chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Malaise, Presyncope, Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 30-OCT-2006 was vaccinated IM with her first dose of GARDASIL, lot #653978/0955F. Immediately after receiving the vaccination the patient fainted. She was sent to the emergency room, where it was determined she had fainted "due to nervousness over the needle." The patient recovered "a few hours" after the vaccination. There was no product quality complaint involved. Additional information has been requested. 01/05/2007 Follow up information has been received from a healthcare worker and an emergency room physician concerning the 17 year old female (previously reported as 18) student with no medical history who on 30-OCT-2006 at 2:58 p.m. received her first dose of GARDASIL, lot #653978/0955F, in the left deltoid. The ER physician reported that on the way back to the waiting room, she felt very lightheaded. She sat down, did not feel well at all and then had an episode of syncope. She did not fall or injure anything. She woke up when she became horizontal. She felt fine in the ER. Her supine blood pressure was 105/50 with a pulse of 74. Standing up, it was 108/60 with a heart rate of 84. The ER physician's impression was that the patient probably had a vasovagal reaction to her injection. She was asked to return immediately if she has any recurrence of these signs or symptoms. He did not feel laboratory testing was indicated for this isolated incident of vasovagal syncope. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning an 18 year old female patient who on 30-OCT-2006 was vaccinated IM with her first dose of GARDASIL, lot #653978/0955F. Immediately after receiving the vaccination the patient fainted. She was sent to the emergency room, where it was determined she had fainted "due to nervousness over the needle." The patient recovered "a few hours" after the vaccination. There was no product quality complaint involved. Additional information has been requested. 01/05/2007 Follow up information has been received from a healthcare worker and an emergency room physician concerning the 17 year old female (previously reported as 18) student with no medical history who on 30-OCT-2006 at 2:58 p.m. received her first dose of GARDASIL, lot #653978/0955F, in the left deltoid. The ER physician reported that on the way back to the waiting room, she felt very lightheaded. She sat down, did not feel well at all and then had an episode of syncope. She did not fall or injure anything. She woke up when she became horizontal. She felt fine in the ER. Her supine blood pressure was 105/50 with a pulse of 74. Standing up, it was 108/60 with a heart rate of 84. The ER physician's impression was that the patient probably had a vasovagal reaction to her injection. She was asked to return immediately if she has any recurrence of these signs or symptoms. He did not feel laboratory testing was indicated for this isolated incident of vasovagal syncope. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: After 1st day, reactions rash, itching on face, arms and legs since Oct 20th 2006. Pt went to see doctor on 11/08/06 but talked to MD on 10/20/06 and got Prednisone on 10/27/06.
Age: 5.0
Sex: U
Vaccine: DTAP, HEPA, IPV
Symptoms: Hypotonia, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 days after Dtap site became hot, hard, red in oval from elbow to shoulder (right upper arm). Pt affected droopy. Dr called by mom, antibiotic prescribed oral, resolved.
Sex: F
Vaccine: FLU3, HEPAB, TD, YF
Symptoms: Abdominal pain, Chills, Diarrhoea, Fatigue, Feeling hot
Clinical narrative: 11/03/2006 at 4am clt developed sx of Nausea, Vomiting and diarrhea. Clt stated she felt very tired with episodes of chills and sweating and sore upper abdomen. No fever. Client states she had GI problems and often experiences GI side effects with medication. 11/09/06 TC to client states n/v stopped on 11/03, but continued to have extreme hotness and sweating thru 11/4. Client was fine on 11/05/06.
Sex: F
Vaccine: FLU3, HEPAB, TD, YF
Symptoms: Hyperhidrosis, Nausea, Vomiting
Clinical narrative: 11/03/2006 at 4am clt developed sx of Nausea, Vomiting and diarrhea. Clt stated she felt very tired with episodes of chills and sweating and sore upper abdomen. No fever. Client states she had GI problems and often experiences GI side effects with medication. 11/09/06 TC to client states n/v stopped on 11/03, but continued to have extreme hotness and sweating thru 11/4. Client was fine on 11/05/06.
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, MNQ, TTOX
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Skin discolouration
Clinical narrative: Swollen arm, fever pain in arm, antibiotics. Follow-up: After receiving the Meningococcal vaccine my arm was very sore. The next day my arm was discolored and swollen followed with a fever. I went to the emergency room and received antibiotics. I went back to my college that night. When swelling got worse I went back to the ER and stayed in the hospital from Friday - Sun.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Dehydration, Hypersensitivity, Muscle spasms, Pyrexia
Clinical narrative: Pt received injections 10/25/06. Flu and HPV in one thigh. Tdap and Menactra in other thigh unk which thigh each given. Pt then went to allergist and received allergy injection in each arm. Admitted 10/26/06 for fever 103, dehydration and muscle cramping, sent home 10/27/06. DC DX: allergic reaction.  2 day history of fever. On same day as immunizations she received routine allergy shots. Immunizations received in thighs and allergy injections in arms. Complained of arms puffed and welted evening prior to admission, became painful. Also blotchiness on legs. Complained of pain in legs. Headache since immunizations, myalgias and arthralgias especially to shoulder area. Neck pain, prickly sensaton in feet. Previous immunization reacion 3 weeks ago with pain and symptomatic problems.  PMH: environmental allergens. Eczema. Roavirus at age 2  months. PE: Extremities, there is injection site visible. No rash, erythema or exudate noted around the injection sites. No other rashes.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: immediately following Injection, my arm started to itch. Started swelling, became red, and hot to touch. About size of Baseball. Duration 24 hrs.
