chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Client had just received his flu shot in the right deltoid muscle by School Nurse.  Fluzone vaccine by Sanofi, Lot # UH478AB, Exipration 6/30/12.  He stood up after receiving the injection and immediately fainted, falling to the floor and hit his head on the hard gym floor.  School Nurse assisted the client to lie on his back but stay lying down.  This nurse was called over with the Emergency Kit.  This nurse's assessment showed the client awake, alert, and orientated.  His skin was pale in color and cool to the touch.  He complained of his head hurting.  A large bump approximately 1 and 1/4 inch in diameter with redness and contusion was noted to the left forehead and eyebrow area.  No other injury noted.  Client was able to move all exremities by command.  Vital signs at 1615 hours by this nurse: Blood Pressure 98/64, Pulse 70, Respirations 24.  His pupils reacted to light quickly equal and bilaterally.  A cold pack was applied to the client's forehead.  Client was encouraged to take slow deep breaths and to stay resting on the floor for another five minutes.  Repeat vital signs at 1620 hours by this nurse: Blood Pressure 100/64, Pulse 64, Respirations 20.  His skin color was still pale, but improving.  Client was assisted to a sitting, and then a standing position.  He walked across the gym with assistance to side wall.  He sat down on a mat and still complained of being dizzy, so was laid down on the mat to rest.  His grandmother had accompanied him to the flu clinic, so the client's mom was notified of the incident at this time.  His mom stated she would come to get him.  Repeat vital signs at 1632 hours by School Nurse: Blood Pressure 90/54, Pulse 64, Respirations 20.  Client still complained of his head hurting and feeling dizzy, so he continued to stay lying down on the mat.  This nurse left to resume flu clinic duties as School Nurse stayed with the client to monitor him.  Per School Nurse there was no change in the client's condition.  Per School Nurse she spoke with the client's family about monitioring for any signs of complications and recommended seeing a doctor for any concerns.  When the client's mom arrived they left the clinic to rest at home.  11/16/11 0800 hours Per School Nurse she spoke with the client's father this morning.  He stated to her that the client does have the large bump on his forehead, but is fine otherwise and had no complications overnight.
Age: 1.06
Sex: M
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site on right thigh became erythematous and swollen. Seen in clinic on 15 Nov. Continued monitoring and no treatment was necessary. Resolving on its own.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Whelp the size of a quarter at the location the vaccination given.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Excessive eye blinking, Head titubation, Tic
Clinical narrative: Developed neurological ticks, head nodding, blinking of eyes, movement of the mouth.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Peripheral coldness, Syncope
Clinical narrative: Client had just received a flu shot in the right deltoid muscle by Nursing Student.  Fluzone vaccine by Sanofi, Lot # UH478AB, Exipration 6/30/12.  Client leaned forward in a faint, but was caught and lowered to the floor by Student Nurse.  This nurse was then called over with the Emergency Kit.  This nurse's assessment showed the client awake, alert, and orientated.  Her skin was pale and cool to the touch.  She stated she felt "fine" and had no complaints.  Vital signs at 1755 hours by this nurse: Blood Pressure 110/70, Pulse 60, Respirations 16.  Client was encouraged to stay resting and lying on the floor.  Vital signs at 1804 hours by this nurse: Blood Pressure 110/72, Pulse 60, Respirations 16.  Client was assisted into a reclined sitting position resting against her mom.  Mom reported the client had just finished playing basketball before coming to get her flu shot and had not eaten yet.  The client's mom gave the client a Fruit Punch Powerade to sip on.  Client stated still no complaints, but was still pale in color and cool to the touch.  Client was assisted up to sit in a nearby chair.  Vital signs at 1815 hours by this nurse: Blood Pressure 110/70, Pulse 60, Respirations 16.  Client's mom gave her a granola bar to eat.  Client stated still no complaints and her color was still a little pale, but was improving.  Client was assisted to stand.  She stayed standing without difficulty.  Client left the clinic with her mom, but was escorted to their car by Student Nurse.  11/16/11 1040 hours This nurse called to follow up on the client's condition today, but had to leave a message.  This nurse also spoke with Dr's. to report the incident.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Diffuse rash.
Age: 1.43
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Bruxism, Chills, Cough, Febrile convulsion, Gaze palsy
Clinical narrative: Pt. with history of fever on this day of 100.0 Also cough, rhinorrhea for 2-3 days. Pt. was brought to ER by parents because she had episode of what appears to be febrile seizure at 1930 . Pt's eyes rolled backwards, she was clenching teeth, her arms were shivering, this lasted 30 to 60 seconds.
Age: 1.43
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Pt. with history of fever on this day of 100.0 Also cough, rhinorrhea for 2-3 days. Pt. was brought to ER by parents because she had episode of what appears to be febrile seizure at 1930 . Pt's eyes rolled backwards, she was clenching teeth, her arms were shivering, this lasted 30 to 60 seconds.
