chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Injection site induration, Injection site swelling, Injection site warmth, Rash
Clinical narrative: DTaP given 4/15/03. In health unit on 4/17/03; left deltoid red, swollen with induration 2.75"x2.75". Small amount bumps in inner at injection site about .5" diameter. Arm warm to touch; no fever.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Dizziness, Paraesthesia, Tremor
Clinical narrative: 15 minutes after vaccine adm. C/O head feels funny, tingling hands and tongue, dizziness, trembling. BP 140/100. P100. seen in ER, client reports MD said anxiety. Client reported feeling light headed one hour after first Hep B injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: redness, swelling right deltoid 2 days after shots.
Age: 1.0
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, PNC, VARCEL
Symptoms: Ear disorder, Rash
Clinical narrative: Mom called Monday 5/5/03 to say son has a rash on trunk and it is spreading: she was on her way to see their MD. I called back today (5/6/03) and Mom on cell phone in car, taking her children to "the Zoo". States he is still "covered" with spots. MD states "probably from his shots" but not certain. Tx 2 days no spots appeared, but severe ear infection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Blister, Erythema, Feeling hot, Swelling, Tenderness
Clinical narrative: Mother reported right arm red, swollen, tender to touch, hot, extending to chest to sternum, back-top of shoulder to clavicle, arm-down to elbow. Also reports an allergic reaction to the bandaid that was applied. "When she removed the bandaid the next day, there was a solid blister under the bandaid". She took child to MD on 4/16/03. He gave antibiotics and steroids.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Crying, Dyskinesia, Erythema
Clinical narrative: Around 7 PM (infant presented to ER later in PM) had high pitched cry and jerking all over - seizure? Was afebrile. On ER exam pt had red ears and red throat. No other symptoms were noted or reported. No treatment. Pediatrician was consulted. Told Mom to give Tylenol as needed.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Thrombocytopenic purpura
Clinical narrative: ITP - hospitalized, received 1gG
Age: 1.2
Sex: M
Vaccine: HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Right thigh - 1.5cm nodule, erythema
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Pt had mild to moderate case of chicken pox, had vaccine on 11/12/1999.
Age: 3.0
Sex: F
Vaccine: DTAP, HEP, HIBV, MMR
Symptoms: Infection
Clinical narrative: Client had chicken pox immunization on 7/11/01. Recently broke out with chicken pox at home, moderate to severe case.
Age: 1.8
Sex: F
Vaccine: UNK
Symptoms: Infection
Clinical narrative: Had varicella just after 1 year. IM chicken pox break out approx 4/15/03.
Age: 5.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Infection
Clinical narrative: Pt broke out with chicken pox-severe case. Had varicella in 2/12/99.
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Chills, Headache, Pain
Clinical narrative: Received Td booster during routine physical 5/5/03 9:30 AM, he felt fine initially then woke up in the middle of the night, 1 AM, 5/6/03, complaining of muscle aches, chills, headache, which persisted through 5/7/03. On 5/7/03, still with some achiness.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Haematoma, Injection site induration
Clinical narrative: Hematoma and induration right arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Pruritus
Clinical narrative: Red "bump" over site of injection right leg. 1 week later - formation of 2 "x 1.5" irregular plaque-like skin reaction-irregular border. Area is raised, welt-like with darker red border. Causes itching, but no fever, child is active.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Rash
Clinical narrative: Diffuse rash over head/trunk. First noted by mother on 4/24/03 at noon.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: 10 x 12 cm area of induration , erythema, and warmth at site of injectino of IPV and Daptacel (left arm). No fever.
Age: 18.0
Sex: M
Vaccine: HEP, TD, UNK
Symptoms: Erythema multiforme
Clinical narrative: Erythema mulliforme minor/onset on day 15 post immunization.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling left arm, redness, shoulder to elbow.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Lymphadenopathy
Clinical narrative: Redness, swelling from left shoulder to elbow. Slight lymph node enlargement-axilla.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm swollen and red.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Laboratory test abnormal, Myalgia
Clinical narrative: Myalgias. Pleuritic chest pain. ST elevation. Low-normal LVEF 50-55% on echo.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Injection site mass
Clinical narrative: On 5/8/03 at 4:01 pm patients mother reported patient has small red knot o LAT.  Mother states not sore to touch, not hot.  Patient doing fine  with no fever.  Applied warm compresses and massage.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Chills, Hypokinesia, Lymphadenopathy
Clinical narrative: Chills, adenopathy. Substernal chest pain radiating down both arms. ST depression. Inferior wall hypokinesis on echo.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Chills, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Chills, adenopathy. Substernal chest pain radiating down both arms. ST depression. Inferior wall hypokinesis on echo.
Age: 26.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Chills, adenopathy. Substernal chest pain radiating down both arms. ST depression. Inferior wall hypokinesis on echo.
