chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large area of erythema and warmth around injection site. Rx - Augmentin 875mg BID x 1 week.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying
Clinical narrative: 3 Hours inconsolable crying with few 5 minute breaks beginning 2 hours after vaccine administration. Normal subsequently.
Age: 7.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse effect
Clinical narrative: None adverse symptoms of signs Tdap given instead of Td to 7 yr old.  0 adverse event onset or reaction just that vaccine given (TDAP) to a 7 yr old.  TD should have been admin.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever 1/2 day following immunizations 2 days after immunization - redness, swelling, pain on right arm at site of MMR. Spontaneous resolution of symptoms by 3 days following immunization.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Contusion, Excoriation, Swelling
Clinical narrative: Right deltoid contusion 7cm x 6cm with .2cm abrasion in center, now 3 days later. no axillary lymph. Mom reports significant swelling the first 2 days but much better today.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Headache, Hot flush, Injection site pain, Nausea
Clinical narrative: 5-30-07 At 1:00am began with body chills and hot flashes very nauseated worsen at 4am no fever started headache continued this morning with headaches nausea and chills but feels a little better. Site tender to touch no swelling. Tylenol and Motrin.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Epistaxis, Headache, Muscle spasms
Clinical narrative: "Headaches since yesterday Tdap". "Right arm and leg cramping". "Bloody nose (profuse)" on 5/27/07. (Saw physician for sx. on 5/28/07).
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Blood pressure decreased, Blood pressure increased, Convulsion, Immediate post-injection reaction, Unresponsive to stimuli
Clinical narrative: Immediately after vaccine administered - client slumped forward, unresponsive seizure-like spasm - regained consciousness and then unresponsive again. BP 50/20, Pulse 48 - 911 call - arrived - client BP increased to 98/50, Pulse 48. Family transport to ER - treated as outpatient - IV fluids given - ER nurse reports oriented, responsive. 5-23-07 Telephone call family, mom reports doing well no problems since event.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 14 Hours after receiving Tdap patient developed severe myalgias, followed by fever and moderate arthralgias. Patient examined 24 hours after injection. On exam temperature 101.2 F, joint exam normal without swelling. Injection site remarkable for moderate pain, minimal swelling and erythema.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia
Clinical narrative: 14 Hours after receiving Tdap patient developed severe myalgias, followed by fever and moderate arthralgias. Patient examined 24 hours after injection. On exam temperature 101.2 F, joint exam normal without swelling. Injection site remarkable for moderate pain, minimal swelling and erythema.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Blood pressure decreased, Syncope
Clinical narrative: After few moments of receiving multiple vax and Gardasil, patient had a syncope, blood pressure dropped. She recovered. 06/06/07-records received. Vaccine record documents on 5/30/07 Gardasil lot# 0522U, Varicella Lot #0455U, Menactra lot#U2277AA, Hepatitis A 2 lot#0246U. After vaccination patien left room and had loss of consciousness for 10 seconds. BP 88/54. Felt better after resting. Walked out of office with mother
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, VARCEL
Symptoms: Blood pressure decreased, Hypotonia
Clinical narrative: After few moments of receiving multiple vax and Gardasil, patient had a syncope, blood pressure dropped. She recovered. 06/06/07-records received. Vaccine record documents on 5/30/07 Gardasil lot# 0522U, Varicella Lot #0455U, Menactra lot#U2277AA, Hepatitis A 2 lot#0246U. After vaccination patien left room and had loss of consciousness for 10 seconds. BP 88/54. Felt better after resting. Walked out of office with mother
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patients parents brought patient brought 2 days after vaccination was given.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Rash, Wrong drug administered
Clinical narrative: Received DT booster had redness/ rash around right deltoid.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Infant developed hives 1 hour after vaccines given. Went to emergency room. Received Benadryl PO and steroid injection. Hives cleared.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Anxiety, Arthralgia, Depression, Fatigue, Headache
Clinical narrative: Fatigue,headache,sleep disturbance, anxiety, depression, joint pain
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Sleep disorder
Clinical narrative: Fatigue,headache,sleep disturbance, anxiety, depression, joint pain
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: Next morning after receiving Pneumococcal - had swelling in affected arm pit and a "red line" moving across deltoid. Pt was seen by a MD and placed on PO Atox. Pt states that she is back to normal now. This is all from pt's recollection of events.
