chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Rash generalised, Rash maculo-papular, Skin disorder, Streptococcus test, Urticaria
Clinical narrative: Woke up in AM with flu like symptoms: headache, myalgia, joint pain, general malaise, slight nausea, slight cough...by 10:00 AM, symptoms intensified, additional fatigue, developed chills and low grade temperature. At 1:30 pm, developed generalized macular papular rash at MD office. Flu test and Strep test were negative. MD diagnosed allergic reaction and administered Decadron injection (6 mg, IM).  Began antihistamines and oral Medrol Dose pack next morning.  Continued with myalgia, fatigue, and dermatological symptoms into late afternoon, early evening with chest appearing sunburned or scalded....also developed itching. By 7 or 8 pm, myalgia, headache, chills reduced and gradually improving. In 24 hours, energy level improved, myalgia, headache, joint pain gone...continued with uticaria and skin appearing scalded, sunburned....this lasted about 4 or 5 days....gradually resolving.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Activities of daily living impaired, Electromyogram normal, Flushing, Loss of consciousness, Malaise
Clinical narrative: Mother states client felt unwell, flushed in face--at the library. Client passed out as they were leaving the library to come home. Regained consciousness, put her in the car, came home, and she said her legs wouldn't move and that she couldn't get out of the car. Mother called physician, and was told to bring client to ER right away. Client admitted to hospital from ER, after spending 8 hours in ER.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal cord normal, Ultrasound Doppler normal
Clinical narrative: Mother states client felt unwell, flushed in face--at the library. Client passed out as they were leaving the library to come home. Regained consciousness, put her in the car, came home, and she said her legs wouldn't move and that she couldn't get out of the car. Mother called physician, and was told to bring client to ER right away. Client admitted to hospital from ER, after spending 8 hours in ER.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Electromyogram normal, Flushing, Loss of consciousness, Malaise, Mobility decreased
Clinical narrative: Mother states client felt unwell, flushed in face--at the library. Client passed out as they were leaving the library to come home. Regained consciousness, put her in the car, came home, and she said her legs wouldn't move and that she couldn't get out of the car. Mother called physician, and was told to bring client to ER right away. Client admitted to hospital from ER, after spending 8 hours in ER.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal cord normal, Ultrasound Doppler normal
Clinical narrative: Mother states client felt unwell, flushed in face--at the library. Client passed out as they were leaving the library to come home. Regained consciousness, put her in the car, came home, and she said her legs wouldn't move and that she couldn't get out of the car. Mother called physician, and was told to bring client to ER right away. Client admitted to hospital from ER, after spending 8 hours in ER.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient deceloped an egg-sized swollen area around the injection site that was itchy and warm to the touch. The area swelled further to about 3 times that size over the next several days. It has since started to diminish in size and irritation.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Borrelia test, Facial pain, Fatigue, Flushing
Clinical narrative: Hair loss, severe fatigue, severe flushing of face, nose, hands, feet. Pain where skin was flushing on face. Pain scale 9/10. Dermatographia.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Hypersensitivity, Laboratory test, Mechanical urticaria, Mononucleosis heterophile test, Pain
Clinical narrative: Hair loss, severe fatigue, severe flushing of face, nose, hands, feet. Pain where skin was flushing on face. Pain scale 9/10. Dermatographia.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Rheumatoid factor, Thyroid function test
Clinical narrative: Hair loss, severe fatigue, severe flushing of face, nose, hands, feet. Pain where skin was flushing on face. Pain scale 9/10. Dermatographia.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Lymph node palpable, Metabolic function test, Pain in extremity
Clinical narrative: Extreme pain left arm extending up to neck, palpable lymph node, left supra clavicular, seen 9/7/12, refused medical attention. Seen by PCP 9/10/12 labs ordered, pending at present time.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Urticaria
Clinical narrative: Swelling/redness when he woke up. Next day swelling and redness wrapped around entire leg. Tuesday 4 September woke up with Hives all over body, swelling/redness wrapped around entire thigh at injection site.  Tuesday night 7:30PM fever (102.1). Wednesday 5 September Hives all over body, swelling/redness wrapped around entire thigh at injection site, no fever. Thursday 6 September, hives and swelling/redness started to fade. Friday 7 September, hives gone and most of swelling/redness gone.
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Dizziness, Fall, Muscular weakness, Myalgia
Clinical narrative: Nausea, muscle hurts, dizziness, joints aching, lesser muscle strength.
Age: 58.0
Sex: F
Vaccine: RAB
Symptoms: Nausea
Clinical narrative: Nausea, muscle hurts, dizziness, joints aching, lesser muscle strength.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. presented with red, swollen, and warm to touch area on left deltoid. Per NP, the pt's father was instructed to take pt home and apply ice 15 min. every 4-6hrs prn comfort & take Ibruprofen every 6hrs prn comfort as well. Pt was to return if symptoms worsen or continue.
