chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Flushing, Nausea, Pruritus, Rash macular
Clinical narrative: Skin flushing - diffuse, splotchy with pruritis, VSS lungs - clear; RRR; (+) abd complaints - nausea (-) emesis; CLARITIN 10mg po, PEPCID 40mg, BENADRYL 25mg po.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nasal congestion, Wheezing
Clinical narrative: Developed sx of wheezing, headache, nasal congestion w/in 2-3 hrs of INFLUENZA vaccine. No fever. H/o asthma - no formal testing - uses albuterol inhaler from recent ER visit.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Neuropathy peripheral, Pain in extremity, Peroneal muscular atrophy
Clinical narrative: Aggravation of pre-existing peripheral neuropathy - states dx of Charcot-Marie-Tooth - but had taken influenza shots previously without problems - did not inform staff of diagnosis - not seen in clinic. Reports 1-4 days of leg achiness, T degrees to 102.5.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Fibromyalgia
Clinical narrative: Pt reports aggravation of fibromyalgia symptoms.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Rash
Clinical narrative: FLUZONE received 10/04/2011 - developed diffuse rash w/in 4 hours; reports diarrhea (8-10 liquid stools) w/in 8 hours. No fever - resolved.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus
Clinical narrative: Diffuse itching 30 min - 1 hour; swelling of lower lip secondary] resolution w/in 24 hour. DECARDON  3mg IM PEPCID 40 mg PO CLARITIN 10 mg po.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Palmar erythema
Clinical narrative: Received FLUZONE at 0700, developed flushed face & palmar erythema approximately 1530. No SOB or wheezing, received CLARITIN 10mg po, PEPCID 40mg po in clinic, BENADRYL 25-50mg for bedtime use.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Maternal exposure during pregnancy, Rash
Clinical narrative: 32 y.o. female, pregnant, 30 weeks gestation, rc'd inactivates flu vac 1/6/12 IM, (L) deltoid. C/O rash to bil. underarms & thighs, since 1/6/12 approx. 12:50 pm. Claims "rash getting better" did not apply or take any meds. Referral issued by clinician to see PMD.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Feeling drunk, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 1 hr had site tenderness, erythema, swelling, paresthesia proceeded down left arm and into shoulder & face, fever, nausea, vomiting, dizziness, "drunk feeling" ensued. Presented to urgent care & treated with prednisone & cephalexin.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: Within 1 hr had site tenderness, erythema, swelling, paresthesia proceeded down left arm and into shoulder & face, fever, nausea, vomiting, dizziness, "drunk feeling" ensued. Presented to urgent care & treated with prednisone & cephalexin.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Edema & red ring around injection site. Tender to touch. Ice to area prn. Also ADVIL prn.
Age: 19.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Dizziness, Pallor, Visual impairment
Clinical narrative: After 2 injection pt. stated she felt like she was going to pass out. St. her vision was going dark. Face pale, assisted to clinic room to lay down - given water & cold compresses to back of neck. Pt was able to ambulate with assistance. No loss of consciousness of pt. Pt rested with nurse present for 30 mins the sat in lobby for 15-20 mins. (Approx 10AM - 10:50AM). Had pt. call us when she arrived home.
Age: 0.53
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Enema administration, Hypophagia, Intussusception, Ultrasound scan abnormal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old healthy full term born female patient with no pertinent medical history and no drug reactions/allergies, who on 25-JUL-2011 and on 23-SEP-2011, was vaccinated orally with the first and the second dose of ROTATEQ (Lot# 668341/0526Z for both doses), respectively. The patient did not experience any adverse event with the first or second dose. On 02-DEC-2011, the patient was vaccinated orally with the third dose of ROTATEQ (Lot#669825/1347AA). There was no concomitant medication. On 15-DEC-2011, the patient presented with vomiting and decreased oral intake but no bloody stool and was taken to the hospital, where an ultrasound was conducted and the patient was diagnosed with intussusception. The patient was admitted overnight for observation and on 15-DEC-2011, was treated with air contrast enema, On an unspecified date, the patient recovered without surgery. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a licensed practical nurse concerning a 11 year old female patient with no drug reactions/allergies, no pertinent medical history and no concurrent conditions who on 04-JAN-2012, was vaccinated with the first dose of GARDASIL (Lot# 670048/0963AA) (dose and route not reported). There was no concomitant medication. On 04-JAN-2012, while in the doctor's office, the patient had a fainting spell and a 10-15-second seizure. The patient recovered while in the office on 04-JAN-2012, left on her own and was doing fine. There was no treatment given for the AEs. The patient was not referred to a neurologist. Upon internal review, seizures were determined to be an other important medical event. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: 3 cm x 3 cm circular wheal of erythema, warmth, tenderness at injection site (R) deltoid. Advised cool compresses, BENADRYL and MOTRIN prn. Return for worsening or no improvement.
