chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: He received the vaccine around 4:00 pm two days ago, once he woke up symptoms of redness and swelling had continued but welting had expanded around the site of injection. Mother gave him Benadryl at night, child states it did not help, but mother states it put him to sleep. This morning is was a bit larger, area in the center has remained constant. Surrounding erythema, up to about 2 hours ago, was more of a white color. Measures 4cm x 3cm.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Erythema, Heat, Pain and Edema at site
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Patient developed a hive like reaction at the injection site. It was approx. 4-5 cm red, raised area. Patient was advised to use cool compresses, Zyrtec, Benadryl prn.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Patient had a hive like reaction at the injection site. It was about 4-5cm red, raised and itchy. Patient was advised to use cool compresses, Zyrtec and Benadryl prn.
Age: 5.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red past elbow & swollen at site. Hot to touch.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Convulsion, Postictal state, Pyrexia, Somnolence, Vomiting
Clinical narrative: Pt had the shots at 11:00 AM 6/15 & developed a fever shortly after and started to sleep more, mother gave TYLENOL for 24hrs & pt was very sleepy. At 3:00 p 6/16 pt was in the waiting room of clinic &  had a seizure x 22 sec. Pt was postictal when I saw her. Had vomited a little.
Age: 17.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Headache, Loss of consciousness, Nausea
Clinical narrative: Within a minute of administering MENACTRA to him he lost consciousness. He was laid flat on the couch and he regained consciousness in another minutes or two with residual nausea and frontal headache.
Age: 18.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Induration, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Painful, firm, red, swelling (L) upper arm within few hours - Fever up to 101. 1 degrees F 48 hrs . Diarrhea, nausea, RIF area pain - local edema - 4" x 6" erythema, induration, swelling, soreness, watch bruising.
Age: 18.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Localised oedema, Nausea, Pain, Pallor
Clinical narrative: Painful, firm, red, swelling (L) upper arm within few hours - Fever up to 101. 1 degrees F 48 hrs . Diarrhea, nausea, RIF area pain - local edema - 4" x 6" erythema, induration, swelling, soreness, watch bruising.
Age: 18.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Painful, firm, red, swelling (L) upper arm within few hours - Fever up to 101. 1 degrees F 48 hrs . Diarrhea, nausea, RIF area pain - local edema - 4" x 6" erythema, induration, swelling, soreness, watch bruising.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Hyperaemia, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Swelling on injection site. Hyperemic & induration.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Gait disturbance, Sensory disturbance
Clinical narrative: Received GARDASIL 6/14/11; that evening he developed sensation "legs aren't helping me" during baseball game and parents noted awkward running gait; seen 6/17/11 in office and though he feels somewhat improved with normal stand mother still feels he runs differently.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: Excoriation, Hypotonia, Syncope, Unresponsive to stimuli
Clinical narrative: Approximately 25 minutes after immunizations, child was walking with mother in Pharmacy and collapsed into merchandise and slid to floor.  Mother said she was limp & unresponsive for about 1 minute.  EMS was called. EMS took vital signs. Mother said EMS told her the vital signs were normal so mom refused transport.  Child has 2 superficial abrasions on her chin approximately 2cm X 1cm each. No bruising noted.  Mom denied other injuries.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Decubitus ulcer, Guillain-Barre syndrome, Lung disorder, Pneumonia
Clinical narrative: This case was reported by a lawyer and described the occurrence of GUILLAIN BARRE syndrome in a 73-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. There were no concurrent medications. On 27 October 2010 the subject received a dose of FLULAVAL in the left deltoid. Within several days of vaccination with FLULAVAL, the subject developed GUILLAIN BARRE syndrome. The subject was hospitalized for three months and in rehabilitation for an additional three months. As a result, the subject developed lung problems, bed sores and suffered from pneumonia several times. At the time of reporting, GUILLAIN BARRE syndrome was improved and the outcome of the other events was unspecified.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Mom called to say her son had developed diarrhea, vomiting and fever - at 4AM 6-7-11. I administered vaccine HPV, and meningitis on 6-6-11. Mom was told if fever higher than 101, vomiting x 6 times - diarrhea x 6 stools take to family physician or ER.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cyanosis, Dyskinesia, Gaze palsy, Immediate post-injection reaction, Muscle rigidity
Clinical narrative: Immediately after injection of Kinrix, child became rigid, eyes rolled back, blue around mouth and had jerking of both arms- lasting approximately 60 seconds. Placed on left side, vital signs monitored, became responsive within 3 minutes. Child observed x 45 minutes without further incident. Mother advised to see physician or urgent care facility for follow- up today.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Unresponsive to stimuli
Clinical narrative: Immediately after injection of Kinrix, child became rigid, eyes rolled back, blue around mouth and had jerking of both arms- lasting approximately 60 seconds. Placed on left side, vital signs monitored, became responsive within 3 minutes. Child observed x 45 minutes without further incident. Mother advised to see physician or urgent care facility for follow- up today.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Patient attended a health fair for students and stated she wanted to receive the Hep B series that was offered.  Patient had completed the Hep B series in 1999.  Patient received an unecessary dose of Hep B vaccine.
