chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Acne, Fluid retention, Rash, Skin papilloma
Clinical narrative: Wart like rashes all over body, Itchy, More like water filled pimples.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Rash
Clinical narrative: Given vaccines, Developed rash (generalized) within 5 minutes, Benadryl administered and within 15 minutes rash had faded.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 5.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Injection site induration, Oedema, Pyrexia
Clinical narrative: Left arm/deltoid with erythema starting 08/10/2006, 1 hour after vaccination over 4 days, persistent fevers (daily temperature 102.2 F), painful left arm, increased erythema, edema, and induration, extending 12 by 12 centimeter by 08/14/2006 after labs done.  Patient seen on  day 4 (08/14/2006) treatment fever control with TYLENOL and MORTRIN, BENADRYL every eight hours. Return to clinic supportive treatment only.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Chills, Dyspnoea, Erythema, Feeling hot, Nausea
Clinical narrative: Got Td on Thursday, 08/10/2006 left arm, on Friday 08/11/2006 started with red arm swelling warm to touch, Saturday 08/12/2006, with nausea, shortness of breath, fever, chills, had an antibiotic called in on Sunday 08/13/2006 had appointment in office 08/14/2006 still had redness with swelling to most of her upper arm, no fever, no shortness of breath.
Age: 24.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia, Swelling
Clinical narrative: Got Td on Thursday, 08/10/2006 left arm, on Friday 08/11/2006 started with red arm swelling warm to touch, Saturday 08/12/2006, with nausea, shortness of breath, fever, chills, had an antibiotic called in on Sunday 08/13/2006 had appointment in office 08/14/2006 still had redness with swelling to most of her upper arm, no fever, no shortness of breath.
Age: 0.18
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying
Clinical narrative: High pitched crying Initial report received from health care professional in the USA on 08-Jul-2005. A 2 month old female patient presented with high pitched crying one day after receiving a number of vaccinations on 06-Jul-2005. The patient received the following injections: 1. Daptacel lot number C2120AA intra muscularly in the right leg; 2 IPOL lot number Y0240 subcutaneously in the right leg; 3. Comvax MSD, lot number 0123R intra muscularly in the left leg; 4. Prevnar Wyeth lot number A9444OA intra muscularly in the left leg. The patient's parents administered acetaminophen and the patient's symptoms resolved. Follow up information received on 11-August-2005. The patient recovered from the adverse event on 07/Jul-2005. The patient did not have any concurrent conditions or concurrent medications and was not on any concurrent medications. The patient did not have any illness at the time of vaccination.
Age: 58.0
Sex: M
Vaccine: HEPAB, IPV, MMR, TD
Symptoms: Mouth ulceration, Rash
Clinical narrative: Initial report received from a pt, who is a veterinarian, on 7/25/05. This 58 year old male pt reported that he had received a set of vaccinations on 7/8/05, TD, IPOL, MMR, Hepatitis A, Hepatitis B, the lot numbers of all the vaccines were unknown. On 7/12/05 he started biting inside of cheeks and tongue. He developed sores that are clearing up. On 7/21/05, he presented with prickly rash on his right knee. Then, on 7/22/05, he had rash to both elbows and knuckles. He has not seen DR. At the time of reporting, the pt did not recover. Follow up received on 10/3/05 as per the additional information, it was stated that the client reported symptoms 13-14 days after the vaccination on 7/8/05. Lot numbers for IPOL and Tetanus and Diphtheria Toxoids absorbed for Adult use were X1212 and U1341AA respectively. He had also received a Rabies booster and Hepatitis A&B vaccine on 8/12/05. The pt was not still recovered at the time of the report.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: This report is the same as for cases 200501561, 200600062, 200600063, and 200600064. Follow information received 2/13/06 from a health care provider. The reporter writes left thigh cellulitis next to the event of injection site reaction on the VAERS form. Additional information is not provided. Follow up information received on 6/8/06 from a health care professional. It was reported that the pt had no illness at the time of vaccination. She had no significant past medical history and no adverse events following prior vaccination. The pt was treated for the events with unspecified antibiotics. No further information is anticipated.
