chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Developing Cellulitis at injection site.
Age: 10.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Upper extremity mass
Clinical narrative: The upper arm where the shot was administered had gotten red, swollen, hard, and hot to the touch. The lump on her arm was about 5 inches in diameter. The doctor prescribed antibiotic (Augmentin) on 10/2.
Age: 1.33
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Irritability, Pyrexia, Urticaria
Clinical narrative: Whelps on arms, legs, slightly fussy, 105* fever.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Axillary pain, Balance disorder, Chills, Dizziness
Clinical narrative: 104.2 FEVER, CHILLS, EXCRUCIATING PAIN IN THE UNDERARM WHERE THE INJECTION WAS GIVEN, DIZZINESS, LIGHT HEADNESS, GENERAL WEAKNESS, INABILITY TO KEEP BALANCE.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: 104.2 FEVER, CHILLS, EXCRUCIATING PAIN IN THE UNDERARM WHERE THE INJECTION WAS GIVEN, DIZZINESS, LIGHT HEADNESS, GENERAL WEAKNESS, INABILITY TO KEEP BALANCE.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Round, red raised area at injection site, slightly warm to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Decreased appetite, Injection site pain, Injection site swelling, Lethargy, Swelling
Clinical narrative: My 4 year-old son, with no medical history and on no medications, was given the KINRIX DTaP-IPV injection from GSK (lot# AC20B213BA) on 9/27/2012 at 4:37 PM in his left arm. At the same time, he was provided the VARIVAX vaccine (lot# H010559) in the same arm and the MMR combined vaccine (lot# H012139) in the right arm, both from Merck.  Also at the same time he was given the FLUMIST vaccine by MEDIMMUNE (lot# AJ2108).The injection site in the left arm was painful and hard to the touch the morning of 9/28/12.  My son was also lethargic and not eating well.  At 9:00 PM, when we removed my son's shirt for his bath, we noticed that his left arm was swollen to more than twice the size and the swelling was extending to his left should blade.  The information sheet on the DTap noted a "minor" reaction of arm swelling that could last for 1-7 days in the arm where the injection was administered.  I called the nurse on duty, the practice that administered the vaccination and was advised to visit the Emergency Room.  The doctor who examined him advised us that this was probably a vaccine reaction, but if the swelling did not improve by the next to start him on the antibiotic prescription that he provided for a possible infection.  The swelling did not get worse, but appeared to improve.  Within 3 days, the swelling was resolved.  I called his pediatrician on 10/2 and asked what could have caused the extreme swelling and was advised that it was probably the pertussis element in the vaccine and the swelling meant that my son had sufficient immune response to the vaccine.  I responded that this response was not normal and he should not have received the vaccine if he had sufficient immune response.  This is a severe reaction and something should have been done to prevent this.  I am very disturbed that we are being required to administer vaccinations to our children when there might be "sufficient immune response".  I also noticed in the literature that the Flumist vaccine that my son received is not supposed to be provided along with other vaccines and could this have probably been the cause.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUN3, MMR, VARCEL
Symptoms: Unevaluable event, Vaccination complication
Clinical narrative: My 4 year-old son, with no medical history and on no medications, was given the KINRIX DTaP-IPV injection from GSK (lot# AC20B213BA) on 9/27/2012 at 4:37 PM in his left arm. At the same time, he was provided the VARIVAX vaccine (lot# H010559) in the same arm and the MMR combined vaccine (lot# H012139) in the right arm, both from Merck.  Also at the same time he was given the FLUMIST vaccine by MEDIMMUNE (lot# AJ2108).The injection site in the left arm was painful and hard to the touch the morning of 9/28/12.  My son was also lethargic and not eating well.  At 9:00 PM, when we removed my son's shirt for his bath, we noticed that his left arm was swollen to more than twice the size and the swelling was extending to his left should blade.  The information sheet on the DTap noted a "minor" reaction of arm swelling that could last for 1-7 days in the arm where the injection was administered.  I called the nurse on duty, the practice that administered the vaccination and was advised to visit the Emergency Room.  The doctor who examined him advised us that this was probably a vaccine reaction, but if the swelling did not improve by the next to start him on the antibiotic prescription that he provided for a possible infection.  The swelling did not get worse, but appeared to improve.  Within 3 days, the swelling was resolved.  I called his pediatrician on 10/2 and asked what could have caused the extreme swelling and was advised that it was probably the pertussis element in the vaccine and the swelling meant that my son had sufficient immune response to the vaccine.  I responded that this response was not normal and he should not have received the vaccine if he had sufficient immune response.  This is a severe reaction and something should have been done to prevent this.  I am very disturbed that we are being required to administer vaccinations to our children when there might be "sufficient immune response".  I also noticed in the literature that the Flumist vaccine that my son received is not supposed to be provided along with other vaccines and could this have probably been the cause.
