chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Cellulitis, Injection site mass, Injection site oedema, Swelling
Clinical narrative: Mom noticed swelling on evening of vaccine with increased pain. Mom brought her b/c increased swelling and hard to touch. Cellulitis treated with Keflex one tsp. 98 degrees x 7 days. Per annual report-Vaccination and adverse event times are according to mother.  Mom also states that the swelling disappeared 9/29/05 before Keflex was given, therefore she did not give client any Keflex.
Age: 7.0
Sex: M
Vaccine: MU
Symptoms: Drug ineffective, Immunoglobulins decreased
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning an 19 year old white male patient. with environmental allergies and no illness at the time of vaccination, who on Aug 4 1992 previously reported as at 4 or 5 years of age was vaccinated with a second dose of mumps virus vaccine live (Jeryl Lynn) (lot 1811T). The patient had received the first dose of mumps virus vaccine live (Jeryl Lynn) on Aug 10 1986 (previously reported as at one year of age. The nurse reported that the patient was applying to become a firefighter and had a titer drawn which showed no immunity to mumps. The nurse did not have the reason why the child was given mono valent vaccines. Unspecified medical attention was sought. Follow up information reported that the patient was found to be non immun to mumps on Jul 27 2004 and Jul 30 2004. Laboratory evaluation revealed Jul 29 2004 it was reported that mumps AB IgG was 0.73 (reference range reported as 0.00 - 0.90 ISR) and the interpretation was negative or non immune, ON Jul 30 2004 laboratory testing showed mumps AB IgG was 0.65 and the interpretation was negative or non immune. On Aug 10 2004 the patient was vaccinated in the left arm with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 647651/1144N) and then tested immune to mumps on Sept 02 2004. Laboratory evaluation collected on Aug 10 2004 and reported on Sept 03 2004 revealed mumps antibody IgG was 1.12 and the interpretation was positive or immune. No further information is available.
Age: 1.0
Sex: F
Vaccine: MU
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her  daughter who in approximately may 2001, at a little over 1 year of age, was vaccinated with a dose of Mump virus vaccine live (Jeryl Lynn). A couple of hours post vaccination, the patient broke out in hives. The patients mother had called the physicians office at the time of the event, and the patient was treated with an unspecified medication. Subsequently, the patient recovered. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: MU
Symptoms: Parotitis
Clinical narrative: Information has been received from a registered nurse concerning a 34 year old female who at 1 and 5 years of age was vaccinated with mumps virus vaccine live (Jeryl Lynn). In march 2004, the patient experienced parotitis that has not resolved. The patient reportedly has a current mumps IGG of 1.68. Unspecified medical attention. No product quality complaint. Additional information has been received.
Age: 38.0
Sex: F
Vaccine: MU
Symptoms: Fatigue, Headache, Malaise, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Initial and follow up information has been received from a physician concerning a 37 year old white female nurse with no known drug allergies and slight anaemia who on Mar 7 2005 was vaccinated SC with a dose of Mumps virus vaccine live (Jeryl Lynn) (lot 650129/0770P). It was noted that there were no other vaccines administered on that day. On Mar 17 2005 the patient experienced fatigue and general malaise. On Mar 18 2005 the patient saw her doctor and experienced a stiff neck, a severe headache described as felt like it was going to explode and she developed a fever of 101F. There was no illness at the time of vaccination. On Mar 2005 the patient's fever broke. On Mar 21 2005, the patient saw her doctor again. The physician reported that sometime on Mar 21 2005, the patient recovered. Additional information is not expected.
Sex: F
Vaccine: MU
Symptoms: Discomfort, Drug ineffective, Viral infection
Clinical narrative: Information has been received from a pharmacist concerning a female who, at an unknown date in her childhood, was vaccinated with a dose of mumps virus vaccine live (Jeryl Lynn). It was reported that the patient had mumps twice since vaccination with mumps virus vaccine live. The patient was being given pain medication for her discomfort. The patients status was reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: None related to the shots.  Died 04/08/2005, Preliminary cause of death - SIDS. Coroner's report not final. Autopsy report received which stated COD as SIDS.
Age: 0.18
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Lethargy, Oral intake reduced, Pyrexia, Somnolence
Clinical narrative: States that he had a temp of 104 while taking Tylenol on the morning after receiving his immunizations.  States he was lethargic, not eating well, and very sleepy.  Saw pediatrician who instructed mother to give tylenol and motrin alternating.  Fever broke around 24 hrs. after starting.  He returned to normal health.
