chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.51
Sex: F
Vaccine: DTP, IPV
Symptoms: Visual disturbance
Clinical narrative: My daughter started having "the shakes" after her 6 month vaccinations. We were never made aware of the dangers of vaccinations until recently. Between ages 1-3 she had continous ear and sinus infections. We recently discovered that she has Pervasive Developmental Disorder - not otherwise specified (Autism Spectrum Disorder) along with hearing sensitivity, phonological disorder, and ADHD. She has also been diagnosed as being toxic for heavy metals including, but not limited to Mercury and Lead. She also has vision problems.  Information received from medical redords states, limp, ataxia, agitated.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema
Clinical narrative: Left arm swelling same day after injections.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema, Injection site pain
Clinical narrative: 4 yo came in for 4 yr check up and received Dtap, IPV, and MMR vaccinations. No prior hx of problems within 24 hrs, pt returned with 12 hr, increasing right leg pain and swelling but no fever. Treated with Benadryl, Tylenol and Motrin and resolution within 72 hrs.
Age: 8.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Dyskinesia, Epilepsy, Epistaxis
Clinical narrative: Head jerking that often continues through sleep, looks like a seizure. No shrugs shoulders toward head and jerking involves shoulders also. No fever, but do suffer of nose bleedings which coincide with the head shaking, sibling (sister) suffered of similar problems after same vax adn lasted for 1 year, now suffers of epilepsy.
Age: 8.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Tic
Clinical narrative: Head jerking that often continues through sleep, looks like a seizure. No shrugs shoulders toward head and jerking involves shoulders also. No fever, but do suffer of nose bleedings which coincide with the head shaking, sibling (sister) suffered of similar problems after same vax adn lasted for 1 year, now suffers of epilepsy.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Arthralgia, Myalgia
Clinical narrative: Severe myalgia, arthralgia, abdominal pain.
Age: 1.57
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis at injection site right and left thighs
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Tenderness
Clinical narrative: Left deltoid red, hot, indurated, and tender. Tx: Augmentin ES 600mg 1 1/2 tsp BID x 10 days. Warm compress qid.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Tenderness
Clinical narrative: Red, warm, tender, and painful left deltoid at vaccine site. Rx: Augmentin ES 600mg PO bid per order. Warm compress.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash macular, Urticaria
Clinical narrative: Blotchy face few min after vaccine, hives on arms later in day.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Flushing, Nausea
Clinical narrative: Patient received vaccine 6/17/05. Patient reported on 6/21/05 that about 2 hours afterwards he experienced dizziness, flushing, and nausea. Dizziness lasted 4 days but lessened in severity each day. No treatment.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Tenderness
Clinical narrative: Red area left arm approximately the size of a peach; warm and tender to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema
Clinical narrative: 3x3cm red area right arm.
Age: 0.34
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: High-pitched crying, Personality disorder
Clinical narrative: Prolonged, high-pitched crying. Personality change less than 24 hours.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Localized swelling and erythema approximately 6x6cm left arm. Treat with cold compresses and topical hydrocortisone.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site reaction, Injection site warmth
Clinical narrative: Large local reaction to right arm; warm to touch and about the size of a lime per mom.
Age: 0.53
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Cough, Pyrexia
Clinical narrative: Patient had 6 month immunization. Temp 101.9 PM and coughing. Mother concerned with breathing. Called 911. ER doctor evaluated. Patient fine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling
Clinical narrative: Swollen left deltoid muscle 9-10cm. Treated with Benadryl by mouth an cool compresses.
Age: 0.78
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Agitation, Irritability, Pyrexia
Clinical narrative: Very fussy, increased temp 102, not able to be consoled for 3 days. Was given Tylenol and Motrin.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth, Medication error
Clinical narrative: Child arm swollen and warm to touch. Shot was given at right lower triceps area instead of thigh.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Urticaria
Clinical narrative: Hives one hour after immunization. No breathing difficulty. Next day, swelling in area of injection with erythema.
Age: 17.0
Sex: M
Vaccine: TD
Symptoms: Rash, Urticaria
Clinical narrative: Breaking out on face started Wednesday night; little bumps. Hives on arms, noticed Thursday. Today, Friday, has scattered hives on arms and legs. Doctor advised Benadryl. To see doctor if continued worsening.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, mild swelling in approximately 4cm area surrounding injection site.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: Headache and lethargy after vaccine. Also temp 100.
Age: 0.6
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Febrile (rectal) 103.2 for 12 hours.
Age: 1.36
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Difficulty in walking, Gait disturbance, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Right thigh swelling within 24 hours after shot had been given along with heat/warm to touch. Limping and refused to bear weight for 24 hours. Fever also present 3 days after immunizations.
Age: 2.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash papular, Skin ulcer
Clinical narrative: Papular rash/lesions. Atypical vs.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Redness and tenderness to injection site. Also hot to touch. Patient given Augmentin 2 tabs PO BID for 7 days.