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Vertigo
Clinical narrative: Initial reported received on 1/19/06 from a health care provider. A male pt, age unspecified received on an unspecified date injection of IPOL, lot number and route and site of administration not reported, an injection of Typhim VI, lot number and route and site of administration not reported, and an injection of YF Vax,  lot number and route and site of administration not reported. At an unspecified amount of time later, he developed severe vertigo which required an ER visit. Other medications and pre existing medical conditions were not provided. Illness at the time of vaccination was none. Per the reporter, lab work was within normal limits. Additional information was not provided. At the time of this report, the pt had not recovered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Large arm swelling, redness
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Initial report received from a health care provider on 3/21/06. A five year old male pt, with a history of an allergy to tree pollen, had received, on 3/14/06, a fifth dose , left arm injection of Tripedia, lot number U1635CA, a fourth dose left arm injection of IPOL, lot number Y0638, and a second dose , left arm injection of MMR vaccine, lot number 0466R. Within 24 hours post vaccination, the pt had developed a softball sized area of redness, swelling, warmth and soreness. At the time of this report, the pt had not recovered from the event. Follow up information received on 4/10/06. The pts event did not require a doctors visit. Routes of administration of the vaccinations were provided. At the time of this report, the pt had recovered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Initial report was received from a health care professional on 3/20/06. A four year old female pt developed a softball sized area of redness, swelling, warmth and soreness at the injection site, one day after receiving Tripedia, lot number U1635CA, expiry date 2/12/07, and Ipol lot number Y0638 on 3/13/06. The pt received in concomitant the injection of MMR II, lot number 0466R. Route of administration and injection site for all vaccines was not reported. Per reporter, the pt denies any illness at the time of vaccination. The reaction occurred at the injection site of Tripedia. Treatment was not reported. At the time of this report the pt has not recovered. Follow up information received on 4/10/06. Per reporter, the pt received the IM injection of Tripedia dose 5 in the upper left arm, the SC injection of Ipol dose 5 in the lower left arm and the SC injection of MMR II dose 5 in the right arm. The swelling at the deltoid was larger than 1/2 dollar, warm and red. Treatment included cool compresses, Tylenol Q4H and Benadryl Q6H, Per reporter the pt recovered. NO further information expected. The reporter for this case is the same as for cases 200600653 and 200600654.
Age: 18.0
Sex: M
Vaccine: IPV, RAB
Symptoms: Decreased appetite, Diarrhoea, Dyspepsia, Gastroenteritis, Nausea
Clinical narrative: Initial report receive from a nurse practitioner on 5/25/06. An 18 year old male pt developed nausea, indigestion, loss of appetite, loose stools and dizziness the day after receiving the injection of Imovax rabies, dose one lot number not reported, Ipol, lot number not reported, and hepatitis A vaccine lot number and manufacturer not reported on 4/20/06. The route and site and administrations for all vaccines was not provided. Per reporter, it is not known if the pt had any illness at the time of vaccination. The pt was seen by a physician. No treatment was reported. AT the time of this report the pt continues to have dizziness. Follow up information received on 5/22/06. On 4/20/06 the pt had received an IM dose of RabAvert, lot number 348011A, in the left deltoid, and IM dose of Hep A vaccine, lot number 1067R, in the right deltoid, and a 0.5cc SC dose of Ipol, lot number Y0824-2 in the left arm. The pt was seen by the physician on 4/25/06 for symptoms of nausea, decreased appetite, indigestion, diarrhea and inability to tolerate a regular diet. The pt reported that the symptoms had begun on 4/20/06, a few hours post immunization. The symptoms were still persisting on 4/25/06 and he was instructed to start a BRAT diet. The health center subsequently received 15 additional reports of students with similar symptoms as the pt. When the health center investigated, they discovered that all 15 students lived in the same dorm as the pt. They were all subsequently diagnosed with viral gastroenteritis. Of those 15 students, the pt was the only one who had received the RabAvert vaccine. It was concluded that the pt did not have a reaction to the rabies vaccine. The pt was diagnosed with viral gastroenteritis. On 4/27/06 the pt was again seen by the physician for persistent diarrhea and was prescribed Imodium. On 4/28/06 the pt reported to the health center that all of his symptoms had resolved.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: In was reported that 8-10 pt, 5 years of age developed swelling, pain, redness and warmth from their shoulder to their elbow approx 24 hours after receiving in the injection route not reported, of Daptacel, dose five lot numbers included C20506AA and C2253AA, in the deltoid and the SC injection of Ipol, lot number Y1051 administered in the same arm as Daptacel on an unspecified date. Specific arm vaccinations were given in was not reported. Needle was 5/8 and 25 gauge. It was not reported if this needle size was used for Daptacel or Ipol. Per reporter the pts had no illness at the time of vaccination. At the time of this report the pts had not recovered.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a RN on 02May06. A 5 yr old female pt with an allergy to walnuts developed left arm swelling large area, redness and sore to touch five days after receiving the injection of the fourth dose of Daptacel, lot number C2431AA (expiry date 14Jan08) and IPOL, lot Y0824-2 (expiry date 15Sep07) on 26Apr06. Both vaccines were administered into the left deltoid. Route of admin was not reported. The pt received in concomitant the injection of MMR, lot 0751F, in the right deltoid.  Per reporter a 5/8", 25 gauge needle was used, however it was not specified for which vaccine. Per the reporter the pt had no illness at the time of vaccination and was not seen by a physician for this event. At the time of this report the pt had not recovered. Same reporter in cases 200601016 and 200601017.
