chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.35
Sex: F
Vaccine: FLU3, HEPA, MEA, PNC, VARCEL
Symptoms: Medication error
Clinical narrative: SPOKE WITH MOTHER AND NOTIFIED HER OF ERROR AND ALSO NOTIFIED DR. AND MY PRACTICE MANAGER AND MEDICATION ERROR PERFORMED
Age: 14.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Gait disturbance, Joint swelling, Oedema peripheral, Pyrexia
Clinical narrative: fever 104, Rt arm swollen from elbow up 1 1/2 size. red spot spread to size of hand. approx 7-8 cm. wrsit redness, rt. ankle swollen ,Mom gave advil on Friday,  called on call PMD  Sat. advised ice arm. give Benadryl. Fever gone still limping ankle, arm stil swollen.
Age: 14.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Body temperature increased, Contusion, Hyperhidrosis, Injection site cellulitis
Clinical narrative: fever 104, Rt arm swollen from elbow up 1 1/2 size. red spot spread to size of hand. approx 7-8 cm. wrsit redness, rt. ankle swollen ,Mom gave advil on Friday,  called on call PMD  Sat. advised ice arm. give Benadryl. Fever gone still limping ankle, arm stil swollen.
Age: 14.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Malaise, Pain
Clinical narrative: fever 104, Rt arm swollen from elbow up 1 1/2 size. red spot spread to size of hand. approx 7-8 cm. wrsit redness, rt. ankle swollen ,Mom gave advil on Friday,  called on call PMD  Sat. advised ice arm. give Benadryl. Fever gone still limping ankle, arm stil swollen.
Age: 14.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: fever 104, Rt arm swollen from elbow up 1 1/2 size. red spot spread to size of hand. approx 7-8 cm. wrsit redness, rt. ankle swollen ,Mom gave advil on Friday,  called on call PMD  Sat. advised ice arm. give Benadryl. Fever gone still limping ankle, arm stil swollen.
Age: 0.16
Sex: F
Vaccine: DTAP, RVX
Symptoms: Diarrhoea
Clinical narrative: diarrhea
Age: 19.0
Sex: M
Vaccine: ANTH
Symptoms: Cough, Fatigue, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: FEVER 102F, VOMITING X1 DAY.  RUNNY NOSE, COUGHING, FATIGUE X5 DAYS.
Age: 63.0
Sex: M
Vaccine: DT, YF
Symptoms: Chills, Headache, Malaise
Clinical narrative: Malaise onset 36-48 h after immunizations; chills and possible fever 42-54 h after initial immunization; documented afebrile Day 3 after immunization with concomittant onset of mild headache lasting <24 hours.  All symptoms resolved by day 4 after immunization.  No antipyretics or other OTCs taken during this illness.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Auricular swelling, Urticaria
Clinical narrative: 3 DAYS AFTER VACCINES PT DEVELOPED MILD URTICARIA TO CHIN AREA AS WELL AS MILD SWELLING TO UPPER EARS; NO RESPIRATORY DISTRESS NOTED.
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: Pt recieved two Hep B vaccines during hospital stay. Date and times are listed under # 10 and 11.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Complains of upper right arm pain since vaccine administered. States is painful to raise arm when dressing. No redness, swelling, or pain with palpation.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Herpes zoster, Rash generalised
Clinical narrative: RASH ALL OVER BODY
Age: 46.0
Sex: F
Vaccine: RAB
Symptoms: Insomnia, Paraesthesia, Tinnitus
Clinical narrative: Nerve tingling at all sites from bottom of feet to scalp after first dose of rabies shot - ongoing.                                      Now new onset progressive bilateral tinnitus (approximately 2 months after first dose)with inability to sleep even with OTC sleep aids.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Epistaxis, Haematemesis, Oxygen supplementation, Pain
Clinical narrative: "Breathing difficulty, fever, body aches, tongue swelling, vomit, blood was showing as secondary issue in the nasal airway area and upper throat areas."  "Some blood was being vomited due to light airway bleeding."  events happened 4 hours after vaccination.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Swollen tongue, Vomiting
Clinical narrative: "Breathing difficulty, fever, body aches, tongue swelling, vomit, blood was showing as secondary issue in the nasal airway area and upper throat areas."  "Some blood was being vomited due to light airway bleeding."  events happened 4 hours after vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Induration, Mass
Clinical narrative: Arm developed a 3 inch diameter redness with hardened lump.  The area felt as if it were a severe burn.  Problem lasted for 10 days.
Age: 21.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Rash papular, Urticaria
Clinical narrative: 18 Days after small pox and anthrax vaccination he noted onset of mildly symptomatic and diffuse papular rash, No systemic or ill symptoms. Impression nonspecific papular rash most likely hive to small pox. Supportive therapy given
Age: 1.77
Sex: F
Vaccine: UNK
Symptoms: Chest X-ray normal, Computerised tomogram, Cough, Crying, Decreased appetite
Clinical narrative: Febrile seizure - Had flu shot 11-14-08, 2nd flu shot 12-18-08, on same day of flu shot cough, fever, crying, decreased appetite called 911.
Age: 1.77
Sex: F
Vaccine: UNK
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Febrile seizure - Had flu shot 11-14-08, 2nd flu shot 12-18-08, on same day of flu shot cough, fever, crying, decreased appetite called 911.
