chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching on various body surfaces. 11 days after vaccine MMR vaccination. Seen 11/23/04,11/24/2004 and 12/01/2004
Age: 1.02
Sex: M
Vaccine: HBHEPB
Symptoms: Viral infection
Clinical narrative: Information has been received from a RN who is a mother of a 13 month old male child who on 01Oct03 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC). On 10Oct03, the pt was positive for B antigens and positive core antigens for hep B. The physician stated that this was not a result of the vaccination with hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) and that he was probably exposed. The reporter also mentioned two female siblings; one was vaccinated with hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) and developed hep B surface antibody quantitative non reactive (WAES310USa02340); the other female sibling was vaccinated with hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) or hep B recombinant (yeast) and had negative titers (WAES0310USA02339). Additional information has been requested. Follow up 03/03/05: Lot number for vaccine number 1 was not provided.
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 2 month old black female with no medical history who on 16Oct03 was vaccinated IM in the left leg with the first dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot 646074/0369N). Concomitant vaccinations on that same day included an IM dose (1st) in the left leg of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot U0997DA), an IM dose (1st) in the right leg of polio virus vaccine inactivated (unspecified) (lot W10022) and an IM dose (1st) in the right leg of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM 1997) (Prevnar) (lot 493266). There was no illness at the time of vaccination. The health professional reported that the pt subsequently developed a fever of 100.8 and swelling at the injection site. At the time of this report, medical attention had not been sought and the outcome was unk. Additional information has been requested.
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site induration
Clinical narrative: Information has been received from a physician concerning a female patient who two months ago, who in approximately January 2004, was vaccinated in the thigh with a dose of hepatitis B virus vaccine + Hib conj vaccine. In approximately January 2004, the patient experienced a knot at the injection site on her thigh. Unspecified medical attention was sought. A product quality complaint was not involved. No further information is available.
Age: 1.05
Sex: M
Vaccine: HBHEPB
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 month old Caucasian male with no past medical history who on 19APR2004 was vaccinated with a third dose of hepatitis B virus vaccine + Hib conj vaccine in the left leg. There was no illness at the time of vaccination.  There were no concomitant vaccinations administered. On 28APR2004 the patient presented with "raging" urticaria. There were no other symptoms. The patient was treated with diphenhydramine HCL and antihistamines. The patient recovered. No product quality complaint involved. There were no relevant diagnostic tests. It was also noted that the patient did not experience any adverse events following prior vaccinations. No further information is expected.
Age: 0.34
Sex: F
Vaccine: HBHEPB
Symptoms: Feeling hot, Injection site reaction, Skin discolouration, Swelling
Clinical narrative: Information has been received from a consumer concerning her 26 week old daughter with asthma who on 17MAR2004 was vaccinated with hepatitis B virus vaccine rHBsAg+Hib conj vaccine. Concomitant medication included budesonide. Subsequently, "later that same day", the patient developed "swelling, heat and small marking at the injection site." Medical attention was sought. The patient was treated with Tylenol and cold compress. It was reported hat "patient still exhibits small marking at the site of injection." The patient's other symptoms subsided within several weeks. No product quality complaint involved. It was also reported that the patient's sibling had a similar reaction (WAES0405USA01949). This is an amended report. The lot number has been added.  Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site swelling, Injection site warmth, Skin discolouration
Clinical narrative: Information has been received from a consumer concerning her 26 month old son who on 17MAR2004 was vaccinated with hepatitis B virus vaccine rHBsAg + Hib conj vaccine. Subsequently, "immediately after administration," the patient developed swelling, heat and small marketing at injection site. Medical attention was sought. The patient was treated with acetaminophen Tylenol and cold compress. The patient's symptoms subsided within several weeks. no product quality complaint involved. It was also reported that the patient's sibling had a similar reaction (WAES 04405USA01765). This is an amended report. The lot number has been added. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site induration
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 10 week old male who on 24MAR2004 was vaccinated with a dose of hepatitis B virus vaccine +Hib conj vaccine. On 24MAR2004, "that evening", the patient developed knots in his leg in the area on the injection. It was noted that treatment was required and the nurse told the mother to put ice on the knots, which resolved the next day on 25MAR2004. The outcome was recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information was received from the reporter and revealed that this was not from hepatitis B virus vaccine +Hibocnj vaccine . No further information has been requested. Follow up 03/03/05: WAES number 604USA00276 does not exist.
Age: 1.25
Sex: M
Vaccine: HBHEPB
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a physician concerning a 15 month old male patient who on 11JUN2004 was vaccinated with a dose of hepatitis B virus vaccine + Hib conj vaccine. The physician reported that redness and swelling appeared immediately. No treatment was required. There was no product quality complaint reported. At the time of the report no other information was available.