Age: 1.58
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: A 19 month old female pt developed left arm redness, swelling involving large area, three days after receiving the injection of the fourth dose of Daptacel, lot number U1342BA and IPOL, lot number Y0638-2(expiry date 07Jul07) on 28Apr06. Both vaccines were administered IM into the left deltoid. The pt received in concomitant the IM injection of Hep A vaccine, lot 0936R, in right arm. Per reporter a 5/8", 25 gauge needle was used, however it was not specified for which vaccine. Per reporter, the reported lot number for Daptacel coincides with Tripedia, not Daptacel. This information was confirmed that lot number U1342BC coincides with Tripedia (expiry date 23Jul06). Confirmation of product received will be requested. Per reporter the pt had no illness at the time of vaccination. The pt did not have a fever and was not seen by a physician for this event. No diagnostic tests were performed. Recovery status of the pt was not reported. Same reporter in cases 200601015 and 200601016.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Feeling hot, Hyperhidrosis, Somnolence, Urinary incontinence
Clinical narrative: Initial report received from a consumer on 08may06. A four year old male child with a medical history of pervasive development disorder, developed profuse sweating, felt warm, appeared to sleep more deeply and wet the bed which began in the evening of the day he received the injection of IPOL, lot number Y1067-2 (expiry date 22Nov07) in the left arm on 17May06. Per reporter, who is the pt's mom, her son had no illness at the time of vaccination. The symptoms lasted for one week. Per mom, the child had recovered, however still has sporadic bed wetting episodes. Follow up information received on 12Jun06 from a health care professional. It was reported that the pt received the IPOL vaccination on 17Apr06. His mother did not notify the physician of any adverse reactions until 10May06. The pt was seen in the physician's office on that day, but by that time his symptoms had already subsided. No further treatment was provided. Further information is not expected.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: A 5 yr old female pt had received a SC, left thigh, fourth dose injection of Ipol, lot number 40638; an IM, left thigh, fifth dose injection of Infanrix, lot AC14B018AA; and a SC, right thigh injection of MMR vaccine, lot number 0377R; on 05May06. The next day, the pt developed a large local reaction of redness and swelling measuring six inches in diameter over the IPOL and Infanrix vaccination sites on the left thigh. Two days later, the pt was evaluated and prescribed ice to the site and Benadryl for any itching. No diagnostic or lab tests were performed. At the time of this report, the pt's recovery status was unk. Follow up information received on 07Jun06 from a healthcare professional. The event did not require Benadryl administration. The reporter confirms the low number as Y0638. It was unk whether the redness and swelling crossed over any joints. Per the reporter, the duration of the event was three to four days.
