chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Soft tissue inflammation, Tenderness, Vaccination complication, X-ray limb normal
Clinical narrative: A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE No-Preservatives 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was adducted. The patient had a pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included "VITORIN". At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as "two days later, pain became severe"). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 05 May 2008, the patient reported to their health care provider that their "arm is good now, sometimes hurts to life, still tender to touch". No further information was provided at the time of the report. Follow-up information received on 13 June 2008 from a physician. This reporter had no additional information to add to the case. No other relevant medical information was added to the case. Follow-up information was received from the original physician on 03 July 2008. The physician had only seen the patient once, and was not aware of her recovery status. Per the physician, "I believe vaccine was injected into subacromial area accidentally by student nurse. Not problem with vaccine- bad placement- too high on arm".
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Drug administered at inappropriate site, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE No-Preservatives 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was adducted. The patient had a pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included "VITORIN". At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as "two days later, pain became severe"). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 05 May 2008, the patient reported to their health care provider that their "arm is good now, sometimes hurts to life, still tender to touch". No further information was provided at the time of the report. Follow-up information received on 13 June 2008 from a physician. This reporter had no additional information to add to the case. No other relevant medical information was added to the case. Follow-up information was received from the original physician on 03 July 2008. The physician had only seen the patient once, and was not aware of her recovery status. Per the physician, "I believe vaccine was injected into subacromial area accidentally by student nurse. Not problem with vaccine- bad placement- too high on arm".
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Soft tissue inflammation, Tenderness, X-ray normal
Clinical narrative: A 44-year-old female patient had received an intramuscular left deltoid injection of FLUZONE No-Preservatives 2007-2008, lot number U2475KA, and on the day of vaccination, she complained of pain at the injection site. Two days later, the pain became severe. Corrective treatments consisted of MOTRIN. On 20 December 2007, the patient received a physician's evaluation and subsequent x-ray with negative results. According to the reporter, it was possible that the vaccine may have been administered too high in the shoulder area, possibly into the bursa. At the time of the report, the pain intensity was mild and the patient reported a shooting pain through the arm when the shoulder was adducted. The patient had a pre-existing allergies to penicillin, amoxicillin and CECLOR and had not been ill at the time of vaccination. Concurrent medications included "VITORIN". At the time of the report, the patient had not recovered from the event. Follow-up information was received 14 May 2008 from a health care professional. According to the reporter, the patient had no history of arm pain. The pain at the injection site began immediately after vaccination and was severe for two days (previously reported as "two days later, pain became severe"). The pain was located high on the patient's left arm just below the joint. An X-ray of the patient's left shoulder was performed with negative results; no bone or joint abnormalities and no soft tissue calcification were seen. The patient was evaluated by a specialist and diagnosed with Subacromial Bursitis and soft tissue inflammation secondary to FLUZONE. She had been evaluated by the specialist on 04 January 2008, 21 January 2008 and 18 February 2008 (evaluation results not reported). On 05 May 2008, the patient reported to their health care provider that their "arm is good now, sometimes hurts to life, still tender to touch". No further information was provided at the time of the report. Follow-up information received on 13 June 2008 from a physician. This reporter had no additional information to add to the case. No other relevant medical information was added to the case. Follow-up information was received from the original physician on 03 July 2008. The physician had only seen the patient once, and was not aware of her recovery status. Per the physician, "I believe vaccine was injected into subacromial area accidentally by student nurse. Not problem with vaccine- bad placement- too high on arm".
Age: 66.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: At sight of injection very swollen (app. 4"), very red, and painfull.  Lasted about 3 to 4 days.  No treatment except cold compresses for 10 minutes at least 4 times a day.
Age: 66.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: At sight of injection very swollen (app. 4"), very red, and painfull.  Lasted about 3 to 4 days.  No treatment except cold compresses for 10 minutes at least 4 times a day.
Age: 21.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Pruritus, Rash papular, Scar
Clinical narrative: Mid Sept 2008 rec'd smallpox vaccine, never scabbed but healed with large 2-in diam scar over the month and a half.  Early Dec with papular rash on arms, intense itchiness for 2 weeks.  Has had some soap changes and may be unrelated to vaccine.  Given antihistamine for itching.  No other symptoms
Age: 4.6
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Oedema peripheral
Clinical narrative: Swelling from elbow to shoulder x 2 days.
Age: 8.2
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram, Full blood count normal, Laboratory test normal
Clinical narrative: Generalized seizure/symptom 2 days post immunization with influenza vaccine.