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain
Clinical narrative: No prodrome reported. Substernal chest pain. ST elevation. Echo normal.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Erythema, Muscle rigidity, Oedema, Rash
Clinical narrative: Both arms started to get red, swollen, bruising, and tightness in muscles next day after receiving immunization.  Dark rash noted after mother placed Hydro. creme on arm that was perscribed by MD at ER visit.  treated with benedryl, amox., and Ibuprofen.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Laboratory test abnormal
Clinical narrative: No prodrome reported. Left-sided chest pain radiating down left arm. ST elevation. Echo normal.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Unevaluable event
Clinical narrative: No prodrome reported. Left-sided chest pain radiating down left arm. ST elevation. Echo normal.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Chills, Laboratory test abnormal, Pain, Pyrexia
Clinical narrative: Aches, feer, chills. Midchest chest pain. Onset interval 12 days. ST elevation. Echo normal.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Dyspnoea, Hyperhidrosis, Hypokinesia, Myocarditis
Clinical narrative: Aches, feer, chills. Midchest chest pain. Onset interval 12 days. ST elevation. Echo normal.
Age: 21.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Nausea, Vomiting
Clinical narrative: Aches, feer, chills. Midchest chest pain. Onset interval 12 days. ST elevation. Echo normal.
Age: 2.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Rash macular
Clinical narrative: Night after injection, the site had started to swell and redden.  By the next day much swelling encircled the thigh area.  Blue blotches also appeared on thigh.  Saw ER doc that evening, he gave tylenol and benedryl told mom to apply cool compresses.  By 4/25/03 somewhat better.
Age: 61.0
Sex: F
Vaccine: SMALL
Symptoms: Asthenia, Fatigue, Headache
Clinical narrative: Complained of fatigue (sleeping all day), headache (occipitol in AM, relieved by Alleve), N- AMs, weakness.
Age: 51.0
Sex: F
Vaccine: SMALL
Symptoms: Arthralgia, Dyspnoea, Pain
Clinical narrative: Pt. was vaccinated on 2-4-03 she has had a history of some knee pain, after vaccination this knee pain increased and she also began experiencing significant pain in her hips. This pain increased in severity she saw a Dr.on 2-17-2003, he gave her Darvocet for pain and perscribed physical therapy 2 times per week. The physical therapy made the pain worse so this was discontinued.She continues to experience farily significant hip pain more on the L side, she feels like the pain intensity is increasing which alarms her, she is unable to sleep through the night due to the pain. She also experiences pain and pulling sensation if she sits for very long. Excercise has been difficult. She also has experienced dyspnea on exertion which is new ( e.g. carrying a load of laundry up the stairs). She plans to call her Dr. Today and go back in since she is not better.
Age: 26.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: 20-30 erythematous papules on trunk. Non-pruritic, pt nontoxic, no oral lesions, pt contacted Beale AFB last night - will follow up there 5/8/03.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Dizziness, Dyspnoea, Heart rate irregular, Pruritus
Clinical narrative: Patient stated he had local tenderness and itching and joint pain 2-3 days after vaccination.  The joint pain was described as persistent  for 3 weeks following vaccination.  He began to have PVCs 2-3 weeks after vaccination.  He said his heart beat irregular and hwe would become lightheaded and SOB. Has not seen doctor. Also reports having had prior PVCs for 10 years occurring occasionally.  PVCs mush less as of this date.  None noted as of 5/9/03.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Tenderness
Clinical narrative: Patient stated he had local tenderness and itching and joint pain 2-3 days after vaccination.  The joint pain was described as persistent  for 3 weeks following vaccination.  He began to have PVCs 2-3 weeks after vaccination.  He said his heart beat irregular and hwe would become lightheaded and SOB. Has not seen doctor. Also reports having had prior PVCs for 10 years occurring occasionally.  PVCs mush less as of this date.  None noted as of 5/9/03.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Emotional disorder, Speech disorder
Clinical narrative: Complains of feeling very emotional, could cry easily.  Also having thought/speech impairments, not profound, begins to say something and words comes out differently
Age: 28.0
Sex: M
Vaccine: SMALL
Symptoms: Cough, Influenza like illness, Insomnia, Malaise, Pyrexia
Clinical narrative: Flu-like symptoms started 03/27/03 - dry hacking cough and malaise 03/29/03 - temp 103 degrees; headache and had trouble sleeping - did not have flu shot.  Dr. consulted with patient and felt he had influenza.  Patient did not go to doctor or seek medication.