Age: 43.0
Sex: F
Vaccine: HEPA, IPV, MEN, MMR, TYP, YF
Symptoms: Chills, Hyperhidrosis
Clinical narrative: Initial report received from a Registered Nurse in the USA on 23//May/2006. A 42 year old female patient became diaphoretic and had chills immediately after receiving the subcutaneous injection of YF-VAX, lot number UE814AA (expiration date 06/Feb/2007) in the right arm, the intramuscular injection of TYPHIM VI, lot number Y0794-2 (expiration date 24/Aug/2007) in the right arm, the subcutaneous injection of Menomune A/C/Y/W-135, lot number UE518AA (Expiration date 23/Jan/2008) in the left arm, the intramuscular injection of HAVRIX, (manufacturer Glaxo Smith Kline) lot number AHAVB106AA in the left arm and the subcutaneous injection of Measles, Mumps, Rubella Vaccine, lot number 0615P (manufacturer Merck) in the left arm. It was reported that all vaccines were received on 23/May/2006. Per reporter, the patient had no illness at the time of vaccination. The patient was diaphoretic and had chills for 20 minutes then fully recovered. No further information is expected. Per reporter, the patient had no pre-existing medical conditions or allergies.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Oedema peripheral
Clinical narrative: An 18 month old female pt, with no past medical history, had received a SC, left arm, third dose injection of Ipol, lot number Y1051; an IM, left arm, fourth dose injection of Tripedia, lot number U1387CA; and an IM, right arm, first dose injection of hep A vaccine, lot 0511F; on 20Jun06. Twenty four hrs later, the pt 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 pt had recovered.
Age: 21.0
Sex: M
Vaccine: JEV, TD
Symptoms: Mouth ulceration
Clinical narrative: From initial information received on 05Jan05 from a RN regarding an adverse event occurring it was reported that a 21 yr old male pt received his first dose of JE VAX, lot number EJN213A, administered SC in the left arm and a second dose of TD, lot number U1341AA, administered IM in the right deltoid on 23Dec04. Several hours later, the pt developed several cold sores on his mouth and several canker sores in his mouth. The pt stated that he was afebrile and denied itching, rash, hives, or any other symptoms. The pt recovered from the events.
Age: 20.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Arthralgia, Chest discomfort, Chest pain, Injection site pain, Skin burning sensation
Clinical narrative: From initial information received on 27Apr05 from a health care professional regarding an adverse event occurring, it was reported that a 20 yr old female pt received a second dose of JEVAX, lot number EJN216B, administered in the left arm and a second dose of RABAVERT, lot number 341011 administered in the right deltoid on 25Apr05 at 10:30AM. Routes of administration were not reported. Five hours later, at 03:30PM on 25Apr2005, the pt developed severe pain and burning from shoulder to wrist in her left arm. She also complained of pain and burning of left side of chest and tightness. The duration of these events was approx eight hrs. There was no difficulty breathing. The pt's recovery status is currently unk. The reporter of this case is the same reporter of case 200500727.
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Blister, Rash papular
Clinical narrative: Multiple vesicles and papules.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Rash
Clinical narrative: Information has been received from a RN concerning a 6 month old white female who on 26Jun06 at 16:15, was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653661/0146F). The RN reported that on 27Jun06 the pt developed rash around her mouth. Medical attention was not sought. At the time of this report, the outcome was unk. Additional information has been requested.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Agitation, Crying, Cyanosis, Oedema peripheral, Screaming
Clinical narrative: Information has been received from a physician concerning a 20 wk old male with a history of premature birth who on 15Jun06 was vaccinated PO with a 2.0mL dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 652964/0145F). Concomitant vaccinations administered on that same day included a dose of diphtheria toxoid (+) hep B virus vaccine rHBsAg (yeast) (+) pertussis acellular 3 component vaccine (+) poliovirus vaccine inactivated (+) tetanus toxoid (Pediarix), Hib conj vaccine (manf unk) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar).  The physician reported that on 15Jun06, an hour after vaccination,  the pt woke up crying and could not be controlled. The pt acted as if his stomach hurt, and cried more after nursing. The pt's lower extremities also became swollen and his legs had a blue color. It was unk if medical attention was sought and no lab/diagnostic tests were performed. On that same day, two hrs after onset, the pt's symptoms resolved on therapy (unspecified). Additional information has been requested. Medical attention was not sought. At the time of this report, the outcome was unk. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a pt who in Jul 2006, was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Concomitant therapy included lansoprazole (Prevacid). The physician reported that in July 2006, the pt experienced rash. Unspecified medical attention was sought. At the time of this report, the pt was noted to be recovering from the rash. Additional information has been requested.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Retching, Vomiting