Age: 1.03
Sex: F
Vaccine: MMR, PPV, VARCEL
Symptoms: Injection site reaction, Pyrexia, Vomiting
Clinical narrative: Large local reaction right thigh. Fever 103.5 on day of vaccine for 3 days. Vomiting two times; no dehydration.
Age: 9.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Medication error
Clinical narrative: This person should have received adult Td instead of DTaP. Age at time of vaccination was 8 years. No adverse reaction occurred.
Age: 1.64
Sex: F
Vaccine: DTAP, IPV
Symptoms: Convulsion, Pyrexia
Clinical narrative: Received Dtap 6/10/05 during well child exam. Fever, subsequent seizure lasting minutes on 6/13/05. No focus of infection on exam.
Age: 1.13
Sex: M
Vaccine: VARCEL
Symptoms: Dry skin, Pruritus, Rash papular
Clinical narrative: On 6/12 noticed a few red papular and spread over body next 3 days, scabbed over, itchy.
Age: 1.28
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site discolouration, Injection site rash
Clinical narrative: Diffuse blanching rash, generalized. Worse on cheeks and forearms.
Age: 1.06
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Periorbital oedema, Rash papular
Clinical narrative: Diffuse papular rash, perioral edema.
Age: 1.06
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Oedema, Rash papular
Clinical narrative: Diffuse papular rash, perioral edema.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Swelling and erythema of left upper arm and to elbow and below elbow to upper forearm, tender 48 hrs after Dtap given to pt.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Urticaria
Clinical narrative: A lot of pain that first night, could not sleep. The next afternoon I noticed a large fire red, hot to the touch area which covered the entire upper arm from just below where the shot was administered to the elbow joint and surrounded by a thick white welt. The Dr's diagnosis s/s a very very large hive. Treatment: Prednisone- 20mg twice daily for 4 days and Zyrtec.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: High fever 5 days 104. No other sx.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site oedema, Pyrexia, Rash
Clinical narrative: Fever and rash on face, swelling at injection site both legs.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Injection site LD with swelling, pain, warmth and redness with an onset of 1 day.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Pyrexia, Tenderness
Clinical narrative: Fever of 101-24 hrs after immunization given, resolved with Tylenol. Spot s/p injection grown today into red eryth area, larger and warm to touch. 7x8cm indurated eryth sl tender to palp. No rash , no d/c. Benadryl 1 tsp tid follow.
Age: 0.54
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Rash erythematous
Clinical narrative: Right leg has 3 3/4cm by 1 7/8cm of leg reddened, raised, hard to touch.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Listless
Clinical narrative: Pediarix, Pedvax, Hib, and Prevnar, administered on 04/14/2005.  Approximately 30 seconds after given, child became listless, although he seemed to recover here in office, Mom states he remained listless for about 40 minutes.
Age: 0.38
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Mom states - few hours after immunization child screamed for one hour - took to ER.  No treatment.
Age: 0.57
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Rash erythematous, Swelling
Clinical narrative: Red, raised, swollen spot - about the size of mother's thumb, left thigh.
Age: 41.0
Sex: F
Vaccine: HEPA, TD
Symptoms: Drug ineffective, Hepatitis A, Laboratory test abnormal, Mononucleosis syndrome, Viral infection
Clinical narrative: This case was reported by a nurse and described the occurrence of hep A infection in a 41 yr old female pt who received hep A vaccine inactivated (Havrix). The reporting nurse stated that the pt received her first dose of Havrix at the health dept on 01Oct03. On the same date, the pt received adult tetanus and diphtheria toxoids adsorbed. Beginning on 01Nov03, the pt travelled for approx 3 weeks. Approx eight weeks after admin of Havrix, on 27Nov03, the pt presented to an urgent care facility with a variety of symptoms. Blood work indicated acute mononucleosis and acute hep A infection. The immunization series with Havrix was discontinued. The events resolved on 16Dec03. The nurse considered the events to be unrelated to vaccination with Havrix.
Age: 58.0
Sex: F
Vaccine: HEPA
Symptoms: Headache, Hypertension, Nausea, Neuropathy peripheral
Clinical narrative: This case was reported by a physician and described the occurrence of peripheral neuropathy in a 58 yr old female pt who received hep A vaccine inactivated (Havrix). On an unspecified date in Dec 2003, the pt received the first dose of Havrix in her arm, immediately, following admin of Havrix vaccine, the pt experienced neuropathy in her arms, legs and feet, headache, nausea and high blood pressure. The reporting physician stated that the pt has seen a couple of physicians concerning this issue. The headache, nausea and high blood pressure improved, but the neuropathy of the arms, legs and feet was unresolved at the time of reporting (12Feb04). The reporting physician considered the events to probably be related to vaccination with Havrix.
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Psychomotor hyperactivity
Clinical narrative: This case was reported by a consumer and described the occurrence of attention deficit hyperactivity disorder in a 5 yr old female pt who received hep A vaccine inactivated (Havrix). A physician or other health care professional has not verified this report. On an unspecified date in Jul 2001, the pt received a dose of Havrix (a dose number not specified). Approx two months later, on an unspecified date in Sep 2001, the pt experienced attention deficit hyperactivity disorder and was seen at a physician's office. The reporter stated that the pt's sister also has attention deficit hyperactivity disorder, but it is unk if she received hep A vaccine. The event was unresolved.