Age: 45.0
Sex: F
Vaccine: SMALL
Symptoms: Blister, Pruritus
Clinical narrative: 2 days after vaccination developed 3 blisters on forearm by elbow, both arms.  Itchy, about 3 days, scabbed over, (light flaky scab)
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Headache, Influenza like illness, Malaise, Pain, Pyrexia
Clinical narrative: States on 04/25 approximately 3:30 pm started to experience body aches.  Over weekend, 04/26-04/27, experienced flu-like symptoms - headache, low-grade fever, malaise, body aches, missed work 04/28 due to symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Pharyngolaryngeal pain, Pruritus, Pyrexia, Rash maculo-papular
Clinical narrative: 24 hours after administration of DTap, IPV and MMR patient developed maculo-papular rash over entire body. Positive itching. Sore throat. Fever (Tmax 103.9). Given Benadryl and Tylenol as recommended by pharmacist.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Abdominal pain upper, Back pain, Dysphagia, Injection site pain, Lymphadenopathy
Clinical narrative: c/o "trouble swallowing last night (5/7/03) and burning sensation in throat, "swelling lymph glands" and c/o stomach and back cramps".  Unsure if symptoms related to Td injection or cat bite.  Also, left arm at injection site sore.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Pharyngolaryngeal pain
Clinical narrative: c/o "trouble swallowing last night (5/7/03) and burning sensation in throat, "swelling lymph glands" and c/o stomach and back cramps".  Unsure if symptoms related to Td injection or cat bite.  Also, left arm at injection site sore.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Otitis media, Pyrexia, Rash, Tonsillitis, Weight decreased
Clinical narrative: Received call from child's pediatrician who stated patient was in her office on 05/01/03 with fever, rash on torso and had MMR on 04/22/03.  Patient also had otitis media and swollen tonsils with poor weight gain.
Age: 47.0
Sex: F
Vaccine: SMALL
Symptoms: Chest pain, Hyperhidrosis, Nausea, Pain, Palpitations
Clinical narrative: 3/10/03 Received smallpox vaccination.  3/17/03 Major take read 5/8/03 Reports noticing heart palpitations for previous 2 weeks.  The palpitations initally were once per day for 2-3 minutes, but gradually increased in frequency.  On 5/8/03 patient developed what she initially thought was 'stomach problems'.  Pain gradually increased in severity 'someone standing on my chest with a knife into my chest'.  Developed nausea and diaphoresis.  Taken to Hospital ER where she was admitted to the step-down unit with R/O MI.  Pain finally relieved with 5 nitroglycerin in ED. 5/9/03 Patient discharged as stress test could not be scheduled until 5/13/03.  Reported 'no heart damage'.  Enzymes were normal as was angiogram.  Reports a history of elevated cholesterol (232), hiatal hernia, GERD and depression. 5/12/03 Continues to have chest pain 3-4X/day./ Pt is hesitant to take nitro for chest pain due to resultant headaches.  Taking ASA and Lopressor 25 mg BID as prescribed in hospital.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash macular
Clinical narrative: Temperatures of 105 were recorded by a new ear thermometer at home.  A rash on the body developed.  When the fever was down, he was acting very normal.  He was seen on 4/21/03 in the clinic and shot given 4/9/03.  His rash was small and macular, no puritis.
Age: 43.0
Sex: M
Vaccine: SMALL
Symptoms: Lymphadenopathy, Rash erythematous, Rash macular
Clinical narrative: 43 yo smallpox vaccinee who developed some "axillary and supraclavicular" adenopathy ~4 days post vaccination and a mild macular rash on his upper extremities 9-10 days post-vaccination. The lesions were small erythematous macules, ~ 8 total.  No papules or vesicles were noted by the examining physician.  He had no c/o fever or myalgias.  He was otherwise doing well.  The rash improved over the next 24-48 hours and was felt to be consistent with a nonspecific dermatologic reaction.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cough, Rash
Clinical narrative: Immunizations were given about 1pm on 4-30-03. Mother states that about 7:30 that night a rash started behind her ears and progressed to the back, belly button, and then face. She was also coughing and mother made an ER visit. Denied trouble breating. Mother states that they gave pt a shot to counteract the reaction and the doctor stated that what happens on the outside usually happens on the inside so patient was given Tagamet and Benadryl.  Sent home with Benadryl 1 1/2 tsp Q 4-6 hours and to return if worse.  Pt followed up with her primary doctor on 7-1-03 and was told she had generalized reactions from either MMR or DTaP and pt should not receive any more of either of these vaccines.
Age: 44.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Breast pain, Chills, Discomfort, Pyrexia
Clinical narrative: 44 yo female who received smallpox vaccine in childhood - vaccinated initially on 3/27/03.  She was determined to be a no-take and was revaccinated on 4/3.  That same day developed a fever and tender axillary lymph nodes which spread to involve her breasts.  Her symptoms were initially reported to us at the clinic on 4/3.  She was advised to take motrin and her discomfort resolved for about a week.  Since that time she has experienced intermittent "sharp, pin-like pain" in her bilateral axillae and breasts (L worse than R).  It does respond transiently to treatment with motrin.  She has no known cardiac disease.  An EKG had been done by a colleague of hers around the time of the first report and this was normal according to the vaccinee.  There is no c/o substernal chest pain or chest tightness.  The pain she has is reproducible to palpation.  She denies nausea, diaphoresis, or SOB.  She was seen by her PMD on 5/12 who did a CXR which was negative.  The MD felt a repeat EKG was not indicated but she did send a CPK (results pending).  A monospot and CBC are also pending.  The PMD felt the patient's history and PE findings are most consistent with fibrocystic breast disease and she has ordered a mammogram which will be done in 2 weeks.
