chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Staring
Clinical narrative: Staring few times for short periods of time during day. 4/28/04:shots and Monday 4/26/04. Referred to PCP for follow up.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Mother states 24 hrs after vaccine right arm swelled up. Redness noted. Warm to touch.
Age: 11.0
Sex: M
Vaccine: TD
Symptoms: Hypersensitivity, Influenza, Urticaria
Clinical narrative: 11 year old male with allergic reaction with approx 20 inches after TD booster. No shortness of breath, positive hives on torso and upper arms. and 1-2 small hives neck area. looked comfortable no wheezing on PE. CTAB; given 2 tsp orally of Benadryl. No hives with 5-10 inches. Flu in 2 days. Benadryl orally every 6 hours for 48 hours. With flu about 2 all/Im, epipen given.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Rash, Rhinorrhoea
Clinical narrative: Rash on face, back and chest for 3 days. Some to legs. Pt had cough and drainage. No one else had reaction.
Age: 1.08
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Fine red raised rash to abdomen, arms, legs, back without fever appeared on 4-16-04.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Hypersensitivity, Oedema
Clinical narrative: Right upper arm is swollen, red after DTaP on 5/06/04. Treated with Benadryl for allergic reaction Calamine lotion for itching.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Blister, Injection site rash, Pruritus, Rash vesicular
Clinical narrative: Approx 24 hours following Td vaccine in left deltoid: appearance of 3 small vesicles 27mm medial to site of injection. Coalesced into 2 (4mmx2mm blisters). Mild complained of itchy.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Oedema, Pruritus
Clinical narrative: 5/13/04 Call from school nurse says child arm swollen, red and has heat. Child sitter called and said area was a little red & swollen last night but child kept scratching area.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Diarrhoea, Groin pain, Headache, Malaise
Clinical narrative: Burning sensation down to hand 3 m and to left neck. Headache 1 1/2-2 months. Fever for 3 days. Myalgia, anthralgia (ankles knees, elbows. Myalgia resolved after 1 1/2 weeks. Continued anthralgia. Diarrhea for 24 hours. Groin pain for 1 wk. Symptoms have resolved with eruption to mild anthralgia and some malaise. Using no meds.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Myalgia, Pyrexia, Skin burning sensation
Clinical narrative: Burning sensation down to hand 3 m and to left neck. Headache 1 1/2-2 months. Fever for 3 days. Myalgia, anthralgia (ankles knees, elbows. Myalgia resolved after 1 1/2 weeks. Continued anthralgia. Diarrhea for 24 hours. Groin pain for 1 wk. Symptoms have resolved with eruption to mild anthralgia and some malaise. Using no meds.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Eyelid oedema, Face oedema
Clinical narrative: Swollen eye lids, lower lip swollen Benadryl given. Occurred 3 hours after mins not seen until 3 days after. And occurred to lesser amount age after 2m, but not at 4m.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Erythema, Rash papular, Skin nodule
Clinical narrative: 4 x 2.5 cm red induration with a group of 3 vesicles in center & 2 red papules right anterior thigh approx 11 days after shot administer.
Age: 1.0
Sex: M
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Diarrhoea, Irritability, Pyrexia, Upper respiratory tract infection, Vomiting
Clinical narrative: Fever to 102.3. Fussiness, emesis, diarrhea & no URI signs. 4 wks later pt & brother had febrile illness with URI signs- resolved spontaneously.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot
Clinical narrative: Parent brought patient into clinic on 5-13-04 complains of pt's arm (left) being hot, red from receiving a vaccination of DTaP # 4 on 5-11-04. This reaction was noticed on 5-12-04. 3 attempts to follow-up were unsuccessful on 5-14-4. 1 attempt on 5-17-04 to follow up was unsuccessful.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Livedo reticularis, Oedema, Pyrexia, Rash
Clinical narrative: Left leg very swollen area 48 hours with rash in pink mottled by 3 by 6 inches. Minimally tender, low grade temp.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Tenderness
Clinical narrative: Left leg very swollen area 48 hours with rash in pink mottled by 3 by 6 inches. Minimally tender, low grade temp.
Age: 1.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Skin nodule
Clinical narrative: 2 weeks history of swelling at the site seen today with a hard red nodule and center ulceration.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Hypersensitivity, Oedema, Pruritus, Rash
Clinical narrative: 19 days after varicella vaccine developed serum sickness type reaction with rash, itching, swollen hands & feet. Treated with steroids with improvement.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site reaction
Clinical narrative: Large local erythema & cellulitis to right arm at right deltoid area.
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Mydriasis, Pyrexia
Clinical narrative: Pt had a fever of 102 and parents noted left pupil dilated greater than right on and off. Evaluated in ER no pupil diff seen bld Cx.
Sex: M
Vaccine: DTP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Erythema over left deltoid & left posterior upper arm.