Age: 33.0
Sex: F
Vaccine: HEPA, IPV, MNQ, YF
Symptoms: Chills, Disorientation, Eyelid ptosis, Headache, Lumbar puncture abnormal
Clinical narrative: 9 days after vaccination, patient began to feel ill. On the 10 day, she developed a rash on the back of her knee, fever at 103 degrees, chills, body aches, jaw pain, Rt. eye ptosis, headache. Rash extending on body. Diagnosed via spinal tap with meningitis. Diagnosed with YEL-AVD per Dr. report. Treated with 10d. KEFLEX. States on 6/15/11, "she still has symptoms, disorientation, headache, fever.
Age: 33.0
Sex: F
Vaccine: HEPA, IPV, MNQ, YF
Symptoms: Malaise, Meningitis, Pain, Pain in jaw, Pyrexia
Clinical narrative: 9 days after vaccination, patient began to feel ill. On the 10 day, she developed a rash on the back of her knee, fever at 103 degrees, chills, body aches, jaw pain, Rt. eye ptosis, headache. Rash extending on body. Diagnosed via spinal tap with meningitis. Diagnosed with YEL-AVD per Dr. report. Treated with 10d. KEFLEX. States on 6/15/11, "she still has symptoms, disorientation, headache, fever.
Age: 33.0
Sex: F
Vaccine: HEPA, IPV, MNQ, YF
Symptoms: Rash generalised, Yellow fever vaccine-associated viscerotropic disease
Clinical narrative: 9 days after vaccination, patient began to feel ill. On the 10 day, she developed a rash on the back of her knee, fever at 103 degrees, chills, body aches, jaw pain, Rt. eye ptosis, headache. Rash extending on body. Diagnosed via spinal tap with meningitis. Diagnosed with YEL-AVD per Dr. report. Treated with 10d. KEFLEX. States on 6/15/11, "she still has symptoms, disorientation, headache, fever.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash maculo-papular
Clinical narrative: PNEUMOVAX given 6/15/11, woke up 6/17/11 morning with a maculopapular diffuse rash on abdomen, back and chest. Treated with ALLEGRA. Patient refused treatment with steroids.
Age: 2.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site swelling
Clinical narrative: Swollen, tenderness upper (L) thigh.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Patient has redness and swelling of her left arm. Warmth, tenderness. Treatment: Cephalexin 500mg three times daily for 7 days.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Drug administration error
Clinical narrative: Patient presented to agency requesting second dose of Hep B vaccine which was administered in error.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Inflammation, Muscle spasms, Musculoskeletal pain, Myalgia
Clinical narrative: Achy, sharp shooting pain in rotator cuff area of shoulder. Started a day after the vaccine, not at vaccine site but up above in shoulder area. Pain worsened over 9 days gradually getting worse instead of better. Very painful at night sleeping/not sleeping.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Sleep disorder
Clinical narrative: Achy, sharp shooting pain in rotator cuff area of shoulder. Started a day after the vaccine, not at vaccine site but up above in shoulder area. Pain worsened over 9 days gradually getting worse instead of better. Very painful at night sleeping/not sleeping.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and heat from injection site distal towards elbow. Continuing to expand for next 72 hours. 4 inches in diameter.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given preservative free vaccine for children 3yrs and older in lieu of baby flu vaccine.