Age: 5.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash, Benadryl.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia oral, Pruritus
Clinical narrative: Numb and tingling left side of face and tongue; itching on face.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Hive like rash on hands and feet, slightly itching non painful.
Age: 1.26
Sex: F
Vaccine: FLUX, MMRV
Symptoms: Crying, Decreased appetite, Injection site reaction, Irritability, Pyrexia
Clinical narrative: Fever of 101.4 for 2 days.  Lesion around injection site.  Loss of appetite, fussiness and crying.
Age: 1.26
Sex: F
Vaccine: FLUX, MMRV
Symptoms: Skin lesion
Clinical narrative: Fever of 101.4 for 2 days.  Lesion around injection site.  Loss of appetite, fussiness and crying.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Tenderness, Urticaria, Viral infection
Clinical narrative: Front left thigh tender to touch followed by raised welt upper left side.  Smaller welt near 1st one next day followed by raised rash below back left waist.  Next day a line of rash spots from left side to front & inner thigh.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Malaise, Pain, Pain in extremity
Clinical narrative: Chills, temp of 101.8, malaise, aches and pain, pain in right arm down to fingertips. Benadryl, Loratidine daily.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left deltoid redness with swelling - 2 by 2 cm area of erythema, not indurated, not fluctuant.
Age: 34.0
Sex: F
Vaccine: FLU3, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Redness, Swelling, and vesicles around injection site of Varicella vaccine (SQ).
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Insomnia
Clinical narrative: Patient had pain and mild tenderness at injection site evening of getting flu shot; 30 days later pain returned and patient cannot sleep well.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Dizziness, Fatigue, Nausea
Clinical narrative: When I received the injection, I had a sharp pain (more than usual for a deltoid injection in the past).  I had extreme fatigue, some lightheadedness, and a small amount of nausea the morning after I received the injection.  I needed to return home from work around mid day and slept for about 2 hours.  Some minor lighheadedness lasted through the following day (10/4) but all adverse symptoms were gone by 10/5).
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Nausea, Rash, Vomiting
Clinical narrative: Fatigue and Nausea. Vomiting two times. Rash on bilateral hands two to three hours post. Rash subsided within 4 hours of onset.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Abasia, Dizziness, Dysstasia, Pain, Pain in extremity
Clinical narrative: Extreme dizziness - could not stand or walk.  High fever off and on,  body aches and pains.  Arm ached constantly even without movement near injection point.  Last for a few hours and now I'm fine.  Arm is still sore but not as bad.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Extreme dizziness - could not stand or walk.  High fever off and on,  body aches and pains.  Arm ached constantly even without movement near injection point.  Last for a few hours and now I'm fine.  Arm is still sore but not as bad.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness, tenderness and warmth at injection site; induration 14 x 16 cm.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Dizziness, Feeling hot, Nausea
Clinical narrative: Felt faint, felt dizzy, very hot, nausea, felt like throwing up.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Dysphagia, Feeling hot, Malaise
Clinical narrative: Chills, ill feeling, hotness, difficulty swallowing.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme: legs, arms, buttocks.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Right arm swollen & pain. (Pneumonia adm right arm).
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Acute myocardial infarction, Cardiomyopathy, Dyspnoea, Fatigue, Immediate post-injection reaction
Clinical narrative: Developed severe fatigue & shortness of breath within 48 hrs. of vaccine administration. Subsequently admitted to hospital on 9/12/12 with severe cardiomyopathy & acute M.I. Noted pain & swelling at injection site immediately.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Developed severe fatigue & shortness of breath within 48 hrs. of vaccine administration. Subsequently admitted to hospital on 9/12/12 with severe cardiomyopathy & acute M.I. Noted pain & swelling at injection site immediately.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: This spontaneous report as received from a male patient with unspecified age, gender, pertinent medical history or drug reaction/allergies. The patient was vaccinated with a dose of ZOSTAVAX on 26-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. The patient experienced a few side effects such as fatigue and headaches after the shot in approximately July 2012. Symptoms went away 2 weeks after vaccine and felt fine at the time of the report. The patient was recovered from fatigue and headaches on approximately 10-AUG-2012. There were not treatment information or diagnostic test reported. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: TYP
Symptoms: Mobility decreased, Myalgia, Pain
Clinical narrative: Pt received Typhoid Vi vaccine in left deltoid on 03/19/2012.  She states she continued to have muscle soreness beyond 3-4 days. She went to her primary physician 4 months later.  She reports it still hurts and impairs her movement in certain ways. Called today to report above.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, swelling, erythema at injection site.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site streaking, Injection site warmth
