chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of myalgia in a 29-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 12 June 2008 at 11:30, the subject inadvertently received a dose of INFANRIX (.5 units unspecified, unknown, left arm), instead of an intended 1st dose of TDAP vaccine. Five hours after vaccination with INFANIX, at 16:30, the subject experienced myalgia, fatigue, joint pain, and sleepiness. The subject returned to the physician's office the next day due to the symptoms being unresolved. The physician referred the subject to a neurologist as a precaution. The reporting healthcare professional indicated that the events were systemic and considered the events to be clinically significant (or requiring intervention). At the time of reporting, the events were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Grand mal convulsion
Clinical narrative: Grand mal seizure x 2 10-11 hours after vaccine administration.  Patient admitted to hospital. 9/22/08-records received for DOS 6/19/08-DC DX: Seizure disorder. Presented with disorientation, posturing, jaw clenching and foaming of mouth, eyes rolling back. Unresponsive after episode with subsequent clonic seizure and post ictal state. Responsive to painful stimuli but would go in and out of post ictal state.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Patient complained of soreness/redness, swelling at injection site with general malaise - redness the size of "silver dollar" - continuing several days after injection.
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Dyskinesia, Fatigue, Immediate post-injection reaction, Malaise, Pallor
Clinical narrative: The patient stated he did not feel well immediately after two vaccines were administered in succession.  He flailed his arms and legs, threw his head back and jerked for approx 5-10 seconds.  He remained on the chair "tired" and pale after this episode.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Pain, Pain in extremity, Syncope
Clinical narrative: Immunization given Mon. 6/16/08, Tues 6/17/08 arm hurt, achy.  Wed 6/18/08-felt dizzy and fainted, later in day doing fine.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Axillary pain, Lethargy, Musculoskeletal chest pain, Pain
Clinical narrative: Pt. received HPV #2 in left deltoid via biojector, approx. 10:00AM 6/18/08.  On 6/19/08, 10:30AM, pt. telephoned RN to report pain from left armpit to left rib area, and lethargy.  Pt. advised to see PMD for continued pain or if pain worsens.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Axillary pain, Fatigue, Musculoskeletal chest pain
Clinical narrative: Pt. received HPV #2 in left deltoid via biojector, approx. 10:00AM 6/18/08.  On 6/19/08, 10:30AM, pt. telephoned RN to report pain from left armpit to left rib area, and lethargy.  Pt. advised to see PMD for continued pain or if pain worsens.
Age: 11.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Pruritus, Swelling, Tenderness, Urticaria
Clinical narrative: Urticarial swelling 1 inch diameter 24 hours later.  Swelling 4 inches in diameter with central tenderness 48 hours after immunization, pruritic - no fever or systemic illness.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Throat tightness
Clinical narrative: C/O feel faint, throat closing up, but eased somewhat after drinking water.  Also c/o feeling really hot.
Age: 0.55
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Skin lesion
Clinical narrative: Erythematous, firm, elevated and round lesions one on each thigh.
Age: 13.0
Sex: F
Vaccine: TYP, YF
Symptoms: Rash
Clinical narrative: Evening of vaccination patient developed a "playing card" sized" rash between her shoulder blades, just below the neck. Denies any other symptoms. Rash was itchy only rarely. Rash has improved slowly, and not fully resolved as of today 6/19/08
Age: 36.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: Rash; Body aches; fever
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Rash; Swelling; Redness
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Heart rate, Immediate post-injection reaction, Malaise, Oxygen saturation decreased, Pallor
Clinical narrative: Within 2 minutes of shot, patient vomited 5 times.  Then, complained of painful pruritis, lump in throat, mucousy sounding in chest.  Developed full body urticaria, dusky on legs, frantically scratching at eyes, face, nose, torso, scaly.  Benadryl given, monitored for 1 hour.  Did not require epi but did continue to feel ill and was hospitalized.  8/8/08 Hospital medical records for 6/6/08. FINAL DX: allergic reaction to vaccinations Records reveal patient experienced immediate vomiting after injections, then had itchy mouth & vomited again.  Tx w/antihistamine & steroids. Developed hives all over w/wheezing that resolved.  Exam revealed eyelid swelling & erythema, facial redness but hives had also resolved.  Remained stable & d/c to home same day on continued antihistamine x 48 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pruritus, Sensation of foreign body, Urticaria, Vomiting
Clinical narrative: Within 2 minutes of shot, patient vomited 5 times.  Then, complained of painful pruritis, lump in throat, mucousy sounding in chest.  Developed full body urticaria, dusky on legs, frantically scratching at eyes, face, nose, torso, scaly.  Benadryl given, monitored for 1 hour.  Did not require epi but did continue to feel ill and was hospitalized.  8/8/08 Hospital medical records for 6/6/08. FINAL DX: allergic reaction to vaccinations Records reveal patient experienced immediate vomiting after injections, then had itchy mouth & vomited again.  Tx w/antihistamine & steroids. Developed hives all over w/wheezing that resolved.  Exam revealed eyelid swelling & erythema, facial redness but hives had also resolved.  Remained stable & d/c to home same day on continued antihistamine x 48 hours.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: New rash appeared on trunk-began 6-16-08 seen in office 6-18-08 consistent with 1 degree varicella infection ~80 erythematous macules diffusely spread trunk & prox extrem.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Patient got welts on both legs. The welt on left leg where the MMR was given was larger then the one on the right. Patient was given 1 tsp of Benadryl.