Sex: U
Vaccine: PPV
Symptoms: Paralysis
Clinical narrative: Information has been received from a consumer concerning her friend who was vaccinated with a dose of PNEUMOVAX 23 (name and manufacturer unspecified) and had a severe reaction as well and was paralyzed for a week. No further information is provided. Upon internal review, paralysis was determined to be other important medical events. This is one of several reports from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Hypertension, No reaction on previous exposure to drug, Shock
Clinical narrative: Information has been received from a 72 year old female concerning herself who was vaccinated with PNEUMOVAX 23 (name and manufacturer unspecified) about a year ago and went into a shock. The caller had to go to the emergency room and her blood pressure was really high. The patient is 72 years old and stated she is not allergic to any medications. She gets a flu vaccine every year and has no reactions. Her blood pressure is still a little high. Upon internal review, shock was determined to be other important medical events. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac enzymes, Chest pain, Electrocardiogram, Influenza like illness, Pain
Clinical narrative: Initial report received from a health care professional on 03 December 2008. A 60-year-old male patient received a left deltoid injection of FLUZONE SV 2008-2009 (lot number U2764AA, route of administration not reported) on 20 November 2008. The patient started having flu-like symptoms of generalized achiness and congestion that evening (onset date of events was also reported as 21 November 2008). The patient then developed chest pain that worsened over the next two-to-three days, sending the patient to the emergency room for treatment. The patient was admitted to the hospital three days after receiving FLUZONE. Length of hospitalization was also reported as three days. The patient underwent an EKG, Stress Echo and lab work of cardiac enzymes and was diagnosed with pericarditis. Treatment during hospitalization was not reported. Patient outcome was reported to be unknown. Documents held by sender: None.
Age: 60.0
Sex: M
Vaccine: FLU3
Symptoms: Pericarditis, Respiratory tract congestion, Stress echocardiogram
Clinical narrative: Initial report received from a health care professional on 03 December 2008. A 60-year-old male patient received a left deltoid injection of FLUZONE SV 2008-2009 (lot number U2764AA, route of administration not reported) on 20 November 2008. The patient started having flu-like symptoms of generalized achiness and congestion that evening (onset date of events was also reported as 21 November 2008). The patient then developed chest pain that worsened over the next two-to-three days, sending the patient to the emergency room for treatment. The patient was admitted to the hospital three days after receiving FLUZONE. Length of hospitalization was also reported as three days. The patient underwent an EKG, Stress Echo and lab work of cardiac enzymes and was diagnosed with pericarditis. Treatment during hospitalization was not reported. Patient outcome was reported to be unknown. Documents held by sender: None.
Age: 39.0
Sex: F
Vaccine: HEP, TYP, HEP, TYP
Symptoms: Anti-SS-A antibody, Anti-SS-B antibody, Antibody test, Biopsy skin abnormal, C-reactive protein normal
Clinical narrative: Initial report received from a health care professional in on 01 December 2008. A female patient (age not reported) received a dose of TYPHIM VI (lot number route/site of administration not reported) a few months ago and continues to have a "divet" at the injection site which is painful when pressed. The event required a doctor visit. Patient outcome reported as unknown. The patient had a TYPHIM VI booster four years ago with no reaction. No further details were provided. Follow-up information received on 03 December 2008 from a physician. A copy of the doctor letter describing the event was provided. This 30-year-old female was in good health without chronic or recent acute illness prior to receipt of the TYPHIM VI booster which was received on 12 July 2008 intramuscularly in the left deltoid. The patient also received the same day an intramuscular right arm injection of ENGERIX-B (manufacturer GlaxoSmithKline, lot number AHBVB596AA). The patient recalled mild local site tenderness to the left deltoid injection site after vaccination, but denied any redness, swelling, erythema, distal paresthesia, or systemic symptoms. Approximately four weeks later (13 September 2008) she noted a painless "divot" at the injection site without inflammation. She believes the "divot" increased in size over the first month, but has since remained stable. The patient denied and trauma to the area before or after her vaccination on 12 July 2008. She denied muscle weakness, or paresthesia. There is no family or personal history of collagen vascular or rheumatoid disease, skin disease, atrophy, psoriasis, or Raynaud's syndrome. The patient received first TYPHIM VI in 2004 without difficulty. An ultrasound of the injection site on 22 September 2008 showed small ill-defined echogenic region in the subcutaneous fatty tissues in the area of symptomology. "Most likely diagnosis for this appearance would be an area of traumatic fat necrosis." Diagnostic studies also included laboratory work up on 24 September 2008 dsDNA, SSA, SSB, Scl-70; Jo-1; Ribo-P; Chromatin and Centromere antibodies; ESR, us-CRP; and complement studies that were all normal; A punch biopsy on 10 November 2008, "mild superficial perivascular dermatitis with mild sclerosis of dermis; Histologic features were non-diagnostic and my represent a normal variant, a mild sclerotic reaction to a vaccine, or subtle changes of early morphea. A comparison to surrounding adjacent normal appearing skin may help". If the condition worsens or persists, a repeat biopsy may aid in clarifying the diagnosis." The recovery status of the patient was not reported. Due to this new information, this case met seriousness criteria and was upgraded to serious. Documents held by sender: Doctor letter.