Age: 14.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Cyanosis, Dizziness, Tremor
Clinical narrative: Became shaky and dizzy. Nail beds on right hand appeared blue which resolved after heating pad was applied and shakiness resolved after drinking orange juice. Had just drank 3 water bottles of cold water.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Fatigue, Headache, Lymph node pain, Lymphadenopathy, Musculoskeletal stiffness
Clinical narrative: Headache, bodyaches, fatigue, nasal congestion, post nasal drip, enlarged/tender axillary and cervical lymph node, neck feels stiff and sore, scattered pustules- 2 on shoulder, one on back and one on left leg.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Nasal congestion, Neck pain, Pain, Rash pustular, Upper-airway cough syndrome
Clinical narrative: Headache, bodyaches, fatigue, nasal congestion, post nasal drip, enlarged/tender axillary and cervical lymph node, neck feels stiff and sore, scattered pustules- 2 on shoulder, one on back and one on left leg.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dry throat, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: Day 2: dry throat, followed by severe sore throat for 2 days.  Day 5: fever for 2 - 3 days.  Day 7 : upper respiratory symptoms - nasal congestion and cough.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Auricular swelling, Chest pain, Erythema, Eye swelling, Lacrimation increased
Clinical narrative: First chest pain followed by vomiting.  Then 15 minutes later on the ride home, bright red skin, swollen eyes, swollen ears, itchy rash from head to toe, watery nose and eyes.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash pruritic, Rhinorrhoea, Vomiting
Clinical narrative: First chest pain followed by vomiting.  Then 15 minutes later on the ride home, bright red skin, swollen eyes, swollen ears, itchy rash from head to toe, watery nose and eyes.
Age: 41.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Arthralgia
Clinical narrative: Marked shoulder joint pain that has not resolved.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: CLIENT RECEIVED THIS IMMUNIZATION AT A WORK FLU CLINIC. ONE HOUR AFTER THE IMMUNIZATION, THE CLIENT FELT SHARP PAIN AT THE INJECTION SITE WHEN SHE WOULD MOVE HER LEFT ARM OR UPON INJECTION SITE PALPATION. ACCORDING TO THE CLIENT, THIS LASTED ABOUT 3 WEEKS. AT THE END OF 3 WEEKS, CLIENT SAID THE PAIN WOULD OCCUR WITH SUDDEN MOVEMENTS OF THE LEFT ARM OR DOING ACTIVITIES SUCH AS DRESSING HERSELF AND WHEN SHE LIFTED HER ARM UP SUDDENLY. THIS LASTED ABOUT 3 WEEKS. NOW CLIENT SAYS THAT PAIN IS MUCH LESS AND IS A DULL PAIN THAT OCCURS ABOUT TWO TIMES A DAY, AGAIN, WHEN SHE LIFTS HER ARM. CLIENT DENIED ANY SWELLING OR REDNESS AFTER THE INJECTION. Client instructed to see her doctor for pain.
Age: 28.0
Sex: F
Vaccine: FLU3, HEP, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema and erythema- site 7cm X 9cm.
Age: 15.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Insomnia, Loss of consciousness, Nervousness, Urticaria
Clinical narrative: Within 12 hours patient got hives on inner thighs.  Was given Claritin antihistamine to counteract reaction.  Hive eased for 12 hours, then returned on lower legs, arms, hips, and stomach.  Was given a second Claritin to try and help sleep.  Hives eased 8 hours later.  Called Dr. for further advise.  Hives again returned on back and buttocks 8 more hours later.  Also a persistent cough developed.  Went to Urgent care pm of the 2nd day after and was given a prescription for Prednisone.  Hives again eased for 24 hours, then returned slightly on feet 4 days later.  Patient is currently on the Prednisone regimen.  Most of the hives are healing and the cough is much better. All other allergic agents have been ruled out. Patient also passed out within minutes of receiving the flu shot, but it was initally attributed to nerves.
Age: 2.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Fall, Loss of consciousness
Clinical narrative: Child passed out in chair, hit the floor and continued to lose conciousness for 15 seconds.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Dyspnoea, Oropharyngeal pain, Pyrexia
Clinical narrative: Wheezing, shortness of breath, cough, sore throat, fever and chills.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Wheezing, shortness of breath, cough, sore throat, fever and chills.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Ataxia, CSF test abnormal, Computerised tomogram abnormal, Hypoaesthesia, Miller Fisher syndrome
Clinical narrative: Started 11/14 with numbness and Tingling in toes and fingers. Progressed to waist and then on Saturday, Nov 12, developed a Bell's Palsy and ataxia.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Nerve conduction studies abnormal, Paraesthesia, VIIth nerve paralysis
Clinical narrative: Started 11/14 with numbness and Tingling in toes and fingers. Progressed to waist and then on Saturday, Nov 12, developed a Bell's Palsy and ataxia.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: Pt's mother states that the patient developed a fever and redness around the area after the vaccinations, and noticed a knot on his right thigh where the Pediarix was administered about a week ago.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia, Rash, Type III immune complex mediated reaction
Clinical narrative: Arthus reaction on injection arm; 4 days later, developed numbness and tingling of his left arm, joint pain in the left arm and right shoulder, rash on left arm.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash on trunk and face.