Age: 43.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site swelling, Lymph node pain
Clinical narrative: Chills, joint pain, 4 inch diameter raised, red, left arm area where injection given. Sore lymph node under arm.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Several days later, fever, chills, headache, body aches.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Cough, Headache, Influenza like illness, Pain
Clinical narrative: 10/31/06 had flu vacc, 11/02/06 began flu symptoms, feverish, chills, headache, achy, productive cough, runny nose, sore throat, will observe for now.
Age: 42.0
Sex: M
Vaccine: FLUX
Symptoms: Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: 10/31/06 had flu vacc, 11/02/06 began flu symptoms, feverish, chills, headache, achy, productive cough, runny nose, sore throat, will observe for now.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Pneumonia, Pyrexia
Clinical narrative: Swelling, redness and pain over right deltoid, developed by next AM fever to 102.6 CXR showed pneumonia on 11/09/06.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Hyperhidrosis, Insomnia, Nausea, Pain
Clinical narrative: Could not sleep, sweating, hurt all over, nausea, headache.
Age: 0.02
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Hyperhidrosis, Pruritus
Clinical narrative: Pt received vaccination around 9am returned to vaccination room at 10:30 with complaints of itching, difficulty breathing, diaphoresis, and dizziness. Fire and medic called to triage pt on site. Pt walked away after treatment.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Nasal congestion
Clinical narrative: 3 days after getting injections noticed dry cough, felt congested, no temp, no redness, no swelling at either site.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Contusion, Myalgia
Clinical narrative: Left bicep area tightened up within 20 minutes of shot; then the left upper arm ached. An 8 on a 1-10 pain scale. Like the bone has been bruised. The area near the bicep actually turned black and blue. By Oct. 6 the aching stopped and the bruising gradually disappeared in 10 days.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea
Clinical narrative: Could not breathe without coughing 3 hours after vaccination.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Left arm pain at site of injection of flu shot began 3 days after injection and has continued to date. Some relief with Ibuprofen. Pain radiating up and down Left arm to shoulder, elbow, armpit, left chest.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation, Joint range of motion decreased, Nasal congestion, Swelling
Clinical narrative: congestion in the 24hours after injection and swelling entire upper Right arm including right shoulder. With inflammation into right axilla very painful with mobility greatly decreased.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Joint range of motion decreased, Urticaria
Clinical narrative: Urticaria upon shots-treatment with Benadryl. Decreased range of motion. Epinephrine. Pulse  x 2 degrees
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Grand mal convulsion
Clinical narrative: Patient has seizure history. Last seizure was over 1 year ago. Had grand mal seizure 31 hours after receiving flu vaccine.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Chills, Confusional state, Decreased appetite, Irritability, Musculoskeletal stiffness
Clinical narrative: Patient received Proquad on 11-3-06. Child had fever 11-4-06 of 101F Tylenol and Motrin given. Mother stopped Tylenol on Sunday; child had no fever. 11-6-06 Child at day care developed temp 102.1F child cranky and sleeping and no appetite. Monday child shivering wanted blanket, stiffened up, child confused. Temp 105.6 at hospital. Tylenol supp given.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC
Symptoms: Pyrexia, Somnolence
Clinical narrative: Patient received Proquad on 11-3-06. Child had fever 11-4-06 of 101F Tylenol and Motrin given. Mother stopped Tylenol on Sunday; child had no fever. 11-6-06 Child at day care developed temp 102.1F child cranky and sleeping and no appetite. Monday child shivering wanted blanket, stiffened up, child confused. Temp 105.6 at hospital. Tylenol supp given.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Insomnia, Pain, Pruritus
Clinical narrative: 5x5 for one day. Right arm red, swollen, warm, painful; rates pain at "7", couldn't sleep because of pain, positive itchy. Instructed patient to apply ice; patient given Clarinex.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Swelling
Clinical narrative: 5x5 for one day. Right arm red, swollen, warm, painful; rates pain at "7", couldn't sleep because of pain, positive itchy. Instructed patient to apply ice; patient given Clarinex.