Age: 46.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Patient had Tdap injection LT arm on 12-28-08. C/o pain movement area below injection site, red swollen. PR saw PMD and was started on prednisone and antibiotic. Improving
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV1
Symptoms: Body temperature increased, Chest X-ray, Convulsion, Full blood count, Hypotonia
Clinical narrative: Infant found listless, poor muscle tone AM following vaccination.  Parent felt he had a seizure while sleeping.  Was taken to ER.  Dx with pneumonia, temp of 102.  Neurologist did feel infant had seizure while sleeping but did not feel it was related to vaccinations he had received.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC, RV1
Symptoms: Listless, Pneumonia
Clinical narrative: Infant found listless, poor muscle tone AM following vaccination.  Parent felt he had a seizure while sleeping.  Was taken to ER.  Dx with pneumonia, temp of 102.  Neurologist did feel infant had seizure while sleeping but did not feel it was related to vaccinations he had received.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Back pain, Blood test, Body temperature increased, Culture positive, Neck pain
Clinical narrative: FLUMIST received 12/27/08. On 12/30/2008 began experiencing itching of nose, 101 f temperature; aching of neck and back. Dad contacted PMD who did rapid flu swab which was positive. Dad called CDC and was told to rep out it to local health dept.
Age: 9.0
Sex: F
Vaccine: FLUN3
Symptoms: Pruritus
Clinical narrative: FLUMIST received 12/27/08. On 12/30/2008 began experiencing itching of nose, 101 f temperature; aching of neck and back. Dad contacted PMD who did rapid flu swab which was positive. Dad called CDC and was told to rep out it to local health dept.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Back pain, Body temperature increased, Culture positive, Epistaxis, Infection
Clinical narrative: Flumist received on Saturday, 12/27/08.  On Tues. 12/30/08 began experiencing itching of nasal cavity, nasal infection, nasal bleeding, 101 degrees F temp.; aching neck & back.  Contacted PMD, who did rapid flu which was positive.  Called CDC and was told to report to local health dept.
Age: 41.0
Sex: M
Vaccine: FLUN3
Symptoms: Neck pain, Pruritus
Clinical narrative: Flumist received on Saturday, 12/27/08.  On Tues. 12/30/08 began experiencing itching of nasal cavity, nasal infection, nasal bleeding, 101 degrees F temp.; aching neck & back.  Contacted PMD, who did rapid flu which was positive.  Called CDC and was told to report to local health dept.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Headache
Clinical narrative: Had a headache from 12-17-08 time given till Dec 28, 2008 almost (2 wks) also hoarseness same time.  Everything is ok now.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Injection site vesicles, Local reaction, Scab
Clinical narrative: This is in follow-up to report (s) previously submitted on 12/23/2008. Information has been received from a physician concerning an approximately 70 year old patient who on an unspecified date was vaccinated with a dose of ZOSTER vaccine (lot # 659759/1873U). The physician reported that after vaccination the patient had shingles at the injection site and then had a "dermatomal outbreak". The patient sought unspecific medical attention. At the time of the report the patient was recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/merck vaccine VZV strain. Follow-up information has been received from a physician concerning a 70 year old female with pencicillin and hydrochlorothiazide/triamterene allergy and a history of chickenpox in childhood who on 07-FEB-2008 was vaccinated in her left arm (deltoid area) with a 0.65ml dose of ZOSTAVAX (Oka/Merck) (lot # 659759/1873U). Concomitant therapy included aspirin, calcium (unspecified ) (+) vitamin D and PROTONIX. On 09-FEB-2008, the patient developed small local cluster followed by more complete left arm dermatome about 5 days later. There were multiple vesicles on the left dermatomo, right across the injection site. She has no recent exposure to chicken pox or shingles. No specimen was obtained because the patient presented after scabs nearly resolved. The rash was also described as an initial cluster of blisters at injection site by 2 days after injection, then full left arm dermatoma with multiple lesions fully crusted and near resolution by 21-FEB-2008. The patient recovered. A direct flourescent antibody was not performed. A photo was not taken. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Dizziness, Mood swings, Muscle spasms, Smear cervix abnormal, Tachycardia
Clinical narrative: Dizziness, lightheaded, tachycardia tinnitus since May 08. 2/24/09 MR received from PCP from 3/2008 to 1/2009 for multiple visits with multiple c/o. PE 3/18/08 with normal exam except wrist tenderness from waitressing. HPV and TDaP given. HPV#2 5/120/08.  First seen 5/28/08 with c/o dizziness and lightheadedness x 4 days. Dx:  Dizziness-no clear etiology. F/U 6/6/08, 9/18/08 with continued sx and now with lower abd pain and suprapubic discomfort.  Neuro consult 7/9/08 with normal exam. DX: Transient lightheadedness of unclear etiology. Encouraged increased H2O and vitamins. 8/18/08 presented with SOB and dizziness. anxiety attack noted 9/18/08. Abnormal PAP with colposcopy 11/2008.Sx continue through 1/09.  W/u (-). DX:  dizziness.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Tinnitus
Clinical narrative: Dizziness, lightheaded, tachycardia tinnitus since May 08. 2/24/09 MR received from PCP from 3/2008 to 1/2009 for multiple visits with multiple c/o. PE 3/18/08 with normal exam except wrist tenderness from waitressing. HPV and TDaP given. HPV#2 5/120/08.  First seen 5/28/08 with c/o dizziness and lightheadedness x 4 days. Dx:  Dizziness-no clear etiology. F/U 6/6/08, 9/18/08 with continued sx and now with lower abd pain and suprapubic discomfort.  Neuro consult 7/9/08 with normal exam. DX: Transient lightheadedness of unclear etiology. Encouraged increased H2O and vitamins. 8/18/08 presented with SOB and dizziness. anxiety attack noted 9/18/08. Abnormal PAP with colposcopy 11/2008.Sx continue through 1/09.  W/u (-). DX:  dizziness.