Age: 0.2
Sex: F
Vaccine: HBHEPB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 2.5 month old female patient who on 1JUN2004 was vaccinated with a dose of hepatitis b virus vaccine + Hib conj vaccine. The physician reported that redness and swelling appeared at the injection site after being vaccinated. No treatment was required. It was noted that the bump still remains. There was no product quality complaint reported. At the time of the report no other information was available. Unspecified medical attention was sought. Additional information has been requested. The physician also mentioned that a 15 month old male patient developed redness and swelling immediately after injection with hepatitis b virus vaccine + Hib conj vaccine.
Age: 0.52
Sex: M
Vaccine: HBHEPB
Symptoms: Injection site haematoma, Injection site mass, Injection site nodule, Vaccination complication
Clinical narrative: Information has been received from a consumer who is the mother of an 8 month old male child who on approximately 15JUL2004, "2 months ago" was vaccinated IM with a 0.5ml dose of hepatitis b virus vaccine + Hib conj vaccine. It was reported that on approximately 15JUL2004, "since the vaccination", there has been a bruise and knot in the muscle at the injection site. It was also noted that the patient changed physician's and "the new pediatrician thought the symptoms were due to a reaction to the vaccine". Unspecified medical attention was sought. The patient had not recovered. There was no product quality complaint involved. Follow up 03/03/05: Lot number for vaccine not provided.  Follow-up information from the physician indicated that the patient had "severe bruising per mom" and a lump the size of a quarter. It was noted that the patient still had the lump which was slightly "bigger than a nickel now:.  Follow-up information from the physician indicated that the lump on the leg went from the size of a quarter down to the size of a dime and that it lasted three months. The patient's outcome was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB, VARCEL
Symptoms: Crying, Irritability, Pyrexia, Screaming
Clinical narrative: Information has been received from a physician concerning a 12 month old female who on 13Sep04 was vaccinated with a dose of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC). Concomitant vaccines included varicella virus vaccine live (MSD). The physician reported that on the night of 13Sep04, the pt developed a fever of 103F and was described as irritable, crying and inconsolable. The pt's fever continued into 14Sep04. The pt was seen at the physician's office and was treated with ibuprofen. On 15Sep04, the pt's fever resolved. At the time of this report, the outcome of the pt's other events was unk. The reporting physician considered fever, irritable, crying and inconsolable to be other important medical events (OMIC). Additional information has been requested. Follow up 03/03/05: Patient date of birth, lot number for vaccine's 1 and 2 not provided.
Age: 0.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning an approximately 17 week old female twin with no medical history who on 23APR2004, at 10:30 Am, was vaccinated with hepatitis B virus vaccine + Hib conj vaccine. Other suspect therapies administered on the same date included a dose of DPT and polio virus vaccine inactivated. On 23APR2004, 12 hours after the vaccination, the patient experienced a fever of 102.7 degrees Farenheit. The patient's twin sister had a fever of 104 degrees and a seizure which lasted forty five minutes after vaccination with hepatitis b virus vaccine + Hib conj vaccine. . Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Oedema peripheral
Clinical narrative: On 15 Mar 04 @ 2000 arms started aching and had small red spot where shot was given. 16 Mar 04 red was from shoulder past elbow and arm had swollen alot. Dr put me on Cephalexin and Ibuprofen for 10 days.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pain, Swelling, Vaccine positive rechallenge
Clinical narrative: Received anthrax shot in left arm. Arm started hurting and swollen about 2 hrs after shot. 24 hrs later arm starting to turn red and hurts. Swollen more than yesterday.
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Fatigue, Headache, Mucosal inflammation, Myalgia, Pain
Clinical narrative: Within 7 hours of receiving the Flu Mist, I had a severe headache and fatigue. The next morning when I woke up  my nose, sinuses and throat where sore and completely dried out.  For the next seven days I kept a constant headache, body/muscle aches, dry mouth/throat,nasal passages and a low fever off and on but mostly I was extremely faigued.  I went to see the doctor on Tues. Nov 2nd.  He said he believed I had a bad reaction to the flu mist. My mucous membranes where dried out and my sinuses red and swollen. I had most of these symptoms until 12/4.
Age: 29.0
Sex: F
Vaccine: FLUN3
Symptoms: Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Within 7 hours of receiving the Flu Mist, I had a severe headache and fatigue. The next morning when I woke up  my nose, sinuses and throat where sore and completely dried out.  For the next seven days I kept a constant headache, body/muscle aches, dry mouth/throat,nasal passages and a low fever off and on but mostly I was extremely faigued.  I went to see the doctor on Tues. Nov 2nd.  He said he believed I had a bad reaction to the flu mist. My mucous membranes where dried out and my sinuses red and swollen. I had most of these symptoms until 12/4.
Age: 1.41
Sex: M
Vaccine: DTAP, PNC
Symptoms: Urticaria
Clinical narrative: Patient received vaccines in the morning.  Child went to daycare for the afternoon.  When mother was undressing the child that evening noticed hive like welts on chest and arms.  Child came in for appointment on 7 December where mother stated that the child developed more this morning.
Age: 1.15
Sex: F
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: 5 pox on chest; 5 pox on back;  No temperature; no discomfort; Did not require medical attention.