Age: 65.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Erythema, Injection site pain, Swelling
Clinical narrative: Vaccine given on 10-31-2006. Arm turned red and swelling within a few hours. Very painful. Temp 100F by 7 pm. Went to hospital. ER doctor confirmed a reaction. Use "ice" and go back to doctor. Went back to doctor on 11/01/06 was told it was cellulitis and given amoxcillan 500 mg for 7 days.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Flu vaccine injected on 11/11/06. Redness at site noted 20-24 hours after injection. Applied warm compress. Increased in size over next 24 hours - scheduled appt with Pediatrician. 10 cm x 8.5 cm redness, warm, positive induration. Rx Duricef. Also seeing allergist.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: It was reported that three employees complained of pain and swelling at the injection site. One employee had redness at the injection site and two other employees complained of pain and swelling and had an egg shaped lump at the injection site (and one of these reported feeling flushed without fever). All reported the area was warm to the touch. Symptoms for all patients except one had resolved by 26-SEP-2005. All patients had received the flu shot in the past with no reactions. This case involves a female patient (age not reported) who developed redness and irritation over the entire top of her arm at the injection site after receiving the intramuscular injection of FLuzone in the deltoid on 21-SEP-2005. Onset date of symptoms and treatment received was not reported. As per reporter the symptoms had resolved by 26-SEP-2005 and patient recovered. Same reporter in cases 2005-01923, 2005-01924, 2005-01925, 2005-01926, 2005-01927. Follow-up information received from a health care provider on 23-NOV-2005. The vaccine administrator's name, patient's date of birth and age are provided. The patient's age is 31 years. No additional information is provided. Further information is not expected.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Flushing, Injection site reaction
Clinical narrative: Initial report of a cluster of six cases with the same lot number was received from a health care professional on the 26/Sep/2005. It was reported that three employees complained of pain and swelling at the injection site. One employee had redness at the injection site and two other employees complained of pain and swelling and had an egg shaped lump at the injection site (and one of these reported feeling flushed without fever). All reported the area was warm to touch.  Symptoms for all patient except one had resolved except for one by 26 September 2005. All patients had received the flu shot in the past with no reactions. This case involves a male patient ( age not reported) developed an oval shaped hard area right below injection site, his face was flushed and his cheeks were red after receiving the intramuscular injection of Fluzone in the deltoid on 21 Sep 2005.  The nurse checked the patient's temperature as he felt feverish but he did not have a fever. Onset date of symptoms and treatment received was not reported. As per reporter the symptoms had resolved by 26 Sep 2005 and patient recovered. Same reported cases 2005-01922, 2005-01924, 2005-01925, 2005-01926, 2005-0192 Follow-up information received on 28 Nov 2005. The patient name and date of birth are clarified. The patient was 30 years old at time of the event. Further information is not expected.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Urticaria
Clinical narrative: Within one hour of receiving vaccine mother called and stated patient now with red welts and Left cheek/back of neck/ lower back. OK breathing, denies chest tightness referred to ER.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Joint range of motion decreased
Clinical narrative: 2 hours after getting injection patient started having flu like symptoms. Could hardly lift arm. Patient took some Tylenol and has been feeling better.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pyrexia, Tachycardia
Clinical narrative: Within several hours of vaccination.  Patient came down with fever, chills and pain at injection site.  Went to emergency room 10/21- Febrile 102.2 degree F, tachycardic to 106.  Patient admitted 10/21.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site induration, Skin ulcer
Clinical narrative: Vesicular lesion 1.5cm at injection site. 7 other vesicles resembling varicella lesions on arms, chest. Follow-up Information sent 16 November, 2006: I am a family doc. I had a patient with an unusual reaction to killed flu vaccine. I am attaching photos. The first two (dated 2004 on photo) were taken Nov 8, 2006, 1 week after vaccination. The lesions appear vesicular and are on both arms, the largest being at the injection site. The second set of three photos were taken Nov 14th, 2006, 2 weeks after vaccination. The lesions at the injection site was 2cm across, appeared to have central clearing with an indurated margin. The lesions are not pruritic. I will fax the VAERS sheet and mail the originals. Thanks for your help and insight.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered, Unevaluable event
Clinical narrative: Administered wrong dose of flu vaccine to patient. Administered 0.5cc IM of Flulaval-Influenza vaccine for Adults to a 6yr old child.  This patient did not have an adverse event the patient was given the wrong dose of medicine.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Swelling, Tenderness, Urticaria
Clinical narrative: 11/4/06 Noticed large red welts with red streaks on right underarm with swelling, tenderness and pain.  Started approximately 24 hours after vaccine.  Seen at Arnot Ogden ER at 10 PM on 11/4/06.  Reaction possibly caused by vaccine per MD.  Placed on Keflex for 7 days.  Symptoms improved, now resolved.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Erythema, Feeling hot, Pain, Pyrexia, Swelling
Clinical narrative: Leg swelling, redness, warmth, pain, low grade temp 99F. Tylenol and Ibuprofen, cool compress.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Localized erythema, pain and swelling at site of injection without any fever and nausea as well.  Being treated with Benadryl and Tylenol.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Large left upper arm cellulitis around left upper arm to left axillae.  Went to ER.  Received 48 hours of IV antibiotics then 10 days of oral antibiotics.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: NL/YG cellulitis on left upper arm with fever, chills.  Resolved with ibuprofen, ice and rest over next 48-72 hours.