Age: 20.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Dizziness, Tachycardia, Tinnitus
Clinical narrative: Dizziness, lightheaded, tachycardia tinnitus since May 08. 2/24/09 MR received from PCP from 3/2008 to 1/2009 for multiple visits with multiple c/o. PE 3/18/08 with normal exam except wrist tenderness from waitressing. HPV and TDaP given. HPV#2 5/120/08.  First seen 5/28/08 with c/o dizziness and lightheadedness x 4 days. Dx:  Dizziness-no clear etiology. F/U 6/6/08, 9/18/08 with continued sx and now with lower abd pain and suprapubic discomfort.  Neuro consult 7/9/08 with normal exam. DX: Transient lightheadedness of unclear etiology. Encouraged increased H2O and vitamins. 8/18/08 presented with SOB and dizziness. anxiety attack noted 9/18/08. Abnormal PAP with colposcopy 11/2008.Sx continue through 1/09.  W/u (-). DX:  dizziness.
Age: 13.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Gait disturbance, Joint swelling, Oedema peripheral, Pyrexia
Clinical narrative: Within 18 hours my son complained of severe pain in his right ankle with some swelling.  Within 24 hours he began a low-grade fever and severe pain and cellulitis at the injection site with two quarter-sized spots appearing.  Within 48 hrs. he had a temperature of 103.5 and redness at the site of the injection had grown to the size of his hand with the upper arm almost doubled in size.  Ankle pain grew worse and the redness in his arm spread to his elbow and creases on the wrist.  Bruising was also noted on his hand.  Severe body aches and malaise and he reported his skin hurt as well.  On-call physician was contacted 48 hrs. after the vaccine and he did not advise taking him to the emergency room.  He advised Advil - which we had already been giving - and Benadryl as well, which we then administered.  72 hrs. later the fever began to lower but returned intermittently with breaking and profuse sweating.  Today is 5 days post-vaccine.  No fever is present and the ankle is improving.  Swelling and redness persists in the arm, though diminished.  Hard, swollen spot where the vaccine was given remains, with redness and pain.  Measures approx. 2"x3".
Age: 13.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Body temperature increased, Contusion, Hyperhidrosis, Injection site cellulitis
Clinical narrative: Within 18 hours my son complained of severe pain in his right ankle with some swelling.  Within 24 hours he began a low-grade fever and severe pain and cellulitis at the injection site with two quarter-sized spots appearing.  Within 48 hrs. he had a temperature of 103.5 and redness at the site of the injection had grown to the size of his hand with the upper arm almost doubled in size.  Ankle pain grew worse and the redness in his arm spread to his elbow and creases on the wrist.  Bruising was also noted on his hand.  Severe body aches and malaise and he reported his skin hurt as well.  On-call physician was contacted 48 hrs. after the vaccine and he did not advise taking him to the emergency room.  He advised Advil - which we had already been giving - and Benadryl as well, which we then administered.  72 hrs. later the fever began to lower but returned intermittently with breaking and profuse sweating.  Today is 5 days post-vaccine.  No fever is present and the ankle is improving.  Swelling and redness persists in the arm, though diminished.  Hard, swollen spot where the vaccine was given remains, with redness and pain.  Measures approx. 2"x3".
Age: 13.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Malaise, Pain
Clinical narrative: Within 18 hours my son complained of severe pain in his right ankle with some swelling.  Within 24 hours he began a low-grade fever and severe pain and cellulitis at the injection site with two quarter-sized spots appearing.  Within 48 hrs. he had a temperature of 103.5 and redness at the site of the injection had grown to the size of his hand with the upper arm almost doubled in size.  Ankle pain grew worse and the redness in his arm spread to his elbow and creases on the wrist.  Bruising was also noted on his hand.  Severe body aches and malaise and he reported his skin hurt as well.  On-call physician was contacted 48 hrs. after the vaccine and he did not advise taking him to the emergency room.  He advised Advil - which we had already been giving - and Benadryl as well, which we then administered.  72 hrs. later the fever began to lower but returned intermittently with breaking and profuse sweating.  Today is 5 days post-vaccine.  No fever is present and the ankle is improving.  Swelling and redness persists in the arm, though diminished.  Hard, swollen spot where the vaccine was given remains, with redness and pain.  Measures approx. 2"x3".