Age: 1.55
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Break through chicken pox; Less than 10 pox on trunk; Did not require medical attention; No temperature; No discomfort.
Age: 20.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Headache, Lymphadenopathy, Pain, Pharyngitis
Clinical narrative: Possible reaction to Smallpox vaccine.  Achiness, headache, swollen glands to throat and left arm pit.
Age: 1.04
Sex: M
Vaccine: FLU3, MMR
Symptoms: Convulsion, Febrile convulsion, Pyrexia, Viral infection
Clinical narrative: On 10/21/04: had synagist fluzone and MMR. On 10/28/04:had temp 104 and seizure x 5 min. Went to ER: final diagnosis from ER was viral syndrome and febrile seizure. On 11/24/04:came to office for more shots and mother  told us had been to ER.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Dizziness, Feeling abnormal, Insomnia, Laryngitis
Clinical narrative: This is a not serious case from a consumer involving sore throat and cough. The reporter causality is not reported. This case qualifies for accelerated reporting. This pt is a 43 year old female who received her first dose of FluMist on 01Nov04. She reports that by the afternoon on 01Nov04 she began feeling weird and light headed, with a low grade fever. the following morning 02Nov04 she felt congested. On 12Nov04 she experienced a low grade fever and lethargy. She reports that from 13Nov04 through 16Nov04 she had a runny nose, sore throat, coughing, throat congestion, as well as the fact that she was sleeping only two to three hours a night due to her symptoms. She started antibiotic therapy on 17No04. She lost her voice for approx 5 days from 11Nov04 until 16Nov04 but now her voice had returned and she is improving overall. No further information is available for this case. Feb 5, 2009 Additional information: Patient date of birth; Product Lot Number; Physician's Information;
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Lethargy, Nasal congestion, Pharyngolaryngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: This is a not serious case from a consumer involving sore throat and cough. The reporter causality is not reported. This case qualifies for accelerated reporting. This pt is a 43 year old female who received her first dose of FluMist on 01Nov04. She reports that by the afternoon on 01Nov04 she began feeling weird and light headed, with a low grade fever. the following morning 02Nov04 she felt congested. On 12Nov04 she experienced a low grade fever and lethargy. She reports that from 13Nov04 through 16Nov04 she had a runny nose, sore throat, coughing, throat congestion, as well as the fact that she was sleeping only two to three hours a night due to her symptoms. She started antibiotic therapy on 17No04. She lost her voice for approx 5 days from 11Nov04 until 16Nov04 but now her voice had returned and she is improving overall. No further information is available for this case. Feb 5, 2009 Additional information: Patient date of birth; Product Lot Number; Physician's Information;
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration
Clinical narrative: 14 cm induration at injection site. Treated with Clarinex
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Hypersensitivity, Oedema
Clinical narrative: Local "allergic" or inflammatory reaction whole upper arm swollen red, not infected
Age: 1.03
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Viral infection
Clinical narrative: Lesions: legs and trunk, 20 per school nurse, looked like bug bites. Became blister like later in day per mother. Saw doctor 12/07/2004: lesions consistent with chicken pox. Shares classroom with child who developed shingles 11/18/04.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site reaction, Swelling, Tenderness
Clinical narrative: Local : erythema, swelling, redness, tender. 1. at site of injection right hip. 2. right inguinal glands swollen: redness, tenderness.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site reaction, Myalgia, Nausea, Pain
Clinical narrative: Immediately after injection, patient stated her arm hurt and she felt pressure at one side. The next day she had decreased energy ad had waves of nausea but no vomiting. Decreased energy lasted 2 weeks. Pain radiated from elbow to neck x 1 week. Currently complains of pressure at injection site and pain when moving arm. Denies swelling. Mass, arm down to site. Has seen chiropractor and GI specialist since incident . No treatment received. Still with symptoms of pain.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Immediately after injection, patient stated her arm hurt and she felt pressure at one side. The next day she had decreased energy ad had waves of nausea but no vomiting. Decreased energy lasted 2 weeks. Pain radiated from elbow to neck x 1 week. Currently complains of pressure at injection site and pain when moving arm. Denies swelling. Mass, arm down to site. Has seen chiropractor and GI specialist since incident . No treatment received. Still with symptoms of pain.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspepsia, Pain, Urticaria
Clinical narrative: Approximately 48 hours after vaccination was received, I ached all over and was very tired. I developed a severe case of hives that evening 11/21/04. Taking Benadryl relieved the hives. The hives reappeared and disappeared over the next three days, but not as severe as the first onset. Stomach upset occurred on 11/25/04.It was 11/26PM before I started to feel normal. I have had flu shot in many previous years, but never had an adverse effect from the shot.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness
Clinical narrative: Child received Aventis flu vaccine dose #2 12/01/2004. History of asthma. Developed drooping of her left hip. Report received on 02/22/2005: Age of patient: 2yrs, 6 monts. Vacine:  FIV No other vaccines give with Flu vaccine.  Diagnosis is Bells Palsy, made by the Pediatrician.  Main symptoms are drooping left hip.  The symptoms occurred the next day after vaccine.  There is documentation of Bells Palsy on the other side 10 months before vaccine.