Age: 23.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Vaccinations administered on 7-9-12. Patient seen in ER on 7-22-12 with reaction that started the previous night. Reported reaction was itching and rash/hives that continued despite Benadryl (taken at noon). Pt given 60 mg Prednisone orally in ER and discharged with prescriptions for Prednisone and Benadryl.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Given Td in EC for laceration of finger. Per patient reaction started after the injection. Reaction reported was pain at injection site, redness, swelling (approx 4-5 cm induration. Rx given in EC for Benadryl.
Age: 30.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Activities of daily living impaired, Dizziness, Headache, Injection site pain, Insomnia
Clinical narrative: Severe headache, dizziness. Fever, nausea and localized swelling. Pain at injection site that kept her awake and precluded any activity for 5 days.
Age: 30.0
Sex: F
Vaccine: DTAP, PPV
Symptoms: Local swelling, Nausea, Pyrexia
Clinical narrative: Severe headache, dizziness. Fever, nausea and localized swelling. Pain at injection site that kept her awake and precluded any activity for 5 days.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Fatigue, Oedema peripheral, Pain
Clinical narrative: Temp 101-104, temple. Achy, tired, arm swollen.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Pruritus, Rash
Clinical narrative: Started breaking out in rash approximately 1 week after given vaccinations. Seen in ER with complaints of itching and rash over trunk and upper extremities. Given rx's for Zyrtec and Hydrocortisone 1% cream and discharged.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Influenza, Pyrexia
Clinical narrative: H/A, fever. Dx'ed Post Influenza Syndrome.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Pruritus, Rash, Swelling face
Clinical narrative: Pt. called the health unit on 08/31/2012 stating that she woke up the morning after receiving Hep A and meningococal shots with face swollen, rash on face and back and itching. Denied any problems with breathing.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Bacterial disease carrier, Biopsy skin abnormal, Blister, Eczema vaccinatum, Erythema
Clinical narrative: Pt seen in primary care clinic on 7-25-12 with neck pain and lumps that started about 2 week after smallpox vaccination. Per provider the vaccination area was covered with bandaid and site was scabbed over.  Entire region had induration and erythema. Pt given Toradol 60 mg injection in clinic and advised to do warm compresses. Pt seen in ER on 7-1-12 with rash and headache. Given Decadron 10 mg orally in ER and discharged with rx's for Benadryl and Fioricet. Pt seen in primary care clinic on 7-27 after being referred back from ER with complaints of itchy, small blisters on extremities, trunk and face. PCP suspected possible self innoculation, gave rx's for Benadryl and Atarax, and referred patient to dermatology clinic. Dermatologist's exam noted 20 papules approximately 0.5-1 cm with central crust formaulation and halo of erythema. Punch biopsy was done of a representative lesion. Pt was started on Cotrimoxazole DS, Bactroban to nares, and Hibiclens wash to cover for possible MRSA and advised to continue the Atarax for nighttime itching. Biopsy noted that there was bacterial colonization of the lesion; fungal stains were negative, gram stains highlights gram positive cocci. Differential diagnosis included post-smallpox vaccine papular spongiotic dermatitis with mechanical trauma, erythema multiforme, and eczema vaccinatum.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema multiforme, Fungal test negative, Gram stain positive, Headache, Injection site erythema
Clinical narrative: Pt seen in primary care clinic on 7-25-12 with neck pain and lumps that started about 2 week after smallpox vaccination. Per provider the vaccination area was covered with bandaid and site was scabbed over.  Entire region had induration and erythema. Pt given Toradol 60 mg injection in clinic and advised to do warm compresses. Pt seen in ER on 7-1-12 with rash and headache. Given Decadron 10 mg orally in ER and discharged with rx's for Benadryl and Fioricet. Pt seen in primary care clinic on 7-27 after being referred back from ER with complaints of itchy, small blisters on extremities, trunk and face. PCP suspected possible self innoculation, gave rx's for Benadryl and Atarax, and referred patient to dermatology clinic. Dermatologist's exam noted 20 papules approximately 0.5-1 cm with central crust formaulation and halo of erythema. Punch biopsy was done of a representative lesion. Pt was started on Cotrimoxazole DS, Bactroban to nares, and Hibiclens wash to cover for possible MRSA and advised to continue the Atarax for nighttime itching. Biopsy noted that there was bacterial colonization of the lesion; fungal stains were negative, gram stains highlights gram positive cocci. Differential diagnosis included post-smallpox vaccine papular spongiotic dermatitis with mechanical trauma, erythema multiforme, and eczema vaccinatum.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site induration, Injection site scab, Injury, Neck pain, Papule
Clinical narrative: Pt seen in primary care clinic on 7-25-12 with neck pain and lumps that started about 2 week after smallpox vaccination. Per provider the vaccination area was covered with bandaid and site was scabbed over.  Entire region had induration and erythema. Pt given Toradol 60 mg injection in clinic and advised to do warm compresses. Pt seen in ER on 7-1-12 with rash and headache. Given Decadron 10 mg orally in ER and discharged with rx's for Benadryl and Fioricet. Pt seen in primary care clinic on 7-27 after being referred back from ER with complaints of itchy, small blisters on extremities, trunk and face. PCP suspected possible self innoculation, gave rx's for Benadryl and Atarax, and referred patient to dermatology clinic. Dermatologist's exam noted 20 papules approximately 0.5-1 cm with central crust formaulation and halo of erythema. Punch biopsy was done of a representative lesion. Pt was started on Cotrimoxazole DS, Bactroban to nares, and Hibiclens wash to cover for possible MRSA and advised to continue the Atarax for nighttime itching. Biopsy noted that there was bacterial colonization of the lesion; fungal stains were negative, gram stains highlights gram positive cocci. Differential diagnosis included post-smallpox vaccine papular spongiotic dermatitis with mechanical trauma, erythema multiforme, and eczema vaccinatum.