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Arthropod bite, Injection site erythema, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: 5/29 Approx 1900 began to have a welt about size of .25 piece. Painful at site, throbbing pain-no itching, hot to touch, raised, red. Throughout evening became bigger-approx 2"x 2" with hand center. Right arm 4/20 sam symptoms as above-very painful 4-5 period. Left arm on 5/31 (L) arm still has knot and is painful to touch. Thought it was a spider bite
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Urticaria
Clinical narrative: 5/29 Approx 1900 began to have a welt about size of .25 piece. Painful at site, throbbing pain-no itching, hot to touch, raised, red. Throughout evening became bigger-approx 2"x 2" with hand center. Right arm 4/20 sam symptoms as above-very painful 4-5 period. Left arm on 5/31 (L) arm still has knot and is painful to touch. Thought it was a spider bite
Age: 56.0
Sex: F
Vaccine: TYP
Symptoms: Cough, Dysgeusia, Dysphonia, Hypoaesthesia, Throat tightness
Clinical narrative: Typhoid vaccination received - within minutes had numbness and strange taste, followed within 30 mins cough, hoarseness, throat tightness. Treated with Benadryl, Prednisone. Symptoms lasted 3 days.
Age: 65.0
Sex: M
Vaccine: TD
Symptoms: Muscle spasms, Myalgia
Clinical narrative: After two day I had painful muscle spasm, lasting for 4 or 5 days. Muscle aches for 8 weeks and still on going.
Age: 21.0
Sex: M
Vaccine: ANTH
Symptoms: Local reaction
Clinical narrative: Large local reaction measuring 20 cm at widest point - does not extend below the elbow - No systemic symptoms
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Hypokinesia
Clinical narrative: Pt described "not able to use left arm for 3 weeks following the Hepatitis A immunization"
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema
Clinical narrative: Redness to both legs. No swelling no heat.
Sex: M
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Hives head to toe, swollen leg with 4 inch diameter of red lacy rash.
Age: 5.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration, Skin lesion, Varicella
Clinical narrative: Varicella vaccine breakthrough. Diagnosed with varicella on 5-30-07. Had approximately 20 lesions. Afebrile.
Age: 8.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
Clinical narrative: None stated
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Erythema, Mass, Pyrexia, Urticaria
Clinical narrative: Lemon sized lump/hives-like, red, itchy, fever for 4 days
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Urticaria
Clinical narrative: Swelling of upper arm - 5 hrs after vaccinated the next day swelling was down some, then hives and redness started to spread 4x6 inch area. Went to doctor and started on Prednisone 5mg and Cefadroxil 500mg (6 day & 10 day respectfully). All symptoms gone in 6 days.
Age: 32.0
Sex: F
Vaccine: RAB
Symptoms: Rash erythematous
Clinical narrative: Donor c/o red rash on left upper arm that began in the evening after receiving a second rabies Imovax vaccine. Donor presented to ZLB Plasma center 4/11/07 with a red pinpoint rash on left upper arm. Consulted Dr with regards to this. Donor denied any other symptoms. Donor deferred from rabies program for her safety.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Pyrexia, Rash macular, Rash papular, Skin lesion
Clinical narrative: Patient developed >20 erythematous macules (approx. 2mm with central papule) discreet lesions over face, trunk and extremities 9 days after 12-month immunizations. Parent reports patient developed low-grade fevers up to 101 for 3 days prior to outbreak of lesions. No other symptoms reported or observed.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Signs and symptoms appeared the next evening, 24 hours after receiving the shot. The area was red, swollen, hardeneded and sore. The redness improved each day and was gone after 1 week. A bruise remains one week later. No treatment was used by patient.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Fall, Malaise, Pallor
Clinical narrative: Client received vaccines, has passed out before from immunizations mother reported.  After receiving vaccines client turned a little pale, client was laid down on a bed and given apple juice to drink.  She stayed down for approximately 10 minutes, then mother and daughter left, stating that she was feeling fine.More than 20 minutes after vaccination, Client returned to clinic with mother and sister to have sister receive vaccinations.  Client stated that she didn't feel well and laid down on the chairs in waiting area.  She mumbled something to mother and had a seizure and rolled off the chairs she was laying on.  Mother caught her and eased her to the floor.  The seizure lasted less than a minute.  Offer to call an ambulance was refused. Cold cloth was applied to forehead and arms. Mother was encouraged to take her to the doctor.  Mother was called 06-05-07 am, mother stated that patient had a doctors appointment today to be seen.  She stated that she was acting normal today and that she would call if the doctor stated  anything wrong.
Sex: M
Vaccine: RUB
Symptoms: Wrong drug administered
Clinical narrative: Patient received rubella vaccine Meruvax instead of intended Hepatitis B vaccine
Sex: M
Vaccine: RUB
Symptoms: Wrong drug administered
Clinical narrative: Patient received Rubella vaccine Meruvax instead of intended Hepatitis B vaccine
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Adult Hep A vaccine given instead of Pedatric HEP A
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Induration, Influenza like illness, Injected limb mobility decreased, Oedema peripheral
Clinical narrative: Pneumococcal vaccine was given May 31, 2007 around 9:30 am. One hr. later arm started hurting thought it was normal. Became very tired went home & took a 21/2 hr. nap. Woke-up my upper arm was all swollen, red & as hard as a rock. I couldn't move my arm for two days, very painful, flu like symptoms. Dr. told me to ice down my arm, take benedryl & asprin. Which did help. As of today I am still under the weather, but am starting to feel better.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Pneumococcal vaccine was given May 31, 2007 around 9:30 am. One hr. later arm started hurting thought it was normal. Became very tired went home & took a 21/2 hr. nap. Woke-up my upper arm was all swollen, red & as hard as a rock. I couldn't move my arm for two days, very painful, flu like symptoms. Dr. told me to ice down my arm, take benedryl & asprin. Which did help. As of today I am still under the weather, but am starting to feel better.
