chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Oedema peripheral, Pain, Photophobia, Platelet count normal
Clinical narrative: 44 yr old female who received her anthrax vaccination SC over her right lower triceps region on 10/18/04. She noted redness, tenderness and swelling at the vaccine site that evening. The local reaction continued to increase in size and intensity, so on 21Oct she went back to the immunization clinic and was told that it was a normal reaction.  By the week end (23 and 24 Oct), the site was very painful and hot to the touch. She also experienced swelling and stiffness of her right hand and found it difficult to make a fist. She took Tylenol throughout the weekend and applied ice packs to the site. She also began experiencing generalized body aches and headaches. On 27Oct, she sought evaluation at the ER. She was diagnosed with cellulitis, started on Clindamycin and given a consult to Allergy and Immunology for evaluation of vaccine adverse reaction. On 10/29/03, she complains of tenderness, redness, swelling and warmth at vaccine site. She continues to have some swelling of the right hand when dependent, and her headache has continued almost constantly since the weekend. (She describes the headache as being different from a regular headache; it is like an electric shock across the frontal area with no associated symptoms except phonophobia; she has been taking Motrin which seems to help a little.) She denies fever, numbness or tingling in arm or hand, fatigue or joint pain. Follow-up Information: An initial VAERS report was filed on this patient in June 2005 by a healthcare provider at the vaccine Healthcare Center. This service member continues to experience headaches, but the swelling of right hand has resolved and the pain of her right hand is diminished. Here is a note after a telephone conversation on 12/4/06: Spoke to patient who is now retired. She has not been evaluated recently for her migraine headaches, but she continues to have episodes about 3 times/month. She is using Imitrex pills and nasal spray for severe headaches. She had also been taking Midrin pm, but when she ran out, she started taking her nortriptyline, which she was able to tolerate after a couple of weeks; noted she had less frequent headaches while taking, but has now run out of that too. Urged to follow up with PCM to resume nortriptyline use. VA disability determination for migraines is still pending. Had history of swollen and painful right hand; has been using paraffin soaks for hand pain pm with improvement; swelling has resolved. Has not taken the influenza vaccine this year.
Age: 43.0
Sex: F
Vaccine: ANTH
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate increased, Tenderness, White blood cell count decreased
Clinical narrative: 44 yr old female who received her anthrax vaccination SC over her right lower triceps region on 10/18/04. She noted redness, tenderness and swelling at the vaccine site that evening. The local reaction continued to increase in size and intensity, so on 21Oct she went back to the immunization clinic and was told that it was a normal reaction.  By the week end (23 and 24 Oct), the site was very painful and hot to the touch. She also experienced swelling and stiffness of her right hand and found it difficult to make a fist. She took Tylenol throughout the weekend and applied ice packs to the site. She also began experiencing generalized body aches and headaches. On 27Oct, she sought evaluation at the ER. She was diagnosed with cellulitis, started on Clindamycin and given a consult to Allergy and Immunology for evaluation of vaccine adverse reaction. On 10/29/03, she complains of tenderness, redness, swelling and warmth at vaccine site. She continues to have some swelling of the right hand when dependent, and her headache has continued almost constantly since the weekend. (She describes the headache as being different from a regular headache; it is like an electric shock across the frontal area with no associated symptoms except phonophobia; she has been taking Motrin which seems to help a little.) She denies fever, numbness or tingling in arm or hand, fatigue or joint pain. Follow-up Information: An initial VAERS report was filed on this patient in June 2005 by a healthcare provider at the vaccine Healthcare Center. This service member continues to experience headaches, but the swelling of right hand has resolved and the pain of her right hand is diminished. Here is a note after a telephone conversation on 12/4/06: Spoke to patient who is now retired. She has not been evaluated recently for her migraine headaches, but she continues to have episodes about 3 times/month. She is using Imitrex pills and nasal spray for severe headaches. She had also been taking Midrin pm, but when she ran out, she started taking her nortriptyline, which she was able to tolerate after a couple of weeks; noted she had less frequent headaches while taking, but has now run out of that too. Urged to follow up with PCM to resume nortriptyline use. VA disability determination for migraines is still pending. Had history of swollen and painful right hand; has been using paraffin soaks for hand pain pm with improvement; swelling has resolved. Has not taken the influenza vaccine this year.
Age: 37.0
Sex: M
Vaccine: ANTH, HEP, HEPA, IPV, MEN, TD, TYP
Symptoms: Skin ulcer
Clinical narrative: Patient received multiple vaccines on 09/13/2004.  Denies significant local reaction at vaccine sites.  Denies significant fever, chills, headaches, myalgias, arthralgias, or fatigue the first several days following vaccine receipt.  Approximately 2 days after vaccine receipt, patient noted lesions appearing on arms (left first, then right).  Before the lesions appeared, the area was pruiritic, then a red, slightly swollen bump appeared - kind of looked like a pimple and had a black dot in the center; within a few days, the lesion would dry out, scab and peel and become ashy appearing.  Initially, the lesions were limited to his upper extremities until after he received his second anthrax vaccine on 10/07/2004.  About 3-4 days later, he noted a flat, round appearing, red lesion, about the size of a quarter on his left inner thigh.  Multiple lesions have appeared since then on his legs, trunk, flank and back.  He has been applying steroid cream (Lidex) which seems to help them clear.  Patient recalls developing similar appearing lesions after serving in the first Gulf War in 1991.  The lesions eventually completely resolved without recurrence.  He was given 10% disability for a skin condition, but extensive evaluation or a specific diagnosis was never made.  He does not recall, and there is no record of him receiving the anthrax vaccine during the first Gulf War.  He denies any other history of skin diseases such as eczema or psoriasis.  He denies a family history of skin diseases.