Age: 26.0
Sex: F
Vaccine: SMALL
Symptoms: Pruritus, Rash, Rash papular, Scab
Clinical narrative: Pt seen in primary care clinic on 7-25-12 with neck pain and lumps that started about 2 week after smallpox vaccination. Per provider the vaccination area was covered with bandaid and site was scabbed over.  Entire region had induration and erythema. Pt given Toradol 60 mg injection in clinic and advised to do warm compresses. Pt seen in ER on 7-1-12 with rash and headache. Given Decadron 10 mg orally in ER and discharged with rx's for Benadryl and Fioricet. Pt seen in primary care clinic on 7-27 after being referred back from ER with complaints of itchy, small blisters on extremities, trunk and face. PCP suspected possible self innoculation, gave rx's for Benadryl and Atarax, and referred patient to dermatology clinic. Dermatologist's exam noted 20 papules approximately 0.5-1 cm with central crust formaulation and halo of erythema. Punch biopsy was done of a representative lesion. Pt was started on Cotrimoxazole DS, Bactroban to nares, and Hibiclens wash to cover for possible MRSA and advised to continue the Atarax for nighttime itching. Biopsy noted that there was bacterial colonization of the lesion; fungal stains were negative, gram stains highlights gram positive cocci. Differential diagnosis included post-smallpox vaccine papular spongiotic dermatitis with mechanical trauma, erythema multiforme, and eczema vaccinatum.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Hypotension, Pharyngeal oedema, Urticaria
Clinical narrative: Hives, airway swelling, and profound hypotension (systolic BP 70s to 80s, diastolic BP palpable only).
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Tremor
Clinical narrative: Patient had shivers and body was shaking. No known fever. Last about an 1/2 hour.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Hypertension, Pyrexia
Clinical narrative: "Patient called in reporting she received both flu and pnemonia vaccines in the bicep area of her arm. She states her B/P went up very high and had a fever. Went to urgent care for treatment. Doctor questioned site of injection. Started on z-pack and steroids; doctor stated she has cellulitis."
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Headache, Neck pain, Pyrexia
Clinical narrative: Fever 104, HA, neck pain, back ache. Took ASA x1, fever went down to 103. Next day Fever started at 102, took ASA x2, reduced it to 101. Today temp 99.3.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: DTAP administered Thursday afternoon. 5th dose. Upon waking Friday morning, I noticed redness and swelling at the injection site. He complained that it hurt. I gave him ibuprofen and put an ice pack on the injection site. By Saturday morning, it had worsened. The red area was about 4 inches in diameter, was hard to the touch and very hot. I called the doctor and was advised to put warm compresses on the area 5-6 times throughout the day and take him to the ER if it got worse. I applied warm compresses. By Sunday morning it had improved slightly. By Monday morning it was looking much better - heat, swelling and color had reduced and he no longer complained that it was painful.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Formication, Paraesthesia, Pruritus
Clinical narrative: Pt. felt like skin had creepy crawlies. Itchy and tingling. No rash or blisters. Pt. reported event today 9-10-12 said had to take Zyrtec to feel better. Being live attenuated virus shared symptom similarities with shingles.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Anaemia, Combined immunodeficiency, Erythema infectiosum, Flow cytometry, Immunology test abnormal
Clinical narrative: Paleness, irritiabilty, profound anemia requiring ICU admission and transfusion. Now diagnosed as severe combined immunodeficiency with parvovirus b19 and rotavirus infections.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Intensive care, Irritability, Pallor, Parvovirus B19 test positive, Polymerase chain reaction
Clinical narrative: Paleness, irritiabilty, profound anemia requiring ICU admission and transfusion. Now diagnosed as severe combined immunodeficiency with parvovirus b19 and rotavirus infections.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Rotavirus infection, Rotavirus test positive, Transfusion
Clinical narrative: Paleness, irritiabilty, profound anemia requiring ICU admission and transfusion. Now diagnosed as severe combined immunodeficiency with parvovirus b19 and rotavirus infections.