Age: 72.0
Sex: M
Vaccine: HEP
Symptoms: Injection site discharge, Injection site induration, Injection site vesicles
Clinical narrative: Blister and the drainage with slight induration directly over site of injection.
Age: 0.34
Sex: M
Vaccine: DTPIHI, MMR, RVX
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: High fever 103.6 and diarrhea.
Age: 0.3
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Vomiting
Clinical narrative: Received PENTACEL on Thursday. Later that night patient started with a high pitched cry lasting 2 hours. Then Friday and Sat had a high pitched cry every time the patient cried. On Friday and Saturday had several episodes of vomiting.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site induration, Injection site infection, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Patient has, red, painful, hard bump at site of injection. It is warm to the touch. We informed patient to go to her MD to be seen as it looks like an infection.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Patient has, red, painful, hard bump at site of injection. It is warm to the touch. We informed patient to go to her MD to be seen as it looks like an infection.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Pain, Pallor
Clinical narrative: C/o being weak, dizzy, pale and body ache.
Age: 8.0
Sex: M
Vaccine: FLUN3
Symptoms: Anaphylactic shock
Clinical narrative: A serious spontaneous report of anaphylactic shock has been received from a health professional concerning an eight-year-old male patient, subsequent to FLUMIST. The patient's medical history included many allergies. Concomitant medications included epinephrine, prednisolone sodium phosphate, prednisone, albuterol and fluticasone propionate. The patient received FLUMIST in Oct-2011. Five hours after receiving FLUMIST, the patient experienced an anaphylactic shock. He was taken to hospital and immediately given epinephrine. The event of anaphylactic shock recovered on 28-Oct-2011.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Injection site pruritus, Rhinorrhoea, Sneezing, Vaccine positive rechallenge
Clinical narrative: Itching at injection site, sneezing, rhinorrhea, audible wheeze, labored breathing, given a dose of injectable Diphenhydramine 50mg/mL and a dose of injectable Epinephrine 1:1000 (1mg/mL) also given O2 at 4 liters. Ambulance was called pt transferred to medical center.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Wheezing
Clinical narrative: Itching at injection site, sneezing, rhinorrhea, audible wheeze, labored breathing, given a dose of injectable Diphenhydramine 50mg/mL and a dose of injectable Epinephrine 1:1000 (1mg/mL) also given O2 at 4 liters. Ambulance was called pt transferred to medical center.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Headache, Pain
Clinical narrative: Headaches a few days after shot; 5 days after shot complained of stomach pains; feeling aches, lower back pain; and sore legs and even pain in joints. 6 days after shot feeling a little better.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Headaches a few days after shot; 5 days after shot complained of stomach pains; feeling aches, lower back pain; and sore legs and even pain in joints. 6 days after shot feeling a little better.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) deltoid area 4 cm red, swollen, warm to touch, tx: symptomatic tx, f/u w/PCP in 48 hrs or sooner of fever or getting worse.
Age: 21.0
Sex: F
Vaccine: HPV2
Symptoms: Injected limb mobility decreased, Injection site pain, Oedema peripheral
Clinical narrative: Goose egg on right arm. Pain down to elbow, tenderness, restricted arm movement from side of body.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Diarrhoea, Eye pruritus, Eyelid margin crusting
Clinical narrative: Severe chills, vomiting, diarrhea, weakness, muscle & skin aches, swelling of injection site, red, itchy, matted eyes.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Myalgia, Ocular hyperaemia, Pain of skin, Vomiting
Clinical narrative: Severe chills, vomiting, diarrhea, weakness, muscle & skin aches, swelling of injection site, red, itchy, matted eyes.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: 2 cm redness to injection site 20-30 mins after injection.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pt has left upper arm soreness, redness 4 inches x 3 inches of swelling nausea, headache, fever 102.5 tympanic.
Age: 19.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Pt has left upper arm soreness, redness 4 inches x 3 inches of swelling nausea, headache, fever 102.5 tympanic.
