chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Lymph node pain, Musculoskeletal stiffness, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Initial report received on 20 August 2007 from a consumer, who is the patient. A 49 year old female patient received ADACEL (lot # was unknown) into the left deltoid on 15 August 2007. The next day she developed left arm stiffness, stomach ache, and diarrhea. On 17 August 2007 she had fever of 99.3 (Fahrenheit), she was weak, tired and had headache. Her arm was red, sore and swollen. On 19 August 2007, the patient called a medical center that recommended heat to site and ZITHROMAX for cellulitis. The patient had not recovered. The patient had allergy to sulfa and amoxicillin. The patient's concomitant medications included FOSAMAX once a week. The patient was not ill at vaccination time and had no adverse reaction following prior vaccinations. Follow-up information received from a health care provider on 04 October 2007. The patient had received an intramuscular left deltoid injection of ADACEL as part of a routine medical examination. On 19 August 2007, the patient presented to the urgent care clinic complaining of flu like symptoms for several days, dizziness, tender axilla and occasional chills. Assessment notes indicate the patient had "left shoulder redness/swelling/tender injection site with tender left axilla/LN". The patient contacted the urgent care clinic on 20 August 2007 the following day and stated that her arm was still "swollen, warm to touch and stiff" and her symptoms of diarrhea and headache continued. The patient stated that her symptoms "aren't worse or better". The patient had not received any vaccinations during the four weeks prior to receipt of ADACEL. The patient's past medical history included hypertension NOS, mitral valve disorder, osteoporosis NEC, endometriosis NOS, anxiety state NOS, backache NOS, and irritable bowel syndrome. Concomitant medications on the day of vaccination included LIBRAX, Lotrisone, desonide, fluocinonide, tobramycin sulfate and FOSAMAX. No further information was provided and the patient had not recovered at the time of the report. Follow-up information was received from the health professional on 29 October 2007. The patient had not received any prior doses of ADACEL. It was unknown if or when the patient had received previous tetanus injections. Treatment for the event began on 19 August 2007, and in addition to ZITHROMAX included ibuprofen for body aches and pain, and heat to injection site. The patient was instructed to follow-up with the physician if symptoms worsened or did not improve; no further contact was noted. It was unknown when the symptoms resolved. No diagnostic tests were ordered.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Skin warm
Clinical narrative: Initial report received on 20 August 2007 from a consumer, who is the patient. A 49 year old female patient received ADACEL (lot # was unknown) into the left deltoid on 15 August 2007. The next day she developed left arm stiffness, stomach ache, and diarrhea. On 17 August 2007 she had fever of 99.3 (Fahrenheit), she was weak, tired and had headache. Her arm was red, sore and swollen. On 19 August 2007, the patient called a medical center that recommended heat to site and ZITHROMAX for cellulitis. The patient had not recovered. The patient had allergy to sulfa and amoxicillin. The patient's concomitant medications included FOSAMAX once a week. The patient was not ill at vaccination time and had no adverse reaction following prior vaccinations. Follow-up information received from a health care provider on 04 October 2007. The patient had received an intramuscular left deltoid injection of ADACEL as part of a routine medical examination. On 19 August 2007, the patient presented to the urgent care clinic complaining of flu like symptoms for several days, dizziness, tender axilla and occasional chills. Assessment notes indicate the patient had "left shoulder redness/swelling/tender injection site with tender left axilla/LN". The patient contacted the urgent care clinic on 20 August 2007 the following day and stated that her arm was still "swollen, warm to touch and stiff" and her symptoms of diarrhea and headache continued. The patient stated that her symptoms "aren't worse or better". The patient had not received any vaccinations during the four weeks prior to receipt of ADACEL. The patient's past medical history included hypertension NOS, mitral valve disorder, osteoporosis NEC, endometriosis NOS, anxiety state NOS, backache NOS, and irritable bowel syndrome. Concomitant medications on the day of vaccination included LIBRAX, Lotrisone, desonide, fluocinonide, tobramycin sulfate and FOSAMAX. No further information was provided and the patient had not recovered at the time of the report. Follow-up information was received from the health professional on 29 October 2007. The patient had not received any prior doses of ADACEL. It was unknown if or when the patient had received previous tetanus injections. Treatment for the event began on 19 August 2007, and in addition to ZITHROMAX included ibuprofen for body aches and pain, and heat to injection site. The patient was instructed to follow-up with the physician if symptoms worsened or did not improve; no further contact was noted. It was unknown when the symptoms resolved. No diagnostic tests were ordered.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Initial report received from a health care provider on 03 October 2007.  A 27-year-old female patient had received a right deltoid intramuscular injection of Adacel, lot number C2825AA on 18 September 2007 and two days later, she developed redness, pain, warmth and hardness 6 cm x 7 cm around the injection site.  On 23 September 2007, the skin at the affected area peeled like a sunburn.  Corrective treatment included Tylenol, ice packs and a topical steroid.  The symptoms subsided however the reporter stated that "a 1 cm and a 2 cm knot" were present under the skin at the affected area.  The patient had not received any other vaccines during the four weeks prior to the receipt of Adacel.  The patient had not experienced any adverse reaction after receipt of a tetanus and diphtheria booster dose in 1998.  The patient had not recovered from the event and no further information was provided.  Follow-up information received on 15 November 2007 from a health care professional.  The redness, warmth, and pain resolved on 03 October 2007.  One of the knots had resolved, and one knot of approximately five mm in size remained.  Treatment included ice packs and topical Desonate.  At the time of this report, all events had resolved except for one small knot at the injection area.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, No reaction on previous exposure to drug, Skin exfoliation