Clinical narrative: Information has been received from a RN concerning a 4 month old female with no known medical history or allergies who on 10Jul06 was vaccinated with a PO dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot653981/0411F). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine, pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) and Hib conj vaccine (manf unk). While being administered rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653981/0411F) the pt began to gag and vomit. Subsequently on 10Jul06, the pt recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/10/2006.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a health professional concerning an 8 wk old female, with no medical history and no allergies who on 10Jul06 was vaccinated with one oral viral of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) (lot 653981/0411F). Concomitant vaccines included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar), a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated and a dose of Hib conj vaccine (manf unk). It was reported that on 10Jul06, while administering rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) the pt swallowed twice and then began to vomit. It was reported that the pt recovered on 10Jul06. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a physician concerning a female infant who on 11Jul06 was vaccinated with an oral 2ml dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). It was reported that within a few minutes, on 11Jul06, the pt vomited the medication. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: RV5
Symptoms: Irritability
Clinical narrative: Information has been received from a physician concerning an 8 week old pt, with no medical history and no allergies, who, two weeks ago on approx 01Jul06, was vaccinated with a single 2ml oral dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). There was no concomitant medication. it was reported that two weeks ago, on approx 01Jul06, the pt became extremely fussy and irritable. At the time of the report the pt had not recovered. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 4 wk old female who on 12Jul06 was vaccinated, by mouth, with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The pt had no symptoms. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 7 week female pt who on 05-JUL-2006, was vaccinated with an oral 2ml first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Concomitant vaccine administered at the same time included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. It was reported that the evening after receiving rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) the pt had a fever over 102 degrees. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on approximately 07-JUL-2006 the patient experienced a fever of 102 degrees and fussiness for 24 hours. It was reported that the patient recovered on 06-JUL-2006. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a pt who in approx Jul 2006 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The NP reported that in approx Jul 2006, within hours of being vaccinated, the pt experienced a fever of 104 deg. Unspecified medical attention was sought. At the time of this report, the outcome was unk. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a RN concerning a pt who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The pt was noted to be ill prior to vaccination. The RN reported that the pt subsequently vomited after receiving rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). It was unk if medical attention was sought and no other symptoms were noted. At the time of this report, the outcome was unk. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 2 month old pt who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The physician reported that the pt subsequently developed hives. Unspecified medical attention was sought and the pt was treated with diphenhydramine HC1 (Benadryl) and steroids. At the time of this report, the pt was noted to be recovering. Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a pt who on approx 05Jul06 was vaccinated PO with a dose of ROTATEQ. The physician reported that on approx 19Jul06, his office received a call from the pt's parents indicating their child had diarrhea. On approx 26Jul06, the physician's office received another call from the pt's parents noting that the diarrhea continued. At the time of this report, no lab/diagnostic tests had been performed and the pt's diarrhea persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 8/10/2006.  Information has been received from a physician and a woman in the physician's office concerning a 9-month-old male who on 07-JUL-2006 (previously reported as approximately 05-JUL-2006) was vaccinated PO with the second dose of ROTATEQ.  It was reported that on 07-JUL-2006 (previously reported as approximately 19-JUL-2006), the physician's office received a call from the patient's parents indicating their child had diarrhea.  On approximately 26-JUL-2006, the physician's office received another call from the patient's parents noting that the diarrhea continued.  No laboratory/diagnostic tests were performed.  On 01-AUG-2006, patient's diarrhea resolved.  Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a RN concerning a 2 month old pt with no medical history or allergies who on 12Jul06 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). Concomitant vaccinations administered on that same day included a dose of hep B vaccine recomb (Engerix B) and possibly other vaccines. The RN reported that on 13Jul06, the pt developed a fever of 101.1F. Unspecified medical attention was sought and no other lab/diagnostic tests were performed. On 14Jul06, 24 hrs after onset, the pt's fever resolved. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 2 month old pt with no medical history who in Jul 2006, was vaccinated PO with the first 2.0mL dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The physician reported that in Jul 2006, 14 days after vaccination, the pt developed very slight diarrhea. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. In Jul 2006, the pt's diarrhea resolved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 8/10/2006.  