chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Full blood count, Injection site pain, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a registered nurse, concerning a 4 year old female child with a history of otitis media, who on 11-DEC-2007 was vaccinated IM in the left thigh, with a dose, 0.5 ml, of Pneumovax 23 (lot #657525/0554U). There was no concomitant medication. On 12-DEC-2007 at 9:00 a.m., the child developed a fever of greater than 102 F, with swelling and soreness at the injection site. The child visited the office that day, and was non-weight bearing, with a fever 104.1 F. The entire quadriceps was tender to the touch, with a small lesion noted at the site. There was no significant bruising or swelling. The child refused to sit up until noon, due to leg pain. Treatment included a prescription for hydrocodone (LORTAB). On 13-DEC-2007, the child continued to have pain and fever despite treatment with acetaminophen (TYLENOL) and ibuprofen (MOTRIN). On 14-DEC-2007, the child's temperature was normal 1 hour after treatment medications, but her leg was still non-weight bearing, painful and sensitive to the touch. The nurse indicated the event was an injection site reaction of fasciitis. Multiple lab tests were performed (results not available). At the time of this report, the child was in the process of admission to the hospital for treatment with IV antibiotics. The nurse considered the events to be serious as disabling/incapacitating. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Red blood cell scan, Tenderness, Weight bearing difficulty
Clinical narrative: Information has been received from a registered nurse, concerning a 4 year old female child with a history of otitis media, who on 11-DEC-2007 was vaccinated IM in the left thigh, with a dose, 0.5 ml, of Pneumovax 23 (lot #657525/0554U). There was no concomitant medication. On 12-DEC-2007 at 9:00 a.m., the child developed a fever of greater than 102 F, with swelling and soreness at the injection site. The child visited the office that day, and was non-weight bearing, with a fever 104.1 F. The entire quadriceps was tender to the touch, with a small lesion noted at the site. There was no significant bruising or swelling. The child refused to sit up until noon, due to leg pain. Treatment included a prescription for hydrocodone (LORTAB). On 13-DEC-2007, the child continued to have pain and fever despite treatment with acetaminophen (TYLENOL) and ibuprofen (MOTRIN). On 14-DEC-2007, the child's temperature was normal 1 hour after treatment medications, but her leg was still non-weight bearing, painful and sensitive to the touch. The nurse indicated the event was an injection site reaction of fasciitis. Multiple lab tests were performed (results not available). At the time of this report, the child was in the process of admission to the hospital for treatment with IV antibiotics. The nurse considered the events to be serious as disabling/incapacitating. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Hypersensitivity, Pain in extremity
Clinical narrative: PATIENT RECEIVED HEP B IN RIGHT DELTOID ON 11-14-07.  HE REPORTS HIS ARM WAS SORE FOR A COUPLE OF DAYS BUT THEN IT WAS OK.  ONE WEE LATER, HE WAS RIDING IN HIS WORK TRUK WITH HIS ARM ON THE WINDOW SILL AND HE HAD SHARP SHOOTING PAINS UP AND DOWN HIS ARM AND THEN HAD INTERMITTANT DISCOMFORT EVER SINCE.  ON 11-26-07, DURING THE NIGHT, THE PAIN BECAME CONSTANT.  HE SAW HIS COMPANY DOCTOR WHO SAID HE WS ALLERGIC TO THE NEEDLE.  TREATMENT WITH PRENISOME DOSE PACK - NO FURTHER PAIN.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Diarrhoea, Fatigue, Nausea, Vomiting
Clinical narrative: nausea 2 days after with a bout of diarrhea, then nausea and vomiting that same evening, then diarrhea and nausea on the third day with exhaustion...
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Wrong technique in drug usage process
Clinical narrative: 12-04-07 PATIENT HAD TB TEST DONE AND FLU SHOT.  12-07-07 PATIENT HAD TB TEST READ, SHE SHOWED US HER LEFT FA WHERE SHE SAID SHE RECEIVED HER FLU SHOT, AREA ON LEFT FA RED, RAISED, APPROXIMATE SIZE OF PENNY.  NURSH ADM. FLUE SHOT INTRADERMALY.  ADMINISTRATOR AND DR NOTIFIED, NO TREATMENT NECESSARY.  ON-GOING FOLLOW UP WITH PATIENT REGARDING LOCAL REACTION. (PPD, SANOFI PASTEUR, C2805AA, INTERDERMALLY)
Age: 1.92
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Pyrexia, Vomiting
Clinical narrative: AT HOME STARTED HAVING HIGH FEVER - 104F GAVE HER TYLENOL THEN HAD SEIZURE AND VOMITING. WENT TO ER SEING DOCTOR TODAY FOR CHECKUP 12-13-07
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood pressure, Gaze palsy, Muscle twitching, Musculoskeletal stiffness, Pallor
Clinical narrative: Patient had a bout of syncope after vaccine was given - approximately 15 sec after injection.  Patient turned white, rolled over, and had stiffened body and started to twitch x 10 sec.  Patients eyes were glossed over and she was temporarily unresponsive, but eyes were opened.  Patient recovered quickly.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Patient had a bout of syncope after vaccine was given - approximately 15 sec after injection.  Patient turned white, rolled over, and had stiffened body and started to twitch x 10 sec.  Patients eyes were glossed over and she was temporarily unresponsive, but eyes were opened.  Patient recovered quickly.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site swelling
Clinical narrative: Large, reddish-purple swelling at area of injection, measuring 14 cm. by 10 cm. on Dec. 21 2007.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: patient experiencing more shingles (she had numerous times before vaccine) this time worse than usual
Age: 0.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Diarrhoea, Laboratory test, Local swelling, Lymphadenopathy
Clinical narrative: Information has been received from a consumer concerning her 16 week old daughter, who in September 2007, was vaccinated with the first dose of PEDIARIX and PREVNAR, which were well tolerated. On 30-NOV-2007, her daughter was administered the second dose of Hib conj vaccine (lot #656517/0257U), of PEDIARIX and of PREVNAR. On 01-DEC-2007 the infant developed a low grade fever. Within 48 hours, (approximately on 03-DEC-2007), her temperature had spiked to 103 degrees, and her neck was swollen, with the lymph nodes swollen "almost to the size of a golf ball," and she was hospitalized. Blood tests were performed (tests not specified, and results not provided). She reported her daughter was hospitalized for 6 days, and currently was recovering, but had also developed diarrhea. No further details were provided. No further information is expected.