Clinical narrative: Initial report received from a health care provider on 03 October 2007.  A 27-year-old female patient had received a right deltoid intramuscular injection of Adacel, lot number C2825AA on 18 September 2007 and two days later, she developed redness, pain, warmth and hardness 6 cm x 7 cm around the injection site.  On 23 September 2007, the skin at the affected area peeled like a sunburn.  Corrective treatment included Tylenol, ice packs and a topical steroid.  The symptoms subsided however the reporter stated that "a 1 cm and a 2 cm knot" were present under the skin at the affected area.  The patient had not received any other vaccines during the four weeks prior to the receipt of Adacel.  The patient had not experienced any adverse reaction after receipt of a tetanus and diphtheria booster dose in 1998.  The patient had not recovered from the event and no further information was provided.  Follow-up information received on 15 November 2007 from a health care professional.  The redness, warmth, and pain resolved on 03 October 2007.  One of the knots had resolved, and one knot of approximately five mm in size remained.  Treatment included ice packs and topical Desonate.  At the time of this report, all events had resolved except for one small knot at the injection area.
Sex: U
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Nodule
Clinical narrative: This case was received from a health professional on 03 October 2007.  A patient (gender not reported) received an injection of Adacel (lot number not reported) and subsequently experienced "nodules and a rheumatological type reaction".  No further information was available.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Musculoskeletal pain, X-ray normal
Clinical narrative: A 39 year old female patient received on 04 October 2007 a dose of Adacel (Lot #C2770AA) intramuscular into the left arm.  The next day, on 05 October 2007, she experienced injection site pain and pain in the entire left shoulder.  The patient had full range of motion.  X-ray of left shoulder was normal.  Anti-inflammatory medication was prescribed.  The patient's medical history included hypothyroidism and the patient's concomitant medications included Synthroid.  The patient's outcome was not reported.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Muscle spasms
Clinical narrative: This report was received from a health professional on 10 October 2007.  A 43-year-old female patient, with an allergy to Levaquin, received a left deltoid intramuscular injection of Adacel (lot number reported as C2827AA) on 05 September 2007.  On 06 September 2007, she complained of muscle spasms, and soreness and tenderness at the injection site.  Per the reporter, the events had been ongoing for approximately one and one-half weeks, and the patient had required a doctor visit.  Other medications were "unknown"; the reporter was unsure if the patient had been ill at the time of vaccination.  At the time of the report, the events had not resolved.  Follow-up information received on 29 October 2007 from a health care professional.  Adacel lot number was corrected to C2824AA.  The case was reviewed, and there was no additional information at this time.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Initial report received on 12 October 2007 from a health care professional.  A 25-year-old female patient had received a first dose, left deltoid, intramuscular injection of Adacel, lot number C2844AA, on 05 October 2007.  Two days later, the patient developed cellulitis at the site of the vaccination.  She was treated with Keflex.  At the time of this report, the patient had recovered.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Injection site mass, Injection site pain, Malaise
Clinical narrative: Initial report received on 16 October 2007 from a nurse practitioner. A 20-year-old female patient, with no concurrent illnesses, a past medical history of seasonal allergies, and who takes Yasmin, had received an intramuscular dose of Adacel (lot number A2731AA) in the left deltoid the morning of 11 October 2007. That evening, the patient felt dizzy, nauseated, and had pain in the left deltoid at the injection site. It was not reported whether the patient sought medical treatment at that time. The patient continued to feel "worse" and approximately five days later, around 16 October 2007, the patient was seen in a college health clinic for evaluation. The patient complained that she had developed additional symptoms of headache, stiff neck, left arm soreness, and a "knot" at the injection site. The patient denied experiencing any fever or vomiting and was sent to the emergency room for evaluation. At the time of this report, the patient had not recovered. A corrective version was created on 23 October 2007 with the same latest received date as the previous version of 16 Oct 2007 for the sole purpose of entering the indication for the Adacel vaccine as prophylactic vaccinations, and to enter the country obtained, and to enter "A" in the A/C field on the product screen under the second therapy tab. No other relevant medically significant information was added to the case.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Initial report received on 16 October 2007 from a nurse practitioner. A 20-year-old female patient, with no concurrent illnesses, a past medical history of seasonal allergies, and who takes Yasmin, had received an intramuscular dose of Adacel (lot number A2731AA) in the left deltoid the morning of 11 October 2007. That evening, the patient felt dizzy, nauseated, and had pain in the left deltoid at the injection site. It was not reported whether the patient sought medical treatment at that time. The patient continued to feel "worse" and approximately five days later, around 16 October 2007, the patient was seen in a college health clinic for evaluation. The patient complained that she had developed additional symptoms of headache, stiff neck, left arm soreness, and a "knot" at the injection site. The patient denied experiencing any fever or vomiting and was sent to the emergency room for evaluation. At the time of this report, the patient had not recovered. A corrective version was created on 23 October 2007 with the same latest received date as the previous version of 16 Oct 2007 for the sole purpose of entering the indication for the Adacel vaccine as prophylactic vaccinations, and to enter the country obtained, and to enter "A" in the A/C field on the product screen under the second therapy tab. No other relevant medically significant information was added to the case.
