chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: HEPAB
Symptoms: Dysgeusia, Incorrect dose administered
Clinical narrative: This case was reported by a nurse and described the occurrence of strange taste in mouth in a 61 year old female subject who was vaccinated with Twinrix for prophylaxis. The nurse reported that, "several other patients" also experienced a strange taste in the mouth following vaccination with Twinrix, however a specified number of subjects was not reported. The subject had no pre-existing medical conditions. There were no concurrent medications. On 29 December 2005, the subject received the 1st dose of Twinrix. On 07 February 2006 at 9:30 am, the subject received 2nd dose of Twinrix (lot AHABB043AA). This is longer than the recommended interval of one month between the 1st and 2nd doses of Twinrix. "Right after getting the Twinrix dose," on 07 February 2006, the subject experienced "a funny taste in her mouth." The event resolved on 07 Feb 2006.  The nurse considered the funny taste in mouth to possible be related to vaccination with Twinrix.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Arthralgia, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of joint pain in a 48 year old female subject who was vaccinated with Twinrix for prophylaxis. There were no concurrent medications. On 19 October 2005 the subject received 1st dose of Twinrix in the right arm (lot AHABB030AA). On 19 October 2005, less than one day after vaccination with Twinrix, the subject experienced joint pain, vomiting, diarrhea and a "low grade temperature." The subject was seen at a physician's office. The events resolved on an unspecified date on or after 19 October 2005 and on or before 25 October 2005.
Age: 30.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: This case was reported by a consumer and described the occurrence of arm weakness in a 30-year-old female subject who was vaccinated with TWINRIX for prophylaxis. A physician or other health care professional has not verified this report. On 14 September 2005 the subject received 1st dose of TWINRIX (lot not specified) to the right arm. On 14 September 2005, less than one day after vaccination with TWINRIX, the subject experienced arm weakness and soreness in the right arm. The subject required unspecified medical attention at the physician's office. At the time of reporting the events were improved.
Age: 59.0
Sex: F
Vaccine: HEPAB
Symptoms: Incorrect route of drug administration, Skin burning sensation
Clinical narrative: This case was reported by a nurse and described the occurrence of burning skin in a 59-year-old female subject who was accidentally exposed to TWINRIX for prophylaxis. The reporter is the subject. The subject's medical history included high blood pressure and high cholesterol. Concurrent medications included PRAVACHOL to treat high cholesterol and ENALAPRIL to treat high blood pressure. The subject reported that on 30 September 2005 she "handled a broken TWINRIX pre-filled syringe and experienced burning (skin) on her hand." The subject "washed her hand several times with water and put white soft paraffin (VASELINE) on her hand." The hand burning resolved on 01 October 2005 "at 10:00 a.m." The subject "did not have the lot number nor expiration date." She reported that "there was one broken syringe in a package of five." Follow-up will not be available.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: Abdominal pain, Constipation, Pregnancy test false positive, Uterine spasm
Clinical narrative: This case was reported by a physician's assistant and described a 32 year old female subject who was vaccinated with Twinrix during the first trimester of pregnancy. Concurrent medications included Ambien, Prevacid, Zyrtec, Colace, and "Urisodil"(unspecified medication). On 10 August 2005, the subject received 1st dose of Twinrix (lot AhABB030AA). The physician assistant reported that, "the patient was 5 weeks pregnant when the Twinrix was administered" (first trimester). At an unspecified time later, the subject experienced uterine and abdominal cramping. Further immunization with Twinrix was delayed until after delivery "or as directed by obstetrician." At the time of reporting, the outcome of the events were unknown; however, the pregnancy was ongoing. Follow-up received on 31 July 2006 from the physician's assistant indicated that the mother had  a history of hypertension, extreme obesity, gastroesphaeal reflux, seasonal allergies and "years" status gastric banding. The abdominal cramping resolved following treatment with Colace and Dulcolax suppositories. The abdominal cramping was attributed to constipation. On 11 April 2006, the mother delivered a healthy, term male via spontaneous vaginal delivery. His APGARS were 9 (one minute) and 10 (five minutes). The infant was reportedly "doing fine" and developing normally.
Age: 44.0
Sex: F
Vaccine: HEPAB, TTOX, TYP
Symptoms: Chest discomfort, Chest pain
Clinical narrative: This case was reported by a nurse and described the occurrence of chest pain in a 43 year old female subject who was vaccinated with Twinrix for prophylaxis. Medical history included codeine allergy and migraine. Concurrent medications included Imitrex for migraine and Allegra, Doxepin, Wellbutrin and Zonegran for unspecified drug indications. The subject told the nurse that at the time of receipt of the vaccinations she, "was very stressed about traveling." On 5 August 2005 the subject received the 1st dose of Twinrix (lot AHABA016AA). On 05 August 2005, the subject was also vaccinated with Typhim Vi and tetanus toxoid vaccine. "Within 24 hours" following the receipt of the vaccinations. On 06 August 2005, the subject experienced chest pain described as mild tightness. The subject was seen by her "regular physician." The events resolved on an unspecified date on or after 06 August 2005 and on or before 02 September 2005. The nurse considered the events to possibly be related to vaccination with Twinrix. Follow up will not be available.