Sex: U
Vaccine: HEPA, TD
Symptoms: Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: This case was reported by a physician and described the occurrence of vertigo in a 20 yr old female pt who received hep A vaccine inactivated (Havrix). The pt's medical history was notable for a normal healthy general physician condition and social alcohol use. On 15Apr04, the pt received the first dose of Havrix (lot VHA786A4) in her right deltoid. The same day, the pt received an injection of Tetanus and diphtheria toxoids adsorbed (adult formulation) in her left deltoid. Approx one hour following the administration of the immunizations. On 15Apr04, the pt experienced vertigo, dizziness, nausea, and vomiting. On 16Apr04, the pt was seen at a physician's office and was treated with oral promethazine hydrochloride (Phenergan). The events resolved on 17Apr04. The immunization series with Havrix was discontinued. The physician considered the events to possibly be related to vaccination with Havrix.
Sex: F
Vaccine: HEPA
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of fever in an adult female pt who received hep A vaccine inactivated (Havrix). The nurse reported that approx 15 pt, experienced fever, facial pain and fatigue following the administration of Havrix, however, pt identifiers were not provided. On an unspecified date in May 2004, the pt received a dose of Havrix in her arm (dose number not specified). Approx 48 hrs after the admin of Havrix, on an unspecified date in May04, the pt experienced fever, facial pain and fatigue. The outcome of the events is unk.
Sex: F
Vaccine: HEPA
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased
Clinical narrative: This case was reported by a physician and described the occurrence of increased alanine aminotransferase in his wifet who had received hep A vaccine inactivated (Havrix). On an unspecified date in Jan 2004, the pt received the first dose of Havrix. Several months after the administration of the first dose of Havrix, on an unspecified date in 2004, the pt experienced increased levels of alanine aminotransferase and aspartate aminotransferase. The outcome of the events is unk. The reporting physician considered the events to possibly be related to vaccination with Havrix.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of vomiting in an 8 yr old female pt who received hep A vaccine inactivated (Havrix). On 28May04 the pt received the first dose of Havrix (lot VHA814A2). At an unspecified time following the admin of Havrix, on 28May04, the pt experienced vomiting. The event resolved on 30May04. The nurse considered the vomiting to possibly be related to vaccination with Havrix.
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Heart rate increased, Visual disturbance
Clinical narrative: This case was reported by a nurse practitioner and described the occurrence of dizziness in an adult female pt who received hep A vaccine inactivated (Havrix). On 05May04, the pt received a dose of hep a inactivated and hep B recombinant vaccine (Twinrix); dose number not specified). At an unspecified time following the administration of Twinrix, on an unspecified date in 2004, the pt developed dizziness. The outcome of the event resolved on an unspecified date. The relationship to Twinrix was not reported. On 16Jun04, the pt received the first dose of Havrix (lot VHA786A4). Although it was the first dose of Havrix, the dose number in the hep A immunization series was not specified. On 16Jun04, the same day as the admin of Havrix, the pt experienced dizziness and felt out of it. On 17Jun04 the pt experienced a rapid heartbeat and blurred vision. The pt sought medical attention. The events resolved on an unspecified date. The nurse practitioner considered the events to possibly be related to vaccination with Havrix.
Age: 58.0
Sex: M
Vaccine: HEPA
Symptoms: Drug ineffective, Medication error
Clinical narrative: This case was reported by a physician and described a 58 year old male pt who did not respond to immunization with Havrix. On 4/22/02, the pt received the first dose of Havrix (lot VHA711B6). Approximately 23 days, post/vax, on 5/15/02, a Hep A antibody titer was "negative". On 6/10/02, the pt received the second dose of Havrix (lot VHA71186). This represents a schedule of approximately seven weeks between the first and second doses of Havrix which is sooner than the recommended interval of six to 12 months. Approximately 11 months after the second administration of Havrix, on 5/15/03, a Hep A antibody titer was "negative". The physician stated that he was concerned, "that there was a problem with this particular lot of Havrix".
