chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Neurodevelopmental disorder
Clinical narrative: A legal complaint was received from an attorney alleging that a male child received series of Tripedia, ActHIB, Engerix B, and Acel-Imune vaccines as well as Hib-TITER vaccine from 8/4/98 through 5/2/00 and subsequently "sustained severe, devastating, and permanent, neurological injuries through mercury toxicity and associated neurological injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via IM injections of mercury" in the "thimerosal-containing vaccinations." According to the legal complaint, the child "was born a perfectly normal, healthy boy whose APGAR scores at birth were well within the normal range." It is alleged that at approximately between 24 and 36 months of age, the child "was neurologically devastated by the accumulations of mercury in his body, having been exposed via IM vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to inability to speak, unresponsive to his environment, and initial loss of language skills, motor skills and affect." According to the legal complaint, the child "suffered severe and permanent injuries" and "sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments."
Sex: F
Vaccine: HIBV
Symptoms: Autism, Drug toxicity, Nervous system disorder
Clinical narrative: A legal complaint was received from an attorney alleging that a female child (birth date not specified) received Hib-TITER vaccine on 4/4/01. According to the legal complaint, as a result of exposure to thimerosal in the vaccine, the child "sustained neurological injuries and as a result of those injuries has been diagnosed with autism and as a result of those injuries has been diagnosed with autism spectrum disorder (OMIC)." No additional info was available as of the date of this report.
Sex: M
Vaccine: DTPHIB, HEP
Symptoms: Abnormal behaviour, Cognitive disorder, Drug toxicity, Drug withdrawal syndrome, Mental retardation severity unspecified
Clinical narrative: A legal complaint was received from an attorney alleging that a male child received Tetramune vaccine on 7/7/98. The child received a series of D.T.P. vaccine from 3/9/98 through 7/1/99 and Engerix B from 2/12/98 through 7/7/98 and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via IM injections of mercury" in the "thimerosal-containing vaccinations." According to the legal complaint, the child "was born a perfectly normal, healthy boy whose APGAR scores at birth were well within the normal range." It is alleged that at approximately 24 months of age, the child "was neurologically devastated by the accumulation of mercury in his body, having been exposed via IM vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills." According to the legal complaint, the child "suffered severe and permanent injuries" and "sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." Vaccination info contained in the legal complaint indicated that the child received D.T.P vaccine beyond 12 months of age.
Sex: M
Vaccine: DTPHIB, HEP
Symptoms: Nervous system disorder, Neurodevelopmental disorder
Clinical narrative: A legal complaint was received from an attorney alleging that a male child received Tetramune vaccine on 7/7/98. The child received a series of D.T.P. vaccine from 3/9/98 through 7/1/99 and Engerix B from 2/12/98 through 7/7/98 and subsequently "suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via IM injections of mercury" in the "thimerosal-containing vaccinations." According to the legal complaint, the child "was born a perfectly normal, healthy boy whose APGAR scores at birth were well within the normal range." It is alleged that at approximately 24 months of age, the child "was neurologically devastated by the accumulation of mercury in his body, having been exposed via IM vaccinations, and suddenly regressed developmentally, losing milestones of neurological development previously achieved, specifically including, but not limited to becoming withdrawn, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills." According to the legal complaint, the child "suffered severe and permanent injuries" and "sustained and will sustain in the future a mental, intellectual, developmental and neurological incapacity and associated learning disabilities, affect disorders and impairments." Vaccination info contained in the legal complaint indicated that the child received D.T.P vaccine beyond 12 months of age.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Neuropathy, Pain
Clinical narrative: Brochial plexus neuropathy R arm started 6 hrs after injection and now 3 weeks later, has pain, weakness in hand grip and resolved sensation.  Seeing neurology for nerve conditions studies.  Follow-up information received on 3/4/2003 states; "slight imporvement.  Still a lot of arm, wrist and hand pain and swelling". Follow up on 01/14/04: "Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  Diagnosis: Brachail neuritis, still with numbness right hand and fingers, symptoms unchanged."