Age: 1.05
Sex: F
Vaccine: FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Cellulitis, Erythema, Papule
Clinical narrative: 1-4-2012 started with red papules on rt- shoulder. Seen in office 1-9-12 with papules over torso head, arms with one on lower rt eyelid. Treated with KEFLEX for cellulitis of one area.
Age: 1.05
Sex: F
Vaccine: FLU3, MMR, VARCEL, FLU3, MMR, VARCEL
Symptoms: Blister, Cellulitis, Erythema of eyelid, Papule, Rash papular
Clinical narrative: 1-4-2012 started with red papules on rt- shoulder. Seen in office 1-9-12 with papules over torso head, arms with one on lower rt eyelid. Treated with KEFLEX for cellulitis of one area.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Convulsion, Crying, Dyskinesia, Fall, Hypertension
Clinical narrative: Within 1 to 2 minutes after receiving this shot my daughter fell back into a chair and had convulsions lasting about 10 seconds. She was stiff and jolting. Non responsive to her name being called. When she came to she was crying and her blood pressure was high.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Muscle rigidity, Unresponsive to stimuli
Clinical narrative: Within 1 to 2 minutes after receiving this shot my daughter fell back into a chair and had convulsions lasting about 10 seconds. She was stiff and jolting. Non responsive to her name being called. When she came to she was crying and her blood pressure was high.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Swelling
Clinical narrative: Bruising at and below injection site. Some swelling. Instructed to take BENADRYL and call family MD if not improved by 1/6/11 (tomorrow).
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Lg area approximately 2" below injection site that had fluid, redness and warmth to touch. Client stated some itching but denies pain. Ice pack applied.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count, Laboratory test, Neck pain, Nodule, Pyrexia
Clinical narrative: Serum sickness enlarged (small apple size knot) fevers, neck pain.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Serum sickness, X-ray
Clinical narrative: Serum sickness enlarged (small apple size knot) fevers, neck pain.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Death, Hypoaesthesia, Inflammation, Injection site warmth, Musculoskeletal discomfort
Clinical narrative: Serum sickness enlarged (small apple size knot) fevers, neck pain.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Myalgia, Oedema peripheral, Pain in extremity, Paraesthesia, Red blood cell sedimentation rate increased
Clinical narrative: Serum sickness enlarged (small apple size knot) fevers, neck pain.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Surgery, White blood cell count increased
Clinical narrative: Serum sickness enlarged (small apple size knot) fevers, neck pain.
Age: 27.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Back pain, Headache, Musculoskeletal stiffness
Clinical narrative: CLIENT WOKE UP WITH LOWER BACK PAIN A 5 ON THE SCALE OF 1:10. ALSO HAD SOME SLIGHT STIFFNESS TO THE BACK OF NECK THAT WAS TRANSIENT COMING AND GOING. LATER IN THE MORNING AT 8:00 AM TOOK SOME TYLENOL FOR A MILD HEADACHE THAT WAS RESOLVED BY TAKING THE TYLENOL.  HER BACK STILL HURT BUT HURT ONLY WHEN SHE MOVED NOT WHEN SHE WAS SITTING OR LYING DOWN. LOWER BACK PAIN WAS UNCOMFORTABLE WHEN WALKING AT A FAST PACE. DENIES PROBLEMS WITH ARMS OR LEGS. INFORMED CLIENT TO SEE DOCTOR IF SYMPTOMS WORSENED AND TO LET CLINIC KNOW IF SYMPTOMS HAD NOT RESOLVED.
Age: 1.02
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous
Clinical narrative: RED RAISED RASH TO CHEEKS AND TORSO, FRONT AND BACK.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Headache, Influenza like illness, Pain in extremity
Clinical narrative: My back started aching and I also got a mild headache. The next morning, I woke up with a worse headache, a worse backache and both legs below the knee were aching when I walked. I had no fever. It was like a mild flu without any fever.
Age: 1.48
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Blood count, Contusion, Headache, Immunoglobulin therapy, Pain
Clinical narrative: I noticed patient was covered in petechiae and bruises that were popping up like crazy.  I called pediatric hematologist and headed to the ER right away.  Platelet count was found to be 7,000.  Returned to clinic on 7/25/11, 8/1/11, 8/9/11, 8/18/11 (received IVIG infusion), 8/19/11(had to return to clinic for side effects of IVIG including high fever, severe headache, and pain.  Was given IV fluids, pain medicine, and started on oral steroids.  Followed up 8/31/11, 9/12/11, and 9/28/11 for blood count checks.
Age: 1.48
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Petechiae, Platelet count, Pyrexia
Clinical narrative: I noticed patient was covered in petechiae and bruises that were popping up like crazy.  I called pediatric hematologist and headed to the ER right away.  Platelet count was found to be 7,000.  Returned to clinic on 7/25/11, 8/1/11, 8/9/11, 8/18/11 (received IVIG infusion), 8/19/11(had to return to clinic for side effects of IVIG including high fever, severe headache, and pain.  Was given IV fluids, pain medicine, and started on oral steroids.  Followed up 8/31/11, 9/12/11, and 9/28/11 for blood count checks.