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Rash erythematous, Rash macular
Clinical narrative: S/post injections. Infant exhibited red macular rash on trunk and extremities. Infant was also red from strenuous crying. No hives. No respiratory stress. Treated. Detained for 15-20 minutes, rash resolved. Infant took bottle, burped and was sleeping comfortably when departed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Erythema, Feeling hot
Clinical narrative: 1.3x3"circular, red, warm to touch on left upper thigh. Treated with Benadryl po, cold compress. 2. 1.5x1.5" circular red spot on right upper arm.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Severe itching, hives with wheals, erythema reaction treated with Benadryl. Hives improved: pt sent home after 1.5 hour observation with prescription of Benedryl and Prednisone.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Feeling hot, Hypokinesia, Injection site erythema, Injection site oedema
Clinical narrative: Arm developed swelling, redness, pain, hot to touch w/in 12 hrs of injection, trouble lifting left arm, chills
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: Arm developed swelling, redness, pain, hot to touch w/in 12 hrs of injection, trouble lifting left arm, chills
Age: 36.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthritis, Lymphadenopathy, Viral infection
Clinical narrative: Vaccine received 11/8/04, on 11/25/04 papules develop, lymph nodes enlarge on neck, axilla and groin. Arthritic joints all last 7-10 days, ER visit dx chicken pox. Prescribe acyclovir. Not taken.
Age: 32.0
Sex: M
Vaccine: FLUN3
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient was given Flu Mist vaccine 6 Dec 04. Later that evening he began to have some itching and came to the medical clinic the next morning where he was examined and assessment of urticaria was made.  He was treated with Benadryl. All treatment provided was outpatient.
Age: 0.62
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Muscle spasms, Muscle twitching, Pyrexia, Vomiting
Clinical narrative: I am physician who took the overnight call from pt's mother.  Pt had been well before 6mos shots but began with 1)fever 104'F  2)"all over body spasms and twitches" per mother over the phone.   I referred pt to local peds ER where they attributed fever/emesis to DTaP administration earlier in the day.  On the ER report it says that Neurol exam was normal.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Chills & Fever
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Erythema, Viral infection
Clinical narrative: ERYTHEMATOUS-BASED VESICLES AND PUSTULES OVER THE BACK AND BUTTOCK AREA - 13 DAYS POST VARICELLA VACCINE  dx: VACCINE INDUCED VARICELLA
Age: 45.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Erythema, Pruritus, Rash erythematous, Urticaria
Clinical narrative: Onset of symptoms occurred 11-24-04, approximately 22 hours after administration. Pt. described hive-like rash starting at both axilla and spreading across the chest, neck and shoulders- discreet raised areas, itching with erythema surrounding them then coalescing to one large area. Pt denied dyspnea or shortness of breath. He took OTC Benadryl for three days and rash subsided. He presented to the immunization clinic on 12-2-04. No visible signs of rash remained. Pt denied new foods or other exposure to new products.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema
Clinical narrative: When patient returned to our office for her third Hepatitis B vaccine. She told us she had some facial swelling near her lips to the extent that it was noticeable by others after the second shot. When questioned further she admitted to minimal swelling near her lips after the first shot.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Conjunctivitis, Electrocardiogram abnormal, Eyelid ptosis, Facial palsy, Headache
Clinical narrative: PATIENT RECEIVED VACCINE ON 10/7/2004 AND ON 10/21/2004 SHE AWOKE WITH FACIAL PARALYSIS, LATER DIAGNOSED AS BELL'S PALSY. Medical Records received on 1/20/2005 states pt experienced ptosis, pain, headache, hypertension and conjunctivitis.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Pain
Clinical narrative: PATIENT RECEIVED VACCINE ON 10/7/2004 AND ON 10/21/2004 SHE AWOKE WITH FACIAL PARALYSIS, LATER DIAGNOSED AS BELL'S PALSY. Medical Records received on 1/20/2005 states pt experienced ptosis, pain, headache, hypertension and conjunctivitis.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Fatigue, Muscular weakness, Pneumonia
Clinical narrative: 11/24 c/o weakness, muscle fatigue, the muscles in her thighs and above her elbows especially. When she exerts her muscles she feels stronger than when she is relaxed. She feels like her muscles are "going to sleep". Went to the ER 11/25/04. EKG and blood tests were OK. A chest x-ray revealed a patch that could be pnuemonia. She has had a cold and has had a little cough since September. They Rxed a Z-pack. She saw her Dr. 11/30 because of the continued muscle weakness. A CAT scan of her chest and blood work were normal. She is scheduled for pulmonary tests and a stress test on 12/13/04.