Age: 69.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Site redness and pruritis, 8 days after administration. Treatement Benadryl re-exam in 2 days, re-exam if worse/problems.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Feeling hot, Injection site reaction
Clinical narrative: 2 days after inj. - had localized cellulitis- red-warm to touch 6 cm x 6 cm.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Irritability, Oedema
Clinical narrative: 05/20/04-vaccines given in AM 5/20/04 pt returned approx. 4 pm with red, swollen legs & irritability.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: Temp 100.9. Vomiting 9 times (after vaccine 5/5/04) and 2 times 5/6/04.  Visited MD's office today- Reaction to vaccine explained, pedialyte given, advance diet as tolerated. (no diarrhea). Return to clinic/ED if vomiting persits. Parent given MD's pager for further questions.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Skin nodule, Tenderness
Clinical narrative: sx noted after a small nodule, hot and warm, tenderness, no fever, arm pn on left arm
Sex: F
Vaccine: TTOX
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Left arm site swollen, red, hot, and tender to touch 1 1/2-2" in diameter.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: 2"x2" size red, hot and swollen at injection site on Right thigh Keflex 125/5 1 tsp P.O. QID x 10 days
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Right thigh at injection site 3" diameter hot, red and swollen. Keflex 250mg Qib x 10 days
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Musculoskeletal stiffness
Clinical narrative: 8"  7 3/4" size red swollen, Hot and very tight Right arm from shoulder to elbow. Sent child to urgent clinic. Keflex 250 Qid X 10 days
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Child brought in by father at 2:50 PM right thigh red, swollen and hot to the touch at injection site, measures 2 1/2" x 3 1/2", Put on Keflex 250/5 1 tsp every 6 hrs x 10 days.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: Red, hot and swollen 3" circle at injection site of right thigh, put on Keflex
Age: 5.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: red, warm, hardness at site on 5/20/04 evening; swelling. Script given if becomes worse. Contact with CDC; stated no treatment. Mom notified.
Age: 20.0
Sex: F
Vaccine: TD
Symptoms: Dyspnoea, Muscle spasms, Pharyngeal oedema, Pharyngitis
Clinical narrative: Td booster given at 2:30PM 05/17/04 at Drs office that evening pt c/o muscle spasms and swollen throat. Taken to ER. Dx: Reaction to Td. Vaccin. 5/19/04 taken back to ER with c/o trouble breathing . Dx: acute pharangitis
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site warmth, Oedema peripheral
Clinical narrative: 5/6/04 Swelling from right deltoid to right elbow. Upper arm warm to touch. Referred to pediatric clinic for evaluation.  Nurse follow up on 06/18/04 states: "Erythema."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: 4 year old with 13x18cm area of redness 2 days after vaccination at site of vaccination
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Pain, Rash macular, Rash pruritic
Clinical narrative: The morning after the vaccination, pt noticed a 4x6 cm macular, indurated, painful, pruitic, erythematous lesion on Right upper arm, at site of DTaP vaccination. Pain improved by 05/20/2004 (Day 2) Pt. given prescription for Tylenol, Benadryl, and Hydrocortisone.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Skin ulcer
Clinical narrative: The morning after the vaccination, pt noticed a 4x6 cm macular, indurated, painful, pruitic, erythematous lesion on Right upper arm, at site of DTaP vaccination. Pain improved by 05/20/2004 (Day 2) Pt. given prescription for Tylenol, Benadryl, and Hydrocortisone.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Petechiae
Clinical narrative: From initial information received on 01/APR/2003 from physician regarding an adverse event occurring in the USA, it was reported that a 58 year old female pt received TD ADS ADULT, given intra muscular in the left arm on 26/MAR/2003. The following day, the patient devloped petechiae on her left ankle and right thigh. PTT and CBC labs were taken, results not provided. The patient had hay fever at the time of vaccination. Reportedly, it is unknown if the pt recovered from this event.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Chills, Erythema, Feeling hot, Gait disturbance
Clinical narrative: From initial information received on 03APR2003 from an office manager regarding an adverse even occurring in the US, it was reported that a 52 year old female pt received TD ADS ADULT, given in the left lateral thigh,with an expiration date of April 2004, at 4:30PM on 24MAR2003. Three hours later, the pt developed a fever of 100 degrees, chills and severe cellulits. It measured 9.5x10.5cm for the outer area, the center was 25mmx40mm, was pink and hot in the outer area and red and hot in the center. Pt also experienced limping. The pt was seen by a physician in a doctor's office and given 500mg of Duricef, 5 mg of Percocent for pain and 750 mg of Relafen. The pt was requested to get bed rest for four days. The pt was seen again on 31MAR2003, by the physician, and had improvement, but the center was till very pronounced, tender and raised 25mmx45mm. The pt has a pre-existing condition of Mitral Valve prolapse, depression and constipation. Reportedly, the pt has not fully recovered form these events. The reporter of this case is the same reporter for case 2003-00498.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia, Tenderness
Clinical narrative: From initial information received on 03APR2003 from an office manager regarding an adverse even occurring in the US, it was reported that a 52 year old female pt received TD ADS ADULT, given in the left lateral thigh,with an expiration date of April 2004, at 4:30PM on 24MAR2003. Three hours later, the pt developed a fever of 100 degrees, chills and severe cellulits. It measured 9.5x10.5cm for the outer area, the center was 25mmx40mm, was pink and hot in the outer area and red and hot in the center. Pt also experienced limping. The pt was seen by a physician in a doctor's office and given 500mg of Duricef, 5 mg of Percocent for pain and 750 mg of Relafen. The pt was requested to get bed rest for four days. The pt was seen again on 31MAR2003, by the physician, and had improvement, but the center was till very pronounced, tender and raised 25mmx45mm. The pt has a pre-existing condition of Mitral Valve prolapse, depression and constipation. Reportedly, the pt has not fully recovered form these events. The reporter of this case is the same reporter for case 2003-00498.