Age: 66.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Dyspnoea, Erythema, Throat tightness
Clinical narrative: Had difficulty breathing, throat closed, turned bright red.  Was given oxygen by ambulance crew en route to emergency room.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site swelling
Clinical narrative: Erythema, warmth, and swelling around injection site of DTAP measuring 14cm in diameter.
Age: 1.03
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Blister, Drug ineffective, Erythema, Pruritus
Clinical narrative: Erythematous bared blisters pearly in some, scabs on others on face and torso, itchy.  Has had varivax on  09/21/1998.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Feeling hot, Injection site erythema, Irritability
Clinical narrative: Right anterior thigh reddened area at needle site in middle, measures 50 mm, very warm to touch.  Child irritable and whinny when area touched.  Mom giving Tylenol and Ibuprofen with teaspoon, alternately.
Age: 0.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PPV
Symptoms: Medication error
Clinical narrative: No symptoms reported.  Called state ASAP after pneumococcal given.  Reported no harm to infant , watch for local reaction at site.  Mother notified will return for Prevnar after 6 months.
Age: 21.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Patient took oral typhoid dose 1 06/24/2005, early afternoon dose 2 06/26/2005 12:00pm.  06/27/2005 10AM diarrhea for few hours, vomited about 3 times.  By 06/27/2005 4pm felt recovered.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site swelling, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever, headache, stiff neck, several hours after Menactra.  Erythema and swelling of left arm/shoulder at injection site.  Afebrile by 06/23/ but still stiff neck.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Rash erythematous
Clinical narrative: 2 inch knot on right arm, red, hot to touch and rash around area less than 24 hours after.  Tylenol, antihistamine, ice to area.
Age: 1.03
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Erythema multiforme, Pyrexia
Clinical narrative: Patient developed erythema multiforme on 06/12/2005.  Fever for 3 days prior to rash.  Fever at time of visit 98 or 99.  Benadryl 25mg/10ml by mouth every 6 hours as needed.  Benadryl creme apply to rash.
Age: 1.01
Sex: M
Vaccine: DTP, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Shots given 10AM 06/07/2005.  Mother noticed few raised red dots on stomach, the am of 06/08/2005.  Child here 06/09/2005 with red raised rash on torso, diaper area and face.  None noticed on arms and legs.  Temperature 99 8PM on 06/08/2005.  Gave Tylenol.  Temperature today is 96.  Rash fading 06/12/2005.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Mom called Thursday am, stating daughter's left arm red and swollen.  Mom had not put ice to it Wednesday as instructed.  Encouraged Mom to give Tylenol and put warm compress Thursday if no better to call Friday.  Called Friday am left arm still red, swollen, and feverish.  Told Mom to take child to pediatrician today.  Was seen by pediatrician on 06/10/2005 Benadryl recommended and patient has recovered.
Age: 1.12
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Developed pruretic rash 06/21/2005, no symptoms illness, fever exposure.  06/23/2005 20 lesions: 4 head, extremities and back; 2mm each, red papules, 13 with roof scratched off.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Father noticed reaction one day after shots were given.  Area where shot was given is warm and red patient had no symptoms.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Right thigh, red, swollen, and hot to touch from knee to groin.
Age: 34.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Headache, Injection site vesicles, Pyrexia, Swelling
Clinical narrative: 06/03/2005 - 5pm left upper arm swelling, red, sore temperature 103 degrees by 7PM.  Treated with extra strength Tylenol and cream, temp did not improve.  06/04/2005 Fever continued redness and swelling now size of softball blisters at injection sites and around sites clear fluid.  06/05/2005 swelling increased, blisters more prominent skin area red and white striped appearance.  Took Benadryl today.  06/06/2005 Benadryl taken again swelling decreased, slight fever headache.
Age: 34.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Tenderness
Clinical narrative: 06/03/2005 - 5pm left upper arm swelling, red, sore temperature 103 degrees by 7PM.  Treated with extra strength Tylenol and cream, temp did not improve.  06/04/2005 Fever continued redness and swelling now size of softball blisters at injection sites and around sites clear fluid.  06/05/2005 swelling increased, blisters more prominent skin area red and white striped appearance.  Took Benadryl today.  06/06/2005 Benadryl taken again swelling decreased, slight fever headache.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Awoke with numerous hives - 06/21/2005.  Taken to emergency room by parents, 06/21/2005.  Returned to clinic 06/22/2005 - given Benadryl for Urticaria and instructions for return if needed.