Age: 11.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: Pt was diagnosed with lyme disease in 1995. In 1998 and 1999 was vaccinated with Lymerix at medical center in the lyme vaccine trial. Since that time has chronic and at times severe headaches-muscle and joint pain. Per follow up, box 8 on original VAES for should not have indicated prolongation of hospitalization. There was only IV therapy as outpatient. Also, this case is a clinical trial and is not worked up by VAERS.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Chills, Heart rate irregular, Hypoaesthesia, Joint stiffness
Clinical narrative: Severely fluctuating blood pressure, chills, heart rhythm irregularities, muscle weakness, numbness face, hand, arm than legs-pins-needle sensation-then stiffness-paralized flu shot at 8a, appt-symptoms hit within 10 mins. Drs. felt I was having a heart attack or stroke-BP hitting 198/100 and more-had CAT scan, MRI-ruled out, heart tests, blood tests, symptoms stayed-told to rest take it easy.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Pain, Paralysis
Clinical narrative: Severely fluctuating blood pressure, chills, heart rhythm irregularities, muscle weakness, numbness face, hand, arm than legs-pins-needle sensation-then stiffness-paralized flu shot at 8a, appt-symptoms hit within 10 mins. Drs. felt I was having a heart attack or stroke-BP hitting 198/100 and more-had CAT scan, MRI-ruled out, heart tests, blood tests, symptoms stayed-told to rest take it easy.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Neurodevelopmental disorder
Clinical narrative: Developmental delays (speech-gross motor delayed). Follow up on 12/05/2002: "At 4 months well child visits infant was unable to flip over, disliked being on her feet, sat poorly, did not push up with arms.  Evaluated by neurologist at 15 months.  Still unable to crawl.  Has speech delay and poor fine and gross motor skills.  Follow up on 02/07/2003, Per MD: "This week chromosome studies confirmed that her hypotonia is the result of Angelman Syndrome.  I therefore do not believe that any vaccines were the cause of this patients developmental problems". Follow-up received on 2/12/03: "This week's chromosome studies verified Asperger syndrome as the cause of hypotonia and developmental delay. The annual follow up received on 12/23/03 states 12/11/03 symptoms were not related to vaccines. Pt diagnosed with angel syndrome.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blindness, Cellulitis, Injection site abscess, Myasthenic syndrome, Paraesthesia
Clinical narrative: Pt red'd flu vaccine which caused a local reaction in her arm She denies being allergic to eggs. She is currently being treated for an abcess in her arms with antibiotics. She does not have a rash or edema. The patient is a 26-year-old woman with Devic's disease who experienced recurrence of right-sided weakness and paresthesia with severe weakness of the right leg of new onset and exacerbation of right optic neuritis with loss of vision in the right eye.  This was temporarily associated with the development of an area of erythema and tenderness consistent with cellulitis at the site of recent immunization in the right deltoid.  The patient is on immunosuppresant therapy with chronic prednisone, recent courses of high-dose methylprednisolone, and mitoxantrone treatment.  In spite of this rather aggressive treatment, she has had problems with recurrent bouts of myelitis everytime that her steroids have been reduced.  Because of the cellulitis and her worsened symptoms, she was admitted for evaluation and treatment.  The patient received an initial dose of methylprednisolone given the appearance of cellulitis with possible abscess.  Attempts were made to obtain culture by needle aspiration.  There was no discrete fluctuant mass, however and no pus could be obtained in spite of an area of considerable swelling and erythema.  Ultrasound did not demonstrate an abscess.  Cultures were negative.  Treatment with high doses of intravenous antibiotics eventually resulted in the marked improvement.  This took several days in spite of the 250-mg dose of methylprednisolone that she received initially.  Because of the possible effects of her multiple sclerosis and her recalcitrant course, famciclovir and atorvastatin were begun.  The patient was discharged on these medications, in addition to her usual prednisone and an oral course of ceftriaxone and metronidazole.  The patient was to return to clinic for outpatient followup.  Annual follow up on 12/23/03, 12/24/03: " (Completed by) person is not known to hospital."
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Injection site pain, Pruritus
Clinical narrative: Received Varivax vaccine right upper arm on 10/22/02. On Sunday 11/3/02, injection site became red, sore, itchy, hot. Developed low-grade fever and subsequent sites of macular papular itchy  lesions scattered on torso, extremities, one on face. Excluded from work until lesions dried.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia, Rash maculo-papular, Skin ulcer
Clinical narrative: Received Varivax vaccine right upper arm on 10/22/02. On Sunday 11/3/02, injection site became red, sore, itchy, hot. Developed low-grade fever and subsequent sites of macular papular itchy  lesions scattered on torso, extremities, one on face. Excluded from work until lesions dried.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site warmth, Pruritus, Pyrexia
Clinical narrative: Received Varivax vaccine right upper arm on 10/22/02. On Sunday 11/3/02, injection site became red, sore, itchy, hot. Developed low-grade fever and subsequent sites of macular papular itchy  lesions scattered on torso, extremities, one on face. Excluded from work until lesions dried.
Age: 33.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash
Clinical narrative: Received Varivax vaccine right upper arm on 10/22/02. On Sunday 11/3/02, injection site became red, sore, itchy, hot. Developed low-grade fever and subsequent sites of macular papular itchy  lesions scattered on torso, extremities, one on face. Excluded from work until lesions dried.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Encephalitis, Influenza like illness, Mental impairment, Pyrexia
Clinical narrative: 52 year old male received flu shot 11/9/02. 11/14 developed fever, chills, flu like illness. 11/15 developed abnormal mental status. On 11/15 he was admitted to hospital for encephalitis; etiology unknown. Possible adverse reaction. A 60-day follow up report received 6/10/2003 adds no new info.  Annual follow up on 03/17/04: "It is unknown if the pt recovered from adverse events."