Age: 13.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Within 18 hours my son complained of severe pain in his right ankle with some swelling.  Within 24 hours he began a low-grade fever and severe pain and cellulitis at the injection site with two quarter-sized spots appearing.  Within 48 hrs. he had a temperature of 103.5 and redness at the site of the injection had grown to the size of his hand with the upper arm almost doubled in size.  Ankle pain grew worse and the redness in his arm spread to his elbow and creases on the wrist.  Bruising was also noted on his hand.  Severe body aches and malaise and he reported his skin hurt as well.  On-call physician was contacted 48 hrs. after the vaccine and he did not advise taking him to the emergency room.  He advised Advil - which we had already been giving - and Benadryl as well, which we then administered.  72 hrs. later the fever began to lower but returned intermittently with breaking and profuse sweating.  Today is 5 days post-vaccine.  No fever is present and the ankle is improving.  Swelling and redness persists in the arm, though diminished.  Hard, swollen spot where the vaccine was given remains, with redness and pain.  Measures approx. 2"x3".
Sex: F
Vaccine: HEP, MMR, TDAP, HEP, MEA, RUB
Symptoms: Anaemia, Psoriasis, Rash
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anemia in a female subject of unspecified age who was vaccinated with ENGERIX B, GlaxoSmithKline. Previous and/or concurrent vaccination included TDAP, non-gsk; unk; unknown given on 24 October 2008; live attenuated MMR (strain not specified); manufacturer unspecified; unknown given on 24 October 2008; MMR, strain not specified; manufacturer unspecified; unknown given on 24 October 2008. On 24 October 2008, the subject received 1st dose of ENGERIX B (unknown, left arm). Three to four days after vaccination with ENGERIX B, the subject experienced rash. On 01 December 2008, 38 days after vaccination with ENGERIX B, the subject experienced anemia and psoriasis. The healthcare professional was reporting on behalf of a clinic nurse. A female subject received ENGERIX B on 24 October 2008; and three to four day later developed a rash on her chest, back and torso. On 01 December 2008, the subject was seen at a dermatologist's office and diagnosed with psoriasis and anemia. Immunization series was discontinued. The reporter stated there was a 10-degree temperature excursion on this lot number and implemented a voluntary recall (incorrect storage of drug). This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified.
Sex: F
Vaccine: HEP, MMR, TDAP, HEP, MEA, RUB
Symptoms: Hypotension, Pruritus generalised, Psoriasis
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of anemia in a female subject of unspecified age who was vaccinated with ENGERIX B, GlaxoSmithKline. Previous and/or concurrent vaccination included TDAP, non-gsk; unk; unknown given on 24 October 2008; live attenuated MMR (strain not specified); manufacturer unspecified; unknown given on 24 October 2008; MMR, strain not specified; manufacturer unspecified; unknown given on 24 October 2008. On 24 October 2008, the subject received 1st dose of ENGERIX B (unknown, left arm). Three to four days after vaccination with ENGERIX B, the subject experienced rash. On 01 December 2008, 38 days after vaccination with ENGERIX B, the subject experienced anemia and psoriasis. The healthcare professional was reporting on behalf of a clinic nurse. A female subject received ENGERIX B on 24 October 2008; and three to four day later developed a rash on her chest, back and torso. On 01 December 2008, the subject was seen at a dermatologist's office and diagnosed with psoriasis and anemia. Immunization series was discontinued. The reporter stated there was a 10-degree temperature excursion on this lot number and implemented a voluntary recall (incorrect storage of drug). This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Diplopia, Eye disorder, Immediate post-injection reaction, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site burning in a 70-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included acid reflux, arthritis, hypertension and hypothyroidism. Concurrent medications included SYNTHROID, Indapamide, Omeprazole and Potassium chloride. On 7 November 2008 at 11:00, the subject received unspecified dose of Influenza vaccine (unknown, right arm). On 7 November 2008, immediately after vaccination with Influenza vaccine, the subject experienced injection site burning, swelling injection site, injection site redness, injection site warmth. On 11 November 2008, the subject experienced injection site itching. On 13 November 2008, the subject experienced double vision. On 21 November 2008, the subject experienced optic nerve disorder and eye disorder. On an unknown date the subject experienced hardness injection site. The subject reported the GSK influenza vaccine lot number as "GSK 375B4". The subject reported that on 07 November 2008, she received GSK flu vaccine injected into her right arm. She immediately noticed burning at the injection site. She stated that I started swelling and immediately got red and hot. She says it stayed that way and she still has a hardened area on her arm two months later. She took ALLEGRA for two days. She says that on the 6th day after the flu vaccine injection that she developed double vision. She called her internist and he referred her to her ophthalmologist. She had an MRI on 21 November 2008 and was told that the 6th optic nerve of the left eye was affected by an event that affected the muscle of her left eye. She is now wearing a patch because of the double vision but they have not recommended any treatment but recommended a "wait and see" approach for about 3 months. In addition, they have discussed that she might need surgery to correct the muscle or prisms in her glasses. She says she is still having double vision although it has improved. The subject called where she received the vaccine and "they read from the package insert regarding flu vaccines causing optic neuritis and advised her to call GSK to report an adverse event". In addition, she stated that she gets a flu vaccination every year and she estimated that she has had 25 previous flu vaccinations without incident. This case was assessed as medically serious by GSK. The subject was treated with Fexofenadine and eye patch. At the time of reporting the events were unresolved.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site pruritus, Injection site swelling, Injection site warmth, Optic nerve disorder