Age: 0.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 16 week old daughter, who in September 2007, was vaccinated with the first dose of PEDIARIX and PREVNAR, which were well tolerated. On 30-NOV-2007, her daughter was administered the second dose of Hib conj vaccine (lot #656517/0257U), of PEDIARIX and of PREVNAR. On 01-DEC-2007 the infant developed a low grade fever. Within 48 hours, (approximately on 03-DEC-2007), her temperature had spiked to 103 degrees, and her neck was swollen, with the lymph nodes swollen "almost to the size of a golf ball," and she was hospitalized. Blood tests were performed (tests not specified, and results not provided). She reported her daughter was hospitalized for 6 days, and currently was recovering, but had also developed diarrhea. No further details were provided. No further information is expected.
Age: 0.92
Sex: M
Vaccine: FLU3
Symptoms: Radioallergosorbent test negative, Urticaria
Clinical narrative: Hives began appearing on torso within 2 hours of shot.  Within 9 hours hives spread to limbs.  By 18 hours post-shot entire body was covered (thousands of hives.)  Patient started on Benedryl after Dr. visit 11/05/07.  Hives did not fully disappear for 2 weeks.
Age: 55.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site ulcer
Clinical narrative: Patient developed 1.5 cm area of redness and ulceration at left deltoid injection site. 0 pain. Has not received medical tx r/t wound.
Sex: F
Vaccine: HIBV
Symptoms: Diplegia
Clinical narrative: Information has been received from a consumer concerning a female who on 04-DEC-2007 was vaccinated with a dose of PedvaxHIB. Subsequently, the patient experienced paralysis in her legs. The child was transported to the hospital. At the time of the report the patient's outcome was unknown. Upon internal review, paralysis of the legs was considered to be an other important medical event. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: HIBV
Symptoms: Lymphadenitis, Neck mass
Clinical narrative: Information has been received from a nurse concerning an 18 week old female who on 30-NOV-2007 was vaccinated with Hib conj vaccine (OMPC) (Lot #656517/0257U).  On approximately 30-NOV-2007 the patient developed a lump on her neck.  She was seen by an ENT for lymphadenitis.  On 06-DEC-2007 the patient was admitted to the hospital.  On 11-DEC-2007 she was discharged.  At the time of this report, the patient was recovering.  It was unknown which dose in the series this was for the patient.  Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Balance disorder, Cranial nerve infection, Dizziness, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a pharmacist, concerning her 21 year old daughter with an allergy to animals, who was vaccinated IM (date not reported), with the first dose of Gardasil (lot # not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 13-NOV-2007 and after the first vaccination (time duration to onset not indicated), her daughter developed a runny nose, followed by dizziness, balance problems and impaired vision. Her daughter missed classes due to the dizziness. She visited the physician's office, and was diagnosed with an infection of the 8th cranial nerve. A diagnostic magnetic resonance imaging (MRI) of the head was negative. At the time of this report, the pharmacist's daughter was recovering from the events. The pharmacist considered the events to be disabling/incapacitating, due to the associated dizziness. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rhinorrhoea, Visual disturbance
Clinical narrative: Information has been received from a pharmacist, concerning her 21 year old daughter with an allergy to animals, who was vaccinated IM (date not reported), with the first dose of Gardasil (lot # not reported). Concomitant therapy included hormonal contraceptives (unspecified). On 13-NOV-2007 and after the first vaccination (time duration to onset not indicated), her daughter developed a runny nose, followed by dizziness, balance problems and impaired vision. Her daughter missed classes due to the dizziness. She visited the physician's office, and was diagnosed with an infection of the 8th cranial nerve. A diagnostic magnetic resonance imaging (MRI) of the head was negative. At the time of this report, the pharmacist's daughter was recovering from the events. The pharmacist considered the events to be disabling/incapacitating, due to the associated dizziness. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure increased, Body temperature increased, Echocardiogram, Erythema, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 41 year old female with high cholesterol and hypertension who on 10-SEP-2007 was vaccinated intramuscularly into the right deltoid with a 0.5 mL first dose of Pneumovax 23 (Lot # 658673/0990U). Concomitant therapy included atorvastatin calcium (LIPITOR), stanolone (PROTONA), metoprolol, mometasone furoate (NASONEX) and amlodipine besylate (NORVASC). Within 24 hours post-vaccination, the patient developed tachycardia, increased blood pressure, hot, red, swollen right arm, with swelling from injection site down to elbow and fever of 104 F. The patient was hospitalized on an unspecified date for 2 days. Blood work was performed and the patient had an increased white blood cell count. An echocardiogram was also performed (results unknown). On an unspecified date, the patient was released from the hospital and at a follow-up visit was feeling better ("improving"). No product quality complaint was involved. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pyrexia, Skin warm, Tachycardia, White blood cell count increased