Age: 45.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Received Tdap and Hep B adult on April 27, 2007.  Phoned Health Department four days later on May 1st to report "rash and bumps moving down the right arm" starting on April 28th.  Area reddened, warm to touch with "bump" at injection site.  Denies hives, fever, or signs of cellulitis such as streaking and swelling of limb. Now has similar rash on left arm.  Recommened ibuprofen for pain and swelling, as well as appropriate use of heat and cold.  Suggested evaluation by MD as is concerned about receiving the rest of her Hep B series; does not want to do so, is very busy with classes. Called her the next day to  check on progress.  Did not use any comfort measures as suggested, and while not worse, had not improved.  On May 10th at 8PM, she returned phone call after hours  in response to another from me phone message asking about her progress and requesting more information for a VAERS report   A total of 5 calls were made, including two evening calls when she suggested per voice mail that this is the best time to reach her. The last call was yesterday, June 4th, 20007.  I left a message at that time stating that I would file the report with the information on hand unless she wished to add or make any changes to what we discussed.  I did not receive a response.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Incorrect dose administered
Clinical narrative: Gave Adult HEP A vaccine instead of pediatric HEP A
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was given Dtap #5 and IPV #4 in left arm on 5/30/07. Next day child's upper arm was red, swollen and warm to touch from shoulder to elbow. Family was in Missouri, stopped by ER. Ice applied. Today has slight redness but most of edema is gone.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Clostridium difficile toxin test, Culture stool, Diarrhoea, Occult blood, Parasite blood test
Clinical narrative: Patient developed a rash (welts) on buttocks the evening that the vaccine was given.  Rotavirus vaccine was given on 5/24/07.  She developed diarrhea on 5/26/07.  She had 1-3 episodes of diarrhea per day from 5/26-6/4/07.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Parasite stool test, Rash, Rotavirus test, Urticaria, White blood cell count
Clinical narrative: Patient developed a rash (welts) on buttocks the evening that the vaccine was given.  Rotavirus vaccine was given on 5/24/07.  She developed diarrhea on 5/26/07.  She had 1-3 episodes of diarrhea per day from 5/26-6/4/07.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site discolouration, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Zostavax SC rec'd 5/31/2007. To clinic 6/4/2007 with localized reaction @ left arm with 3 inch diameter area pink et warm with 1 1/4 inch diameter center that is red, hard et raised. C/O itch subsiding with scratching @ perimeter only. C/O  "fullness et pressure" @ occipital area of head et neck. Afebrile @ home. Temp @ clinic 98.0
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Zostavax SC rec'd 5/31/2007. To clinic 6/4/2007 with localized reaction @ left arm with 3 inch diameter area pink et warm with 1 1/4 inch diameter center that is red, hard et raised. C/O itch subsiding with scratching @ perimeter only. C/O  "fullness et pressure" @ occipital area of head et neck. Afebrile @ home. Temp @ clinic 98.0
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash pustular, Urticaria
Clinical narrative: Large (1") whelt from Chick Pox vaccine within 1 hour.  4-5" within 24 hours.  Redness covering 12", and multiply pustuiles within 36 hours.  Treatment:  Ibuprofen and cold compresses.  Sister presented with chicken pox virus within 10 days and missed last 3 days of school.  Confirmed by Dr. visit.