Age: 27.0
Sex: F
Vaccine: HEPA
Symptoms: Coma, Dyspnoea, Malaise
Clinical narrative: Hepatitis A vaccine ( AHAVB043CA exp. 6/16/2007) given in right deltoid at 4:28pm.  4:35pm report not feeling well. 4:40 difficulty breathing. 4:42 unresponsive. 4:45 Epinephrine given (1cc) in left deltoid. 4:47 responsive.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Injection site induration, Injection site oedema, Oedema
Clinical narrative: Swelling and firmness to both thighs from injection site to the knee area (approx 3-4cm). Swelling to right calf also. No other symptoms noted by RN. Hep B vaccination and Hep B immune globulin given IM the night before and swelling first noted next morning at 0730.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: Large 2x5 cm indurated lobulated subcutaneous nodule in the left arm
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Back pain, Ear pain, Headache, Neck pain, Pain
Clinical narrative: Felt achy, headache, earache, neck pain and back pain for 24 hours, no fever, increased sleeping.  Treated with Tylenol.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Back pain, Dizziness, Hyperhidrosis, Nausea, Syncope
Clinical narrative: Patient was apprehensive prior to injection.  On way home from office, developed back pain, nausea, sweating.  While getting water, developed light headedness and tunnel vision, then experienced syncope.  Currently improved.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Tunnel vision
Clinical narrative: Patient was apprehensive prior to injection.  On way home from office, developed back pain, nausea, sweating.  While getting water, developed light headedness and tunnel vision, then experienced syncope.  Currently improved.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: 1 cm wheal at injection site 5 minutes after injection.  Mom states maternal uncles children had similar reaction to varicella vaccine.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Hypotonia, Listless, Pyrexia
Clinical narrative: Low grade temp 100.7 limp/listless. EEG/CT scan lab normal.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Bacterial infection, Drug ineffective, Sepsis
Clinical narrative: Pneumococcal infection, drug ineffective
Age: 1.51
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Bacterial infection, Drug ineffective, Sepsis
Clinical narrative: Pneumococcal infection; drug ineffective
Age: 0.47
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Bacterial infection, Drug ineffective, Sepsis
Clinical narrative: Pneumococcal infection/drug ineffective
Age: 1.01
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Bacterial infection, Drug ineffective, Sepsis
Clinical narrative: Pneumococcal infection; drug ineffective.
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Headache, Injection site erythema, Injection site oedema, Myalgia, Pyrexia
Clinical narrative: Elevated temp to 102, headache, body aches, redness, swelling, tenderness to site-left deltoid.
Age: 25.0
Sex: F
Vaccine: MMR, TD
Symptoms: Tenderness
Clinical narrative: Elevated temp to 102, headache, body aches, redness, swelling, tenderness to site-left deltoid.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, DTAPHEPBIP, HIBV, PNC
Symptoms: Medication error
Clinical narrative: Infant was given immunizations of DTAP, HIB, HEP B and IPV on 5/9/05 and was repeated on 5/16/05. Parent was told No adverse reaction noted.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Asthenia, Bacterial infection, Cellulitis, Chills, Erythema
Clinical narrative: Local smallpox reaction; probable cellulitis; generalized malaise rule out sepsis.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Headache, Hyperhidrosis, Malaise, Necrosis, Pain
Clinical narrative: Local smallpox reaction; probable cellulitis; generalized malaise rule out sepsis.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Sepsis, Swelling, Vomiting
Clinical narrative: Local smallpox reaction; probable cellulitis; generalized malaise rule out sepsis.
Age: 29.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Cellulitis, Malaise, Sepsis, Viral infection, White blood cell disorder
Clinical narrative: Local smallpox reaction; probable cellulitis; generalized malaise rule out sepsis.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Injection site warmth, Joint swelling, Rash, Urticaria
Clinical narrative: 8 cm x 9 cm area erythema and induration surrounding central punctate lesion when shot given to L upper arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Skin ulcer
Clinical narrative: 8 cm x 9 cm area erythema and induration surrounding central punctate lesion when shot given to L upper arm.
Age: 9.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Medication error
Clinical narrative: Patient is recent immigrant. Catch-up vaccine schedule instituted. DTaP was given mistakenly despite patients age.
Age: 9.0
Sex: F
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Medication error
Clinical narrative: Patient is recent immigrant. Catch-up vaccine schedule instituted. DTaP was given mistakenly despite patient's age.
Age: 1.76
Sex: M
Vaccine: DTAPH, IPV, MMR, PNC, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: post xanthem rash on 6/30/05 appeared all over trunk, legs and groin-scattered pink papules without excoreation, on trunk, groin and limbs and cheeks; some very fine. no itching noted.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Dysgeusia, Malaise
Clinical narrative: Pt. reported a metallic taste in his mouth about 5-10 min. after receiving his 2nd dose of HBV on 1/28/2005.  Also reported feeling "blah" for 3 or 4 days after receiving vaccine.  Pt. has a history of asthma; did not report any exacerbation of asthmatic symptoms after receiving vaccine; neither did he report any hives or pruritis.  Symptoms resolved without medication or medical intervention.