Age: 0.26
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Convulsion, Culture negative, Electroencephalogram normal, Full blood count normal, Lumbar puncture normal
Clinical narrative: Presumed seizure.  Fever >39 degrees.
Age: 0.26
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Urine analysis normal
Clinical narrative: Presumed seizure.  Fever >39 degrees.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Rash, Vaccine positive rechallenge
Clinical narrative: Bilateral Inguinal Adenopathy, Had this reaction with first course of Gardasil vaccine. This was the second vaccine and had same reaction,  Skin in groin area broke out with rash on both sides 2 days after adenopathy noted.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood test, Chills, Headache, Malaise
Clinical narrative: Severe body chills, high fever of 103F with fast onset, headache, body aches.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Urine analysis
Clinical narrative: Severe body chills, high fever of 103F with fast onset, headache, body aches.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Dysstasia, Mobility decreased, Myelitis transverse, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Unable to stand /use leg.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Abasia, Abdominal pain, Anti-SS-A antibody negative, Anti-SS-B antibody negative, Antinuclear antibody negative
Clinical narrative: Unable to stand /use leg.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Back pain, Balance disorder, Bladder catheterisation, Blood creatinine normal, Blood culture
Clinical narrative: Unable to stand /use leg.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Blood glucose increased, Blood glucose normal, Bowel movement irregularity, C-reactive protein normal, CSF cell count
Clinical narrative: Unable to stand /use leg.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: CSF glucose normal, CSF neutrophil count increased, CSF protein normal, Culture urine, Cytomegalovirus test
Clinical narrative: Unable to stand /use leg.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Enterovirus test, Full blood count normal, Gram stain, Gram stain negative, HIV test negative
Clinical narrative: Unable to stand /use leg.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Haematocrit normal, Haemoglobin normal, Herpes simplex serology negative, Intensive care, Irritability
Clinical narrative: Unable to stand /use leg.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Laboratory test normal, Lymphocyte percentage decreased, Muscular weakness, Myelitis transverse, Nervous system disorder
Clinical narrative: Unable to stand /use leg.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Neutrophil percentage increased, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal cord abnormal, Plasmapheresis, Platelet count normal
Clinical narrative: Unable to stand /use leg.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Protein total normal, Red blood cell sedimentation rate normal, Suprapubic pain, Urinary retention, Varicella virus test
Clinical narrative: Unable to stand /use leg.
Age: 2.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Viral test negative, Weight bearing difficulty, White blood cell count normal
Clinical narrative: Unable to stand /use leg.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Vomited immediately following vaccination; no treatment needed.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm red, swollen, and warm to touch. Patient reports soreness into axilla. Advised by Dr. to use ice and Benadryl.
Age: 1.26
Sex: M
Vaccine: DTAP, HEPA, PNC13
Symptoms: No therapeutic response, Pyrexia, Rash
Clinical narrative: Mother reports child developed fever of 104.7 not responsive to Ibuprofen. She took him to ER and they treated him with Tylenol with some improvement. Mom alternated tylenol and ibuprofen until 9/1/12 when fever finally normalized. On 9/1/12 child developed diffuse rash which lasted until 9/3/12.
Age: 1.53
Sex: M
Vaccine: DTAP, FLU3, MMR, PNC13, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: 4 year vaccines given in AM. No adverse reaction reported. MD was informed of event. No treatment required.
Age: 69.0
Sex: F
Vaccine: YF
Symptoms: Dysphagia, Sensation of foreign body
Clinical narrative: Pt felt like she had a knot in her throat, difficulty swallowing. No problems breathing, just swallowing.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Immobile, Musculoskeletal pain, Musculoskeletal stiffness, Pain, Soft tissue inflammation
Clinical narrative: Shoulder Pain, Stiffness, Soreness, Immobility, Treated with Ibuprofen 800mg with no effect.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Chills
Clinical narrative: Started with severe back ache and headache. I didn't think much about it until the next morning when i was brushing my teeth and started throwing up. My whole body was in intense pain and i had the chills. My head felt like i was hit with a hammer, the pain was so bad. Nausea lasted until about 3:30 pm that day. I literally couldn't get off the bed due to the weakness and dizziness. When the nausea settled i was able to drag myself out of bed where my joints and head were still in extreme pain. I stayed up a couple of hours took some advil and went back to bed. Got up this morning and except for a sore stomach and a slight headache, I am fine now.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Headache, Mobility decreased, Nausea, Pain
Clinical narrative: Started with severe back ache and headache. I didn't think much about it until the next morning when i was brushing my teeth and started throwing up. My whole body was in intense pain and i had the chills. My head felt like i was hit with a hammer, the pain was so bad. Nausea lasted until about 3:30 pm that day. I literally couldn't get off the bed due to the weakness and dizziness. When the nausea settled i was able to drag myself out of bed where my joints and head were still in extreme pain. I stayed up a couple of hours took some advil and went back to bed. Got up this morning and except for a sore stomach and a slight headache, I am fine now.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: Started with severe back ache and headache. I didn't think much about it until the next morning when i was brushing my teeth and started throwing up. My whole body was in intense pain and i had the chills. My head felt like i was hit with a hammer, the pain was so bad. Nausea lasted until about 3:30 pm that day. I literally couldn't get off the bed due to the weakness and dizziness. When the nausea settled i was able to drag myself out of bed where my joints and head were still in extreme pain. I stayed up a couple of hours took some advil and went back to bed. Got up this morning and except for a sore stomach and a slight headache, I am fine now.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Discomfort, Injection site pain, Paraesthesia
Clinical narrative: Patient reported immediate discomfort described as pain and tingling in the elbow. Patient pulled away from the needle during administration.