Clinical narrative: Extreme itching, knot at site of injection, red/hot injection site, 2 inch wide by 4 inch long red streak, pain - These side effects are still present as of today, Oct 8th, 2012.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Extreme itching, knot at site of injection, red/hot injection site, 2 inch wide by 4 inch long red streak, pain - These side effects are still present as of today, Oct 8th, 2012.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Impaired driving ability, Joint range of motion decreased, Mobility decreased, Musculoskeletal pain
Clinical narrative: Within a few hours of receiving the flu shot in my upper left arm, I experienced a massive, acute pain in my back shoulder.  That pain spread across my upper shoulder down my left arm.  I have had the flu shot every year for almost two decades and have never experienced anything like this.  There was no redness or swelling on my outer skin.  But I cannot move my shoulder in any direction.  The pain is worse when I sleep.  I cannot lift my arm in any direction without pain in the muscles.  Lifting and driving have also become difficult.  Taking Tylenol or Aleve nor applying tiger balm help.  I've also applied heating pad regularly.  The pain is lessened, but mobility has never been restored.  This is now day 12 and I am very concerned.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Within a few hours of receiving the flu shot in my upper left arm, I experienced a massive, acute pain in my back shoulder.  That pain spread across my upper shoulder down my left arm.  I have had the flu shot every year for almost two decades and have never experienced anything like this.  There was no redness or swelling on my outer skin.  But I cannot move my shoulder in any direction.  The pain is worse when I sleep.  I cannot lift my arm in any direction without pain in the muscles.  Lifting and driving have also become difficult.  Taking Tylenol or Aleve nor applying tiger balm help.  I've also applied heating pad regularly.  The pain is lessened, but mobility has never been restored.  This is now day 12 and I am very concerned.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Golfball sized lump at injections site, painful, red, warm to the touch.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Activities of daily living impaired, Bronchitis, Chest X-ray normal, Cough, Fatigue
Clinical narrative: Injection site hot, tender. 7/29/12 low-grade fever, tired. 7/30/12 started coughing, very tired. 7/31/12 coughing worse, low-grade fever; went back to clinic; said I'd picked up something, not from vaccine; very tired but managed to work my job. 8/1/12 coughing worse; left work early; clinic unable to see me; sent me to another clinic; said I had bronchitis & gave me an inhaler & cough syrup but not from vaccine. 8/2 & 8/3/12 missed work; slept continually since evening of 8/1/12; coughing & fever continued. 8/4/12 Symptoms continue to worsen; saw Dr.; said follow previuos recommendations; gave me antibiotic Rx but said not to take it; it's a virus or something but not from vaccine. 8/6/12 started antibiotics as not getting better; dragged myself through week of work. 8/10/12 felt a little better & thought I could go to work; at 4:15 pm I started to cough & cough; syrup & inhaler didn't stop them completely; when I told my husband he immediately took me to emergency room for chest xray but not pneumonia; continue antibiotics.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypersomnia, Injection site pain, Injection site warmth, Pyrexia, Viral infection
Clinical narrative: Injection site hot, tender. 7/29/12 low-grade fever, tired. 7/30/12 started coughing, very tired. 7/31/12 coughing worse, low-grade fever; went back to clinic; said I'd picked up something, not from vaccine; very tired but managed to work my job. 8/1/12 coughing worse; left work early; clinic unable to see me; sent me to another clinic; said I had bronchitis & gave me an inhaler & cough syrup but not from vaccine. 8/2 & 8/3/12 missed work; slept continually since evening of 8/1/12; coughing & fever continued. 8/4/12 Symptoms continue to worsen; saw Dr.; said follow previuos recommendations; gave me antibiotic Rx but said not to take it; it's a virus or something but not from vaccine. 8/6/12 started antibiotics as not getting better; dragged myself through week of work. 8/10/12 felt a little better & thought I could go to work; at 4:15 pm I started to cough & cough; syrup & inhaler didn't stop them completely; when I told my husband he immediately took me to emergency room for chest xray but not pneumonia; continue antibiotics.
Age: 1.66
Sex: M
Vaccine: DTAP, HEPA, MMR, PNC13, VARCEL
Symptoms: Abscess drainage, Injection site abscess, Injection site nodule
Clinical narrative: Knot continuously to get bigger at injection site per caregiver (left upper thigh).
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Injection site reaction, Oedema, Paraesthesia
Clinical narrative: 10/08/2012 client reports experiencing weeping from injection site, tingling in fingers of injection site arm and intermittent headaches. Reports feeling feverish, without elevated temperature.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: Fever, body aches, light headed, nausea.