Age: 33.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Full blood count, Injection site erythema, Metabolic function test, Red blood cell sedimentation rate
Clinical narrative: A 34 year old female patient received on 22 October 2007 a dose of Adacel (lot #C2824AA), intramuscular into the left deltoid.  She also received concomitantly Hep B vaccine (lot #AHBVB431BA), intramuscular into the right deltoid.  One day post vaccination, on 23 October 2007, the patient experienced erythema at the injection site, left deltoid and arthralgia of the left elbow.  She was seen in the office 2 days post vaccination.  Non steroidal inflammatory was prescribed.  Symptoms had eased and she had only small indurated area at the injection site of the left deltoid and joint pain in the left elbow.  Relevant diagnostic tests/laboratory data included: CBC, metabolic panel and Sedimenation rate (sed rate).  Results were not reported.  The patient medical history included allergy to sulfa.  The patient was not taking concomitant medications and had no illness at vaccination time.  No other vaccines given at the same time.  The patient did not have, per reporter, adverse event following prior vaccination.  The patient had not recovered.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site vesicles, Pain
Clinical narrative: This case was reported by a health professional on 17 September 2007.  A 24-year-old male patient received an intramuscular left deltoid injection of Adacel (lot number C2769AA) on 14 September 2007.  The following day, he developed a blister at the injection site, in addition to a "dull pain" and numbness.  He presented to the emergency room on 17 September 2007; treatment was not provided.  At the time of the report, the patient had not yet recovered.  Additionally, the patient had also received an injection of Tubersol intradermally in the right forearm on 08 August 2007.  Follow-up information received on 24 October 2007 from a health care professional.  The patient received no treatment.  In response to a query asking when the events resolved, the reporter responded "unknown".
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site pain, Injection site swelling, Pain
Clinical narrative: Chills, achy, swollen arm where injection was put. Arm sore for about a week.
Age: 38.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Rash erythematous, Rash maculo-papular, Rash pruritic, Rash vesicular, Scab
Clinical narrative: Pt vaccinated as per standard of care. Pt to travel confirmed via serology pt never had chicken pox. Pt given Varivax 0.5cc 1/9/07. Pt reported (11/26/07) noted skin - maculopapules and extreme pruritus.
Age: 38.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Skin lesion
Clinical narrative: Pt vaccinated as per standard of care. Pt to travel confirmed via serology pt never had chicken pox. Pt given Varivax 0.5cc 1/9/07. Pt reported (11/26/07) noted skin - maculopapules and extreme pruritus.