Age: 0.35
Sex: F
Vaccine: DPP, HIBV, OPV, RVX
Symptoms: Injection site rash
Clinical narrative: Rash developed on both legs around injection sites.
Age: 3.0
Sex: F
Vaccine: DTPHEP, DTPIHI
Symptoms: Computerised tomogram, Convulsion, Laboratory test, Nuclear magnetic resonance imaging, Vaccine positive rechallenge
Clinical narrative: Seizure every time she was given a vaccine-Taken to hospital -suffered from seizures for several years, current condition attributed to this.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a healthcare worker, concerning a 69 (currently 72) year old female patient with hypertension, asthma, chronic kidney disease, gastroesophageal reflux disease (GERD), allergic rhinitis and allergy to codeine, DARVON, TALWIN and tetracycline. In approximately 2009 "two to three years ago", the patient was vaccinated with a dose of PNEUMOVAX23 dose, route and frequency were not provided. In approximately 2009 "two to three years ago, the patient experienced swelling of the entire arm, after receiving a dose of PNEUMOVAX in that arm. On an unspecified date, the patient was evaluated in the emergency room. It was unknown if patient was admitted as an "in-patient" in the hospital at that time. At the time of the report the outcome of the patient was recovered, date unspecified. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Malaria, Malaria antibody test positive, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13 year old female patient with no pertinent medical history drug reactions or allergies who on 24-FEB-2011 was vaccinated IM with a third dose of GARDASIL (Lot# not reported). On 25-FEB-2011, 24 hours after vaccination, the patient developed fever and headache. The patient was diagnosed with malaria, a blood slide was positive for malaria on 28-FEB-2011. The patient was treated with "MALAFIN" and acetaminophen. On 01-MAR-2011, symptoms resolved. The event was not considered a serious adverse event, the patient only had outpatient investigations. Information has been received from a physician, author of the article. Adverse events were reported, there were 3 episodes of proven or presumptive malaria, one of which resulted in hospital admission. Additional information is not expected.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling
Clinical narrative: PENTACEL given in AM today has swelling & redness of right thigh; inconsolable crying for 2 hrs. Seen in office again this P.M. Ibuprofen given, F/U in AM if symptoms persist.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: On 8/30/12 redness, swelling, pain, warmth at injection sites (R) VARIVAX - 6" redness & warmth on 8/30; better 8/31 (L) Tdap & MENACTRA 1 1/2" - heart shaped, hot, hard, tired, 3 hr nap 8/30, low grade fever, tx with TYLENOL. 9/4/12 Arms did improve each day, but still were sore.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: On 8/30/12 redness, swelling, pain, warmth at injection sites (R) VARIVAX - 6" redness & warmth on 8/30; better 8/31 (L) Tdap & MENACTRA 1 1/2" - heart shaped, hot, hard, tired, 3 hr nap 8/30, low grade fever, tx with TYLENOL. 9/4/12 Arms did improve each day, but still were sore.
Age: 1.2
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash, Rubella
Clinical narrative: Rash (Rubella).
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Constant, nonstop crying from time vaccine was given until the next day as per mom. Child was seen at hospital emergency room. No rx given.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Pain of skin
Clinical narrative: Significant hair loss, hair thinning on scalp and scalp tenderness. Have begun now using hair regrowth products with no significant improvement.