Age: 68.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Inflammation, Nodule, Pruritus, Swelling
Clinical narrative: 10/01/12 red, swollen, inflamed knot, itching, 1 1/2 inches apply BENADRYL cream.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Oedema peripheral, Pain in extremity, Pyrexia, Rash erythematous, Rash macular
Clinical narrative: Red, blotchy rash on R arm, swollen, painful, fever to 102.4F, wheezing.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Wheezing
Clinical narrative: Red, blotchy rash on R arm, swollen, painful, fever to 102.4F, wheezing.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Nodule, Pain in jaw, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling tongue, knot felt under jaw/neck near lymph node on right side (vaccine administered into left deltoid 1.5 hours prior.  TMJ sore and tender, right side of face tingly and numb.  No problems with speaking, drinking, etc.  No changes in vision, speech, hearing.  Symptoms only in facial area on Right side.  Arms and legs with normal sensation.  No chest pain or shortness of breath.  By 6pm that day, all symptoms were resolved and have not recurred.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Tingling tongue, knot felt under jaw/neck near lymph node on right side (vaccine administered into left deltoid 1.5 hours prior.  TMJ sore and tender, right side of face tingly and numb.  No problems with speaking, drinking, etc.  No changes in vision, speech, hearing.  Symptoms only in facial area on Right side.  Arms and legs with normal sensation.  No chest pain or shortness of breath.  By 6pm that day, all symptoms were resolved and have not recurred.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Acne, Erythema, Pruritus, Urticaria
Clinical narrative: 4 puffy red welts about 1 inch each across upper chest and neck as well as whiteheaded small pimples. Extremely itchy. Also in b/of right arm near elbow.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Rash maculo-papular
Clinical narrative: Approximately one day after vaccination pt started to develop redness, warm, itching, swelling of injection site. Pt also developed maculopapular and vesicular rash. Pt advised to continue using BENADRYL.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Approximately one day after vaccination pt started to develop redness, warm, itching, swelling of injection site. Pt also developed maculopapular and vesicular rash. Pt advised to continue using BENADRYL.
Age: 14.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Vaccine given on 9/29, and next day awoke with hives on lower back, forearms, and ankles. 10/2/12 - Hives fading. No new ones. Patient has been taking BENADRYL 50mg twice daily.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache, Influenza, Pain
Clinical narrative: Evening after injection I became very tired and had to go to bed 2-3 hrs before regular bedtime. The next day I began having flu symptoms (bad headache, body aches, dizziness, fatigue). By noon of that day I had a 101.5 fever that lasted till that evening. Today, Monday 10-8, I still have bad body aches, headache and fatigue.
Age: 46.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Evening after injection I became very tired and had to go to bed 2-3 hrs before regular bedtime. The next day I began having flu symptoms (bad headache, body aches, dizziness, fatigue). By noon of that day I had a 101.5 fever that lasted till that evening. Today, Monday 10-8, I still have bad body aches, headache and fatigue.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Lymphadenopathy, Oropharyngeal pain, Vomiting
Clinical narrative: CHILLS, SORE THROAT, SWOLLEN THROAT GLANDS, VOMITING. TOOK EXCEDRIN IN THE MIDDLE OF THE NIGHT FOR SORE THROAT. RESTED FOR 48 HOURS.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Oedema, Pain, Skin warm
Clinical narrative: Red, warm to the touch, painful, can feel heat coming off the arm, edema.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Aspiration joint, Musculoskeletal pain
Clinical narrative: Patient went to ER with shoulder pain, was admitted with severe shoulder inflammation. They determined there was no infection. Shoulder was aspirated 3 times.  Discharged on 10/8/2012 on physical therapy and Cephalexin.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Terrible pain and nerve prickling in vaccinated arm. Pain still present 7 days later.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Chills, Generalized Aching, Shaky, Fatigue, Arm sore from Elbow to top of Shoulder, Headache.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Chills, Generalized Aching, Shaky, Fatigue, Arm sore from Elbow to top of Shoulder, Headache.