Age: 44.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Fibrocystic breast disease, Pain, Palpitations, Pyrexia, Tenderness
Clinical narrative: 44 yo female who received smallpox vaccine in childhood - vaccinated initially on 3/27/03.  She was determined to be a no-take and was revaccinated on 4/3.  That same day developed a fever and tender axillary lymph nodes which spread to involve her breasts.  Her symptoms were initially reported to us at the clinic on 4/3.  She was advised to take motrin and her discomfort resolved for about a week.  Since that time she has experienced intermittent "sharp, pin-like pain" in her bilateral axillae and breasts (L worse than R).  It does respond transiently to treatment with motrin.  She has no known cardiac disease.  An EKG had been done by a colleague of hers around the time of the first report and this was normal according to the vaccinee.  There is no c/o substernal chest pain or chest tightness.  The pain she has is reproducible to palpation.  She denies nausea, diaphoresis, or SOB.  She was seen by her PMD on 5/12 who did a CXR which was negative.  The MD felt a repeat EKG was not indicated but she did send a CPK (results pending).  A monospot and CBC are also pending.  The PMD felt the patient's history and PE findings are most consistent with fibrocystic breast disease and she has ordered a mammogram which will be done in 2 weeks.
Age: 4.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cellulitis, Gait disturbance, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse who is the mother of a 4 year old female who on 4/15/03 was vaccinated IM with a dose of varicella virus vaccine live. It was reported that the pt's mother saw the nurse give the vaccine IM and did not aspirate to check if she was in a blood vessel. On 4/15/03 the child developed a large welt at the site of the injection and a "cellulitis/phlebitis." The child went back to the office for treatment and was released from the office on an antibiotic. Subsequently, the pt is recovering with sequalae. It was noted that a product quality complaint was not involved. Upon internal review, cellulitis and phlebitis were determined to be an other important medical event (OMIC). Additional info has been requested. This is in follow up to report(s) previously submitted on 5/8/03: Information has been received from a physician and a registered NICU nurse who is the mother of a 4 year old female with streptococcus throat infection approximately 2 weeks prior to vaccination who on 4/15/03 was vaccinated SC (also reported as IM per the mother) with a dose of varicella virus vaccine (lot # 644148/0966M). At the time of the vaccination the child was well. It was reported that the patient's mother saw the nurse give the vaccine IM and did not aspirate toc heck if she was in a blood vessel. The physician reported that the mother had also reported to her that the injection was given IM and that the medical assistant did not aspirate to check if she was in a blood vessel at the time of injection. The physician reported that she spoke to her medical assistant and that she reported that she gave the injection SC. ON 4/15/03 the mother reported that the child developed a large welt at the site of the injection and a cellulitis/phlebitis. On 4/25/03 the patient was brought into the office by the mother with a 6cmx5cm oval lump area that was surrounded by mottled skin. It was also noted that there was a bit of redness streaking along a vein that the physician felt could be phlebitis. While the child was in the office the mother reported that the child had a fever (date of onset not reported) and was not herself (date of onset not reported). On 4/25/03, the physician did a rapid strept test which was positive so she treated the patient with cephalexin for 10 days for the possible phlebitis and strept throat. The physician reported that she did not think that this was cellulitis and maybe not even a phlebitis but she felt that the cephalexin was a good precautionary measure. As of 5/2/03 the patient has since recovered (previously reported as recovering with sequalae). It was reported that from 4/1/03 until 4/6/03 the patient was treated for azythromycin for strept throat. No product quality complaint was involved. It was noted that the child's mother had been apprehensive about vaccinations. Upon internal review, cellulitis and phlebitis were determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pain, Phlebitis, Pyrexia, Skin striae
Clinical narrative: Information has been received from a registered nurse who is the mother of a 4 year old female who on 4/15/03 was vaccinated IM with a dose of varicella virus vaccine live. It was reported that the pt's mother saw the nurse give the vaccine IM and did not aspirate to check if she was in a blood vessel. On 4/15/03 the child developed a large welt at the site of the injection and a "cellulitis/phlebitis." The child went back to the office for treatment and was released from the office on an antibiotic. Subsequently, the pt is recovering with sequalae. It was noted that a product quality complaint was not involved. Upon internal review, cellulitis and phlebitis were determined to be an other important medical event (OMIC). Additional info has been requested. This is in follow up to report(s) previously submitted on 5/8/03: Information has been received from a physician and a registered NICU nurse who is the mother of a 4 year old female with streptococcus throat infection approximately 2 weeks prior to vaccination who on 4/15/03 was vaccinated SC (also reported as IM per the mother) with a dose of varicella virus vaccine (lot # 644148/0966M). At the time of the vaccination the child was well. It was reported that the patient's mother saw the nurse give the vaccine IM and did not aspirate toc heck if she was in a blood vessel. The physician reported that the mother had also reported to her that the injection was given IM and that the medical assistant did not aspirate to