Age: 1.05
Sex: F
Vaccine: IPV, MMR, PNC
Symptoms: Rash papular
Clinical narrative: Scattered pink papules and crusted spots on chest, arms and legs.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient presented with rash covering body.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain upper, Anorexia, Delusion, Dyskinesia, Hearing impaired
Clinical narrative: 4 hours after immunization had stomach ache, low grade fever.  10:30 PM had high fever, delusional, jerky motions for 2 hours.  Swollen glands and could not hear out of left ear.  Achy muscles, sore throat and not eating.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Lymphadenopathy, Myalgia, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: 4 hours after immunization had stomach ache, low grade fever.  10:30 PM had high fever, delusional, jerky motions for 2 hours.  Swollen glands and could not hear out of left ear.  Achy muscles, sore throat and not eating.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: Patient reports rash/hives all over body, began on 11/8/06 (2 days after receiving vaccine).
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: Vaccine given 11/1/06.  Fever, chills, dizziness developed that day, lasting until 11/6/06.
Age: 63.0
Sex: F
Vaccine: HEPA, IPV, MEN, TYP, YF
Symptoms: Glossodynia, Pruritus, Rash, Tongue oedema
Clinical narrative: 5 days after recieving vaccine noted swelling and soreness of her tongue which is still present. Also noted a fine ,itchy rash on forehead which appeared at the same time.Tthe rash lasted a few days and has now subsided.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Headache, Hyperhidrosis, Vomiting
Clinical narrative: Received flu shot on 11/10/06 in the morning, was fine all day, at approximately 345pm developed bad headache, sweating, vomiting and chills. no neck pain or stiffness. took tylenol. did not go to the emergency room.
Age: 37.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Hypoaesthesia, Oral mucosal blistering, Pain, Swelling
Clinical narrative: 11-15-06 noticed numbness, swelling, pain, and blisters roof of mouth behind two front teeth. Stomach ache evening of 11-13-06. Will go to see a doctor if symptoms do not resolve.
Age: 49.0
Sex: M
Vaccine: FLUN3
Symptoms: Influenza like illness, Pain, Pharyngitis, Rhinitis, Viral infection
Clinical narrative: Seen on 14Nov06 with c/o cold and flu sx. Following Flu Mist inoculation 3 days prior. Non-specific symptoms listed, generalized achiness. Diagnosed as Viral Syndrome (NOS) s/p Flumist 3 days prior. Motrin prn, Robitussin DM, push fluids.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Injection given Sub Q intead of IM. Ice pack to arm immediately.  No adverse symptoms. No local irritation or inflammation.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Pruritus
Clinical narrative: Received inactivated flu vaccine approx. 0830 11/15/06 was sent to outpatient tx. unit approx 1440 with c/o itching then dry cough and some dypsnea. BP 122/79, P 91, R 22 O2 sat 100%, 1444 epinephrine 0.4 given IM right deltiod, albuteral via nebulizer x3 starting at 1445, IV of 0.9%NS started , 1505 Benadryl 50mgm given IVP, 1510 Solu-medrol 125mggm given IVP at this time BP 146/71, P123, O2 sat 98%. Monitored for 3 hours and discharged to home-respiratory symptoms resolved
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Bursitis, Fatigue, Malaise, Pharyngolaryngeal pain
Clinical narrative: Received vaccination at hospital during annual flu shot administraion. Vaccination to Right deltoid.  Swelling and tenderness of right elbow on 11/07/2006. Increasing fatique and general joint tenderness to all joints-onset evening of 11/07/2006. Low grade fever, running nose, sore throat and general mailaise, onset 11/10/06. Fever resolution on 11/13/06. R elbow continues to be swollen and inflamed as of this report. Right arm weakness persists.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea, Swelling, Tenderness
Clinical narrative: Received vaccination at hospital during annual flu shot administraion. Vaccination to Right deltoid.  Swelling and tenderness of right elbow on 11/07/2006. Increasing fatique and general joint tenderness to all joints-onset evening of 11/07/2006. Low grade fever, running nose, sore throat and general mailaise, onset 11/10/06. Fever resolution on 11/13/06. R elbow continues to be swollen and inflamed as of this report. Right arm weakness persists.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Irritability, Rash, Rash maculo-papular, Vomiting
Clinical narrative: Developed pinpoint rash on back 24 hours after vaccines.  Then developed macular papular rash on arms.  Slightly fussy but was feeding well.  No fever.  Emesis x 1 morning of 11/3/06.  Per ER report.
Age: 62.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Back pain
Clinical narrative: Low back pain onset same day as immunizations.   No h/o injuries or trauma. Has improved over last 2 days somewhat.  No fever, no other arthralgias or myalgias, no weakness or numbness.  Patient has had h/o of similar episodes of low back pain x 2 in her life.  Immunizations given include Td right deltoid and influenza vaccine left deltoid.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site warmth, Oedema peripheral, Urticaria
Clinical narrative: Arm was swollen, hot to the touch, welts from the elbow to the shoulder. This lasted for two days, I was very uncomfortable and I stayed in bed taking Advil and Benadryl. By the 4th day, I felt back to normal.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: RT HAD 5CM SWELLING, REDNESS.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Swelling
Clinical narrative: Patient developed erythema (2 days post-vacine) with swelling and redness.  Main involved area was approximately baseball sized with some diffuse smaller surrounding red areas.