Age: 1.28
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: attenuated varicella
Age: 30.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Injection site reaction, Viral infection
Clinical narrative: Small pox spread on left arm in deltoid area, one questionable papule on forearm, no pustule there. D/W Dr.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Vomiting
Clinical narrative: Pt woke up day after receiving shot with a headache and vomiting.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Developed fever and severe headache the evening he received the vaccine. The following day, fever up to 104 and would not respond to Tylenol or ibuprofen, was treated that afternoon in the ED. 2nd day the fever remained low grade. Mother stated it took him approx 3 days to recover.
Age: 4.0
Sex: F
Vaccine: HEPA, PNC
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Child's left lower deltoid red with swelling. Started on 6/29/05 AM, cool packs with Benadryl given.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Generalized urticaria on anterior abdomen.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot
Clinical narrative: Redness, hard warm to area on left arm approximately 6x4.
Age: 1.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Infection, Pyrexia, Rash
Clinical narrative: 05/16/2005 Started with fever and broke out in rash that by 05/17/2005 went to doctor and diagnosed with chickenpox.
Age: 1.79
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, VARCEL
Symptoms: Cellulitis, Erythema, Feeling hot, Swelling
Clinical narrative: 06/28/2005 - Called and said left leg has a red 2x3 area below middle injection site, warm to touch.  No hives, no fever, no difficulty walking.  06/29/2005 called again increased redness.  seen in office to re-evaluate 11cm x 7 1/2cm area of redness and swelling, received Augmentin for possible Cellulitis.
Age: 1.28
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema
Clinical narrative: Erythematous and indurated at right upper arm.  Nontender, moves arm well.  Benadryl 3/4 teaspoon every 6 hours.
Age: 0.5
Sex: M
Vaccine: DTAP, PNC
Symptoms: Respiratory disorder, Urticaria
Clinical narrative: Approximately 10 minutes after receiving #3 DTAP and #3 Prevnar shot, patient broke out in pruritic, urticarial rash, is generalized, and respiratory symptoms.
Age: 83.0
Sex: F
Vaccine: PPV, TD
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Redness and swelling in the left arm with soreness.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: I only want to report that the varicella vaccine in 2 of my children was not effective as thought.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: I only want to report that the varicella vaccine in 2 of my children was not effective as thought.
Age: 0.36
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Tremor
Clinical narrative: Tremors involving head, shoulders, arms as he falls asleep (similar to benign myoclonic tremors). Began 2 days after receiving 2nd set of vaccines. No testing at this time. No treatment.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia, Rash macular
Clinical narrative: Macular rash cheeks, arm, back and legs, fever.
Age: 1.35
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Skin discolouration, Swelling, Urticaria
Clinical narrative: Five days after his shots, he broke out with hives alll over his body. His legs were the worst. They were swollen. Underneath his eyes, they turned black. We brought him to the ER. We were given an Epi Pen and to give him Benadryl. We did for 2 weeks.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis L arm secondary to immunizations. Augmentin 600mg bid 10d started 6/23/05.
Age: 0.34
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 101.2, Tylenol as needed.
Age: 32.0
Sex: F
Vaccine: TTOX
Symptoms: Dehydration, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: Note HCT was 52. She called at 15:30 complaining of s/s dizziness, headache, nausea, vomited unknown amount, sweating. When she left Center with no complaints. Outside tempature was in the 90's. No airconditioning in car. Was treated in ER for dehydration later on that evening.
Age: 32.0
Sex: F
Vaccine: TTOX
Symptoms: Vomiting
Clinical narrative: Note HCT was 52. She called at 15:30 complaining of s/s dizziness, headache, nausea, vomited unknown amount, sweating. When she left Center with no complaints. Outside tempature was in the 90's. No airconditioning in car. Was treated in ER for dehydration later on that evening.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness, nausea, room spinning 1 to 5 mins after shot. Pt was monitored, rest, seated with feet elevated, ice compress behind head/neck as needed, water. Monitored 90 mins. Driven home. Follow-up call, pt felt fine.
Age: 18.0
Sex: U
Vaccine: HEP, TD
Symptoms: Eye irritation, Injection site erythema, Pyrexia
Clinical narrative: Itchy eyes, mild fever and redness to injection site right deltoid. Tx: Benadryl 50mg x 2 doses.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Localized 4.5cm x 3.5cm area of induration and erythema. No systemic reation.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Localized erythema to R deltoid area about 5cm x 7cm. Rx: Benadryl 15/5mg, 1 tsp every 4 to 6 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Skin ulcer
Clinical narrative: 13cm x 10cm patch red papular lesions in ring pattern R lateral thigh covering area which was reddish purple for 4-5 days after shot. RX: Westcort cream bid.