Age: 1.1
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash papular
Clinical narrative: Prevnar, Hib, MMR, Varicella immunizations given 5/31/2007. Mother reports fever 6/1/2007 103.2 et 6/2/2007 102.4. Today has 7 papular lesions varying in size from approx. 3mm to 3mm X 10mm irregular in size. PCP notified previously et recommends use of Tylenol alternated with ibuprofen for fever et notification of HD staff.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Malaise
Clinical narrative: Gardasil vaccination given on Wednesday, May 30, 2007. Patient reported general malaise and mild joint pain on Saturday, June 2, 2007. Pain became increasingly more severe from Sunday, June 3 to Monday, June 4th. I took patient back to see the doctor on Monday, June 4th and described all symptoms to doctors. Doctors cannot figure out what is wrong. Patient has normal body temperature of 97.8% and has not yet had a fever.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Arthralgia, Musculoskeletal pain
Clinical narrative: Gardasil vaccination given on Wednesday, May 30, 2007. Patient reported general malaise and mild joint pain on Saturday, June 2, 2007. Pain became increasingly more severe from Sunday, June 3 to Monday, June 4th. I took patient back to see the doctor on Monday, June 4th and described all symptoms to doctors. Doctors cannot figure out what is wrong. Patient has normal body temperature of 97.8% and has not yet had a fever.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: urticarial rash all over body esp.on belly
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, VARZOS
Symptoms: Injection site pain, Wrong drug administered
Clinical narrative: Father said child complained his leg was sore on 6-4-07. Better on 6-5-07. Wrong vaccine given to patient should have been ProQuad - not Zostavax
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Heat therapy, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Varivax placed on 5/30/07, 2 days RTC L arm with swelling, redness and warm to touch. (70 cm length, 40 cm width). Advised warm compress and Tylenol PRN
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration
Clinical narrative: Induration of 3.0cm asked her and remain for observation - 15 minutes - left without recheck. Called and mailed patient parent letter. Advised patient will not give 2nd Varicella per MD.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: School nurse called office today. She described a swollen, red and hot knot at injection site measuring 3" x 4". Will mark redness, apply ice and bring in center tomorrow if no better.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Convulsion
Clinical narrative: Patient has a known seizure disorder and takes Topamax and Zonegron. 5 Minutes after shot had a seizure lasting less than 1 minute and 15 minutes after seizure shot had a seizure lasting less than one minute.
Age: 0.75
Sex: F
Vaccine: HEPA
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Pyrexia, Wheezing
Clinical narrative: Information has been received from the another concerning her 9 month old female child with history reported as unremarkable and allergies none who on 09-MAY-2006 was vaccinated with hepatitis A vaccine inactivated. No other medications were reported. On approximately 23-MAY-2006, "about 2 weeks after vaccination", the patient experienced fever of 101 Fahrenheit. The child also experienced wheezing. The physician informed the mother via telephone that vaccine should not have been administered prior to 12 months of age. The mother did not visit the physician again and reported that she is taking her daughter to a new physician today (23-MAY-2006). At the time of reporting the patient had not recovered. The patient required emergency room/doctor visit.  Additional information has been requested.
Age: 1.48
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Oedema peripheral, Skin discolouration
Clinical narrative: Information has been received from a registered nurse concerning a 18 month old female (weight 21# 13 oz; height 31.5") with medical history and drug reactions/allergies not reported who on 20-JUN-2006 was vaccinated with hepatitis A virus vaccine inactivated, intramuscularly (IM). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. On 20-JUN-2006 a few hours after immunizations that evening, the patient's mother noticed darkening of the feet. The next morning on 21-JUN-2006, the patient's mother noticed swelling of the hands and feet of the patient. On 21-JUN-2006, the patient visited the physician and was treated with diphenhydramine HC1 (BENADRYL). No product quality complaint was involved. The patient recovered from the darkening of the feet a few hours later and recovered from the swelling of the hands and feet a few days later (previously the outcome of the events were not reported). Additional information has been requested. Initial report received from a health care professional on 23/JUN/2006.  An 18-month-old female patient, with no past medical history, had received a subcutaneous, left arm, third dose injection of IPOL, lot number Y1051; an intramuscular, left arm, fourth dose injection of TRIPEDIA, lot number U1387CA; and an intramuscular, right arm, first dose injection of HEPATITIS A vaccine, manufacturer Merck, lot number 0511F, on 20/Jun/2006.  Twenty-four hours later, the patient experienced swelling of her hands and feet.  She had no pitting edema and no edema elsewhere on her body.  The event required a doctor's visit.  At the time of this report, the patient had recovered.  Follow-up information received on 01/Aug/2006 from a health care provider.  The patient was treated with BENADRYL as needed.  No additional information was provided.
Age: 2.17
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC, DTAP, FLU3, HEPA, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from an office manager concerning a 26-month-old male with no allergies or medical history who on 10-JAN-2007 at 14:00 PM was vaccinated in the lower left thigh with a 0.5 mL first dose of hepatitis A vaccine inactivated (lot # 654814/0804F). Concomitant vaccination at the same time included a fourth dose in the upper left thigh of DTaP (unspecified) (+) tetanus toxoid (lot # C2405AA), a second dose in the upper right thigh of Fluzone (lot # UT21763A), and a fourth dose in the lower right thigh of Prevnar (lot # B08670F1). There was no illness at the time of vaccination. On 12-JAN-2007, at 9:50 AM, the patient developed inflammation of 4 x 7 cm and induration of 2 x 4 cm at the injection site of hepatitis A. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. The patient had no adverse events following prior vaccination. A product quality complaint was not involved. Follow-up information was received from the office manager who reported that in the evening of 10-JAN-2007, the patient had redness on his left thigh. It had increased in size to a large area of erythema of 4 cm by 7.5 cm and an area of induration 2 cm by 4 cm. A doctor's visit was reported and the patient recovered on an  unspecified date. Additional information is not expected.