Age: 62.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Pruritus, Swelling
Clinical narrative: From initial information received on 01MAY2003 from a nurse regarding an adverse event occuring in the USA, it was reported that a 62 year old female pt received TD ADS ADULT given inramuscularly in the right deltodi and TUBERSOL 5 TU, given in the right forearm on 22APR2003. On 29APR2003, the pt experienced a local reaction of redness, swelling and itching from the deltoid down to the elbow. The pt was evaluated by a physician and diagnosed with cellulitis. She was prescribed cortisone, Keflex and Zyrtec. It was reported that the events were resolving as of 30APR2003.
Sex: U
Vaccine: TD
Symptoms: Injection site reaction
Clinical narrative: From initial information received on 08MAY2003 from a nurse regarding adverse events of seven children after being vaccinated with TD on 05MAY2003. No information was provided regarding the identities of the pts or their adverse events. Telephone contact was made with the reporter on 16MAY2003 and follow up is expected. From additional information received on 29DEC2003 through a telephone call to a registered nurse regarding a VAERS report involving seven children, it was reported that in the opinion of this public health nurse, she felt that two of the seven cases required reporting. The nurse stated that reports were submitted to VAERS, but b/c she did not keep copies, she was unable to provide pt identifying information at this time. She described the first case as an immediate reaction post vaccination. The nurse stated that the child had lasted a few minutes and disappeared. The child saw a PMD that afternoon, but had no symptoms at that time. Reportedly,t he child recovered. The child did have a similar reaction to a DPT vaccine. The reporter HCP promised to follow up and fax completed VAERS forms to Aventis by 07JAN2004. No other information was provided at this time. The reporter of this case is the same reporter of case 200400003.
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Injection site nodule
Clinical narrative: From initial information received on 07MAY2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 44 year old female pt received a TD ADS ADULT, administered intramuscularly in the left outer arm on 17APR2003 at 2:10 PM. Five days after the injection, the pt developed a fine, tender nodule 1cmx2cm at the injection site. The adverse event onset data was also reported as 18APR2003. Per the reporter, the vaccine may have possibly been given subcutaneously. It was also reported that the pt was given other vaccinations on the same day, but the products were not listed on the source document. It was reported that the pt recovered from this event.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Headache, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: From initial information received on 05/09/03 from a health professional, regarding an adverse event occurring in the US, it was reported that a 14 year old male pt received 0.5 milliliters of his sixth dose of TD ADS ADULT, Lot # U0830AA, in the right deltoid on 05/05/03.  The following day, the pt felt ill with a headache, dizziness and was hot (temperature not taken), along with redness, swelling and soreness at the injection site. Reportedly, the redness and swelling are still present and is the size of 1/2 of an orange. The pt had the nurse at the school assess the site. Reportedly, the pt did not recover from these events. From additional correspondence received on 04/19/03 from the reporter, the pt was seen for a follow up on 05/12/03 at 12:30PM. At that time it was noted that there was no swelling or redness on the left arm. The pt felt well and had no complaint of pain in his arm. Reportedly, the pt recovered from this event. No further information is anticipated, this case is considered closed.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: From initial information received on 05/09/03 from a health professional, regarding an adverse event occurring in the US, it was reported that a 14 year old male pt received 0.5 milliliters of his sixth dose of TD ADS ADULT, Lot # U0830AA, in the right deltoid on 05/05/03.  The following day, the pt felt ill with a headache, dizziness and was hot (temperature not taken), along with redness, swelling and soreness at the injection site. Reportedly, the redness and swelling are still present and is the size of 1/2 of an orange. The pt had the nurse at the school assess the site. Reportedly, the pt did not recover from these events. From additional correspondence received on 04/19/03 from the reporter, the pt was seen for a follow up on 05/12/03 at 12:30PM. At that time it was noted that there was no swelling or redness on the left arm. The pt felt well and had no complaint of pain in his arm. Reportedly, the pt recovered from this event. No further information is anticipated, this case is considered closed.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Injection site erythema, Injection site oedema, Malaise
Clinical narrative: From initial information received on 05/15/03 from a nurse regarding an adverse event occurring in the USA, it was reported that a 42 year old female pt received TD ADS ADULT, Lot # U0526AA, administered in the left deltoid on the morning of 05/12/03.  Pt developed headache, malaise, night sweats, nausea and chills within 24 hours. The pt also experienced local redness and swelling at the site of injection.  The pt was seen by a physician.  It was reported that the pt had not recovered from these events at the time of this report.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Nausea, Night sweats
Clinical narrative: From initial information received on 05/15/03 from a nurse regarding an adverse event occurring in the USA, it was reported that a 42 year old female pt received TD ADS ADULT, Lot # U0526AA, administered in the left deltoid on the morning of 05/12/03.  Pt developed headache, malaise, night sweats, nausea and chills within 24 hours. The pt also experienced local redness and swelling at the site of injection.  The pt was seen by a physician.  It was reported that the pt had not recovered from these events at the time of this report.