Age: 6.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: This case was reported by a nurse and described the occurrence of stomach pain in a 6 year old female patient who received hepatitis A vaccine inactivated (Havrix).  The patient's medical history included reactive airway disease, and allergy to nuts, animals, pollen, shellfish, and dustmites.  At the time of administration of the second dose of Havrix, the patient was not receiving any concurrent medications.  On 07/21/2004, the patient received the second dose of Havrix (lot VHA839A2).  On the same day as the administration of Havrix, on 07/21/2004, the patient experienced stomach pain and had one loose bowel movement.  The loose bowel movement resolved on 07/21/2004 and the stomach pain resolved on 07/23/2004.  The nurse considered the events to not be related to vaccination with Havrix.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Dehydration, Diarrhoea, Dizziness, Nausea, Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of dehydration in a 26 month old male pt who received Havrix. On 1/20/04, the pt received the first dose of Havrix, in the RA (lot VHA777A2). Approximately, 2 days following the administration of Havrix on 1/22/04, the pt experienced nausea and vomiting, dizziness, diarrhea, dehydration and "had a rash". The pt was seen in an ER. Additional info received from Mfr on 8/11/04, indicated that the pt "was hydrated" in the ER. The events resolved on an unspecified date.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: This case was reported by a nurse and described the occurrence of dehydration in a 26 month old male pt who received Havrix. On 1/20/04, the pt received the first dose of Havrix, in the RA (lot VHA777A2). Approximately, 2 days following the administration of Havrix on 1/22/04, the pt experienced nausea and vomiting, dizziness, diarrhea, dehydration and "had a rash". The pt was seen in an ER. Additional info received from Mfr on 8/11/04, indicated that the pt "was hydrated" in the ER. The events resolved on an unspecified date.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 27 month old male patient who received hepatitis A vaccine inactivated (Havrix).  The patient's medical history was notable for upper respiratory infection on an unspecified date.  On 07/27/2004, the patient received the first dose of Havrix in the left thigh.  During the administration of Havrix, on 07/27/2004, the patient moved which resulted in the needle coming out of the patient's thigh.  The nurse stated that some of the vaccine was administered subcutaneously.  The recommended route of administration for Havrix is intramuscular.  One day following the administration of Havrix, on 07/28/2004, the patient experienced injection site reaction characterized as redness and swelling.  The nurse stated that the injection site reaction was nickel sized.  The patient was seen at a physician's office.  The injection site reaction resolved on 08/01/2004.  The nurse considered the events to no be related to vaccination with Havrix.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Abnormal behaviour, Pyrexia
Clinical narrative: This case was reported by a health professional and described the occurrence of fever in a 3 year old female pt who received Havrix. At the time of administration of Havrix, the pt was not receiving any concurrent medication. On 8/4/04, the pt received the 1st dose of Havrix (lot VHA776B2). Approximately 1 day, post/vax of Havrix, on 8/5/04, the pt experienced fever and unspecified "behavior problems". The pt was seen at a physician's office. The outcome of the events is unknown at the time of initial reporting. The health professional conseidered the events to probably be related to vaccination with Havrix.
Age: 25.0
Sex: F
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse and described a 25 year old female patient who received Hepatitis A vaccine and subsequently tested positive for Hepatitis A IgM antibody.  The patient's past medical history was notable for exposure to fecal contamination on 06/28/2004.  The nurse reported that it is unknown if the fecal contamination was infected with Hepatitis A.  On 06/29/2004, the patient received the first dose of Hepatitis A vaccine.  On 06/29/2004, a Hepatitis A IgM antibody test was positive.  The patient was seen at a physician's office.  The reporter stated that the patient shows no signs or symptoms of Hepatitis A and their liver function test was normal.  The nurse considered the event to be related to vaccination with Hepatitis A vaccine and considered the event, an appropriate immune response.
Age: 53.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Arthralgia, Drug ineffective
Clinical narrative: This case described the occurrence of joint pain in a 53 year old female pt who received hepatitis A and hepatitis B. The report was initially received from the pt and partially confirmed by a physician. The pt's medical history was notable for codeine allergy and liver failure. The reporting physician stated that a "liver biopsy failed to disclose an etiology, but there was a suggestion that there could be some association with alcohol". Medical history also included the onset of menopause on an unspecified date in 2004, tonsillectomy and tinnitus. The pt is a nonsmoker. Concurrent medications included Synthroid for an unspecified medical condition and Valium for sleep. On an unspecified date, the pt "tested negative for Hep A, B, and C". The pt stated that she was "a candidate for a liver transplant and was placed on an accelerated dosing schedule for hepatitis A and B vaccination. On 6/21/04, the pt received "two doses" of hepatitis A in her left arm. On 6/21/04, the pt also received 2 doses of hepatitis B in her right arm. Approximately 1 day, post/vax of hepatitis A and B vaccine, on 6/22/04, the pt experienced joint pain throughout her body. She was seen at a physician's office. The joint pain persisted. On 7/21/04, the pt received a dose of Twinrix as the 3rd dose in the hepatitis A and B immunization series. The joint pain persisted. At an unspecified date, post/vax of Twinrix, the pt "found out through subsequent testing, that her liver is functioning normally again"., The pt was seen on 11/2/04 by the reporting physician. He reported that the pt's joint pains were "quite diffuse, including the jaws, elbows, fingers, pelvis, knees and ankles. There were no objective signs of inflammation in any joint, no substantial morning stiffness, no rash and no vasculitis problems". The joint pain was ongoing at the time of follow-up, 11/2/04. The reporting physician considered the joint pain to be "a possible reaction to hepatitis B vaccine.