check if she was in a blood vessel at the time of injection. The physician reported that she spoke to her medical assistant and that she reported that she gave the injection SC. ON 4/15/03 the mother reported that the child developed a large welt at the site of the injection and a cellulitis/phlebitis. On 4/25/03 the patient was brought into the office by the mother with a 6cmx5cm oval lump area that was surrounded by mottled skin. It was also noted that there was a bit of redness streaking along a vein that the physician felt could be phlebitis. While the child was in the office the mother reported that the child had a fever (date of onset not reported) and was not herself (date of onset not reported). On 4/25/03, the physician did a rapid strept test which was positive so she treated the patient with cephalexin for 10 days for the possible phlebitis and strept throat. The physician reported that she did not think that this was cellulitis and maybe not even a phlebitis but she felt that the cephalexin was a good precautionary measure. As of 5/2/03 the patient has since recovered (previously reported as recovering with sequalae). It was reported that from 4/1/03 until 4/6/03 the patient was treated for azythromycin for strept throat. No product quality complaint was involved. It was noted that the child's mother had been apprehensive about vaccinations. Upon internal review, cellulitis and phlebitis were determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Bacterial infection, Cellulitis, Injection site phlebitis, Injection site reaction
Clinical narrative: Information has been received from a registered nurse who is the mother of a 4 year old female who on 4/15/03 was vaccinated IM with a dose of varicella virus vaccine live. It was reported that the pt's mother saw the nurse give the vaccine IM and did not aspirate to check if she was in a blood vessel. On 4/15/03 the child developed a large welt at the site of the injection and a "cellulitis/phlebitis." The child went back to the office for treatment and was released from the office on an antibiotic. Subsequently, the pt is recovering with sequalae. It was noted that a product quality complaint was not involved. Upon internal review, cellulitis and phlebitis were determined to be an other important medical event (OMIC). Additional info has been requested. This is in follow up to report(s) previously submitted on 5/8/03: Information has been received from a physician and a registered NICU nurse who is the mother of a 4 year old female with streptococcus throat infection approximately 2 weeks prior to vaccination who on 4/15/03 was vaccinated SC (also reported as IM per the mother) with a dose of varicella virus vaccine (lot # 644148/0966M). At the time of the vaccination the child was well. It was reported that the patient's mother saw the nurse give the vaccine IM and did not aspirate toc heck if she was in a blood vessel. The physician reported that the mother had also reported to her that the injection was given IM and that the medical assistant did not aspirate to check if she was in a blood vessel at the time of injection. The physician reported that she spoke to her medical assistant and that she reported that she gave the injection SC. ON 4/15/03 the mother reported that the child developed a large welt at the site of the injection and a cellulitis/phlebitis. On 4/25/03 the patient was brought into the office by the mother with a 6cmx5cm oval lump area that was surrounded by mottled skin. It was also noted that there was a bit of redness streaking along a vein that the physician felt could be phlebitis. While the child was in the office the mother reported that the child had a fever (date of onset not reported) and was not herself (date of onset not reported). On 4/25/03, the physician did a rapid strept test which was positive so she treated the patient with cephalexin for 10 days for the possible phlebitis and strept throat. The physician reported that she did not think that this was cellulitis and maybe not even a phlebitis but she felt that the cephalexin was a good precautionary measure. As of 5/2/03 the patient has since recovered (previously reported as recovering with sequalae). It was reported that from 4/1/03 until 4/6/03 the patient was treated for azythromycin for strept throat. No product quality complaint was involved. It was noted that the child's mother had been apprehensive about vaccinations. Upon internal review, cellulitis and phlebitis were determined to be an other important medical event (OMIC). Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Asthenia, Chest discomfort, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Patient had heart attack 11 days after vaccination. Before heart attack, patient felt shortness of breath and chest tightness (heaviness).
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Hypoaesthesia, Laboratory test abnormal, Myocarditis
Clinical narrative: Patient had heart attack 11 days after vaccination. Before heart attack, patient felt shortness of breath and chest tightness (heaviness).
Age: 35.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest discomfort, Dyspnoea, Laboratory test abnormal, Myocardial infarction
Clinical narrative: Patient had heart attack 11 days after vaccination. Before heart attack, patient felt shortness of breath and chest tightness (heaviness).
Sex: F
Vaccine: HEP, UNK
Symptoms: Abnormal behaviour, Autism
Clinical narrative: Information has been received from a registered nurse concerning a female pt in the 6th grade who was vaccinated with a dose of hep B virus vaccine. The pt was vaccinated as a young child with "other vaccines" that had mercury in them. Subsequently, the pt developed autism or autistic behaviors. Unspecified medical attention was sought. It was noted that product quality complaint was not involved. Upon internal review, autism or autistic behaviors was considered to be an other important medical event (OMIC). Additional info is not expected.