Age: 18.0
Sex: F
Vaccine: TD
Symptoms: Back pain, Headache, Pain
Clinical narrative: From initial information received on 05/16/03 from an LPN, regarding an adverse event occurring in the US, it was reported that an 18 year old female pt received a dose of TD ADS ADULT, Lot # U0831AA (site/route not reported) on 05/12/03.  The expiration date for this product is 10/28/04.  Three days later, the pt went back to the clinic's office with a severe headache, neck aches, and pain down her spine, everything hurt. The pt was treated with Flexeril for the pain and Motrin. Reportedly, the pt is improving.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Chills, Headache, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: From initial information received on 05/20/03 from a physician regarding an adverse event occurring in the USA, it was reported that a 42 year old female pt received TD ADS ADULT, Lot # U0522AA on 05/17/03.  The route and site were not reported. 24 hours later the pt developed redness, swelling and pain at the injection site. The pt also developed fever, chills, malaise and mild headache. The recovery status of the pt is unknown.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Malaise, Pyrexia
Clinical narrative: From initial information received on 05/20/03 from a physician regarding an adverse event occurring in the USA, it was reported that a 42 year old female pt received TD ADS ADULT, Lot # U0522AA on 05/17/03.  The route and site were not reported. 24 hours later the pt developed redness, swelling and pain at the injection site. The pt also developed fever, chills, malaise and mild headache. The recovery status of the pt is unknown.
Age: 16.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Oedema, Pain
Clinical narrative: From initial information received on 05/23/03 from a physician, regarding an adverse event occurring in the US, it was reported that a 16 year old female pt received a dose of TD ADS ADULT, in the left arm on 05/13/03.  The lot # and route were not reported. The same day, the pt experienced pain at the injection site as well as the entire arm, muscle aches and mild swelling of her fingers. Reportedly, the pt is improving.
Age: 58.0
Sex: F
Vaccine: TD
Symptoms: Injection site abscess, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: From initial information received on 05/27/03 from a healthcare professional, regarding an adverse event occurring in the US, it was reported that a 58 year old female pt received a dose of TD ADS ADULT, Lot # U0831AA, given IM in the right arm on 05/23/03.  On 05/26/03, three days later, the pt developed a red, painful, swollen area at the injection site with puss discharge. On an unspecified date, the pt was seen by a physician.  Reportedly, the recovery status is unknown. The reporter of this case is the same reporter for case: 2003-01358.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: From initial information received on 05/29/03, from a health care professional regarding an adverse event occurring in the USA, it was reported that a female pt received a TD ADS ADULT vaccination, Lot # U0824AA, administered in the left deltoid on 05/22/03.  An unspecified time later the pt developed local redness, swelling, warmth and induration at the injection site. It was reported that the pt was afebrile at the MD visit, but then reported fever and swollen lymph nodes. The recovery status of the pt was not reported.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Chills, Erythema, Pain, Pruritus
Clinical narrative: From initial information received on 06/03/03 from a RN, regarding an adverse event occurring in the US, it was reported that a 42 year old male pt received a dose of TD ADS ADULT, Lot # U0838AA, given IM in the right deltoid on 05/29/03.  The following day, the pt developed a large local reaction of redness, covering his upper arm, soreness and mild itching. The pt also experienced chills, did not have a temperature was afebrile at the time of exam. On an unspecified date, the pt was seen by a physician, in a doctor's office and was prescribed Zyrtec and Zithromax. At the time of vaccination, the pt was taking Keflex. The recovery status was not reported.