Age: 49.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dizziness, Myalgia, Nausea, Pyrexia, Viral infection
Clinical narrative: This case was reported by a pharmacist and described the occurrence of myalgia in a 48 year old female patient who received hepatitis A vaccine inactivated (Havrix).  On 08/18/2004, the patient received the first dose of Havrix in the right leg.  On 08/18/2004, the patient also received an injection of typhoid vaccine.  Approximately 2 days after the administration of Havrix, on 08/20/2004, the patient experienced myalgia.  On 08/24/2004, the patient experienced a fever greater than 101 degrees Fahrenheit, nausea and vomited twice.  On 08/26/2004, the fever and vomiting resolved.  On 08/27/2004, the myalgias got worse.  The patient was seen in the emergency room.  A complete blood count revealed a white blood count of 4.6 and lymphocyte count of 51%.  The patient was told in the emergency room that the events were probably due to a viral infection.  ON 08/29/2004, the patient experienced dizziness.  She was seen by a neurologist.  A CAT scan was normal.  At the time of initial reporting, the myalgia had worsened, and the dizziness and nausea were ongoing.  The reporting pharmacist considered the events to not be related to vaccination Havrix.
Age: 49.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Vomiting
Clinical narrative: This case was reported by a pharmacist and described the occurrence of myalgia in a 48 year old female patient who received hepatitis A vaccine inactivated (Havrix).  On 08/18/2004, the patient received the first dose of Havrix in the right leg.  On 08/18/2004, the patient also received an injection of typhoid vaccine.  Approximately 2 days after the administration of Havrix, on 08/20/2004, the patient experienced myalgia.  On 08/24/2004, the patient experienced a fever greater than 101 degrees Fahrenheit, nausea and vomited twice.  On 08/26/2004, the fever and vomiting resolved.  On 08/27/2004, the myalgias got worse.  The patient was seen in the emergency room.  A complete blood count revealed a white blood count of 4.6 and lymphocyte count of 51%.  The patient was told in the emergency room that the events were probably due to a viral infection.  ON 08/29/2004, the patient experienced dizziness.  She was seen by a neurologist.  A CAT scan was normal.  At the time of initial reporting, the myalgia had worsened, and the dizziness and nausea were ongoing.  The reporting pharmacist considered the events to not be related to vaccination Havrix.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Coma, Convulsion, Dizziness, Dyskinesia, Dyspnoea
Clinical narrative: This case was reported by a pharmacist and described the occurrence of a seizure in a 17 yr old female pt who received hep A vaccine inactivated (Havrix). The pt's medical history was notable for insulin resistance. Prior to the vaccination with Havrix, on 23Sep04, the pt's medical history was negative for seizure, cerebral palsy, neurological handicap, congenital abnormality, diabetes, renal failure, alcohol or drug abuse, or any other CNS conditions. On 23Sep04, at 2:15PM, the pt received the first dose of Havrix (lotVHA805A6). Five minutes following the administration of Havrix, at 2:20PM, the pt felt dizzy and then experienced approx 30 seconds of seizure like activity, characterized as unresponsiveness to verbal commands, eyes rolling backwards, stiff jerking of arms and legs, clenched teeth, and labored breathing. Emergency response was called. At the time of the seizure, 2:20PM, blood pressure was 160/90mm Hg, heart rate was 72 beats per minute and blood glucose was 103. Approx 10 minutes later, at 2:29PM, the pt lost consciousness for approx three seconds. Upon regaining consciousness, the pt remembered the event and did not experience urine or fecal incontinence. At 2:30PM, blood pressure was 110/70 mmHg, heart rate was 60 beats per minute and blood glucose was 85, the pt was transported to the hospital and treated with intravenous fluids. She was treated and released later the same day and was not hospitalized. All the events resolved on 23Sep04. The pharmacist considered that the events were life threatening and jeopardized the pt. The vaccination series with Havrix was discontinued. The reporting pharmacist considered the events to be related to vaccination with Havrix.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Gaze palsy, Heart rate increased, Hypertension, Loss of consciousness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of a seizure in a 17 yr old female pt who received hep A vaccine inactivated (Havrix). The pt's medical history was notable for insulin resistance. Prior to the vaccination with Havrix, on 23Sep04, the pt's medical history was negative for seizure, cerebral palsy, neurological handicap, congenital abnormality, diabetes, renal failure, alcohol or drug abuse, or any other CNS conditions. On 23Sep04, at 2:15PM, the pt received the first dose of Havrix (lotVHA805A6). Five minutes following the administration of Havrix, at 2:20PM, the pt felt dizzy and then experienced approx 30 seconds of seizure like activity, characterized as unresponsiveness to verbal commands, eyes rolling backwards, stiff jerking of arms and legs, clenched teeth, and labored breathing. Emergency response was called. At the time of the seizure, 2:20PM, blood pressure was 160/90mm Hg, heart rate was 72 beats per minute and blood glucose was 103. Approx 10 minutes later, at 2:29PM, the pt lost consciousness for approx three seconds. Upon regaining consciousness, the pt remembered the event and did not experience urine or fecal incontinence. At 2:30PM, blood pressure was 110/70 mmHg, heart rate was 60 beats per minute and blood glucose was 85, the pt was transported to the hospital and treated with intravenous fluids. She was treated and released later the same day and was not hospitalized. All the events resolved on 23Sep04. The pharmacist considered that the events were life threatening and jeopardized the pt. The vaccination series with Havrix was discontinued. The reporting pharmacist considered the events to be related to vaccination with Havrix.