Information has been received from a physician concerning a 2-month-old patient with no medical history who on July 2006, was vaccinated PO with the first 2.0 mL dose of ROTATEQ.  The physician reported that in July 2006, 14 days after vaccination, the patient developed very slight diarrhea.  Unspecified medical attention was sought, but no laboratory / diagnostic tests were performed.  In July 2006, 1-2 days after onset, the patient's diarrhea resolved.  Additional information is not expected.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 6 month old male who on approx 27Jul06 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). It was unk if medical attention was sought. At the time of this report, no adverse reaction was noted. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Diarrhea Information has been received from a physician concerning a patient who was  was vaccinated  with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). The physician reported that the patient subsequently developed very slight diarrhea. It was unknown if medical attention was sought. At the time of this report the outcome was unknown. Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Inappropriate schedule of drug administration; no adverse effect Information has been received from a physician concerning a 6 month old female who on approximately 27-JUL2--6 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). It was unknown if medical attention was sought. At the time of this report no adverse reaction was noted. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Inappropriate schedule of drug administration; no adverse effect Information has been received from a physician concerning a 6 month old male who on approximately 27-JUL-2006 was vaccinated PO with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). It was unknown if medical attention was sought. At the time of this report, no adverse reaction was noted. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site pain, Injection site swelling, Rash, Swelling
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on unspecified date was vaccinated with a 0.5 ml of HPV rLI 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced painful swelling " the size of a golf ball".  The patient recovered by the "next day".  Unspecified medical attention was sought.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pain, Swelling
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on unspecified date was vaccinated with a 0.5 ml of HPV rLI 6 11 16 18 VLP vaccine (yeast). Subsequently the patient experienced painful swelling " the size of a golf ball".  The patient recovered by the "next day".  Unspecified medical attention was sought.  Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: HEPAB
Symptoms: Heart rate irregular, Myalgia, Pain
Clinical narrative: 8/11/06 Hep A- Hep B vaccination #1 given at SC 11:35 RA, SADR at that time for next hour. Approx 6:30pm that day pt took daily dose of Zyprexa 15 mg PO then 30 mins - 1 hour later had pain in opposite LA and had heard rate slow down and stay slow till next morning. LA pain deltoid remained constant till noon next day. States LA pain a 6 on scale of 10, Described as a pulled muscle pain.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site warmth
Clinical narrative: 2 inch x 2 inch area left arm, red, hot to touch and hard.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: 2 inch x 2 inch area left arm, red, hot to touch and hard.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 7/26/2006 from a health care professional. A 45 year old female pt received a booster dose of Decavac, lot number U1724AA, IM in the right deltoid. Five days later, the pt developed redness approx one inch below the injection site. The redness extended down to the elbow. The pt also complained of tenderness and swelling at the site of injection . The pt was seen by a physician and was treated with oral prednisone. As per the reporter, the pts recovery status is unknown. The reporter of this case is the same as for non serious case 200601913, which involved a report of injection site inflammation following the administration of Decavac, lot number U1596DA.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site oedema, Pyrexia
Clinical narrative: Seriousness criteria other medically significant (OMIC). Initial report received on 8/3/2006 from a nurse. A 26 year old female pt who had a wound to her finger had received a first dose of Adacel, lot number C2559AA, on 8/1/2006. The route and site of administration of the Adacel was not reported. The pts would to her finger was treated the same day with Omnicef. The following day, the pt developed a fever of 104 degs F, and her arm was swollen at the Adacel injection site. Tylenol was prescribed, and the fever remained high the following day. The temperature reading the following day on 8/3/06, was not reported. Per the reporter, the pt was to be re evaluated by the physician if the fever remained high. The recovery status of the pt was reported as unknown.
Age: 44.0
Sex: M
Vaccine: ANTH, FLUX, HEP, HEPA, IPV, MEN
Symptoms: Anxiety, Blindness, Depression, Glaucoma, Hypertension
Clinical narrative: High temperature, high blood pressure, vision loss, possible glaucoma, muscle ache, anxiety, depression.  11/16/06 Received medical records from VAMC which reveal patient seen 9/03 for acute supurative conjunctivitis.  No other problems noted until 6/05 when eval by neurosurgeon for neck & back pain after falling from truck on deployment 2004.  Disc bulging noted at that time at C4-5, C5-6 &  C6-7.  HNP t L5-S1.  Had received 2 epidural blocks for lumbar pain with some resolution.  Next seen 8/06 by neurosurgeon still c/o LBP & neck pain.  Was receiving PT.  Felt that surgery would not benefit patient & he was to continue PT & meds.  Vaccination record also included with records.