Age: 25.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain, Myalgia
Clinical narrative: From initial information received on 06/19/03 from the pt regarding an adverse event occurring in the USA, it was reported that the pt, a 25 year old female, received  TD Adult vaccination, Lot # not reported, administered IM in the right arm on 06/18/03.  About one hour after vaccination, the pt developed muscle cramps. The next morning the pt had generalized muscle aches and also pain and redness at the injection site. Reportedly the pt recovered from this experience. From additional information received on 10/27/03 from a health care professional, it was reported that the pt did not develop redness at the injection site. In addition, the pt's full address including the county was provided. Reportedly, the pt did not receive any other vaccines within four weeks of the date of this vaccination and did not take any concomitant medications at the time of vaccination. No further information is anticipated, this case is considered closed.
Age: 37.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Dizziness, Feeling hot, Flushing, Headache, Hyperventilation
Clinical narrative: From initial information received on 06/25/03 from a health care professional regarding an adverse event, occurring in the USA, it was reported that a 37 year old female pt received her first dose of JE-VAX Lot # ENJ210B, and first dose of Imovax Rabies, Lot # U0584, both administered in the right arm on 05/30/03.  The pt has no immediate reaction or side effects. During the day on 06/08/3 the pt noted mild intermitted malaise and occasional minimal tingling type paresthesia in the toes of both feet. These came in waves and lasted only short periods of time. During the night on 06/09/03 pt noted she felt a little lightheaded upon awakening.  When she laid back down, she had an episode of marked dizziness, which was non-spinning in type, more of a lightheaded sensation. She had alternate feelings that she was flushed or warm with being cold. She had no fever nor true shivers or rigorous chills. Pt developed bilateral tingling paresthesias in her hands and forearms symmetrically and a mild occipital throbbing headache, different in character than previous migraines. She did admit that she became somewhat anxious and may have hyperventilated. Pt went to ER for evaluation, her physical examination, sedimentation rate, CBC and other blood studies were unremarkable. She had no urticaria, rash, lip or tongue swelling, wheezing, nor shortness of breath, no myalgias, arthralgias, fever, speech or visual or other special sensory deficits, nor any motor weakness. Her symptoms abated in less than one hour of total duration. Pt had only mild lethargy the following day and then returned completely normal.  The pt had also received concurrent immunization with Td vaccine, Havrix and Engerix B on 05/29/03.
Age: 37.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Paraesthesia
Clinical narrative: From initial information received on 06/25/03 from a health care professional regarding an adverse event, occurring in the USA, it was reported that a 37 year old female pt received her first dose of JE-VAX Lot # ENJ210B, and first dose of Imovax Rabies, Lot # U0584, both administered in the right arm on 05/30/03.  The pt has no immediate reaction or side effects. During the day on 06/08/3 the pt noted mild intermitted malaise and occasional minimal tingling type paresthesia in the toes of both feet. These came in waves and lasted only short periods of time. During the night on 06/09/03 pt noted she felt a little lightheaded upon awakening.  When she laid back down, she had an episode of marked dizziness, which was non-spinning in type, more of a lightheaded sensation. She had alternate feelings that she was flushed or warm with being cold. She had no fever nor true shivers or rigorous chills. Pt developed bilateral tingling paresthesias in her hands and forearms symmetrically and a mild occipital throbbing headache, different in character than previous migraines. She did admit that she became somewhat anxious and may have hyperventilated. Pt went to ER for evaluation, her physical examination, sedimentation rate, CBC and other blood studies were unremarkable. She had no urticaria, rash, lip or tongue swelling, wheezing, nor shortness of breath, no myalgias, arthralgias, fever, speech or visual or other special sensory deficits, nor any motor weakness. Her symptoms abated in less than one hour of total duration. Pt had only mild lethargy the following day and then returned completely normal.  The pt had also received concurrent immunization with Td vaccine, Havrix and Engerix B on 05/29/03.
Sex: M
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: From initial information received on 06/26/03 from a physician regarding an adverse event occurring in the USA, it was reported that a male pt received TD ADS ADULT, Lot # U0827AA, administered in the left deltoid on 06/23/03. Sometime later (exact onset unknown per reporter), the pt's entire left upper arm was red, swollen, warm and painful.  The pt also reported having a fever, but his temperature was not taken. The pt was seen in the ER on 06/25/03.  The pt's recovery status is unknown.  The reporter of this case also stated that there were a total of three pt's to report. Specifics were only provided for this case. No information was provided for the other two pt's.  From additional information received on 09/24/03 through telephone contact with the reporting physician, he clarified that at the time he was completing the VAERS form, he though two other pt's had experienced similar reactions, but stated, "as it turned out only 1 pt experienced this adverse event".  From additional information received through a telephone call on 11/11/03 to the physician regarding the follow-up contact of 09/24/03, it was reported that the AE report pertained to only one pt, not three as originally reported. The physician was reluctant to provide any further information. No further information regarding this case is expected from this contact. No further information is anticipated, this case is considered closed.