Age: 48.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain, Chills, Hyperhidrosis, Pyrexia, Urticaria
Clinical narrative: Received FluMist vaccine on Monday, 11/29/04 at approximately 1:00 p.m.  No prior allegry to eggs or the regular flu shot vaccine I received in 2003, 2002, and 2001 without any problems.  Started to develop hives over entire body by about 7:00 p.m. on 11/29/04.  Called doctor on Tuesday afternoon (11/30/04) around 3:00 p.m.  Was told to take Benadryl for hives on body and face.  Called Registered Nurse Phone Line on Tuesday evening (11/30/04) around 11:00 p.m. Called my rheumatologist on Tuesday (11/30/04) about 11:30 p.m.  I was prescribed 20 mg of prednisone with Benadryl to be taken at that time.  On Wednesday (12/1/04) the hives had not diminished at all over entire body and face.  Around 5:30 p.m. called the Registered Nurse Phone Line.  Around 6:00 p.m. called doctor, who prescribed another 20 mg prednisone to be taken with Benadryl at that time.  Benadryl had no effect.  Thursday morning (12/2/04) around 1:00 a.m. had low-grade temperature of 99.2, with sweating alternating with chills, and mild intestinal discomfort.  Saw doctor on Thursday morning (12/2/04) in her office at about 11:00 a.m.  Hives and white-edged ring shaped red spots still covered body and face.  She said the activity on my skin was hives and flu virus. Doctor prescribed a decreasing dose of prednisone, starting with 40 mg, along with Allegra 180 once a day, and topical Lidex.  Lidex had no effect. Thursday (12/2/04) hives were suppressed by prednisone and Allegra 180 for about 10 hours.  Friday (12/3/04) hives were suppressed by prednisone and Allegra 180 for about 14 hours.  Hives and red spots have been suppressed by prednisone and Allegra 180 since Saturday (12/4/04).  As of Wednesday (12/8/04), have two more days of .05 mg of prednisone with one Allegra 180 daily.  Scheduled to take Allegra 180 through Sunday (12/13/04).
Age: 16.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Brain oedema, Cardio-respiratory arrest, Cerebral haemorrhage, Convulsion, Fall
Clinical narrative: Patient fainted and fell to the floor several minutes after receiving the Hep B vaccine (#3) and sustained a head injury. The patient went into a seizure and cardiopulmonary arrest and CPR was not successful. Follow Up: frontal lobe contusion, cerebral hemorrhage, cerebral edema Autopsy report received which revealed COD as blunt head trauma, occipital scalp contusion, contre-coup contusions, 10-ml subarachnoid hemorrhage of right frontal region, cerebral edema and transtentorial herniation.
Age: 16.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Injury, Syncope
Clinical narrative: Patient fainted and fell to the floor several minutes after receiving the Hep B vaccine (#3) and sustained a head injury. The patient went into a seizure and cardiopulmonary arrest and CPR was not successful. Follow Up: frontal lobe contusion, cerebral hemorrhage, cerebral edema Autopsy report received which revealed COD as blunt head trauma, occipital scalp contusion, contre-coup contusions, 10-ml subarachnoid hemorrhage of right frontal region, cerebral edema and transtentorial herniation.
Age: 16.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Chest pain, Convulsion, Delirium, Injury, Loss of consciousness
Clinical narrative: Patient fainted and fell to the floor several minutes after receiving the Hep B vaccine (#3) and sustained a head injury. The patient went into a seizure and cardiopulmonary arrest and CPR was not successful. Follow Up: frontal lobe contusion, cerebral hemorrhage, cerebral edema Autopsy report received which revealed COD as blunt head trauma, occipital scalp contusion, contre-coup contusions, 10-ml subarachnoid hemorrhage of right frontal region, cerebral edema and transtentorial herniation.