Age: 9.0
Sex: F
Vaccine: FLU(H1N1), VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash at injection site possibly due to infection
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Balance disorder, Decreased appetite, Diarrhoea, Injection site pain, Myalgia
Clinical narrative: Loss of appetite, feeling feverish, loss of balance, fatigue, muscle aches, diarrhea next morning, pain at injection site.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Loss of appetite, feeling feverish, loss of balance, fatigue, muscle aches, diarrhea next morning, pain at injection site.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: SWOLLEN AND RED STARTING AT 6 PM ON MONDAY EVENING.  REDNESS AND SWELLING LESS TODAY ON CHECK.  TOOK TYLENOL AND ICE PACKS TO AREA FOR 2 DAYS.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness and inflammation of site. Seen in office on 6/17- redness spreading, inflammation improving
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Cellulitis, Erythema, Induration, Injection site reaction, Pyrexia
Clinical narrative: Patient had a reaction at the site of the PCV-13, approximately 36-48 hours following vaccination.  She had a 7 cm area of redness and induration, but no significant pain.  She also has had a 102 fever on and off. Dx'd with cellulitis.  We will continue with cool compress and she can have ibuprofen.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Abdominal pain, Decreased appetite, Injection site pain, Productive cough, Pyrexia
Clinical narrative: pain in abdomen; fever (100.5); productive cough; loss of appetite; pain in injection area
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Full blood count normal, Laboratory test normal, Pyrexia, Rash, Rash vesicular
Clinical narrative: Fever to 103 on 6/16/11. Positive vesicular to ulcerative to crusting rash on all 4 extremities (started 6/15/11). Evaluated by me on 6/16/11. Patient admitted to hospital 6/16/11 started on IVF positive oral acyclovir 80mg/hr/day.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Scab, Skin ulcer, Smear site unspecified abnormal, Varicella virus test
Clinical narrative: Fever to 103 on 6/16/11. Positive vesicular to ulcerative to crusting rash on all 4 extremities (started 6/15/11). Evaluated by me on 6/16/11. Patient admitted to hospital 6/16/11 started on IVF positive oral acyclovir 80mg/hr/day.
Age: 26.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Erythema, Full blood count, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Had immunization 6-14-2011 about 6:30 pm, on 6-15-11 in the AM noted redness and swelling in Rt. arm at site. Became warm & spread to 5"x6" redness & induration on 6-16-11. On 6-17-11 came to our office & redness, warmth & swelling is now 12"x10". Started on KEFLEX.
Age: 26.0
Sex: F
Vaccine: MMR, PPV
Symptoms: Pain in extremity, Skin warm, Ultrasound scan, White blood cell count
Clinical narrative: Had immunization 6-14-2011 about 6:30 pm, on 6-15-11 in the AM noted redness and swelling in Rt. arm at site. Became warm & spread to 5"x6" redness & induration on 6-16-11. On 6-17-11 came to our office & redness, warmth & swelling is now 12"x10". Started on KEFLEX.
Age: 1.27
Sex: F
Vaccine: MMR, PNC13
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Vaccine on 6/2/11. On evening of vaccine pt developed fever T-100.1 -> next day T increased to 101 & on 6/4/11 T=102. Local effect of redness & swelling.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Syncope
Clinical narrative: Syncope episode after Tdap, Hepatitis A vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Full blood count, Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Pt seen by Dr. for reaction to immunizations. Localized reaction on right thigh. Redness, firm, warm to the touch.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash maculo-papular, Rash pruritic, Vomiting
Clinical narrative: On 6/1/11, pt was given vaccines below. On 6/10/11 started with fever & 1 episode of vomiting on 6/11/11, followed by itchy rash on face that afternoon, spreading to rest of body. Coalescing flat topped raised papules/macules. Resolved with 2 doses of BENADRYL on 6/13/11.
Age: 37.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chest pain, Cough, Injection site pain, Joint range of motion decreased, Pyrexia
Clinical narrative: Tender & sensitive at site, chest pain, cough, fever, severe decreased ROM of LUE, location of injection.
Age: 4.0
Sex: F
Vaccine: DTPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: she recieved 3 shots..the MMR, IPV and chicken pox..she was given 2 shots in 1 leg and the 3rd in a different leg..the leg that had 2 shots in it is swollen like the size of my palm of my hand.no fever..just swollen and red
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Feeling hot, Rash generalised
Clinical narrative: Red rash from head to toe with heat. Recommended to give Benadryl. The rash is still present to date.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Site of injection on left leg is red and swollen. Child complains of soreness in leg. There is no fever associated.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to the touch, slight itching.  Area affected is approx 2 x 3 inches.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Mobility decreased, Presyncope
Clinical narrative: Patient became so dizzy she almost passed out and continued to be so dizzy for 4 days she couldn't get out of bed. She continues to have dizziness for over a year since the shot.