Age: 38.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Pruritus, Rash maculo-papular
Clinical narrative: Pt vaccinated as per standard of care. Pt to travel confirmed via serology pt never had chicken pox. Pt given Varivax 0.5cc 1/9/07. Pt reported (11/26/07) noted skin - maculopapules and extreme pruritus.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site rash, Rash generalised, Swelling
Clinical narrative: Information has been received from a licensed practical nurse (LPN), concerning a 21 week old male patient with no pertinent history, who on 05-DEC-2007 was vaccinated IM with a dose, 0.5 ml, of PedvaxHIB (lot #657385/0677U). Concomitant vaccine therapy included a dose of Prevnar and a dose of Pediarix. On 06-DEC-2007 the infant developed a rash and significant swelling all over his body. He was taken to an emergency room. Treatment included Prednisone, and the infant was then released. At the time of this report, the child had recovered from the events (duration not specified). The LPN considered the events to be serious as disabling/incapacitating (noting the "significant swelling all over his body"), and as an other important medical event. Additional information has been requested.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from a licensed practical nurse (LPN), concerning a 21 week old male patient with no pertinent history, who on 05-DEC-2007 was vaccinated IM with a dose, 0.5 ml, of PedvaxHIB (lot #657385/0677U). Concomitant vaccine therapy included a dose of Prevnar and a dose of Pediarix. On 06-DEC-2007 the infant developed a rash and significant swelling all over his body. He was taken to an emergency room. Treatment included Prednisone, and the infant was then released. At the time of this report, the child had recovered from the events (duration not specified). The LPN considered the events to be serious as disabling/incapacitating (noting the "significant swelling all over his body"), and as an other important medical event. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: ANTH
Symptoms: Chest discomfort, Dyspnoea, Pruritus generalised
Clinical narrative: Pt. received two doses of Anthrax vaccine.  First dose given 3 November 2007 without reaction.  The second dose given 8 December 2007.  Pt reported C/O SOB, chest tightness, and generalized itchiness.  SX began aprox. 6 Hrs after immunization.  Pt stated she took Benadryl for SX with relief of SX.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Joint stiffness, Pain in extremity
Clinical narrative: 3 cm erythematous raised area over vaccination site. Has soreness and stiffness to arm and shoulder joint. No meds
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Received Pneumovax on 11/6/07. That evening her arm was red, swollen and sore. Wednesday(11/7/07) the swelling was above and below her elbow. Sh was using cold compresses and Ibuprofen after seeing her MD. On 11/8/07 the arm was not as red or swollen. On 11/9/07 arm was back to normal.
Age: 46.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Muscle atrophy
Clinical narrative: Nickle size muscle wasting left lower deltoid. Patient noticed 11/13/07. No pain or weakness. Treatment - Physical Therapy. 10/23/07 TDap and 11/6/07 Flu vaccine (Both left deltoid)
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination complication
Clinical narrative: We received on 13 DEC 2007 the following information from a health care professional: A 23-year-old male patient, born on 29 AUG 1984, was vaccinated i.m. with Fluvirin 2006/2007 (expired on 30 JUN 2006), batch no. 69690, on 10 DEC 2007.  On 12 DEC 2007 the patient developed an adverse vaccination reaction (not further specified) and was hospitalized.  The patient was still hospitalized at time of reporting.  Further information was requested.  Company assessment: seriousness criterion: hospitalization.  Causality: insufficient data.  The amount of data is insufficient to assess causality of this case.  Expectedness assessment: Administration of expired vaccine is not expected.  No change in benefit-risk-ratio.  No measures necessary.  Ref no.: NA07-007052.
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site erythema, Injection site warmth, Vision blurred, Vomiting
Clinical narrative: Larette Fitts came into immunization mobile "CareVan" van to receive Hep A/B (Twinrix®) vaccine.  ½ hour after being immunized patient c/o redness, heat at site, vomiting, and blurred vision.  Nurse at facility where patient is housed (Caritas Intake, 140 N. Ashland Avenue, Chicago)  stated she administered 50mg benadryl to patient. Twenty minutes after patient received benadryl patient stated that she felt much better.
Age: 0.5
Sex: M
Vaccine: DTAP, FLUX, HIBV, PNC
Symptoms: Cough, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 7 month old son with a history of jaundice at birth and no known drug reactions/allergies who in November 2007 (exact date not reported), was vaccinated (route and site not reported) with a PedvaxHIB (manufacturer unknown). Mother thought the vaccine her son received was recalled but was unsure if he received PedvaxHIB (lot# not reported). The mother could not specify which vaccine her son had received. Concomitant therapy included acetaminophen (TYLENOL). In November 2007 (exact date not reported), post vaccination, the patient developed a fever, vomiting and cough. The patient was admitted into the hospital 3 days after. It was concluded that the patient had bronchitis. The mother reported that the patient was still vomiting but thought it might be from teething and that he still had a cough. The mother also reported that the patient had loose stool. The patient did receive unspecified medical attention. No diagnostic labs tests were performed. Additional information has been requested. 6/2/08-records received for DOS 11/19-11/20/07-DC DX: bronchiolitis. Presented to ED with C/O cough and cough times 2 days, trouble breathing since yesterday worse today. Poor feeding all day. Lungs diminished breath sounds, wheezes upon inspiration upon expiration. Respirations rapid labored intercostal retractions accessory muscle use. Body temperature increased.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Chest discomfort, Dyspnoea, Immediate post-injection reaction, Injection site erythema, Intercostal retraction
Clinical narrative: Information has been received from a consumer concerning her 19 week old son with a history of pneumonia (approximately October 2007) who on 16-NOV-2007 was vaccinated with a dose of Hib conj vaccine (OMPC).  Concomitant therapy included lansoprazole (PREVACID).  On 16-NOV-2007, as soon as he received the shot, his face started turning blotchy and the injection site was really red as well.  He stayed at the physician's office for a little longer that day.  On 22-NOV-2007, six days later he was having difficulty breathing, chest problems and retractions.  He was admitted to the hospital and stayed there for 5 days.  His white blood cell count was up, but he did not have pneumonia.  At the time of the report the patient was recovering.  Additional information has been requested. 1/2/08-records received for DOS 11/6-11/10/07-DC DX: Bronchiolitis, resolving. GERD, Presented with 1 week of congestion and cough. New wheezing and new fever 101. Increased spit up over last 48 hours. Stools loose. Records received for DOS 12/7-12/11/07-DX Bronchiolitis. Seen in clinic oxygen saturation 98%, mild respiratory distress noted by subcostal and suprasternal retractions. Nasal congestions, afebrile.