Age: 16.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Pain
Clinical narrative: Patient fainted and fell to the floor several minutes after receiving the Hep B vaccine (#3) and sustained a head injury. The patient went into a seizure and cardiopulmonary arrest and CPR was not successful. Follow Up: frontal lobe contusion, cerebral hemorrhage, cerebral edema Autopsy report received which revealed COD as blunt head trauma, occipital scalp contusion, contre-coup contusions, 10-ml subarachnoid hemorrhage of right frontal region, cerebral edema and transtentorial herniation.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Unevaluable event
Clinical narrative: This case was reported by a consumer and described the occurrence of death in a 2-month-old male patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed. The reporter is the sister of the patient. A physician or other health care professional has not verified this report. On an unspecified date, the patient received a dose of Infanrix (dose number not specified). At an unspecified time following the administration of Infanrix, on an unspecified date, the patient died. The cause of death was not provided. It is unknown whether an autopsy was performed.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Cyanosis, Listless, Somnolence
Clinical narrative: Feet and hands blue, pt listless, sleeping, seen by Dr at clinic, monitored and discharged with no treatment. Resolved on own. *Should this infant be tested for egg allergy*
Age: 0.46
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV
Symptoms: Bacterial infection, Contusion, Cough, Crying, Injection site erythema
Clinical narrative: Pt came in to office day after immunizations with redness, Sl swelling, feverish and tender discoloration above inj site and up to armpit. Pt temp 102.8, inconsolable crying. Bruised looking along left side and across buttocks. From discharge summary states group B strep, from medical records cough. msv
Age: 0.46
Sex: M
Vaccine: DTAP, FLU3, HIBV, IPV
Symptoms: Pyrexia, Screaming, Skin discolouration, Swelling, Tenderness
Clinical narrative: Pt came in to office day after immunizations with redness, Sl swelling, feverish and tender discoloration above inj site and up to armpit. Pt temp 102.8, inconsolable crying. Bruised looking along left side and across buttocks. From discharge summary states group B strep, from medical records cough. msv
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Anorexia, Asthenia, CSF test abnormal, Cough, Dehydration
Clinical narrative: Right frontal headache, numbness, weakness, vocal cord paralysis, Guillain-Barre Syndrome. IVIG started 12/4/04.   12/09/04 Spoke with reporter. Patient is a retired MD and hospital volunteer. He received Fluzone, lot U1527AA on 11/15/04 at the hospital. He was well at the time and within the month prior to the best of reporter's knowledge. He receives flu vaccine each year and has not experienced an AE previously. There is no known history of prior GBS or related illness. Initially it was thought that this gentleman was suffering from sinusitis due to his c/o frontal HA. He was treated with Biaxin, but got progressively worse and by 12/2/04 he was admitted to hospital with nausea, facial numbness, and an episode of falling. He has been treated with IVIG and Acyclovir and diagnosed with a variant of GBS. Yesterday he was transferred to ICU and prognosis is guarded. Pt has been up to bedside commode and appears oriented with clear speech, but hoarseness.  Medical records received on 12/15/2004 states pt remains in hospital at time of follow-up. Diagnosis of GBS confirmed. Pt experienced the following symptoms: right-sided earache and eye ache, hoarseness, sore throat & upper airway congestion, anorexia, and hypoglycemia. On PE symptoms were noted of dehydration, slurred speech, dysphagia, increasing cough, sinus tachycardia, and rhonchi. Follow Up: Admitted to hospital 12/2/04. Transferred from floor to ICU on 12/8/04. Initially treated for suspected sinusitis (Biaxin). Progressively worsened: nausea, falling, facial paralysis. Treated with Acyclovir and IVIG. Currently oriented with clear speech and hoarseness. Follow up 02/22/05: Recovery status unknown.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Dysarthria, Dysphagia, Dysphonia, Ear pain, Eye pain
Clinical narrative: Right frontal headache, numbness, weakness, vocal cord paralysis, Guillain-Barre Syndrome. IVIG started 12/4/04.   12/09/04 Spoke with reporter. Patient is a retired MD and hospital volunteer. He received Fluzone, lot U1527AA on 11/15/04 at the hospital. He was well at the time and within the month prior to the best of reporter's knowledge. He receives flu vaccine each year and has not experienced an AE previously. There is no known history of prior GBS or related illness. Initially it was thought that this gentleman was suffering from sinusitis due to his c/o frontal HA. He was treated with Biaxin, but got progressively worse and by 12/2/04 he was admitted to hospital with nausea, facial numbness, and an episode of falling. He has been treated with IVIG and Acyclovir and diagnosed with a variant of GBS. Yesterday he was transferred to ICU and prognosis is guarded. Pt has been up to bedside commode and appears oriented with clear speech, but hoarseness.  Medical records received on 12/15/2004 states pt remains in hospital at time of follow-up. Diagnosis of GBS confirmed. Pt experienced the following symptoms: right-sided earache and eye ache, hoarseness, sore throat & upper airway congestion, anorexia, and hypoglycemia. On PE symptoms were noted of dehydration, slurred speech, dysphagia, increasing cough, sinus tachycardia, and rhonchi. Follow Up: Admitted to hospital 12/2/04. Transferred from floor to ICU on 12/8/04. Initially treated for suspected sinusitis (Biaxin). Progressively worsened: nausea, falling, facial paralysis. Treated with Acyclovir and IVIG. Currently oriented with clear speech and hoarseness. Follow up 02/22/05: Recovery status unknown.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy, Fall, Guillain-Barre syndrome, Headache, Hyperglycaemia