Age: 1.1
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Breath holding, Crying, Gaze palsy, Hypotonia, Pallor
Clinical narrative: Post giving vaccine "patient" quit breathing, eye rolled back and her body went limp for approx 5-10 sec. During vaccine administration "patient" was crying. Mother took "patient" immediately outside patted her back along; I dad talking to "patient" in her face and she started crying again. CHN immediately followed outside. Mother said this is the second time "patient" has done this when crying. It happens all the time and you think she is not to take a breath but she does", mother states. see routine note; Post episode skin , pale, alert, smiling, walking, color improved before leaving home. At home for approx. 30min after vaccine administration. No further episodes. AR HR 120. BP 198/50. Mother said chiropractor said "patient" may have "infant asthma". Mother also said "patient" dad did this when he was a baby.
Age: 1.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling (about 1/2 dollar size accdg to grandmother) on injection site persistent after injection.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: L UE swollen 1 1/2 x size of R UE 3x5cm red raised nontender warm wheal ext positive FROM.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Varicella vaccine, VARIVAX (Oka Merck) given to employee, it is the #2 vaccine needed to complete the 2 shot series.  States, R arm deltoid, outer area, SQ started hurting, 6/19 noted in humeral area, injection site raised, red & swollen around the armpit.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Infection, Pain, Pruritus, Pyrexia, Swelling
Clinical narrative: Symptoms: Area swollen, fever, itching, pain, infection.  Treatment: Keflex (Cephalexin), Vicodin.
Age: 35.0
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a pharmacist concerning a 35 to 40 year-old0female nursing student who was not accepted entrance into school because "the college will not accept the titers for the patient". There was no further clarification on what "unacceptable titers" means. It was possible that the patient received measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) as a child but this can not be confirmed. Medical attention was sought. On an unspecified date, recently, the patient received a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The titer status after this administration was unknown. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: HIBV, MMR, PNC
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 13-month-old (previously reported as 13-month-old) who on 02-AUG-2007 was vaccinated subcutaneously in the left arm with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 655346/1324F). Concomitant vaccines administered on 02-AUG-2007 intramuscularly in the right vastus lateralis (RVL) included a third dose of Hib conj vaccine (OMPC) (MSD) (lot # 655547/0076U) and a fourth intramuscular dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) administered in the left vastus lateralis (LVL). On the 02-AUG-2007 10 minutes post vaccination the patient developed wheal approximately 1cm x 1cm at the injection site. It was reported the patient did not receive any follow-up and was not treated. Nurse stated "she has never seen such a reaction before". On 02-AUG-2007 the patient recovered. Lot check has been requested. This is one of several reports from the same source. The records of testing prior to release of lot 655346/1324F have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Information has been received from a physician and a consumer concerning her 15 month old daughter with no pertinent medical history or drug allergies who on 19-OCT-2007 was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no concomitant medication. On that same day (also reported as 26-OCT-2007) the patient's mother felt a pea-sized mass in the groin. The pediatrician examined the mass and stated that the mass was an enlarged lymph gland. No labs or diagnostic studies were performed. No treatment was rendered, although the enlarged lymph gland could be biopsied in in two months if it still persisted. There was no product quality complaint. The reporter felt that enlarged lymph gland was not related to therapy with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) injection of 19-OCT2007. No further information is available.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, MMR, MMRV
Symptoms: Fatigue, Incorrect dose administered, Injection site pain, Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on 17-DEC-2007 was vaccinated with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy given that same day included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). The nurse reported the incident was due to human error, there was no product confusion. The patient did not experience any known symptoms. There was no product quality complaint. Additional information is not expected. Further information has been received from the nurse practitioner regarding this four year old female who was vaccinated on 17-DEC-2007 with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 654893/1029F) SQ in the right quad (second dose) and secondary suspect therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (Lot # 656894/0917U) first dose in the right quad. Additional concomitant vaccines included Hepatitis A (GSK) lot# AHAVB182AA IM right quad, DTAP (GSK) lot # ac14B051AA, IM left quad, IPV (SANOFI) Lot # A0169 SQ left quad and FLU vaccine (SANOFI) lot # U2513AA, IM left quad. It was reported that the patient was not seen within 48 hours of vaccination. On 21-DEC-2007 the patients father stated there was no adverse event, only mild tenderness to both legs with mild fatigue. The patients mother stated on 15-JAN-2008 that "there was no adverse side effects except for mild pain at the site for two or three days."