Age: 12.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: 3 inch x 6 inch local reaction around injection site (redness, swelling, pain).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Severe injection site reaction: left arm diameter size of a baseball, patient reports tender to touch, and warm to touch, itching, red and irritated. In last 24 H visually it looks like a red, large bump. Patient denied systemic effects and counseled to put ice pack and oral BENADRYL if necessary.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Severe injection site reaction: left arm diameter size of a baseball, patient reports tender to touch, and warm to touch, itching, red and irritated. In last 24 H visually it looks like a red, large bump. Patient denied systemic effects and counseled to put ice pack and oral BENADRYL if necessary.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Pain in upper arm & shoulder about 5 hrs after shot - severe pain in moving arm any directions - cld Dr. on call on form given - was told should only last 24 hrs or less - cld own Dr. following day - same report - went away about 36 hrs - nurse checked on me next day after shot.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Apnoeic attack, Blood electrolytes normal, Convulsion, Cyanosis, Depressed level of consciousness
Clinical narrative: Apneic event with stiffness and cyanosis followed by floppy and decreased arousability slowly resolving suspicious for 30-90 sec seizure about 4 hour after first set of immunizations
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Electroencephalogram normal, Hypotonia, Musculoskeletal stiffness, Neurological examination normal
Clinical narrative: Apneic event with stiffness and cyanosis followed by floppy and decreased arousability slowly resolving suspicious for 30-90 sec seizure about 4 hour after first set of immunizations
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Joint swelling, Mobility decreased, Muscle swelling, Polymyalgia rheumatica
Clinical narrative: Polymyalgia Rheumatica - Pt had swelling of joints and muscles.  Very difficult to move to the point of not being able to get out of bed.  Treated with a month of Prednisone 20mg daily and has been on Prenisone 10mg daily since.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: started having nausea and vomiting that cont until went to the ER on 6/18/11 passed out in the ER and couldn't remember what treatment recieved felt better then on afternoon of 6/19/11 became nauseated and started vomiting again was sent home and plans to see pcp on 6/22/11
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Bone pain, Headache, Injection site reaction, Lethargy, Musculoskeletal pain
Clinical narrative: Soreness at base of skull, neck, and shoulders radiating down arms. Extreme lethargy. Persistent headache. Pain and lethargy has not lessened in 5 days. Fever now at injection site. Chronic headache.
Age: 41.0
Sex: F
Vaccine: DTAP
Symptoms: Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Soreness at base of skull, neck, and shoulders radiating down arms. Extreme lethargy. Persistent headache. Pain and lethargy has not lessened in 5 days. Fever now at injection site. Chronic headache.
Age: 20.0
Sex: M
Vaccine: ANTH, HEPAB, TYP
Symptoms: Skin lesion
Clinical narrative: Multiple small lesions on chest, back and thighs.
Age: 15.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypoaesthesia, Injection site pain, Lymphadenopathy, Pain in jaw, Paraesthesia
Clinical narrative: Sore at injection site, swollen glands on neck, jaw pain, 103.00 fever, vomiting, now numbness and tingling from waist to top of head.
Age: 15.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Sore at injection site, swollen glands on neck, jaw pain, 103.00 fever, vomiting, now numbness and tingling from waist to top of head.
Age: 15.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Headache, Hypoaesthesia, Lymphadenopathy, Muscle twitching, Pain in jaw
Clinical narrative: Sore at injection site, swollen glands on neck, jaw pain, 103.00 fever, vomiting, now numbness and tingling from waist to top of head.
Age: 15.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Paraesthesia, Pyrexia, Tremor, Vomiting
Clinical narrative: Sore at injection site, swollen glands on neck, jaw pain, 103.00 fever, vomiting, now numbness and tingling from waist to top of head.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal discomfort, Arthralgia, Balance disorder
Clinical narrative: Approximately 2-3 hours after injection developed disequilibrium, stomach discomfort and arthralgias. Symptoms lasted 5 hours and resolved.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Insomnia, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: The pt. received ZOSTAVAX injection 6-16-11. The following afternoon, her arm began to hurt and kept her up all night. She was also vomiting. She came into the Rx on Sat 6-18-11. Her arm had a well-defined red spot approximately 1" in diameter and was surrounded by a lighter shade of red approximately 5" in diameter, extending down to her elbow. I sent her to Urgent Care where she had a mild fever. They started her on IV antibiotics & gave her a KEFLEX Rx. She returned the following day, Sun. 6-19-11 to the clinic per their recommendation. Pt was afebrile, but the reaction was worse. They IV antibiotics, give CLEOCIN Rx. Pt will return 6/20/11 to clinic (tomorrow) for F/U.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Blister, Erythema, Ultrasound scan, Urticaria
Clinical narrative: Negative for fever. Started with hives at injection site two days post shot. Treated with cephalexin and sulfamethoxazole.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site urticaria, Ultrasound scan
Clinical narrative: Negative for fever. Started with hives at injection site two days post shot. Treated with cephalexin and sulfamethoxazole.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Eating disorder, Enema administration, Haematochezia, Intussusception, Lethargy
Clinical narrative: Blood in stool, sleepy, feeding poorly. Went to ER at local hosp and transferred to another hospital for Intussusception.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Surgery, Ultrasound abdomen
Clinical narrative: Blood in stool, sleepy, feeding poorly. Went to ER at local hosp and transferred to another hospital for Intussusception.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5, DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Feeding disorder of infancy or early childhood, Haematochezia, Intussusception, Somnolence
Clinical narrative: Blood in stool, sleepy, feeding poorly. Went to ER at local hosp and transferred to another hospital for Intussusception.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Abdominal pain, Abdominal pain upper, Arthralgia, Asthenia, Decreased appetite
Clinical narrative: Vomiting, severe stomach and abdominal pain, severe and constant knee joint pain, rash at site of injection along with burning, irritation and bruising, loss of appetite, unusual tiredness and weakness.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Fatigue, Injection site haematoma, Injection site irritation, Injection site pain, Injection site rash
Clinical narrative: Vomiting, severe stomach and abdominal pain, severe and constant knee joint pain, rash at site of injection along with burning, irritation and bruising, loss of appetite, unusual tiredness and weakness.