Age: 0.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Laboratory test, Rash macular, White blood cell count increased
Clinical narrative: Information has been received from a consumer concerning her 19 week old son with a history of pneumonia (approximately October 2007) who on 16-NOV-2007 was vaccinated with a dose of Hib conj vaccine (OMPC).  Concomitant therapy included lansoprazole (PREVACID).  On 16-NOV-2007, as soon as he received the shot, his face started turning blotchy and the injection site was really red as well.  He stayed at the physician's office for a little longer that day.  On 22-NOV-2007, six days later he was having difficulty breathing, chest problems and retractions.  He was admitted to the hospital and stayed there for 5 days.  His white blood cell count was up, but he did not have pneumonia.  At the time of the report the patient was recovering.  Additional information has been requested. 1/2/08-records received for DOS 11/6-11/10/07-DC DX: Bronchiolitis, resolving. GERD, Presented with 1 week of congestion and cough. New wheezing and new fever 101. Increased spit up over last 48 hours. Stools loose. Records received for DOS 12/7-12/11/07-DX Bronchiolitis. Seen in clinic oxygen saturation 98%, mild respiratory distress noted by subcostal and suprasternal retractions. Nasal congestions, afebrile.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Computerised tomogram normal, Headache
Clinical narrative: Information has been received from a healthcare worker concerning a 75-year-old female with a history of "treatment back pain stenosis", an allergy to CARDIZEM and LOPRESSOR who on 29-NOV-2007 was vaccinated subcutaneous in the left arm with a 0.5 ml dose of Zostavax (lot # 658395/0966U). Concomitant therapy included hydrochlorothiazide (manufacturer unspecified), MONOPRIL, aspirin, VICODIN, ULTRACET, multi-vitamins (unspecified) and calcium (unspecified). On 11-DEC-2007 the patient called the "office" and reported that she had a headache since 09-DEC-2007. The headache was described as a 9 out of 10 and intolerable. The patient also reported that her blood pressure was elevated. The patient went to the emergency room and was released with a negative CAT scan on 11-DEC-2007. As of 17-DEC-2007 the patient still had a headache which has lessened but is still intolerable. At the time of the report the patient's status was recovering. A product quality complaint was not involved. The adverse events reported were considered to be disabling by the reporter. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal neuralgia
Clinical narrative: Information has been received from a retired physician concerning his 73 year old wife with a codeine allergy and no other pertinent medical history who on approximately 23-OCT-2007 "6-8 weeks ago," was vaccinated with one dose of Zostavax (Oka/Merck). On approximately 27-NOV-2007 "3 weeks ago," the patient experienced trigeminal neuralgia. The trigeminal neuralgia was misdiagnosed as a dental problem. Medical attention was sought by contacting her primary care physician. No labs or diagnostic studies were performed. The patient's trigeminal neuralgia persisted. There was no product quality complaint. Trigeminal neuralgia was considered to be disabling by the physician. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Brain damage, Laboratory test, Nervous system disorder, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history who in December 2007, was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  Possible concomitant therapy included hormonal contraceptives (unspecified).  In December 2007, one day after vaccination, the patient experienced tingling and paralysis in both of her feet.  She was taken to the emergency department of a hospital and they did many different tests.  A magnetic resonance imaging (MRI), spinal cord tests and many other tests were performed, (results not reported).  The physicians reported that she had an auto-immune response of her brain and spinal cord which had created lesions and had damaged her brain and spinal cord.  The mother did not believe that her daughter had to stay overnight in the hospital.  The patient was receiving care at home.  The mother did not know if her daughter had any reaction following the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  At the time of the report the patient had not recovered.  Upon internal review paralysis in both feet was considered to be an other important medical event.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Paralysis, Spinal cord disorder
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with no pertinent medical history who in December 2007, was vaccinated with a second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  Possible concomitant therapy included hormonal contraceptives (unspecified).  In December 2007, one day after vaccination, the patient experienced tingling and paralysis in both of her feet.  She was taken to the emergency department of a hospital and they did many different tests.  A magnetic resonance imaging (MRI), spinal cord tests and many other tests were performed, (results not reported).  The physicians reported that she had an auto-immune response of her brain and spinal cord which had created lesions and had damaged her brain and spinal cord.  The mother did not believe that her daughter had to stay overnight in the hospital.  The patient was receiving care at home.  The mother did not know if her daughter had any reaction following the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  At the time of the report the patient had not recovered.  Upon internal review paralysis in both feet was considered to be an other important medical event.  Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a person working in a physician's office concerning two patients who were vaccinated with a dose rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot #657665/1460U).  In December 2007, "in the last two weeks", the two patients experienced bloody stools.  The patients recovered with no hospital visit or hospitalization required.  Upon internal review, the patients' bloody stools were considered to be other important medical events.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Age: 16.0
Sex: M
Vaccine: TDAP
Symptoms: Expired drug administered
Clinical narrative: None-CDC stated that Tdap should be given right away to assure he is covered. Client was given Tdap that had expired 10-19-07.