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 82-year-old female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. On 19 February 2008 the subject received unspecified dose of Fluarix (.5 mL, left arm). On 19 February 2008, less than one day after vaccination with Fluarix, the subject experienced injection site pain and bruising at the injection site. At the time of reporting the events were unresolved. The pharmacist considered the events were probably related to vaccination with fluarix.
Sex: F
Vaccine: FLU3
Symptoms: Cough, Influenza, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of influenza in an adult female subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Fluarix (unknown). At an unspecified time after vaccination with Fluarix, in February 2008, the subject experienced influenza and vaccination failure. At an unspecified time after vaccination with Fluarix and on a unspecified date, the subject experienced cough. This case was assessed as medically serious by GSK. The subject was treated with oseltamivir phosphate (TAMIFLU). At the time of reporting the event of influenza was improved, but the subject still had a cough.
Sex: U
Vaccine: FLU3
Symptoms: Malaise, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician and described the occurrence of generalized malaise in an unspecified number of adult subject of unspecified gender who was vaccinated with influenza virus vaccine (FLUARIX, GlaxoSmithKline) for prophylaxis. It was reported that an unspecified number of subjects experienced malaise following previous vaccinations. On an unspecified date the subject received 1st dose of FLUARIX (1 ml, unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced generalized malaise. At the time of reporting the event was resolved. The physician considered the event was probably related to vaccination with FLUARIX. Per the source document, the physician noted that he has noticed malaise in approximately one out of three adult subjects. He was making a broad observation and specific details regarding the number of subjects, time of administration or other details were not provided. The physician noted that the subjects then refuse to obtain subsequent FLUARIX vaccinations in later years due to the malaise. It was reported that an unspecified number of subjects experienced malaise following previous influenza injections and following previous vaccinations.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: A 25-year-old female patient had received an intramuscular left deltoid booster dose of ADACEL, lot number C2825AA on 14 May 2008 at 12:00 pm and 12 hours later, she developed a fever of 101 Fahrenheit, chills, aching joints, left swollen cervical glands and inflammation at the injection site which was red, hot and swollen. The event did not require a doctor's visit and the patient had no known allergies. The needle size used for vaccination administration had been 25 gauge, 1 inch. At the time of the report, the patient was recovered from the event. No further information was provided.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Lymphadenopathy, Pyrexia
Clinical narrative: A 25-year-old female patient had received an intramuscular left deltoid booster dose of ADACEL, lot number C2825AA on 14 May 2008 at 12:00 pm and 12 hours later, she developed a fever of 101 Fahrenheit, chills, aching joints, left swollen cervical glands and inflammation at the injection site which was red, hot and swollen. The event did not require a doctor's visit and the patient had no known allergies. The needle size used for vaccination administration had been 25 gauge, 1 inch. At the time of the report, the patient was recovered from the event. No further information was provided.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Muscle tightness, Myalgia
Clinical narrative: A 23-year-old female patient, who had no concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a second, left arm dose of ADACEL (lot # C2989AA), and a left forearm dose of TUBERSOL (lot # C2682AA) on 11 March 2008. The route of administration for both the ADACEL AND TUBERSOL were not provided. A few hours after receiving the ADACEL vaccine in the left arm, the patient developed redness, warmth, and swelling at the site. She also felt feverish, mild muscle aches, and experienced some muscle tightness in the middle of her chest. The patient did not experience any difficulty breathing. All the symptoms resolved spontaneously approximately four days after onset. No medical attention was sought, and treatment was not rendered. The patient recovered.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: A 23-year-old female patient, who had no concurrent illnesses, pre-existing medical conditions, or use of other medications, had received a second, left arm dose of ADACEL (lot # C2989AA), and a left forearm dose of TUBERSOL (lot # C2682AA) on 11 March 2008. The route of administration for both the ADACEL AND TUBERSOL were not provided. A few hours after receiving the ADACEL vaccine in the left arm, the patient developed redness, warmth, and swelling at the site. She also felt feverish, mild muscle aches, and experienced some muscle tightness in the middle of her chest. The patient did not experience any difficulty breathing. All the symptoms resolved spontaneously approximately four days after onset. No medical attention was sought, and treatment was not rendered. The patient recovered.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Injection site induration, Injection site pain, Pain, Pharyngolaryngeal pain
Clinical narrative: Initial report received on 18 March 2008 from a health care professional. A 30 year old female patient received on 13 March 2008 an intramuscular dose of ADACEL (lot # C2842AA) in the left deltoid. The patient had no illness at the time of vaccination. After an unspecified period following vaccination, the patient developed a cough, body aches, a sore throat, and low grade fever. Additionally, the injection site was very tender and had an area of induration measuring approximately 2.5 cm by 4.5 cm. The number of doses of ADACEL is unknown. The patient had an allergy to penicillin and BACTRIM, no medical history, and concurrent medications were not reported. At the time of the report (18 March 2008), the patient had not recovered.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Initial report received on 18 March 2008 from a health care professional. A 30 year old female patient received on 13 March 2008 an intramuscular dose of ADACEL (lot # C2842AA) in the left deltoid. The patient had no illness at the time of vaccination. After an unspecified period following vaccination, the patient developed a cough, body aches, a sore throat, and low grade fever. Additionally, the injection site was very tender and had an area of induration measuring approximately 2.5 cm by 4.5 cm. The number of doses of ADACEL is unknown. The patient had an allergy to penicillin and BACTRIM, no medical history, and concurrent medications were not reported. At the time of the report (18 March 2008), the patient had not recovered.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Cough, Decreased appetite, Diarrhoea, Emotional distress, Insomnia