Age: 2.17
Sex: M
Vaccine: DTAP, FLU3, HEPA, PNC, DTAP, FLU3, HEPA, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Information has been received from an office manager concerning a 26-month-old male with no allergies or medical history who on 10-JAN-2007 at 14:00 PM was vaccinated in the lower left thigh with a 0.5 mL first dose of hepatitis A vaccine inactivated (lot # 654814/0804F). Concomitant vaccination at the same time included a fourth dose in the upper left thigh of DTaP (unspecified) (+) tetanus toxoid (lot # C2405AA), a second dose in the upper right thigh of Fluzone (lot # UT21763A), and a fourth dose in the lower right thigh of Prevnar (lot # B08670F1). There was no illness at the time of vaccination. On 12-JAN-2007, at 9:50 AM, the patient developed inflammation of 4 x 7 cm and induration of 2 x 4 cm at the injection site of hepatitis A. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. The patient had no adverse events following prior vaccination. A product quality complaint was not involved. Follow-up information was received from the office manager who reported that in the evening of 10-JAN-2007, the patient had redness on his left thigh. It had increased in size to a large area of erythema of 4 cm by 7.5 cm and an area of induration 2 cm by 4 cm. A doctor's visit was reported and the patient recovered on an  unspecified date. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: HEP, HEPA, HEP, HEPA
Symptoms: Pruritus
Clinical narrative: Information has been received from GlaxoSmithKline (manufacturer report number A0604293A) via a medical assistant concerning a 58 year old female with penicillin allergy and a history of hypertension who on 24-APR-2006 was vaccinated with a dose of Vaqta and a first dose of Engerix B (lot AHBVB156AA). On 24-APR-2006, the patient developed internal pruritis. On 25-APR-2006, the patient was seen in the emergency room and was treated with diphenhydramine HCl (BENADRYL) and loratadine (CLARITIN). On 01-MAY-2006, the patient recovered from the internal pruritis. Internal pruritis was considered to be an other important medical event. No further information is available.
Age: 0.33
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory arrest
Clinical narrative: Initial information received on 23 May 2007 from another manufacturer, report# WAES0702USA04116. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning an 18 week old female patient with no medical history or allergies who on 06-FEB-2007 was vaccinated with a 2 mL PO first dose of Rotateq. Concomitant vaccination administered that day included a dose in the left leg of PEDIARIX (AC21B051AA), a dose in the right leg ACTHIB (lot # UE99399) and a dose in the right leg of PREVNAR (lot # B36258A). There was no illness at the time of vaccination. Subsequently the patient stopped breathing for a short time. The patient was taken to the hospital. It was not reported if the patient was admitted. The patients outcome was not reported. There was no product quality complaint involved." "Follow-up information indicated that on 09-FEB-2007 the patient was watching television when she held her breath for two minutes. She turned yellow and pale. He lips and hands turned blue. The patient was admitted to the hospital, and was discharged on an unknown date. The patient was hospitalized for three days. While hospitalized the patient had blood work performed but the results were not reported. The patient was considered to be recovered in April 2007. The patient had no adverse events following prior vaccination. Additional information is not expected". ActHIB lot number UE99399 is not a valid sanofi pasteur lot number.
Age: 0.33
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Breath holding, Cyanosis, Laboratory test, Pallor, Respiratory arrest
Clinical narrative: Initial information received on 23 May 2007 from another manufacturer, report# WAES0702USA04116. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning an 18 week old female patient with no medical history or allergies who on 06-FEB-2007 was vaccinated with a 2 mL PO first dose of Rotateq. Concomitant vaccination administered that day included a dose in the left leg of PEDIARIX (AC21B051AA), a dose in the right leg ACTHIB (lot # UE99399) and a dose in the right leg of PREVNAR (lot # B36258A). There was no illness at the time of vaccination. Subsequently the patient stopped breathing for a short time. The patient was taken to the hospital. It was not reported if the patient was admitted. The patients outcome was not reported. There was no product quality complaint involved." "Follow-up information indicated that on 09-FEB-2007 the patient was watching television when she held her breath for two minutes. She turned yellow and pale. He lips and hands turned blue. The patient was admitted to the hospital, and was discharged on an unknown date. The patient was hospitalized for three days. While hospitalized the patient had blood work performed but the results were not reported. The patient was considered to be recovered in April 2007. The patient had no adverse events following prior vaccination. Additional information is not expected". ActHIB lot number UE99399 is not a valid sanofi pasteur lot number.