Age: 24.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Pt had redness, swelling, low grade 99.5 degree temperature and vomiting x 1, nausea. Swelling, redness to (R) upper deltoid area. Foster mother stated also her son had been ill with nausea and vomiting 2-3 days prior. Pt given steroid and antibiotic on 1-6-2012 advised client and was given by foster mother Ibuprofen on 1-5-2012.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Swelling, Vomiting
Clinical narrative: Pt had redness, swelling, low grade 99.5 degree temperature and vomiting x 1, nausea. Swelling, redness to (R) upper deltoid area. Foster mother stated also her son had been ill with nausea and vomiting 2-3 days prior. Pt given steroid and antibiotic on 1-6-2012 advised client and was given by foster mother Ibuprofen on 1-5-2012.
Age: 21.0
Sex: F
Vaccine: SMALL
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Vaccinated 4 Dec 11. Discovered 19 Dec 11. She was 7 wks pregnant.
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Chills, Pyrexia
Clinical narrative: Fevers & chills started at 2300. Took (1) one 200 mg Ibuprofen at 0200 and 0600.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Swelling, Urticaria
Clinical narrative: Started swelling 6 hours post chicken pox vaccine. 48 hours after vax wheal & induration 60 mm x 70 mm. Erythema 140 mm x 140 mm.
Age: 22.0
Sex: F
Vaccine: ANTH, HEPA, SMALL, TYP, ANTH, HEPA, SMALL, TYP
Symptoms: Dyspnoea, Flushing, Hypopnoea
Clinical narrative: Member describes SOB, having to take shallow breaths. Along with periods of feeling flush.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Hypoaesthesia, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received MENACTRA vaccine on 12-16-11 in right deltoid muscle. Mother noticed swelling of right arm from shoulder to elbow, redness & warm to touch and numbness at times in right arm. Presented at MD office on 12/19/11 with the same above symptoms. MD ordered MOTRIN 200mg one TID, cold compresses. 12/20/11 the right arm was slightly red, swelling markedly decreased and no further numbness. Patient went to school on 12/20/11.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Oedema peripheral
Clinical narrative: Patient received MENACTRA vaccine on 12-16-11 in right deltoid muscle. Mother noticed swelling of right arm from shoulder to elbow, redness & warm to touch and numbness at times in right arm. Presented at MD office on 12/19/11 with the same above symptoms. MD ordered MOTRIN 200mg one TID, cold compresses. 12/20/11 the right arm was slightly red, swelling markedly decreased and no further numbness. Patient went to school on 12/20/11.
Age: 1.27
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm swollen, red, warm to touch, and painful. Mom states "cool compress was applied around 9 pm & ibuprofen given to child. Further states it not as painful as yesterday."
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Neck pain
Clinical narrative: Terrible head and neck pain.
Age: 1.08
Sex: M
Vaccine: HIBV, MM, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Viral infection
Clinical narrative: Fever of 101, followed a few days later by rash on trunk.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Allergy test positive, Cold exposure injury, Laboratory test normal, Pruritus, Seasonal allergy
Clinical narrative: Hives occurring almost daily lasting 30 min to 1 hour. Exacerbated by cold temperature. Diffuse, itchy.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Hives occurring almost daily lasting 30 min to 1 hour. Exacerbated by cold temperature. Diffuse, itchy.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Blindness, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: Numbness, pain in limbs loss of vision & balance. Treated with IVIG for Guillain-Barre syndrome.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pain in extremity
Clinical narrative: Numbness, pain in limbs loss of vision & balance. Treated with IVIG for Guillain-Barre syndrome.
Age: 65.0
Sex: F
Vaccine: YF
Symptoms: Lip swelling, Urticaria
Clinical narrative: 2 - 3 facial hives. Swollen lower lip. Approximately 90 minutes after injection. Took BENADRYL 25 mg.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Clumsiness, Grip strength decreased, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Symptoms included tingling in both extremities, along w/numbness both arms, "itchy sensations", muscle pain both arms, "clumsiness difficulty holding pen. No hives, no respiratory symptoms.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Symptoms included tingling in both extremities, along w/numbness both arms, "itchy sensations", muscle pain both arms, "clumsiness difficulty holding pen. No hives, no respiratory symptoms.