Age: 1.0
Sex: M
Vaccine: HBHEPB, HEPA, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site turned red and hot, and swelled to size of half a golfball. Gradually went down over a course of 4 months.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Optic neuritis, Visual acuity reduced
Clinical narrative: Flu shot given on 11/8/07. Patient reports 1)onset of bilateral eye discomfort on 11/17/07, 2) decreased bilateral eyesight starting 11/17/07 and sight very reduced by 12/4/07 ("I could only see shapes"). Patient reports that he was seen by othalmologist who informed him that he has optic neuropathy that was triggered by the flu shot. Patient reports that Dr. has predicted a full recovery with an estimated time of midFebruary 2008. No medications given 1/2/08-records received for DOS 12/5/07-DX: bilateral disc edema. 12/19/07-gradually improving. Tenderness resolved.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Child seen in clinic on 12/12 for large area of redness and swelling, hot to touch and painful. treated with antibiotics.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity, Rash
Clinical narrative: Rash on Left arm 24 hours after injection, Left arm pain with pain radiating to joints throughout body approximately 72 hours after injection.  Continues with Left arm pain
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Chills, Headache, Malaise, Pyrexia
Clinical narrative: Global headache, malaise at 7PM                  Fever to 102F orally with chills, backache, bilateral hip pain at 11PM                       All resolved with ibuprofen, acetaminophen at home. Fever recurred at 5AM, resolved with ibuprofen. No fever on presentation.
Age: 22.0
Sex: M
Vaccine: FLUN3
Symptoms: Oedema mouth, Sneezing
Clinical narrative: PT HAD NO PREVIOUS HISTORY OF INFLUENZA VACCINE. HE STATED THE HE "NEVER RECEIVED FLU SHOT BEFORE, EVER". IMMEDIATE ORAL SWELLING, SNEEZING, UNLABORED RESPIRATION, ALERT AND ORIENTED X 3. SEEN IN ER AND WAS DISCHARGED WITH PREDNISONE, CLARITIN AND BENADRYL.
Age: 43.0
Sex: F
Vaccine: HEPAB
Symptoms: Hypoaesthesia facial, Lymphadenopathy, Oedema mouth, Pharyngolaryngeal pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swollen gland in a 43-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis.  Previous and/or concurrent vaccination included hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix); GlaxoSmithKline; unknown; unknown given on an unspecified date.  On 14 December 2007, the subject received 2nd dose of Twinrix (.5 ml, unknown, left arm).  On 15 December 2007, 1 day after vaccination with Twinrix, the subject experienced left swollen glands, swelling under tongue on left side, sore throat and left side of face numb.  The healthcare professional considered the events were disabling.  The subject was treated with diphenhydramine hydrochloride (Benadryl) after contacting the health department.  At the time of reporting the events were unresolved.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B core antigen positive, Jaundice
Clinical narrative: This case was reported by a physician and described the occurrence of hepatitis B core antibody positive in a female subject of unspecified age who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified) for prophylaxis.  The subject's medical history included steroid injection treatment.  In 1991, the subject received unspecified dose of Hepatitis B vaccine (unknown).  At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced jaundice.  The subject had laboratory test performed which showed positive for hepatitis B core antibody.  The subject was previously treated by a physician who gave her steroid injections and used a contaminated needle.  This case was assessed as medically serious by GSK.  Relevant test results included hepatitis B core antibody positive.  At the time of reporting the outcome of the events were unspecified.  The physician considered the events were probably related to vaccination with Hepatitis B vaccine.