Age: 0.33
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Skin discolouration
Clinical narrative: Initial information received on 23 May 2007 from another manufacturer, report# WAES0702USA04116. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning an 18 week old female patient with no medical history or allergies who on 06-FEB-2007 was vaccinated with a 2 mL PO first dose of Rotateq. Concomitant vaccination administered that day included a dose in the left leg of PEDIARIX (AC21B051AA), a dose in the right leg ACTHIB (lot # UE99399) and a dose in the right leg of PREVNAR (lot # B36258A). There was no illness at the time of vaccination. Subsequently the patient stopped breathing for a short time. The patient was taken to the hospital. It was not reported if the patient was admitted. The patients outcome was not reported. There was no product quality complaint involved." "Follow-up information indicated that on 09-FEB-2007 the patient was watching television when she held her breath for two minutes. She turned yellow and pale. He lips and hands turned blue. The patient was admitted to the hospital, and was discharged on an unknown date. The patient was hospitalized for three days. While hospitalized the patient had blood work performed but the results were not reported. The patient was considered to be recovered in April 2007. The patient had no adverse events following prior vaccination. Additional information is not expected". ActHIB lot number UE99399 is not a valid sanofi pasteur lot number.
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Lethargy, Rash
Clinical narrative: Initial report received on 23 May 2007 from another manufacturer, report# WAES0703USA04991. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 4-year-old female with no pre-existing allergies, birth defects, or medical conditions who on 26-MAR-2007 at 11:30 am was vaccinated subcutaneously in the left thigh with a 0.5 ml booster (second) dose of Varivax (lot# 656262/1497F). Concomitant vaccinations included: a fifth dose of Tripedia (lot# C2553AA) given intramuscularly in the right thigh; a fourth dose of IPOL (lot# Z0240) given subcutaneously in the left thigh; a second dose of MMR II (lot# 654153/0951F) given subcutaneously in the right thigh. There was no illness at the time of vaccination. On 26-MAR-2007, ten minutes following vaccination, the patient experienced a severe allergic reaction, a rash, became very lethargic and had breathing problems. Further information also reported that the patient developed sneezing, coughing, hives at the injection site of Varivax (left thigh) and flushed skin and hives over the entire body and shivering. In a follow-up phone call placed on 10-MAY-2007 it was reported that the patient also experienced a hypotensive episode. Unspecified medical attention was sought and the patient was given Benadryl and symptoms resolved. No epinephrine was given. No product quality complaint was involved. The physician considered the hypotensive episode, breathing difficulty and hives all over to be life threatening events. Additional information has been requested."
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Chills, Cough, Dyspnoea, Flushing, Hypersensitivity
Clinical narrative: Initial report received on 23 May 2007 from another manufacturer, report# WAES0703USA04991. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 4-year-old female with no pre-existing allergies, birth defects, or medical conditions who on 26-MAR-2007 at 11:30 am was vaccinated subcutaneously in the left thigh with a 0.5 ml booster (second) dose of Varivax (lot# 656262/1497F). Concomitant vaccinations included: a fifth dose of Tripedia (lot# C2553AA) given intramuscularly in the right thigh; a fourth dose of IPOL (lot# Z0240) given subcutaneously in the left thigh; a second dose of MMR II (lot# 654153/0951F) given subcutaneously in the right thigh. There was no illness at the time of vaccination. On 26-MAR-2007, ten minutes following vaccination, the patient experienced a severe allergic reaction, a rash, became very lethargic and had breathing problems. Further information also reported that the patient developed sneezing, coughing, hives at the injection site of Varivax (left thigh) and flushed skin and hives over the entire body and shivering. In a follow-up phone call placed on 10-MAY-2007 it was reported that the patient also experienced a hypotensive episode. Unspecified medical attention was sought and the patient was given Benadryl and symptoms resolved. No epinephrine was given. No product quality complaint was involved. The physician considered the hypotensive episode, breathing difficulty and hives all over to be life threatening events. Additional information has been requested."
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Hypotension, Injection site urticaria, Lethargy, Rash, Sneezing
Clinical narrative: Initial report received on 23 May 2007 from another manufacturer, report# WAES0703USA04991. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 4-year-old female with no pre-existing allergies, birth defects, or medical conditions who on 26-MAR-2007 at 11:30 am was vaccinated subcutaneously in the left thigh with a 0.5 ml booster (second) dose of Varivax (lot# 656262/1497F). Concomitant vaccinations included: a fifth dose of Tripedia (lot# C2553AA) given intramuscularly in the right thigh; a fourth dose of IPOL (lot# Z0240) given subcutaneously in the left thigh; a second dose of MMR II (lot# 654153/0951F) given subcutaneously in the right thigh. There was no illness at the time of vaccination. On 26-MAR-2007, ten minutes following vaccination, the patient experienced a severe allergic reaction, a rash, became very lethargic and had breathing problems. Further information also reported that the patient developed sneezing, coughing, hives at the injection site of Varivax (left thigh) and flushed skin and hives over the entire body and shivering. In a follow-up phone call placed on 10-MAY-2007 it was reported that the patient also experienced a hypotensive episode. Unspecified medical attention was sought and the patient was given Benadryl and symptoms resolved. No epinephrine was given. No product quality complaint was involved. The physician considered the hypotensive episode, breathing difficulty and hives all over to be life threatening events. Additional information has been requested."