Clinical narrative: This case was received from a health professional on 15 March 2008. A 53-year-old female patient, with a history of depression and mitral valve prolapse, received a left deltoid intramuscular injection of ADACEL (lot number C2888AA) on 14 March 2008. The day after vaccine administration, she complained of nausea, diarrhea, cough, decreased appetite, decreased sleep, and feeling overwhelmed. At the time of the report, the events had not yet recovered.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: This case was received from a health professional on 15 March 2008. A 53-year-old female patient, with a history of depression and mitral valve prolapse, received a left deltoid intramuscular injection of ADACEL (lot number C2888AA) on 14 March 2008. The day after vaccine administration, she complained of nausea, diarrhea, cough, decreased appetite, decreased sleep, and feeling overwhelmed. At the time of the report, the events had not yet recovered.
Sex: U
Vaccine: TDAP
Symptoms: Neurological symptom
Clinical narrative: Initial report was received from a physician on 21 March 2008. A physician, who is a neurologist, reported that a patient (identifiers not provided) may have experienced a possible neurological reaction after receipt of ADACEL. No further information was provided at the time of the report.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Cold sweat, Dizziness, Headache, Nausea
Clinical narrative: Initial report received 03 April 2008 from a health care professional. A 28-year-old male patient with a history of allergy to aspirin, had received a first dose, intramuscular left deltoid injection of ADACEL, lot number C2937AA on 02 April 2008 and within nine hours of vaccination, he developed blurry vision, headache, dizziness, cold sweats, nausea, vomiting and a temperature of 99.4 degrees Fahrenheit. The patient had no illness at the time of vaccination. At the time of the report, the patient had not recovered from the event and had been scheduled to see his physician on 03 April 2008. No further information was provided.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Vision blurred, Vomiting
Clinical narrative: Initial report received 03 April 2008 from a health care professional. A 28-year-old male patient with a history of allergy to aspirin, had received a first dose, intramuscular left deltoid injection of ADACEL, lot number C2937AA on 02 April 2008 and within nine hours of vaccination, he developed blurry vision, headache, dizziness, cold sweats, nausea, vomiting and a temperature of 99.4 degrees Fahrenheit. The patient had no illness at the time of vaccination. At the time of the report, the patient had not recovered from the event and had been scheduled to see his physician on 03 April 2008. No further information was provided.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Aggression, Blood pressure increased, Injection site pain, No reaction on previous exposure to drug
Clinical narrative: Initial report received on 07 April 2008 from a nurse. A 45 year old male patient received on 02 April 2008 an intramuscular right deltoid injection of ADACEL (lot# C2767AA). No concomitant vaccines administered. By evening, on the day of administration, the patient had an increase in BP to 150/90 and he became confrontational. These symptoms lasted for 24 hours. Corrective measures were not reported. The patient also experienced soreness of the right deltoid, which was the injection site. The patient had no adverse event follow prior vaccination. He was allergic to penicillin, COMPAZINE, and HYDROCODONE. No other medical history was reported. Concomitant medications unknown. On the day of the report, 07 April 2008, the patient had recovered.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Eye swelling, Injection site erythema, Injection site pruritus, Injection site rash, Oral contraception
Clinical narrative: Initial report received on 26 April 2008 from a physician. A 30 year old female patient with a history of allergic rhinitis received on 14 April 2008 a right deltoid intramuscular injection of ADACEL (lot # C2341AA). Twenty-four hours post-vaccination, the patient developed a red itchy rash at the injection site. Throughout the day, the rash became widespread, over her body and the patient started BENADRYL and steroids. The rash faded somewhat. On 16 April 2006, tow days post-vaccination, the rash returned and the patient and some facial swelling and her eyes were swollen and puffy. The patient had no adverse event following prior vaccinations. Concurrent medication included oral contraceptives. At the time of the report, 16 April 2008, the patient had not recovered. Follow-up information was received 19 May 2008 from a physician. The event onset was confirmed to have started 24 hours post vaccination on 15 April 2008. Treatments prescribed for the event included BENADRYL and both oral and topical steroids. At the time of the report, the patient had not recovered from the event. No further information was provided.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised, Swelling face
Clinical narrative: Initial report received on 26 April 2008 from a physician. A 30 year old female patient with a history of allergic rhinitis received on 14 April 2008 a right deltoid intramuscular injection of ADACEL (lot # C2341AA). Twenty-four hours post-vaccination, the patient developed a red itchy rash at the injection site. Throughout the day, the rash became widespread, over her body and the patient started BENADRYL and steroids. The rash faded somewhat. On 16 April 2006, tow days post-vaccination, the rash returned and the patient and some facial swelling and her eyes were swollen and puffy. The patient had no adverse event following prior vaccinations. Concurrent medication included oral contraceptives. At the time of the report, 16 April 2008, the patient had not recovered. Follow-up information was received 19 May 2008 from a physician. The event onset was confirmed to have started 24 hours post vaccination on 15 April 2008. Treatments prescribed for the event included BENADRYL and both oral and topical steroids. At the time of the report, the patient had not recovered from the event. No further information was provided.