Age: 44.0
Sex: M
Vaccine: ANTH, FLUX, HEP, HEPA, IPV, MEN
Symptoms: Myalgia, Pyrexia
Clinical narrative: High temperature, high blood pressure, vision loss, possible glaucoma, muscle ache, anxiety, depression.  11/16/06 Received medical records from VAMC which reveal patient seen 9/03 for acute supurative conjunctivitis.  No other problems noted until 6/05 when eval by neurosurgeon for neck & back pain after falling from truck on deployment 2004.  Disc bulging noted at that time at C4-5, C5-6 &  C6-7.  HNP t L5-S1.  Had received 2 epidural blocks for lumbar pain with some resolution.  Next seen 8/06 by neurosurgeon still c/o LBP & neck pain.  Was receiving PT.  Felt that surgery would not benefit patient & he was to continue PT & meds.  Vaccination record also included with records.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 24 year old female with no medical history and no drug allergies who "last week" on approximately 12-JUL-2006 was vaccinated with HPV vaccine rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml).  Concomitant therapy that day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid.  The vaccines were administered in different arms.  Subsequently, "12 hours after vaccination" the patient developed a rash throughout her whole body that lasted for two days.  Unspecified medical attention was sought.  The patient recovered two days after injection.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Pain, Swelling
Clinical narrative: Information has been received from a physician concerning an approximately 16 year old female who on 19-JUL-2006 was vaccinated with HPV rLI 6 11 16 18 VLP vaccine (yeast).  It was reported that "immediately after the injection", on 19-JUL-2006, the patient experienced pain and stinging at the injection site that lasted about 2 minutes and radiated the arm.  The patient also reported feeling faint following the injection and experienced swelling.  It was reported that the swelling went down but the pain persisted.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Loss of consciousness, Syncope, Syncope vasovagal
Clinical narrative: Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no  drug allergies who on 27-JUL-2006 was vaccinated intramuscularly in the right deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F).  There were no concomitant medications.  At the time of vaccination the patient experienced extreme pain at the injection site and fainted.  The nurse reported that "the onset of the pain was immediate and lasted for 1 and a half to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right".  The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no post- ictal state.  Unspecified medical attention was sought.  Subsequently, the same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode.  The patient did not wish to continue the series as a result of the adverse experience.  Additional information has been requested. 01/05/2007 This is in follow-up to report(s) previously submitted on 8/10/2006. Information has been received from a registered nurse and a physician concerning a 16 year old female no medical history and no drug allergies who on 27-JUL-2006 at 13:30 was vaccinated intramuscularly in the right deltoid with the first dose of GARDASIL (0.5 ml) (lot # 653650/0702F). There were no concomitant medications. At the time of vaccination the patient experienced extreme pain at the injection site and fainted. The nurse reported that "the onset of the pain was immediate and lasted for 1 1/2 to 2 minutes and then the patient passed out for 15 to 20 seconds and then was all right". The physician reported that the patient had a vasovagal syncopal episode, was not incontinent, and experienced no post-ictal state. Unspecified medical attention was sought. Subsequently, that same day the patient recovered from the extreme pain at the injection site and vasovagal syncopal episode. The patient did not wish to continue the series as a result of the adverse experience. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician and registered nurse concerning a 21 year old female with no medical history of drug allergies who on 27-JUL-2006 was vaccinated intramuscularly in the left deltoid with the first dose of HPV rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml) (lot#653650/0702F).  Concomitant therapy included possible hormonal contraceptives (unspecified).  On 27-JUL-2006 the patient experienced extreme pain at the injection site.  The onset of the pain was immediate and lasted for 5 to 6 minutes and then resolved.  Unspecified medical attention was sought.  It was reported that the patient does not wish to continue the series of vaccinations.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: DTP, HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 28-JUL-2006 was vaccinated with HPV rLI 3 11 16 18 VLP vaccine (yeast).  Concomitant vaccination on 28-JUL-2006 included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid.  The patient stated that following vaccination on 28-JUL-2006, she " experienced a great deal of pain at the injection site".  Unspecified medical attention was sought.  At the time of this report, the outcome of the event was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Information has been received from a 67 year old male consumer with high blood pressure and enlarged prostate who on 08-JUL-2006 was vaccinated SC in the left arm with a 0.5 ml dose of varicella-zoster virus vaccine live (Merck).  