Age: 60.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity, Tendon pain
Clinical narrative: Patient states that 4-5 days after receiving his zoster and flu shots, he is experiencing leg tendon aching and pain in extremities. Reported 9 days after shot.  He had also received a zoster vaccine of the same brand and manufacturer previously in March of the same year.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Injection site erythema, Injection site pain
Clinical narrative: Pt recieved vaccine noticed pain when vaccine was injected into Left deltoid. within 1 hour pain moved up into the shoulder area.  Injection site red and almost rashy like noticed the next day- size of a quarter. At 1030am on Friday became nausea and vomited at about 1100am.  Run to pharmacy to pick up meds and spoke with pharmacist who questioned whether she had the high dose vaccine.  Pt went home feeling fatigued. Feverish, and arm/shoulder aching pt felt bad and stayed in bed rest of the day.  Arm was still sore Sunday 10/7/12 and today - tender to touch on Monday. Noticed more arthritic pain across shoulders and neck still as of today.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Musculoskeletal pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pt recieved vaccine noticed pain when vaccine was injected into Left deltoid. within 1 hour pain moved up into the shoulder area.  Injection site red and almost rashy like noticed the next day- size of a quarter. At 1030am on Friday became nausea and vomited at about 1100am.  Run to pharmacy to pick up meds and spoke with pharmacist who questioned whether she had the high dose vaccine.  Pt went home feeling fatigued. Feverish, and arm/shoulder aching pt felt bad and stayed in bed rest of the day.  Arm was still sore Sunday 10/7/12 and today - tender to touch on Monday. Noticed more arthritic pain across shoulders and neck still as of today.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness, Vomiting
Clinical narrative: Pt recieved vaccine noticed pain when vaccine was injected into Left deltoid. within 1 hour pain moved up into the shoulder area.  Injection site red and almost rashy like noticed the next day- size of a quarter. At 1030am on Friday became nausea and vomited at about 1100am.  Run to pharmacy to pick up meds and spoke with pharmacist who questioned whether she had the high dose vaccine.  Pt went home feeling fatigued. Feverish, and arm/shoulder aching pt felt bad and stayed in bed rest of the day.  Arm was still sore Sunday 10/7/12 and today - tender to touch on Monday. Noticed more arthritic pain across shoulders and neck still as of today.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Vomiting
Clinical narrative: Vomiting, diarrhea, dizziness, difficulty breathing.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Tachycardia, Wheezing
Clinical narrative: Gradually worsening SOB, coughing, wheezing, tachycardia.
Age: 0.35
Sex: F
Vaccine: 6VAX-F, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Fever 102.3 for 24hrs. Diarrhea for one week. No cooing for one month.
Age: 62.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Local reaction
Clinical narrative: Awoke next am with large local reaction to rt arm.  Site was tender, red and warm to touch with firm center. Approx size of fist.  Did not seek treatment symptoms improving when reported. Reports local reaction with previous flu vaccine and each time reaction larger.
Age: 62.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Vaccine positive rechallenge
Clinical narrative: Awoke next am with large local reaction to rt arm.  Site was tender, red and warm to touch with firm center. Approx size of fist.  Did not seek treatment symptoms improving when reported. Reports local reaction with previous flu vaccine and each time reaction larger.
Age: 15.0
Sex: F
Vaccine: FLU3, HEPA, HPV4
Symptoms: Syncope
Clinical narrative: Client fainted, was given water after the episode passed. No injuries seen. Client was sitting at the time of the fainting episode and was held in sitting position until regained consciousness.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Tenderness
Clinical narrative: Tender swollen about the size of a quarter, then became more swollen about 6 inches around.
Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: Severe arm pain. Pain was so severe that I could not move it for 24 hours and pain was severe for 3 days. Today is day 6 and it is still sore and feel hot when moved. Fever of 100.5 for 12 hours and heart rate between 104 - 111 while lying down.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus
Clinical narrative: On 10/3/12, pt reports she felt burning/itching around her belly button. She noted no rash. On 10/6/12, she still had the burning/itching around belly button and also developed itching under her left arm, also with no rash. By 10/8/12, all symptoms had stopped. Pt did not go to MD or receive any medications for her symptoms.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Erythema
Clinical narrative: Pain in left arm pit beginning the night of the vaccine. The following day, red streaks noted from left shoulder to the center of chest. Streaks lasted 2-2 1/2 weeks.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Ear discomfort, Hyperaesthesia, Hyperhidrosis, Nasal discomfort
Clinical narrative: Sudden burning in nose, ear canals, heavy discharge post nasal and from nose. Body aches, skin sensitivity, chills, sweats. Normal body temp was recorded. Complete stopped up sinuses for several hours.  Used nose drops to get enough air to be able to go to sleep. Felt better but not perfect the following day, by the 2nd day I was back to normal, much faster than a recovery from a normal cold.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paranasal sinus hypersecretion, Rhinorrhoea, Sinus congestion
Clinical narrative: Sudden burning in nose, ear canals, heavy discharge post nasal and from nose. Body aches, skin sensitivity, chills, sweats. Normal body temp was recorded. Complete stopped up sinuses for several hours.  Used nose drops to get enough air to be able to go to sleep. Felt better but not perfect the following day, by the 2nd day I was back to normal, much faster than a recovery from a normal cold.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Musculoskeletal pain, Oropharyngeal pain, Pyrexia, X-ray
Clinical narrative: Shoulder was so sore, I could barely lift it. On Monday, I returned to the same clinic on Monday (9/10/2012) due to continued flu symptoms and to complain of significant shoulder pain.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Dysphagia, Eye swelling, Retching
Clinical narrative: Coughing, difficulty swallowing, swollen eyes, gagging. Benadryl, Advil.