Age: 39.0
Sex: F
Vaccine: HEP, TYP, HEP, TYP
Symptoms: Double stranded DNA antibody, Injection site atrophy, Injection site dermatitis, Injection site induration, Injection site necrosis
Clinical narrative: Initial report received from a health care professional in on 01 December 2008. A female patient (age not reported) received a dose of TYPHIM VI (lot number route/site of administration not reported) a few months ago and continues to have a "divet" at the injection site which is painful when pressed. The event required a doctor visit. Patient outcome reported as unknown. The patient had a TYPHIM VI booster four years ago with no reaction. No further details were provided. Follow-up information received on 03 December 2008 from a physician. A copy of the doctor letter describing the event was provided. This 30-year-old female was in good health without chronic or recent acute illness prior to receipt of the TYPHIM VI booster which was received on 12 July 2008 intramuscularly in the left deltoid. The patient also received the same day an intramuscular right arm injection of ENGERIX-B (manufacturer GlaxoSmithKline, lot number AHBVB596AA). The patient recalled mild local site tenderness to the left deltoid injection site after vaccination, but denied any redness, swelling, erythema, distal paresthesia, or systemic symptoms. Approximately four weeks later (13 September 2008) she noted a painless "divot" at the injection site without inflammation. She believes the "divot" increased in size over the first month, but has since remained stable. The patient denied and trauma to the area before or after her vaccination on 12 July 2008. She denied muscle weakness, or paresthesia. There is no family or personal history of collagen vascular or rheumatoid disease, skin disease, atrophy, psoriasis, or Raynaud's syndrome. The patient received first TYPHIM VI in 2004 without difficulty. An ultrasound of the injection site on 22 September 2008 showed small ill-defined echogenic region in the subcutaneous fatty tissues in the area of symptomology. "Most likely diagnosis for this appearance would be an area of traumatic fat necrosis." Diagnostic studies also included laboratory work up on 24 September 2008 dsDNA, SSA, SSB, Scl-70; Jo-1; Ribo-P; Chromatin and Centromere antibodies; ESR, us-CRP; and complement studies that were all normal; A punch biopsy on 10 November 2008, "mild superficial perivascular dermatitis with mild sclerosis of dermis; Histologic features were non-diagnostic and my represent a normal variant, a mild sclerotic reaction to a vaccine, or subtle changes of early morphea. A comparison to surrounding adjacent normal appearing skin may help". If the condition worsens or persists, a repeat biopsy may aid in clarifying the diagnosis." The recovery status of the patient was not reported. Due to this new information, this case met seriousness criteria and was upgraded to serious. Documents held by sender: Doctor letter.
Age: 39.0
Sex: F
Vaccine: HEP, TYP, HEP, TYP
Symptoms: Injection site pain, Red blood cell sedimentation rate normal
Clinical narrative: Initial report received from a health care professional in on 01 December 2008. A female patient (age not reported) received a dose of TYPHIM VI (lot number route/site of administration not reported) a few months ago and continues to have a "divet" at the injection site which is painful when pressed. The event required a doctor visit. Patient outcome reported as unknown. The patient had a TYPHIM VI booster four years ago with no reaction. No further details were provided. Follow-up information received on 03 December 2008 from a physician. A copy of the doctor letter describing the event was provided. This 30-year-old female was in good health without chronic or recent acute illness prior to receipt of the TYPHIM VI booster which was received on 12 July 2008 intramuscularly in the left deltoid. The patient also received the same day an intramuscular right arm injection of ENGERIX-B (manufacturer GlaxoSmithKline, lot number AHBVB596AA). The patient recalled mild local site tenderness to the left deltoid injection site after vaccination, but denied any redness, swelling, erythema, distal paresthesia, or systemic symptoms. Approximately four weeks later (13 September 2008) she noted a painless "divot" at the injection site without inflammation. She believes the "divot" increased in size over the first month, but has since remained stable. The patient denied and trauma to the area before or after her vaccination on 12 July 2008. She denied muscle weakness, or paresthesia. There is no family or personal history of collagen vascular or rheumatoid disease, skin disease, atrophy, psoriasis, or Raynaud's syndrome. The patient received first TYPHIM VI in 2004 without difficulty. An ultrasound of the injection site on 22 September 2008 showed small ill-defined echogenic region in the subcutaneous fatty tissues in the area of symptomology. "Most likely diagnosis for this appearance would be an area of traumatic fat necrosis." Diagnostic studies also included laboratory work up on 24 September 2008 dsDNA, SSA, SSB, Scl-70; Jo-1; Ribo-P; Chromatin and Centromere antibodies; ESR, us-CRP; and complement studies that were all normal; A punch biopsy on 10 November 2008, "mild superficial perivascular dermatitis with mild sclerosis of dermis; Histologic features were non-diagnostic and my represent a normal variant, a mild sclerotic reaction to a vaccine, or subtle changes of early morphea. A comparison to surrounding adjacent normal appearing skin may help". If the condition worsens or persists, a repeat biopsy may aid in clarifying the diagnosis." The recovery status of the patient was not reported. Due to this new information, this case met seriousness criteria and was upgraded to serious. Documents held by sender: Doctor letter.