Age: 1.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Cough, Diarrhoea, Laboratory test abnormal, Pyrexia, Rash
Clinical narrative: Rash beginning on 6/10/05, fever 101.8F beginning 6/11/05, diarrhea, moderate vomiting, coryza, occasional cough.
Age: 1.21
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Rhinitis, Vomiting
Clinical narrative: Rash beginning on 6/10/05, fever 101.8F beginning 6/11/05, diarrhea, moderate vomiting, coryza, occasional cough.
Age: 13.0
Sex: F
Vaccine: HEP, RV
Symptoms: Dry skin, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Approximately 2hrs. after receiving her 2nd HBV and a PPD she broke out in an itchy rash on her face, arms, and front torso...confluent, papular, dry, with some hive-like raised areas. She has no history of any allergic reactions and was well on the day of the vaccinations. PPd was positive in 2 days...referred to PHD for followup.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Abdominal pain, Depressed level of consciousness, Irritability, Pyrexia, Screaming
Clinical narrative: During a recall phone call, Mother stated infant was sleepy, irritable, and difficult to arouse for a couple of days after 1st set of immunizations on 02/09/2005. No follow-up actions taken.  Mom stated after 2nd set of immunizations on 04/21/2005, child vomitted approximately 2 hours after shots and "screamed and irritable for 3 days like colic". Otherwise child is a very content, happy baby per mom. Difficult to console with low-grade temp. (<101 degrees F). Mom gave Tylenol to child and she was still irritable. Child has recovered per mom. Instructed to consult with child's doctor for following immunizations.
Age: 0.37
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Somnolence, Vomiting
Clinical narrative: During a recall phone call, Mother stated infant was sleepy, irritable, and difficult to arouse for a couple of days after 1st set of immunizations on 02/09/2005. No follow-up actions taken.  Mom stated after 2nd set of immunizations on 04/21/2005, child vomitted approximately 2 hours after shots and "screamed and irritable for 3 days like colic". Otherwise child is a very content, happy baby per mom. Difficult to console with low-grade temp. (<101 degrees F). Mom gave Tylenol to child and she was still irritable. Child has recovered per mom. Instructed to consult with child's doctor for following immunizations.
Age: 1.1
Sex: F
Vaccine: MMR
Symptoms: Encephalitis, Lethargy, Pyrexia, Rash
Clinical narrative: Child began with rash 3 days post MMR vaccination.  Mom took to Dr. who associated rash with vaccine.  Mom took child home, rash worsened and acquired fever of 103 degrees F, responsive but lethargic.  Admitted to hospital.  Child quarantined with rash and encephalitis per mom. Hospitalized for approximately 2 days.
Age: 31.0
Sex: M
Vaccine: SMALL
Symptoms: Infection transmission via personal contact, Lymphadenopathy
Clinical narrative: Patients Daughter hugged patient on Sept. 24th 2005 and put right index finger on uncovered smallpox vaccination site.  Patient's daughter presented to clinic today 4 October 2005 with two lesions on right index finger.  Patients daughter also had swollen lymph gland left axillary.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Somnolence, Speech disorder
Clinical narrative: Mother noticed that patient was very sleepy for 24 hours after vaccine administration, as she was after her 2 month immunizations. After that, parents and daycare worker noticed a significant decrease in patient's spontaneous verbalizations, which had been fairly good. This lasted about one month. Patient now 7 months and verbalizing spontaneously again.
Age: 19.0
Sex: M
Vaccine: MNQ
Symptoms: Grand mal convulsion, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: A grand mal seizure within 24 hours of shot. A warm reddened, sore area the size of a coffee cup still occuring 3 days later.
Age: 12.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Convulsion, Eye movement disorder
Clinical narrative: This case was reported by a physician via a representative and described the occurrence of seizure in a 12 year old female subject who was vaccinated with Boostrix for prophylaxis. Previous and/or concurrent vaccination included hepatitis A vaccine given on 22 September 2005. Concurrent medications included Tuberculin PPD (PPD). On 22 September 2005 the subject received unspecified dose of Boostrix (unknown). On 22 September 2005, immediately following the vaccination with Boostrix, the subject experienced seizure manifested by his eyes rolling back in head and series of convulsions that lasted a couple of minutes. The pt was taken to the hospital but was released. This case was assessed as medically serious (OMIC) by the manufacturer. On 22 September 2005, the event resolved.