Age: 11.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Vomiting
Clinical narrative: Vomiting, severe stomach and abdominal pain, severe and constant knee joint pain, rash at site of injection along with burning, irritation and bruising, loss of appetite, unusual tiredness and weakness.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Injection site swelling
Clinical narrative: A temp 99.6 at hospital, 103.0 MD. Headache, body aches, weakness, chills. Inj. site warm swollen. Rx TYLENOL/ice.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Pain
Clinical narrative: A temp 99.6 at hospital, 103.0 MD. Headache, body aches, weakness, chills. Inj. site warm swollen. Rx TYLENOL/ice.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess sterile
Clinical narrative: Sterile Abscess
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Death, Loss of consciousness, Resuscitation
Clinical narrative: A consumer reported that he/she obtained the information from internet concerning a 17 years old woman who in June 2007 was vaccinated the first dose of GARDASIL. In the afternoon of the same day, in June 2007, the patient was found unconscious (without signs of life) by her mother. The doctor from the emergency crew attempted resuscitation, but without success. The cause of death was unspecified. This is one of several reports received from the same source. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Electromyogram abnormal, Musculoskeletal pain, Scapulothoracic dissociation
Clinical narrative: Information has been received from a consumer concerning her 17 year old daughter who in 2007 (also reported as "around 2007") was vaccinated with a "full series" of GARDASIL (lot #, dose and route not reported). There was no concomitant medication. In early 2009 the patient was having "shoulder pain and a snapping scapula". The patient sought medical attention by office visit. The mother reported that an electromyogram was performed by a neurologist indicated possible amyotrophic lateral sclerosis (ALS) or Muscular Dystrophy. At the time of the report, the patient had not recovered. Upon internal view, possible amyotrophic lateral sclerosis was determined to be an other important medical event. No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Electrocardiogram normal, Presyncope, Syncope
Clinical narrative: Near syncope after immunization, slumped to floor. BP 84/58. Episode lasted about 3 minutes.
Age: 0.34
Sex: M
Vaccine: DTAP, PNC, RV5
Symptoms: Diarrhoea, Teething
Clinical narrative: Mom called 6/10/11 with c/o infant having 1-2 day history of diarrhea (watery) stools.  Started Tuesday 6/7/11; Appetite still good. Mom wonders if related to vaccine. Referred to primary care provider (PCP) for evaluation of diarrhea.  F/U with mom 6/13/11 who stated that PCP states diarrhea related to teething and not to vaccine. Mom stated diarrhea has resolved.
Age: 38.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen (size of an egg), red and very itchy. Three weeks later red, and itchy gone, but have a bump the size of a pea that will not go down.
Age: 38.0
Sex: F
Vaccine: TD, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: Swollen (size of an egg), red and very itchy. Three weeks later red, and itchy gone, but have a bump the size of a pea that will not go down.
Age: 0.84
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: No adverse event
Clinical narrative: This patient received HIBERIX for her 3rd dose of Hib. No adverse reaction reported.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Firm, warm red area 2 1/2" x 3" on (L) deltoid x 2 days.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Oedema peripheral, Rash erythematous
Clinical narrative: Left arm swelling and diffuse erythematous rash c/w allergic rx.