Clinical narrative: Information has been received from a medical assistant concerning a 41 year old female with high cholesterol and hypertension who on 10-SEP-2007 was vaccinated intramuscularly into the right deltoid with a 0.5 mL first dose of Pneumovax 23 (Lot # 658673/0990U). Concomitant therapy included atorvastatin calcium (LIPITOR), stanolone (PROTONA), metoprolol, mometasone furoate (NASONEX) and amlodipine besylate (NORVASC). Within 24 hours post-vaccination, the patient developed tachycardia, increased blood pressure, hot, red, swollen right arm, with swelling from injection site down to elbow and fever of 104 F. The patient was hospitalized on an unspecified date for 2 days. Blood work was performed and the patient had an increased white blood cell count. An echocardiogram was also performed (results unknown). On an unspecified date, the patient was released from the hospital and at a follow-up visit was feeling better ("improving"). No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abasia, Body temperature increased, Injection site infection, Pyrexia, Surgery
Clinical narrative: Information has been received from the mother of a 4 year old male with chronic sinus infections who on 05-DEC-2007 was vaccinated with Pneumovax 23. Concomitant therapy included cefixime (SUPRAX) and influenza virus vaccine (unspecified) "in the other leg". On 05-DEC-2007 the patient developed a fever of 104 degrees and "could not walk". On 06-DEC-2007, he was taken to the emergency room and was admitted to the hospital. The mother reported that an infection had begun in her son's leg at the injection site. She reported that his leg had to be drained via a leg tube in his leg. She stated that he had to have two emergency surgeries and six stitches in his leg. She reported that he was hospitalized for four days and then discharged home to continue with unspecified antibiotics for 6 weeks. She stated that he is recovering at home. Additional information has been requested. 1/4/08 Reviewed hospital medical records which reveal patient experienced fever, swelling, pain & induration of left thigh. Admitted 12/6-12/10/2007.  Taken to OR 12/6 & again on 12/9 for I&D of left thigh.  Allergy/Immunology, ortho & ID consults done.  ID consult mentions that patient also received flu vax. Tx w/multiple IV antibiotics.  Progressed well & d/c to home on continued oral antibiotics.  FINAL DX: myofasciitis, left thigh; chronic otitis media bilateral ears; and yeast infection left axilla. 1/8/08 Received vax record which confirms patient received flu & pneumo.  VAERS database updated w/same.
Age: 4.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Abasia, Incisional drainage, Injection site erythema, Injection site pain, Joint swelling
Clinical narrative: Information has been received from the mother of a 4 year old male with chronic sinus infections who on 05-DEC-2007 was vaccinated with Pneumovax 23. Concomitant therapy included cefixime (SUPRAX) and influenza virus vaccine (unspecified) "in the other leg". On 05-DEC-2007 the patient developed a fever of 104 degrees and "could not walk". On 06-DEC-2007, he was taken to the emergency room and was admitted to the hospital. The mother reported that an infection had begun in her son's leg at the injection site. She reported that his leg had to be drained via a leg tube in his leg. She stated that he had to have two emergency surgeries and six stitches in his leg. She reported that he was hospitalized for four days and then discharged home to continue with unspecified antibiotics for 6 weeks. She stated that he is recovering at home. Additional information has been requested. 1/4/08 Reviewed hospital medical records which reveal patient experienced fever, swelling, pain & induration of left thigh. Admitted 12/6-12/10/2007.  Taken to OR 12/6 & again on 12/9 for I&D of left thigh.  Allergy/Immunology, ortho & ID consults done.  ID consult mentions that patient also received flu vax. Tx w/multiple IV antibiotics.  Progressed well & d/c to home on continued oral antibiotics.  FINAL DX: myofasciitis, left thigh; chronic otitis media bilateral ears; and yeast infection left axilla. 1/8/08 Received vax record which confirms patient received flu & pneumo.  VAERS database updated w/same.