Sex: M
Vaccine: HEP
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the mercury-based preservative thimerosal during the period from September 1997 through January 1999. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer toxic neurological effects of mercury poisoning. Vaccination history: a first, second, and third dose of hep B virus vaccine were given on 9/15/97, 11/17/97 and on 4/27/98. First, second, third and fourth doses of Haemophilus B conjugate vaccine was given on 9/15/97, 11/17/97, 1/20/98 and 10/26/98. First, second, third and fourth doses of diphtheria toxoid (+) tetanus toxoid vaccine was given on 9/15/97, 11/17/97, 1/20/98 and 1/25/99. First, second and third doses of poliovirus vaccine was given on 9/15/97, 11/17/97 and 1/25/99. A first dose of MMR II was given on 10/26/98 and a first dose of varicella virus vaccine was given on 7/20/98. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). Upon request complete medical records are available. No further info is available.
Sex: M
Vaccine: HEP
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the period from April 1996 through October 1997. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Vaccination history: A second and third dose of hep B vaccine were given on 5/6/96 (1198B) and on 1/1/97 (615998/06420) IM. A first dose of hep B virus vaccine was given on 4/6/96, a route and manufac. unknown. A dose of Haemophilus B conjugate of diphtheria toxoid (+) poliovirus vaccine inactivated (+) tetanus toxoid (6M711EV) in the left thigh on 10/15/96. Two doses of diphtheria toxoid (+) Haemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid were given in the left thigh on 6/11/96 and 8/20/96. Three doses of poliovirus vaccine (Orimune) was given orally on 6/11/96 (07397) and 8/10/96 (0746A) and on 10/15/97 (0760F). A dose of MMR II was given on 7/15/97 SC (D013E/0185). A dose of Haemophilus B conjugate vaccine (HibTiter) (M271AA) was given in the right thigh on 10/24/96. A dose of varicella virus vaccine live was given in the left thigh on 4/17/97. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). Upon request complete medical records wil be provided. No further info is available.
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the period from November 1997 through April 1999. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Vaccination history: A dose of hep B virus vaccine was given on 11/3/97, 1/9/98 and 3/30/98. A first, second, third and fourth dose of Haemophilus B conjugate vaccine and diphtheria toxoid (+) pertussis vaccie (+) tetanus toxoid were given on 11/3/97, 1/9/98, 3/3/98 and 4/21/99. Poliovirus vaccine was given orally on 11/3/97, 1/9/98 and 4/21/99. A tuberculin purified protein derivative test and MMR II were given on 9/28/98. A dose of Haemophilus B conjugate vaccine was given on 4/21/99. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). Upon request a complete copy of medical records is available. No further info is available.
Sex: M
Vaccine: HEP
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received from a legal firm regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the period from July 1992 through August 1996. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Follow up info was received in the form of an immunization record. It was reported that the pt was vaccinated with a first dose of hep B virus vaccine on 5/14/93, a second dose on approximately 8/18/93, and a third dose on 5/10/94. Other immunizations included: diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and Haemophilus B conjugate vaccine on 7/12/92, 9/26/92, 11/28//92 and 9/25/93; diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid on 8/8/96; poliovirus vaccine on 7/12/92, 9/26/92, 9/25/93 and 8/8/96; MMR II on 9/25/93 and 6/23/98; and varicella virus vaccine on 1/26/96. The pt was also administered a TB skin test on 5/14/93; results were not reported. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). No further info is available. A copy of the pt's complete medical record is available upon request
Sex: F
Vaccine: HEP, UNK, VARCEL
Symptoms: Drug toxicity, Nervous system disorder
Clinical narrative: Information has been received regarding a case in litigation concerning a female child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the period from October 1997 through February 1999. The alleged result of these vaccinations is that the pt suffers from and in the future will continue to suffer the toxic neurological effects of mercury poisoning. Follow up info was received that included a vaccine administration record. The pt was vaccinated with hep B virus vaccine and varicella virus vaccine live. Upon internal review, mercury poisoning and neurological disorder were considered to be other important medical event (OMIC). Additional info has been requested.
Age: 1.5
Sex: M
Vaccine: MMR, PNC
Symptoms: Autism, Bacterial infection, Electroencephalogram abnormal, Epilepsy, Otitis media
Clinical narrative: Had MMR and Prevnar vaccines on 4/23/01. Exactly 20 days later, got a mild infection and was put on antibiotics. He then woke up at 3AM with fever and seizures. Also his illness got worse and worse over time. Went from ear infection in one ear to severe infection in both ears, chest infection and strep throat. Hospital test showed no reason for seizures. Diagnosed with autism one year later. A 60-day follow up report received 7/29/2003 adds: Pt not recovered. Nonverbal, sensory integration dysfunction. Diagnosed with autism.
Age: 1.5
Sex: M
Vaccine: MMR, PNC
Symptoms: Pharyngitis, Pyrexia
Clinical narrative: Had MMR and Prevnar vaccines on 4/23/01. Exactly 20 days later, got a mild infection and was put on antibiotics. He then woke up at 3AM with fever and seizures. Also his illness got worse and worse over time. Went from ear infection in one ear to severe infection in both ears, chest infection and strep throat. Hospital test showed no reason for seizures. Diagnosed with autism one year later. A 60-day follow up report received 7/29/2003 adds: Pt not recovered. Nonverbal, sensory integration dysfunction. Diagnosed with autism.