Sex: F
Vaccine: HPV4
Symptoms: Delivery, Drug exposure before pregnancy, No adverse event
Clinical narrative: Information has been received from the pregnancy registry for GARDASIL from a nurse concerning an 18 year old female with pertinent medical history reported as none and no known drug reactions or allergies who on 17-APR-2007 was vaccinated with the first dose of GARDASIL (lot # 657621/0387U) 0.5ml, IM. The second dose of GARDASIL (lot # 657736/0389U0), 0.5 ml, IM was given on 15-JUN-2007. Concomitant therapy included prenatal vitamins (unspecified) and ferrous sulfate (unspecified). The third dose of GARDASIL (lot # 659055/1522U), 0.5 ml, IM was given on 26-DEC-2007. Subsequently the patient became pregnant. She sought medical attention via an office visit. Her last menstrual period was reported as 29-NOV-2007. Her estimated delivery date was 04-SEP-2008. No adverse event was reported. Follow-up information was received from a licensed practical nurse which reported that on 14-AUG-2008 the patient gave vaginal birth to a liveborn male weighing 5 lbs. 12.3 oz, APGAR= 9/10. She was 37 weeks from her last menstrual period. The infant was reported to be normal and there were no congenital anomalies of complications. On an unspecified date the baby developed jaundice. The baby was seen on 19-AUG-2008 at which time it was reported that the baby was feeding on demand. Laboratory values from 16-AUG-08 were all within normal limits and on 19-AUG the baby had gained 5 ounces and the jaundice had resolved. The baby was rechecked on 10-22-08 with no further mention of jaundice. Follow-up information was received from a licensed practical nurse which reported that on 14-AUG-2008 the patient gave birth to a liveborn male weighing 5 lbs. 12.3 oz, APGAR= 10/10 (previously reported as 9/10), length 19 inch. The infant was reported to be normal and there were no congenital anomalies or other complications. The patient's concomitant therapy included prenatal vitamins daily, TANDEM daily for low iron and globulin, RHOGAM at 28 week gestation. Additional information is not expected. The mother's AE has been captured in WAES # 0806USA02842B1B1.
Age: 8.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Red dot rash all over his body.
Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Pallor, Tonic clonic movements
Clinical narrative: After receiving MCV4 vaccine pt. c/o dizziness, became pale, had a 1 min LOC with 10 sec of tonic-clonic movements. RN's reclined pt., placed ice pack at back of neck -> pt. became conscious. BP 88/58. After 5-10 min, given ginger ale & BP=98/66.
Age: 23.0
Sex: M
Vaccine: HPV4
Symptoms: Hyperaesthesia, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Severely sore arm from Gardasil shot. It is still sore 5 days later, and touching it is painful. The arm cannot bear weight very well and many common movements are painful.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Cough
Clinical narrative: Paroxysmal cough.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: High fever (103.8) the night that vaccines were given.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1, DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Patient administered ROTARIX on 5/26/11 at 2 mos well child visit. On 5/28/11 small amount of blood noted in stool and has persisted. Now has some diarrhea. No other symptoms. Child feels well.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1, DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Anal fissure, Diarrhoea, Haematochezia
Clinical narrative: Patient administered ROTARIX on 5/26/11 at 2 mos well child visit. On 5/28/11 small amount of blood noted in stool and has persisted. Now has some diarrhea. No other symptoms. Child feels well.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1, DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of blood in stools in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DAPTACEL (Sanofi), ACTHIB (Sanofi), IPOL (Sanofi) and PREVNAR 13 (Wyeth Labs) all given on 26 May 2011. Concurrent medications included POLY-VI-SOL w/ iron. On 26 May 2011 the subject received 1st dose of ROTARIX at 1.0 ml orally. One day after receiving ROTARIX vaccine, on 27 May 2011, the subject developed blood in her stools. Diarrhea started on 04 June 2011 and the subject was seen in the physician's office on 06 June 2011. It was reported that the baby appeared to be a healthy baby. It was also reported that the child had diarrhea at the time of the visit. The physician noticed the development of an anal fissure that was not seen on the baby's two month check-up. This case was assessed as medically serious by GSK. At the time of reporting blood in the stools and diarrhea were unresolved. The outcome of the anal fissure was not known.
Age: 0.19
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1, DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Anal fissure, Diarrhoea, Haematochezia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of blood in stools in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included DAPTACEL (Sanofi), ACTHIB (Sanofi), IPOL (Sanofi) and PREVNAR 13 (Wyeth Labs) all given on 26 May 2011. Concurrent medications included POLY-VI-SOL w/ iron. On 26 May 2011 the subject received 1st dose of ROTARIX at 1.0 ml orally. One day after receiving ROTARIX vaccine, on 27 May 2011, the subject developed blood in her stools. Diarrhea started on 04 June 2011 and the subject was seen in the physician's office on 06 June 2011. It was reported that the baby appeared to be a healthy baby. It was also reported that the child had diarrhea at the time of the visit. The physician noticed the development of an anal fissure that was not seen on the baby's two month check-up. This case was assessed as medically serious by GSK. At the time of reporting blood in the stools and diarrhea were unresolved. The outcome of the anal fissure was not known.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Anaphylactic reaction, Blister, Erythema, Induration
Clinical narrative: Local erythema & induration & bullae formation without systemic sx. Suggestive of anaphylaxis.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Discomfort, Injection site erythema, Injection site haematoma, Skin warm
Clinical narrative: Erythema & bruising present at rt. upper arm. Area feels warm to touch. Patient notes discomfort at 3/10. She has taken Ibuprofen for pain. Cellulitis present. Cephalexin 500mg one two times daily x 10 days.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Lip swelling, Pyrexia, Urticaria
Clinical narrative: Pt with swelling (L) arm at site of immunization and fever within 24 hr, then developed hives, lip swelling on & off x 2 wk.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of injection site of ADACEL. Allergic reaction - Prednisone 10mg 1 daily for 5 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Fever, raised and swollen around site that immunization was given. DTaP reaction measured 45mm on left deltoid and warm to touch.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Blood glucose normal, Haemoglobin normal, Syncope
Clinical narrative: Syncope
Age: 1.45
Sex: M
Vaccine: IPV, PNC13, IPV, PNC13, IPV, PNC
Symptoms: Convulsion, Malaise, Pyrexia
Clinical narrative: Febrile, illness, seizures.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site cellulitis, Pyrexia
Clinical narrative: Pt reports developed cellulitis to site with fever & chills. Sought treatment with PCP. Notified by pt when returning to work.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed right upper arm swelling, pain and redness which migrated to armpit area.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Oedema peripheral
Clinical narrative: Patient developed right upper arm swelling, pain and redness which migrated to armpit area.