Age: 55.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: L deltoid, warm-red. No fever, area of redness, 8 cm x 3 cm.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Culture negative, Headache, Myalgia, Nausea
Clinical narrative: Fever to 104 degrees, joint & muscle pain, headache nausea, treated in Emergency Dept.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever to 104 degrees, joint & muscle pain, headache nausea, treated in Emergency Dept.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain, Pain
Clinical narrative: Pt came to office 8-31-12 stating since she received flu shot on 11-4-11 she had (L) arm pain at the site. Reports at the time their was some bruising at the site. Pain improved for a few months then worsened. Took ibuprofen x 3 wks. Pain with driving, lifting arm above head or behind back.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Red, itchy rash. Small bumps over 1/2 - 3/4 of my entire body. Started in "hot zones" progressed over all body parts.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Oedema peripheral, Pyrexia
Clinical narrative: Patient had PNEUMOVAX at 1030. Developed fever 102.5 at 1900. Arm swollen & hard area approximately 3 in x 3 in. Heat packs & BENADRYL given. No further fever & arm clear per my assessment today.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Lip swelling, Swelling face
Clinical narrative: Woke up 8-4-12 with swollen face, lips no shortness of breath went to ER.
Age: 48.0
Sex: M
Vaccine: ANTH
Symptoms: Musculoskeletal pain
Clinical narrative: Persistent left shoulder pain.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient got the injection on Friday 9-7-12 and noticed her arm getting red where the shot was given and by Monday 9-10-12 the whole arm (back of arm) was red, warm, & a little swollen from elbow to arm pit.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Patient got the injection on Friday 9-7-12 and noticed her arm getting red where the shot was given and by Monday 9-10-12 the whole arm (back of arm) was red, warm, & a little swollen from elbow to arm pit.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Bronchitis, Chills, Cough, Dizziness, Injection site swelling
Clinical narrative: Within 4 hours developed chills, fever, swelling at the site of injection. Dry cough & lightheadedness. Patient went to physician's office; Bronchitis.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Within 4 hours developed chills, fever, swelling at the site of injection. Dry cough & lightheadedness. Patient went to physician's office; Bronchitis.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Activities of daily living impaired, Anaphylactic shock, Asthma, Bronchitis, Condition aggravated
Clinical narrative: Within 4 hours developed chills, fever, swelling at the site of injection. Dry cough & lightheadedness. Patient went to physician's office; Bronchitis.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cough, Faeces discoloured, Fatigue, Influenza, Injection site erythema
Clinical narrative: Within 4 hours developed chills, fever, swelling at the site of injection. Dry cough & lightheadedness. Patient went to physician's office; Bronchitis.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site swelling
Clinical narrative: Within 4 hours developed chills, fever, swelling at the site of injection. Dry cough & lightheadedness. Patient went to physician's office; Bronchitis.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dyspnoea
Clinical narrative: Pt mom called 3 hours post inj stating she had to carry child to ER for trouble breathing.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Syncope
Clinical narrative: Patient fainted after administration of 3rd vaccine (HPV-4). Pt was standing, fell forward onto exam table, then onto knees and onto floor. Immediately regained consciousness. Was put into sitting position with head between knees.
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site vesicles, Vaccination site pain, Vaccination site warmth
Clinical narrative: About 24 hrs. after injection site of chicken pox vaccine pt. noted red, pinpoint blistery, warm and painful. Seen in clinic with red center about 15 x 30 mm, pink edges extending to 80mm diameter.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site reaction, Pyrexia, Rash erythematous
Clinical narrative: Developed fever up to 103.7 within 24 hours of vaccine, fever resolved within 24 hours. 48 hours after vaccine developed pink, blanchable, small bumps of forearm. Still present at 72 hours post vaccine.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Patient reports having a 1 inch to 1 1/4 in round, red, "blister-like" area approximately 1/2 inch below the area of injection on her left arm. It is not painful or itchy. She claims that this area first appeared Saturday (9/8).
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Syncope
Clinical narrative: About 3 minutes after receiving Tdap vaccine the pt fainted. He was sitting in a chair and slid to the floor. Pt is know to fain in the past with tattoos & injection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: 8/16/12 - Day of injection got hives on arm at site, I applied ice and anti-itch spray next 3 days hives going down with alcohol and spray. 5th day no signs of hives on 8/21/12.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Broke out in an itchy red rash. Druggist told me to use BENADRYL - it went away overnight.