Age: 11.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dysgeusia, Facial palsy, Ophthalmoplegia
Clinical narrative: Acute Bell Palsy, noon on 11/15/06. Left sided. Neuro exam normal. 12/19/06 Received medical records from reporter/provider which reveal patient in good health on day of vax.  Next visit was 11/16/06 which revealed that on 11/15 patient abruptly developed droop of left face, smiling only on right side, decreased taste on left side.  Left eye would not close tightly & could not raise left eyebrow.  Treated w/eye ointment. Final DX: Bells Palsy.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Dysphagia, Dyspnoea, Injection site pain
Clinical narrative: At the time of injection (11:55 a.m. Tuesday morning Nov. 14th 2006) I was healthy, just finished a 3 mile run, was well hydrated and feeling great.  After the injection I started going down hill in the evening.  Starting with a sore arm at site for injection.  Then aches and pains, followed by very sore throat and still today it is hard to swallow. Could not sleep that night due to the aches, sinus congestion, inability to breath through nose, sore throat and every joint aching as well as muscle aches that included even my gums and scalp.  The next day I had absolutely no energy, could not get up and function.  Stayed in bed all day unable to participate in daily life, and took Sudafed, Advil and throat spray. These symptoms continued through the night of the 14th through all day on the 15th and are some what subsiding but still very much present on the 16th.  The reaction was so severe I swore off ever getting another flu shot.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Insomnia, Myalgia, Nasal congestion, Pain, Pharyngolaryngeal pain
Clinical narrative: At the time of injection (11:55 a.m. Tuesday morning Nov. 14th 2006) I was healthy, just finished a 3 mile run, was well hydrated and feeling great.  After the injection I started going down hill in the evening.  Starting with a sore arm at site for injection.  Then aches and pains, followed by very sore throat and still today it is hard to swallow. Could not sleep that night due to the aches, sinus congestion, inability to breath through nose, sore throat and every joint aching as well as muscle aches that included even my gums and scalp.  The next day I had absolutely no energy, could not get up and function.  Stayed in bed all day unable to participate in daily life, and took Sudafed, Advil and throat spray. These symptoms continued through the night of the 14th through all day on the 15th and are some what subsiding but still very much present on the 16th.  The reaction was so severe I swore off ever getting another flu shot.
Age: 53.0
Sex: M
Vaccine: DTPHIB, FLUX, PPV
Symptoms: Erythema, Joint range of motion decreased, Musculoskeletal stiffness, Swelling
Clinical narrative: Pneumonia vaccine, noteworthy reaction.  Received immunization in right leg.  About 6 hours after this, developed stiffness and swelling in leg muscle from hip to knee, so severe that I literally could not bend the leg more than a few degrees.  It took 15 minutes to bend it enough to sit in an automobile, and then another 15 minutes to unbend it upon standing up.  Skin was light pink on front and inner leg, about 10 degrees warmer to touch than opposite leg, and leg had swollen about 10-15% larger than other leg, to the point the skin was stretched.  This extreme swelling and stiffness/warmth lasted 30 hours and then slowly dissipated over the following three days, with some redness and swelling remaining between knee and 8" above knee for another 3 days.  So, a little over a week altogether.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: MOTHER CALLED TO CANCEL NEXT APPT. WHICH WAS TO BE NOV. 17, 06, STATED THAT CHILD HAD A FEVER OF 104 FOR THREE DAYS AND THAN A RASH. IT TOOK A LONG TIME FOR HER TO FEEL BETTER. SHE WILL WAIT 2 MONTHS AND TRY SHOTS AGAIN.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Joint range of motion decreased, Pain, Paraesthesia
Clinical narrative: Pain in my left arm, left hand tingling, painful shoulder.  Range of Motion are severly limeted.  Have recieved a shot of toradal at Doctors office.  Also took a prescription of prednazone.  A nerve damage test is scheduled for november 27th.  I feel like I am losing strenghth in my left arm and shoulder.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Injection site induration, Injection site warmth
Clinical narrative: large erythematous area 7" x 3.5", hot to touch demarcated borders middle of area is hard not painful
Age: 5.0
Sex: M
Vaccine: FLUN3
Symptoms: Asthma, Condition aggravated, Cough
Clinical narrative: Per mom, asthma symptoms since the intranasal influenza vaccine was administered. Symptoms were intermittent but cough was fairly consistent since the vaccine was given.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site erythema, Injection site warmth, Rash, Rash macular
Clinical narrative: Approximately 4 to 5 hours later, patient developed pain in joints throughout body; upper arm where vaccines were administered was red, warm (looked like blotchy rash).