Age: 1.63
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: L anterior thigh, moderate edema and erythema, medial thigh only, from mid thigh to femoral area. Not tender to touch. No fever.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: 6/28/05 Child awoke complaining of hot leg, tennis ball size knot R injection site. Redness became larger, extended from knee to hip. Some pain in foot. 6/29/05, size of mom's hand with increased redness to hip. Hot to touch. Denies fever, seizure. Used cool compress, Tylenol. Improved today with decreased redness.
Age: 48.0
Sex: F
Vaccine: RUB
Symptoms: Arthralgia, Joint stiffness, Lymphadenopathy
Clinical narrative: Vaccine administered on 6/9/05. Pt reports having developed lymphadenopathy on 6/19 and stiffness, pain and swelling of both knees on 6/22. SX resolving by 6/26.
Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Dyskinesia, Eye disorder, Feeling hot, Pyrexia
Clinical narrative: Fever 101-102 x 3 days. Crying 1/2 hours for 4 days. Wide eyes, red face and jerking but not seizures.
Age: 5.0
Sex: F
Vaccine: DTP, VARCEL
Symptoms: Rash papular
Clinical narrative: Multiple papules
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Generalized urticaria-received diphenhydramine p.o. began at 9 pm on 6/28/05. Received vaccine at 2:55 pm 6/28/05. Patient stable at this date.
Age: 11.0
Sex: F
Vaccine: TTOX
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: RA at deltoid, swollen, red, itching, pain and warm to the touch.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Medication error
Clinical narrative: MMR immunization administered IM instead of SQ.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Myoclonus
Clinical narrative: Myoclonus both arms. Getting better.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Dyskinesia, Muscle twitching, Pyrexia, Vomiting
Clinical narrative: Fever of 103, vomiting, jerking movements of legs while asleep, twitching.  started 0600 07-05-05.  fever down and appeared ok by noon.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Infection, Injection site reaction
Clinical narrative: severe local reaction few days after vaccine. pruritis 2 weeks after vaccine, jaundice 6/17.  secondary foot infection from scratching. given few dose of doxycycline and Bactrim. On 7/1 bilirubin 4.9, sl increased AST/ALT. Hepatitis panel negative
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Jaundice, Pruritus
Clinical narrative: severe local reaction few days after vaccine. pruritis 2 weeks after vaccine, jaundice 6/17.  secondary foot infection from scratching. given few dose of doxycycline and Bactrim. On 7/1 bilirubin 4.9, sl increased AST/ALT. Hepatitis panel negative
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Pyrexia
Clinical narrative: Fever of 102.7 degrees orally on A.M. of 7/6/2005.  Pt also feels weak.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Anxiety, Condition aggravated, Convulsion, Cyanosis, Hyperglycaemia
Clinical narrative: Child developed seizure activity within 8 hours after a DTaP and an IPV was given.  Additional terms found in Discharge Summary rec'd on 07/21/2005 were vomit, agravation of previous condition, hypoxia, perioral cyanosis, hyperglycemia, and hyponatremia. Discharge Summary received stated patient experienced anxiety and bit tongue.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Hyponatraemia, Hypoxia, Injury, Vomiting
Clinical narrative: Child developed seizure activity within 8 hours after a DTaP and an IPV was given.  Additional terms found in Discharge Summary rec'd on 07/21/2005 were vomit, agravation of previous condition, hypoxia, perioral cyanosis, hyperglycemia, and hyponatremia. Discharge Summary received stated patient experienced anxiety and bit tongue.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Immediately after receiving DTaP IPV and MMR, patient began having difficulty breathing and wheezing which required albuterol treatment, benadryl, and prednisolone.  Patient recovered fully.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 4 x 6 area of erythema/edema at injection site
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Difficulty in walking, Musculoskeletal stiffness, Oedema, Pain
Clinical narrative: The leg where the shot was done was very stiff and swollen, she had a hard time walking and was painful if not on drugs, around the shot it got red for 2", we had to give her Tylenol and Iboprufen for 4 days. Still swollen and sensitive to touch after almost a week.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Oedema
Clinical narrative: Erythema/edema 2 days post immunization. Given Keflex x10 days and Benadryl.
Age: 1.02
Sex: F
Vaccine: HBHEPB, MMR, PNC
Symptoms: Erythema, Pyrexia, Rash, Somnolence
Clinical narrative: She had a fever of 103.5 or higher for 3 days. Then she slept for a day, if she wasn't sleeping she was staring off into space. She then came down with red raised bumps all over her body. She had those for about 5 days.