Age: 4.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Pyrexia, Surgery, Ultrasound scan
Clinical narrative: Information has been received from the mother of a 4 year old male with chronic sinus infections who on 05-DEC-2007 was vaccinated with Pneumovax 23. Concomitant therapy included cefixime (SUPRAX) and influenza virus vaccine (unspecified) "in the other leg". On 05-DEC-2007 the patient developed a fever of 104 degrees and "could not walk". On 06-DEC-2007, he was taken to the emergency room and was admitted to the hospital. The mother reported that an infection had begun in her son's leg at the injection site. She reported that his leg had to be drained via a leg tube in his leg. She stated that he had to have two emergency surgeries and six stitches in his leg. She reported that he was hospitalized for four days and then discharged home to continue with unspecified antibiotics for 6 weeks. She stated that he is recovering at home. Additional information has been requested. 1/4/08 Reviewed hospital medical records which reveal patient experienced fever, swelling, pain & induration of left thigh. Admitted 12/6-12/10/2007.  Taken to OR 12/6 & again on 12/9 for I&D of left thigh.  Allergy/Immunology, ortho & ID consults done.  ID consult mentions that patient also received flu vax. Tx w/multiple IV antibiotics.  Progressed well & d/c to home on continued oral antibiotics.  FINAL DX: myofasciitis, left thigh; chronic otitis media bilateral ears; and yeast infection left axilla. 1/8/08 Received vax record which confirms patient received flu & pneumo.  VAERS database updated w/same.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray, Dyspnoea, Pleural effusion, Pneumonitis
Clinical narrative: Information has been received from a doctor of pharmacy, concerning a 77 year old female patient with coronary disease and a history of colon cancer, who on approximately 01-DEC-2007 (possibly 30-NOV-2007) was vaccinated with the fourth dose of Pneumovax 23 (lot # not provided). On approximately 02-DEC-2007 ("within 24 hours") the patient experienced shortness of breath, and was examined by her cardiologist. Treatment included an increased dose of furosemide (LASIX), with no response noted. On 05-DEC-2007, the patient was diagnosed with pneumonitis and was hospitalized. A chest x-ray showed pleural effusion. At the time of this report, the patient was recovering from pneumonitis. The reporting pharmacist considered pneumonitis to be serious as disabling/incapacitating and as an other important medical event. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Asphyxia, Death
Clinical narrative: Patient expired on 12/8/07 after an accidental suffocation at home.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Red/swollen, rash like area, itching at injection site
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Bronchitis, Malaise
Clinical narrative: Tues Nov 12-Following injection, patient talked with nurse and started to work. Patient began to fell bad-similiar to patient's twice a year sinus infections. As soon as patient got to work around 11 am, all patient could do was hand my sick leave request that just read "I feel terrible." Patient went home and stayed there. Patient was weak sick Tues, Wed, Thurs, Fri. Patient saw their doctor on Thurs Nov 15, patient physician diagnosed bronchitis. Antibiotic helped slowly. This was as bad as the flu.
Age: 0.1
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Phone call to family no adverse effects reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Severe pain in right upper extremity at vaccine site. Has persisted for greater than 6 weeks.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea
Clinical narrative: Had Rotateq, Daptacel, Ipol, Comvax and Prevnar on 12/5/07. Diarrhea began 12-6-07 and has continued. Not bloody. Having 3 stools a day.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Gaze palsy, Hypoaesthesia, Immediate post-injection reaction, Musculoskeletal stiffness
Clinical narrative: Pt receive flu and HPV vaccine. Became stiff immediately following HPV. Eyes deviated to (L),increase salivation, (R)arm raised to chest. Placed on floor.Nasal cannula @2L applied. PO 100%. Resp equal and unlabored. Able to focus on father after approx 1 min. Began talking and laughing/crying. Sat pt and given juice(had not eaten since 1100)Visidex 112. PO 99-100% on room air. While sitting in chair, stated difficulty breathing. PO 94-95% on room air. Placed on nasal cannula @2L. States improvement. PO 100%.Resp unlabored. C/o numbness to nose. Cap refill <3secs. Pt talking(tearful at times)and anxious. Dr. notified. Pt to to PED's ER via wheelchair and monitored and released later.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Oxygen supplementation, Salivary hypersecretion
Clinical narrative: Pt receive flu and HPV vaccine. Became stiff immediately following HPV. Eyes deviated to (L),increase salivation, (R)arm raised to chest. Placed on floor.Nasal cannula @2L applied. PO 100%. Resp equal and unlabored. Able to focus on father after approx 1 min. Began talking and laughing/crying. Sat pt and given juice(had not eaten since 1100)Visidex 112. PO 99-100% on room air. While sitting in chair, stated difficulty breathing. PO 94-95% on room air. Placed on nasal cannula @2L. States improvement. PO 100%.Resp unlabored. C/o numbness to nose. Cap refill <3secs. Pt talking(tearful at times)and anxious. Dr. notified. Pt to to PED's ER via wheelchair and monitored and released later.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Blood culture, Computerised tomogram, Full blood count, Lumbar puncture, Unevaluable event