Age: 0.24
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Expired drug administered
Clinical narrative: Patient was administered an expired vaccine on 11/3/11. Lot # C3501AA with Exp. date 5/25/2011 was found in box with Lot # C3581AB with exp. date 11/12/11. This was only discovered after the nurse administered vaccine to the pt. Vaccine given at approx. 4:45 pm. PENTACEL vaccine. Pt is rescheduled for vaccine - PENTACEL on 12/5/11.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Feeling abnormal, Nausea, Vertigo, Vomiting
Clinical narrative: See attached sheet. Patient stated in pre-screening that after receiving the flu shot she vomits and gets a fever after each time but wanted the flu shot because, "its better to be sick for three days vs getting the flu." RN checked her screening form and administered the injection. Patient was instructed to stay in the monitoring area. After approximately 10 minutes, patient complained of feeling nauseous, before she could be moved to the cot she ran to the restroom. Writer followed and heard patient vomiting. Patient complained of vertigo, writer applied a cool rag and monitored her. After approximately 10 minutes patient stated she felt well enough to walk back to the room. Patient was instructed to stay on the cot. After another 10 minutes patient stood up and complained that her back felt like, "its on fire" and stated she didn't feel right. Writer offered to contact her superior, patient stated no. RN took vitals, BP 122/78, P 84, R 18. LHI nursing educator was contacted and talked with RN, patient was instructed to contact her own primary care physician and that this reaction has nothing to do with the flu vaccine but it still related to her kidney infection. Patient stayed in the monitoring area for approximately 15 minutes she stated she felt better and rejoined her office.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: On the am of 11-16-11, care taker noticed a baseball size, bright red, swollen hot area on child's (L) leg. Recc. to mark area with pen to track size expansion. Recc warm compress to notify pediatrician for further care.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Extensive swelling of vaccinated limb, Feeling hot, Vaccination site reaction
Clinical narrative: Extensive swelling of vaccinated limb; Localized erythema; Localized feeling of warmth; Vaccination site reaction
Age: 1.8
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Body temperature increased, Febrile convulsion, Irritability
Clinical narrative: Initial report received from an extraction from VAERS database (VAERS identification number 400859) using a third party query tool on 27 January 2011. A female child, age reported as 1.8 (no birth date provided), received on 21 September 2010 a right arm intramuscular injection (dose 1) of FLUZONE, lot number UT3566BA and a right arm intramuscular injection (dose 1) of PREVNAR 13, Pfizer/Wyeth lot number E52353. The patient's had mild cold symptoms at the time of vaccination. She had no medical history and took no concomitant medications. The patient received the vaccines on the afternoon of 21 September 2010 while at a well check visit. The parents stated that the child was irritable on that evening. On 22 September 2010 at approximately 11:20 AM, she had likely a febrile seizure with a temperature recorded by mother as 103.5 tympanic. The episode resolved after approximately 5 minutes. The patient was brought to the physician for an evaluation. The outcome was reported as recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Crying, Febrile convulsion, Full blood count, Loss of consciousness, Skin warm
Clinical narrative: Initial report received form an extraction from VAERS database (VAERS identification number 401359) using a third party query tool on 27 January 2011. A female child, age reported as 1.8 (no birth date provided), received on 29 September 2010 a right arm intramuscular injection (dose 1) of FLUZONE, lot number UT3570EA. The patient had an allergy to OMNICEF. The patient had no current illness but just cried for a few minutes and then was totally back to normal. On 29  September 2010, the patient woke up burning up and would not stop crying. She then started to vomit, pass out and then starting seizing for about a minute. Paramedics were called and the patient was taken for an Emergency Visit. She was evaluated and a complete blood count (CBC), urinalysis (UA) and a streptococcal test were performed however, the results were not reported. The diagnosis was a febrile seizure. The outcome was reported as recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Streptococcus test, Urine analysis, Vomiting
Clinical narrative: Initial report received form an extraction from VAERS database (VAERS identification number 401359) using a third party query tool on 27 January 2011. A female child, age reported as 1.8 (no birth date provided), received on 29 September 2010 a right arm intramuscular injection (dose 1) of FLUZONE, lot number UT3570EA. The patient had an allergy to OMNICEF. The patient had no current illness but just cried for a few minutes and then was totally back to normal. On 29  September 2010, the patient woke up burning up and would not stop crying. She then started to vomit, pass out and then starting seizing for about a minute. Paramedics were called and the patient was taken for an Emergency Visit. She was evaluated and a complete blood count (CBC), urinalysis (UA) and a streptococcal test were performed however, the results were not reported. The diagnosis was a febrile seizure. The outcome was reported as recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Cough, Febrile convulsion, Irritability, Postictal state, Pyrexia
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 401447. A child female patient (age reported as 1.1) had received an intramuscular left leg injection of FLUZONE, lot number UT3570DA (dose 0) and a subcutaneous right leg injection of MMR II (Merck, lot number 1709Y, dose 0) and a subcutaneous left leg injection of VARIVAX (Merck, lot number 0066Z, dose 0) on 28 September 2010 and an unspecified amount of time later that day, the patient experienced a febrile seizure, very high fever, postictal state, respiratory tract congestion, irritability and cough. The patient had an emergency visit. At the time of vaccination, the patient had no concurrent illness and no past medical history. Outcome was recovered (date not reported). Documents held by sender: None.