Age: 0.52
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Epilepsy, Metabolic function test normal
Clinical narrative: From initial information received on 29/Jun/2005 from a physician regarding an adverse event occurring in the USA, it was reported that a 6 month old male pt received a third dose of ActHIB, lot number UE420AA (alternate lot number X1250-2), administered IM in the left thigh and a third dose of Daptacel, lot number C1398AA, administered IM in the right thigh at 5 PM on 18/Jan/2005. Fifteen hours post-vaccination, during the morning of 19/Jan/2005 and again on 31/Jan/2005 the pt experienced additional seizure. The pt was admitted to the hospital and discharged home on 01/Feb/2005. The pt then experienced his 4th seizure on an unspecified date and was admitted to another hospital. A CT Scan, metabolic work up, MRI and two video EEGs were normal. On 11/Feb/2005, the pt was diagnosed with partial epilepsy. In May 2005, a neurologist diagnosed the pt with epilepsy. The pt's past medical history is significant for a contusion suffered in September 2004 after he was dropped from a car seat by his sister. One of his parents has a past medical history of seizure disorder. Per the pt's parent he has a past medical history of seizure disorder. Per the physician that pt had no adverse events following previous doses of Daptacel at two and four months of age. There is no history of neurological symptoms in the pt's siblings following vaccination. As per the reporting physician, it is her medical opinion that the vaccine did not cause the seizure, but probably brought an underlying condition to the surface. The pt's recovery status is currently unknown. From additional information received on July 2008, it was reported that the Trileptal and Diastat suppositories were prescribed by the attending physician at the time of the event and the patient remains on these medications. 13/Jul/2005: During internal review of this case, it was noted that this patient had also received a first dose of , lot number 20240, in December 2004. The exact date was not specified. This information was previously captured in the product section but not included in the narrative.
Age: 0.52
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Nuclear magnetic resonance imaging normal
Clinical narrative: From initial information received on 29/Jun/2005 from a physician regarding an adverse event occurring in the USA, it was reported that a 6 month old male pt received a third dose of ActHIB, lot number UE420AA (alternate lot number X1250-2), administered IM in the left thigh and a third dose of Daptacel, lot number C1398AA, administered IM in the right thigh at 5 PM on 18/Jan/2005. Fifteen hours post-vaccination, during the morning of 19/Jan/2005 and again on 31/Jan/2005 the pt experienced additional seizure. The pt was admitted to the hospital and discharged home on 01/Feb/2005. The pt then experienced his 4th seizure on an unspecified date and was admitted to another hospital. A CT Scan, metabolic work up, MRI and two video EEGs were normal. On 11/Feb/2005, the pt was diagnosed with partial epilepsy. In May 2005, a neurologist diagnosed the pt with epilepsy. The pt's past medical history is significant for a contusion suffered in September 2004 after he was dropped from a car seat by his sister. One of his parents has a past medical history of seizure disorder. Per the pt's parent he has a past medical history of seizure disorder. Per the physician that pt had no adverse events following previous doses of Daptacel at two and four months of age. There is no history of neurological symptoms in the pt's siblings following vaccination. As per the reporting physician, it is her medical opinion that the vaccine did not cause the seizure, but probably brought an underlying condition to the surface. The pt's recovery status is currently unknown. From additional information received on July 2008, it was reported that the Trileptal and Diastat suppositories were prescribed by the attending physician at the time of the event and the patient remains on these medications. 13/Jul/2005: During internal review of this case, it was noted that this patient had also received a first dose of , lot number 20240, in December 2004. The exact date was not specified. This information was previously captured in the product section but not included in the narrative.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Redness 5cm at injection site. Hot for 24 hours. No treatment at this time.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Arthralgia, Pyrexia, Urticaria
Clinical narrative: Diffuse urticarial rash and fever 100.2 began 2 1/2 hrs after Pediarix, HIB, Prevnar were given. Pt was irritable with joint pain, large and small urticarial plaques with blueish hues, almost target lesions from head to toe but mostly seen on lower extremities. Pt treated with Zyrtec and Tylenol. Rash and symptoms gone 6/30/2005 in AM.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: Local reaction L deltoid plus erythema.
Age: 87.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: Abdominal pain (severe(, nausea, diarrhea, vomiting, headache, fever and chills. "Itchy" skin without rash. Still has some residual effects.
Age: 87.0
Sex: F
Vaccine: TYP
Symptoms: Pruritus, Pyrexia, Vomiting
Clinical narrative: Abdominal pain (severe(, nausea, diarrhea, vomiting, headache, fever and chills. "Itchy" skin without rash. Still has some residual effects.
Age: 9.0
Sex: F
Vaccine: MNQ, TYP
Symptoms: Abdominal pain
Clinical narrative: 7/5/05 Received message from parent, patient experiencing abdominal cramping. Taken dose 1 and 2. Parent stopping 3 and 4. Started morning after dose 1.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Arthralgia, Chromaturia, Lymphadenopathy, Nausea, Pharyngolaryngeal pain
Clinical narrative: Viral illness, little nausea, low grade temperature, achy joints, sore throat, dark urine on exam, swollen lymph node left side neck.  Urinalysis showed 1+ bilirubin.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Viral infection
Clinical narrative: Viral illness, little nausea, low grade temperature, achy joints, sore throat, dark urine on exam, swollen lymph node left side neck.  Urinalysis showed 1+ bilirubin.
Age: 1.01
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever for 5 days after vaccines.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site induration
Clinical narrative: 6x9cm local shoulder area of induration and erythema.
Age: 19.0
Sex: F
Vaccine: DTAP
Symptoms: Medication error
Clinical narrative: Vaccination error (DTAP given to adult instead of TD).  No adverse events.