Age: 35.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Oedema peripheral, Surgery
Clinical narrative: Swollen left arm with marked edema and requirement of opening arm surgically. 1/10/08-ER records received for DOS 11/17/07-DX: left arm cellulitis. Started with fever night before, arm at injection site painful and difficult to move. Blood culture no growth. 3/17/08-records received for DOS 11/17-11/23/07-DC DX: Cellulitis of upper arm and forearm. Upper extremity infection following vaccination as an outpatient. Onychomycosis of nail and foot. Presented to ED with swelling and pain of arm. Swelling continued to increase area dusky in color. Rash medial to injection site. Exploratory surgery of the site, incision and drainage.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Headache, Nausea, Scan brain, Syncope
Clinical narrative: HPV 0.5 ml IM R Deltoid, Pt with syncopal episode once head trauma. MD eval to pt. Tylenol given for HA. Pt with nausea/vomiting-CT ordered
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: HPV 0.5 ml IM R Deltoid, Pt with syncopal episode once head trauma. MD eval to pt. Tylenol given for HA. Pt with nausea/vomiting-CT ordered
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Head injury, Syncope
Clinical narrative: HPV 0.5 ml IM R Deltoid.  Patient with syncopal episode and head trauma.  Patient in trendelenberg position.  Water given, vital signs monitored and patient discharged stable.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Seen in clinic on 12/17/07 for complaint of "swollen left arm" at site where received Gardasil vaccine with initial sore redness swell after vaccination after 8 hours, but pain continues with limited range of motion.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Abdominal X-ray, Catheter placement, Screaming
Clinical narrative: Within 1-2 hrs of administration-Baby started screaming-afebrile went to ER for evaluation after 6 hours of screaming, cried all night and next day. Seen in office next AM. Flat plate of ABD (-)/ urine cath sent and lab
Age: 1.3
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Spiked high fever, and had febrile seizure the night of the day the vaccines were administered.  Fever resolved by the next day.
Age: 1.1
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A circular erythamatous, swollen area about 1 inch x 1 inch in size on left lateral thigh.
Age: 1.0
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: erythematous plague on (L) upper thigh at vaccine site 1.2 x 1.2 cm noted 1-2 days after shot and still persists 2 wks after shot-seems less thickened now
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Heart rate increased, Oxygen saturation decreased, Pruritus, Urticaria, Vomiting
Clinical narrative: Pt had sudden onset of hives with pruritus and vomiting with increased HR and decreased O2 sats. Max HR 188, lowest Sats 93% RA.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Bronchospasm, Injection site pruritus, Pharyngeal oedema, Pruritus generalised
Clinical narrative: Itching at site, generalized itchy, swelling in throat, bronchospasm.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity, Rash macular
Clinical narrative: first dose given 11/6/07, 11/7/07 Rash on back Dx Allergic vs viral, Sent home from school. 11/29/07 Sent home from school Macules on back off and on. 12/7/07 Pt came for 2nd flu-Nurse noted rash-had provider see pt gave ok for #4. 12/19/07 Rash resolving-Paraflu vaccine
Age: 16.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: 20 cm erythema, tenderness and warmth
Age: 12.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Dysphonia, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 100 deg F Feever, Vomiting, Headache, Tiredness, Hoarseness, Heavy Congestion, Body Aches. 12-07-07 had a yearly physical also T-dao shot and Meningococcal Vaccine at 4:30 by 8:00 Symptoms started to occur seen by doctor Sunday. Also called Doctor Saturday. Somewhat Still Congested
Age: 12.0
Sex: F
Vaccine: MEN, TDAP
Symptoms: Respiratory tract congestion, Vomiting
Clinical narrative: 100 deg F Feever, Vomiting, Headache, Tiredness, Hoarseness, Heavy Congestion, Body Aches. 12-07-07 had a yearly physical also T-dao shot and Meningococcal Vaccine at 4:30 by 8:00 Symptoms started to occur seen by doctor Sunday. Also called Doctor Saturday. Somewhat Still Congested
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure normal, Cold sweat, Syncope
Clinical narrative: Clammy skin, fainting spells lasting 10 to 20 seconds.  Had patient to smell ammonium salts.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Skin warm
Clinical narrative: worsening redness, increased warmth, fever increased on the next day
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm hot swollen, red area size of 2 dollar bills. 2 hrs after rec. vac. painful. Dr Rx Benadryl (OTC) 2 tablets PO. Now, 2 tabs 6 hrs later, Keflex 500mg QID x 7 D. #2B, no RF. Appt with doctor on 12-20-07. Doctor continue Benadryl x 2 days if not better 12-21-07. Rx Cipro 250mg BID x 7 d.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, redness, sore (leg) Tylenol given at 8:00 am
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: onset this am small localized red area over injection site
Age: 1.2
Sex: M
Vaccine: DTAP, HEPA, IPV, VARCEL
Symptoms: Erythema induratum