Age: 46.0
Sex: M
Vaccine: HEPAB
Symptoms: Headache, Malaise, Vertigo
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of vertigo in a 45-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. Concurrent medications included Atenolol and Atorvastatin calcium (Atorvastatin) for unspecified medical conditions. On 17 August 2005 the subject received the first dose of Twinrix (lot AHABB078AA). At an unspecified time following receipt of the first dose of Twinrix, on 17 August 2005, the subject experienced vertigo, malaise and headache. The subject was seen at a physician's office and was treated with meclozine (Meclizine) and paracetamol (Acetaminophen). At the time of initial reporting, 22 August 2005, the events were ongoing. The nurse practitioner considered  the events to possibly be related to vaccination with Twinrix. On follow-up received from the nurse practitioner on 28 September 2006, the nurse noted the subject was a male. The events had resolved completely. ON an unspecified date, Twinrix was reintroduced without incident. In the nurse practitioner's opinion, the events may have been associated with a concurrent illness.
Age: 71.0
Sex: F
Vaccine: HEPAB
Symptoms: Chills, Diarrhoea, Urticaria, Vomiting, Wheezing
Clinical narrative: This case was reported by a physician and described the occurrence of hives in a 70-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis. The subject has no history of allergies and does not consume alcohol or tobacco. On 17 August 2005, the subject received a dose of Twinrix (dose number and lot number not provided). At an unspecified time after vaccination with Twinrix, on 17 August 2005, the subject experienced hives, diarrhea, chills, wheezing, and vomiting. The subject went to the emergency room on 18 August 2005 and received unspecified treatment for the events. The events resolved on 18 August 2005. The physician considered the events to possibly be related to vaccination with Twinrix.
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Ear disorder, Vertigo
Clinical narrative: This case was reported by a nurse and described the occurrence of vertigo in a 61-year-old male subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) for prophylaxis. The subject is a physician and the subject's office administered the vaccination. On an unspecified date in 2004 the subject received the first dose of Twinrix in his right arm. On an unspecified date in 2004, "at some point after the first Twinrix injection," the subject experienced vertigo and inner ear problems and "had to visit the emergency room." The events resolved on an unspecified date on or before 23 June 2005. The vaccination course with Twinrix was discontinued.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, raised, no tenderness, swollen, red area right distal and lateral to injection site which lies at margin. 5x8 cm wide, 1 day post, no treatment.
Age: 0.83
Sex: M
Vaccine: FLU3
Symptoms: Respiratory distress, Tachypnoea, Wheezing
Clinical narrative: Pt had 2nd dose of 0.25ml preservative free Fluzone at 5:50 pm and began wheezing with respiratory distress 45 minutes later. Pt received neb x2 and Prelone with adequate relief. Pt was wheeze free next day.  MR received revealing a healthy 9 month old in for well visit with only c/o mild chest congestion beginning that am. 1st Flu given at that time with no problem.  Infant began wheezing ~45 minutes after 2nd vax. Seen by MD and PE showed mild respiratory distress, a RR of 70, audible wheezing and decreased aeration. Given Xopenex nebs and Orapred with improvement noted.  F/U next day with resolution of wheezing, and lungs CTA.  Nebs were continued for 48 hrs.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Hypoaesthesia, Nausea, Paraesthesia, Pharyngeal oedema
Clinical narrative: Nausea, vomiting x 1, itching, red face, throat swelling sensation, numbness and tingling in hands and face.
Sex: U
Vaccine: FLU3
Symptoms: Pruritus, Vomiting
Clinical narrative: Nausea, vomiting x 1, itching, red face, throat swelling sensation, numbness and tingling in hands and face.
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and Vomiting.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pain
Clinical narrative: AT deltoid, red, hot to touch, hard ball 62mm x 36mm. Body aches.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster, Valtrex
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Migraine, Swelling, Tenderness
Clinical narrative: Recieved flu vaccine in Right Deltoid.  Reported swelling and tenderness under R arm in armpit area.  Resoved with in 5 days with out medical intevention.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: Day of vaccine, developed elevated temperature, chills, nausea, spastic BM's, body ache, severe swelling of left arm; splotchy red rash on left arm spreading to neck, other arm and partially down chest; 3 very sore lumps on left arm.  Rx'd on 11/19/06 with Keflex qid and Zyrtec. 11/21/2006 A little better, 2 lumps on arm still present (2" and 1 1/2" diameter) - a little better.  Private provider (staff) stated client did not need to be seen if she were improving.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Swelling
Clinical narrative: Day of vaccine, developed elevated temperature, chills, nausea, spastic BM's, body ache, severe swelling of left arm; splotchy red rash on left arm spreading to neck, other arm and partially down chest; 3 very sore lumps on left arm.  Rx'd on 11/19/06 with Keflex qid and Zyrtec. 11/21/2006 A little better, 2 lumps on arm still present (2" and 1 1/2" diameter) - a little better.  Private provider (staff) stated client did not need to be seen if she were improving.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, TD
Symptoms: Abasia, Blood pressure increased, Flank pain
Clinical narrative: Complained of severe flank pain and inablility to walk.  Sat down in chair in lobby.  Given juice and encouraged for her to relax.  Emergency squad called and VS checked BP 156/98 per squad members.  Declined transport.  Encouraged her to seel medical attention at the local hospital, daughter in law picked up and advised of this as well.  When patient left, she voiced she felt much better and was able to walk out to car by herself.