Age: 43.0
Sex: M
Vaccine: HEP, HEPA, TDAP, TYP
Symptoms: Injection site erythema, Injection site pain, Rash maculo-papular
Clinical narrative: Initial report received on 30 April 2008 from a nurse. A 43-year-old male (also reported as 44-year-old) patient whit no concurrent illnesses, had received on 25 February 2008 an intramuscular left deltoid injection of ADACEL (lot # C2904AA); an intramuscular left deltoid of TYPHIX Vi (Lot # Z0960-2) an intramuscular right deltoid injection of "HEP A" vaccine (manufacturer GlaxoSmithKline, Lot # AHBAB171AA); and an intramuscular right deltoid injection of "HEP B" vaccine (manufacturer GlaxoSmithKline, Lot # AHBVB517AA). The trade name for "HEP A" and "HEP B" vaccine were not provided. Twenty-four hours post-vaccination, the patient's left arm became red and tender at the injection site. Several days later the patient developed dime and nickel sized red, raised and dried plaques of skin on the left deltoid, legs, abdomen, and forearms. The patient was evaluated by a physician and prescribed BENADRYL with no results. The patient received further treatments, but also did not experience any change in her condition. No relevant diagnostic tests/laboratory data were performed. At the time of this report, the patient had not recovered.
Age: 41.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Headache, Lymphadenopathy, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Initial report received from a nurse in the USA on 15 May 2008. A 41 year old, female patient (with a medical history of eczema behind her left ear and scalp) complained of congestion, headache (moderate), swollen glands,  body aches and intermittent fevers (temperatures 99-101), the next day after she received ADACEL (lot number C2937AA) intramuscularly in the left deltoid and HAVRIX Hepatitis A vaccine (GlaxoSmithKline) intramuscularly in the right deltoid on 30 April 2008 at 10:30 AM. The patient had a TdaP vaccine > 5 years ago. The patient did not have any illness at the time of vaccination. On 07 May 2008, the patient called the reporter with concerns. On 08 May 2008 there was still no change - the patient did not have a recent medical evaluation with her primary care physician. The patient's recovery status was not reported.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was received on 16 May 2008 from a health professional, and is one of a cluster of ten patients. A female patient experienced received  an injection of ADACEL (lot number C2864AA), and subsequently experienced injection site redness and pain with swelling extending to the axillary area. No additional information was provided. The health professional also reported nine other patients who experienced similar events following administration of ADACEL. Those events are captured in cases 2008-01609, 2008-01610, 2008-01611, 2008-01612, 2008-01613, 2008-01614, 2008-01615, 2008-01616, and 2008-01617.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Insomnia
Clinical narrative: Initial report received on 10 April 2008 from a consumer, who is also the patient, in the USA. A 60 yr old female patient with no medical history received on 04 April 2008 an intramuscular left arm injection of ADACEL (lot # unknown). There was illness at the time of vaccination. On 06 April 2008, 2 days post-vaccination, the patient experienced itching at the injection site and insomnia. At the time of the report, 10 April 2008, the patient had not recovered.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Dyspnoea, Injection site pain, Injection site swelling, Limb injury
Clinical narrative: This case reported by a health are professional in the United States on 14 April 2008. A 53-year-old female patient received a left upper arm intramuscular injection of ADACEL (lot number C2853AA) on 04 April 2008, after sustaining a scratch to the right hand. Medical history included an iodine allergy, she was not ill at the time of vaccination. On 10 April 2008 the patient presented to her physician with left arm soreness and swelling at the injection site, and was treated with KEFLEX four times daily. On 11 April 2008 she experienced severe chest discomfort, syncope, and shortness of breath, and was airlifted to the hospital. The patient subsequently recovered, no additional information was provided. The reporter considered the events to be life-threatening.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: This case reported by a health are professional in the United States on 14 April 2008. A 53-year-old female patient received a left upper arm intramuscular injection of ADACEL (lot number C2853AA) on 04 April 2008, after sustaining a scratch to the right hand. Medical history included an iodine allergy, she was not ill at the time of vaccination. On 10 April 2008 the patient presented to her physician with left arm soreness and swelling at the injection site, and was treated with KEFLEX four times daily. On 11 April 2008 she experienced severe chest discomfort, syncope, and shortness of breath, and was airlifted to the hospital. The patient subsequently recovered, no additional information was provided. The reporter considered the events to be life-threatening.