Clinical narrative: Right frontal headache, numbness, weakness, vocal cord paralysis, Guillain-Barre Syndrome. IVIG started 12/4/04.   12/09/04 Spoke with reporter. Patient is a retired MD and hospital volunteer. He received Fluzone, lot U1527AA on 11/15/04 at the hospital. He was well at the time and within the month prior to the best of reporter's knowledge. He receives flu vaccine each year and has not experienced an AE previously. There is no known history of prior GBS or related illness. Initially it was thought that this gentleman was suffering from sinusitis due to his c/o frontal HA. He was treated with Biaxin, but got progressively worse and by 12/2/04 he was admitted to hospital with nausea, facial numbness, and an episode of falling. He has been treated with IVIG and Acyclovir and diagnosed with a variant of GBS. Yesterday he was transferred to ICU and prognosis is guarded. Pt has been up to bedside commode and appears oriented with clear speech, but hoarseness.  Medical records received on 12/15/2004 states pt remains in hospital at time of follow-up. Diagnosis of GBS confirmed. Pt experienced the following symptoms: right-sided earache and eye ache, hoarseness, sore throat & upper airway congestion, anorexia, and hypoglycemia. On PE symptoms were noted of dehydration, slurred speech, dysphagia, increasing cough, sinus tachycardia, and rhonchi. Follow Up: Admitted to hospital 12/2/04. Transferred from floor to ICU on 12/8/04. Initially treated for suspected sinusitis (Biaxin). Progressively worsened: nausea, falling, facial paralysis. Treated with Acyclovir and IVIG. Currently oriented with clear speech and hoarseness. Follow up 02/22/05: Recovery status unknown.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Hypoglycaemia, Hyponatraemia, Lung disorder, Nasal congestion
Clinical narrative: Right frontal headache, numbness, weakness, vocal cord paralysis, Guillain-Barre Syndrome. IVIG started 12/4/04.   12/09/04 Spoke with reporter. Patient is a retired MD and hospital volunteer. He received Fluzone, lot U1527AA on 11/15/04 at the hospital. He was well at the time and within the month prior to the best of reporter's knowledge. He receives flu vaccine each year and has not experienced an AE previously. There is no known history of prior GBS or related illness. Initially it was thought that this gentleman was suffering from sinusitis due to his c/o frontal HA. He was treated with Biaxin, but got progressively worse and by 12/2/04 he was admitted to hospital with nausea, facial numbness, and an episode of falling. He has been treated with IVIG and Acyclovir and diagnosed with a variant of GBS. Yesterday he was transferred to ICU and prognosis is guarded. Pt has been up to bedside commode and appears oriented with clear speech, but hoarseness.  Medical records received on 12/15/2004 states pt remains in hospital at time of follow-up. Diagnosis of GBS confirmed. Pt experienced the following symptoms: right-sided earache and eye ache, hoarseness, sore throat & upper airway congestion, anorexia, and hypoglycemia. On PE symptoms were noted of dehydration, slurred speech, dysphagia, increasing cough, sinus tachycardia, and rhonchi. Follow Up: Admitted to hospital 12/2/04. Transferred from floor to ICU on 12/8/04. Initially treated for suspected sinusitis (Biaxin). Progressively worsened: nausea, falling, facial paralysis. Treated with Acyclovir and IVIG. Currently oriented with clear speech and hoarseness. Follow up 02/22/05: Recovery status unknown.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea, Pharyngolaryngeal pain, Sinus tachycardia, Sinusitis, Vocal cord paralysis
Clinical narrative: Right frontal headache, numbness, weakness, vocal cord paralysis, Guillain-Barre Syndrome. IVIG started 12/4/04.   12/09/04 Spoke with reporter. Patient is a retired MD and hospital volunteer. He received Fluzone, lot U1527AA on 11/15/04 at the hospital. He was well at the time and within the month prior to the best of reporter's knowledge. He receives flu vaccine each year and has not experienced an AE previously. There is no known history of prior GBS or related illness. Initially it was thought that this gentleman was suffering from sinusitis due to his c/o frontal HA. He was treated with Biaxin, but got progressively worse and by 12/2/04 he was admitted to hospital with nausea, facial numbness, and an episode of falling. He has been treated with IVIG and Acyclovir and diagnosed with a variant of GBS. Yesterday he was transferred to ICU and prognosis is guarded. Pt has been up to bedside commode and appears oriented with clear speech, but hoarseness.  Medical records received on 12/15/2004 states pt remains in hospital at time of follow-up. Diagnosis of GBS confirmed. Pt experienced the following symptoms: right-sided earache and eye ache, hoarseness, sore throat & upper airway congestion, anorexia, and hypoglycemia. On PE symptoms were noted of dehydration, slurred speech, dysphagia, increasing cough, sinus tachycardia, and rhonchi. Follow Up: Admitted to hospital 12/2/04. Transferred from floor to ICU on 12/8/04. Initially treated for suspected sinusitis (Biaxin). Progressively worsened: nausea, falling, facial paralysis. Treated with Acyclovir and IVIG. Currently oriented with clear speech and hoarseness. Follow up 02/22/05: Recovery status unknown.
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis 4cmx8cm on left thigh, placed on Bactrim 2 teaspoons twice a day
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Dizzy, diaphoretic, weak, nausea, felt above symptoms immediately on a lifted head off pillow in AM to get out of bed, felt fine if laid perfectly still. Symptoms started to subside in early afternoon. Felt fine about 4:30PM
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Within 24-48 hrs, +redness, pain, and induration Left leg around injection site.
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Mom states w/i evening of shot +redness, pain, and induration around injection site, increasing over past 48 hours.