Age: 62.0
Sex: M
Vaccine: FLUX
Symptoms: Infection, Nasal congestion, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Flu Vaccine innoculation:  11/07/06 Sore throat, sinus infection, chest conjestion:       11/11/06      11/13-15/06 - worsening symptoms      11/16-17/06 - bed riddden (fever of 102.1 deg. F) - physician prescribed 5-day regimen of Azithromycin antibiotic (500 mg dose - first day; 250 mg dose thererafter)      11/21/06 - much improved; oral cavities and chest draining
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nasal congestion, Pharyngitis, Pyrexia
Clinical narrative: Influenza Injection received 11/01/06.  Sore Throat started 11/3/06.  Acute pharangitis lasted 7 days.  Hoarseness lasted about 7 days as well.  Nasal congestion started about 5 days after injection and continues.  Fevers/Chills started about 7 days after injection and continued till 11/18/06.  Fever Max 101.4.   Out of work for 2 weeks.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Facial palsy, Fatigue, Hyperhidrosis, Pain
Clinical narrative: On 11/17/06 patient experienced weakness, fatigue, aches, sweats.  Went to see doctor on 11/21/06 and doctor diagnosed patient with Bells Palsy. 03/15/07-records received from PCP for DOS 11/7/06-1/30/07- note dated 11/7/07-DX:Bell's Palsy. Visit 1/23/07-upper respiratory infection. Otalgia onleft side. 1/30/07-DX: otitis externa. PE:Opens/closes eyes without problem. Asymmetric smile.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site reaction
Clinical narrative: Patient developed a significant local reaction at the injection site requiring antibiotics, steroids and analgesics.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Anorexia, Blood creatine phosphokinase increased, Brain neoplasm, Cellulitis, Injection site erythema
Clinical narrative: Cellulitis: This is a 4 year old boy admitted with mild fever, decreased appetite, irritability, and expanding ~10 cm indurated, erythematous, nonfluctuatant lesion on his L-thigh after receiving a Pneumovaccine on this leg on Thursday afternoon, concerning for cellulitis.  He was afebrile on admission but spiked to 102.2 11/19, improved with tylenol & motrin. CRP was elevated to 250 and WBC to 19.3 K consistent with local infection. He has improved now with 3 days of iv clindamycin (275 mg q6h) and will be sent home on po clindamycin to complete a 10 day course of antibiotics. 12/21/06-DC Summary for DOS 11/19-11/21/06-received and reviewed.  DX: Cellulitis secondary to vaccination Fever. Treated with IV Clindamycin PMH: developmentally delayed secondary to midbrain pilocytic astrocytoma resection/VP shunt placement and multiple revisions.
Age: 5.0
Sex: M
Vaccine: PPV
Symptoms: Injection site induration, Irritability, Pyrexia, Skin ulcer, White blood cell count increased
Clinical narrative: Cellulitis: This is a 4 year old boy admitted with mild fever, decreased appetite, irritability, and expanding ~10 cm indurated, erythematous, nonfluctuatant lesion on his L-thigh after receiving a Pneumovaccine on this leg on Thursday afternoon, concerning for cellulitis.  He was afebrile on admission but spiked to 102.2 11/19, improved with tylenol & motrin. CRP was elevated to 250 and WBC to 19.3 K consistent with local infection. He has improved now with 3 days of iv clindamycin (275 mg q6h) and will be sent home on po clindamycin to complete a 10 day course of antibiotics. 12/21/06-DC Summary for DOS 11/19-11/21/06-received and reviewed.  DX: Cellulitis secondary to vaccination Fever. Treated with IV Clindamycin PMH: developmentally delayed secondary to midbrain pilocytic astrocytoma resection/VP shunt placement and multiple revisions.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Nausea, Pain, Photophobia
Clinical narrative: Around noon had pain in left area of forehead, took Rx Midril 2 tablets for migraine then 2 tabs more @ 2am 11/16/06.  Had nausea, light sensitivity & dull ache for 4 more until noon on 11/17/06.
Age: 9.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Convulsion, Fatigue, Pyrexia
Clinical narrative: Pt with a history of seizures.  10 days after receiving Tdap, MMR, Hep A, Hep B immunizations pt spiked a fever of 104.  Had a 1 minute seizure.  Mother treated with phenobarbital, ibuprofen and tylenol.  12 hours later pt is tired but doing well.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Rash erythematous, Skin atrophy
Clinical narrative: Raised red rash under affected arm 48 hours later x 3 days; noticed indentation in armpit 96 hours later; atrophy left deltoid muscle 1 week later.