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Medication error, Skin discolouration
Clinical narrative: From initial information received on 07/11/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a male correctional facility employee (age and date of birth not reported) received TD ADS ADULT, Lot # not reported, in error ID in 10/02.  The product that was supposed to be administered was Tubersol, as per the reporter. .1cc of TD ADS ADULT was administered to the pt in the arm. An unspecified time later, the pt sought treatment in the ER due to a localized reaction, which was described as "red lines/streaks going up his arm from the administration site". At the time of this report there was still a discolored, darkened area persisting at the site and the pt has been seen several times by the reporter for this problem. The pt has not recovered from these events.
Age: 30.0
Sex: F
Vaccine: TD
Symptoms: Injection site abscess, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: From initial information received on 05/27/03 from a health care professional regarding an adverse event occurring in the US, it was reported that a 30 year old female pt received a dose of TD ADS /ADULT, Lot # U0831AA, given IM in the right arm on the evening of 05/20/03.  On 05/07/03, seven days later, the pt developed a red, painful, swollen area at the injection site with clear discharge. Reportedly, the recovery status is unknown. From additional information received on 01/07/04 from health care professional, the pt's address and the responsible physician's name were provided.  The reporter of this case is the same reporter for case: 2003-01030.
Age: 67.0
Sex: M
Vaccine: PPV, TD
Symptoms: Muscular weakness
Clinical narrative: From initial information received on 07/24/03 from a physician, regarding an adverse event occurring in the USA, it was reported that a 67 year old male pt received TD ADS ADULT, Lot # U0839AA, given IM in the left deltoid and Pneumococcal vaccine, Lot # 0955M, given IM in the right deltoid on 07/22/03.  That same day, the pt gradually developed weakness in his left shoulder and had "0.5 strength in shoulder abduction". Reportedly the pt did not recover from this event.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Difficulty in walking, Hypoaesthesia, Pain, Pyrexia
Clinical narrative: From initial information received from manufacturer regarding an adverse event occurring in the USA, it was reported by a physician that a female child received Tetanus Toxoid, Lot # and manufacturer unknown, on 06/30/03.  Sometime after the vaccination, exact date not reported, the pt developed pain, numbness in lower extremities and difficulty walking. The pt's recovery status is currently unknown. From additional information received on 08/05/03, from a CMA, it was reported that the pt is a 12 year old female, who had received her first dose of TD ADS ADULT, Lot # U0831AA, given IM in the right arm at 12:30 PM on 06/30/03.  That evening on 06/30/03 the pt experienced tenderness at the site of injection and generalized muscle pain, especially in the thighs. She also experienced a low grade fever the following day. Reportedly, the pt recovered from these events. No further information is anticipated, this case is considered closed.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Headache, Malaise, Myalgia, Nausea
Clinical narrative: From initial information received on 08/13/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 29 year old male pt received TD ADS ADULT, Lot # U837AA, expiration date 01/27/05 on 08/11/03. Four hours later, the pt experienced systemic symptoms of headache, nausea, neuralgias, myalgias, and malaise.  At the time of this report, the pt had been experiencing these events for two days and they were still continuing. The pt's recovery status is unknown. From additional information received through a telephone call on 10/29/03 to the physician's office, the responsible physician's full name and address were provided. No other information was provided at this time. From additional information received on 11/10/03 from the physician, the vaccine was administered IM in the right deltoid. Symptoms of arthralgia continued through 08/14/03. Symptoms of myalgia and neuralgia developed in the knees, joints and elbows. Drugs used to treat the symptoms included Tylenol and Lortab.  There was no relevant diagnostic tests performed. It is unknown whether the pt received any previous influenza vaccinations. The pt's pre-existing medical condition included anxiety. Paxil was the only concomitant medication at the time of vaccination. The pt's recovery status is currently unknown as there has been no follow up since 08/14/03.  No further information is anticipated, this case is considered closed.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Neuralgia
Clinical narrative: From initial information received on 08/13/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 29 year old male pt received TD ADS ADULT, Lot # U837AA, expiration date 01/27/05 on 08/11/03. Four hours later, the pt experienced systemic symptoms of headache, nausea, neuralgias, myalgias, and malaise.  At the time of this report, the pt had been experiencing these events for two days and they were still continuing. The pt's recovery status is unknown. From additional information received through a telephone call on 10/29/03 to the physician's office, the responsible physician's full name and address were provided. No other information was provided at this time. From additional information received on 11/10/03 from the physician, the vaccine was administered IM in the right deltoid. Symptoms of arthralgia continued through 08/14/03. Symptoms of myalgia and neuralgia developed in the knees, joints and elbows. Drugs used to treat the symptoms included Tylenol and Lortab.  There was no relevant diagnostic tests performed. It is unknown whether the pt received any previous influenza vaccinations. The pt's pre-existing medical condition included anxiety. Paxil was the only concomitant medication at the time of vaccination. The pt's recovery status is currently unknown as there has been no follow up since 08/14/03.  No further information is anticipated, this case is considered closed.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Fatigue, Joint stiffness, Tremor