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Respiratory tract congestion
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 401447. A child female patient (age reported as 1.1) had received an intramuscular left leg injection of FLUZONE, lot number UT3570DA (dose 0) and a subcutaneous right leg injection of MMR II (Merck, lot number 1709Y, dose 0) and a subcutaneous left leg injection of VARIVAX (Merck, lot number 0066Z, dose 0) on 28 September 2010 and an unspecified amount of time later that day, the patient experienced a febrile seizure, very high fever, postictal state, respiratory tract congestion, irritability and cough. The patient had an emergency visit. At the time of vaccination, the patient had no concurrent illness and no past medical history. Outcome was recovered (date not reported). Documents held by sender: None.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, HIBV, PNC13
Symptoms: Blood culture, Chest X-ray, Culture urine, Electrocardiogram, Febrile convulsion
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 401879. A 1-year-old male patient received an intramuscular first right leg injection of FLUZONE (lot number UT3562BA), a first intramuscular right leg injection of HAVRIX (GlaxoSmithKline, lot number), a fourth intramuscular left leg injection of PEDVAXHIB (Merck, lot number 0236Z), and a fourth intramuscular left leg injection of PREVNAR13 (Pfizer/Wyeth, lot number E80082) on 23 September 2010. One day post-vaccination, the patient experienced a febrile seizure and was seen in the emergency department. Diagnostic testing included a CBC, blood cultures, chest x-ray, urine cultures, and ECG. Concomitant medications included acid mantle/1% hydrocortisone cream. The patient had no reported medical history and was not ill at the time of vaccination. He subsequently recovered. Documents held by sender: None.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, HIBV, PNC13
Symptoms: Full blood count
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 401879. A 1-year-old male patient received an intramuscular first right leg injection of FLUZONE (lot number UT3562BA), a first intramuscular right leg injection of HAVRIX (GlaxoSmithKline, lot number), a fourth intramuscular left leg injection of PEDVAXHIB (Merck, lot number 0236Z), and a fourth intramuscular left leg injection of PREVNAR13 (Pfizer/Wyeth, lot number E80082) on 23 September 2010. One day post-vaccination, the patient experienced a febrile seizure and was seen in the emergency department. Diagnostic testing included a CBC, blood cultures, chest x-ray, urine cultures, and ECG. Concomitant medications included acid mantle/1% hydrocortisone cream. The patient had no reported medical history and was not ill at the time of vaccination. He subsequently recovered. Documents held by sender: None.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, HIBV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number 401887. A 1-year-old female patient received an intramuscular first left leg injection of FLUZONE (lot number UT3562BA), a first intramuscular right leg injection of VAQTA (Merck, lot number 0795Z), a third intramuscular left leg injection of PEDVAXHIB (Merck, lot number 0236Z), and a first intramuscular right leg injection of PREVNAR13 (Pfizer/Wyeth, lot number E72960) on 20 September 2010. The day of vaccination, the patient experienced a febrile seizure and was referred to neurology. She subsequently recovered. The patient had no reported medical history and was not ill at the time of vaccination. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number (VAERS ID 402187). A female patient with a reported age of 1.7 (months or years were not reported), had received a second dose left leg injection of FLUZONE, lot number UT3570EA on 13 September 2010 and 16 hours later on 14 September 2010 experienced a febrile seizure. The patient was evaluated in the emergency room (ER) and treated with antipyretics. No further information was provided at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Febrile convulsion
Clinical narrative: This case was received on 27 January 2011 via a third party query tool search on the VAERS database, under reference number (VAERS ID 404166). A female patient with a reported age of 0.8 (months or years were not reported), had received a first dose "subcutaneous" left leg injection of FLUZONE, lot number UT3566BA on 18 September 2010 and "within 12 hours" later experienced a febrile seizure. The patient was "observed" in the emergency room (ER). No testing was completed and patient was released without treatment. No further information was provided at the time of the report. The patient's outcome was reported as recovered (date not reported). Documents held by sender: none.