Age: 49.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Muscle atrophy, Rash, Rash maculo-papular
Clinical narrative: Raised red rash under affected arm 48 hours later x 3 days; noticed indentation in armpit 96 hours later; atrophy left deltoid muscle 1 week later.
Age: 29.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: Nose started bleeding last night at around 12:00am after receiving Flumist earlier in the day.  It stopped bleeding only to start again about an hour later.
Age: 47.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Malaise, Nausea, Pyrexia
Clinical narrative: Day after receipt of Tdap and Hepatitis B vaccine vaccine recipient developed low grade fever, estimated at <100° F, nausea, generalized malaise and arthalgia which continues through report date.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: On 10/25/06 Flu Vaccination given. Patient noted rt arm (deltoid) more tender then usual and has remained for over three weeks. Pain has improved but still present and bothersome with movement. No pain at rest. No weakness or numbness and tingling.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Lethargy, Pallor, Throat tightness
Clinical narrative: within 15 minutes of vaccine, symptoms of lethargy, pallor, weakness, and tightness in throat.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Rash erythematous, Rash vesicular
Clinical narrative: Pt presented to clinic w/ approx 3-4 d of vesicular rash on erythematous base on chest, abdomen, back, neck and upper arms.  Non-pruritic, non-painful.  No systemic sx.  No specific tx warranted.
Age: 1.36
Sex: F
Vaccine: MMRV
Symptoms: Herpes zoster, Laboratory test abnormal, Skin ulcer
Clinical narrative: Pt. received her MMRV on her left thigh on 09/05/2006, given by nurse and by 5-6 weeks later developed a case of Herpes Zoster large lesion at the area where the vaccine was administered and was seen by a local dermatologist that tested the lessions and was positive for Tzanck smear and treated it with zovirax and resolved it. Mother denies any previous history of varicella infection. I became her doctor on 11/16/06 and you can still see the large area affected already healed on her left external upper thigh region. pt. is asymptomatic. parents are not upset about it as far as i can tell, but i felt that you might need to know this incident for research purposes benefits. I have not heard of this happening before.So, I thought it would be a good idea to transmit this information to your agency.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Injection on Friday, Nov. 17, 2006 at ~1430. Pain reported in evening. Patient unable to sleep as a result of pain and required Tylenol. The next morning, patient reported pain, redness, warmth and swelling in upper arm, below injection site. Patient required visit to Urgicare center. Patient received dose of Rocephin and prescription for Keflex. On Sunday, Nov. 19, 2006, redness, warmth and swelling progressed to forearm. Pain still present. Monday, Nov. 20, patient taken to see primary care doctor to evaluate arm.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Sleep disorder
Clinical narrative: Injection on Friday, Nov. 17, 2006 at ~1430. Pain reported in evening. Patient unable to sleep as a result of pain and required Tylenol. The next morning, patient reported pain, redness, warmth and swelling in upper arm, below injection site. Patient required visit to Urgicare center. Patient received dose of Rocephin and prescription for Keflex. On Sunday, Nov. 19, 2006, redness, warmth and swelling progressed to forearm. Pain still present. Monday, Nov. 20, patient taken to see primary care doctor to evaluate arm.
Age: 0.69
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Medication error
Clinical narrative: no adverse events as of yet.  8 month old received immunizations scheduled for a 4 year old.
Age: 29.0
Sex: M
Vaccine: UNK
Symptoms: Medication error
Clinical narrative: No adverse event: PPD inadvertently substituted for flu vaccince.  0.5ml of PPD given deep IM in deltoid.  No adverse events.  No local reaction.  Patient recently PPD negative prior to this event.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pleocytosis, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 2-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On 15 November 2006 the subject received 1st dose of Pediarix.  On 15 November 2006, the subject also received 1st dose of 7-valent pneumococcal conjugate vaccine (Prevnar), and 1st dose of Haemophilus influenzae type b vaccine (unspecified).  On 15 November 2006, less than one day after vaccination with Pediarix, the subject experienced a fever.  The subject was seen in the emergency room on an unspecified date on or after 15 November 2006 and on or before 17 November 2006.  Laboratory analyses performed while the subject was in the emergency room revealed pleocytosis.  The subject was hospitalized and the healthcare professional considered the events were clinically significant (or requiring intervention). The outcome of the events was not reported. (OMIC)
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea
Clinical narrative: My mother had a doctor's appointment with MD for a flu shot 10:00 am on November 6, 2006. Immediately after the shot at approximately 11:00 am as they were driving away from the office she started gasping for breath, the paramedics were called and they never revived her.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Right arm erythema, warmth and pain starting one day after receiving Pneumococcal and influenza shots in same arm.
Age: 12.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Pt had likely partial complex seizure 10 minute after vaccine so went to ER. No prior seizure.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea x 10 days, 5-6 times a day. MR received revealing that after 2 month vax. infant began having 5-6 mucusy stools/day. This continued for 10 days but began to taper in number toward the end. Day 12 s/p vax. mother reports still having smelly mucusy stools less frequently. No vomiting, no fever, appetite good.  No other F/u records. Office RN reports speaking with mom ~3 weeks s/p vax. and stools are 1/day and normal.