Sex: U
Vaccine: HEPA
Symptoms: Drug ineffective
Clinical narrative: This was reported by a physician's assistant and describes an unspecified number of unidentified patients who did not respond to immunization with Hepatitis A inactivated vaccine (Havrix) and Hepatitis B vaccine recombinant (Engerix-B).  The patient's medical history, concurrent conditions, and concurrent medications were not reported.  The patient received an unspecified number of injections of Havrix and Engerix-B.  At an unspecified time post-immunization, it was determined that the patient failed to seroconvert.  Report received via Merck and Co, Inc.
Age: 51.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hypokinesia, Injection site pain, Myalgia
Clinical narrative: This case was reported by a nurse and described the occurrence of an injection site reaction in a 50 year old male patient who received Hepatitis A vaccine inactivated (Havrix).  The patient's medical history was notable for allergy to Ceftin.  On 01/16/2003, the patient received the first dose of Havrix.  On 12/07/2004, the patient received the second dose of Havrix in the left deltoid.  The recommended interval between the 2 doses of Havrix is 6 to 12 months.  On the same day, the patient received a dose of Hepatitis B vaccine recombinant (Engerix-B) in the right deltoid.  At an unspecified time later the same day, the patient experienced a local injection site reaction manifested by deep muscle pain in the upper left deltoid.  The patient was seen at a physician's office.  The nurse stated that, this patient complains that the pain in the left arm inhibits his ability to sleep on his arm and it also prevents him from using his arm to its fullest potential.  The event was ongoing as of 01/26/2005.  The nurse considered the event to be related to vaccinations with Havrix.
Age: 58.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Face oedema, Hormone level abnormal, Influenza like illness, Mucous membrane disorder
Clinical narrative: 06/07/05 Immediate light headed/dizziness. Detained and reclined. 06/08 discoloration and swelling  of inside lip and mouth. membrane mouth sore, mouth wash ? also experienced flu like symptoms. 06/13/05  small red patch/rash 06/14/05 rash on right side areas spres agressively, with itchyness. 06/15 no signs of any rash. Went to ER for tx.
Age: 58.0
Sex: F
Vaccine: YF
Symptoms: Rash, Stomatitis
Clinical narrative: 06/07/05 Immediate light headed/dizziness. Detained and reclined. 06/08 discoloration and swelling  of inside lip and mouth. membrane mouth sore, mouth wash ? also experienced flu like symptoms. 06/13/05  small red patch/rash 06/14/05 rash on right side areas spres agressively, with itchyness. 06/15 no signs of any rash. Went to ER for tx.
Age: 13.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Nausea, Pallor, Syncope, Vomiting
Clinical narrative: 6/1/05 at 9:46 am:  After receiving Td and Varicella vaccines the client fainted.  BP=100/80; Pulse=88.  Patient monitored with BP and pulse assessment every 15 minutes - within normal limits. Patient vomited x3 during stay in clinic.  BP and pulse remained stable.  Notified patient's private MD and sent of office with mother at 11:30 am. MD visit:  assessment as pale white female teen who had only eaten a banana the night before as her evening meal.  On the morning of immunizations, did not eat breakfast.  States has a fear of shots.  Nausea persisted in MD's office.  Rested in office approx. 30 minutes and left with mother.  Color significantly improved.  Fluids and small meals encouraged.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Decreased appetite, Insomnia, Irritability, Pain
Clinical narrative: This patient did well as a 2 month old with his vaccines, but at 4 months the patient developed some different symptoms.  For an entire week he cried nearly constantly as if in pain, slept poorly and ate poorly.  He had a documented maximum temperature of 100.5 only, had no vomiting, diarrhea, nor rash.  He was seen by myself on day #4 and other than being fussy, there was nothing on physical exam.  The patient had lost only one ounce at that visit compared to the visit where he received his vaccines.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia, Screaming, Weight decreased
Clinical narrative: This patient did well as a 2 month old with his vaccines, but at 4 months the patient developed some different symptoms.  For an entire week he cried nearly constantly as if in pain, slept poorly and ate poorly.  He had a documented maximum temperature of 100.5 only, had no vomiting, diarrhea, nor rash.  He was seen by myself on day #4 and other than being fussy, there was nothing on physical exam.  The patient had lost only one ounce at that visit compared to the visit where he received his vaccines.
Age: 1.13
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC
Symptoms: Convulsion, Dehydration, Musculoskeletal stiffness
Clinical narrative: Client was hospitalized over night with seizure activity.  Mother denied fever at time of seizure.  Had been ill the day before vaccination with vomiting.  Mother reported that aprox 6 hours after immunization child was breastfeeding and began to get stiff and convulse.  Mother reported that child had MRI, CAT scan, EEG et blood work.  Results of these test not available at this clinic but mother states child was dehydrated.  Will fu with MD.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC
Symptoms: Irritability, Oedema
Clinical narrative: Patient received her 1-year-old immunizations today including the MMR for the first time. Paitent went to urgent care on 6/15/05, the day she received her immunizations. "Patient has been fussy all day but has been eating and drinking normally. She has had no fever but her mom and grandma note she seems to have body swelling. Her face isn't effected and she has had no wheezing. No toxic symptoms. She takes Tylenol. NKMA." MD spoke with another MD: "I spoke about this case with MD as I had never seen a reaction such as this before. Mom assures me this child isn't usually "this puffy" just by her normal exam and normal O2 SATs and afebrile nature, the mom was quite concerned. I spoke with MD who reassured me that such an immunization reaction is not usual but is also not terribly concerning. He advised Benadryl 1 tsp q6h. Follow up with PCP in the a.m. Precautions are given to mom."