Sex: F
Vaccine: FLU3, MMRV, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Initial report received from an extraction from VAERS database (VAERS identification number 406370) using a third party query tool on 27 January 2011. A female child, age reported as 1.2 (no birth date provided), received on 21 October 2010 an intramuscular left leg injection (dose 1) of FLUZONE, sanofi pasteur lot number UT3570DA, a subcutaneous right leg injection (dose 1) of PROQUAD, Merck lot number 0194Z and an intramuscular left leg injection (dose 3) of PREVNAR, Pfizer/Wyeth lot number 914265. The patient had no illness, no medical history and no concomitant medications. On 21 October 2010, the patient developed a high fever and a febrile seizure. He was seen in the Emergency Room (ER). The outcome was reported as recovered. Documents held by sender: None.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Diarrhoea, Dysgeusia, Malaise, Nausea
Clinical narrative: Initial report received from a consumer on 25 October 2010. A 77-year-old male patient, with a history of hyperlipidemia, received on 23 October 2010 at 2:00 PM an injection (route and site not reported) of FLUZONE HIGH-DOSE, lot number U3610AA. The patient's concomitant medication was a multivitamin. On 23 October 2010 at 4:00 PM, he experienced nausea, diarrhea, a temperature of 100.4 (units not provided), general malaise and a funny taste in the mouth which changed from fruity to acidic to metallic. The patient stated that he reacts this way to all vaccines and that he was a sensitive person. He had a history of receiving a yearly flu shot. The patient was not seen by a physician. The outcome was reported as recovered. Follow-up information was received from a health care professional on 22 November 2010 reported the name of the vaccine provider and the county where vaccine was administered. The outcome remains recovered. Follow-up information received from a health care professional on 16 December 2010. The site and route of administration of the FLUZONE administered on 23 October 2010 was intramuscular in the left deltoid. The patient was not seen by a physician and no treatment was required. No further information is expected. Documents held by sender: None.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain in extremity, X-ray normal
Clinical narrative: Initial report was received 18 November 2010 from a health care professional. A cluster of three unspecified adverse events occurred (patients unidentified and number of patients not reported) out of a total of 600 vaccinees who had received FLUZONE HIGH DOSE (lot number not reported). The reporter had completed VAERS forms for each of the three events. Outcomes were not reported. Follow-up information was received from a health care professional on 07 January 2011. This case has been identified as a 72-year old female patient who received a right deltoid intramuscular injection of FLUZONE HIGH DOSE, lot number U3617AA. The patient's medical history and concomitant medications were not reported. The patient had no illness at the time of vaccination and no other vaccinations within 4 weeks of the FLUZONE HIGH DOSE. On 04 October 2010, the patient notified the health department that she had right arm weakness and pain since approximately 24-48 hours (reported as 06 October 2010) after vaccination. The patient was evaluated by her primary care physician (PCP). A right shoulder x-ray was performed and reported as within normal limits (WNL). The patient denied any fever, erythema or local reaction. She stated that her right arm function was improving. The patient felt that it was going to resolve and stated she was doing better now. The outcome was reported as recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Injected limb mobility decreased, Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: Initial report received on 06 September 2011 from a health care professional. A 65 year-old female patient who has seasonal allergies that are treated with unspecified allergy shots, had received a first 0.5 mL left deltoid dose of FLUZONE HIGH-DOSE (lot number UH436AC, route not provided) on 03 September 2011 between 1 and 2 pm and around 2 am the next morning she experienced a sore arm with sore/stiff muscle to where it was hard to lift the arm she was vaccinated in. Her neck on that side was also stiff, and she had a slight headache. The patient reported she could not sleep on that side of her body. Two days later, the muscle stiffness was slightly better, but there was no mention made of the other symptoms and whether they had resolved. The patient was "perfect" prior to the flu shot. It was noted the patient had received a tetanus shot 3 month prior, and an allergy shot 1 month prior. It was noted the patient takes concomitant medications COZAAR; however indication for medication was not provided. At the time of this report, the muscle stiffness was recovering/resolving, but it was unknown if the other symptoms had recovered. Patient was considered not recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Initial report received on 06 September 2011 from a health care professional. A 65 year-old female patient who has seasonal allergies that are treated with unspecified allergy shots, had received a first 0.5 mL left deltoid dose of FLUZONE HIGH-DOSE (lot number UH436AC, route not provided) on 03 September 2011 between 1 and 2 pm and around 2 am the next morning she experienced a sore arm with sore/stiff muscle to where it was hard to lift the arm she was vaccinated in. Her neck on that side was also stiff, and she had a slight headache. The patient reported she could not sleep on that side of her body. Two days later, the muscle stiffness was slightly better, but there was no mention made of the other symptoms and whether they had resolved. The patient was "perfect" prior to the flu shot. It was noted the patient had received a tetanus shot 3 month prior, and an allergy shot 1 month prior. It was noted the patient takes concomitant medications COZAAR; however indication for medication was not provided. At the time of this report, the muscle stiffness was recovering/resolving, but it was unknown if the other symptoms had recovered. Patient was considered not recovered. Documents held by sender: None.