Age: 78.0
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Has had nausea and diarrhea, was vomiting even through nose, for a day and a half. Took some Pepto Bismol, stool finally began to harden today. Pt feeling much better.
Age: 78.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Diarrhoea, Fall, Malaise, Nausea, Syncope
Clinical narrative: Nausea and diarrhea. She was vomiting and fainted in the kitchen floor hitting the wall and making a hole. The nausea and diarrhea have decreased but still feels bad.
Age: 78.0
Sex: F
Vaccine: FLUX, TTOX
Symptoms: Vomiting
Clinical narrative: Nausea and diarrhea. She was vomiting and fainted in the kitchen floor hitting the wall and making a hole. The nausea and diarrhea have decreased but still feels bad.
Age: 39.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Abscess, Pruritus
Clinical narrative: 04-JUN-2006 patient complains of itching and dryness of lips. 06-JUN-2006 patient complains of "bubbles" on both lips with yellowish liquid discharge and continued itching. 08-JUN-2006 patient complains of painful lips, itching resolved and has several reddened bumps at left corner of mouth. Lips swollen, reddened, peeling. Seen by MD. Treated with Benadryl cream to lips.
Age: 39.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Dry mouth, Erythema, Face oedema, Pain
Clinical narrative: 04-JUN-2006 patient complains of itching and dryness of lips. 06-JUN-2006 patient complains of "bubbles" on both lips with yellowish liquid discharge and continued itching. 08-JUN-2006 patient complains of painful lips, itching resolved and has several reddened bumps at left corner of mouth. Lips swollen, reddened, peeling. Seen by MD. Treated with Benadryl cream to lips.
Age: 39.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Pruritus, Skin exfoliation
Clinical narrative: 04-JUN-2006 patient complains of itching and dryness of lips. 06-JUN-2006 patient complains of "bubbles" on both lips with yellowish liquid discharge and continued itching. 08-JUN-2006 patient complains of painful lips, itching resolved and has several reddened bumps at left corner of mouth. Lips swollen, reddened, peeling. Seen by MD. Treated with Benadryl cream to lips.
Age: 0.17
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Diarrhoea, Haematochezia
Clinical narrative: Information has been received concerning an 8 week old female, with no medical history and no allergies, who on 9/13/06, at 3:00pm, was vaccainted with a first oral dose of Rotavirus vaccine (lot 653915/0389F). Concomitant vaccines administered at the same time included a first IM dose in the upper left thigh of Prevnar (lot 1308666C), a first IM dose in the lower left thigh of Hib vaccine (lot 654625/0507F), a first SC dose in the right thigh of poliovirus vaccine IPOL (lot Z04205) and a first IM dose in the right thigh of Tripedia (lot U1985AB). Concomitant medication included acetaminophen (Tylenol), infant. There was no illness at the time of vaccination and no adverse events following prior vaccination. Beginning that evening on 9/13/06, at 7:00pm the pt experienced frequent stools/diarrhea. Beginning on 9/17/06 the pts mother began noticing flecks of blood in the diarrhea stool, two episodes. The pt was afebrile, had normal activity, and had a normal appetite. It was noted that the pts diet was Similac advance. It was noted the OV was pending for 9/19/06. At the time of the report the pt continued with diarrhea. Upon internal review, the flecks of blood in the diarrhea stool was considered to be an other important medical event (OMIC).  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released. Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Abdominal pain, Agitation, Crying, Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a physician concerning a 19 week old male with no medical history or allergies who on 8/22/06 and 10/24/2006 was vaccinated PO with the first and second 2.0 ml doses, respectively, of Rotavirus vaccine (lot 655175/0849F). There was no concomitant therapy. The physician reported that on 11/4/06, the pt experienced uncontrolled screaming for hours. The pt was taken to ER where and acetaminophen (Tylenol) suppository was given which helped quiet him. A physical examination was negative and the pt was sent home. Within 15 minutes, the pt was taken to pediatric ER. On 11/5/06, the pt was admitted to a hospital for evaluation for intussusception. An abdominal X ray and ultrasound ruled out intussusception. It was noted that the pt was administered IV fluids. On 11/6/06, the pt was discharged from the hospital. The pt subsequently recovered. The pt was scheduled to be seen in the physicians office on 11/8/06. No product quality complaint was involved. No other information was provided. The pts experience was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Age: 0.34
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5
Symptoms: Crying, Screaming
Clinical narrative: Information has been received from a physician concerning a 19 week old male with no medical history or allergies who on 8/22/06 and 10/24/2006 was vaccinated PO with the first and second 2.0 ml doses, respectively, of Rotavirus vaccine (lot 655175/0849F). There was no concomitant therapy. The physician reported that on 11/4/06, the pt experienced uncontrolled screaming for hours. The pt was taken to ER where and acetaminophen (Tylenol) suppository was given which helped quiet him. A physical examination was negative and the pt was sent home. Within 15 minutes, the pt was taken to pediatric ER. On 11/5/06, the pt was admitted to a hospital for evaluation for intussusception. An abdominal X ray and ultrasound ruled out intussusception. It was noted that the pt was administered IV fluids. On 11/6/06, the pt was discharged from the hospital. The pt subsequently recovered. The pt was scheduled to be seen in the physicians office on 11/8/06. No product quality complaint was involved. No other information was provided. The pts experience was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with a penicillin allergy and a history of a splenectomy who on 10/27/2006 was vaccinated SC in the left arm with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651329/1047P). Concomitant vaccine therapy included a dose of influenza virus vaccine (unspec). There was no other concomitant therapy. That evening the pt experienced a cellulitis like reaction at the injection site. Her left arm became red, swollen and sore and she developed a fever. On 10/28/06 the pt developed shortness of breath and was hospitalized. The pt was diagnosed with cellulitis of the left arm. During her stay she was administered an unspecified antibiotic through a PICC line. Her white blood cell count was 46.2. All cultures were negative. An MRI of the upper left arm was performed. She was hospitalized for 5 days. On 11/7/06 the pt was seen by a physician and was reported to be recovering. On 11/14/06 it was reported that the pt had fully recovered (exact date not specified). It was noted that the pt had been vaccinated with Pneumococcal 23v polysaccharide vaccine five years ago with no reported reaction. The nurse is requesting that a lot check be performed. No product quality complaint was involved. The reporter felt that the pts experiences were considered to be immediately life threatening and other important medical events (OMIC). Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Cellulitis, Dyspnoea, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with a penicillin allergy and a history of a splenectomy who on 10/27/2006 was vaccinated SC in the left arm with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651329/1047P). Concomitant vaccine therapy included a dose of influenza virus vaccine (unspec). There was no other concomitant therapy. That evening the pt experienced a cellulitis like reaction at the injection site. Her left arm became red, swollen and sore and she developed a fever. On 10/28/06 the pt developed shortness of breath and was hospitalized. The pt was diagnosed with cellulitis of the left arm. During her stay she was administered an unspecified antibiotic through a PICC line. Her white blood cell count was 46.2. All cultures were negative. An MRI of the upper left arm was performed. She was hospitalized for 5 days. On 11/7/06 the pt was seen by a physician and was reported to be recovering. On 11/14/06 it was reported that the pt had fully recovered (exact date not specified). It was noted that the pt had been vaccinated with Pneumococcal 23v polysaccharide vaccine five years ago with no reported reaction. The nurse is requesting that a lot check be performed. No product quality complaint was involved. The reporter felt that the pts experiences were considered to be immediately life threatening and other important medical events (OMIC). Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Injection site reaction, Pyrexia, White blood cell count increased
Clinical narrative: Information has been received from a registered nurse concerning a 24 year old female with a penicillin allergy and a history of a splenectomy who on 10/27/2006 was vaccinated SC in the left arm with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651329/1047P). Concomitant vaccine therapy included a dose of influenza virus vaccine (unspec). There was no other concomitant therapy. That evening the pt experienced a cellulitis like reaction at the injection site. Her left arm became red, swollen and sore and she developed a fever. On 10/28/06 the pt developed shortness of breath and was hospitalized. The pt was diagnosed with cellulitis of the left arm. During her stay she was administered an unspecified antibiotic through a PICC line. Her white blood cell count was 46.2. All cultures were negative. An MRI of the upper left arm was performed. She was hospitalized for 5 days. On 11/7/06 the pt was seen by a physician and was reported to be recovering. On 11/14/06 it was reported that the pt had fully recovered (exact date not specified). It was noted that the pt had been vaccinated with Pneumococcal 23v polysaccharide vaccine five years ago with no reported reaction. The nurse is requesting that a lot check be performed. No product quality complaint was involved. The reporter felt that the pts experiences were considered to be immediately life threatening and other important medical events (OMIC). Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Bronchitis, Cerebrovascular accident, Decreased appetite, Eyelid ptosis
Clinical narrative: Vaccine administered 11/3/06. 11/8/06 atient developed a bronchopneumonia syndrome, treated from ED with 5 days of Azithromycin. On 11/17/06 I admited him to hospital with a TIA causing left hemiparesis and speach deficit. He cleared neurologically but still feels terribly weak. -- Maybe unrelated, but I thought I'd report.  MR from PCP received.  HPI: Four days S/P flu vax. patient developed symtoms of bronchitis vs. pneumonia and was treated in the ER with Zithromax.  He was seen on day 10 s/p vax still c/o weakness, fever, and unintentional weight loss. Assessment:  Viral URI. On 11/17/2006 (2 weeks s/p flu vax.) he awoke from a nap with left sided hemiparesis, facial ptosis, and slight expressive aphasia. He was admitted to the hospital with a DX: Resolving CVA/TIA. Impression: resolving CVA/TIA probably in the left midbrain area. F/U visit on 11/21/2006  for c/o weakness, severe fatigue, and 10 lb. weight loss since getting flu shot. Assessment: Fatigue with terrible loss of appetite, ? pallor, ? due to flu vax. pneumonia recovery, TIA recovery, ?? another process in the brain/brainstem. TIA, Bronchitis acute. MR received from hospital.  No new COSTARTs.  No discharge summary sent with records. No d/c summary available.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Hemiparesis, Laboratory test abnormal, Pallor, Pneumonia
Clinical narrative: Vaccine administered 11/3/06. 11/8/06 atient developed a bronchopneumonia syndrome, treated from ED with 5 days of Azithromycin. On 11/17/06 I admited him to hospital with a TIA causing left hemiparesis and speach deficit. He cleared neurologically but still feels terribly weak. -- Maybe unrelated, but I thought I'd report.  MR from PCP received.  HPI: Four days S/P flu vax. patient developed symtoms of bronchitis vs. pneumonia and was treated in the ER with Zithromax.  He was seen on day 10 s/p vax still c/o weakness, fever, and unintentional weight loss. Assessment:  Viral URI. On 11/17/2006 (2 weeks s/p flu vax.) he awoke from a nap with left sided hemiparesis, facial ptosis, and slight expressive aphasia. He was admitted to the hospital with a DX: Resolving CVA/TIA. Impression: resolving CVA/TIA probably in the left midbrain area. F/U visit on 11/21/2006  for c/o weakness, severe fatigue, and 10 lb. weight loss since getting flu shot. Assessment: Fatigue with terrible loss of appetite, ? pallor, ? due to flu vax. pneumonia recovery, TIA recovery, ?? another process in the brain/brainstem. TIA, Bronchitis acute. MR received from hospital.  No new COSTARTs.  No discharge summary sent with records. No d/c summary available.