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Report received from colleague at CDC, who spoke with provider. Immediately after vaccination with Menactra, site was "red and itchy". Seen day after vaccination with 11 x 12 cm swelling ("from shoulder to elbow") and redness on injected arm. No reported fever. Additional symptoms and signs included "burning", warmth at site, and headache. Symptomatic treatment with diphenydramine given. No call back or other follow up from patient as of 2 days after follow up visit; provider assumes condition has resolved. Had received most recent dose of Td 6/8/04, also in left deltoid. (lot # SP U1185AA) Provided expressed concern that this event, as well as some mild erythema and tenderness after Td last year that was not medically attended, may be related to latex content of vaccine packaging.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Oedema, Pruritus, Similar reaction on previous exposure to drug
Clinical narrative: Report received from colleague at CDC, who spoke with provider. Immediately after vaccination with Menactra, site was "red and itchy". Seen day after vaccination with 11 x 12 cm swelling ("from shoulder to elbow") and redness on injected arm. No reported fever. Additional symptoms and signs included "burning", warmth at site, and headache. Symptomatic treatment with diphenydramine given. No call back or other follow up from patient as of 2 days after follow up visit; provider assumes condition has resolved. Had received most recent dose of Td 6/8/04, also in left deltoid. (lot # SP U1185AA) Provided expressed concern that this event, as well as some mild erythema and tenderness after Td last year that was not medically attended, may be related to latex content of vaccine packaging.
Age: 45.0
Sex: M
Vaccine: TYP, YF
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre Syndrome after receiving Typhoid Vi and Yellow fever vaccines. 4 weeks. Seen in ER and admitted inpatient ward for observation.
Age: 22.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Pain
Clinical narrative: Pt states her entire L arm is very sore. She denies redness or swelling. She did not check her temperatur, but had body aches and fatigue that resolved by day 2 after getting the vaccine.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Lymphadenopathy
Clinical narrative: Rec the second Hepatitis B vaccination on 6-8-05 at Pvt MD office. The reason she contacted me was because I have previously given her the yellow fever vaccination on April 1, 2005. A couple of days after the 2nd vaccination of Hep B, around June 11th she stated she got a knot in her back and went to a chiropractor to assist with the pain. At that time the chiropractor asked if she had sone anything different and the vaccination was the only thing she could think of.  Then on the 18th she developed enlarged lymphs that she thought was related to her teeth. She went to the dentist who assured her nothing was wrong with her teeth.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Tenderness
Clinical narrative: Severe redness, tenderness, swelling of left arm within 12 hours of DTaP, with fever to 103, treated with Motrin, Keflex, Benadryl
Age: 10.0
Sex: F
Vaccine: HEP, HEPA, MMR, TD
Symptoms: Convulsion
Clinical narrative: Patient received vaccines on june 20 2005 through EIS, TD, MMR, HEPA, HEBB.  She had completed vaccines and was standing at corner when she collapsed and fell to floor having small seizure.  She recovered quickly and was seen by provider.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Decreased appetite, Otitis media, Pneumonia, Pyrexia, Swelling
Clinical narrative: 6/14/2005 Fever started decreased intake of food and fluids.  6/15/2005 leg swollen, no redness seen by doctor otitis media, phorymsites, pneumonia, Sent to ER for IV fluids, 6/16/2005 seen by doctor no fever for 24 hours.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Hypersensitivity, Pain, Swelling
Clinical narrative: complained of left arm increase swelling redness after vaccine. 6/13/2005 eval at clinic Patient currently is on aloe treatment for pain hypersensitivity start dry 06/13/2005
Sex: M
Vaccine: DTAP, HBPV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever develop 12 hours post vaccines fever 102
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site oedema
Clinical narrative: erythema 06/08 and swelling in LA from 06/09 from upper arm to forearm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site vesicles, Injection site warmth
Clinical narrative: Left deltoid blisters, swelling, redness and warmth. Tx Benadryl, Ice and antibiotic ointment PRN
Age: 0.47
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Diarrhoea, Insomnia, Irritability, Nasal congestion, Vomiting
Clinical narrative: Nasal congestion, irritable, fussy, not sleeping, emesis, some diarrhea
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Dyspnoea, Rash
Clinical narrative: Rash, breathing difficulty.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Diarrhoea, Erythema, Vomiting
Clinical narrative: From initial information received from the patient, who is a healthcare professional, regarding an adverse event occurring in the USA, it was reported that the 48 year old female patient received a dose of TET TOX Booster USP, lot number unknown, administered intra-muscularly in the left deltoid on 08/05/2004.  The patient was administered the tetanus product because of a needle stick after a blood draw.  Her last tetanus booster was reportedly eight years ago.  The emergency room informed the patient her healthcare provider requires a tetanus booster every 5 years.  One day after receiving the product, the patient developed a large local reaction consisting of redness, vomiting and diarrhea.  The patient self medicated with Motrin and Tylenol.  She had not recovered from these events at the time of this report.  From additional information received on 09/13/2004 from the responsible physician, it was reported that the physician has no knowledge of this reaction except as told by the patient.  She reported that she was not the emergency room medical doctor, but is the patient's primary care physician.  No new medical information was provided at this time.