Age: 65.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Initial report received on 06 September 2011 from a health care professional. A 65 year-old female patient who has seasonal allergies that are treated with unspecified allergy shots, had received a first 0.5 mL left deltoid dose of FLUZONE HIGH-DOSE (lot number UH436AC, route not provided) on 03 September 2011 between 1 and 2 pm and around 2 am the next morning she experienced a sore arm with sore/stiff muscle to where it was hard to lift the arm she was vaccinated in. Her neck on that side was also stiff, and she had a slight headache. The patient reported she could not sleep on that side of her body. Two days later, the muscle stiffness was slightly better, but there was no mention made of the other symptoms and whether they had resolved. The patient was "perfect" prior to the flu shot. It was noted the patient had received a tetanus shot 3 month prior, and an allergy shot 1 month prior. It was noted the patient takes concomitant medications COZAAR; however indication for medication was not provided. At the time of this report, the muscle stiffness was recovering/resolving, but it was unknown if the other symptoms had recovered. Patient was considered not recovered. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Henoch-Schonlein purpura, Joint swelling, Purpura, Rash, Urine analysis normal
Clinical narrative: Patient began developing a rash the night of the vaccination. The next day (11/12) she developed Henoch Schonlein Purpura. She had the purpura rash, ans swollen joints. We are still dealing with it...waiting to see if it progresses further.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Injected limb mobility decreased, Injection site pain, Neck pain
Clinical narrative: Pain around site. Hard to lift right arm that it was administered in. Pain on right side of neck. Tetanus shot.
Age: 30.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Erythema, Injection site pain, Oedema, Pain, Pruritus
Clinical narrative: Pain noticed in Right deltoid when stretching out arms above head on 9 Nov 2011. Noticed erythema, edema, warm to touch, and pruritis larger than a 50 cent piece but smaller than my palm to begin with. Tender to touch.  Erythema, edema, pruritis all larger than the size of my palm. Tender to touch. Symptoms started the day after injection (9 Nov) and progressively got worse until 13 Nov, when erythema dissipated.  Edema dissipated by 15 Nov 2011.
Age: 30.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Skin warm, Tenderness
Clinical narrative: Pain noticed in Right deltoid when stretching out arms above head on 9 Nov 2011. Noticed erythema, edema, warm to touch, and pruritis larger than a 50 cent piece but smaller than my palm to begin with. Tender to touch.  Erythema, edema, pruritis all larger than the size of my palm. Tender to touch. Symptoms started the day after injection (9 Nov) and progressively got worse until 13 Nov, when erythema dissipated.  Edema dissipated by 15 Nov 2011.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Heat rash
Clinical narrative: Member reported with concern due to break out from sweating, he has two satellites one is located just below the original site, the other one is on right elbow (Brachial area). All sites are being covered and member received additional care instructions to prevent any further sites. Member instructed to follow up if any additional sites appear or if symptoms become worse.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Otitis media, Pneumonia primary atypical
Clinical narrative: Received FLUMIST 11/7/11. Developed OM 11/11/11. Diagnosed with atypical pneumonia 11/13/11. Treated with ZITHROMAX, albuterol. No admission.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Urticaria
Clinical narrative: C/O pain the evening of vaccine. Then found hives following morning.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Localised oedema, Skin warm
Clinical narrative: 24 hours after injection (L) deltoid edema & erythema 7 cm 2 & raised & warm.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient with a history of positive for lyme disease who on 29-SEP-2009, was vaccinated with the first dose of GARDASIL (lot # 562300/0100Y, expiration date: 19-APR-2011) (dose and site of administration not reported) and in December 2009, the patient was vaccinated with the second dose of GARDASIL (lot number, dose and site of administration not reported). Concomitant therapy included cyproheptadine hydrochloride  and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid vaccine. On unspecified date, the patient started experiencing migraines after GARDASIL administration which then subsided after a month and came back after a second dose in December 2009. The patient sought unspecified medical attention. No treatment was given for the treatment of the adverse event. At the time of the report, the patient had not recovered. Follow up information has been received from a health care professional concerning the female student patient with no pre-existing allergies, birth defects, medical conditions or illness at time of vaccination who on 01-DEC-2009, at 16:03, was vaccinated intramuscularly with the second dose of GARDASIL (lot number: 662724/0313Y). On 06-OCT-2009, at 14:57, the patient experienced migraines. At the time of this report, migraines were ongoing. Laboratories and a computed axial tomography were recommended. The patient was also referred with a neurologist. The patient sought unspecified medical attention. Migraines were considered to be disabling by the reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 68 year old female consumer reporting on herself who in December 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included hydrocodone. The patient reported that 2 years later, on 01-OCT-2011 she experienced shingles and was hospitalized after receiving ZOSTAVAX (Merck). The patient received unspecified treatment for the AE. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 1.92
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site mass, Pyrexia
Clinical narrative: Fever x 2 days, ""knot in leg" (benign - resolved).
Age: 10.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Developed rash on opposite arm of injection within several hours. Parent took child to PMD. Dx hives had cortisone inj & prednisone rx.