Age: 19.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest pain, Decreased appetite, Headache, Insomnia, Pyrexia
Clinical narrative: 1-11-12 Pt calls approx 300pm talks to nurse who gave HPV#1 2nd MENVEO vaccine on 1-10-12 at approx 230pm - pt says at 730pm 1-10-12 she c/o headache, lost appetite fever 101, trouble sleeping and chest pains - says fever down to 99 1-11-12 but still having chest pain - nurse told her to have family take her to local ER - pt also has asthma tried to call pt 1-12-12 wrong phone no in chart.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Erythema, Heart rate increased, Hyperhidrosis
Clinical narrative: Became very red-faced and had trouble breathing immediately upon receiving flu vaccine- this lasted approximately 10-15 minutes - BP elevated, HR elevated on admission to E.D. Diaphoretic, felt "tingly" all over.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Paraesthesia
Clinical narrative: Became very red-faced and had trouble breathing immediately upon receiving flu vaccine- this lasted approximately 10-15 minutes - BP elevated, HR elevated on admission to E.D. Diaphoretic, felt "tingly" all over.
Age: 35.0
Sex: F
Vaccine: HEPAB
Symptoms: Maternal exposure during pregnancy, Premature delivery
Clinical narrative: This retrospective pregnancy case was reported by a consumer (also the subject) and described the occurrence of premature birth in a 35-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. Concurrent medical conditions included toxemia. On 7 December 2011 the subject received a dose of TWINRIX (details unknown) and experienced vaccine exposure during the third trimester of her pregnancy. Date of last menstrual period and estimated date of delivery were not provided. On 24 December 2011. 17 days after vaccination with TWINRIX, the subject delivered a live female at 36 weeks gestation [premature birth]. Delivery method, infant weight and APGAR scores were not reported. At the time of the report, the consumer reported that the infant was "doing well". The consumer attributed the premature birth to her toxemia, not to receiving TWINRIX.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Felt sharp pain and burning in (R) deltoid injection site which continues when she attempts to lift arm above shoulder level or to back. No prior tx. until saw M.D. on 1/11/12. She recommended TYLENOL, ice/heat, ROM.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Breast pain, Breast swelling, Fatigue, Flank pain, Headache
Clinical narrative: Within 12 hours of receiving vaccine pt was feeling ill: nausea, vomiting, severe headache. On 01/07/12 pt developed pain and swelling on underside of right arm, on right side of body, right breast and into the neck. Pt states she felt extremely fatigued and feverish. Today, 1/12/12 swelling is resolving as well as nausea and headache but still experiencing fatigue.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Local swelling, Malaise, Nausea, Neck pain, Oedema peripheral
Clinical narrative: Within 12 hours of receiving vaccine pt was feeling ill: nausea, vomiting, severe headache. On 01/07/12 pt developed pain and swelling on underside of right arm, on right side of body, right breast and into the neck. Pt states she felt extremely fatigued and feverish. Today, 1/12/12 swelling is resolving as well as nausea and headache but still experiencing fatigue.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Within 12 hours of receiving vaccine pt was feeling ill: nausea, vomiting, severe headache. On 01/07/12 pt developed pain and swelling on underside of right arm, on right side of body, right breast and into the neck. Pt states she felt extremely fatigued and feverish. Today, 1/12/12 swelling is resolving as well as nausea and headache but still experiencing fatigue.
Age: 1.26
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Ear infection, Pyrexia, Sinusitis
Clinical narrative: Mother calls facility reports child might have had a reaction. Reports fever. 01/10/2012 0900 Mother reports fever persists. 01/11/2010 0900 Mother reports fever broke over night. 01/11/2012 0900 Mother reports fever 101.0 after Tylenol instructed Mother to consult provider. 01/12/2012 0830 Mother reports taking child to provder and diagnosed with ear infection and sinus infection.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: "Painful spasms located on the lateral side of my left leg for approx. 20 -30 minutes", says patient. No treatment needed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Injection site pain, Malaise
Clinical narrative: Intense burning pain from injection site shoulder joint - > elbow. Lasted x 4 days also reported malaise/dizziness.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Asthma, Condition aggravated, Dyspnoea, Erythema, Hypersensitivity
Clinical narrative: Pt. given pneumonia vaccine and had an immediate reaction of redness in the arms, face and sob. Lungs did have wheezing throughout the lung fields (they were clear during the exam) thus I will classify this as an adverse reaction/allergy. Pt. given a nebulizer treatment --> and wheezing cleared about 90%. Pt. felt much improved. Plan: Rx for prednisone 40 mg for 3 days will be sent to pharmacy. Pt. to RTC or the ER for any return of allergic like reactions including worsening asthma, SOB, wheezing, swelling, rash or other problems. Pt. agrees.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Rash, Swelling, Wheezing
Clinical narrative: Pt. given pneumonia vaccine and had an immediate reaction of redness in the arms, face and sob. Lungs did have wheezing throughout the lung fields (they were clear during the exam) thus I will classify this as an adverse reaction/allergy. Pt. given a nebulizer treatment --> and wheezing cleared about 90%. Pt. felt much improved. Plan: Rx for prednisone 40 mg for 3 days will be sent to pharmacy. Pt. to RTC or the ER for any return of allergic like reactions including worsening asthma, SOB, wheezing, swelling, rash or other problems. Pt. agrees.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache, Neck pain, Oropharyngeal pain, Pain
Clinical narrative: Fever, stomachache, head ache, neck ache, general soreness, sore throat, congestion.