Clinical narrative: From initial information received on 08/14/03 from a physician regarding an adverse event occurring in the USA, it was reported that a 34 year old female pt received TD ADS ADULT, Lot # U0836AA, administered at 14:00 on 07/08/03.  The route and site were not reported. Two days later, the pt experienced stiffness, fatigue, joint pain, and shakiness. Treatment included unspecified pain medication. The pt was still experiencing symptoms at the time of this report. From additional information received through a telephone call on 10/29/03 from a health care professional, the reporter's full address was provided. No additional information was provided at this time.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: From initial information received on 08/20/03 from a health care professional regarding ad adverse event occurring in the USA, it was reported that a 61 year old female pt received TD ADS ADULT, Lot # U0841AA, administered IM in the right deltoid on 08/08/03.  Six days later, the pt developed cellulitis at the injection site. The pt's recovery status is unknown.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Chest discomfort, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: From initial information received on 29/May/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 31 year old female patient received TDS ADS adult, lot number U)833AA, administered intra-muscularly in the left deltoid on 23/May/2003. The next day, the patient developed a fever, which lasted for four days (temperature ranging from 100 to 101 degrees Fahrenheit), chest tightness and a swollen, red area at the injection site. Treatment included Ibuprofen 400 mg every six hours. Reportedly, the patient recovered from this experience. The reporter of this case is the same reporter for case 2003-01031, 2003-01545, 2003-01546 and 2003-01554.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Headache, Injection site oedema, Injection site reaction, Musculoskeletal stiffness
Clinical narrative: From initial information received on 22/Aug/2003 from a physician regarding an adverse event occurring in the U.S.A., it was reported that a 15-year-old female patient received TD ADS adult, lot number U0838AA, administered in the left deltoid on 18/Aug/2003 at 10:00 am. Later that day, the patient developed a large, golf ball-sized swelling with a bruised appearance at the injection site. The patient also experienced a headache, stiff neck and aching all over. The patient had not recovered at the time of this report.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Pain, Skin nodule
Clinical narrative: From initial information received on 22/Aug/2003 from a physician regarding an adverse event occurring in the U.S.A., it was reported that a 15-year-old female patient received TD ADS adult, lot number U0838AA, administered in the left deltoid on 18/Aug/2003 at 10:00 am. Later that day, the patient developed a large, golf ball-sized swelling with a bruised appearance at the injection site. The patient also experienced a headache, stiff neck and aching all over. The patient had not recovered at the time of this report.
Age: 14.0
Sex: M
Vaccine: HEP, TD
Symptoms: Headache, Oedema, Skin nodule
Clinical narrative: From initial information received on 27/Aug/2003 from a health care professional regarding an adverse event occurring in the U.S.A., it was reported that a 14-year old male patient received TD ADS adult, lot number U0844AA, administered intra-muscularly in the left deltoid, and a dose of Hepatitis B vaccine, lot number ENG5384A2, administered intra-muscularly in the right deltoid on 13/Aug/2003. The next day, the patient developed swollen neck nodules and a headache. An MRI of the brain was done, however, no results were provided. The patient's recovery status is unknown.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Injection site induration, Skin hyperpigmentation
Clinical narrative: From initial information received on 28/Aug/2003 from a health care professional regarding an adverse event occurring the U.S.A., it was reported that a 15-year-old female patient received TD ADS adult, lot number U0839AA, administered intra-muscularly in the left deltoid on 07/Jul/2003. 49 days later, on 25/Aug/2003, the patient developed a 5 cm x 3.5cm hyperpigmented patch with skin induration at the injection site. The patient was scheduled for an appointment with a dermatologist. The patient's recovery status is unknown.
Age: 20.0
Sex: M
Vaccine: MMR, TD
Symptoms: Dyskinesia, Pyrexia
Clinical narrative: From initial information received on 03/Oct/2003 from health care professional regarding an adverse event occurring in the USA, it was reported that a 20-year-old male patient received a dose of Td vaccine, lot number U0991AA, administered intra-muscularly in the left deltoid and his second dose of Measles, mumps and rubella vaccine, lot number 1014M, administered subcutaneously in the right arm on 02/Oct/2003 at 2:00 PM. On 03/Oct/2003 at 9:30 AM, the patient had a temperature of 101 degrees and jerky movements of the entire body. The patient recovery status was not reported.
