Approximately 5 hrs after injection, pt experienced ++ swelling in her upper arm and said it felt "lumpy" and hurt to touch. No previous reaction to pneumonia shot.
Age: 1.01
Sex: F
Vaccine: FLUX, HIBV, MMR, VARCEL
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Vesicular rash at site of varicella vaccine about 10-14d after vaccination.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Dysgeusia
Clinical narrative: Pt developed back pain & chest pain 3 hours after vaccination symptoms lasted 20 minutes. Also developed a metallic taste in mouth. This symptom is currently ongoing.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Decreased appetite, Headache, Myalgia, Nausea
Clinical narrative: Patient is a 30 y.o. female presenting with fever. Primary symptoms of the febrile illness include fever, headaches, abdominal pain, nausea and myalgias (generalized). Primary symptoms do not include cough, vomiting, dysuria or rash. The headache is not associated with weakness. The myalgias are not associated with weakness. 30 y.o. female presents to ED with c/o HA onset 1.5 ago s/p receiving flu shot, hives onset 3 days ago and fever of 102 onset 2 days ago. (+)Muscle aches and decreased appetite. Pt states that she took BENADRYL for the hives which resolved. Has been taking TYLENOL for fever without relief. Pt also c/o abd pain. Hx of iron deficiency and Von Willebrand disease.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: Patient is a 30 y.o. female presenting with fever. Primary symptoms of the febrile illness include fever, headaches, abdominal pain, nausea and myalgias (generalized). Primary symptoms do not include cough, vomiting, dysuria or rash. The headache is not associated with weakness. The myalgias are not associated with weakness. 30 y.o. female presents to ED with c/o HA onset 1.5 ago s/p receiving flu shot, hives onset 3 days ago and fever of 102 onset 2 days ago. (+)Muscle aches and decreased appetite. Pt states that she took BENADRYL for the hives which resolved. Has been taking TYLENOL for fever without relief. Pt also c/o abd pain. Hx of iron deficiency and Von Willebrand disease.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Vet was administered vaccine that was kept above storage temperature. No adverse event noted.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Dysarthria, Movement disorder
Clinical narrative: Pt claims he woke up at 3 am and couldn't move for awhile and he had slurred speech. His wife is a nurse, so he called her at work. They determined on their own that it was from the flu shot. Did not seek dr care.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm very sore, she has been taking (Rx) RELAFEN and TYLENOL OTC. She thinks the shot was given too high on her arm?
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Movement disorder, Pain in extremity
Clinical narrative: PNEUMOVAX <"Severe pain in arm, like he had surgery with no pain meds." Extreme difficulty in moving arm. Referred to primary care.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Pain, Vomiting
Clinical narrative: Major diarrhea, vomiting, body ache, chills for first day. Milder for day two.
Sex: U
Vaccine: FLU3
Symptoms: Chills, Pain, Pyrexia, Wheezing
Clinical narrative: Initial report was received 04 November 2010 from a health care professional which involved a cluster of six patients out of 160 vaccinees who all experienced similar events after receiving FLUZONE, lot number U3775CA. One of the six patients also experienced wheezing and has been captured separately in this case. The other five patients have been captured in case number 2010-06367. An unidentified patient (age, sex and date of birth not reported) had received FLUZONE, lot number U3775CA (route, site and date of administration not reported) and an unspecified amount of time later, they developed wheezing, body aches, a fever and chills. Information pertaining to the date of vaccination and event onset, concomitant vaccines, concurrent illness and past medical history were not reported. Outcome was not reported. The reporter for this case is the same as for case number 2010-06367.