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Urticaria
Clinical narrative: Started out as red splotches like rash. Splotches first noticed approximately 2-3 days after Anthrax vaccination. Diffuse urticarial, no angioedema, no wheezing, no palatine itching.
Age: 21.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Injection site pain, Pruritus, Tenderness
Clinical narrative: On my left shoulder I had a reaction to the anthrax shot. This was my third shot. When I take off or put on a shirt it hurts to lift it. It itches sometimes. 9 x 11 cm area of erythema, pruritic, tender. Zyrtec, Motrin, HC 1%.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Rash, Throat tightness
Clinical narrative: Diffuse skin rash distant from AVA site after #1 and #2 shots. Also with throat "tightness" after each shot. Symptoms started about 48 hours after shots. Lasted 3-4 days.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Injection site inflammation, Injection site warmth, Oedema
Clinical narrative: 2nd shot, I got inflammation, extremely sore redness in a 2.5in. diameter, swelling, hot to the touch, for 3 days so far. Motrin did not help the pain.
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Fatigue, Headache, Injection site induration, Rash
Clinical narrative: My arm tripled in size and was hard as a rock. I had a red rash covering 6 inches of my arm. It all lated 3-4 days. I was also very tired with a headache. It was my 7th booster and I had no problems before.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Pharyngitis, Rhinitis, Sinusitis
Clinical narrative: Sinus and cold symptoms developed lasting 3-5 days after each shot.
Age: 33.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema, Tenderness
Clinical narrative: About 82mm area of erythema, swelling, tenderness. Zyrtec, Motrin .
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Feeling hot, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Left deltoid injection site swollen, itchy, hot, arm is tight. Erythema and swelling too 5.5cm below elbow. Began as swelling around injection site. Erythema 28.5cm in circumfrerence. Treated with Medrol, Zyrtec, Prednisone, and Motrin.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Pain
Clinical narrative: c/o painful right upper arm x 2 weeks. Pain began after flu shot and continues with decrease use of right limb (only due to pain). requires assistance dressing and other activities. Pt tried aspirin x 3 days "no help" Adv: heat, advil. See PMD if sx persist. States " no swelling or discoloration" at sit (right arm). Has full range of motion, normal tempature normal use of hand/ fingers.
Age: 88.0
Sex: M
Vaccine: FLUX
Symptoms: Rash
Clinical narrative: Received vaccine on 11/12. Reported evening of 11/13 a rash. Reported to provider on 11/14. Rash on both legs, no temperature, no itching or swelling.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site hypersensitivity, Injection site oedema, Pyrexia
Clinical narrative: Symptoms began 11/16/02; patient had fever, rendess, swelling and itching at site of injection localized to left deltoid muscle region; Raised nodule noted, no blisters, no red hives, no drainage, no open areas; treatment to continue, monitoring symptoms.
Age: 16.0
Sex: M
Vaccine: TD
Symptoms: Asthenia, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: Complaints of being hot, weakness, pale, diaphretic. States has had reactions to immunizations in past. States did have lunch. Given liquids and laid down. Mom notified. After 45 minutes was feeling better. School nurse notified.
Age: 5.8
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Convulsion, Eye movement disorder, Loss of consciousness
Clinical narrative: Patient had a seizure episode about 50.5 hours after receiving immunization shots. Father described episode: generalized tonic seizure with loss of consciousness, rolling of eyes and foaming mouth. Loss of consciousness for 2-3 minutes. No fever, no postietal period.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Pyrexia
Clinical narrative: Pt c/o Lt arm pain, local tenderness, erythema, and fever. Temperature at office 100 degrees. Medications prescribed-Duricef 500mg bid x 14 days. Medrol dose pack. Dx: myalgia. R/O early cellulitis.
Age: 46.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Pt c/o arm pain, rt., tenderness, fever, muscle aches later the same day as injection. Dx: myalgia and cellulitis medication prescribed Duricef 500mg bid x 10 days. Adn Ed-Flex caps 1-2 q 6 hrs prn muscle aches. To return to clinic prn temp=99 degrees.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Injection site warmth, Myalgia, Nasal congestion
Clinical narrative: Pt c/o Rt. arm pain, redness, warmth, swelling, nasal congestion and fever. had pneumonia shot Wednesday and now with adverse reaction. Dx: myalgia and acute maxillary sinusitis. Medication prescribed Medrol dose pak and Levaquin 500mg qd x 10 days. Return to clinic as needed. Temp=99.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Sinusitis
Clinical narrative: Pt c/o Rt. arm pain, redness, warmth, swelling, nasal congestion and fever. had pneumonia shot Wednesday and now with adverse reaction. Dx: myalgia and acute maxillary sinusitis. Medication prescribed Medrol dose pak and Levaquin 500mg qd x 10 days. Return to clinic as needed. Temp=99.