Age: 42.0
Sex: M
Vaccine: TD
Symptoms: Injection site swelling
Clinical narrative: Immediately upon given td vaccine - patient's left arm started to swell.  No redness, just swelling at localized injection site.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Located erythema/swelling in injection site.
Age: 1.02
Sex: M
Vaccine: MMR, PNC
Symptoms: Erythema
Clinical narrative: Redness noted immediately after vaccines given and bandaids applied with approximately 3 to 4 cm to upper left arm site and approximately 2cm to left thigh site and after approximately 50 minutes no redness seen with mild puffiness to left upper arm.  No treatment given.
Age: 1.46
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: 9 days after vaccination, varicella-like rash and low-grade fever (about 100 axillary.)
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Feeling hot, Pruritus
Clinical narrative: Pruritis and feeling of warmth almost immediately after immunization. Developed dyspnea within four hours.
Age: 1.26
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: spiked fever 8 days after and then had febrile seizure
Age: 1.11
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: 6/25/05-Pink spots appeared on stomach.  6/29/05-Rash now appears on face, upper back and upper chest-almost solid in apperance on that date.  Seen by MD who feels it is rash associated with MMR.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain, Crying, Diarrhoea, Pain, Viral infection
Clinical narrative: Within 1 week began having stomach cramps and diarrhea; severe pain and crying; lasted for over 1 week
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Fibromyalgia, Laboratory test abnormal
Clinical narrative: I suddenly became sick immediately after receiving the flu shot at work.  I had all the symptoms of Guillian Barre Syndrome except paralysis.  Then symptoms proved to be Fibromyalgia.  Lost my job!!
Age: 24.0
Sex: F
Vaccine: JEV, TYP, JEV
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: On 11 April, at 10pm, client noticed a transient tingling sensation around her mouth.  The next morning at 6:45, on her way to work, the tingling sensation resumed on the left side of her jaw and lips progressing to the left face, arm, leg, and back.  It was described as tingling then numbness as a "novocaine" sensation.  It was excluxively on the whole left side of her body.  These sensations lasted approximately 48 hours from the early am onset, 12 April 2005.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Pruritus, Rash
Clinical narrative: From initial info received on 6/2/05 and 6/3/05 from an RN regarding an adverse event occurring in the USA, it was reported that an 18 year old female pt received her 1st dose of Menactra, lot U1573AC, IM, in the left deltoid and a dose of Tubersol 5 TU, lot C1954AA, ID, in the left forearm at 17:30 on 5/31/05. 60 minutes later, at 18:30, the pt developed a red, itchy rash on her chest and arms. The rash spread and grew more itchy throughout the following day. The reporter stated that the symptoms were considered to be urticaria. The pt did not experience any respiratory difficulties. She was seen by a physician and was treated with IV Solu-Medrol. She was sent home on prednisone, loratadine and ranitidine. Per the reporter, the pt recovered from these events.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: From initial info received on 6/2/05 and 6/3/05 from an RN regarding an adverse event occurring in the USA, it was reported that an 18 year old female pt received her 1st dose of Menactra, lot U1573AC, IM, in the left deltoid and a dose of Tubersol 5 TU, lot C1954AA, ID, in the left forearm at 17:30 on 5/31/05. 60 minutes later, at 18:30, the pt developed a red, itchy rash on her chest and arms. The rash spread and grew more itchy throughout the following day. The reporter stated that the symptoms were considered to be urticaria. The pt did not experience any respiratory difficulties. She was seen by a physician and was treated with IV Solu-Medrol. She was sent home on prednisone, loratadine and ranitidine. Per the reporter, the pt recovered from these events.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ, MNQ
Symptoms: Hypersensitivity, Rash pruritic, Urticaria
Clinical narrative: From initial info received on 6/2/05 and 6/3/05 from an RN regarding an adverse event occurring in the USA, it was reported that an 18 year old female pt received her 1st dose of Menactra, lot U1573AC, IM, in the left deltoid and a dose of Tubersol 5 TU, lot C1954AA, ID, in the left forearm at 17:30 on 5/31/05. 60 minutes later, at 18:30, the pt developed a red, itchy rash on her chest and arms. The rash spread and grew more itchy throughout the following day. The reporter stated that the symptoms were considered to be urticaria. The pt did not experience any respiratory difficulties. She was seen by a physician and was treated with IV Solu-Medrol. She was sent home on prednisone, loratadine and ranitidine. Per the reporter, the pt recovered from these events.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fatigue, Lymphadenopathy, Malaise, Medication error, Pain