Clinical narrative: This spontaneous report was submitted in relation to an emergency department visit whereby a menigitis rule-out work up was associated with a recent administration of HPV Vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR
Symptoms: Wrong drug administered
Clinical narrative: Inadvertently received Pediarix (DTaP-IPV-HBV) vaccine instead of DTaP.  Also received IPV and MMR vaccines at the same time on 12-19-2007.  E-mailed NIPINFO for guidance informed to complete VAERS report, take steps to ensure that mistake does not happen again and that no intervention is needed for the child. There was no adverse event.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Client was given MMR Varicella 10-12-2007 & given again 12-19-2007 due to vaccine was not put on hard copy immunization record-only computer record.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Right arm and hand are feeling weak, hurts to lift,complains of pain at the site of injection to just below the elbow on the right arm. Pain when lifting. Has seen PMD who reports grips are equal.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Pt called into clinic to inform PCP that her arm is hot, swollen, painful from shoulder to elbow, can not raise arm.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: REDNESS, SWELLING, ITCHING
Age: 0.28
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death
Clinical narrative: Found Dead in Crib 2/27/2008 Autopsy Summary received with COD: Sudden Infant Death Syndrome (SIDS).  Contributing:  Acute Bilateral Otitis Media.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Eye swelling, Herpes zoster, Ophthalmological examination abnormal, Rash
Clinical narrative: Adverse reaction to shingles vaccine 1.  Dec 12, 2007: Injection of Zoster Vaccine Live 2. Dec 13-14 red rash on left upper scalp  3.  Dec 15-16 hives and shingles lesions on left forehead, scalp, nose, and around left eye 4.  Dec 17, 2007 Went to PA who diagosed Shingles, prescribed Valtrex 1 gm, Hydroxzine HCL 25 mg, and Hydrocodone/APAP Tab 5-500 mg  5.  Refered to Optomologist for left eye swelling, who prescribed Pred Forte 1% drops and Alphagan 0.1% drops.  6. Dec 19, 2007: Returned to opthomologist, found eye pressure 34, more drops.  7. Dec. 20, 2007:  Returned to optomologist, eye pressure dropped to 25.  Some viral lesions and cell involvement in left eye.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Adverse reaction to shingles vaccine 1.  Dec 12, 2007: Injection of Zoster Vaccine Live 2. Dec 13-14 red rash on left upper scalp  3.  Dec 15-16 hives and shingles lesions on left forehead, scalp, nose, and around left eye 4.  Dec 17, 2007 Went to PA who diagosed Shingles, prescribed Valtrex 1 gm, Hydroxzine HCL 25 mg, and Hydrocodone/APAP Tab 5-500 mg  5.  Refered to Optomologist for left eye swelling, who prescribed Pred Forte 1% drops and Alphagan 0.1% drops.  6. Dec 19, 2007: Returned to opthomologist, found eye pressure 34, more drops.  7. Dec. 20, 2007:  Returned to optomologist, eye pressure dropped to 25.  Some viral lesions and cell involvement in left eye.
Age: 39.0
Sex: F
Vaccine: DTP, HEPA
Symptoms: Eye discharge, Eye irritation, Facial paresis, Ocular hyperaemia, Skin turgor decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of facial muscle weakness in a 39-year-old female subject who was vaccinated with Havrix for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included DTP vaccine given the same day as Havrix. On 19 October 2007 at 12:00 the subject received 1st dose of Havrix (unknown, left arm) because she was traveling abroad. On 26 October 2007, 7 days after vaccination with Havrix, the subject experienced muscle weakness, loose skin, eye irritation, eye redness, eyes oozing and weight loss. This case was assessed as medically serious. At the time of reporting the events were unresolved.
Age: 39.0
Sex: F
Vaccine: DTP, HEPA
Symptoms: Weight decreased
Clinical narrative: This case was reported by a consumer and described the occurrence of facial muscle weakness in a 39-year-old female subject who was vaccinated with Havrix for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medications included DTP vaccine given the same day as Havrix. On 19 October 2007 at 12:00 the subject received 1st dose of Havrix (unknown, left arm) because she was traveling abroad. On 26 October 2007, 7 days after vaccination with Havrix, the subject experienced muscle weakness, loose skin, eye irritation, eye redness, eyes oozing and weight loss. This case was assessed as medically serious. At the time of reporting the events were unresolved.
Age: 0.3
Sex: M
Vaccine: HIBV, IPV
Symptoms: Infection, Myositis, Nuclear magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: IPV-HIB on 29/11 - 12/10 Fever and pain. Hosp. from 12/10 through 12/13 - MRI inflammation muscle then treated with muscle infection w/ antibiotics. 12/18 Continue w/ left leg pain, unable to bear weight.  01/08/2008 MR received for 2 admissions DOS 12/10-13/2007 with D/C DX: Lower extremity Myositis and 12/26-28/2007 with D/C DX: Osteomyelitis. Infant initially presented to ER from PCP's office with 4-5 day hx of refusal to bear weight/ L leg/knee pain. (+) fever.  PE (+) for L knee swelling and tenderness to palpation. (+) productive cough. Txd with abx which finished 12/24/07.  Then returned with swelling over L distal thigh. Antibiotics resumed to be continued as outpt.