Concomitant therapy included Terazosin hydrochloride (HYTRIN) and testosterone gel.  On 13-JUL-2006 the patient experienced soreness in the left arm where the shot was administered.  By 14-JUL-2006 the patient had severe muscle pain in the left arm.  Aspirin was taken and alleviated the pain.  On 15-JUL-2006 the patient developed a fever of 101 degrees.  The fever dissipated by the morning of 16-JUL-2006.  Unspecified medical attention was sought.  The patient recovered on 17-JUL-2006.  There was no product quality complaint involved.  Additional information has been requested. Follow up - information received from the physician indicated that he did not have any information from the patient about any adverse reactions. Additional information in not expected.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pulmonary congestion, Pyrexia
Clinical narrative: Information has been received from a 75 year old male consumer with a history of shingles "once or twice many years ago" and no other reported allergies or history who approximately 20-JUN-2006 was vaccinated with a dose of varicella-zoster virus vaccine live.  Concomitant therapy included finasteride (MSD), pravastatin Na (PRAVACHOL), levothyroxine Na (SYNTHROID) and probenecid (BENEMID). About 4 weeks after vaccination, on approximately 18-JUL-2006, the patient developed a high fever and felt very sick with chest congestion and flu-like symptoms.  He said was seen by his doctor and the doctor's diagnosis was that he had a bacterial infection.  Subsequently, the patient recovered.  There was no product quality complaint involved.  Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: HBHEPB, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Given 7/28/06, Lg local rx right thigh. Injection site swell. 8/2/06 1 1/2 cm slight induration and mild erythema. Not tender. Spoke with mom 8/14/06. Spot was resolved. No redness or signs of swelling.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Left arm red and swollen 1 inch diameter.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia
Clinical narrative: Localized myalgia x 2W
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Blister, Dermatitis bullous, Injection site reaction, Skin ulcer
Clinical narrative: 08/02/2006 pt started with blisters pm on right tricep. ProQuad (MMR/Varivax) given on right tricep 8/1/06. 8/3/06 seen in office with right tricep multiple blisters and 3 bullous lesions.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Received vaccine approx 36 hours ago. Left arm red, swollen and warm to touch, Advised Motrin and cold compresses.
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Headache, Joint stiffness
Clinical narrative: Joints pain and stiffness, headaches.
Age: 24.0
Sex: F
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site vesicles
Clinical narrative: Grandmother states found child arm red and swollen about 12 noon on 8/12/06. Child c/o pain. On 8/13/06 grandmother stated a small amount of blisters appeared so cold pack was applied for about 10 minutes. Child appeared with father today, left arm red, swollen and moderate amount of vesicles. Redness measuring about 10cm x 7 cm. No fever complaints just pain.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site vesicles, Injection site warmth, Pruritus
Clinical narrative: Vaccines Rec'd 7/19/06, reaction began 7/20/06 seen in clinic 7/21/06 with hot, red, swollen upper left arm with blisters. Pt given Keflex 125mg TID x 10 days and Mom instructed to use OTC Benadryl cream and Capsules for itching.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Bone disorder, Influenza like illness, Injection site hypersensitivity, Pain
Clinical narrative: 6/15/06 received the TD on Thursday am. She started having SX on Friday night, Flu-like aching in upper body. Vaccine site turned red on Thursday PM. Presented to the Emergency Sat am with bones aching all over. Stayed about 2 hours, had an INT inserted and Demerol was administered. Pt left the ER. Stated she felt better the next day.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Headache, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Within 30 minutes fever 102, child vomiting, arm right hot, swollen, red, c/o HA, TC to mom 6/26/06 child OK.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Vomiting
Clinical narrative: Within 30 minutes fever 102, child vomiting, arm right hot, swollen, red, c/o HA, TC to mom 6/26/06 child OK.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: 06/18/2005 high fever 104 continuing until 6/20/05 saw Dr put on Azithromycin 250mg completed 6/25/06, Methylprednisone 4mg 21 tabs, 2 remaining tablets.
Age: 0.75
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Warmth, redness, slightly, swollen, Tx with Benadryl.
Age: 1.07
Sex: F
Vaccine: HBHEPB, HEPA, PNC
Symptoms: Abnormal behaviour, Convulsion, Eye movement disorder
Clinical narrative: Seizure like activity for 3 weeks off and on following immunizations. Eyes rolled back a to side banged head not cooperative. Had from 1-9 times ad day during this period.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Right Upper arm near injection site was swollen to about golf ball size. Minimal erythema. Advised cool compresses and Motrin