Age: 64.0
Sex: F
Vaccine: TYP, YF
Symptoms: Abdominal pain, Diarrhoea haemorrhagic, Hyperhidrosis, Nausea
Clinical narrative: Pt. took 1 oral typhoid pill in the evening of 9-7-12. On 9-8-12 at 12N - having abnormal pain cramping, sweating, nausea, visited emg. room gave 2l of IV fluids, Morphine & Meds for nausea, also having bloody diarrhea. Discharged after 8 hr.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Borrelia test negative, Epstein-Barr virus test negative, Eyelid ptosis, Full blood count normal, Herpes simplex serology negative
Clinical narrative: Developed Bell's Palsy on Rt. side on 3/14/12 unable to smile equally broadly or shut eye completely. Mild ptosis. Unable to raise eyebrows for a few weeks, then full resolution by 2-3 mos. Saw neurologist & ENT. Took MEDROL dose pack; used artificial tears.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging brain normal, Red blood cell sedimentation rate normal, VIIth nerve paralysis
Clinical narrative: Developed Bell's Palsy on Rt. side on 3/14/12 unable to smile equally broadly or shut eye completely. Mild ptosis. Unable to raise eyebrows for a few weeks, then full resolution by 2-3 mos. Saw neurologist & ENT. Took MEDROL dose pack; used artificial tears.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site warmth, Nausea, Night sweats
Clinical narrative: Injection site rxn (warm, redness from elbow to injection site), 24 hrs after injection developed chills, night sweats & nausea about system symptoms resolved within 48 hrs.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt called this clinic reporting soreness, stiffness and limited ROM in Lt shoulder, upper back, and neck. Tdap vaccination on 8/7/12. Reported to this clinic 8/31/12.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Soreness for 2 days from vaccine redness, swelling & warm to the touch developed on 8/31/12. Tried BENADRYL & did not help. Seen by Dr. on 8/31/12.
Age: 1.01
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Pt developed a chicken pox like rash approx. 2 wks after vaccine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Area of redness, swelling, and pain approximately 6" x 3" lasting for 1 week. No treatment.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Red induration around injection site 15-20 cm in size. Happened within hours of immunization given.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Culture urine negative, Haematocrit normal, Haemoglobin normal, Laboratory test normal, Lymphocyte percentage increased
Clinical narrative: Began with fever/rash 2-3 day after vaccines better then return of sx 9/1 - 9/4 also has URI sx - which began before vaccine.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Platelet count normal, Pyrexia, Rash, Streptococcus test, Urine analysis
Clinical narrative: Began with fever/rash 2-3 day after vaccines better then return of sx 9/1 - 9/4 also has URI sx - which began before vaccine.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: White blood cell count normal
Clinical narrative: Began with fever/rash 2-3 day after vaccines better then return of sx 9/1 - 9/4 also has URI sx - which began before vaccine.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Balance disorder, Fatigue, Gingival infection, Influenza
Clinical narrative: Respiratory problems, weak, tired, off balance all occurring within 2 weeks of getting vaccine, tooth & gum infection and then a tooth pulled, flu symptoms.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory disorder, Tooth extraction, Tooth infection
Clinical narrative: Respiratory problems, weak, tired, off balance all occurring within 2 weeks of getting vaccine, tooth & gum infection and then a tooth pulled, flu symptoms.
Age: 55.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelled and itching at sight of vaccine - patient not feeling ill reaction to ZOSTAVAX.
Sex: U
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: 9-5 symptoms of all over rash. Starting the night of the vaccine. The rash continues unabated even after 5 days.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: 9 days after shot administered, area began to itch - rash (diffuse) covering 1 1/2 - 2 inches wide occurred in area given. Alcohol wipes reduce itching No blisters.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 9/6/12 - Phone reporting that inj. site had redness & swelling since inj. 9-7-12 - Phone call to patient - report golf ball size swelling that was now improving.
Age: 49.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Oedema peripheral, Pruritus, Rash
Clinical narrative: Patient presented with right arm swollen, hot, itchy and rash along upper outside right arm in the afternoon day after injection. Recommended BENADRYL & to seek medical attention if worsened.
Age: 1.34
Sex: F
Vaccine: DTAP, IPV
Symptoms: Diarrhoea, Frequent bowel movements
Clinical narrative: Onset of diarrhea - Sept 4, 2012. Very loose frequent stools vaccinated on 8/28/12 DAPTACEL & IPV stools are returning to normal on 9/10/12. Used probiotic.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Myalgia, Pain in extremity
Clinical narrative: 10-09-10- Pt came to the clinic c/o (L) arm pain. Which started August 3rd 1 one day after Tdap pain worse on August 4th 2012 pain lasted 10-12 days. Pt went to ER - stayed for 7 hours received pain med/steroids/saw her doctor last week came to clinic to file VAERS Pt states the pain in muscles & upper back.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC
Symptoms: Febrile convulsion, Pyrexia, Tremor
Clinical narrative: Pt. received MMR, PREVNAR & Hep A 8-21-12. On 8-23-12 pt. ran a fever of 102 degrees-102.5 degrees & started shaking, pt. was taken to local ER; & 8/24/12 was brought to our clinic - dx: febrile seizure duration x 4 minutes.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Immediate post-injection reaction, Injection site swelling
Clinical narrative: Pt swelled up at site of injection (immediately). However, he did not feel any pain or itching. I followed up with pt and he was doing fine. Reported a little bruising that went away and no other symptoms.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Increased upper airway secretion, Wheezing
Clinical narrative: Wheezing, raspy, difficulty breathing, increased mucus production, decreased 2 BENADRYL.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pruritus, Swollen tongue
Clinical narrative: Pt said she started to feel itchy around 10 pm then she became dizzy and her tongue swelled. She didn't go to emergency room. She is doing better now.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pain, swelling in right arm starting evening of vaccination continuing for 3 days. No hives or redness. Patient took BENADRYL and noticed improvement in swelling. Complete resolution in 3 days.