Age: 59.0
Sex: U
Vaccine: TTOX
Symptoms: Hypokinesia, Pain
Clinical narrative: Pain in the left arm, while doing certain activities
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Oedema
Clinical narrative: Bilateral palpation edema 15 min after vaccinations. Pt administered Benadryl 25mg 10.5ml IM right Gluteal muscle. Prescription given for Prednisone per MD.
Age: 6.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Erythema
Clinical narrative: Diffuse erythema right upper arm 8cm x7cm. Rx. Keflex 2 BID x 2 days
Age: 4.0
Sex: M
Vaccine: PPV
Symptoms: Difficulty in walking, Hypokinesia, Oedema
Clinical narrative: Leg swollen and edematous. Cant' walk on it.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Difficulty in walking, Feeling hot, Lethargy, Oedema, Pyrexia
Clinical narrative: Hot swollen leg bump around to back of leg, fever, lethargy, can't walk.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Skin nodule
Clinical narrative: Hot swollen leg bump around to back of leg, fever, lethargy, can't walk.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Abnormal behaviour, Injection site erythema, Injection site oedema, Injection site rash, Lethargy
Clinical narrative: Leg red, swollen, with red bumps around injection site, child was lethargic and not himself.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site inflammation
Clinical narrative: APDT given 11/05/2004 LD Inflammation from shoulder to elbow Followup 02/09/07: Left deltoid swelling from elbow to shoulder, 11/06/04. Seen by MD, who advised motrin and ice.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site oedema, Injection site pain, Pain, Urticaria
Clinical narrative: Discomfort left shoulder, some swelling at site, achy, headache, hives over left shoulder, some overweight left side of neck (vaccine given IM left deltoid).
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Pharyngolaryngeal pain, Swelling
Clinical narrative: A report was received from a healthcare professional on 10/07/2003 concerning a 21 year old female vaccinee who developed a swollen, aching arm, flu-like symptoms including body aches and a sore throat on 10/03/2003 after receiving Fluvirin vaccine on 10/03/2003. The vaccinee's arm became swollen and ached following vaccination.  That evening the vaccinee experienced flu-like symptoms including body aches and a sore throat.  The doctor who administered the vaccine and a co-worker were also given the same vaccination and both experienced the same symptoms.  The vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Pain, Pharyngolaryngeal pain, Swelling
Clinical narrative: A report was received from a healthcare professional on 10/07/2003 concerning a 36 year old female vaccinee who developed a swollen, aching arm, flu-like symptoms including body aches and a sore throat on 10/03/2003 after receiving Fluvirin vaccine on 10/03/2003. The vaccinee's arm became swollen and ached following vaccination.  That evening the vaccinee experienced flu-like symptoms including body aches and a sore throat.  The co-worker who administered the vaccine and a second co-worker were also given the same vaccination and both experienced the same symptoms.  The vaccinee had recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Injection site hypersensitivity, Pruritus
Clinical narrative: A report was received from a health care professional on 11Dec03 concerning a 34 year old female vaccinee who experienced hypersensitivity with a feeling of itching in the throat and tightening, redness and a feeling of itching all over her body and difficulty breathing, which was considered medically significant, on 15Oct03 at 21:25 hours after receiving Fluvirin vaccine on 15Oct03 at 21:00 hours. The vaccinee has a history of several environmental allergies and comedications included cetirizine hydrochloride, citalogram and another drug to be confirmed. On 15Oct03 at 21:25 hours the vaccinee experienced a feeling of itching in the throat and tightening and took 50mg oral diphenhydramine hydrochloride. By 22:00 hours the attending physician referred the vaccinee to the ER for additional treatment as the vaccinees entire body had become red and itchy. The vaccinee received additional treatment with IV diphenhydramine hydrochloride and IV methylprednisolone sodium succinate in the ER and was discharged home on 16Oct03 at approximately 00:30 hours on 40mg oral prednisolone sodium phosphate for 15 days, 20mg cetirizine hydrochloride and 200mg oral diphenhydramine hydrochloride daily. The vaccinee was seen by a physician on the 16Oct03 and due to continued, itching and difficulty breathing was given 125mg IM methylprednisolone sodium succinate. The outcome was not reported at the time of this report. There was insufficient information to determine the reporters causality assessment. Follow up pending. Follow up received 18Jun04: follow up information received from an occupational health nurse on 18Jun04. The vaccinee was diagnosed as having an anaphylactic reaction to flu vaccine. Her symptoms included itchiness and swollen tongue. The symptoms started on 15Oct03 following vaccination and resolved on 16Oct03 (swollen tongue) and on 17Oct03 (itchiness). She had received flu vaccine for the previous two years without reaction. Her last influenza vaccination was given on 20Oct02. The anaphylactic reaction was treated with 125mg SoluMedrol, 50mg Benadryl and 40mg Prednisone for 5 days. Her concomitant medications included Zyrtec 10mg, Albuterol Inhaler, Esgic and Benadryl. Her past medications included Keflex and Vicodin. The reporter considers the event serious as medical intervention was required. The reporter has submitted a report on this case.