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Speech disorder, Transient ischaemic attack, Viral infection, Weight decreased
Clinical narrative: Vaccine administered 11/3/06. 11/8/06 atient developed a bronchopneumonia syndrome, treated from ED with 5 days of Azithromycin. On 11/17/06 I admited him to hospital with a TIA causing left hemiparesis and speach deficit. He cleared neurologically but still feels terribly weak. -- Maybe unrelated, but I thought I'd report.  MR from PCP received.  HPI: Four days S/P flu vax. patient developed symtoms of bronchitis vs. pneumonia and was treated in the ER with Zithromax.  He was seen on day 10 s/p vax still c/o weakness, fever, and unintentional weight loss. Assessment:  Viral URI. On 11/17/2006 (2 weeks s/p flu vax.) he awoke from a nap with left sided hemiparesis, facial ptosis, and slight expressive aphasia. He was admitted to the hospital with a DX: Resolving CVA/TIA. Impression: resolving CVA/TIA probably in the left midbrain area. F/U visit on 11/21/2006  for c/o weakness, severe fatigue, and 10 lb. weight loss since getting flu shot. Assessment: Fatigue with terrible loss of appetite, ? pallor, ? due to flu vax. pneumonia recovery, TIA recovery, ?? another process in the brain/brainstem. TIA, Bronchitis acute. MR received from hospital.  No new COSTARTs.  No discharge summary sent with records. No d/c summary available.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Dizziness, Hyperventilation, Hypokinesia, Lethargy
Clinical narrative: Client states she became lethargic and could not move her arms or speak. She was taken by ambulance to the ER, The doctors could not find any indications of a stroke or other complication. Dr stated he dose not believe this incident was related to the flu vaccine.  12/19/06 Received hospital records which reveal patient admitted 11/14/06 for observation after feeling paresthesia, sleepiness, dizziness & speech impairment s/p flu shot.  Overnight observation. Improved & d/c home in AM 11/15/06. Final DX: possible adverse reaction fo flu vaccine w/hyperventilation.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Somnolence, Vaccination complication
Clinical narrative: Client states she became lethargic and could not move her arms or speak. She was taken by ambulance to the ER, The doctors could not find any indications of a stroke or other complication. Dr stated he dose not believe this incident was related to the flu vaccine.  12/19/06 Received hospital records which reveal patient admitted 11/14/06 for observation after feeling paresthesia, sleepiness, dizziness & speech impairment s/p flu shot.  Overnight observation. Improved & d/c home in AM 11/15/06. Final DX: possible adverse reaction fo flu vaccine w/hyperventilation.
Age: 36.0
Sex: M
Vaccine: YF
Symptoms: Dyspnoea, Eye inflammation, Inflammation, Injection site erythema, Injection site oedema
Clinical narrative: Localized erythema, edematous reaction at vaccination site. Pt c/o difficulty speaking, throat constriction, slight breathing problem, watering eyes, inflammation behind eyes, glottal inflammation. 500 NS 2 c 03mm Epinephrine 25 mg.