Age: 39.0
Sex: F
Vaccine: HEP, TYP, HEP, TYP
Symptoms: Tenderness
Clinical narrative: Initial report received from a health care professional in on 01 December 2008. A female patient (age not reported) received a dose of TYPHIM VI (lot number route/site of administration not reported) a few months ago and continues to have a "divet" at the injection site which is painful when pressed. The event required a doctor visit. Patient outcome reported as unknown. The patient had a TYPHIM VI booster four years ago with no reaction. No further details were provided. Follow-up information received on 03 December 2008 from a physician. A copy of the doctor letter describing the event was provided. This 30-year-old female was in good health without chronic or recent acute illness prior to receipt of the TYPHIM VI booster which was received on 12 July 2008 intramuscularly in the left deltoid. The patient also received the same day an intramuscular right arm injection of ENGERIX-B (manufacturer GlaxoSmithKline, lot number AHBVB596AA). The patient recalled mild local site tenderness to the left deltoid injection site after vaccination, but denied any redness, swelling, erythema, distal paresthesia, or systemic symptoms. Approximately four weeks later (13 September 2008) she noted a painless "divot" at the injection site without inflammation. She believes the "divot" increased in size over the first month, but has since remained stable. The patient denied and trauma to the area before or after her vaccination on 12 July 2008. She denied muscle weakness, or paresthesia. There is no family or personal history of collagen vascular or rheumatoid disease, skin disease, atrophy, psoriasis, or Raynaud's syndrome. The patient received first TYPHIM VI in 2004 without difficulty. An ultrasound of the injection site on 22 September 2008 showed small ill-defined echogenic region in the subcutaneous fatty tissues in the area of symptomology. "Most likely diagnosis for this appearance would be an area of traumatic fat necrosis." Diagnostic studies also included laboratory work up on 24 September 2008 dsDNA, SSA, SSB, Scl-70; Jo-1; Ribo-P; Chromatin and Centromere antibodies; ESR, us-CRP; and complement studies that were all normal; A punch biopsy on 10 November 2008, "mild superficial perivascular dermatitis with mild sclerosis of dermis; Histologic features were non-diagnostic and my represent a normal variant, a mild sclerotic reaction to a vaccine, or subtle changes of early morphea. A comparison to surrounding adjacent normal appearing skin may help". If the condition worsens or persists, a repeat biopsy may aid in clarifying the diagnosis." The recovery status of the patient was not reported. Due to this new information, this case met seriousness criteria and was upgraded to serious. Documents held by sender: Doctor letter.