Sex: U
Vaccine: TDAP
Symptoms: Body temperature increased, Ear congestion, Limb discomfort, Nausea, Rhinorrhoea
Clinical narrative: Initial report received on 16 May 2008 from a nurse in the United States. Five female patients (ages and dates of birth not reported) had received an intramuscular injection of ADACEL (Lot # C2899AA) on 14 May 2008. The routes and sites of administration were not provided. At an unspecified amount of time later, on the same day, the patients experienced nausea, runny noses, stuffy ears, temperature of 100.0 to 101.0 degrees Fahrenheit, and sore arms. The patients did not receive medical attention and no treatment was provided. No diagnostic tests, or laboratory data were performed. At the time of this report, it was "unknown" if the patients had recovered.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Blood creatinine increased, Fibromyalgia, Haematology test, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from the mother of a 24 year old female consumer with allergy to CELEXA and allergy to metals who on 05-JUN-2007 was vaccinated with the first dose of GARDASIL (lot #655849/0263U), 0.5 mL IM in the arm. Concomitant therapy included VALIUM, baclofen, prednisone, TORISEL, "dizanidine HCl" [therapy unspecified], PERCOCET, oxycodone, PRILOSEC, estradiol, ZOLOFT, ALLEGRA, albuterol and "birth control pills" (unspecified). On 05-JUN-2007 after getting her first 0.5 mL dose of GARDASIL, the patient's arm was "warm and hard for a couple of weeks" and the patient recovered from this event. On approximately 19-JUN-2007, a couple of weeks after the first vaccination, the patient's clavicular lymph node swelled up. The swelling was almost gone when the patient received the second dose of GARDASIL (Lot #658100/0525U) on 08-AUG-2007. On 09-AUG-2007, after the second dose, every lymph node in the patient's body swelled up. She could not open her mouth and could not relax her muscles. The patient was admitted to the hospital for 3 days, her serum creatine kinase level went up to 500 and she was diagnosed with rhabdomyolysis. The patient had muscle missing on the bottom of her right foot and she had symptoms of fibromyalgia. She had muscle contractures and spasms and had rashes on top of the spasms. The patient developed hormonal problems, did not have her period for 6 months and was having night sweats. The patient's left eye was "out of focus" and the muscles were "jumping around in her left eye." She had a magnetic resonance imaging (MRI), blood work and an eye test performed which results were not reported. At the time of reporting, the patient was recovering from the events while on therapy (unspecified). No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Muscle contractions involuntary, Muscle spasms, Night sweats, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from the mother of a 24 year old female consumer with allergy to CELEXA and allergy to metals who on 05-JUN-2007 was vaccinated with the first dose of GARDASIL (lot #655849/0263U), 0.5 mL IM in the arm. Concomitant therapy included VALIUM, baclofen, prednisone, TORISEL, "dizanidine HCl" [therapy unspecified], PERCOCET, oxycodone, PRILOSEC, estradiol, ZOLOFT, ALLEGRA, albuterol and "birth control pills" (unspecified). On 05-JUN-2007 after getting her first 0.5 mL dose of GARDASIL, the patient's arm was "warm and hard for a couple of weeks" and the patient recovered from this event. On approximately 19-JUN-2007, a couple of weeks after the first vaccination, the patient's clavicular lymph node swelled up. The swelling was almost gone when the patient received the second dose of GARDASIL (Lot #658100/0525U) on 08-AUG-2007. On 09-AUG-2007, after the second dose, every lymph node in the patient's body swelled up. She could not open her mouth and could not relax her muscles. The patient was admitted to the hospital for 3 days, her serum creatine kinase level went up to 500 and she was diagnosed with rhabdomyolysis. The patient had muscle missing on the bottom of her right foot and she had symptoms of fibromyalgia. She had muscle contractures and spasms and had rashes on top of the spasms. The patient developed hormonal problems, did not have her period for 6 months and was having night sweats. The patient's left eye was "out of focus" and the muscles were "jumping around in her left eye." She had a magnetic resonance imaging (MRI), blood work and an eye test performed which results were not reported. At the time of reporting, the patient was recovering from the events while on therapy (unspecified). No product quality complaint was involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Ophthalmological examination, Rash, Rhabdomyolysis, Trismus, Vision blurred