Age: 15.0
Sex: M
Vaccine: FLU3, HEPA, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Musculoskeletal stiffness, Staring, Unresponsive to stimuli
Clinical narrative: After immunizations were administered, patient said he was feeling fine and requested to go to the waiting room. While he and his mother were walking to the waiting room, his mother stated, "He's feeling dizzy." We were guiding him to a chair to sit down. As he was starting to sit, his body became very stiff, eyes fixed, and he was unresponsive. His body fell backwards into the chair and his head lightly hit the wall. This seizure like activity lasted around 10 seconds. He was very pale and sweaty. 911 was called. Vitals as soon as he became responsive: BP 80/40, pulse 52. Patient became alert to person, place, and surroundings again. He said he felt fine again. 911 arrived. EMS recommended he be evaluated by the local ER since he had no history of similar instances. Patient was able to walk to the ambulance. He was then taken to the ER for evaluation. Patient had not eaten breakfast that morning and he was very nervous about getting shots. I called the mother about 4:30 p.m. on 6-14-11 and she said that patient was doing fine. She said the ER ran several tests and could not find anything wrong. The ER recommended that they follow-up with a neurologist. She said after leaving the ER, they went and ate and patient ate very well. I attempted to obtain a copy of the ER report from the local hospital, but have been unsuccessful.
Age: 4.0
Sex: M
Vaccine: IPV, PNC
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Received IPV Fri 6-10-11 MOC reports he had fever to 100.8. TYLENOL given q 4 hours, Sat 6/11/11. Red area and pain (R) thigh injection site. Would not walk by self PM everything ok.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt broke out in hives 5 minutes after vaccines given - head to toe hives. No respiratory distress. She was closely monitored and vitals stable. After speaking with pediatrician on-call was advised to go to ER for further observation. Hives slowly resolved. Pt was given oral BENADRYL.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Urticaria
Clinical narrative: Hives to face, neck, chest, arms, and legs; bilaterial.  Urticarial and red. No wheezing or shortness of breath.  Was told to go to the ER.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: red rash to face and trunk
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Dizziness, Eye swelling, Lethargy, Local swelling, Ocular hyperaemia
Clinical narrative: Fever of 102-104 every three hours for 72 hours. Swollen red eyes, swollen neck and cheeks, rash all over the body. Dizziness, lethargic.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash generalised, Swelling face
Clinical narrative: Fever of 102-104 every three hours for 72 hours. Swollen red eyes, swollen neck and cheeks, rash all over the body. Dizziness, lethargic.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: fever of 100.4, dizziness, head pain
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pallor
Clinical narrative: Left thigh warm/red/blanching. Ordered hydrocortisone cream, Atarax, cool compresses, and return to clinic Monday if no improvement.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Blood test, Diarrhoea, Joint swelling, Pyrexia
Clinical narrative: Next day from TDAP, had fever 100.4 and diarrhea.  One week later had severe joint pain with swelling and fever again. Went to Dr., was put on antiinflammatory meds and did blood work.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Allergy to vaccine, Erythema, Mass, Oedema peripheral, Pain
Clinical narrative: A large lump, swelling, heat & redness all the way down to my elbow, then on Saturday the heat was so intense that my arm throb with pain.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Skin warm
Clinical narrative: A large lump, swelling, heat & redness all the way down to my elbow, then on Saturday the heat was so intense that my arm throb with pain.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: 6/13/11 On examination per Dr. - (Lt) deltoid mild tenderness and warmth. No significant swelling noted. 6/15/11 Exam of left deltoid mild swelling no warmth or redness, pain on palpation movement. Headache persistent and some nausea.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: 6/13/11 On examination per Dr. - (Lt) deltoid mild tenderness and warmth. No significant swelling noted. 6/15/11 Exam of left deltoid mild swelling no warmth or redness, pain on palpation movement. Headache persistent and some nausea.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Local swelling, Oral pain
Clinical narrative: Received MMR 5/9/11. On 5/27/11 - woke up with symptoms of mouth soreness & swollen neck in Rt side. Symptoms lasted for 1 week. No fever or other symptoms.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site rash
Clinical narrative: Rash around the site of vaccination one day after vaccination. Pt took BENADRYL 50 mg three times daily for 2 days. The rash disappeared and pt feels better now.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Mom states she noted on 6/18/11 quarter size redness of (R) upper posterior arm. On 6/19/11 noted increased redness with increased warmth to approx. 1/2 of upper right posterior arm with few fine raised red bumps. Enc. TYLENOL prn, elevation of arm on pillow & ice packs. Adv. call if worsens or no improvement noted.