Age: 70.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Eye swelling, Swollen tongue, Throat irritation
Clinical narrative: Coughing, difficulty swallowing, swollen eyes, gagging. Benadryl, Advil.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Balance disorder, Coordination abnormal, Lethargy, Pyrexia
Clinical narrative: Lethargic, staring off into space, low grade fever, progressed into vomitting and additional fever. Has strange behaviors of staring off, unbalanced and cordination is off.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Staring, Vomiting
Clinical narrative: Lethargic, staring off into space, low grade fever, progressed into vomitting and additional fever. Has strange behaviors of staring off, unbalanced and cordination is off.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Headache, Hypoaesthesia oral, Musculoskeletal stiffness
Clinical narrative: Pt received flu shot and seemed ok, but later returned to the clinic and said that his tongue was numb, and had a headache and felt stiff. 911 called but no treatment was given.
Age: 20.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Hypoaesthesia oral, Paraesthesia
Clinical narrative: Pt received flu shot and seemed ok, but later returned to the clinic and said that his tongue was numb, and had a headache and felt stiff. 911 called but no treatment was given.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Oropharyngeal pain, Pain, Rhinorrhoea
Clinical narrative: Sore throat, cough, runny nose, body aches.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Pt. developed 'cellulitis' after her ZOSTAVAX injection was given.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test abnormal, Cellulitis, Pain in extremity
Clinical narrative: Pt. developed 'cellulitis' after her ZOSTAVAX injection was given.
Age: 15.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest X-ray, Computerised tomogram head, Condition aggravated, Full blood count, Headache
Clinical narrative: Redness and swelling of (R) upper arm where pneumonia vaccine given. At same time  patient experienced fever, N/V and severe H.A. Had increased WBC with (L) shift. Transferred to hospital where he had spinal tap and was diagnosed with meningitis.
Age: 15.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Lumbar puncture abnormal, Meningitis, Metabolic function test
Clinical narrative: Redness and swelling of (R) upper arm where pneumonia vaccine given. At same time  patient experienced fever, N/V and severe H.A. Had increased WBC with (L) shift. Transferred to hospital where he had spinal tap and was diagnosed with meningitis.
Age: 15.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Nausea, Pyrexia, Urine analysis, Vomiting, White blood cell count increased
Clinical narrative: Redness and swelling of (R) upper arm where pneumonia vaccine given. At same time  patient experienced fever, N/V and severe H.A. Had increased WBC with (L) shift. Transferred to hospital where he had spinal tap and was diagnosed with meningitis.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Oedema peripheral
Clinical narrative: 10/5/12 approx 3pm arm swelling up & short of breath.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Rt leg 4 inches red swollen, hard, and hot to the touch reaction.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Rash macular
Clinical narrative: Within 2 hrs of vaccine administration feel pin point red macular rash from neck down on palms & soles confluent rash.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Acute urticaria. Treatment: 9/27/12 Betamethasone Acetate 3mg, Betamethasone sodium phosphate 3mg and Hydroxyzine 25mg IM. 10/1/12 Betamethasone Acetate 3mg, Betamethasone sodium phosphate 3mg IM and prescription for Medrol Dose Pak 4mg. Take as directed.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Convulsion, Gaze palsy, Loss of consciousness, Muscle twitching
Clinical narrative: At the end of yearly visit, pt received 3 vaccines: HPV, MENACTRA, and Hep a. Pt started to pass out/when I called out to her. She started having a seizures. Her arms were twitching and her eyes were rolling back in her head.
Age: 13.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dyspnoea, Flushing, Headache, Lip swelling
Clinical narrative: Within 2 hours of vaccine administration, she developed c/o SOB, facial flushing and lip swelling with headache.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Headache, Musculoskeletal stiffness
Clinical narrative: Pt presented 10/4 complaining of stiff neck and persistent headache. Stated neck became very stiff in the evening of flu shot, stiffness from left shoulder up into left side of neck. Had slight headache all day - but worsened after flu shot & still had slight stiffness and lightheaded on Thursday 10/4/12.
Age: 1.05
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Autism, Decreased eye contact, Expressive language disorder, Irritability, Laboratory test
Clinical narrative: Began approx 15 months fever; loss of eye contact; loss of language/communication; began hand flapping, stimming began; increased irritability diagnosed with Autism Disorder.