Age: 11.0
Sex: F
Vaccine: VARCEL, HEP, VARCEL
Symptoms: Dermatitis bullous, Pruritus
Clinical narrative: Had chicken pox rash all over body on arm, chest, back, scalp, feet, legs. Really itchy. Lumps behind ear lobes.
Age: 11.0
Sex: F
Vaccine: VARCEL, HEP, VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Had chicken pox rash all over body on arm, chest, back, scalp, feet, legs. Really itchy. Lumps behind ear lobes.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Varicella given 7/15/98 at clinic. Came to clinic 11/18/02 with skin rash-few vesicular erythematous lesion on upper chest, scalp, face. Tx-Atarax, Keflex, Bactracin.
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: It was reported that a patient (2 of 3) received a Tripedia vaccination, date not specified. Reportedly 24-48 hours after vaccination the patient developed a local reaction of swelling, redness, and erythema at the injection site. Further information is requested. From additional correspondence received on 5/7/01, additional patient, vaccine, vaccine administrator and responsible physician information was provided. From mailed correspondence received on 6/19/01, the patient's age and the date of vaccination was provided. Reviewed, no additional information at this time. From mailed correspondence received on 8/28/01, it was reported that the patient recovered from this experience. This case is closed.
Age: 1.8
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: It was reported that a 22 month old patient received TriHIBit and an IPOL vaccination on 5/10/01. Reportedly sometime after the vaccination (date not specified) the patient developed a large local reaction. From mailed correspondence received on 7/19/01 it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information was also provided. From telephone contact on 8/7/01 it was reported that the patient developed a red, swollen, hard, warm area at the injection site in the deltoid, 10-20mm in diameter. This reaction resolved. This case is closed.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Pneumonia
Clinical narrative: Informed by coroner pt found dead by parents this am.
Age: 0.2
Sex: F
Vaccine: DT, HEP, HIBV, IPV
Symptoms: Agitation, Pyrexia
Clinical narrative: Infant became inconsolable with prolonged crying a few hours after vaccines given. Develped  a fever up to 101 and required a sepsis workup and hospitalization, sepsis and w/u negative.
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Lethargy, Pallor, Pyrexia, Sepsis, White blood cell count increased
Clinical narrative: Baby developed fever, lethargy, pallor the evening and morning following vaccines. Had elevated WBC and CRP. Sepsis workup performed cultures all negative. On Rocephin for 7 days. Hospitalized 11/7-11/10. I was the attending for his hospital stay. Per acknowledgement: No further information available, please contact private physician.  Nurse follow up on 06/16/04 states: "clinical sepsis, WBC increased." Nurse follow up on 06/16/04 states: "no new information."
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Urticaria
Clinical narrative: Urticaria to both arms and lateral sides of the body.
Age: 33.0
Sex: M
Vaccine: ANTH, FLUX
Symptoms: Diarrhoea, Nausea, Pain, Vomiting
Clinical narrative: Vomiting, diarrhea, nausea, general aches 1 day following flu shot/ anthrax vaccination (possible reaction) IV fluid administered / toradol given improvement.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dehydration, Diarrhoea, Dizziness, Nausea
Clinical narrative: I first felt swelling and burning in my left arm the next day. On Saturday 11/9/02, I experienced severe nausea, vomiting and diarrhea till 11/16/02. I also had hives, dizziness and weakness. I went to my doctor and they stated I had a reaction to the flu shot and that I was dehydrated. I also had a high temperature. On 11/22/02 I was take to the ER with the same symptoms. The ER took blood work. Again I was told I was dehydrated. I needed two IVs and Phenaphen at the ER on 11/22/02. I was sick for 16 days.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Oedema, Pain, Pyrexia, Urticaria, Vomiting
Clinical narrative: I first felt swelling and burning in my left arm the next day. On Saturday 11/9/02, I experienced severe nausea, vomiting and diarrhea till 11/16/02. I also had hives, dizziness and weakness. I went to my doctor and they stated I had a reaction to the flu shot and that I was dehydrated. I also had a high temperature. On 11/22/02 I was take to the ER with the same symptoms. The ER took blood work. Again I was told I was dehydrated. I needed two IVs and Phenaphen at the ER on 11/22/02. I was sick for 16 days.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Tenderness
Clinical narrative: Left axillary tenderness, onset 24 hours after injection, persisting now for 3 days.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain
Clinical narrative: About 4 hours after receiving Pnuemonia vaccine, patient's left deltoid started to hurt and she took Ibuprofen. Area from left elbow to left breast nipple line became progressively red, puffy and sore. After 24 hours area started to itch and redness faded. Did not notify doctor or seek medical treatment.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema, Pain, Vasodilation procedure
Clinical narrative: Left arm began to ache that afternoon "as if it would fall off." By 9pm discovered that arm was hot, red, swollen - went to ER - received IV antibiotics, discharged around midnight - sent home on Augmentin for 6 days.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Loss of consciousness, Neck pain