Age: 0.54
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Agitation, Coma, Convulsion, Crying, Lethargy
Clinical narrative: My daughter received vaccination on 11 Mar and on 17 Mar seemed sluggish, did a piercing cry at the time of her feeding. I put her to bed assuming she was tired. The mornign of March 18, I noticed that she was in the same position that I had previously left her. Possible seizure 4 months (glazed stare, staring, no response to voice for about 1 minute). Returned to normal state quickly so event was not reported. On the morning of Mar 18 at about 0655 my husband noticed that my daughter had vomit on her clothes and blanket. He put on her on the bed to gather her tub to give her a bath. He heard her scream and returned to find my daughter on the floor, lethargic and unresponsive, he immediately called me at work. I told him to call 911. She was rushed to hospital. She was unresponsive. She was helicoptered to hospital and diagnosed with severe brain damage.
Age: 0.54
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Nervous system disorder, Sluggishness, Staring, Vomiting
Clinical narrative: My daughter received vaccination on 11 Mar and on 17 Mar seemed sluggish, did a piercing cry at the time of her feeding. I put her to bed assuming she was tired. The mornign of March 18, I noticed that she was in the same position that I had previously left her. Possible seizure 4 months (glazed stare, staring, no response to voice for about 1 minute). Returned to normal state quickly so event was not reported. On the morning of Mar 18 at about 0655 my husband noticed that my daughter had vomit on her clothes and blanket. He put on her on the bed to gather her tub to give her a bath. He heard her scream and returned to find my daughter on the floor, lethargic and unresponsive, he immediately called me at work. I told him to call 911. She was rushed to hospital. She was unresponsive. She was helicoptered to hospital and diagnosed with severe brain damage.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Abasia, Coma, Sluggishness
Clinical narrative: Given MMR and Varivax on 3/19/03. Child had problem 4/3/03. Mom called answering service at 7pm. Questionable. Ate chalk at 3pm. Sluggish and unresponsive at 7pm. Taken to ER unable to walk. Not recognizing family members. Admitted. Took several days to recover. Recovery totally. LP normal. Urine dry screen negative. large # of metabolic tests normal.
Age: 18.0
Sex: M
Vaccine: FLUX, HEPAB, IPV, MEN, MMR, PPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: 20 yo male unknown history transferred with AMS. Pt experienced a seizure in the field. Brought to ED with temp 102.3. Intubated. Seized during sedation with etomidate . Given Decadron and Dilantin. Admitted. Vented overnight.
Age: 15.0
Sex: M
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: Antisocial behaviour, Autism, Cognitive disorder, Convulsion, Diarrhoea
Clinical narrative: MMR. Had severe reaction approximately 2 weeks after shot, high fever, severe diarrhea, high pitched screaming, glazed eyes. Eventually had seizures and autistic symptoms. 2 months later was given DPT, chicken pox, and polio; started seizures after this round of vaccinations and within 2 months lost language and socialization. He lost everything. Reporter states onset date of seizures was in mid-may 1999 at which time child was hospitalized for 24-36 hours and started on Depakote.  Autism was formally diagnosed in 2002.
Age: 15.0
Sex: M
Vaccine: DTP, HIBV, MMR, OPV
Symptoms: High-pitched crying, Laboratory test abnormal, Pyrexia, Speech disorder
Clinical narrative: MMR. Had severe reaction approximately 2 weeks after shot, high fever, severe diarrhea, high pitched screaming, glazed eyes. Eventually had seizures and autistic symptoms. 2 months later was given DPT, chicken pox, and polio; started seizures after this round of vaccinations and within 2 months lost language and socialization. He lost everything. Reporter states onset date of seizures was in mid-may 1999 at which time child was hospitalized for 24-36 hours and started on Depakote.  Autism was formally diagnosed in 2002.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Upper respiratory tract infection
Clinical narrative: URI symptoms subsequent to each vaccination (Anthrax) worsening (#1-#3). No fever, no chills. Increased localized swelling.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Injection site oedema, Tenderness
Clinical narrative: Pt has area of redness extending from injection site approx 3 inches in circular area. Area is slightly edematous, warm to touch and firm. Pt states area is tender to touch.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema
Clinical narrative: Greater than 4 cm local erythematous reaction to Anthrax. Had other shot x 2 in 1991.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Skin ulcer
Clinical narrative: Local reaction noted 4 x 5 cm raised lesion left arm.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives (size of "bug bites") on hands started about 1 week following vaccine and has exponentially spread over entire body. Denies any other symptoms of illness pre-post vaccine. Rx - Axid, Zyrtec D (both started 12/5), Prednisone (started 12/19).