Clinical narrative: This case was reported by a consumer and described the occurrence of injection site burning in a 70-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included acid reflux, arthritis, hypertension and hypothyroidism. Concurrent medications included SYNTHROID, Indapamide, Omeprazole and Potassium chloride. On 7 November 2008 at 11:00, the subject received unspecified dose of Influenza vaccine (unknown, right arm). On 7 November 2008, immediately after vaccination with Influenza vaccine, the subject experienced injection site burning, swelling injection site, injection site redness, injection site warmth. On 11 November 2008, the subject experienced injection site itching. On 13 November 2008, the subject experienced double vision. On 21 November 2008, the subject experienced optic nerve disorder and eye disorder. On an unknown date the subject experienced hardness injection site. The subject reported the GSK influenza vaccine lot number as "GSK 375B4". The subject reported that on 07 November 2008, she received GSK flu vaccine injected into her right arm. She immediately noticed burning at the injection site. She stated that I started swelling and immediately got red and hot. She says it stayed that way and she still has a hardened area on her arm two months later. She took ALLEGRA for two days. She says that on the 6th day after the flu vaccine injection that she developed double vision. She called her internist and he referred her to her ophthalmologist. She had an MRI on 21 November 2008 and was told that the 6th optic nerve of the left eye was affected by an event that affected the muscle of her left eye. She is now wearing a patch because of the double vision but they have not recommended any treatment but recommended a "wait and see" approach for about 3 months. In addition, they have discussed that she might need surgery to correct the muscle or prisms in her glasses. She says she is still having double vision although it has improved. The subject called where she received the vaccine and "they read from the package insert regarding flu vaccines causing optic neuritis and advised her to call GSK to report an adverse event". In addition, she stated that she gets a flu vaccination every year and she estimated that she has had 25 previous flu vaccinations without incident. This case was assessed as medically serious by GSK. The subject was treated with Fexofenadine and eye patch. At the time of reporting the events were unresolved.
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Bronchitis, Rash, Scar
Clinical narrative: This case was reported by a pharmacist (also the subject) and described the occurrence of arm rash in a female subject of unspecified age who was vaccinated with FLUARIX, GlaxoSmithKline.  There were no concurrent medications.  On 27 October 2008 at 11:00 the subject received a dose of FLUARIX in the right arm.  On 29 October 2008, 2 days after vaccination with FLUARIX, the subject experienced a rash on her arms and legs.  The rash has resulted in scarring in the rash areas since the rash has not resolved.  The subject was evaluated three times at an urgent care office.  The pharmacist considered the events were clinically significant (or requiring intervention).  She was first treated with three doses of Depo medrol at 80 mg (this was thought to be the dose).  Then one week later, the subject was prescribed a 6-day prednisone taper for the continuing rash.  The taper started at 50 mg and she was instructed to decrease the dose by 5 mg every 2 days.  At the time of reporting, the subject was at 35 mg and the rash was not improving, but was getting worse.  The subject also tried treatment with Atarax and Zyrtec which did not resolve the rash.  The subject developed bronchitis some time after receiving FLUARIX for which she was prescribed Amoxil.  The subject did not relate the FLUARIX to the development of bronchitis.  The subject initially thought that the Amoxil she was taking for bronchitis was improving the rash, but then the rash worsened again.  The subject has not been evaluated by a dermatologist, nor had a skin biopsy.  Blood work performed was normal.  At the time of reporting the rash was unresolved and worsening at times, scarring was unresolved and the outcome of bronchitis was not specifically mentioned.  The rash was considered possibly related to treatment with FLUARIX.  The pharmacist mentioned that she was not certain of the brand of flu vaccine that she received, but she knew it was a GlaxoSmithKline product and that it was in a single dose syringe (FLUARIX) versus a multidose vial (FLULAVAL).
Age: 1.4
Sex: M
Vaccine: FLU3
Symptoms: Injection site warmth, Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, Heat @ site.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pain
Clinical narrative: Shortness of breath, bodyaches.  Treated with TORADOL IM & ALBUTEROL NEBULIZER X 2.  Symptoms started around 1800.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Pt recvd menactra + Hep A vaccine within 5 mins of receiving the vaccine the patient was getting ready to leave and passed out in our waiting room.  Patient was "out" no longer than 30 sec. and walked herself to waiting room.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Pain, Tremor
Clinical narrative: Developed shaking, shivering with pain around 1am after receiving flu shot at 6 pm night before. Symptoms lasted about 3 hours. Pain was headache.