Age: 19.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Similar reaction on previous exposure to drug, Syncope, Visual disturbance, Visual field defect
Clinical narrative: Pt fainted after vaccine, anxious. Pt's mother reported gradual loss of peripheral vision on right side. Confirmed by ophthalmology since decreased vision on right started 8/23/05.
Age: 19.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Anxiety, Blood pressure decreased, Dizziness, Heart rate increased, Panic reaction
Clinical narrative: Pt fainted after vaccine, anxious. Pt's mother reported gradual loss of peripheral vision on right side. Confirmed by ophthalmology since decreased vision on right started 8/23/05.
Age: 19.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Paraesthesia, Syncope vasovagal, Tremor, Tunnel vision, Visual acuity reduced
Clinical narrative: Pt fainted after vaccine, anxious. Pt's mother reported gradual loss of peripheral vision on right side. Confirmed by ophthalmology since decreased vision on right started 8/23/05.
Age: 19.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Visual disturbance
Clinical narrative: Pt fainted after vaccine, anxious. Pt's mother reported gradual loss of peripheral vision on right side. Confirmed by ophthalmology since decreased vision on right started 8/23/05.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Arthralgia, Asthenia, Difficulty in walking, Dyspnoea, Fatigue
Clinical narrative: Pt. fatigue, weak, barely could run around during softball game, felt like legs couldn't support her. Complaining of general malaise by night. Possibly took Advil. on 6/19 got bitten by tick and blood tests were done to check for lyme disease by 7/12 started with amoxicillin treatment  but changed to doxycyline by 7/19. Finished treatment by 8/16. All lyme tests have been negative. 7/14 trouble walking, needed assistance to the point of needing crutches. 7/31 felt weak all over, even weak to breathe.  Seen by rheumatologist on 7/29. 8/16 had been feeling well for a couple of days by this time; went to college on 8/20. 8/23 had hard time walking again and got worse to the 25th so pt could barely move, paralytic pain. In September 2005 more joint pain as opposed to before that it was more weakness. As of today has been on Celebrex for 3 weeks. Has ups and downs. Pt currently being treated as if fibromyalgia.  Medic Record rec'd 11/7/05 -- additional med hx - spondylopathy. Information from Follow-up report states: The neurologist just called me back. At this point, he believes that the pt has neither GBS nor lyme. She has complained of pain (everywhere) and weakness (diffuse) for three months (begining 1 mo after Menactra), and he states tht she has "nothing" neurologically. So far, all tests - including physical exam, EMG, and LP - are within normal limits. Most specifically, she has normal strength. He will see her again and will contact me when/if he has any further information.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fibromyalgia, Pain, Paralysis
Clinical narrative: Pt. fatigue, weak, barely could run around during softball game, felt like legs couldn't support her. Complaining of general malaise by night. Possibly took Advil. on 6/19 got bitten by tick and blood tests were done to check for lyme disease by 7/12 started with amoxicillin treatment  but changed to doxycyline by 7/19. Finished treatment by 8/16. All lyme tests have been negative. 7/14 trouble walking, needed assistance to the point of needing crutches. 7/31 felt weak all over, even weak to breathe.  Seen by rheumatologist on 7/29. 8/16 had been feeling well for a couple of days by this time; went to college on 8/20. 8/23 had hard time walking again and got worse to the 25th so pt could barely move, paralytic pain. In September 2005 more joint pain as opposed to before that it was more weakness. As of today has been on Celebrex for 3 weeks. Has ups and downs. Pt currently being treated as if fibromyalgia.  Medic Record rec'd 11/7/05 -- additional med hx - spondylopathy. Information from Follow-up report states: The neurologist just called me back. At this point, he believes that the pt has neither GBS nor lyme. She has complained of pain (everywhere) and weakness (diffuse) for three months (begining 1 mo after Menactra), and he states tht she has "nothing" neurologically. So far, all tests - including physical exam, EMG, and LP - are within normal limits. Most specifically, she has normal strength. He will see her again and will contact me when/if he has any further information.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Fibromyalgia, Gait disturbance, Hypokinesia, Malaise