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Pt's right upper arm became red, swollen and painful to move. Symptoms started AM after shots were given. Redness and swelling extended from shoulder to below elbow. Symptoms began improving 4 days after shot given.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Joint range of motion decreased, Oedema, Pain
Clinical narrative: Pt's right upper arm became red, swollen and painful to move. Symptoms started AM after shots were given. Redness and swelling extended from shoulder to below elbow. Symptoms began improving 4 days after shot given.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Pt's right upper arm became red, swollen and painful to move. Symptoms started AM after shots were given. Redness and swelling extended from shoulder to below elbow. Symptoms began improving 4 days after shot given.
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: Unconsolable crying after receiving shots.  Fever to 103.5
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: Patient came in Thursday May 8, 2003 at 12:20 and explained that patient had bumped into door with her left arm and it was then when she noticed that her arm started getting red and later got worse.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Neck pain, Rash, Visual disturbance
Clinical narrative: 01/31/2002: Visual disturbance, flashing lights x 1 day, neck pain.   02/09/2003: Rash to stomach and chest, swollen glands in neck, lump in back of neck to Left side midway between ear and midline of neck at base of neck.
Age: 4.1
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: 01/17/2003: Father called to report that the childs Left arm was swollen, warm and reddened from elbow to shoulder.  Denies any difficulty moving the arm.  Advised symptomatic Treatment, Tylenol or Advil and cold compresses.  Advised to notify Family Doctor if not resolved in 2-3 days.   01/17/2003 @ 10:45: Contacted family Dr. Spoke with vaccinee and reported above symptoms, shots received, advised treatment and follow up if necessary. 01/22/2003: Follow up care
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: 01/23/2003: Telephoned office to say child has a rash that looks like chicken pox.  Noted that yesterday child was not feeling well, some diarrhea and vomitings and low fever.  Advised this is possible reaction to vaccine, instructed regarding symptomatic treatment.  Verbalized understanding of instructions.  Advised to contact family Doctor if not improved in next 3-4 days.  Family Doctor notified.
Age: 1.4
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Feeling hot, Injection site erythema, Swelling
Clinical narrative: 01/23/2003 @ 16:00: Left leg swollen from knee to hip.  Red, warm to touch at injection site.  Mother states does not bother child.  Instructed to give Tylenol if needed as prescribed and use cold compresses if need.  Mother verbalizes understanding.  Also instructed to follow up with Doctor if unresolved in 2-3 days.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia, Rash pustular
Clinical narrative: Had 5 scattered tiny single pustules, scabbed over with erythema on right shoulder, right and left chest wall, right hip and left ankle, that developed approximately 03/31/2003.  Rash not pruritic.  Temperature 99 degrees F, 122/61-HR 74, Respiratory Rate 18.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Swelling, Tenderness
Clinical narrative: Marked local reaction with intense warmth, swelling and tenderness of upper arm, shoulder extending almost to elbow.
Age: 10.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Feeling hot, Oral mucosal blistering, Pyrexia, Swelling face
Clinical narrative: 03/26/2003: Telephone call from school nurse-Advised patients condition and reaction. On 03/21/2003: Patient received Hep B injection in school setting.  States after a few minutes "felt hot, lip began swelling".  Later went to visit relative for weekend when returned on 03/23/2003.  Lip very swollen, had sore on lip "like a cold sore", fever 102, complained of fatigue, advised mom to take child to doctor.
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: Got DTaP on 04/30/2003:  Swelling, redness, noted at Left upper lateral thigh since 05/01/2003.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Application site reaction
Clinical narrative: large local reaction to DTaP and MMR
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Coordination abnormal, Rash
Clinical narrative: Vaccine 04/26, 05/03 rash trunk right.  Atoxia - incortination. Improving 05/07/2003
Age: 24.0
Sex: F
Vaccine: MEA
Symptoms: Dehydration, Injection site rash, Myalgia, Pyrexia
Clinical narrative: Onset before sore throat; next day "high fever" (no thermometer) which continued until 04/25 AM at about 103 degrees F (temperature first taken 04/24 at 20:00-was 103).  Then late 04/25 fever back up to 103.4 degrees F.  Seen at hospital.  Diagnosis probable influenza with dehydration.  Patient has a cough since 04/21 and severe muscle aches; also 3 spots rash on left arm, on near injection site, size of dime; others smaller.  Now temperature normal, still with much coughing.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eye swelling, Ocular hyperaemia, Rash
Clinical narrative: Rash to whole body, eyes swollen, sclera red
Age: 1.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Erythema, Irritability, Rash papular
Clinical narrative: Seven days later became very cranky and developed a fixed erythematous nodular/papular rash.  Strep throat cx (-)/observed and resolved over >= 1 week.
Age: 0.11
Sex: M
Vaccine: DTAP, HIBV, OPV
Symptoms: Pyrexia, Respiratory tract infection, Tremor
Clinical narrative: Both times patient had shots he became very ill.  The 1st time (DTAP & HIB) patient had a 104.7 degree F temperature.  Last time (Polio & HIB) he got 104 degree F temperature with an intense lung infection and he got the shakes.