Age: 36.0
Sex: M
Vaccine: YF
Symptoms: Lacrimation increased, Speech disorder, Throat tightness
Clinical narrative: Localized erythema, edematous reaction at vaccination site. Pt c/o difficulty speaking, throat constriction, slight breathing problem, watering eyes, inflammation behind eyes, glottal inflammation. 500 NS 2 c 03mm Epinephrine 25 mg.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Facial palsy, Hypoaesthesia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial information received on 11/9/06 from a health care professional. An 83 year old female pt received a dose of Fluzone SV 2006 2007 USP, lot number U2186AA, administered IM in the left deltoid on 10/30/06. Within 24 hours, the pt developed right side facial numbness. On 11/2/06, the pt developed right side facial paralysis and was seen in a physicians office the following day. No treatment was given. At the time of this report, the pt had not recovered from the events.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Hypersensitivity, Pruritus
Clinical narrative: Information has been received from a physician and a health professional concerning a 43 month old male who on 5/9/06 was vaccinated with a dose of varicella virus vaccine live. On 5/9/06, within one hour of vaccination, the pt experienced a severe allergic reaction. He was noted to have erythema and generalized itching. There was no respiratory distress. He returned to the pediatricians office and received epinephrine, Benadryl and prednisone. This was noted to be an intervention to prevent serious criteria. He did not require hospitalization. The events improved after treatment. The pt was stable at the time of the report. He received a skin testing which was positive for an allergy to gelatin. There was no product quality complaint. The reporter considered the events to be other important medical events (OMIC). Additional information has been requested.
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Irritability, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with an oral dose of Rotavirus vaccine. Subsequently the pt experienced  a low grade fever and crankiness. One week later, the pt was hospitalized for approx 48 hours due to vomiting, crankiness, and dehydration. The pt was discharged and was considered to be recovered. The physician also reported that the pts mother opted out of the second dose of Rotavirus vaccine. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: Information has been received from a physician concerning a 2 month old female who was vaccinated with a 2ml dose of Rotavirus vaccine. On the next day, the pt died. The physician stated that the infant received all of her vaccines on time and wad in perfect health. The medical examiner ruled the cause of death as sudden infant death syndrome. Unspecified medical attention was sought. No product quality complaint was involved. NO other information was provided. The reporter considered the pts reaction to be immediately life threatening. Additional information has been requested.  12/28/06 Received autopsy report which reveals COD as Category II SIDS, cosleeping with parents in adult bed.  Manner of death undetermined.
Age: 2.0
Sex: M
Vaccine: HIBV, MMR, PNC, PPV, VARCEL
Symptoms: Autism, Metal poisoning
Clinical narrative: Information has been received from a consumer concerning his 2 year old son with allergies to oats, gluten, wheat, eggs and dairy who on unspecified dates since 2002 was vaccainted with dosed os MMR (lot 0038M), Pneumococcal vaccine, polyval (Lot 0813M), Varicella virus vaccine live (lot 644087/0975M), Hib conj vaccine (lot 0652M and 1527K) and Prevnar, in addition to unspecified other childhood vaccines. Subsequently, in approx 2004, he was diagnosed with autism with high mercury levels. Medical attention was sought, a CT of the pts head was performed (results not provided). At the time of the report, at the age of 4, the pt was being treated by a Naturopathic doctor to help increase the immune system and then reduce the mercury levels. No further information was provided. There was no product quality complaint involved. Upon internal review autism was determined to be an other important medical event (OMIC). Additional information has been requested. 1/4/10 Autism and mercury poisoning.
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a male relative of an employee at the physicians office who on 11/7/06 was vaccainted SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 655500/1005F). On approx 11/7/06 the pt developed a painful and swollen injection site in his arm and was hospitalized. At the time of the report, the pt outcome was unk. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site pain, Injection site reaction, Injection site warmth, Vaccine positive rechallenge
Clinical narrative: Pt presented with cellulitis to right upper arm, painful and warm to touch. Given Rocetin 1gm IM and a prescription for Augmentin 875 mg One tab twice a day for 10 days.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Itching arms legs progressed 11/17/06 arms cleared, to left scapula and down hands. Prednisone.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives, itching of arms, legs.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Diarrhoea, Headache, Nausea, Pyrexia
Clinical narrative: On 10/11/06 at about 3:30 pm. I became nauseated. I had diarrhea and vomiting and a low grade fever 100-101 on 10/12, as well as a achy joints and a headache. I stayed on clear fluids, tea for 48 hours and recovered. I've reacted to previous flu shots in past.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: On 10/11/06 at about 3:30 pm. I became nauseated. I had diarrhea and vomiting and a low grade fever 100-101 on 10/12, as well as a achy joints and a headache. I stayed on clear fluids, tea for 48 hours and recovered. I've reacted to previous flu shots in past.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chest discomfort, Eye pain, Fatigue, Headache
Clinical narrative: HA generalized joint pain, pain behind eyes, sensitivity to light, increased nasal secretions, chest tightness, generalized fatigue SX last 2 1/2 days. Began evening of vaccine. Missed 5 hours of work on 10/12/06.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Photophobia, Rhinorrhoea
Clinical narrative: HA generalized joint pain, pain behind eyes, sensitivity to light, increased nasal secretions, chest tightness, generalized fatigue SX last 2 1/2 days. Began evening of vaccine. Missed 5 hours of work on 10/12/06.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypertension, Pain, Rash
Clinical narrative: Red rash along front and back, left side. Blood pressure 201/110 in doctors office. Placed pain patch Lidoderm over affected areas. Given prescription for Acyclovir, Methylprednisolone.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Site of injection was sore to the touch, feverish at site lasted more than 1 week.