Age: 11.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, stomachache, head ache, neck ache, general soreness, sore throat, congestion.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site atrophy
Clinical narrative: Seen at this office for consult 1/6/2012.  Documented significant subcutaneous atrophy L upper arm, possible triceps muscle.  3x5 cm area, picture taken and on file.
Age: 30.0
Sex: M
Vaccine: FLUX, PPV, TD
Symptoms: Disorientation, Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Disoriented, dizzy, headache, body aches, extremely sore and fever all day and over night of 101-103 degrees.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Fatigue, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Stomachache, sore throat, fever, headache, fatigue.
Age: 16.0
Sex: F
Vaccine: MU, UNK
Symptoms: Abdominal pain lower, Alopecia, Arthralgia, Back pain, Chest pain
Clinical narrative: Headaches; Legs going numb; Nausea; Chest pains-right side; Joint pains; Lower right abdominal pains; Chronic fatigue; Mood changes-light Hair loss-noticed in shower; Back pain. Now the left side of abdomen hurts-more than Right.
Age: 16.0
Sex: F
Vaccine: MU, UNK
Symptoms: Fatigue, Headache, Hypoaesthesia, Mood altered, Nausea
Clinical narrative: Headaches; Legs going numb; Nausea; Chest pains-right side; Joint pains; Lower right abdominal pains; Chronic fatigue; Mood changes-light Hair loss-noticed in shower; Back pain. Now the left side of abdomen hurts-more than Right.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site reaction, Paraesthesia
Clinical narrative: Patient received injection and had a little pink area around injection. I called to follow up a few hours later and mom said she was busy but that a few minutes after leaving the phamacy she was fine and no redness around inj site. I received a call from mom today stating last night the area began to turn blue/red (it would come and go) and began to experience tingling and soreness. She took her to ER last night concerned it may be a blood clot and ultrasound confirmed not blood clot. She was given Vicodin and Motrin, she said she is almost all cleared up now but wanted to let me know. I told her to please folow up with her Dr if any changes.
Age: 25.0
Sex: F
Vaccine: MNQ
Symptoms: Ultrasound scan normal
Clinical narrative: Patient received injection and had a little pink area around injection. I called to follow up a few hours later and mom said she was busy but that a few minutes after leaving the phamacy she was fine and no redness around inj site. I received a call from mom today stating last night the area began to turn blue/red (it would come and go) and began to experience tingling and soreness. She took her to ER last night concerned it may be a blood clot and ultrasound confirmed not blood clot. She was given Vicodin and Motrin, she said she is almost all cleared up now but wanted to let me know. I told her to please folow up with her Dr if any changes.
Age: 48.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Computerised tomogram, Injection site cellulitis, Injection site streaking, Joint stiffness, Oedema peripheral
Clinical narrative: Fever, red streaks running down arm around vaccine site, body aches, arm swelling and extreme joint stiffness.
Age: 48.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain, Pyrexia, X-ray
Clinical narrative: Fever, red streaks running down arm around vaccine site, body aches, arm swelling and extreme joint stiffness.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Received 2 vaccines at school clinic Tdap & MENACTRA 1/11/12 (R) arm very sore unable to move arm (R) hand tingling. Also c/o dizziness when seen today 1/12/12 no redness/swelling noted.
Age: 0.59
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site inflammation, Rotator cuff syndrome
Clinical narrative: Patient reported inflammation at site of injection the following day. She went to her physician and was told she had inflammation of the rotator cuff, this required 4 weeks of physical therapy. (Received all information from patient on 1/12/12).
Age: 48.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Nodule, Swelling, Tenderness
Clinical narrative: Swollen tender nodules 3 weeks after shots.
Age: 14.0
Sex: F
Vaccine: FLUN3
Symptoms: Chest discomfort, Dyspnoea, Pruritus, Urticaria
Clinical narrative: Approximately 20 minutes after receiving FLUMIST patient reported itching to right forearm. Quarter sized hives noted & c/o difficulty breathing shortness of breath, tightness in chest. No other area on body with hive. BENADRYL 50 mg given PO. Pt observed for 30 min and discharged from clinic to home.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt received Varicella vaccine in right thigh on 10 Jan 2012. Pt taken to ER on 11 Jan 2012 for redness, swelling, warmth to right thigh. Pt brought to clinic on 12 Jan 2012 to be assessed by PEDS MD. No fever noted.
Age: 0.4
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dysstasia, Muscular weakness, Weight bearing difficulty
Clinical narrative: After being vaccinated, the patient wasn't able to stand and hold her own weight. It seemed like her leg muscles were weak.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Patient experienced redness, swelling. MD prescribed Cephalexin.