Clinical narrative: Pt. fatigue, weak, barely could run around during softball game, felt like legs couldn't support her. Complaining of general malaise by night. Possibly took Advil. on 6/19 got bitten by tick and blood tests were done to check for lyme disease by 7/12 started with amoxicillin treatment  but changed to doxycyline by 7/19. Finished treatment by 8/16. All lyme tests have been negative. 7/14 trouble walking, needed assistance to the point of needing crutches. 7/31 felt weak all over, even weak to breathe.  Seen by rheumatologist on 7/29. 8/16 had been feeling well for a couple of days by this time; went to college on 8/20. 8/23 had hard time walking again and got worse to the 25th so pt could barely move, paralytic pain. In September 2005 more joint pain as opposed to before that it was more weakness. As of today has been on Celebrex for 3 weeks. Has ups and downs. Pt currently being treated as if fibromyalgia.  Medic Record rec'd 11/7/05 -- additional med hx - spondylopathy. Information from Follow-up report states: The neurologist just called me back. At this point, he believes that the pt has neither GBS nor lyme. She has complained of pain (everywhere) and weakness (diffuse) for three months (begining 1 mo after Menactra), and he states tht she has "nothing" neurologically. So far, all tests - including physical exam, EMG, and LP - are within normal limits. Most specifically, she has normal strength. He will see her again and will contact me when/if he has any further information.
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Irritability, Pyrexia
Clinical narrative: Mom called 10/4/05 at 2PM. States baby fussy last noc. Fever this morning 100.7 R. States she gave Motrin last noc. Fussy today. Denies redness/knots at injection site.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Chest pain, Cough, Malaise, Myalgia
Clinical narrative: 24 hrs after injection fever, malaise, myalgia, burning sensation in chest, airway swelling and cough non productive, dry, visual disturbance with white strobe light left eye, no sore throat, weakness.
Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Pharyngeal oedema, Pyrexia, Visual disturbance
Clinical narrative: 24 hrs after injection fever, malaise, myalgia, burning sensation in chest, airway swelling and cough non productive, dry, visual disturbance with white strobe light left eye, no sore throat, weakness.
Age: 56.0
Sex: M
Vaccine: TD
Symptoms: Diarrhoea, Injection site erythema, Pyrexia, Tenderness, Vomiting
Clinical narrative: Injection administered on 9/30/05 and pt come in for f/u visit on 10/3/05 stating on Sat 10/1/05 pt had fever, vomiting, diarrhea, redness and tenderness at left deltoid region where tetanus was administered.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Erythema, swelling, firmness around injection site
Age: 19.0
Sex: M
Vaccine: RAB
Symptoms: Face oedema, Rhinitis, Urticaria
Clinical narrative: 20 Minutes after Rabies #3 injection pt had facial swelling, hives, rhinitis, threatening. Benadryl 50mg, PO given, 0.3ml epinephrine IM, O2 and transported to local ER via EMS.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot
Clinical narrative: RUE with 6cm x 8cm erythematous hot nontender rash, no induration.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: Pt had 103 fever for 3 1/2 days controlled with Tylenol. Had rash on face and arms. Really grumpy.
Age: 34.0
Sex: M
Vaccine: MEN
Symptoms: Asthenia, Coordination abnormal, Gait disturbance, Guillain-Barre syndrome, Hypokinesia
Clinical narrative: Initial information received on 26Sept2005.  It was reported that a 34 yr old pt developed Guillian Barre Syndrome after receiving Menomune (lot number, site and route of administration not reported) on 30Nov90. On 12Dec90, the pt developed elevated weakness which began in the feet and moved upwards. The pt was unable to walk and dropped things. The pt had mild upper respiratory infection symptoms one week prior to admission. An IGM on 17Dec90 was abnormal and consistent with Guillain Barre Syndrome. The pt received five plasmapheresis exchanges. No further information reported. No further information expected. Other nine cases received are U200000490, U200000491, 200401816, 200501908, 200501909, 200501910, 200501911, 200501912, 200501913.