Age: 19.0
Sex: M
Vaccine: FLU3, HEPAB, YF
Symptoms: Head injury, Hyperhidrosis, Immediate post-injection reaction, Nausea, Skin discolouration
Clinical narrative: Patient filled out info sheet stating he had fainted w/previous injection at Dr's office(date unknown, but in 2008). He came to get FLUVIRIN, TWINRIX and YF-Vax. I gave him Flu and TWINRIX in left arm. Within <1 minute his head went back against the wall and he lost his color in his face. Then he slid off his chair to a sitting up position on the floor and moaned a few times. I panicked, thinking "what should I do first?" and came into the pharmacy asking to call 911. I grabbed the ekit and went back out to patient. He immediately snapped out of it and said that once he heard my voice he was ok. But then he needed to lie down soon after this- and his color was not better. He also was sweaty on his face and felt nauseous and asked for a bag to breathe in and out of. I gave him a bag and a dixie cup of water-but before I got these for him I came back into pharmacy and call 911. They came w/in 10 minutes and measured BP, pulse, etc. He continued lying on the floor while they questioned him and then about 10 minutes later they asked me to give his YFVax while they were still there. I did, and he seemed fine. They recommended he, go to the hospital and the next time I checked the hallway they were gone.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a female registered with ankylosing spondylitis. Who on 21-Nov-2008 was vaccinated with a dose of ZOSTER vaccine (lot # not provided). After vaccination, nurse developed a very large welt, about 3-4 inches in diameter on her left arm. The nurse also experienced swelling, warmth and soreness at the site. The nurse reported that she used cold compresses to reduce swelling of the welt. The area was still red and sore 24-Nov-2008. At the time of reporting (24-Nov-2008) the outcome of the very large welt, swelling and warmth was not reported. Additional information has been requested. Follow-up information has been received from a registered nurse a 46 year old female with ankylosing spondylitis. Who on 21-Nov-2008 was vaccinated with a dose of ZOSTER vaccine (lot #658205/1085U) subsequently. On 10-OCT-2008 the reporter was vaccinated with FLUZONE and pneumococcal vaccine, polyval (MSD). On 22 NOV-2008 the patient developed red, warm at the site, hard induration starting at approximately 3x5 cm increasing to approximately 8x12 cm. painful and itching and had a patch of shingles down the center of the induration. The patient was prescribed with (MEDROL DOSE PACK). On 28-NOV-2008 the patient recovered. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a female registered with ankylosing spondylitis. Who on 21-Nov-2008 was vaccinated with a dose of ZOSTER vaccine (lot # not provided). After vaccination, nurse developed a very large welt, about 3-4 inches in diameter on her left arm. The nurse also experienced swelling, warmth and soreness at the site. The nurse reported that she used cold compresses to reduce swelling of the welt. The area was still red and sore 24-Nov-2008. At the time of reporting (24-Nov-2008) the outcome of the very large welt, swelling and warmth was not reported. Additional information has been requested. Follow-up information has been received from a registered nurse a 46 year old female with ankylosing spondylitis. Who on 21-Nov-2008 was vaccinated with a dose of ZOSTER vaccine (lot #658205/1085U) subsequently. On 10-OCT-2008 the reporter was vaccinated with FLUZONE and pneumococcal vaccine, polyval (MSD). On 22 NOV-2008 the patient developed red, warm at the site, hard induration starting at approximately 3x5 cm increasing to approximately 8x12 cm. painful and itching and had a patch of shingles down the center of the induration. The patient was prescribed with (MEDROL DOSE PACK). On 28-NOV-2008 the patient recovered. Additional information is not expected.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy
Clinical narrative: Pt. examined and vaccinated on 12/23/08 for well visit - normal exam. Pt found by parent in crib morning of 12/24 apneic - SIDS is preliminary cause of death - coroner's report not available.   2/2/09 Received Autopsy Report which states COD as sudden unexplained death in an infant & manner of death as undetermined.  2/2/09 Autopsy report also states patient experienced cold s/s.  Last seen by PCP on 12/23/08 for vaccinations, had been given Tylenol x 3 doses.  Was fed & had been placed in crib face down w/head turned to side & 2 blankets on.    2/4/09 Received PCP office & vaccine records. Records reveal patient in good health on 12/23/08 w/only dry patchy areas on legs & back & left eye turning intermittently.
Age: 1.8
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Cough, Nasopharyngitis, Pneumonia, Vomiting
Clinical narrative: Developed cold, cough, vomiting after Influenza vaccination, requiring hospitalization for Pneumonia.  1/26/2009 MR received for DOS 12/15/2008-1/xx/2009. No D/C Summary sent since pt still hospitalized. DX: Pneumonia. S/P Respiratory Failure with intubation.  Pt presented with worsening fever, SOB and cough x 2 days. PE (+) for dry mucous membranes,nasal flaring, retractions and grunting. O2 sat 88% on RA. Started on O2 NC then later intubated for further respiratory decline. May require tracheostomy. TX abx. Still hospitalized.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Pallor, Visual impairment
Clinical narrative: Within 5 mins of receiving HPV injection pt became pale, lightheaded, vision became black, diaphoretic. Had pt wheeled to obs. room- monitored pt for 20 min - full recovery - discharged to Mom care.
Age: 44.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Headache, Laboratory test abnormal, Myalgia, Pyrexia, Yellow fever
Clinical narrative: Saw PCP With X 3days fever 99 , HA, myalgia on 11/12/08 Blood drawn for yellow fever IgG and Igm. Results was antibody low-unable to separate for IgG/IgM. Flu 11/14/2008 with improved symptoms, Concealed further appts with PCP. Symptoms resolved totally.
Age: 0.9
Sex: F
Vaccine: FLU3
Symptoms: Eczema
Clinical narrative: Hours after flu vaccine administered, developed diffuse eczematous rash that persisted months after vaccine given. Rash comes and goes.