Age: 0.18
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Haematochezia, Mucous stools
Clinical narrative: Bloody, mucousy loose stools began 1-11-12. Received vaccinations on 1-10-12.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Borrelia test negative, Endotracheal intubation, Guillain-Barre syndrome, Intensive care, Muscular weakness
Clinical narrative: Guillain Barre Syndrome. Pt admitted to hospital.
Age: 75.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome. Pt admitted to hospital.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Antinuclear antibody, Arthralgia, C-reactive protein, Full blood count, Joint stiffness
Clinical narrative: Arm which vaccine given became very painful - joints became painful & stiff - mobility/movement became difficult d/t pain.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Red blood cell sedimentation rate increased, Rheumatoid factor
Clinical narrative: Arm which vaccine given became very painful - joints became painful & stiff - mobility/movement became difficult d/t pain.
Age: 1.05
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site papule, Injection site warmth
Clinical narrative: Right leg - 1 inch red, warm but not tender nonfluctuant nodule on Rt. thigh at injection site of flu and varicella w/overlying 1-2mm papule x 2 - remainder of skin without rash. Noticed by parent 2-3 days prior.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Induration, Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 60 year old female patient with diabetes and no drug reactions or allergies, who on 18-NOV-2011 was vaccinated with 0.65 ml single dose of ZOSTAVAX (Merck) subcutaneously (lot number 671596/1056AA, Exp. Date: 05-OCT-2012). Concomitant therapy included pravastatin Na, metformin (manufacturer unknown), loratadine  (MSD) and aspirin. The physician reported that on 21-NOV-2011, the patient returned to the practice with fever and redness and swelling of the arm, that started at the injection site and continued down the arm toward the elbow. No lab diagnostics studies were performed. KEFLEX, BENADRYL and ADVIL were given as a treatment for the experience. The patient was also instructed to elevate the arm. At the time of the report, the patient was recovering. Follow up information has been received from the physician concerning the female patient with no illness at the time of vaccination, no adverse events following prior vaccinations and no pre-existing medical conditions (previously reported as with diabetes) no pre-existing allergies and birth defects who on 18-NOV-2011 at 10:36 am was vaccinated subcutaneously with 0.65 ml second dose of ZOSTAVAX (Merck) (lot number 671596/1056AA, Exp Date: 05-OCT-2012). The physician reported that the patient was complaining of tingling, redness, swelling site of injection on 18-NOV-2011 at 10:36 (also reported as 24 hours on 19-NOV-2011). The physician also reported the following findings: in left tricep area, raised firm vesicular lesion the size of a lime with surrounding tissue erythema. On 22-NOV-2011 the patient had recovered from tingling, redness and swelling of the injection site and from left tricep area - raised firm vesicular lesion size of a line with surrounding tissue erythema. Tingling, redness and swelling of the injection site; and firm vesicular lesion with surrounding tissue erythema were considered to be other important medical event by the physician because required medical/surgical intervention. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Paraesthesia, Pyrexia, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 60 year old female patient with diabetes and no drug reactions or allergies, who on 18-NOV-2011 was vaccinated with 0.65 ml single dose of ZOSTAVAX (Merck) subcutaneously (lot number 671596/1056AA, Exp. Date: 05-OCT-2012). Concomitant therapy included pravastatin Na, metformin (manufacturer unknown), loratadine  (MSD) and aspirin. The physician reported that on 21-NOV-2011, the patient returned to the practice with fever and redness and swelling of the arm, that started at the injection site and continued down the arm toward the elbow. No lab diagnostics studies were performed. KEFLEX, BENADRYL and ADVIL were given as a treatment for the experience. The patient was also instructed to elevate the arm. At the time of the report, the patient was recovering. Follow up information has been received from the physician concerning the female patient with no illness at the time of vaccination, no adverse events following prior vaccinations and no pre-existing medical conditions (previously reported as with diabetes) no pre-existing allergies and birth defects who on 18-NOV-2011 at 10:36 am was vaccinated subcutaneously with 0.65 ml second dose of ZOSTAVAX (Merck) (lot number 671596/1056AA, Exp Date: 05-OCT-2012). The physician reported that the patient was complaining of tingling, redness, swelling site of injection on 18-NOV-2011 at 10:36 (also reported as 24 hours on 19-NOV-2011). The physician also reported the following findings: in left tricep area, raised firm vesicular lesion the size of a lime with surrounding tissue erythema. On 22-NOV-2011 the patient had recovered from tingling, redness and swelling of the injection site and from left tricep area - raised firm vesicular lesion size of a line with surrounding tissue erythema. Tingling, redness and swelling of the injection site; and firm vesicular lesion with surrounding tissue erythema were considered to be other important medical event by the physician because required medical/surgical intervention. No further information is available.