Age: 34.0
Sex: M
Vaccine: MEN
Symptoms: Pharyngitis
Clinical narrative: Initial information received on 26Sept2005.  It was reported that a 34 yr old pt developed Guillian Barre Syndrome after receiving Menomune (lot number, site and route of administration not reported) on 30Nov90. On 12Dec90, the pt developed elevated weakness which began in the feet and moved upwards. The pt was unable to walk and dropped things. The pt had mild upper respiratory infection symptoms one week prior to admission. An IGM on 17Dec90 was abnormal and consistent with Guillain Barre Syndrome. The pt received five plasmapheresis exchanges. No further information reported. No further information expected. Other nine cases received are U200000490, U200000491, 200401816, 200501908, 200501909, 200501910, 200501911, 200501912, 200501913.
Age: 20.0
Sex: M
Vaccine: MEN
Symptoms: Asthenia, Guillain-Barre syndrome, Hypokinesia, Pain, Pharyngitis
Clinical narrative: Initial information received on 26Sept05. A 20 yr old pt developed Guillain Barre Syndrome after receiving Menomune (lot number, site and route of administration not reported) on 17May93. On 01Jun93, 15 days post immunization the pt noticed bilateral calf cramping and weakness. The weakness progressed and by 04June93 the pt was unable to walk, had some milder upper extremity weakness. The pt also complained of upper respiratory like symptoms. No further information received. No further information expected. Other nine cases received are U200000490, U200000491, 200401816, 200501908, 200501909, 200501910, 200501911, 200501912, 200501914.
Age: 19.0
Sex: U
Vaccine: MEN
Symptoms: Asthenia, Guillain-Barre syndrome, Hypokinesia
Clinical narrative: Initial information received on 26Sep05. A 19 1/2 yr old pt (gender not reported) developed leg weakness 7 days after receiving Menomune A/C/Y/W-135 vaccine on 05Nov93. The pt received the initial battery of vaccines for recruits. On 12Nov93, the pt developed leg weakness which quickly progressed to the point of being unable to stand. The pt's arms also became weakened. The pt was hospitalized and plasmapheresed. The pt's condition improved greatly and the pt was diagnosed with Guillain Barre syndrome. No further information is expected. Other nine cases received are U200000490, U200000491, 200401816, 200501908, 200501909, 200501910, 200501911, 200501913, 200501914.
Age: 9.0
Sex: U
Vaccine: MEN
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypokinesia, Paraesthesia
Clinical narrative: Initial information received on 26Sept05. A 9 yr old pt (gender not reported) developed Guillain Barre Syndrome following the administration of Menomune A/C/Y/W-135 on 14Mar98. Lot number, route and site of administration was not reported. The pt developed tingling of the arms and legs and had difficulty walking 31 days post immunization. The pt had progressively worsening symmetric paresthesia which began distally and moved peripherally over a 2 wk period. The pt was admitted to the hospital and was diagnosed with Guillian Barre Syndrome. No further information provided. No further information is expected. Other nine cases received are U200000490, U200000491, 200401816, 200501908, 200501909, 200501910, 200501911, 200501913, 200501914.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: I submitted a VAERS report on behalf of our son in 1999, and was contacted by someone from the FDA in 2002, but I have received no followup data that the vaccines reported were subsequently tested for safety. Our son has overlap of 5 vaccine lot numbers with another child with autism (see info listed in question #14) and one overlap with at least 2 other children with autism. Given all of the recent publicity regarding vaccine-related developmental problems in children, I want to know in writing, the findings from your followup to the VAERS report from the FDA, as it relates to the overlap with the other vaccine injured children reported by me. With all of the changes to the FDA, a coverup of some kind appears to be going on as it relates to the safety of vaccines in the past decade. Your response would be greatly appreciated.
Age: 12.0
Sex: U
Vaccine: MEN
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial information received on 26Sept05. A 12 year old pt (gender not reported) experienced Guillain Barre syndrome on 14Jun00, 13 days after receiving Menomune A/C/Y/W-135 vaccine (lot number, route and site of admin not reported) on 01Jun00. The pt was hospitalized. No further information is available. No further information is expected. Other nine cases received are U200000490, U200000491, 200401816, 200501908, 200501909, 200501911, 200501912, 200501913, 200501914.
Age: 56.0
Sex: M
Vaccine: MEN
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Myasthenic syndrome, Paraesthesia
Clinical narrative: Initial information received on 26Sept05. A 56 yr old, male pt, developed numbness and tingling of the hands and feet on 22Jun04, 27 days after receiving Menomune A/C/Y/W-135 vaccine on 26May04 (lot number, route and site of admin not reported). The numbness went to his legs and body and he was unable to stand. On 26Jun04, he went to the ER and they reportedly misdiagnosed him. The pt returned to the hospital on 29Jun04 and was diagnosed with Guillain Barre Syndrome. He was treated with 5 blast IV CG antibody. No further information is expected. Other nine cases received are U200000490, U200000491, 200401816, 200501908, 2005-01910, 200501911, 200501912, 200501913, 200501914.