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Vertigo
Clinical narrative: 2 WEEKS AFTER VACCINATION PT HAD SEVERE VERTIGO SAW PMD AND GIVEN RX FOR ANTIVERT.  AS OF 11/14/06 PT STILL WITH DIZZINESS.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vertigo
Clinical narrative: 2 weeks after flu vaccine, patient had severe dizziness and "vertigo"; Saw PMD and was given Rx for antivert.  As of 11/14/2006 patient had improved some, but still c/o some dizziness.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Disorientation, Dyskinesia, Eye movement disorder, Pallor, Syncope
Clinical narrative: Within a minute of giving injection in rt deltoid, pt experienced pallor, syncope, rolling back of the eyes followed by jerky movements of upper & lower extremities. After 5 seconds, she became responsive, but disoriented to place. Pt stated that she had not eaten much all day.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Apnoea, Bronchitis, Cough, Febrile convulsion, Leukocytosis
Clinical narrative: Infant had fever to 103.9, rhythmic movements, period of apnea < 1 minute, required 4 breaths of CPR, 20 compressions. Pt brought to ED. 12/8/06 Received medical records from hospital which reveal patient had experienced bronchitis s/s of fever, cough & congestion for approx 4 days prior to admit on 11/14/06.  Was on antibiotics for same.  Temp in ER was 103.4.  Parents reported seizure like activity for approx 5 min with apnea & cyanosis.  During hospitalization, continued to improve on antibiotics & was d/c to home on 11/16/06 to continue oral antibiotics. Final DX: LLL Pneumonia; febrile seizure; & bronchitis, resolved.
Age: 0.53
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Movement disorder, Nasal congestion, Pneumonia, Pyrexia
Clinical narrative: Infant had fever to 103.9, rhythmic movements, period of apnea < 1 minute, required 4 breaths of CPR, 20 compressions. Pt brought to ED. 12/8/06 Received medical records from hospital which reveal patient had experienced bronchitis s/s of fever, cough & congestion for approx 4 days prior to admit on 11/14/06.  Was on antibiotics for same.  Temp in ER was 103.4.  Parents reported seizure like activity for approx 5 min with apnea & cyanosis.  During hospitalization, continued to improve on antibiotics & was d/c to home on 11/16/06 to continue oral antibiotics. Final DX: LLL Pneumonia; febrile seizure; & bronchitis, resolved.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, CSF test abnormal, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Developed Guillain Barre Syndrome about 1 week after receiving flu vaccine. Had strep pharyngitis about 6 weeks before onset of Guillain Barre. Experienced peripheral numbness and about 1 week prior to requiring hospitalization for weakness on 11/08/2006.  5/11/07 Received medical records from hospital which reveal patient experienced LE numbness, difficulty walking & went to ER.  Neuro consult done.  LP done was abnormal & combined w/LE areflexia, ataxia, paresis of LEs admitted 11/8/06-11/18/06 for GBS.  Tx w/plasmapheresis x 5 w/good results.  Continued to have some weakness of toes & numbness of LEs but was minimal at D/C to home w/PT.   FINAL DX: Guillain Barre syndrome, s/p plasmapheresis.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Demyelination, Guillain-Barre syndrome
Clinical narrative: 2 weeks after Menactra developed Guillian Barre syndrome. DC DX: acute inflammatory demyelinating polyneuropathy.  Presented with numbness in the soles of feet that began 4 days prior to admission that was associated with muscle tightness of his thigh. Following day experienced a headache that was around his forehead and goes to back of his head. Right side of face drooping and felt unsteady.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Mom said about 48 hours after shot, within 15 minutes, upper body waist broke out in very red and irritating hives. Mom gave her BENADRYL and hydrocortisone topical. Mom called Dr next day 11/16 to inform that blisters were almost completely dry. Doing better.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dry mouth, Headache, Paraesthesia, Somnolence
Clinical narrative: Dizziness, cotton mouth, drowsiness. Unable to stay awake, hard to move mouth, facial muscles, tingling in face. Headache could feel inject contents move up and through arm in a rush about 5 min after given. Next day-headache, still dizziness with fast motion. Hard to focus attention.