Age: 68.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Information has been received from a Registered Pharmacist (R.Ph.) concerning a 68 year old male patient with none pertinent medical history and none drug reactions who on 23-DEC-2011 was vaccinated intramuscular in left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot#669579/0595AA, exp. 30-AUG-2012). There was no concomitant medication. On 05-JAN-2012 the patient call to the pharmacist and said that he could not lift his left arm in which the injection was given. No lab diagnostic studies were performed. At the time of the report the patient's status was not recovered. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Arthritis, Injected limb mobility decreased, Injection site discomfort, Injection site joint pain, Muscle spasms
Clinical narrative: Information has been received from a Registered Pharmacist (R.Ph.) concerning a 68 year old male patient with none pertinent medical history and none drug reactions who on 23-DEC-2011 was vaccinated intramuscular in left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot#669579/0595AA, exp. 30-AUG-2012). There was no concomitant medication. On 05-JAN-2012 the patient call to the pharmacist and said that he could not lift his left arm in which the injection was given. No lab diagnostic studies were performed. At the time of the report the patient's status was not recovered. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, FLU3, PPV
Symptoms: Osteoarthritis, Paraesthesia, Radiculopathy, Rotator cuff syndrome, X-ray abnormal
Clinical narrative: Information has been received from a Registered Pharmacist (R.Ph.) concerning a 68 year old male patient with none pertinent medical history and none drug reactions who on 23-DEC-2011 was vaccinated intramuscular in left deltoid with a 0.5 ml dose of PNEUMOVAX 23 (Lot#669579/0595AA, exp. 30-AUG-2012). There was no concomitant medication. On 05-JAN-2012 the patient call to the pharmacist and said that he could not lift his left arm in which the injection was given. No lab diagnostic studies were performed. At the time of the report the patient's status was not recovered. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: FLU3, HEP, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 1/12/12 12 x 8 cm area of erythema with warmth and tenderness. No mass, no discharge (L) deltoid area.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: SWELLING AND PAIN LEFT DELTOID.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Small blisters on same arm as the injection site that ruptured and itched. Applied OTC meds. Very little help. The rash spread to my shoulders, back, and side. I reported this to my primary care Dr. and was given an appointment for examination on 10/21/2011. Photos were taken and submitted to the Dermatology Dept. It was stated that they didn't know what it was. I was given prescribtions for methylprednisolone and triamcinolone. These helped for about 5 days. I was given an appointment for dermatology on 11/11/2011. They examined and recommend continuing with the triamcinolone as long as it was helping with the itch, but didn't know what it was. I reported this again to my PCP on 11/28/2011. More photos but no answers yet.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Acute onset of vomiting and diarrhea. Has been ongoing for 6 hours. No fever or evidence of infection. No exposure to ill individuals, suspect foods or recent travel. Was healthy on day of vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Dysarthria, Headache, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Pale and woozy/dizzy afer MCV4 followed by sleepiness.  Instant migraine-intensity headache that remitted quickly.  Some word slurring.  Pox 95% and BP's with sys in upper 80's.  Redness at injection site marks and fading quickly.  Some repeat ausculation with good air movement.  Color improving since  first came into room to time returned with popsicle.  Improved enough to leave clinic quickly once started to improve.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Pallor, Skin discolouration, Somnolence
Clinical narrative: Pale and woozy/dizzy afer MCV4 followed by sleepiness.  Instant migraine-intensity headache that remitted quickly.  Some word slurring.  Pox 95% and BP's with sys in upper 80's.  Redness at injection site marks and fading quickly.  Some repeat ausculation with good air movement.  Color improving since  first came into room to time returned with popsicle.  Improved enough to leave clinic quickly once started to improve.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: HIV test negative, Pyrexia, Varicella post vaccine
Clinical narrative: (1/9/12) Patient was seen in MD office for Physical. She was given Varicella at the time of visit. On 1/13/2012 to pick up forms and physician discovered patient had chicken pox. No other illness - temperature 99.3 - pt instructed for home isolation, counseled on fever, TYLENOL, ER if symptoms worsen.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Electrocardiogram, Pruritus, Tremor
Clinical narrative: Pruritus, internal tremors, began 2 hours after injection - BENADRYL 12.5mg IM, DECADRON IM - then c/o chest discomfort. EKG done.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: (R) UA - had a rash site of FLUZONE. Now rash resolved & pin head size erythema, site of injection.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Patient present at clinic requesting to report that she had developed shingles - diagnosis made by primary Dr by physical assessment but no laboratory specimen taken. Per client developed rash on abdomen on 12/12/2011. Seen by primary Dr and diagnosis per client was shingles - verbalized treated with oral antiviral medications. Does verbalized "less pain with this occurrence of shingles" as compared to initial case of shingles in 2000. Client request report of developing shingles after vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: On 10/10/11 patient was diagnosed with shingles (10/8/11 onset). She is on immune-suppressing medicine for RA. She is worried that her husband vaccine gave her the shingles. I advised her that there is no evidence of this in the literature.