Age: 17.0
Sex: M
Vaccine: DTAP
Symptoms: Heart disease congenital, Heart rate decreased, Laboratory test, Scan
Clinical narrative: Initial information was received 08 December 2008 from a consumer (patient's aunt). A 17 year old male patient with no medical conditions received an injection of "TDAP or DTaP" (manufacturer, lot number and date not reported). The patient went to the dentist two weeks after receiving the vaccine and was found to have a decreased heart rate of 29. The patient was hospitalized and awaiting pacemaker insertion. The patient had multiple tests and scans completed (specific tests and date of tests not reported). The patient was told by his pediatric cardiologist that his condition was congenital. The patient's recovery status was not reported. No further information was provided. List of Documents held by Sender: None.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, TYP
Symptoms: Erythema, Gait disturbance, Injection site reaction, Oedema, Pruritus
Clinical narrative: ON 12 DEC 08 PT RECEIVED KINRIX (GSK)& HEP A IN HER LT THIGH; ON 15 DEC 08 PT PRESENTED WITH LOCALIZED REACTION AT SITE OF ADMINISTRATION. PT HAD EDEMA & ERYTHEMA WITH DIAMETER OF 6.5 CM. PT C/O ITCHING, SORENESS & DIFFICULTY WALKING AFTER ADMINISTRATION OF KINRIX.  PT ALSO RECEIVED IPPD IN LT FOREARM AND TYPHOID IN RT THIGH.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, TYP
Symptoms: Tenderness
Clinical narrative: ON 12 DEC 08 PT RECEIVED KINRIX (GSK)& HEP A IN HER LT THIGH; ON 15 DEC 08 PT PRESENTED WITH LOCALIZED REACTION AT SITE OF ADMINISTRATION. PT HAD EDEMA & ERYTHEMA WITH DIAMETER OF 6.5 CM. PT C/O ITCHING, SORENESS & DIFFICULTY WALKING AFTER ADMINISTRATION OF KINRIX.  PT ALSO RECEIVED IPPD IN LT FOREARM AND TYPHOID IN RT THIGH.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given a dose of Rotavirus vaccine and she shouldn't have recieved it because she was over the age of 12 weeks and this was her first dose.  The patient had no signs or symptoms of an adverse event, but received a vaccine that they shouldn't have.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Chills, Conjunctivitis, Eye discharge, Malaise
Clinical narrative: Malaise, fever, chills followed by slow onset of asthma (with wheezes), photophobia, conjunctivitis (with thick yellow discharge).  treated with Albuterol inhaler & Advair (spaced 3 hours apart), 2 tabs of benadryl and another 2 puffs of albuterol before bed (12am).  Symptoms resolved completely by the 8am.  Considered visiting the emergency room, but symptoms improved by the evening.  I am a medical professional- if I wasn't I would have definitely gone to the ER.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia, Pyrexia, Wheezing
Clinical narrative: Malaise, fever, chills followed by slow onset of asthma (with wheezes), photophobia, conjunctivitis (with thick yellow discharge).  treated with Albuterol inhaler & Advair (spaced 3 hours apart), 2 tabs of benadryl and another 2 puffs of albuterol before bed (12am).  Symptoms resolved completely by the 8am.  Considered visiting the emergency room, but symptoms improved by the evening.  I am a medical professional- if I wasn't I would have definitely gone to the ER.
Age: 1.58
Sex: F
Vaccine: DTAP
Symptoms: Injection site induration, Irritability, Oedema peripheral, Restlessness
Clinical narrative: 24 hours after injection of Dtap (Daptacel) observed to  have swelling in L upper leg down to knee.  Hard Lump at site of injection.  Cranky and restless last night per mother
Age: 40.0
Sex: M
Vaccine: FLUN3, HEPAB
Symptoms: Incorrect route of drug administration
Clinical narrative: PATIENT GIVEN HEP A/B TWINRIX INTRANASAL VICE FLU-MIST. THERE WAS NO ADVERSE REACTION TO THE VACCINE. PATIENT FOLLOWED UP THE NEXT DAY WITHOUT ANY COMPLICATIONS.  STAFF MEMBER WAS TAKEN OFF GIVING IMMUNIZATIONS AND WILL BE ATTENDING THE NEXT CLASS FOR IMMUNIZATION ADMINISTRATION.
Sex: F
Vaccine: FLUX
Symptoms: Eye irritation, Intraocular pressure increased, Lacrimal disorder, Postnasal drip
Clinical narrative: Patient states after given intra nasal flu mist noted post nasal drip and eye irritation within 30 minutes after vaccine administered experienced occular pressure. Sent to the ER for med evaluation. Symptoms resolved.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Swelling L medial side with 4cm oval erythema patch, Neg warmth, neg puritis, neg discharge
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Pinpoint, red, flat lesions noted on face, neck,shoulder and chest.  Noted by parent soon after shots administered and she returned to office within 2 hours of shots where child seen by ARNP. No fever, not itchy, don't blanch, child appears to have no other changes. Advised monitoring, Ibuprofen, see MD if worsening of symptoms.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Blood alcohol increased, Blood glucose increased, Blood potassium decreased, Blood urea increased, Cough