Clinical narrative: Information has been received from the mother of a 24 year old female consumer with allergy to CELEXA and allergy to metals who on 05-JUN-2007 was vaccinated with the first dose of GARDASIL (lot #655849/0263U), 0.5 mL IM in the arm. Concomitant therapy included VALIUM, baclofen, prednisone, TORISEL, "dizanidine HCl" [therapy unspecified], PERCOCET, oxycodone, PRILOSEC, estradiol, ZOLOFT, ALLEGRA, albuterol and "birth control pills" (unspecified). On 05-JUN-2007 after getting her first 0.5 mL dose of GARDASIL, the patient's arm was "warm and hard for a couple of weeks" and the patient recovered from this event. On approximately 19-JUN-2007, a couple of weeks after the first vaccination, the patient's clavicular lymph node swelled up. The swelling was almost gone when the patient received the second dose of GARDASIL (Lot #658100/0525U) on 08-AUG-2007. On 09-AUG-2007, after the second dose, every lymph node in the patient's body swelled up. She could not open her mouth and could not relax her muscles. The patient was admitted to the hospital for 3 days, her serum creatine kinase level went up to 500 and she was diagnosed with rhabdomyolysis. The patient had muscle missing on the bottom of her right foot and she had symptoms of fibromyalgia. She had muscle contractures and spasms and had rashes on top of the spasms. The patient developed hormonal problems, did not have her period for 6 months and was having night sweats. The patient's left eye was "out of focus" and the muscles were "jumping around in her left eye." She had a magnetic resonance imaging (MRI), blood work and an eye test performed which results were not reported. At the time of reporting, the patient was recovering from the events while on therapy (unspecified). No product quality complaint was involved. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Axillary pain, Flank pain, Injected limb mobility decreased, Joint range of motion decreased
Clinical narrative: No treatment to date prescribed (3) pain medications 1) Ibuprofen 400 mg tablet; 2) Acetaminophen-COD #3; 3) Noprixen 500 mg; symptoms from May 23 onward include, itchy, swollen left arm, left underarm sore, couldn't move, left hip, thigh, buttocks sore, left back rib cage, front left ankle burning, smell burnt popcorn, chest, back, arms burning, ears, head burning, whole body burning, sides of throat sore, vaginal odor, bladder hurting, right eyelid drooping, numb forehead, vaginal itching and discharge, no yeast, sore ankles, more dizziness, thirsty, excessive sweating at rest, loss of appetite, burning increases with touch or any pressure, less urinating, brown urine, nightmares, very sleepy again as in the 31 days after receiving vaccine.  Now use a cane.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Mobility decreased, Swelling, Tenderness
Clinical narrative: No treatment to date prescribed (3) pain medications 1) Ibuprofen 400 mg tablet; 2) Acetaminophen-COD #3; 3) Noprixen 500 mg; symptoms from May 23 onward include, itchy, swollen left arm, left underarm sore, couldn't move, left hip, thigh, buttocks sore, left back rib cage, front left ankle burning, smell burnt popcorn, chest, back, arms burning, ears, head burning, whole body burning, sides of throat sore, vaginal odor, bladder hurting, right eyelid drooping, numb forehead, vaginal itching and discharge, no yeast, sore ankles, more dizziness, thirsty, excessive sweating at rest, loss of appetite, burning increases with touch or any pressure, less urinating, brown urine, nightmares, very sleepy again as in the 31 days after receiving vaccine.  Now use a cane.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Anorexia, Arthralgia, Bladder pain, Burning sensation, Chromaturia
Clinical narrative: No treatment to date prescribed (3) pain medications 1) Ibuprofen 400 mg tablet; 2) Acetaminophen-COD #3; 3) Noprixen 500 mg; symptoms from May 23 onward include, itchy, swollen left arm, left underarm sore, couldn't move, left hip, thigh, buttocks sore, left back rib cage, front left ankle burning, smell burnt popcorn, chest, back, arms burning, ears, head burning, whole body burning, sides of throat sore, vaginal odor, bladder hurting, right eyelid drooping, numb forehead, vaginal itching and discharge, no yeast, sore ankles, more dizziness, thirsty, excessive sweating at rest, loss of appetite, burning increases with touch or any pressure, less urinating, brown urine, nightmares, very sleepy again as in the 31 days after receiving vaccine.  Now use a cane.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dizziness, Eyelid disorder, Hyperaesthesia, Hyperhidrosis, Hypoaesthesia facial