Age: 1.39
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: Patient had a fever of 103.4 F and blotches on stomach on 6-18-11.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Tremor
Clinical narrative: Very pale after administrating HPV vaccine, possible small seizure, shaking, sweating, passed out for less than a minute. Had him wait for 15 min after accident. Pt well after.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Rapid onset swelling, erythema, pruritus of (R) upper arm within 30 minutes of injection.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt received Varicella vaccine on 9-21-98 & 4-7-09. Diagnosed with varicella on 6-17-11 at clinic and confirmed by doctor in our office on 6-20-11.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt states that from time she received the injection on 10/10/10 she has had pain at injection site. The pain is worse at night when she lays on it or puts it in a certain position.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Hyperhidrosis, Pain in extremity, Swelling
Clinical narrative: Arm pain, erythema, swelling, sweats.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Sx: slight redness at (L) upper arm, no heat, no swelling. Redness about 22 mm in diameter at varicella vacc. site. Tx: ice packs.
Age: 1.09
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: 6/17/2011 Chicken pox disease. This was diagnosed by doctor. Varicella #1 received on 12/07/2009.
Age: 26.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site vesicles, Pain in extremity
Clinical narrative: Severe (L) extremity pain. Erythema with swelling to LUE, large intact blisters upper arm and back.
Age: 26.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: White blood cell count increased
Clinical narrative: Severe (L) extremity pain. Erythema with swelling to LUE, large intact blisters upper arm and back.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site inflammation, Lymphadenopathy, Pyrexia
Clinical narrative: The next day pt. woke up with fever, chills, lymph node swelling inj. site inflamed, headache.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pyrexia, Skin warm, Tenderness
Clinical narrative: Pt developed fever, redness, warmth and tenderness within 24 hrs of injection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Pt. received vaccine Fri 6/17 and presented to the pharmacy Sun. 6/19 with local reaction: 2 inch diameter area at injection site raised, red area warm to the touch and somewhat itchy.
Age: 1.04
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Injection site atrophy, Injection site discolouration
Clinical narrative: 1 cm hypopigmented & atrophied area at shot site.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Hives mainly on legs & buttocks.
Age: 10.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient returned to clinic 6/17/2011 1 1/2 inch circular erythematous swelling (R) lateral upper arm.
Age: 59.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antigen positive, Hepatitis B virus test positive, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of hepatitis b antigen positive in a 59-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 5 April 2011, 6 January 2011, 2 December 2010 and 4 November 2010 the subject received 4th dose, 3rd dose, 2nd dose and 1st dose of ENGERIX B at 40 mcg, intramuscularly, 20 mcg in each arm. On 26 may 2011, 51 days after vaccination with the 4th dose of ENGERIX B, the subject experienced had a positive Hepatitis B Titer on a lab test. The subject was positive for hepatitis B antigen. This was considered to be vaccination failure. At the time of reporting the outcome of the events was unspecified.
Age: 29.0
Sex: F
Vaccine: TYP
Symptoms: Body temperature increased, Chest discomfort, Dysphonia, Myalgia
Clinical narrative: Pt. was seen in ER on 6/15/11 at 1632 with hoarseness, elevated temp, chest tightness, muscle aches today. Pt states she has been taking live typhoid vaccines. Took last dose 6/14 - AM.
Age: 75.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Ischaemic stroke
Clinical narrative: Case number PHHY2011CN51645 is an initial literature report received on 06 Jun 2011. The authors presented a case of ischemic stroke after H1N1 vaccination. This report refers to a 75 year old male patient. His medical history was not reported. He was vaccinated with H1N1 vaccine (manufacturer and batch number: unknown). He experienced posterior circulation ischemia after vaccination. The outcome was not reported. The author commented that the causal relationship between vaccination and ischemic stroke was still unsettled.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Autoimmune thrombocytopenia, Platelet count decreased
Clinical narrative: Immune thrombocytopenia.