Age: 1.6
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Seen on 1-7-09 = lt leq red + swollen + warm to touch ordered- TYLENOL, Compresses, HC cream & BENADRYL po-> RECK 1-8-09 -> (on AMOX for OM)- 1-8-09-AB changed to CLINDAMYCIN- Re checked on 1-9-08 -> area of erythema no longer warm to touch- Dx Cellulitis secondary to immunization.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient had a flu shot in October 2008.  She felt immediate pain in shoulder, radiating down arm.  She felt the flu shot was given higher up on her shoulder than previous flu shots.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Cellulitis, Rash pustular
Clinical narrative: Member developed a satellite pustule near vaccine site.  Area appeared to have a generalized cellulitis around site.  Member sent to ER and was treated and released.  Member was given BACTROBAN 20% to use on a questionable pustule on side of his nose.  No other medications or treatment given.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL
Symptoms: Injection site cellulitis, Injection site pustule, Rash pustular
Clinical narrative: Member developed a satellite pustule near vaccine site.  Area appeared to have a generalized cellulitis around site.  Member sent to ER and was treated and released.  Member was given BACTROBAN 20% to use on a questionable pustule on side of his nose.  No other medications or treatment given.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Agitation, Burning sensation, Diarrhoea, Hyperhidrosis, Insomnia
Clinical narrative: Burning itch over upper body, extremities + bottoms of feet. Felt very "hyper" "wired". Difficulty sleeping that night, diarrhea, sweats, swollen axillary lymph nodes. Symptoms resolved after 72 hours.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Lymphadenopathy, Pruritus
Clinical narrative: Burning itch over upper body, extremities + bottoms of feet. Felt very "hyper" "wired". Difficulty sleeping that night, diarrhea, sweats, swollen axillary lymph nodes. Symptoms resolved after 72 hours.
Sex: U
Vaccine: FLU3
Symptoms: Cellulitis
Clinical narrative: Right Arm cellulitis.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram, Injected limb mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: 10/20/08 Vaccinated at 9AM- Pain in left upper arm 4PM and continues. Shot was given top of arm at shoulder in back. Saw family doctor, neurologist 12/08. Appt 1/13 with orthopedic Dr. Pain still in left arm and into shoulder cap. Condition is on going.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: Slept 14 hours; woke up dizzy; then complained of a stomachache.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient fainted 4 days after vaccination per mom's report: with HPV vaccine patient was getting up from sitting down on couch when she fainted.  Mom was in other room and heard her.  Patient got up right away and has been acting fine.  No fever, no cold symptoms.
Age: 1.1
Sex: M
Vaccine: HEPA, PNC
Symptoms: Erythema
Clinical narrative: Erythema 20 x 20 over (L) arm PCV7 site.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Pyrexia, Visual impairment
Clinical narrative: Dizzy, headache, brown spot in vision - 30 mins. - fever 102 degrees x 9hrs. Headache and dizzy after 72hrs.
Age: 26.0
Sex: F
Vaccine: HEP
Symptoms: Blister, Headache
Clinical narrative: Blister at the side where HEPTAVAX was given with headache for a few hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Pain, Pallor, Skin warm
Clinical narrative: (L) deltoid with 11.5cm x 13cm area of erythema.  Warm to touch, painful on palpation. Area blanches on palpation, sl erythematous no clearly demarcated edges.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site pain, Injection site pruritus
Clinical narrative: 20cm erythema, pruritis and pain at site of VARICELLA injection within 24 hours vaccine. Seen at 48 hours.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Oedema, Rash generalised, Urticaria
Clinical narrative: Generalized body rash with mild edema,"patches" and hives.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Electrocardiogram, Nerve injury, Neuropathy peripheral, Osteomyelitis, Thrombosis
Clinical narrative: Nerve damage in right arm. I have peripheral neuropathy, blood clots, bone infection and blood veins infected in right arm.
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Vein disorder, X-ray
Clinical narrative: Nerve damage in right arm. I have peripheral neuropathy, blood clots, bone infection and blood veins infected in right arm.