Age: 0.3
Sex: M
Vaccine: HIBV, IPV
Symptoms: Pyrexia, Ultrasound scan, Weight bearing difficulty
Clinical narrative: IPV-HIB on 29/11 - 12/10 Fever and pain. Hosp. from 12/10 through 12/13 - MRI inflammation muscle then treated with muscle infection w/ antibiotics. 12/18 Continue w/ left leg pain, unable to bear weight.  01/08/2008 MR received for 2 admissions DOS 12/10-13/2007 with D/C DX: Lower extremity Myositis and 12/26-28/2007 with D/C DX: Osteomyelitis. Infant initially presented to ER from PCP's office with 4-5 day hx of refusal to bear weight/ L leg/knee pain. (+) fever.  PE (+) for L knee swelling and tenderness to palpation. (+) productive cough. Txd with abx which finished 12/24/07.  Then returned with swelling over L distal thigh. Antibiotics resumed to be continued as outpt.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Paralysis
Clinical narrative: "Complete paralysis below neck" rapidly improved.  12/26/2007 MR received for DOS 9/30-10/10/2007 with D/C DX:  Conversion Disorder.  Anxiety Disorder.  Major Depression.  Mild Demyelinating Polyneuropathy.  Hx of Ovarian CA.  Celiac Artery Stenosis s/p angioplasty and stent.  Bradycardia. Pt presented to local hospital with sudden onset of severe upper and lower extremity weakness rapidly progressing to the point of paraplegia.  Transfered to higher level of care at this facility.  On PE loss of sensation from shoulders down.  Absent reflexes upper and lower except plantar flexor is neutral. Loss of strength in upper and lower extremities.  Multiple consultations.  Pt noted to be under multiple stresses with significant anxiety.  Similar episode 3 yrs ago. Bradycardia noted in ICU. Pt showed rapid improvement over 24 hr period however c/o significant numbness/paresthesias in lower extremities which continued.  Exam 10/8/07 shows continued hyporeflexia, no motor deficits.  Requiring use of walker for ambulation. D/Cd home after unable to get into rehab facility.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Complained of severely sore arm and "unable to go to school"
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Disorientation, Erythema, Feeling abnormal, Oedema peripheral
Clinical narrative: Within an hour or two of shot I experienced redness, swelling, burning in face on side of shot, hives, hands swelled, arm swelled, itching.  Later I developed some congestion & body aches.  On 12/03/07 still have body aches & slight itchiness with just a little congestion.  No visible hives or swelling.  Also on 12/03/07, I felt "funny".  Somewhat scatterbrained like my thoughts were not as cohesive as normal.  I felt something was not right.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pruritus, Respiratory tract congestion, Swelling, Urticaria
Clinical narrative: Within an hour or two of shot I experienced redness, swelling, burning in face on side of shot, hives, hands swelled, arm swelled, itching.  Later I developed some congestion & body aches.  On 12/03/07 still have body aches & slight itchiness with just a little congestion.  No visible hives or swelling.  Also on 12/03/07, I felt "funny".  Somewhat scatterbrained like my thoughts were not as cohesive as normal.  I felt something was not right.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness at injection site.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: Posterior R arm with red, hot, wheal 6.5 cm x 3cm which started 12/13/07 and has progressively gotten larger.  Pt denies any systemic S/S.
Age: 3.0
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Mother states one week after Pt received Comvax started with fever that went up to 104.9.  Went to ER.  Fever x3 days.  Site red & tender Rt thigh.
Age: 1.3
Sex: F
Vaccine: DTAP, FLU3, PNC, VARCEL
Symptoms: Decreased appetite, Insomnia, Irritability, Urticaria
Clinical narrative: Hives on legs and feet.  Irritable.  Decrease in appetite and decrease in sleep.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster, Immediate post-injection reaction
Clinical narrative: Severe herpes zoster along left arm immediately following 2nd HPV vaccine.  Now on Neurontin, Valtrex, pain meds.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Infection, Oedema peripheral, Pain in extremity
Clinical narrative: 10/3 patient experienced discomfort and swelling of L arm between shoulder and elbow, which worsened by Friday 10/5 when she consulted us by phone.  Because of extent of swelling and discomfort we referred pt. to physician, who prescribed Keflex x7 days for infection.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Headache, Laboratory test, Migraine, Ocular hyperaemia
Clinical narrative: Complained of "bad headache" and "swollen red eyes" which started 2 hours after injection, seen by primary care physician who diagnosed "migraine" and prescribed medicine (unknown what), headache continued and she went to emergency room, meningitis was suspected.  Labs and "tests" done, refused spinal tap, spent a day in emergency room Percecet, compazine and IV fluids.  Recovered 48 hours after flu shot.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Malaise, Oedema peripheral, Pain, Tenderness
Clinical narrative: The next day pt felt very "sick", achy.  Took Tylenol.  2 days later arm became very tender, red, swollen, the size of a baseball.  One week later arm is still swollen & tender but redness is abating.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, No reaction on previous exposure to drug, Pyrexia, Tremor