Age: 54.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain, Pain in jaw
Clinical narrative: From initial information received on 24/Oct/2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 54-year-old female patient received a dose of TD ADS Adult, lot number U0826AA, expiration date 23/Sep/2004, administered in the right deltoid (route of administration not reported), on 21/Oct/2003. The following day, the patient developed jaw pain, achiness in arm and joints, and stiffness in the right deltoid where the vaccine was administered. The next day, the patient stayed home and took Motrin after which she felt better the following day.
Age: 31.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Skin discolouration
Clinical narrative: From initial information received on 26/Oct/2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 31-year-old female patient inadvertently received a 0.1 ml dose of TD ADS adult, lot number U0922AA, administered intra-dermally in the forearm on 24/Oct/2003. Two days later, the patient developed redness, induration and discoloration at the injection site. The patient's recovery status is currently unknown.
Age: 66.0
Sex: F
Vaccine: PPV, TD
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: From initial information received on 19/Nov/2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 66-year old female patient received a dose of TD ADS Adult, lot number U0844AA, administered intra-muscularly in the right deltoid, and a dose of Pnumococcal vaccine, lot number 08714, manufacturer, administered intra-muscularly in the right deltoid on 12/Oct/2003. 7 days later, the patient developed general fatigue, weakness, and redness and warmth at the injection site. The patient's concomitant medications included Nitroglycerin as necessary. The patient's recovery status is currently unknown.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Skin nodule, Tenderness
Clinical narrative: From initial information received on 09/Dec/2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 11-year old female patient received her first dose of TD ADS adult, lot number U0831AA, administered intra-muscularly in the left deltoid on 23/Jun/2003. Two days later, the patient developed a lump on her arm that was reddened and tender to touch. Warm soaks, Tylenol and Benadryl were advised. The child was taken to the emergency room. Mother called on 26/June/2003 and stated that the child was diagnosed with cellulitis vs allergic reaction. The patient was given Keflex 500 mg three times a day. The patient's concomitant medications include Advair, Albuterol nebs, Singulair, and Zyrtec. Her pre-existing medical history included asthma, seasonal allergies, and local cellulitis vs allergic reaction after flu vaccine (case #U2002-01023). Reportedly, the patient recovered from these events.
Sex: U
Vaccine: TD
Symptoms: Dizziness, Erythema, Nausea, Rash
Clinical narrative: From initial information received on 29/Dec/2003 from a registered nurse regarding an adverse event occurring in the USA, it was reported through a telephone call regarding a VAERS report involving seven children that a child, age and gender not reported, received a dose of TD ADS adult, no other vaccine information provided, on an unspecified date. Approximately ten minutes later, the patient developed generalized reddened rash, dizziness and nausea. The symptoms lasted several hours and by the time the child saw the PMD, they were gone. Reportedly, the patient recovered from these events. In the opinion of this public health nurse, she felt that two of the seven cases requiring reporting. The nurse stated that reports were submitted to VAERS, but because she did not keep copies, she was unable to provide patient identifying information at this time. The reporter (HCP) promised to follow-up and fax completed VAERS forms to manufacturer by 07/Jan/2004. No other information was provided at this time. The reporter of this case is the same reporter of case 2003-00995.
Age: 37.0
Sex: F
Vaccine: TD
Symptoms: Muscle spasms
Clinical narrative: From initial information received on 16/Jan/2004 from a registered nurse regarding an adverse event, occurring in the USA it was reported that a 37-year-old female patient received a TD adult vaccination, lot number U1015AA, administered intra-muscular in the left deltoid on 13/Jan/2004. Later that same day the patient experienced leg cramping in areas of both shins. It was reported that the leg cramping persists and the patient has not yet recovered after 3 days.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white female student who on 13-May-1996 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (lot #612223/1129B). On 17-Nov-2003 the patient "contracted" varicella. Subsequently, the patient recovered. No further information is expected.
Age: 1.25
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a physician concerning a 15-month-old white male with no medical history who on 07-Nov-2003 was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live. Concomitant vaccinations on that same day included the third dose IM in the right thigh of hepatitis B virus vaccine rHBsAg (yeast) (Lot #645479/0215N) and the first dose SQ in the right thigh of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine (Lot #645406/0133N). There was no illness at the time of vaccination. The physician reported that on 12-Nov-2003, the patient developed a severe varicella rash. Medical attention was not sought and no laboratory diagnostic tests were performed. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a woman in a doctor's office concerning a 4-year-old white female with a recent shingles exposure who on 06-Jan-2000 was vaccinated with a first dose of varicella virus vaccine live. The reporter indicated that the patient's mother had shingles on 01-Nov-2003. On 10-Nov-2003 the patient broke out with 50 pox. It was noted that the patient "recovered fine." No further information is expected.