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Gastroenteritis, Pyrexia, Vomiting
Clinical narrative: Information has been received from a nurse concerning a male who was vaccinated with all three doses of ROTATEQ at appropriate intervals. In November 2008, 1 week after receiving the third dose, the patient developed high fever, vomiting and diarrhea. The patient was hospitalized for gastroenteritis. Gastroenteritis was considered to be immediately life-threatening. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Diagnostic procedure, Vertigo
Clinical narrative: Information has been received from a physician concerning a 63 year old female patient with upper respiratory tract infection at the time of vaccination and hypertension and glaucoma who on 29-DEC-2008 was vaccinated from her primary care physician with a dose of ZOSTAVAX. Concomitant therapy included Lisinopril (manufacturer unknown), Xalatan, Diazepam, Amoxicillin, Aleve and Tylenol. On 31-DEC-2008 the patient experienced vertigo. The patient was seen in the office and underwent balance testing (results not reported). The physician stated that the patient had gotten better regarding her symptoms. Experienced vertigo was considered to be disabling as the patient was unable to drive. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Drug exposure during pregnancy, Ultrasound scan
Clinical narrative: Information has been received for the pregnancy registry for GARDASIL from a physician concerning a 15 year old female who on 23-OCT-2008 was vaccinated with a third dose of GARDASIL (lot # 659184/0843X). It was reported that the patient was pregnant since August 2008 (LMP: August 2008). An ultrasound test was performed on 08-DEC-2008, which showed gestation of 22 weeks and 1 day. The physician reported that the patient had an elective termination of her pregnancy. The patient had no previous pregnancies. Upon internal review, elective termination of pregnancy was considered to be an other important medical event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Redness noted at injection site on left leg, without itching. Presented to the primary care provider the following day and received prescription for Augmentin for cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness noted at injection site on left leg, without itching. Presented to the primary care provider the following day and received prescription for Augmentin for cellulitis.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatine phosphokinase increased, Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: after first two HPV shots had muscle soreness and slight fever.  After Shot #3 had severe whole body myalgias and stiffness "I can hardly move".  Tender in all major trigger points.  This report made by treating physician, vaccinating physician is patient's OBGYN, so I do not have vaccine lot number information
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Varicella
Clinical narrative: Patient has received two Varicella vaccinations.  The first vaccination was given by our office (administer unknown) on 8-19-02.  The second vaccination was the MMRV combo given on 9-6-06.  On 1-10-09 Dominik was seen in our office and diagnosed with chickenpox.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Dyskinesia, Hypoxia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: PT RECEIVED GARDASIL, MENACTRA AND ADACEL IMMUNIZATIONS ON 01-12-09.  AFTER INJECTIONS, PT GOT DIZZY AND PALE WHILE SITTING UPRIGHT IN CHAIR IN EXAM ROOM.  PT SLUMPED DOWN, HAD A BRIEF LOC WITH MILD IRREGULAR JERKING OF EXTREMITIES THAT LASTED APPROX 10 SECONDS. + URINARY INCONTINENCE.  PT WOKE STARTLED AND SURPRISED ASKING "WHAT HAPPENED?"  THE EPISODE WAS WITNESSED BY DR.  DR. DOCUMENTED "THIS SEEMS TO HAVE BEEN A VASOVAGAL SPELL WITH A SUPERIMPOSED HYPOXIC SEIZURE."
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pallor, Syncope vasovagal, Urinary incontinence
Clinical narrative: PT RECEIVED GARDASIL, MENACTRA AND ADACEL IMMUNIZATIONS ON 01-12-09.  AFTER INJECTIONS, PT GOT DIZZY AND PALE WHILE SITTING UPRIGHT IN CHAIR IN EXAM ROOM.  PT SLUMPED DOWN, HAD A BRIEF LOC WITH MILD IRREGULAR JERKING OF EXTREMITIES THAT LASTED APPROX 10 SECONDS. + URINARY INCONTINENCE.  PT WOKE STARTLED AND SURPRISED ASKING "WHAT HAPPENED?"  THE EPISODE WAS WITNESSED BY DR.  DR. DOCUMENTED "THIS SEEMS TO HAVE BEEN A VASOVAGAL SPELL WITH A SUPERIMPOSED HYPOXIC SEIZURE."
Age: 0.8
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Convulsion, Pyrexia, Tremor
Clinical narrative: On 1-9-09 patient had a seizure at 7:00 pm. No fever was noted by his mom.  Diastat 2.5 mg was given rectally times two doses and patient was fully recovered by 8:00 pm.  On 1-11-09 at 1:30 am patient had a fever of 102.7 and was having tremors. His mom gave him 3/4 tsp. of motrin and tylenol.  At 2:00 am he had a seizure. Diastat was given times one dose. Patient fully recovered from seizure by 11:00 am that morning.
Age: 6.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Oropharyngeal pain, Pyrexia, Streptococcal identification test, Streptococcal identification test negative
Clinical narrative: PT PRESENTED TO OFFICE ON 12-24-08 WITH C/O SORE THROAT, COUGH AND FEVER.  STREP SCREEN PERFORMED, RESULTS NEGATIVE.  DR. DX'D PT WITH POSSIBLE FLUMIST SIDE EFFECT.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Malaise, Myalgia
Clinical narrative: Headache, malaise, myalgias began approximately 16 hours after receiving the vaccine. Approximately 24 hours later, they began to improve and had resolved approximately 8 hours after that.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV
Symptoms: Irritability, Pyrexia, Rash, Wheezing
Clinical narrative: 3 days following vaccination patient developed fever to 102, irritability, rash, wheezing
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Back pain, Erythema, Headache
Clinical narrative: Started complaining with joint pain, backpain, headache, and face red the day after the vaccine.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Depressed level of consciousness, Hypophagia, Pyrexia, Somnolence
Clinical narrative: 1/8, 11:40am - parent returned to health department; states infant difficult to arouse, sleeyp, only sipping at bottle.  Had fever (100.1F rectal),  1/7, around 2 pm gave <0.4 cc infant tylenol, then again between 6 & 7 pm gave same amount of tylenol & again 1/8 am around 8:30.  Advised to take infant to ER (no PMD) and stop tylenol.  1/9, mother stopped tylenol, no ER visit; infant "fine" to her - drinking formula & without fever.  Mother did not follow up with a physician; infant alert, easily arousable, feeding well, without fever.