Clinical narrative: Patient came to the office late this afternoon because of the onset of rigors and feeling ill.  Due to her situation, we saw her right away.  By history, she was feeling perhaps a little under the weather yesterday in a nonspecific way.  She got up feeling well this morning, and remembers having her influenza vaccine at about 10:30, this morning.  She felt fine afterwards and had a massage done for neck discomfort between 2:00 and 3:00.  It was about 3:00 in the afternoon that she started having rigors.  She comes in to the office shaking and covering herself up with a jacket.  She was not aware that she is febrile, but is.  On reviewing her medications, she takes nothing by prescription, but is on a number of herbs and vitamins.  I questioned her in detail regarding this illness as there is no obvious explanation for the rigors.  She denies headache or dizziness, sinus symptoms, or sore throat.  There has been no nausea or vomiting, abdominal pain and no diarrhea or change in bowel habits.  She has absolutely no cough, shortness of breath, chest pain, or myalgias at this point.  She denies any urinary symptoms.  There has been no rash.  She has had a flu shot every year without problem.  There has been no itch or urticaria with this flu shot.  She has had a history of smoking, goiter, and from a surgical standpoint is that only a fine needle aspiration of the thyroid and carpal tunnel release.  Blood pressure 110/68.  Heart rate 80 and regular.  Temperature 102.2, which I checked several times.  O2 saturation is 99%.  On exam, she is shivering and has rigors.  She is alert and otherwise looks well.  She feels warm.  On ENT examination, there is no adenopathy.  Her ears are normal.  Pharynx is clear.  No erythema.  Lungs, clear.  Good breath sounds anteriorly and posteriorly.  Heart exam normal.  No murmur.  Abdomen - soft and nontender.  There is no hepatosplenomegaly.  No tenderness anywhere.  No hernia.  Extremities - normal.  No edema.  Skin - no rash.  From the lab standpoint, we checked a urinalysis, which was clear and a white count, which was 9000.  I stayed with her for about 45 minutes through this evaluation.  By then end of the period of time, the rigors had stopped and her fever had peaked up to 102.2.  Again, on re-reviewing the history, there is no symptom that directs us in any area.  Theoretically, this could be a flu shot reaction or reaction to massage, less likely.  More than likely, this is a viral syndrome.  I impressed on her the need to let us know if things change or worsen.  I will call her tonight and we will have someone call her tomorrow morning.  She knows to call us when or if needed.  Presently, there is nothing to use an antibiotic for and I think we need to simply follow.  She is well aware of this and agrees.  Case is closed on 10/23/07 at 9:10 pm.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal, Vaccination complication, Viral infection, White blood cell count normal
Clinical narrative: Patient came to the office late this afternoon because of the onset of rigors and feeling ill.  Due to her situation, we saw her right away.  By history, she was feeling perhaps a little under the weather yesterday in a nonspecific way.  She got up feeling well this morning, and remembers having her influenza vaccine at about 10:30, this morning.  She felt fine afterwards and had a massage done for neck discomfort between 2:00 and 3:00.  It was about 3:00 in the afternoon that she started having rigors.  She comes in to the office shaking and covering herself up with a jacket.  She was not aware that she is febrile, but is.  On reviewing her medications, she takes nothing by prescription, but is on a number of herbs and vitamins.  I questioned her in detail regarding this illness as there is no obvious explanation for the rigors.  She denies headache or dizziness, sinus symptoms, or sore throat.  There has been no nausea or vomiting, abdominal pain and no diarrhea or change in bowel habits.  She has absolutely no cough, shortness of breath, chest pain, or myalgias at this point.  She denies any urinary symptoms.  There has been no rash.  She has had a flu shot every year without problem.  There has been no itch or urticaria with this flu shot.  She has had a history of smoking, goiter, and from a surgical standpoint is that only a fine needle aspiration of the thyroid and carpal tunnel release.  Blood pressure 110/68.  Heart rate 80 and regular.  Temperature 102.2, which I checked several times.  O2 saturation is 99%.  On exam, she is shivering and has rigors.  She is alert and otherwise looks well.  She feels warm.  On ENT examination, there is no adenopathy.  Her ears are normal.  Pharynx is clear.  No erythema.  Lungs, clear.  Good breath sounds anteriorly and posteriorly.  Heart exam normal.  No murmur.  Abdomen - soft and nontender.  There is no hepatosplenomegaly.  No tenderness anywhere.  No hernia.  Extremities - normal.  No edema.  Skin - no rash.  From the lab standpoint, we checked a urinalysis, which was clear and a white count, which was 9000.  I stayed with her for about 45 minutes through this evaluation.  By then end of the period of time, the rigors had stopped and her fever had peaked up to 102.2.  Again, on re-reviewing the history, there is no symptom that directs us in any area.  Theoretically, this could be a flu shot reaction or reaction to massage, less likely.  More than likely, this is a viral syndrome.  I impressed on her the need to let us know if things change or worsen.  I will call her tonight and we will have someone call her tomorrow morning.  She knows to call us when or if needed.  Presently, there is nothing to use an antibiotic for and I think we need to simply follow.  She is well aware of this and agrees.  Case is closed on 10/23/07 at 9:10 pm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Lt arm deltoid area extremely edematous, reddened, warm to touch.  Redness/edema measure 18 cm x 12 cm.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Redness, swelling on left arm.  Prelone given, otc Benadryl, rechecked on 12/13/07 at 2nd appt.  Redness gone, swelling down.  Still hard spots on left arm.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site
Clinical narrative: None-adverse event.  Gardasil #1 given in gluteal area instead of deltoid or lateral thigh.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Headache every day to current, 11 days to current.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC, VARCEL