Sex: U
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Fatigue
Clinical narrative: Initial report received from a health care professional on 22 October 2010. An unidentified patient had received an intramuscular injection of FLUZONE HIGH-DOSE (lot number not reported) on an unspecified date after vaccination the patient experienced weakness, shortness of breath (SOB) and fatigue. Medical history was not reported. Per the reporter, the recovery status is unknown. The reporter for this case is the same as for cases 2010-06115 and 2010-06116. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Pain, Tremor
Clinical narrative: Initial case received from a consumer, who is also the patient, on 07 September 2011. A female patient received FLUZONE HIGH-DOES (lot not reported) on 04 September 2011. One day post-vaccination, she experienced aches, leg shakes, weakness, and chills. She did not take her temperature, but self-treated with acetaminophen. She was not seen by a physician, and reported that it was her first year receiving FLUZONE HIGH DOSE.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Body temperature increased, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Initial case was received on 03 November 2010 from a consumer who is also the patient. A 69 year old female patient received on 02 November 2010 an injection of FLUZONE HIGH DOSE (lot number not reported). On 02 November 2010 the patient experienced a temperature of "101.2", swelling and soreness at the injection site and back and neck aches. She also complained of a sinus infection. The patient stated she was "not acutely ill" at the time of the vaccination. She was allergic to pet danders, epinephrine and had a milk intolerance. She stated she "reacts to anything injected into her." Concomitant medications included ASTROPRO, ibuprofen and SYNDRIN. No physician evaluation was needed per the patient. The symptoms were resolving. Documents held by sender: None.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Sinusitis
Clinical narrative: Initial case was received on 03 November 2010 from a consumer who is also the patient. A 69 year old female patient received on 02 November 2010 an injection of FLUZONE HIGH DOSE (lot number not reported). On 02 November 2010 the patient experienced a temperature of "101.2", swelling and soreness at the injection site and back and neck aches. She also complained of a sinus infection. The patient stated she was "not acutely ill" at the time of the vaccination. She was allergic to pet danders, epinephrine and had a milk intolerance. She stated she "reacts to anything injected into her." Concomitant medications included ASTROPRO, ibuprofen and SYNDRIN. No physician evaluation was needed per the patient. The symptoms were resolving. Documents held by sender: None.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Pyrexia, Respiratory tract congestion, Sneezing
Clinical narrative: Initial report was received 01 November 2010 from a consumer, who is the patient's sister. A female patient (age and date of birth not reported) had received a first dose injection of FLUZONE HIGH-DOSE (lot number, route, site and date of administration not reported) and one week later, she experienced coughing, sneezing and congestion. it was unknown if the event required a doctor's visit. Laboratory and diagnostic test results were not reported. At the time of the report, the patient's recovery status was unknown and the reporter had no additional information to provide. Follow-up information was received from the consumer's sister on 22 November 2010. The 83-year-old female patient received FLUZONE HIGH-DOSE on 08 October 2010. On the 10 October 2010, two days later, the patient also developed fever and chills. The outcome was reported as recovered. The reporter for this case is the same as for case number 2010-06289. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Respiratory rate increased
Clinical narrative: Initial report received from a consumer's parent on 03 February 2011. A 4-year-old female patient received on 13 December 2010 an intramuscular injection (site not reported) of FLUZONE, lot number U3573FA. The patient had no medical history and took no concomitant medications. She had no illness at the time of vaccination, had no other vaccines within 4 weeks of the FLUZONE and had no adverse event following prior vaccinations. Three days after vaccination on 17 December 2010, the patient developed an oral temperature of 102.9 (units not provided) and rapid breathing. The patient was seen 2 hours later in an Urgent Care facility where her temperature was 99. No fever reducer was given. The patient was given albuterol and her symptoms cleared up. The patient's mother stated that about 2months earlier the same situation occurred without having received a vaccination. The mother felt that the symptoms were not related to the vaccine. The outcome was reported as recovered. Documents held by sender: None.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Palpitations, Throat irritation
Clinical narrative: Initial report was received 17 December 2010 from a health consumer, who is also the patient. A 49-year-old female patient had received an intramuscular injection of FLUZONE, lot number UT3568BA on 12 October 2010 and three and a half hours later, she experienced a racing heart, burning throat and her face and ears were red. She had no illness at the time of vaccination and she had been taking TOPROL XL and Amaprozol concomitantly. Her past medical history included Penicillin and seasonal allergies. The event did not require a doctor's visit and outcome was reported as recovered. The patient had previously experienced a similar event following a flu vaccination 10 years ago. Follow-up information was received from the patient on 31 January 2011. The patient was taking omeprazole concomitantly (previously reported as "amaprazol"). Significant past medical history included hypertension and gastroesophageal reflux disease (GERD). The symptoms persisted for approximately 18 hours, and resolved on 13 October 2010. The patient did not seek treatment for the symptoms. No additional information was available. Documents held by sender: None.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Chest discomfort, Skin reaction