Age: 1.02
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Less than 20 erythematous, papules on trunk. Fever 101.4.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site urticaria
Clinical narrative: Pruritic hives around area of vaccine administration.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Fatigue, Oedema peripheral, Pain, Pyrexia
Clinical narrative: 101-102 fever. Severe aches.  Arm red and swollen. Horrible aches fever for 2-1/2 days. Swelling and tired for 8 days.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: 101-102 fever. Severe aches.  Arm red and swollen. Horrible aches fever for 2-1/2 days. Swelling and tired for 8 days.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Breast tenderness, Injection site erythema, Injection site pain, Injection site reaction, Rash macular
Clinical narrative: Tenderness to site -woke her during night when laying on affected side (left deltoid). Next day area red with blotchy area that spread to inner aspect of left arm by that night (Wed 11/16). Tenderness to touch that extended to left breast and neck. Took Cipro and Benadryl --- by next morning Thursday 11/17 area still red and blotchy with some tenderness but improved from day before.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Tenderness to site -woke her during night when laying on affected side (left deltoid). Next day area red with blotchy area that spread to inner aspect of left arm by that night (Wed 11/16). Tenderness to touch that extended to left breast and neck. Took Cipro and Benadryl --- by next morning Thursday 11/17 area still red and blotchy with some tenderness but improved from day before.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Asthma, Chills, Condition aggravated, Dyspnoea
Clinical narrative: Chills, sweating, extreme fatigue, weakness, short of breath, exacerbation of asthma.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Hyperhidrosis
Clinical narrative: Chills, sweating, extreme fatigue, weakness, short of breath, exacerbation of asthma.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes zoster, Musculoskeletal chest pain, Rash
Clinical narrative: Pain, rash R lower exterior ribcage area.
Age: 11.0
Sex: F
Vaccine: HPV4, IPV, MNQ, TD
Symptoms: Dizziness
Clinical narrative: S/S lightheadedness and dizziness.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased
Clinical narrative: TEMP 102.4 X 1 DAY, THEN <100 X 2 DAYS.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Cough, Dyspnoea, Heart rate increased, Palpitations
Clinical narrative: Began wheezing, cough, palpitations. initially. Progressed to fever, chills and shortness of breath and extremely rapid heart beat. Temperature taken at 5:35PM was 102.2F.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Wheezing
Clinical narrative: Began wheezing, cough, palpitations. initially. Progressed to fever, chills and shortness of breath and extremely rapid heart beat. Temperature taken at 5:35PM was 102.2F.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives, starting at injection site (left thigh) spread all over body.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site nerve damage, Injection site pain, Insomnia
Clinical narrative: Patient has had dozens of flu shots, but none have hurt as much as this one did when it was administered or for such a long time afterward - more than three weeks later! Arm is so sore patient can barely move it and has lost sleep. Apparently the pharmacist/technician hit a nerve in the deltoid area. Whatever the case, it was not administered correctly. Patient has applied heat and taken NSAIDS, but should not have to do this almost a month after receiving a shot. Next year, patient is going to a real nurse and getting the shot in the hip.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient has had dozens of flu shots, but none have hurt as much as this one did when it was administered or for such a long time afterward - more than three weeks later! Arm is so sore patient can barely move it and has lost sleep. Apparently the pharmacist/technician hit a nerve in the deltoid area. Whatever the case, it was not administered correctly. Patient has applied heat and taken NSAIDS, but should not have to do this almost a month after receiving a shot. Next year, patient is going to a real nurse and getting the shot in the hip.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain for about 1 month was told take TYLENOL.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Pyrexia, Speech disorder
Clinical narrative: Pt received FLUZONE shot on Thursday Oct 20th 2011 at a school based clinic that day. Pt is autistic. Parents noted he was less fussy that night. Saturday and Sunday he had a fever. Monday he was slow having flu-like symptoms. Patient also began suffering with "ST" words. This has been his major symptom the last 3 weeks. Patient had shot last year also. Parents did not take him into the provider to be examined.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria
Clinical narrative: Patient reported 4 x 3 in whelp at injection site. Still present 48 hours after injection.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dizziness
Clinical narrative: Patient told me today that the day after her flu shot she woke up dizzy and coughing non-stop for 4 hours straight. Then both side effects stopped. She told me this happened once before after a flu shot.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Balance disorder, Fall, Hemiparesis, Nausea
Clinical narrative: Patient received high dose flu vaccine 9-28-11. At 4:00 P.M., became nauseated and had a large emesis. Went to take a shower lost balance and fell backward into tub. Wife found him 3 hours later. Back pain x 24 hours. Right sided weakness for 1/2 day.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Patient received high dose flu vaccine 9-28-11. At 4:00 P.M., became nauseated and had a large emesis. Went to take a shower lost balance and fell backward into tub. Wife found him 3 hours later. Back pain x 24 hours. Right sided weakness for 1/2 day.
Age: 46.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Rash erythematous
Clinical narrative: Swelling around injection site and spreading to elbow; red rash; patient took BENADRYL.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: CSF protein increased, Electromyogram abnormal, Guillain-Barre syndrome, Neuropathy peripheral, Rash
Clinical narrative: Acute neuropathy/GBS (357.OAP)/Rash mild form GBS, did not required treatment or hospitalization.