Symptoms: Full blood count normal, Pyrexia, Rash
Clinical narrative: Rash, fever
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Rt thigh redness around sites and very warm and painful to the touch.  Augmentin 400 BID and Benadryl.  Is following up 1 week.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received vaccine 12/18/07 - 12/20/07 noticed red area dime size.  12/21/07 - area increased to golf ball size.  Red, no fever or neurological changes.  Kept bandaged on at night.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Local reaction, Oedema peripheral
Clinical narrative: Local L arm reaction.  Swelling over the forearm, upper arm.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia, Throat irritation
Clinical narrative: Received immunizations Varivax & Hep A #2 in L delt.  Following a.m. had fever & arm swelling with redness L injection site.  Symptoms stable until 24 hrs after injection, developed lip tingling & throat tightness with pain & arm.  This occurred after a nap.  He was given Benadryl & presented to office with resolution of symptoms.  Exam was normal except for erythema around injection.  Some residual h/a.  Was prescribed Albuterol inhaler although no wheeze on exam.  Completely resolved 12/17/07.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Throat tightness
Clinical narrative: Received immunizations Varivax & Hep A #2 in L delt.  Following a.m. had fever & arm swelling with redness L injection site.  Symptoms stable until 24 hrs after injection, developed lip tingling & throat tightness with pain & arm.  This occurred after a nap.  He was given Benadryl & presented to office with resolution of symptoms.  Exam was normal except for erythema around injection.  Some residual h/a.  Was prescribed Albuterol inhaler although no wheeze on exam.  Completely resolved 12/17/07.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: erythema 10x10 cm surrounding inject site with pain, redness x 8mm
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Injection site pain, Nausea, Tremor
Clinical narrative: 11/15/07 Received PPV 23 vaccine RD at flu clinic which ran from 3-5:30pm. At 6pm 11/15/07 client states pain (L) arm at injection site with chills-skaes 11/16/07 c/o Temp 100.1 with nausea no vomiting. Called primary MD (I) heat-ice and ibuprofen. No Ibuprofen taken. Took Demerol-Vicodin instead used ice on and off.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure
Age: 23.0
Sex: U
Vaccine: TD
Symptoms: Hyperhidrosis, Pallor
Clinical narrative: Patient became pale and diaphoretic after Td vaccination.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pneumovax give 12/17/07 at approx 10:30 am. Pt called later that afternoon about 4:30pm to report area felt itchy/swollen. Declined to come in-advised to take Benadryl and ice to the area per Dr. 12/18/07 contacted pt-swelling decreased-12/19/07 convinced pt to stop by-mild swelling Rt arm with slight redness toward inside of upper arm-checked by Dr.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: 24 hrs after vax developed erythematous raised plaque: 9 mm X 6 mm, warm to touch, mildly tender: No other sx: Improved daily.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Mass, Pain, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of lump (NOS) in a 47-year-old female subject who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  Concurrent medical conditions included hypertension, reflux and coronary artery disease.  In 2005 the subject received unspecified dose of Fluarix (unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced lump (NOS), erythema, swelling and pain.  At the time of reporting the outcome of the events was unspecified.  Follow-up received on 10 October 2007 indicated that the subject had experienced the same reaction with the influenza vaccine (unknown manufacturer) that she received in 2003 and 2004.  She had no problems with the influenza nasal spray.  She stated that following vaccination with Fluarix, she immediately experienced lump (NOS), erythema, swelling and pain.  The events resolved.  The reporter considered that the events were probably related to the use of Fluarix.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Musculoskeletal stiffness
Clinical narrative: This case was reported by a pharmacy clinical coordinator via a sales representative, and described the occurrence of red face in a female subject of unspecified age who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 1 October 2007 at 13:00 the subject received the first dose of Fluarix (.5ml, unknown) at a pharmacy influenza vaccination clinic.  On 1 October 2007, within 3 hours of vaccination with Fluarix, the subject experienced redness of the face and neck and neck stiffness.  At the time of reporting the events were unresolved.
Sex: U
Vaccine: FLU3
Symptoms: Injection site infection
Clinical narrative: This case was reported by a pharmacy student and described the occurrence of injection site infection in a subject of unspecified age and gender who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Fluarix (.5ml, unknown).  At an unspecified time after vaccination with Fluarix, the subject experienced injection site infection.  At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: FLU3
Symptoms: Injection site infection, Staphylococcal infection
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of staphylococcal infection in a subject of unspecified age and gender who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On an unspecified date the subject received unspecified dose of Fluarix in the left deltoid.  An unspecified amount of time after vaccination with Fluarix, the subject experienced staphylococcal infection at the injection site.  At the time of reporting the outcome of the events was unspecified.  Reporter questioned if the lot of vaccine used could have been contaminated.