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Initial report received on 23 May 2007 from another manufacturer, report# WAES0703USA04991. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 4-year-old female with no pre-existing allergies, birth defects, or medical conditions who on 26-MAR-2007 at 11:30 am was vaccinated subcutaneously in the left thigh with a 0.5 ml booster (second) dose of Varivax (lot# 656262/1497F). Concomitant vaccinations included: a fifth dose of Tripedia (lot# C2553AA) given intramuscularly in the right thigh; a fourth dose of IPOL (lot# Z0240) given subcutaneously in the left thigh; a second dose of MMR II (lot# 654153/0951F) given subcutaneously in the right thigh. There was no illness at the time of vaccination. On 26-MAR-2007, ten minutes following vaccination, the patient experienced a severe allergic reaction, a rash, became very lethargic and had breathing problems. Further information also reported that the patient developed sneezing, coughing, hives at the injection site of Varivax (left thigh) and flushed skin and hives over the entire body and shivering. In a follow-up phone call placed on 10-MAY-2007 it was reported that the patient also experienced a hypotensive episode. Unspecified medical attention was sought and the patient was given Benadryl and symptoms resolved. No epinephrine was given. No product quality complaint was involved. The physician considered the hypotensive episode, breathing difficulty and hives all over to be life threatening events. Additional information has been requested."
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Chills, Cough, Flushing, Injection site urticaria, Sneezing
Clinical narrative: Initial report received on 23 May 2007 from another manufacturer, report# WAES0703USA04991. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 4-year-old female with no pre-existing allergies, birth defects, or medical conditions who on 26-MAR-2007 at 11:30 am was vaccinated subcutaneously in the left thigh with a 0.5 ml booster (second) dose of Varivax (lot# 656262/1497F). Concomitant vaccinations included: a fifth dose of Tripedia (lot# C2553AA) given intramuscularly in the right thigh; a fourth dose of IPOL (lot# Z0240) given subcutaneously in the left thigh; a second dose of MMR II (lot# 654153/0951F) given subcutaneously in the right thigh. There was no illness at the time of vaccination. On 26-MAR-2007, ten minutes following vaccination, the patient experienced a severe allergic reaction, a rash, became very lethargic and had breathing problems. Further information also reported that the patient developed sneezing, coughing, hives at the injection site of Varivax (left thigh) and flushed skin and hives over the entire body and shivering. In a follow-up phone call placed on 10-MAY-2007 it was reported that the patient also experienced a hypotensive episode. Unspecified medical attention was sought and the patient was given Benadryl and symptoms resolved. No epinephrine was given. No product quality complaint was involved. The physician considered the hypotensive episode, breathing difficulty and hives all over to be life threatening events. Additional information has been requested."
Age: 4.0
Sex: F
Vaccine: VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Flushing, Injection site urticaria, Pruritus, Syncope
Clinical narrative: Initial report received on 23 May 2007 from another manufacturer, report# WAES0703USA04991. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 4-year-old female with no pre-existing allergies, birth defects, or medical conditions who on 26-MAR-2007 at 11:30 am was vaccinated subcutaneously in the left thigh with a 0.5 ml booster (second) dose of Varivax (lot# 656262/1497F). Concomitant vaccinations included: a fifth dose of Tripedia (lot# C2553AA) given intramuscularly in the right thigh; a fourth dose of IPOL (lot# Z0240) given subcutaneously in the left thigh; a second dose of MMR II (lot# 654153/0951F) given subcutaneously in the right thigh. There was no illness at the time of vaccination. On 26-MAR-2007, ten minutes following vaccination, the patient experienced a severe allergic reaction, a rash, became very lethargic and had breathing problems. Further information also reported that the patient developed sneezing, coughing, hives at the injection site of Varivax (left thigh) and flushed skin and hives over the entire body and shivering. In a follow-up phone call placed on 10-MAY-2007 it was reported that the patient also experienced a hypotensive episode. Unspecified medical attention was sought and the patient was given Benadryl and symptoms resolved. No epinephrine was given. No product quality complaint was involved. The physician considered the hypotensive episode, breathing difficulty and hives all over to be life threatening events. Additional information has been requested."