Clinical narrative: Pt. received flu vaccination at 1600 hrs. on 12-15-08.  At 1900 hrs. pt called nurse to say she had been coughing and felt "like there was a lump in my throat", for the past 20 minutes.  Pt denied difficulty breathing. Nurse instructed her to take 2 benadryl tabs and have husband take her to ER stat.  Pt entered ER with coughing and wheezing and c/o sore throat. tachycardia @120. Tachypenia @ 24-28. Wheezes in all lung fields. Benadryl 50 mg IVP @2020 hrs. Lab tests done. Pt. had nebulizer treatment with little relief at 2000 hrs. Pt. discharged ambulatory at 2110. Medrol dose pack as directed. Push fluids.  Potassium 10mcg PO daily, Benadryl 50 mg every 4-6 hrs X 2 doses than as needed. Return if symptoms worsen. Follow-up in clinic in 1 week.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Haemoglobin increased, Oropharyngeal pain, Sensation of foreign body, Tachycardia, Tachypnoea
Clinical narrative: Pt. received flu vaccination at 1600 hrs. on 12-15-08.  At 1900 hrs. pt called nurse to say she had been coughing and felt "like there was a lump in my throat", for the past 20 minutes.  Pt denied difficulty breathing. Nurse instructed her to take 2 benadryl tabs and have husband take her to ER stat.  Pt entered ER with coughing and wheezing and c/o sore throat. tachycardia @120. Tachypenia @ 24-28. Wheezes in all lung fields. Benadryl 50 mg IVP @2020 hrs. Lab tests done. Pt. had nebulizer treatment with little relief at 2000 hrs. Pt. discharged ambulatory at 2110. Medrol dose pack as directed. Push fluids.  Potassium 10mcg PO daily, Benadryl 50 mg every 4-6 hrs X 2 doses than as needed. Return if symptoms worsen. Follow-up in clinic in 1 week.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Pt. received flu vaccination at 1600 hrs. on 12-15-08.  At 1900 hrs. pt called nurse to say she had been coughing and felt "like there was a lump in my throat", for the past 20 minutes.  Pt denied difficulty breathing. Nurse instructed her to take 2 benadryl tabs and have husband take her to ER stat.  Pt entered ER with coughing and wheezing and c/o sore throat. tachycardia @120. Tachypenia @ 24-28. Wheezes in all lung fields. Benadryl 50 mg IVP @2020 hrs. Lab tests done. Pt. had nebulizer treatment with little relief at 2000 hrs. Pt. discharged ambulatory at 2110. Medrol dose pack as directed. Push fluids.  Potassium 10mcg PO daily, Benadryl 50 mg every 4-6 hrs X 2 doses than as needed. Return if symptoms worsen. Follow-up in clinic in 1 week.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: After injection left upper arm hurt, became warm and swollen down to elbow by evening. Visit made to MD who prescribed Prednisone and Keflex.
Age: 80.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Dizziness, Pain, Pain in extremity, Pyrexia
Clinical narrative: 11-04-08 Legs aching then general aches, weak and dizzy.  Noon temp 105 degree F orally.  Called Dr. but unable to reach.  Called CCHD and told to use cool packs and Tylenol or ibuprofen and to go to the ER if doesn't keep temp down.  4 p.m. temp 102.4 F 2:30 p.m. Dr. called adn gave antibiotics.  11-3-08 PM able to eat.  11-6-08 still a bit dizzy and weak.  11-6-08 BP 144/69 P 88.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Culture, Culture positive, Injection site erythema, Injection site induration, Staphylococcal infection
Clinical narrative: Client's mother reported approximately 10 days after client received her immunizations that a hard, red lump appeared on client's left thigh. Client was afebrile and did not seemed bothered by the lump. Client's parents brought her into her pediatrician who had a culture completed. Culture showed staph per client's mother. Client received oral antibiotic treatment for 10 days as well as an antibiotic cream. Client has had no previous problems with any vaccinations. Received her 2nd flu 0.25 immunization on 12/12/08 and had no reaction per client's mom as of 12/16/08.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Nasopharyngitis, Upper respiratory tract congestion
Clinical narrative: Pt. had flu vaccine @ 4pm. Later in the evening felt she was coming down w/cold. c/o feeling short of breath and some congestion, but did not feel it warranted calling MD.  Took cold medicine and went to bed. Feeling fine today.
Age: 42.0
Sex: M
Vaccine: YF
Symptoms: C-reactive protein, Full blood count, Leukocytoclastic vasculitis, Pallor, Rash erythematous
Clinical narrative: Red rash developed on anterior chest area with blanching and refill with pressure. Doctor suspects allergic vasculitis but due to live vaccine prescribed antihistamine
Age: 42.0
Sex: M
Vaccine: YF
Symptoms: Red blood cell sedimentation rate, Urine analysis
Clinical narrative: Red rash developed on anterior chest area with blanching and refill with pressure. Doctor suspects allergic vasculitis but due to live vaccine prescribed antihistamine
Age: 54.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Hypoaesthesia oral, Immediate post-injection reaction, Swollen tongue
Clinical narrative: Within 5 minutes of administering immunizations pt. reports tongue feeling swelling and numbness, heaviness in chest
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Drug exposure during pregnancy
Clinical narrative: Client received vaccines on 12-1-08 and found out on 12-11-08 she is pregnant.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: Within 14 hours of receiving flu shot, pt awoke with severe red, swollen, itchy hives from head to toe.