Age: 87.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Staphylococcal infection
Clinical narrative: PNEUMOVAX 23 administered 9/6/12. Pt called 9/7 complaining of pain. Advised ice & MOTRIN went to ER 9/10/12. MD gave 1 hour IV antibiotics for staph; Primary MD gave CIPRO 9/10/12.
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site urticaria
Clinical narrative: - Whelps at injection site. -Tx - BENADRYL.
Age: 53.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site urticaria
Clinical narrative: - Whelps at injection site. - Tx - BENADRYL.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction about 24 hrs after administration which grew very large (red, swollen, itchy). On 9/1/12 pt noticed a rash developing on her (L) side of abdomen. Rash continued to spread & is located from neck to buttocks. A patch on her neck is very red & swollen (pt noticed this on 9/7). Pt reports rash is somewhat itchy but not painful.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Rash, Rash pruritic
Clinical narrative: Injection site reaction about 24 hrs after administration which grew very large (red, swollen, itchy). On 9/1/12 pt noticed a rash developing on her (L) side of abdomen. Rash continued to spread & is located from neck to buttocks. A patch on her neck is very red & swollen (pt noticed this on 9/7). Pt reports rash is somewhat itchy but not painful.
Age: 67.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain, Headache, Hypoaesthesia, Myalgia, Nausea
Clinical narrative: 5Sep - fever to 100, headache, nausea, abdominal pain, myalgias. 6Sep - (R) hand numbness, patchy paresthesias in neck, head, (L) arm, (L) foot.
Age: 67.0
Sex: F
Vaccine: RAB
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: 5Sep - fever to 100, headache, nausea, abdominal pain, myalgias. 6Sep - (R) hand numbness, patchy paresthesias in neck, head, (L) arm, (L) foot.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash started 10pm day of vaccine - 2 am hives especially lower extremities. Reported next day. No fever, aches, dizziness, edema. Pt says he feels fine. Thinks rash has peaked. Pt picked up BENADRYL to help with itching.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site pain, Pain
Clinical narrative: Patient has been experiencing extreme pain in area of injection (right deltoid) as well as elbow area, presents as stabbing pain when pt tries to use area. Ongoing since injection but gradually lessening.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash appeared within 7 days of vaccine.
Sex: U
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. The patient was vaccinated with GARDASIL in August 2012, "in the past 8 days". Lot #, route and specified date were not reported. It was reported that the patient experienced syncope and vomiting within 5 minutes of receiving GARDASIL. The outcome of syncope and vomiting was unknown. The patient sought medical attention for the adverse event occurred in the physician's office. This is one of several reports received from the same source. (1209USA002964, 1209USA003021, 1209USA003022, 1209USA003023, 1209USA003024). Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with GARDASIL in August 2012, "in the past 8 days". Lot#, route and specified date were not reported. It was reported that the patient experienced syncope and vomiting with in 5 minutes of receiving GARDASIL. The outcome of syncope and vomiting was unknown. The patient sought medical attention for the adverse event occurred in the physician's office. This is one of several reports received from the same source. (1209USA002964, 1209USA003021, 1209USA003022, 1209USA001616, 1209USA003024). Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient was vaccinated with GARDASIL in August 2012, "in the past 8 days". Lot#, route and specified date were not reported. It was reported that the patient experienced syncope and vomiting with in 5 minutes of receiving GARDASIL. The outcome of syncope and vomiting was unknown. The patient sought medical attention for the adverse event occurred in the physician's office. This is one of several reports received from the same source. (1209USA002964, 1209USA001616, 1209USA003022, 1209USA003023, 1209USA003024). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a female patient with fibromyalgia, depression and anxiety and no known drug allergies who on 01-SEP-2012 was vaccinated with a dose of ZOSTAVAX, subcutaneous (dose not provided) (lot # 671779/0169AE, expiration date on 06-MAR-2013, sterile diluent lot # H012409 expiration date in June 2014). Concomitant therapy included acetaminophen, VICODIN, lorazepam, trazodone hydrochloride, gabapentin, ZOLOFT, PROAIR, LIPITOR, PRILOSEC and SKELAXIN. On 02-SEP-2012, the patient developed cellulitis after receiving the ZOSTAVAX. The injection site was swollen, red and hard with some "white colored" area near the site. The patient went to an emergency room (ER) to receive an intravenous antibiotic and the patient was released. The patient also was treated with KEFLEX. At the time of the report, the patient was recovering from the event. The relatedness for cellulitis was unknown for ZOSTAVAX. This is one of several reports received from the same source. Additional information has been requested.