Age: 1.05
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Stereotypy
Clinical narrative: Began approx 15 months fever; loss of eye contact; loss of language/communication; began hand flapping, stimming began; increased irritability diagnosed with Autism Disorder.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Blood immunoglobulin G, Erythema, Injection site erythema, Injection site induration
Clinical narrative: Ct reports tenderness & redness last night. TC to this RN am stating area red & warm & hard at injection site seen at 4:45 pm area warm & hard 50 mm x 50 mm. Encourage apply moist compress & seek medically attention if S&S increased.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Tenderness, Varicella virus test negative
Clinical narrative: Ct reports tenderness & redness last night. TC to this RN am stating area red & warm & hard at injection site seen at 4:45 pm area warm & hard 50 mm x 50 mm. Encourage apply moist compress & seek medically attention if S&S increased.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Oedema, Pain in extremity, Paraesthesia
Clinical narrative: 10-5-2012 PM - (L) arm sore. 10-6-2012 barely able to raise (L) arm. 10-7-2012 101.6 (O) redness, edema. 10-8-2012 12:00 - entire deltoid red, swollen, hot to touch fingers tingling ice pack applied axilla red.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: 10-5-2012 PM - (L) arm sore. 10-6-2012 barely able to raise (L) arm. 10-7-2012 101.6 (O) redness, edema. 10-8-2012 12:00 - entire deltoid red, swollen, hot to touch fingers tingling ice pack applied axilla red.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Onset 2 days after vaccination of pruritic vesicles on bilateral arms. Treated with FAMVIR 500g TID x 5 days.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Headache, Thinking abnormal, Vertigo
Clinical narrative: Headache, "spinning" within my head - aggravating brain thoughts, dizziness, imbalance. Lying down promoted headaches - rising to sitting position caused almost blackouts - better after 8 days.
Age: 62.0
Sex: M
Vaccine: FLU3, HEPA, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt developed shingles rash on T6-T7 area 3-4 days after injection (right side).
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Oedema peripheral, Skin discolouration
Clinical narrative: Pt reported badly bruised arm that swelled and was black. Pt also on blood thinner, so told that she may experience worse bruising. Pt requested report filed.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Movement disorder, Oropharyngeal pain, Pain, Sleep disorder
Clinical narrative: Patient received vaccine on 9/27/12 at 5pm, by 7:30pm she has soreness all over body, achy all night, can't sleep, can't turn in bed. Next day, hard time walking, sore throat. She said she have not contact her doctor, pharmacist advise to take TYLENOL/MOTRIN.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Musculoskeletal pain
Clinical narrative: Sharp shoulder pain when lifting objects & discomfort while sleeping (to the level that she sleeps only on one side).
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Lacrimation increased, Ocular hyperaemia, Pain
Clinical narrative: Throat closing - cough, red, watery eyes, headache, aches (body).
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: Throat closing - cough, red, watery eyes, headache, aches (body).
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Cyanosis, Injection site discolouration, Injection site reaction
Clinical narrative: Pt was administered FLUZONE High Dose on Left arm (Bicep) claims that it's all black & blue.
Age: 32.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Dizziness, Erythema, Feeling hot, Headache, Pyrexia
Clinical narrative: Dizziness, redness putting off heat. Headache, fever.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Influenza like illness, Oral mucosal blistering
Clinical narrative: Blisters in mouth. Flu-like symptoms (severe) x 2 wks. 101 degrees temperature.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 13.0
Sex: M
Vaccine: MMRV, MNQ
Symptoms: Erythema, Lymph node pain, Oedema peripheral, Similar reaction on previous exposure to drug
Clinical narrative: Pt received Hep B #2 at our office on 10/3/12. Retrd to office 10/8/12 with red swollen arm  and tender lymph node in axilla (L) side. Had same reaction 03/12 after receiving Hep B #1.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Fever - area swollen, itchy on (R) arm.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Malaise, Oedema peripheral
Clinical narrative: Pt. states that he didn't feel well overall and that there was massive swelling in his legs & feet after being vaccinated with high-dose FLUZONE.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: 24 hours after vaccine Pt had swollen red arm. (From armpit to mid forearm). Pt saw Dr.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Glossodynia, Swelling
Clinical narrative: Tongue burning, swelling.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Received PNEUMOVAX and FLUZONE-HD on 10/1/12. That evening she developed fever and malaise which lasted several days. The injection site became red, inflamed and swollen and spread down arm.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Oedema peripheral, Pyrexia
Clinical narrative: Received PNEUMOVAX and FLUZONE-HD on 10/1/12. That evening she developed fever and malaise which lasted several days. The injection site became red, inflamed and swollen and spread down arm.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Malaise, Pyrexia
Clinical narrative: Fever 100.5 degrees, severe "sick feeling", redness & warmth on arm at injection site, stayed in bed for 2 days before feeling well enough to get up. Took TYLENOL & fluids & rested.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Erythema, Feeling hot, Headache, Local reaction