Age: 74.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Biopsy skin abnormal, Pain, Rash, Rash vesicular
Clinical narrative: Pt received the shingles vaccine on 11/25/08 for a routine f/u visit.  On 12/10/08, pt called clinic reporting a painful rash to chest and back since 12/6/08.  During urgent visit appt, pt noted to have vesicular rash in T4 dermatome of L chest and back and biopsy taken which was positive (VZV detected).
Age: 5.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Cellulitis, Rash erythematous, Rash pruritic
Clinical narrative: MMR WAS GIVEN ON RIGHT GLUTEAL AREA IM (12/14/2008) AND TODAY(12/16/2008) CELLULITIS IS PRESENT 11CM X 9.5CM ON RIGHT BUTTOCK AND ERYTHEMITUS, RED, ITCHY RASH AROUND BOTH EYES ALSO PRESENT. PT WAS PLACED ON KEFLEX 250MG BID FOR 10 DAYS AND PRELONE 10CC BID FOR 7DAYS. PT TO RETURN TO CLINIC TOMORROW FOR RE-CHECK
Age: 48.0
Sex: F
Vaccine: MMR, PPV, TDAP
Symptoms: Chills, Discomfort, Induration, Injection site erythema, Injection site pain
Clinical narrative: Few hours after PPV23--small knot and discomfort.  18 hours after shot--2 cm redness on site with warmth to touch.  24 hours after shot--3 cm redness on site, warm to touch, tender; some wheezing.  ti hours after shot--fever, wheezing, body chills and 4 cm redness with tenderness at site, warm to touch.
Age: 48.0
Sex: F
Vaccine: MMR, PPV, TDAP
Symptoms: Injection site warmth, Pyrexia, Wheezing
Clinical narrative: Few hours after PPV23--small knot and discomfort.  18 hours after shot--2 cm redness on site with warmth to touch.  24 hours after shot--3 cm redness on site, warm to touch, tender; some wheezing.  ti hours after shot--fever, wheezing, body chills and 4 cm redness with tenderness at site, warm to touch.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: She reports she had right arm pain the day following the injection (the arm she received the injection. She reports progressive worsening pain. Unable to use arm with lifting and certain movements. First saw a physician on 12/15/08.
Sex: M
Vaccine: LYME
Symptoms: Chronic myeloid leukaemia
Clinical narrative: Chronic Myelogenous Leukemia.We do not have information on dates of the administration of Lymerix. My husband had 2 doses while he was employed. This would have been between the years 1985 and 1991.  12/30/2008 MR received from oncologist from 8/12/08 to 12/22/08 with DX:  Chronic Myelogenous Leukemia-chronic phase. Pt initially presented with 3 month hx of decreased exercise tolerance with SOB and dyspnea on exertion. Noted to have neutrophilia and thrombocytosis. DX with CML 2' to bone marrow bx results. Started on Gleevac. Continued to have fatigue with tx.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Chest X-ray abnormal, Computerised tomogram abnormal, Full blood count abnormal, Hodgkin's disease, Positron emission tomogram abnormal
Clinical narrative: Patient received last of 3 Gardasil vaccinations. Approximately 2 months later was diagnosed with Hodgkins Lymphoma.  Symptoms became evident just after the third vaccination. 3/9/09-records received-office visit 1/22/09-C/O tired SOB, Irregular menses which is secondary to chemo. Monitor labs if not better 3-6 mos.  4/29/09-records received-office visit 1/23/08 for C/O possible brachial cleft cyst or neck mass.  Past 2 weeks swelling in left axilla. Decreased energy and generalized pruritus.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan abnormal
Clinical narrative: Patient received last of 3 Gardasil vaccinations. Approximately 2 months later was diagnosed with Hodgkins Lymphoma.  Symptoms became evident just after the third vaccination. 3/9/09-records received-office visit 1/22/09-C/O tired SOB, Irregular menses which is secondary to chemo. Monitor labs if not better 3-6 mos.  4/29/09-records received-office visit 1/23/08 for C/O possible brachial cleft cyst or neck mass.  Past 2 weeks swelling in left axilla. Decreased energy and generalized pruritus.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apnoea, Convulsion, Crying, Irritability, Nervous system disorder
Clinical narrative: On December 2nd, my son received his 2 month vaccinations, he became EXTREMELY fussy.  He cried non-stop for almost 5 hours until I finally decided on giving him Tylenol.  I was against giving him any medicine.  He calmed down but then began fussing about an hour after and started having what I believe were seizures.  His face started to distort and freeze.  During these episodes, he stopped breathing, didn't respond, and they lasted 5-15 seconds.  After his hospitalization and monitoring, his nurses could not give me a diagnosis.  I am currently in the process of getting him evaluation for neurological problems and of course changing his PCP because the previous PCP didn't care about anything that happened to my son.  In fact, during his stay, we NEVER seen a doctor. 1/8/09-records received for DOS 12/2/08-presented to ED C/O shaking arm, fussy. Parent has not observed any abnormal movements of arms or legs, however observed fixed jaw and contraction of platysma muscle and staring episodes and did not respond to stimuli. Diagnoses: abnormal movement activity, possible aytpical seizures. possible adverse reaction to immunizations. Observed overnight.