Age: 0.31
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Incorrect dose administered
Clinical narrative: Rotateq initial dose administered at 16 weeks
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure decreased, Disorientation, Dizziness, Dry mouth, Headache
Clinical narrative: Dizzy, disoriented, roaring in head, unable to stay awake, lowered blood pressure. Lasted approximately 15 hours. Extreme dry mouth.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence
Clinical narrative: Dizzy, disoriented, roaring in head, unable to stay awake, lowered blood pressure. Lasted approximately 15 hours. Extreme dry mouth.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Disturbance in attention, Dizziness, Dry mouth, Headache, Swelling
Clinical narrative: Dizziness, cotton mouth, headache, could not focus, swelling on arm the size of a quarter for about 3 days.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Rash maculo-papular
Clinical narrative: Client reported today by phone - on 11/8/06 left arm red, warm to touch and raised area blotches. Seen at her Dr office the afternoon on 11/8/06 for stomach problems, reflux and COPD did but doctor see the area. reported to health dept 11/16/06 at 3:30 pm to nurse.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Cerebral infarction, Encephalitis, Hypoaesthesia, Laboratory test abnormal, Migraine
Clinical narrative: None Stated.  11/30/06 Received medical records from hospital which reveal patient was admitted 11/7/06 w/right sided numbness & tingling of arm, leg & cheek for 15 hours.  Migraine HA normal pattern was 1-2/month but since flu shot had increased to 2-3/week with one episode of difficulty with word finding & writing.  Patient improved with use of steroids. PT/OT/ST evals done. FINAL DX: left pontine lesion, cerebral infarction vs ADEM. 12/14/06 Received medical records from neuro which reveal patient initially evaluated 11/17/06.  Exam revealed: five finger dexterity exam was abnormal on right; decreased response to pain & temp on entire right side; impaired finger to nose movement on right; impaired balance with ataxic gait. Unable to make a clear diagnosis.  MRI was to be repeated in approx 6 mos Final Dx: ADEM vs MS.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Multiple sclerosis, Nuclear magnetic resonance imaging brain abnormal, Paraesthesia, Speech disorder
Clinical narrative: None Stated.  11/30/06 Received medical records from hospital which reveal patient was admitted 11/7/06 w/right sided numbness & tingling of arm, leg & cheek for 15 hours.  Migraine HA normal pattern was 1-2/month but since flu shot had increased to 2-3/week with one episode of difficulty with word finding & writing.  Patient improved with use of steroids. PT/OT/ST evals done. FINAL DX: left pontine lesion, cerebral infarction vs ADEM. 12/14/06 Received medical records from neuro which reveal patient initially evaluated 11/17/06.  Exam revealed: five finger dexterity exam was abnormal on right; decreased response to pain & temp on entire right side; impaired finger to nose movement on right; impaired balance with ataxic gait. Unable to make a clear diagnosis.  MRI was to be repeated in approx 6 mos Final Dx: ADEM vs MS.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Eye pain, Fatigue, Pharyngolaryngeal pain
Clinical narrative: Received at 1:00 pm - Became very tired about 2 hrs after, by bed time my eyes were burning, I was sneezing, coughing and had a terrible sore throat. had chills, fever that night and next 2 nights.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Sneezing
Clinical narrative: Received at 1:00 pm - Became very tired about 2 hrs after, by bed time my eyes were burning, I was sneezing, coughing and had a terrible sore throat. had chills, fever that night and next 2 nights.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Dysphagia, Ear discomfort, Ear pain
Clinical narrative: 11/15 8:00 Started coughing - burning in lungs and esophagus with each deep breath - pain in lungs. Tightness in chest, ears feeling full and painful, eyes painful. hard to swallow, gums feeling puffy. Face swollen. 11/16 Today face still swollen, eyes with discharge (yellow). feeling very tired.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Eye discharge, Eye pain, Lung disorder, Oesophageal disorder, Pain
Clinical narrative: 11/15 8:00 Started coughing - burning in lungs and esophagus with each deep breath - pain in lungs. Tightness in chest, ears feeling full and painful, eyes painful. hard to swallow, gums feeling puffy. Face swollen. 11/16 Today face still swollen, eyes with discharge (yellow). feeling very tired.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: 11/15 8:00 Started coughing - burning in lungs and esophagus with each deep breath - pain in lungs. Tightness in chest, ears feeling full and painful, eyes painful. hard to swallow, gums feeling puffy. Face swollen. 11/16 Today face still swollen, eyes with discharge (yellow). feeling very tired.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Pt received Pneumovax 11-13-06; Next day noticed swelling to right deltoid and baseball round induration. Two days later noticed red streaks 3-5" long maybe 3/4" wide encircling upper armpit. Deltoid hot to touch and tender. Also red blotchy, red, raised rash to forearm/elbow. No itching.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Tic
Clinical narrative: Received Influenza vaccine 11/3/06. 11/9/06 had acute onset of facial simple motor tics.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Drooling, Dysarthria, Face oedema, Facial palsy
Clinical narrative: 11-10-06 Left arm sore weak heavy; 11-11-06 no ss; 11-12-06 no ss; 11-13-06 no ss; 11-14-06 numbness to anterior left side, left eye twitch, speech slurred, left side of face edema; 11-15-06 ss worse.  11/20/06 Received medical records which reveal patient seen in ER with numbness of left face, left eye weakness, left facial swelling, left facial droop.  Left eye was tearing more & was drooling from left side of mouth.  Treated w/steroids & antiviral.  D/C to home from ER to f/u with PCP. Final DX: Bells Palsy./ss
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Muscle twitching, Pain
Clinical narrative: 11-10-06 Left arm sore weak heavy; 11-11-06 no ss; 11-12-06 no ss; 11-13-06 no ss; 11-14-06 numbness to anterior left side, left eye twitch, speech slurred, left side of face edema; 11-15-06 ss worse.  11/20/06 Received medical records which reveal patient seen in ER with numbness of left face, left eye weakness, left facial swelling, left facial droop.  Left eye was tearing more & was drooling from left side of mouth.  Treated w/steroids & antiviral.  D/C to home from ER to f/u with PCP. Final DX: Bells Palsy./ss
Age: 0.16
Sex: F
Vaccine: RV5
Symptoms: Choking, Vomiting
Clinical narrative: Approx. 2-3 minutes after the Rotateq vaccine was administered orally the infant vomited up 1-2 oz of fluid. The fluid was partially clear and some milk. The infant began choking and had to be bulb suctioned.