Clinical narrative: Qd post varicella vaccine developed right 1cm erythematic/indurated/at thigh - anterior afebrile.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Herpes zoster, Rash, Rash macular, Rash vesicular
Clinical narrative: Information has been received concerning a 69 year old male who on 07-MAR-2007 at 9:30 AM was vaccinated intramuscularly with a dose of Zostavax (Oka/Merck) (lot #565606/0033U). On 01-JUL-2007 the patient experienced pain in the right facial area around and behind the ears and suddenly developed a macular vesicular rash in cervical C2 distribution, compatible with shingles. The patient was given famiciclovir (FAMVIR) and pregabalin (LYRICA). Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received concerning a 69 year old male who on 07-MAR-2007 at 9:30 AM was vaccinated intramuscularly with a dose of Zostavax (Oka/Merck) (lot #565606/0033U). On 01-JUL-2007 the patient experienced pain in the right facial area around and behind the ears and suddenly developed a macular vesicular rash in cervical C2 distribution, compatible with shingles. The patient was given famiciclovir (FAMVIR) and pregabalin (LYRICA). Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an "over 60 year old" female pharmacist with a history of chickenpox who "recently" administered Zostavax (Oka/Merck) to an unspecified number of patients. Concomitant therapy included famciclovir (FAMVIR) and lysine. On 22-AUG-2007 the patient developed a rash on her head that was about 6 inches and painful when touched. The patient did not receive the vaccine, she just administered it. Unspecified medical attention was sought. At the time of this report the patient was recovering and the rash seemed to be drying up. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Accidental exposure, Pain, Rash
Clinical narrative: Information has been received from an "over 60 year old" female pharmacist with a history of chickenpox who "recently" administered Zostavax (Oka/Merck) to an unspecified number of patients. Concomitant therapy included famciclovir (FAMVIR) and lysine. On 22-AUG-2007 the patient developed a rash on her head that was about 6 inches and painful when touched. The patient did not receive the vaccine, she just administered it. Unspecified medical attention was sought. At the time of this report the patient was recovering and the rash seemed to be drying up. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Local reaction, Urticaria
Clinical narrative: Information has been received from a physician and a 64 year old female with osteoarthritis, coronary artery disease, high cholesterol, and allergic rhinitis and a history of hives while on therapy with celecoxib (CELEBREX) and tiredness with sulfa drugs who on 20-AUG-2007 was vaccinated with a 0.5ml first dose of Zostavax (Oka/Merck) (Lot# "076U") given IM in her right deltoid. There was no illness at the time of vaccination. Concomitant therapy included clopidogrel bisulfate (PLAVIS), aspirin, pravastatin na (PRAVACHOL), albuterol, vitamins (unspecified), glucosamine, chondroitin, flaxseed, etodolac, and fexofenadine hydrochloride (ALLEGRA). On 21-AUG-2007 the patient developed a rash on her arms and lower legs. It started off as itchiness and progressed to swelling and redness (Patient also reported as measles). On 28-AUG-2007 she developed hives. In follow-up received on 07-SEP-2007, the physician reported that on 21-AUG-2007 the patient developed a moderate local reaction consisting of pain, swelling, and warmth. On 28-AUg-2007 the patient developed a urticarial rash in sun-exposed areas. No lab studies were performed. The physician noted the patient had not had a recent exposure to chicken pox or shingles. On an unspecified date the patient recovered. The patient had no adverse event following prior vaccination. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Local reaction, Pain, Rash, Skin warm
Clinical narrative: Information has been received from a physician and a 64 year old female with osteoarthritis, coronary artery disease, high cholesterol, and allergic rhinitis and a history of hives while on therapy with celecoxib (CELEBREX) and tiredness with sulfa drugs who on 20-AUG-2007 was vaccinated with a 0.5ml first dose of Zostavax (Oka/Merck) (Lot# "076U") given IM in her right deltoid. There was no illness at the time of vaccination. Concomitant therapy included clopidogrel bisulfate (PLAVIS), aspirin, pravastatin na (PRAVACHOL), albuterol, vitamins (unspecified), glucosamine, chondroitin, flaxseed, etodolac, and fexofenadine hydrochloride (ALLEGRA). On 21-AUG-2007 the patient developed a rash on her arms and lower legs. It started off as itchiness and progressed to swelling and redness (Patient also reported as measles). On 28-AUG-2007 she developed hives. In follow-up received on 07-SEP-2007, the physician reported that on 21-AUG-2007 the patient developed a moderate local reaction consisting of pain, swelling, and warmth. On 28-AUg-2007 the patient developed a urticarial rash in sun-exposed areas. No lab studies were performed. The physician noted the patient had not had a recent exposure to chicken pox or shingles. On an unspecified date the patient recovered. The patient had no adverse event following prior vaccination. No further information was provided. There was no product quality complaint involved. Additional information is not expected.