Clinical narrative: A report was received from a regulatory authority on 11/18/02, concerning a 31 year old male vaccinee who experienced headache, collapse, and neck pain which were considered to be medically significant, 2 minutes after receiving the Fluvirin vaccine on 10/11/02. The patient had no known allergies and no known previous adverse reactions. On 10/11/02, the vaccinee collapsed within 2 minutes of receiving the Fluvirin vaccine and injured himself in a fall. Since then, the vaccinee has had persistent occipital headaches and some pain on moving his neck, especially rotation to the right. He had a week off work and has received treatment with non-steroidal anti-inflamamatory drugs. The headaches and the pain on movement have considerably improved. There was insufficient information to determine the reporter's causality assessment.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Amnesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: A report was received from a health care professional on 10/25/02, concerning a vaccinee of unknown demography who experienced short term memory loss, two hours after receiving Fluvirin IM in 10/02. It was reported initially on 10/25/02 that in October,2002, the vaccinee experienced memory loss for approximately 24 hours after receiving 0.5ml Fluvirin IM in October, 2002. The symptom was reported to be "self-limiting'. It was reported that the vaccinee did not receive medical intervention and recovered without sequelae. follow-up information received on 11/06/02;an addendum was received which reported that the vaccinee was a 76 year old female who was vaccinated on 10/19/02 with Fluvirin (batch # E34692HA) and experienced short term memory lose for two days and injection site local reaction of pain, redness and swelling and had resolved within 2 days of onset. All symptoms were self-limiting. On an unknown date, the vaccinee was admitted to hospital due to memory loss and underwent a MRI examination, the results of which were found to be normal. The reporter did not have information on the past medical and drug history of the patient. There was insufficient information to determine the reporter's causality assessment.  Follow up on 12/23/2002: "Follow up information received on 12/11/2002: a follow-up was received which reported that the vaccinee experienced stinging when she received the vaccine followed later by pain in the right arm.  The redness was the size of a jar lid/large lump.  It was also reported that the redness and swelling lasted for 7 days and the vaccinee was hospitalized for 3 days.  It was reported that no other medical diagnosis was made and the vaccinee has had no symptoms since.  The outcome was reported as resolved.  The batch number has been confirmed as E3469244A and not E24692MA as previously reported which is not identified as a batch number.  It was reported that the vaccinee had a previous incident of memory loss following pneumovax administration.  The reporter did not have information on drug history of the patient.  There was insufficient information to determine the reporter's causality assessment."
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Client here complaining of left arm pain which continues since she received her influenza vaccine on 10/16/02. Client states that immediately at the time of the shot, she felt a strong pressure all the way down her arm to her wrist. The pressure quickly started leaving, but the pain continued at the site, radiating down to her wrist. Client discussed it with doctor on Thursday, while in the office for a routine visit. He advised client to apply hot compresses to the site, but to continue to use the arm like normal. Client states she discontinued using hot compresses after 2 days, but the pain continued to radiate down to the wrist for 2 weeks. At present, client states that she still has stabbing pain at the injection site, which radiates down to her elbow, when she raises her left arm or moves it into certain positions. The pain no longer extends to the wrist. Client indicates a spot on her left, uppar arm, about 2 fingerbreadths below the acromion process as the still painful, injection site. No redness, bruising or swelling noted at this time. Advised client to follow up with her family doctor if pain continues.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Left arm became swollen, red, and sore 2 hours after getting Pneumonia shot--no trouble breathing pain controlled with Tylenol and ice to injection site.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Loss of consciousness
Clinical narrative: Patient said she felt weak for 30 seconds and then passed out and them came to. This occurred 12 hours later. Didn't go to ER.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Face oedema, Flatulence, Swelling
Clinical narrative: Elevated BP. Normal prior to shot; detected elevated day after shot. Values have ranged from 170/90 to 208/110. Norvasc prescribed on 11/20/2002. Moderate edema of face and neck. Lasted about 5 days. Excess gas, flatulence. Lasted about 5 days. Shortness of breath, decreased ability to exercise. Symptoms reduced considerably over 5-10 days.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness
Clinical narrative: I was given the vaccine at 12 noon. I waited 15 minutes. No problem. I was driving home at 12:30 PM. I stopped at stop light, I became dizzy and almost fainted, became dizzy. I stopped the car and finally got home. I was alright in an hour.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Hyperhidrosis
Clinical narrative: I received vaccine at 2:45 PM at my jobsite and at approximately 9:00 PM, I began to get chills and at 11:00 PM took my shower at the end of my 8 hour shift and had chills while taking hot shower. I arrived home at 11:45 PM on evening of 11/07/02 and was extremely chilled and short breathed and wrapped up in blankets and went to bed and woke up approximately 7:00 AM on morning of 11/8/02 and was soaked from sweat and had severe headache.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Within 24 hours, arm became very painful and swollen. Thought she had fever, then developed redness around injection site that spread to cover most of upper arm; very warm and painful for four days.