Age: 36.0
Sex: F
Vaccine: MEN, PPV, MEN
Symptoms: Abasia, Back pain, Coordination abnormal, Guillain-Barre syndrome, Headache
Clinical narrative: Initial information received on 26Sep05. A 36 yr old female pt was diagnosed with Guillian Barre syndrome after receiving Menomune (lot number, site and route of administration not reported) on 30Dec04. The pt also received the pneumococcal vaccination (product and manf not reported) on the same day (lot number, site and route of administration not reported). The pt had received her annual influenzae shot (product and manf not reported) on 10Nov04. Approx 2-3 days following the pneumococcal injection the pt reported a swollen reddened and painful arm. The MD treated her for localized cellulitis. The pt reportedly continued to feel bad and on 22Jan05 began to complain of numbness to her lower extremities and low back pain. The pain and numbness progressed over a five day period to the point to where the pt could not sit, stand or walk. She was seen in the ER on 27Jan05 and was admitted for intractable back pain. Her leg weakness and pain has continued. The pt remains unable to stand or walk and now has a neurogenic bladder requiring catheterization. EMG done on 06Feb05 was indicative of Guillain Barre. Diagnosis was confirmed. As of the time this report was received the pt still was hospitalized, on 09Feb05. No further information expected. Other nine cases received are U200000490, U200000491, 200401816, 200501909, 200501910, 200501911, 200501912, 200501913, 200501914.
Age: 36.0
Sex: F
Vaccine: MEN, PPV, MEN
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Laboratory test abnormal, Neurogenic bladder
Clinical narrative: Initial information received on 26Sep05. A 36 yr old female pt was diagnosed with Guillian Barre syndrome after receiving Menomune (lot number, site and route of administration not reported) on 30Dec04. The pt also received the pneumococcal vaccination (product and manf not reported) on the same day (lot number, site and route of administration not reported). The pt had received her annual influenzae shot (product and manf not reported) on 10Nov04. Approx 2-3 days following the pneumococcal injection the pt reported a swollen reddened and painful arm. The MD treated her for localized cellulitis. The pt reportedly continued to feel bad and on 22Jan05 began to complain of numbness to her lower extremities and low back pain. The pain and numbness progressed over a five day period to the point to where the pt could not sit, stand or walk. She was seen in the ER on 27Jan05 and was admitted for intractable back pain. Her leg weakness and pain has continued. The pt remains unable to stand or walk and now has a neurogenic bladder requiring catheterization. EMG done on 06Feb05 was indicative of Guillain Barre. Diagnosis was confirmed. As of the time this report was received the pt still was hospitalized, on 09Feb05. No further information expected. Other nine cases received are U200000490, U200000491, 200401816, 200501909, 200501910, 200501911, 200501912, 200501913, 200501914.
Age: 36.0
Sex: F
Vaccine: MEN, PPV, MEN
Symptoms: Tachycardia, Visual disturbance
Clinical narrative: Initial information received on 26Sep05. A 36 yr old female pt was diagnosed with Guillian Barre syndrome after receiving Menomune (lot number, site and route of administration not reported) on 30Dec04. The pt also received the pneumococcal vaccination (product and manf not reported) on the same day (lot number, site and route of administration not reported). The pt had received her annual influenzae shot (product and manf not reported) on 10Nov04. Approx 2-3 days following the pneumococcal injection the pt reported a swollen reddened and painful arm. The MD treated her for localized cellulitis. The pt reportedly continued to feel bad and on 22Jan05 began to complain of numbness to her lower extremities and low back pain. The pain and numbness progressed over a five day period to the point to where the pt could not sit, stand or walk. She was seen in the ER on 27Jan05 and was admitted for intractable back pain. Her leg weakness and pain has continued. The pt remains unable to stand or walk and now has a neurogenic bladder requiring catheterization. EMG done on 06Feb05 was indicative of Guillain Barre. Diagnosis was confirmed. As of the time this report was received the pt still was hospitalized, on 09Feb05. No further information expected. Other nine cases received are U200000490, U200000491, 200401816, 200501909, 200501910, 200501911, 200501912, 200501913, 200501914.