Age: 1.0
Sex: F
Vaccine: DTAPH, FLU3, MMRV
Symptoms: Erythema, Injection site induration
Clinical narrative: Right arm with area of 2 cm x 2 1/4 cm erythema. No pain with palpation. Very minor firmness at site.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Erythema, Pain, Swelling
Clinical narrative: Redness and soreness of left arm with swelling and blisters.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Arm is red, hot and swollen. This occurred approx 1 day after immunized. Pt treated with 50 mg Benadryl IM.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella-zoster virus vaccine live instead of varicella virus vaccine live. The patient was supposed to be vaccinated with varicella virus vaccine live to prevent chickenpox. The physician reported that there was no product confusion. There was no product quality complaint involved. Additional information from the physician indicated that the problem with the product confusion was that both of the vaccines have varicella vaccine in one form or another on the product and that caused product confusion for the medica assistant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Information has been received from a healthcare worker concerning an adult male pt who on approx 9/17/06 was vaccinated with a dose of Varicella Zoster Vaccine Live. the pt returned to the physicians office about one week later, on approx 9/24/06 with shingles. A product quality complaint was not involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a 70 year old male physician with no allergies and a history of chickenpox as a child and no recent exposure to chickenpox or herpes zoster and no other medical history who on 10-AUG-2006 was vaccinated in the right upper arm with a 0.5 ml dose of ZOSTAVAX (lot #652966/0623F). There was no concomitant medication. On 10-AUG-2006 and 11-AUG-2006, the patient had erythema at the injection site. On 03-OCT-2006, the patient developed shingles after vaccination. He had four lesions on the left lower anterior abdomen. Three of the lesions were clustered and the one lesion was outward. He described the symptoms as "shingles, unilateral, erythematous papules, and a surrounding pallor-like a halo." He mentioned that he was not experiencing any pain, but there was itchiness involved. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information was received from the patient who reported that on 05-OCT-2006 he collected and would be submitting lesion (papule) specimens. He had two slides and a cotton swab. He noted that he developed "four itchy papular lesions, three in a cluster and one by itself on the left side - T-11 dermatone." He did not have any pain currently, but would evaluate the pain initially at a three out of a scale of 10. He was very concerned that the vaccination was causing a reactivation of natural VZV disease to present now as herpes zoster or that it was actually causing the herpes zoster. Additional information was received from the patient who reported that the date of onset of the herpes zoster was 03-OCT-2006. The area of involvement included the right lower anterior abdomen at T-11. There were found lesions, three in a cluster and out outlier. His body temperature was noted to be normal. He rated his pain as 3 to 4 on a scale of 1 to 10, with 10 being the most. He had no other systemic symptoms and subsequently recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the vaccine VZV strain. Results indicated that the specimen was inadequate, negative for B-globin, no strain ID. No further information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female with a history of shingles who on 02-OCT-2006 was vaccinated with a 0.65 mL dose of ZOSTAVAX. On 02-OCT-2006 the patient experienced swelling and redness around the injection site and shoulder and neck. Unspecified medical attention was sought. Subsequently the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who on 13-SEP-2006 was vaccinated with a 0.65 ml dose of ZOSTAVAX. Subsequently "two to three weeks after vaccination," on approximately 27-SEP-2006, the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug level decreased
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included rituximab (RITUXAN). Subsequently, the patient may have possibly experienced decrease in rituximab (RITUXAN) levels after vaccination. The pharmacist could not provide any further information and was not reporting an adverse experience. The patient sought unspecified medical attention. No product quality complaint was involved. No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Discomfort, Herpes zoster, Pain, Viral infection
Clinical narrative: Information has been received from a physician concerning a 72 year old female who on 10/06/2006 was vaccainted with a dose of Varicella Zoster vaccine. On 10/09/2006 the pt complained of pain mid back radiating to under the right breast. On 10/10/06 the physician reported that no rash was currently present. it was reported that two days after vaccination the pt developed shingles. the pts husband reported that his wife was vaccainted at her primary care physicians office on 10/05/06. On 10/10/06, the pt revisited her primary care physician and was diagnosed with an outbreak of shingles. the physician prescribed Famvir 500 mg and Tylenol with Codeine 3. At the time of the report, the pt was coping with the pain and discomfort of shingles and had not recovered. Additional information has been requested.