Clinical narrative: No treatment to date prescribed (3) pain medications 1) Ibuprofen 400 mg tablet; 2) Acetaminophen-COD #3; 3) Noprixen 500 mg; symptoms from May 23 onward include, itchy, swollen left arm, left underarm sore, couldn't move, left hip, thigh, buttocks sore, left back rib cage, front left ankle burning, smell burnt popcorn, chest, back, arms burning, ears, head burning, whole body burning, sides of throat sore, vaginal odor, bladder hurting, right eyelid drooping, numb forehead, vaginal itching and discharge, no yeast, sore ankles, more dizziness, thirsty, excessive sweating at rest, loss of appetite, burning increases with touch or any pressure, less urinating, brown urine, nightmares, very sleepy again as in the 31 days after receiving vaccine.  Now use a cane.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Hypokinesia, Nightmare, Oedema peripheral, Pain in extremity, Pharyngolaryngeal pain
Clinical narrative: No treatment to date prescribed (3) pain medications 1) Ibuprofen 400 mg tablet; 2) Acetaminophen-COD #3; 3) Noprixen 500 mg; symptoms from May 23 onward include, itchy, swollen left arm, left underarm sore, couldn't move, left hip, thigh, buttocks sore, left back rib cage, front left ankle burning, smell burnt popcorn, chest, back, arms burning, ears, head burning, whole body burning, sides of throat sore, vaginal odor, bladder hurting, right eyelid drooping, numb forehead, vaginal itching and discharge, no yeast, sore ankles, more dizziness, thirsty, excessive sweating at rest, loss of appetite, burning increases with touch or any pressure, less urinating, brown urine, nightmares, very sleepy again as in the 31 days after receiving vaccine.  Now use a cane.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pruritus, Skin odour abnormal, Somnolence, Thirst, Urine output decreased
Clinical narrative: No treatment to date prescribed (3) pain medications 1) Ibuprofen 400 mg tablet; 2) Acetaminophen-COD #3; 3) Noprixen 500 mg; symptoms from May 23 onward include, itchy, swollen left arm, left underarm sore, couldn't move, left hip, thigh, buttocks sore, left back rib cage, front left ankle burning, smell burnt popcorn, chest, back, arms burning, ears, head burning, whole body burning, sides of throat sore, vaginal odor, bladder hurting, right eyelid drooping, numb forehead, vaginal itching and discharge, no yeast, sore ankles, more dizziness, thirsty, excessive sweating at rest, loss of appetite, burning increases with touch or any pressure, less urinating, brown urine, nightmares, very sleepy again as in the 31 days after receiving vaccine.  Now use a cane.
Age: 41.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vaginal discharge, Vulvovaginal pruritus
Clinical narrative: No treatment to date prescribed (3) pain medications 1) Ibuprofen 400 mg tablet; 2) Acetaminophen-COD #3; 3) Noprixen 500 mg; symptoms from May 23 onward include, itchy, swollen left arm, left underarm sore, couldn't move, left hip, thigh, buttocks sore, left back rib cage, front left ankle burning, smell burnt popcorn, chest, back, arms burning, ears, head burning, whole body burning, sides of throat sore, vaginal odor, bladder hurting, right eyelid drooping, numb forehead, vaginal itching and discharge, no yeast, sore ankles, more dizziness, thirsty, excessive sweating at rest, loss of appetite, burning increases with touch or any pressure, less urinating, brown urine, nightmares, very sleepy again as in the 31 days after receiving vaccine.  Now use a cane.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Apgar score normal, Arrested labour, Caesarean section, Drug exposure during pregnancy, Foetal distress syndrome
Clinical narrative: Initial and follow up information has been received from a certified nurse midwife and a nurse for the Pregnancy Registry for GARDASIL concerning a female (age not reported) who in July 2007, was vaccinated intramuscularly with the first 0.5 mL dose of GARDASIL. The certified nurse midwife reported that the patient was already pregnant (about 20 weeks gestation) when she received her first dose of GARDASIL. The patient sought unspecified medical attention. No other symptoms were noted. There was no product quality complaint involved. On 06-JUN-2008 a follow up telephone call was made to the doctor's office to know the patient's pregnancy outcome information and a telephone message was left. ON 11-JUN-2008 a nurse called back and reported that the patient had a primary cesarean section at term on 31-JAN-2008 and delivered a healthy and normal male baby weighing 7 lb, 10 oz. The baby's apgar score was 9/9. It was reported that the reason for the C-section was arrested descent in second stage with fetal intolerance to labor resulting in multiple deep variable decelerations. No complication was reported. Upon internal review patient having arrested descent in second stage of labor and fetal intolerance to labor resulting in multiple deep variable decelerations which required a cesarean section delivery were determined to be other important medical events. Additional information is not expected.