Clinical narrative: Employee received influenza vaccine at 2pm on 9/25/12. Localized reaction of redness, swelling, warmth, pain noted at 7pm. On 9/26/12, awoke at 5AM with pain & stiffness to left side of neck, upper back, shoulder & left arm along with a dull headache.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity
Clinical narrative: Employee received influenza vaccine at 2pm on 9/25/12. Localized reaction of redness, swelling, warmth, pain noted at 7pm. On 9/26/12, awoke at 5AM with pain & stiffness to left side of neck, upper back, shoulder & left arm along with a dull headache.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Employee received influenza vaccine at 2pm on 9/25/12. Localized reaction of redness, swelling, warmth, pain noted at 7pm. On 9/26/12, awoke at 5AM with pain & stiffness to left side of neck, upper back, shoulder & left arm along with a dull headache.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Flushing, Headache, Migraine
Clinical narrative: Within 30 minutes developed generalized itching & flushing of skin, cough. Within 1 hr aura with slight headache progressing to migraine. Migraine x 3 days associated with vomiting & diarrhea. (L) arm swollen. Rx with IMITREX & antiemetic.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema peripheral, Pruritus generalised, Vomiting
Clinical narrative: Within 30 minutes developed generalized itching & flushing of skin, cough. Within 1 hr aura with slight headache progressing to migraine. Migraine x 3 days associated with vomiting & diarrhea. (L) arm swollen. Rx with IMITREX & antiemetic.
Age: 0.22
Sex: M
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was given Tdap at 2 month well child check; instead of DTaP.
Age: 11.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Upon completion of giving MMR vaccine, pt developed a raised wheal the size of a 50 cent piece. Around area skin was red and hot to the touch.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Urticaria
Clinical narrative: Rash, itching/swelling around the site of administration. Wheal larger than a silver dollar, no leaking. Given BENADRYL at E.R.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Induration, Injected limb mobility decreased, Injection site pain, Oedema peripheral, Pain in extremity
Clinical narrative: This spontaneous report as received form a pharmacist refers to a 68 years old female patient. The patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) in left arm and a dose of INFLUENZA (manufacturer unknown) (Lot # not reported) in her right arm on 22-SEP-2012. Concomitant medications included: Warfarin. The pharmacist reported that on 23-SEP-2012, the patient experienced left arm hard was swollen, painful and kind of hard to move and tender down to the elbow. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a 36 years old female patient refers to herself. The patient was vaccinated SC, with 3 doses of GARDASIL (lot number not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The patient stated that her mother who was nurse gave her the second dose 3 months after the first dose, and the third dose 2 months after the second doses. She had no side effects. It was unknown if the patient had sought medical attention. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research (reference number# MRK239) conducted by Observant LLC refers to her child who was a 15 year old female patient. The patient was vaccinated with GARDASIL (Lot#, dose/frequency, route unspecified) in 2006, then the patient experienced muscle pain at dose on an unknown date. Subsequently patient recovered with sequelae from muscle pain at dose. It was reported that event did not re-appear after the next dose. The reporter felt that muscle pain at dose was non-serious and it was related to the therapy with GARDASIL. Patient's sister experienced unspecified adverse event post vaccine of GARDASIL (MARRS# 1209USA011061). Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Unevaluable event
Clinical narrative: This spontaneous report as received from a consumer, as part of a marketing research conducted by Observant LLC refers to her child who was a 14 year old female patient. The patient was vaccinated with GARDASIL (Lot#, dose/frequency, route unspecified) in June 2012, then the patient experienced muscle pain at dose on an unknown date in 2012. Subsequently patient recovered with sequelae. The reporter felt that unspecified adverse event at dose was non-serious and it was related to the therapy with GARDASIL. Patient's sister experienced muscle pain at dose post vaccine of GARDASIL (MARR# 1210USA002222). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Immediate post-injection reaction, Oedema peripheral, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient in her 20's. The patient was vaccinated intramuscularly with dose 1, 0.5 ml GARDASIL (lot# not reported) about 1 year ago, in approximately September 2011. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient experienced immediate redness and swelling of her entire arm within a few minutes of administration of her first dose of GARDASIL in approximately September 2011. The patient also experienced syncope in approximately September 2011. The patient sought medical attention in the office and received BENADRYL. No laboratory diagnostic studies were performed. Subsequently on an unknown date, the patient recovered. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 14 years old female patient. The patient was vaccinated with dose 1 and dose 2 of GARDASIL on 14-MAR-2012 and 22-SEP-2012, respectively (dose, route, site of administration and lot # not reported). No adverse effects reported. Additional information is not expected.