Age: 12.0
Sex: M
Vaccine: TTOX
Symptoms: Erythema, Feeling hot, Hypokinesia, Injection site induration, Injury
Clinical narrative: From initial information received on 03/08/2005 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a 12 year old male patient had a laceration wound to his finger and received a dose of TET TOX Booster USP vaccine, lot number not reported, administered in the left deltoid on 03/06/2005 at 10:00PM.  The route of administration was not reported.  Ten hours later, at 08:00AM on 03/07/2005, the patient was unable to move his left arm.  The site of injection was hardened and the patient had sever pain.  There was no redness, swelling or warmth at the site.  At the time of this report, the patient had not recovered from these events.
Age: 12.0
Sex: M
Vaccine: TTOX
Symptoms: Pain, Swelling
Clinical narrative: From initial information received on 03/08/2005 from the patient's parent regarding an adverse event occurring in the USA, it was reported that a 12 year old male patient had a laceration wound to his finger and received a dose of TET TOX Booster USP vaccine, lot number not reported, administered in the left deltoid on 03/06/2005 at 10:00PM.  The route of administration was not reported.  Ten hours later, at 08:00AM on 03/07/2005, the patient was unable to move his left arm.  The site of injection was hardened and the patient had sever pain.  There was no redness, swelling or warmth at the site.  At the time of this report, the patient had not recovered from these events.
Age: 1.96
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Viral infection
Clinical narrative: In office on 06/10/2005 varicella DX by physician. Broke out in  rash 4-5 days prior to office visit.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Autism, Crying, Sleep disorder
Clinical narrative: Approximately three hours after the shots,  started screaming uncontrollably for 30 minutes. The doctor's office had warned us of this and told us to give Tylenol when it occurred. After about 15 minutes the cryiyng stopped.   From 6-15 weeks, had been sleeping through the night. The day we got these shots he stopped sleeping through the night (waking every hour) and didn't sleep more than an hour at a time until the following January, 2004.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Rash maculo-papular
Clinical narrative: PAPULE & MACULAR RASH TO TORSO AND LOWER EXTREMITES - 7 TO 10 DAYS AFTER IMMUNIZATION.  TREATED WITH CIPRO 500mg, ATARAX 25mg AND ZYRTEC 10mg.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Headache, Heart rate increased, Nausea, Pyrexia
Clinical narrative: Received a Meningococcal Vaccine on June 21st at 6:00 pm.About 24 hours after the shot developed a sudden high fever, a headache, was felt very sick to his stomach, was dizzy and his heart was racing. I brought him to hospital. I was told him more than likely had a reaction to the shot. They ran blood test and urine test which came back okay. I was told to give him Advil and Tylenol alternating, each one three hours apart. I was also told to watch him closely and also that I needed to bring him back the next day,which is June 23rd, to make sure he is doing better.
Age: 1.68
Sex: M
Vaccine: PNC
Symptoms: Body temperature increased, Injection site erythema, Injection site hypersensitivity, Irritability, Oedema peripheral
Clinical narrative: Leg swelled and turned red within 12 hours of vaccine. Low grade fever, decreased eating, increased sleep and fussiness 18 hours after vaccines.
Age: 1.68
Sex: M
Vaccine: PNC
Symptoms: Somnolence
Clinical narrative: Leg swelled and turned red within 12 hours of vaccine. Low grade fever, decreased eating, increased sleep and fussiness 18 hours after vaccines.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Seen by MD Because of irritability, started after immunizations. Temp 102 axillary. Chest Xray clear. WBC WNL. DX; viral illness more likely pertussis rxn.
Age: 1.23
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever and first time seizure.
Age: 1.37
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Oedema, Pain, Skin discolouration
Clinical narrative: Mid right leg has area of erythema and is painful for child since yesterday. NR activity, no fussiness. 15x6cm area of redness, little swelling central area of 3cm purplish coloring.
Age: 0.04
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site hypersensitivity
Clinical narrative: Swelling and erythema at the time of the vaccine on the left upper arm.
Age: 24.0
Sex: F
Vaccine: TTOX
Symptoms: Medication error, Rash
Clinical narrative: Pt may have been given tetanus instead of PPD in (Left ID Forearm. 10mm rxn 05/23/2005. 06/06/2005 still has residual looking rash. No tx given.