Age: 36.0
Sex: F
Vaccine: MEN, PPV, MEN
Symptoms: Asthenia, Back pain, Cellulitis, Difficulty in walking, Guillain-Barre syndrome
Clinical narrative: Initial information received on 26Sep05. A 36 yr old female pt was diagnosed with Guillian Barre syndrome after receiving Menomune (lot number, site and route of administration not reported) on 30Dec04. The pt also received the pneumococcal vaccination (product and manf not reported) on the same day (lot number, site and route of administration not reported). The pt had received her annual influenzae shot (product and manf not reported) on 10Nov04. Approx 2-3 days following the pneumococcal injection the pt reported a swollen reddened and painful arm. The MD treated her for localized cellulitis. The pt reportedly continued to feel bad and on 22Jan05 began to complain of numbness to her lower extremities and low back pain. The pain and numbness progressed over a five day period to the point to where the pt could not sit, stand or walk. She was seen in the ER on 27Jan05 and was admitted for intractable back pain. Her leg weakness and pain has continued. The pt remains unable to stand or walk and now has a neurogenic bladder requiring catheterization. EMG done on 06Feb05 was indicative of Guillain Barre. Diagnosis was confirmed. As of the time this report was received the pt still was hospitalized, on 09Feb05. No further information expected. Other nine cases received are U200000490, U200000491, 200401816, 200501909, 200501910, 200501911, 200501912, 200501913, 200501914.
Age: 36.0
Sex: F
Vaccine: MEN, PPV, MEN
Symptoms: Hypoaesthesia, Hypokinesia, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Initial information received on 26Sep05. A 36 yr old female pt was diagnosed with Guillian Barre syndrome after receiving Menomune (lot number, site and route of administration not reported) on 30Dec04. The pt also received the pneumococcal vaccination (product and manf not reported) on the same day (lot number, site and route of administration not reported). The pt had received her annual influenzae shot (product and manf not reported) on 10Nov04. Approx 2-3 days following the pneumococcal injection the pt reported a swollen reddened and painful arm. The MD treated her for localized cellulitis. The pt reportedly continued to feel bad and on 22Jan05 began to complain of numbness to her lower extremities and low back pain. The pain and numbness progressed over a five day period to the point to where the pt could not sit, stand or walk. She was seen in the ER on 27Jan05 and was admitted for intractable back pain. Her leg weakness and pain has continued. The pt remains unable to stand or walk and now has a neurogenic bladder requiring catheterization. EMG done on 06Feb05 was indicative of Guillain Barre. Diagnosis was confirmed. As of the time this report was received the pt still was hospitalized, on 09Feb05. No further information expected. Other nine cases received are U200000490, U200000491, 200401816, 200501909, 200501910, 200501911, 200501912, 200501913, 200501914.
Age: 36.0
Sex: F
Vaccine: MEN, PPV, MEN
Symptoms: Neurogenic bladder
Clinical narrative: Initial information received on 26Sep05. A 36 yr old female pt was diagnosed with Guillian Barre syndrome after receiving Menomune (lot number, site and route of administration not reported) on 30Dec04. The pt also received the pneumococcal vaccination (product and manf not reported) on the same day (lot number, site and route of administration not reported). The pt had received her annual influenzae shot (product and manf not reported) on 10Nov04. Approx 2-3 days following the pneumococcal injection the pt reported a swollen reddened and painful arm. The MD treated her for localized cellulitis. The pt reportedly continued to feel bad and on 22Jan05 began to complain of numbness to her lower extremities and low back pain. The pain and numbness progressed over a five day period to the point to where the pt could not sit, stand or walk. She was seen in the ER on 27Jan05 and was admitted for intractable back pain. Her leg weakness and pain has continued. The pt remains unable to stand or walk and now has a neurogenic bladder requiring catheterization. EMG done on 06Feb05 was indicative of Guillain Barre. Diagnosis was confirmed. As of the time this report was received the pt still was hospitalized, on 09Feb05. No further information expected. Other nine cases received are U200000490, U200000491, 200401816, 200501909, 200501910, 200501911, 200501912, 200501913, 200501914.