Clinical narrative: Initial report was received 13 September 2011 from a consumer, who is also the patient. A male patient (age not reported) had received a first dose of ACAM2000 (lot number VV04-003A) in the left arm, and a first dose of TYPHIM VI, lot number G1124-1, and a first dose of Anthrax vaccine (other manufacturer, lot number SAV288) on 09 September 2011. The patient had previously received an injection of FLUZONE, lot number UH453AB on 14 August 2011. On 13 September 2011, four days after receiving ACAM2000, TYPHIM VI and Anthrax vaccines, the patient experienced very mild chest pressure and he found "two spots"; one behind both ears between the ear and the hairline. The patient was advised to be evaluated by their physician on 13 September 2011. Relevant laboratory and diagnostic test data was unknown at the time of the report. Past medical history, concomitant medications and concurrent illnesses were not reported. Outcome was unknown. Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administration error, Injection site reaction
Clinical narrative: Initial report received from a consumer's parent on 23 December 2010. A 10-year-old male child received this year an intramuscular injection (site not reported) of FLUZONE, lot number not reported. The patient had a history of asthma and weak immune response. The patient had no known allergies, no illness at the time of vaccination and no other vaccines within 4 weeks of the FLUZONE. The patient's concomitant medications were reported as unknown. The patient was seen by a pulmonologist for vaccinations and received incremental doses of the flu vaccine. He had slight reaction at site this year. The patient was seen by a doctor. The outcome was not reported. The reporter for this case is the same as case 2010-07129. Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial report was received 14 October 2010 from a consumer, who is also the patient. A 66-year-old female, who had been taking ALLEGRA concomitantly, had received a left deltoid intramuscular injection of FLUZONE, lot number U3187AA on 07 October 2009 and on the evening of vaccination, the patient developed pain at the injection site which worsened over time until she was unable to lift her arm. She was seen by an internist, an orthopedic physician and a neurologist (results and findings not reported). The patient had no known drug allergies and no medical conditions. She had received past Influenza vaccinations for "many years". At the time of the report, the patient stated her arm felt better but there were limitations (not specified). Outcome was not recovered. Follow-up information received from a health care professional on 17 December 2010 reported that the patient had no drug allergies and denied any medical conditions. The outcome remained not recovered. Documents held by sender: None.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Initial case was received on 06 October 2010 from a consumer/patient. A 51 year old female patient received on 05 October 2010, a subcutaneous injection of FLUZONE (lot number UH184AB). On 06 October 2010, the patient experienced a red, warm, tender and hard injection site the size of a fifty cent piece. The patient had no illness at the time of the vaccination and no vaccinations within 4 weeks. She had no pre-existing medical conditions, no allergies and no concomitant medications. No treatment was prescribed. The outcome was unknown. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Initial report was received from a consumer on 29 September 2010. A female patient (age and past medical history not reported0, had received FLUZONE, lot number UH181AB (date, site and route of administration not reported) and an unspecified amount of time later, experienced swelling and warmth with pain down the arm, "from fingers to armpit". No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Dyskinesia, Eye movement disorder
Clinical narrative: Initial report was received from a consumer who is also the patient's parent on 20 September 2010. An eight year-old male patient with no reported illness at the time of vaccination, had received FLUZONE (lot number, site and route of administration not reported) on 02 September 2010, and "two days" after vaccination he experienced neck jerking and "eye twitching". The parent described the eye movement as the "pupils of his eyes" would move back and forth (left to right), randomly several times in a day. She stated the eye movement events had decreased but have not stopped. The patient was evaluated by his primary care professional. No treatments were reported. The patient had a follow-up appointment scheduled to see a neurologist. No further information was available at the time of this report. The patient's outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Electrocardiogram normal, Palpitations
Clinical narrative: Initial case received on 16 September 2010 from a patient. A female patient received an injection of FLUZONE (lot number not reported) on 11 September 2010. She experienced a "racing heart", elevated blood pressure, and dizziness five minutes post vaccination. She treated herself with an "extra dose" beta-blocker. She was evaluated at an urgent care facility, where an electrocardiogram (EKG) was performed. Per the patient, the EKG was normal/negative (no report was provided). Her pre-existing medical conditions included a latex allergy and supraventricular tachycardia (SVT). Concomitant medications included beta-blockers. She denied any acute illness at the time of the vaccination. The patient fully recovered and "felt better" by evening of the same day. Documents held by sender: None.