Age: 73.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Blister, Pain, Pruritus, Rash erythematous, Varicella
Clinical narrative: This spontaneous consumer report (initial receipt: 03-Jan-2012) concerns a 73-year old male patient, who had a medical history of high blood pressure and allergy to tomatos and grapefruit. Concomitant medications included fexofenadine, omeprazole and high blood pressure med (medication). On ??-Aug-2011 the patient received AFLURIA. He also received 1 time ZOSTAVAX subcutaneous injection for shingles prevention. On ??-Aug-2011 the patient had an outbreak of what he believed to be chickenpox. He had tiny red spots (blisters) and clear liquid came out. He also stinging and itch continuing since vaccination. Treatment included salve fluocinodine 0.05%. The event outcome was not reported.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Rheumatoid arthritis, Vaccination complication
Clinical narrative: Initial report was received on 05 January 2012 from a consumer who is also the patient. A female patient who was 27 year-old at the time of vaccination (date of birth not reported) had received an INFLUENZA VACCINE (manufacturer, lot number, route and site of administration not reported) "many years ago, 1976 to be exact" and weeks later had a "horrible reaction" and was finally diagnosed with rheumatoid arthritis. According to the patient, none of the physicians at the time knew to relate the injection with the symptoms and therefore was "misdiagnosed". According to the patient, they  had Guillain Barre syndrome. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC
Symptoms: Convulsion
Clinical narrative: Initial report was received from another manufacturer on 06 January 2012 (Manufacturer Report Number 2011286944/ US-PFIZER INC-2012286944). A nine-month-old female patient had received an injection of PENTACEL, sanofi pasteur Ltd. (lot number, route and site of administration not reported), PREVNAR, Pfizer (lot number, route and site of administration not reported), an influenza vaccination (manufacturer, lot number, route and site of administration not reported) and a hepatitis B vaccination (manufacturer, lot number, route and site of administration not reported) on 17 November 2011. An unspecified amount of time later on 17 November 2011, the patient experienced several seizures and was taken to the emergency room. The relevant therapeutic measure taken in response of the event and relevant laboratory data of the patient were unknown. It was unknown if the patient took any concomitant medications or had any relevant past medical history. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Blood glucose decreased, Fall, Hyperhidrosis
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 06 January 2012. A male patient (age and date of birth not reported) had received an injection of an influenza vaccine (trade name, manufacturer, lot number, route, site and date of vaccination not reported) and an unspecified amount of time later started sweating and "the next thing he knew he was on the floor." The patient reported that the health care professional (HCP) mentioned that his blood sugar dropped in the 20's. The patient's concomitant medication included HUMALOG. Illness at the time of vaccination and pre-existing medical conditions were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain, Serum sickness-like reaction, Urticaria
Clinical narrative: Initial report was received on 19 October 2011 from a health care professional, at which time this case was assessed as non-serious listed. Based upon follow-up information received on 06 January 2012 from a health care professional, it was determined this case now meets seriousness criteria (OTHER-MEDICALLY SIGNIFICANT) and this case has been upgraded from non-serious to serious. This narrative includes information reported on both dates. A four-year-old female patient had received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number U4231B on 14 November 2011. On 15 November 2011, the patient experienced hives and a urticarial rash. The patient was treated with BENADRYL by mouth (PO) every six hours (q6h) for two days. The patient then went to an urgent care center and was prescribed prednisolone 15 milligrams (mg) twice a day (BID) for three days. When the patient came off prednisolone, she complained of knee and wrist pain. No swelling of the joints was noted and the patient was diagnosed with serum sickness type of reaction. The patient responded to slowly tapering the course of prednisolone but later had achy episodes and was referred to a rheumatologist. The patient took no concomitant therapy, had no any other vaccinations within four weeks prior to the administration of FLUZONE, no illness at time of vaccination, no known allergy and no relevant medical history. The patient had not experienced adverse events following prior vaccination. The patient's birth weight was 3420 grams (g) and had two brothers and sisters. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Lip swelling, Pruritus, Swelling face, Swollen tongue
Clinical narrative: Initial report was received from a consumer, who was also the patient, on 03 January 2012. A 73-year-old male patient had received an intramuscular injection of FLUZONE HIGH-DOSE, sanofi pasteur Inc. (lot number, date and site of administration not reported) in August or September (year not reported). Approximately 2-3 weeks later, the patient experienced itching on the fingers and toes which persisted at the time of the report. Around the end of November, the patient also developed a swollen tongue, lips and cheeks. The patient's doctor discontinued ezetimibe and VYTORIN and started the patient on LIPITOR and the swelling resolved. The patient denied any illness at the time of vaccination, other vaccinations received within four weeks of FLUZONE HIGH-DOSE and any adverse event following prior vaccinations. The patient had a medical history of high cholesterol. The patient's concomitant medications included VYTORIN, "BENATAR" and finasteride 5 milligrams (mg). The patient received an influenza vaccine annually. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site pruritus
Clinical narrative: Itching at injection site that lasted for 2 to 3 days. Injection site sensitive to being touched (feels bruised) for several months afterward even up to present time 1/13/2012.