Age: 60.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Blood glucose increased, Erythema, Injection site hypersensitivity, Injection site swelling, Pruritus
Clinical narrative: Left arm swollen and itchy at injection site. She is diabetic. Now blood sugars are out of control. Has red area 3-4 inch diameter on arm. Used ice and ibuprofen.
Age: 0.75
Sex: M
Vaccine: FLU3
Symptoms: Irritability, Pyrexia
Clinical narrative: Influenza vaccine given 11/14. That night had fever 104.05 and extreme irritability 11/15. Still very irritable; no fever.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Marked cellulitis L arm.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Circumscribed area on left deltoid at shot site location-center of area dark purple surrounded by red area, raised, warm to touch. Occurred within 3 hrs. No fever noted. Gradually subsided over 1 week period.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Client states she got hives from head to toe early Thursday morning 10/31/02. She went to family physician. He gave her a shot and prescription for steroid pack. She began to feel fine on second day. Symptoms disappeared by third day.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis right arm.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Urticaria
Clinical narrative: Vaccine given 10/29/02. Hives began 10/31/02 08:30PM. 4:00 AM 11/01/02 having some difficulty breathing. Called doctor 06:00 AM, was told to take 2 Benadryl. Went to hospital shortly thereafter. Given adrenaline plus 2 other medications.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Disorientation, Dry mouth, Eye irritation, Headache, Lacrimation increased
Clinical narrative: Constant headache, fever, shakes, disoriented, dry mouth, watery/itchy eyes. Started 2  days after shot.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: Constant headache, fever, shakes, disoriented, dry mouth, watery/itchy eyes. Started 2  days after shot.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: Around 11/13 developed hives on body, arms, and legs. itching and swelling in mouth. This condition improved and worsened till 11/19 when it was worse and he saw doctor. Was given Zyrtec and condition improved after 1 dose. His HCTZ and baby ASA was also stopped at that time.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dizziness, Flushing, Headache, Heart rate increased
Clinical narrative: Nausea, muscle aches, chills, lightheadedness, flushing (warm) feeling, headache, increased heart rate. Intermittent and varying symptoms for the last 18 days.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia, Nausea
Clinical narrative: Nausea, muscle aches, chills, lightheadedness, flushing (warm) feeling, headache, increased heart rate. Intermittent and varying symptoms for the last 18 days.
Age: 38.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site swelling, Pruritus, Rash
Clinical narrative: Received flu vaccine in left deltoid muscle at approximately 2:30 PM. At approximately 3:25 PM, reported red spots and itching of both arms. Minimal site swelling (approximately 3cm), non raised rash on inner right antecubital area and similar on left arm. Denied difficulty breathing. Benadryl 25mg given with resolution of rash in 40 minutes. BP and P stable. BP 150/100 and Pulse 68.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Client presented to nurse requesting explanation of redness on left arm. She also expressed concern about the use of sterile needles in clinic environment. RN observed client's left deltoid area, where she had received flu vaccination two days earlier on 11/12/02. Site was notable for an erythematous area that was warm to touch. There was not swelling or discharge. Area was approximately 1.5" below injection site, and approximately 2"x4" wide with an irregular border. Client denied pain or discomfort and stated "I'm not so worried about my arm, but whether or not you used sterile needles." Nurse explained use of Universal Precautions to client. Client was advised that she could have a local reaction to vaccine. She reported that she didn't think it was necessary to see a doctor, and just needed to be assured that sterile technique and Universal precautions were used. Nurse offered reassurance, education and counseling to client. Client was advised to apply cold compresses to site and return for observation tomorrow. Client appeared to be without distress when she left. Client presented to nurse this day for observation of injection site on left deltoid. Client reports she applied cold compresses last night that provided some relief. Client also stated she thought site looked less red and denied pain or discomfort. RN observed client's left deltoid area. Site was found to be cool to touch, redness was present but diminished and more diffuse. No swelling or discharge was noted. Area now appearing as pink band with irregular border, beginning approximately 1.5" below injection site and approximately 3"x5" wide from lateral aspect to posterior aspect of left upper arm. Client denied pain or discomfort. Client requested reassurance again from nurse regarding sterile technique. Nurse provided education regarding Universal Precautions and the transmission of HIV virus. Client stated she was relieved and felt better and appeared without distress when she left.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Oedema, Pain, Pyrexia, Tenderness
Clinical narrative: Left deltoid with edema, painful, and tender to touch. Duration approximately 3 days, fever and chills. Client start analgesics and Panadol. Used cold compress and alcohol solution.