Clinical narrative: From initial info received from the pt's parent regarding an adverse event occurring in the USA, it was reported that a 17 year old female pt received a Menactra vaccination, lot U61493AC, SC in the right lower arm below the triceps arms on 5/27/05. She had received a Menomune vaccine 5/24/04. Later that same day, the pt developed swollen lymph nodes with pain at the axillary area, a temperature of 99.8F, chills and general malaise. Initially, the pt was dx'd with cellulitis and was treated with Keflex and Tylenol. Per the pt's father, who is a physician, the local reaction and lymphadenopathy has resolved but she continues to have a temperature at night ranging from 99.5F to 99.8F. The pt's father has consulted an Infectious Disease specialist colleague.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: From initial info received from the pt's parent regarding an adverse event occurring in the USA, it was reported that a 17 year old female pt received a Menactra vaccination, lot U61493AC, SC in the right lower arm below the triceps arms on 5/27/05. She had received a Menomune vaccine 5/24/04. Later that same day, the pt developed swollen lymph nodes with pain at the axillary area, a temperature of 99.8F, chills and general malaise. Initially, the pt was dx'd with cellulitis and was treated with Keflex and Tylenol. Per the pt's father, who is a physician, the local reaction and lymphadenopathy has resolved but she continues to have a temperature at night ranging from 99.5F to 99.8F. The pt's father has consulted an Infectious Disease specialist colleague.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Chills, Lymphadenopathy, Malaise, Medication error
Clinical narrative: From initial info received from the pt's parent regarding an adverse event occurring in the USA, it was reported that a 17 year old female pt received a Menactra vaccination, lot U61493AC, SC in the right lower arm below the triceps arms on 5/27/05. She had received a Menomune vaccine 5/24/04. Later that same day, the pt developed swollen lymph nodes with pain at the axillary area, a temperature of 99.8F, chills and general malaise. Initially, the pt was dx'd with cellulitis and was treated with Keflex and Tylenol. Per the pt's father, who is a physician, the local reaction and lymphadenopathy has resolved but she continues to have a temperature at night ranging from 99.5F to 99.8F. The pt's father has consulted an Infectious Disease specialist colleague.
Age: 17.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: From initial info received from the pt's parent regarding an adverse event occurring in the USA, it was reported that a 17 year old female pt received a Menactra vaccination, lot U61493AC, SC in the right lower arm below the triceps arms on 5/27/05. She had received a Menomune vaccine 5/24/04. Later that same day, the pt developed swollen lymph nodes with pain at the axillary area, a temperature of 99.8F, chills and general malaise. Initially, the pt was dx'd with cellulitis and was treated with Keflex and Tylenol. Per the pt's father, who is a physician, the local reaction and lymphadenopathy has resolved but she continues to have a temperature at night ranging from 99.5F to 99.8F. The pt's father has consulted an Infectious Disease specialist colleague.
Age: 2.0
Sex: M
Vaccine: HEP, MMR, VARCEL, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Urticaria
Clinical narrative: Information has been received from a MA concerning a 25 month old male who on 22-JUN-2005 was vaccinated in his left leg with the first dose of Varivax. Secondary suspect vaccinations included a dose of Recombivax HB given in the left leg and a dose of MMR II given in the right leg. Other concomitant therapy included erythromycin ophthalmic ointment. On the same day the pt developed welts and redness at the injection site on the left leg and redness at the injection site on the right leg. Unspecified medical attention was sought and the pt was treated with Benadryl. The pt recovered on an unknown date. No product quality complaint was involved. The MA considered the pt's adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: HEP, MMR, VARCEL, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a MA concerning a 25 month old male who on 22-JUN-2005 was vaccinated in his left leg with the first dose of Varivax. Secondary suspect vaccinations included a dose of Recombivax HB given in the left leg and a dose of MMR II given in the right leg. Other concomitant therapy included erythromycin ophthalmic ointment. On the same day the pt developed welts and redness at the injection site on the left leg and redness at the injection site on the right leg. Unspecified medical attention was sought and the pt was treated with Benadryl. The pt recovered on an unknown date. No product quality complaint was involved. The MA considered the pt's adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Chills, Face oedema, Pharyngolaryngeal pain, Vomiting
Clinical narrative: Within 10-15 minutes of administration of DTaP/IPV/MMR (pre kindergarten visit) pt complained of throat hurting, swelling of lips and face. Within minutes developed vomiting and chills. Epinephrine 0.2cc given x 1 with improvement. Depomedrol 40 mg IM.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Rash
Clinical narrative: From initial info received on 6/3/05 from a physician regarding an adverse event occurring in the USA, it was reported that an 18 year old female pt received a dose of Menactra, lot U1588AA, IM in an unspecified site on 5/25/05. Two days later, on 5/27/05, the pt developed a rash on her face and neck. The pt was seen by a physician. Per the reporter, the pt recovered from the event.
Age: 58.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Flushing, Medication error
Clinical narrative: From initial info received on 6/7/05 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 58 year old male pt received a dose of Menactra, lot U1492AB and a dose of Havrix, lot AHAVB0543BA, administered on 6/2/05. The routes and sites of administration were unknown as per the reporter. The following day, on 6/3/05, the pt developed redness on his face, entire arms and legs. There was no itching and no fever reported. The duration of the redness was 2 days and the symptoms then disappeared. The pt recovered from the event.  Follow up report received on Sept 6, 2005 from a health care professional. It is reported that no previous doses of Havrix was given prior to the June 2m, 2005 injection. No laboratory testing was done. Information was reviewed by the responsible physician and no addiitonal information can be provided at this time. No further information is expected.