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: On December 2nd, my son received his 2 month vaccinations, he became EXTREMELY fussy.  He cried non-stop for almost 5 hours until I finally decided on giving him Tylenol.  I was against giving him any medicine.  He calmed down but then began fussing about an hour after and started having what I believe were seizures.  His face started to distort and freeze.  During these episodes, he stopped breathing, didn't respond, and they lasted 5-15 seconds.  After his hospitalization and monitoring, his nurses could not give me a diagnosis.  I am currently in the process of getting him evaluation for neurological problems and of course changing his PCP because the previous PCP didn't care about anything that happened to my son.  In fact, during his stay, we NEVER seen a doctor. 1/8/09-records received for DOS 12/2/08-presented to ED C/O shaking arm, fussy. Parent has not observed any abnormal movements of arms or legs, however observed fixed jaw and contraction of platysma muscle and staring episodes and did not respond to stimuli. Diagnoses: abnormal movement activity, possible aytpical seizures. possible adverse reaction to immunizations. Observed overnight.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Amnesia, Anger, Arthralgia, Autoimmune disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, flu-like symptoms, fatigue, headaches, short term memory loss, cognitive problems, back pain, neck pain, shoulder pain, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 10 December 2008 via an interview between the subject and attorney(s). The subject had a history of fatigue and depression. The subject was vaccinated with LYMERIX on 07 April 1999, 04 May 1999, and 02 June 1999. In the summer of 1999 the subject developed achy joints (upper back, shoulders, ankles, knees). In the winter of 2000 he developed depression and cognitive problems. Cognitive problems were described as "forgetfulness, brain fog, slow processing speed, memory problems, word searching, and disorganization". In 2000 or 2001 he experienced sleep disturbance and testing reportedly confirmed sleep apnea. In 2001 he developed fatigue and severe headaches. Diagnostic tests reportedly showed a "small aneurysm" in the brain, and the subject was advised that the aneurysm was "nothing to worry about". In 2002 he developed stomach problems which "caused weight gain, weight loss, and diarrhea". In 2004 he experienced temper/anger issues and noted that he had quit his previous three jobs after he "blew up at work". In November 2008 he developed hand pain (unable to grip or shake hands without pain). Treatment including a breathing machine, NEXIUM, ROCEPHIN (to treat Lyme disease), unspecified stimulants, and other unspecified medications. With the exception of stomach issues, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed by GSK to be medically significant.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Back pain, Cognitive disorder, Condition aggravated, Depression, Diarrhoea
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, flu-like symptoms, fatigue, headaches, short term memory loss, cognitive problems, back pain, neck pain, shoulder pain, decreased activities of daily life, rheumatologic, neurologic and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism, all reportedly caused by vaccination with LYMERIX. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 10 December 2008 via an interview between the subject and attorney(s). The subject had a history of fatigue and depression. The subject was vaccinated with LYMERIX on 07 April 1999, 04 May 1999, and 02 June 1999. In the summer of 1999 the subject developed achy joints (upper back, shoulders, ankles, knees). In the winter of 2000 he developed depression and cognitive problems. Cognitive problems were described as "forgetfulness, brain fog, slow processing speed, memory problems, word searching, and disorganization". In 2000 or 2001 he experienced sleep disturbance and testing reportedly confirmed sleep apnea. In 2001 he developed fatigue and severe headaches. Diagnostic tests reportedly showed a "small aneurysm" in the brain, and the subject was advised that the aneurysm was "nothing to worry about". In 2002 he developed stomach problems which "caused weight gain, weight loss, and diarrhea". In 2004 he experienced temper/anger issues and noted that he had quit his previous three jobs after he "blew up at work". In November 2008 he developed hand pain (unable to grip or shake hands without pain). Treatment including a breathing machine, NEXIUM, ROCEPHIN (to treat Lyme disease), unspecified stimulants, and other unspecified medications. With the exception of stomach issues, the events were unresolved at the time of this report. Based upon follow up information, this case was assessed by GSK to be medically significant.