Age: 26.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Contusion, Feeling hot, Injection site swelling, Pain, Skin burning sensation
Clinical narrative: Bruised site 1.75" within 48 hours. Hot to touch, painful and burning for 3 days. Slightly raised and in perfect circle. ER visit x 2 for check up and pain medication. Increased to 3" diameter. 11/21/02 resolving with pain and is itchy.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Face oedema, Pruritus
Clinical narrative: Swelling of eyes; labored breathing, itching
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site swelling
Clinical narrative: 4cm red, raised, warm area at site of DTaP injection. Right deltoid muscle.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, HIBV, IPV, PNC
Symptoms: Overdose
Clinical narrative: A nurse reported that a 4 month old male inadvertently received an injection of HibTITER and an injection of Comvax on 8/19/02. This report was received on the date of vaccination; no adverse experience had occurred at that time. This information has been forwarded to manufacturer.
Age: 3.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Infection
Clinical narrative: Varivax administered in office on 11/14/00. Patient presented to office on 11/19/2002 with s/s of varicella. Dx with varicella zoster.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Fatigue, Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Fatigue, axillary LAN, general malaise, no appetite, fever, weight loss, rash.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Weight decreased
Clinical narrative: Fatigue, axillary LAN, general malaise, no appetite, fever, weight loss, rash.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: Raised, red, itchy, fluid-filled bumps all over body. Low grade fever. Benadryl liquid. Diagnosis Chicken Pox.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: Red, raised, fluid-filled spots on chest, back, face, hands, hair. Very itchy; elevated temperature. Duration 2 days.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Red, blistered, itchy spots all over body, elevated temperature, diagnosis chicken pox.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Local reaction at vaccine site left thigh beginning one day after vaccines given. Induration, redness noted. 12cmx9cm area of induration/erythema on 9/27/02. No fever.
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Lymph node pain
Clinical narrative: Fever to 102.2, On Tylenol, Redness with increased warmth, induration, Left deltoid area associated tenderness also left axillary, lymph glands
Age: 49.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Fever to 102.2, On Tylenol, Redness with increased warmth, induration, Left deltoid area associated tenderness also left axillary, lymph glands
Age: 41.0
Sex: M
Vaccine: UNK
Symptoms: Dyspepsia, Pharyngitis, Rhinitis
Clinical narrative: Right ear became plugged 1 hour after shot. Then severe cold symptoms the next day. Lost voice on day 3. Took 2 weeks to get over most of it. Sever stomach upset day 2.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Injection site mass, Screaming, Urticaria
Clinical narrative: Small red welt on right thigh noted on 11/22/02. Then noted in PM on 11/23/02, a lump approximately 2 inches in diameter, warm to touch and red. High pitched squeal lasting a few minutes. Reported to on call doctor who call parents on 11/23/02 and checked on child on 11/24/02.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature decreased, Injection site swelling, Pruritus
Clinical narrative: Area of injection is swollen, red and itches.
Age: 1.3
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Hyperaemia, Injection site induration
Clinical narrative: Hyperemia and induration approximately 3"x3" in diameter
Sex: U
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Within 12- 24 hours after immunizations. patient developed fever 102, vomiting, mild diarrhea.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Injection site oedema, Rash
Clinical narrative: Right leg became swollen and "rash" to entire body approx x 1 week after shot was given.
Age: 24.0
Sex: M
Vaccine: HEP, TD, UNK
Symptoms: Mental impairment, Syncope
Clinical narrative: Approximately two minutes after hep A injection pt fainted. After approx. 3 minutes pt was fully oriented to time, place, person, situation. Pt stated he felt like he was in a "fog" v/x taken  juice and granola bar given.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Per mom, child given DTaP, IPV, Comvax, Flu and Prevnar and had redness on 11/25/02. Later that day temp increased 102.5 and has been up and down all night and day. Today noted that area LVL inj where flu vacc given with induration.
Age: 1.0
Sex: M
Vaccine: FLU3, HBHEPB, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Gave SQ MMR and within 5-10 min, noted 1" x 3" induration/erythema.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Injection site erythema, Pyrexia
Clinical narrative: Large (grapefruit sized) local redness which spread to elbow and chest. Joint soreness. Elbow and shoulder. Fever 101 degrees. did not see phy. Taking Benadryl, Ibuprofen and cold packs (feel better than warm packs).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Anorexia, Irritability, Malaise, Pyrexia
Clinical narrative: Tuesday am 9-11 am shot. Wednesday am awoke ill. No appetite, fussy and irritable. Didn't sense temp at first. By mid-afternoon temp. greater than 100 deg F gave Tylenol which brought temp down. Temp not taken by thermometer.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Swelling, redness on inner aspect of R arm. Redness had a streking effect to it.