Age: 0.5
Sex: F
Vaccine: RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Dehydration, Gastroenteritis rotavirus
Clinical narrative: Initial report received on 23 May 2007 from another manufacturer, report# WAES0704USA01568. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 6-month-old female with no pertinent medical history and no drug reactions/allergies who was vaccinated PO on 07-FEB-2007 at 4-months of age with the second dose of Rotateq (Lot # 655866/1110F). There was no illness at the time of vaccination. The first dose was administered at 2-months of age. Concomitant vaccinations that day included a second dose of IPOL (Lot # 20324) administered IM, a second dose of Tripedia (Lot # C627AA) administered IM, a second dose of ActHib (Lot # 4F990A1A) administered IM, and a second dose of Prevnar (Lot # B08670A) administered IM. Subsequently, on 18-MAR-2007, the patient developed diarrhea and vomiting. On 19-MAR-2007, the patient was admitted to the hospital for 24 hours for dehydration. The patient's stool was positive for rotavirus disease. She was treated with IV fluids. Subsequently, the patient recovered, and was discharged to home on 20-MAR-2007. There was no product quality complaint. There were no adverse events following prior vaccinations. The event was considered to be an other important medical event by the reporter. No additional information is expected." ActHib lot# 4F990A1A and IPOL lot# 20324 are not valid sanofi pasteur lot numbers. Tripedia lot# C2627AA is not a valid lot number for the product Tripedia.
Age: 0.5
Sex: F
Vaccine: RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Dehydration, Diarrhoea, Gastroenteritis rotavirus, Rotavirus test positive, Vomiting
Clinical narrative: Initial report received on 23 May 2007 from another manufacturer, report# WAES0704USA01568. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a physician concerning a 6-month-old female with no pertinent medical history and no drug reactions/allergies who was vaccinated PO on 07-FEB-2007 at 4-months of age with the second dose of Rotateq (Lot # 655866/1110F). There was no illness at the time of vaccination. The first dose was administered at 2-months of age. Concomitant vaccinations that day included a second dose of IPOL (Lot # 20324) administered IM, a second dose of Tripedia (Lot # C627AA) administered IM, a second dose of ActHib (Lot # 4F990A1A) administered IM, and a second dose of Prevnar (Lot # B08670A) administered IM. Subsequently, on 18-MAR-2007, the patient developed diarrhea and vomiting. On 19-MAR-2007, the patient was admitted to the hospital for 24 hours for dehydration. The patient's stool was positive for rotavirus disease. She was treated with IV fluids. Subsequently, the patient recovered, and was discharged to home on 20-MAR-2007. There was no product quality complaint. There were no adverse events following prior vaccinations. The event was considered to be an other important medical event by the reporter. No additional information is expected." ActHib lot# 4F990A1A and IPOL lot# 20324 are not valid sanofi pasteur lot numbers. Tripedia lot# C2627AA is not a valid lot number for the product Tripedia.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Barium double contrast, Intussusception, Vomiting
Clinical narrative: Initial information received on 23 May 2007 from another manufacturer, report# WAES0705USA01934. The initial reporter to this manufacturer had been the FDA, VAERS# 277882-1. Verbatim from the report: " Information has been received from the FDA (MFR# 277882-1) through the CDC concerning a 21 week female with a history of pilonidal dimple congenital who on 03-APR-2007 was vaccinated with a dose of Rotateq (lot# 656188/1238F). Concomitant vaccination administered that day included a dose of Daptacel (lot # C2569AA), a dose of ActHib (lot # UF073AA) and a dose of Prevnar (lot # B08672K). On 26-APR-2007 the patient developed vomiting. On 27-APR-2007 the patient developed bilious vomiting and was hospitalized. The patient was hospitalized on 27-APR-2007 and 28-APR-2008. The patient was diagnosed with intussusception which was reduced with air enema. The patient subsequently recovered. No further information is available". ActHib lot number UF073AA corresponds to sanofi pasteur ltd. lot number Z1096-2.
Age: 0.4
Sex: F
Vaccine: DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5, DTAP, HIBV, PNC, RV5
Symptoms: Intussusception, Vomiting
Clinical narrative: Initial information received on 23 May 2007 from another manufacturer, report# WAES0705USA01934. The initial reporter to this manufacturer had been the FDA, VAERS# 277882-1. Verbatim from the report: " Information has been received from the FDA (MFR# 277882-1) through the CDC concerning a 21 week female with a history of pilonidal dimple congenital who on 03-APR-2007 was vaccinated with a dose of Rotateq (lot# 656188/1238F). Concomitant vaccination administered that day included a dose of Daptacel (lot # C2569AA), a dose of ActHib (lot # UF073AA) and a dose of Prevnar (lot # B08672K). On 26-APR-2007 the patient developed vomiting. On 27-APR-2007 the patient developed bilious vomiting and was hospitalized. The patient was hospitalized on 27-APR-2007 and 28-APR-2008. The patient was diagnosed with intussusception which was reduced with air enema. The patient subsequently recovered. No further information is available". ActHib lot number UF073AA corresponds to sanofi pasteur ltd. lot number Z1096-2.