Sex: U
Vaccine: FLUX
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Celulitis of left arm (shoulder to wrist).
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Headache, Pruritus, Rash
Clinical narrative: Itchy, rash 2 days, HA, vesicular lesions.
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Vomiting
Clinical narrative: About 2 hrs after giving the varicella vacc she started with nausea and then vomiting. No fever. I saw her again at the office and gave Benadryl. Her vomiting persisted. Admitted to the hospital for observation.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site reaction
Clinical narrative: It was reported that a 22 month old patient (2 of 3) received a Trihibit (combination ActHib and Tripedia) and an IPOL vaccination on 05.10.01. Reportedly sometimes after the vaccination (date not specified), the patient developed a large local reaction. From mailed correspondence received on 07/19/01, it was reported that the patient recovered from this experience. Additional patient, vaccine administrator and responsible physician information was also provided. From telephone contact on 08/07/01, it was reported that the patient developed a red, swollen, hard, warm area at the injection site in the deltoid 10-20mm in diameter. This reaction resolved. This case is closed.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: It was reported that an 18 month old patient (3 of 3) received a Trihibit and an IPOL vacicnation on 5/10/01. Reportedly sometime after the vaccination (date not specified) the patient developed a large local reaction. From mailed correspondence received on 7/19/01, additional patient, vaccine, vaccine administrator and responsible physician information was provided. From telephone contact on 8/7/01 it was reported that the patient developed a red, swollen, hard, warm area at the injection site in the deltoid, 10-20 mm in diameter. This reaction resolved. This case is closed.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: From telephone contact from reporting physician's office stated that a patient (2 of 3) received a Trihibit vaccination and an IPOL vaccination on 6/22/01. Reportedly the patient developed a local reaction of swelling and redness at the injection site (site not specified). From additional correspondence received on 9/6/01, additional patient, vaccine, vaccine administrator and responsible physician information was provided. This case is closed.
Sex: U
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: From telephone contact from reporting physician's office stated that a patient (3 of 3) received a Trihibit vaccination and an IPOL vaccination on 6/22/01. Reportedly the patient devleoped a local reaction of swelling and redness at the injection site (site not specified).
Age: 1.6
Sex: M
Vaccine: HEP, HIBV
Symptoms: Injection site reaction
Clinical narrative: From telephone contact with reporting physician it was stated that a 19-month-old male patient received an ActHIB and an Engerix Hepatitis B vaccination on June 25, 2001. The next morning the patient developed a large local reaction, red and hard, warm area at the injection site (site not specified). Patient was seen in physician's office on June 27, 2001. The reaction completely resolved.
Age: 0.2
Sex: F
Vaccine: HIBV, IPV, PNC
Symptoms: Skin discolouration
Clinical narrative: From telephone contact with manufacturer on 11/5/01 it was reported that a 10 week old female infant received an ActHIB, an IPOL and a Prevnar vaccination at 10:30am (date not specified). At 3:00pm the patient awoke from nap, the patient's mother reported both legs from waist to toes were purple. At 4:30pm when patient was seen in physician's office the symptoms resolved. This case is closed.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Urticaria
Clinical narrative: From correspondence received from manufacturer, it was reported that a 15 month old female patient received an ActHIB, and IPOL and an Infanrix vaccination, date not specified. Sometime following the vaccinations the patient developed hives. Liquid Benadryl was administered and the symptoms resolved within 24-48 hours.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: From correspondence received on November 19, 2001 it was reported on that a 2-month-old female patient received an ActHIB vaccination lot#UA604A2 administered on November 8, 2001 in her left thigh. The patient also received an IPOL vaccination lot# T1128-2 and an Infanrix vaccination lot# DTPA507AZ both administration in her right thigh. It reported to physician that a local reaction of redness and moderate swelling occurred 2 hours post immunization. The physician prescribed acetaminphen, which was effective. the child was rechecked November 11, 2001 and reaction was noted to have resolved.
Age: 1.6
Sex: M
Vaccine: HIBV
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: It was reported that a 19 month old male patient received an ActHib vaccination, administered on 12/18/01. The next day, the patient developed a large "baseball size" reddened area at the injection site.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Dysphonia, Screaming
Clinical narrative: From correspondence received from manufacturer it was reported that a 4 month old female patient received an ActHIB, an IPOL, a Tripedia and a Prevnar vaccination on 7/16/01. Reportedly on 7/18/01 the patient developed high-pitched crying and hoarseness. These symptoms subsided on 7/24/01 and the patient recovered. The patient received her 6 month vaccines separately in dequential doses, no problems when administered this way.