Age: 18.0
Sex: F
Vaccine: TD, TD
Symptoms: Convulsion, Syncope
Clinical narrative: Initial report received from a health care professional on 9/21/05. An 18 year old female patient with a medical history of an amoxicillin allergy, had received an IM injection of TD ADS ADULT, lot U1341AA, in the left deltoid on 9/12/05. Ten seconds post-vaccination, the patient experienced a syncopal reaction, which lasted for ten seconds. The patient recovered for 30 seconds and then had a seizure which lasted for ten seconds. She was taken to an emergency room. She was advised that she had experienced a vagal response, but she is allergic to amoxicillin so therefore allergic to TD. Routine blood work and brain scan were completed, but no results were provided. The patient recovered from these events. (OMIC)
Age: 18.0
Sex: F
Vaccine: TD, TD
Symptoms: Convulsion, Hypersensitivity, Syncope, Syncope vasovagal
Clinical narrative: Initial report received from a health care professional on 9/21/05. An 18 year old female patient with a medical history of an amoxicillin allergy, had received an IM injection of TD ADS ADULT, lot U1341AA, in the left deltoid on 9/12/05. Ten seconds post-vaccination, the patient experienced a syncopal reaction, which lasted for ten seconds. The patient recovered for 30 seconds and then had a seizure which lasted for ten seconds. She was taken to an emergency room. She was advised that she had experienced a vagal response, but she is allergic to amoxicillin so therefore allergic to TD. Routine blood work and brain scan were completed, but no results were provided. The patient recovered from these events. (OMIC)
Age: 0.32
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Pt died less than two hours after vaccine. Tentative diagnosis  - SIDS. Former premature baby with in utero marijuana exposure. Autopsy report rec'd 10/25/2005, box 7 complete., COD stated as SIDS.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Malaise, Myalgia
Clinical narrative: Vaccine on 9/29/05. On 9/30/05 started with body aches, headaches, malaise. Lasted 4 days.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache
Clinical narrative: Severe headache all evening after vaccine
Sex: F
Vaccine: PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer regarding a female patient who experienced autism. The patient received the fifth dose on an unspecified date. Relevant medical history was not provided. The indication for Prevnar was immunization. Product was administered on an unspecified date. The dose regimen was 1 dose. Concomitant medications were not reported. A mother reported that her daughter was administered a fifth dose of Prevnar (overdose) on an unspecified date. Sometime in September 2005, the mother states that her child was diagnosed with autism. No additional information was available at the time of this report.
Sex: M
Vaccine: HIBV, PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection) was received from a consumer regarding a male patient who experienced autism. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Hib titer vaccine was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection). Concomitant medications were not reported. On an unspecified date, the patient was diagnosed with autism. Outcome was unknown. No additional information was available at the time of this report.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Pt rec'd Menactra on 8/8. On to Dr on 9/7/05 c/o weakness and numbness in left hand and both feet. Referred to neurologist. Pt diagnosed with GBS and required hospitalization, date and duration not known by neurologist. Pt recovering at home.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Asthenia, Coordination abnormal, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Pt rec'd Menactra on 8/8. On to Dr on 9/7/05 c/o weakness and numbness in left hand and both feet. Referred to neurologist. Pt diagnosed with GBS and required hospitalization, date and duration not known by neurologist. Pt recovering at home.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hyporeflexia, Myalgia, Polyneuropathy, Sensory disturbance
Clinical narrative: Pt rec'd Menactra on 8/8. On to Dr on 9/7/05 c/o weakness and numbness in left hand and both feet. Referred to neurologist. Pt diagnosed with GBS and required hospitalization, date and duration not known by neurologist. Pt recovering at home.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Angioneurotic oedema, Erythema, Urticaria, Vomiting
Clinical narrative: Approx 20 minutes after vax pts face, hands, feet became red, pt vomited. Pt returned to office and was given Benedryl. Pt continued with hive and therefore was admitted to hospital for observation of angina edema/urticaria. 1/13/06 Review of medical record. Admitting & D/C diagnosis confirmed as angioedema and urticaria.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, MNQ
Symptoms: Medication error
Clinical narrative: Menactra given instead of Prevnar. No adverse reaction and no treatment needed. Child too young for MENACTRA.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, MNQ
Symptoms: Medication error
Clinical narrative: Menactra given instead of Prevnar, no adverse reaction, no treatment needed. Child too young for MENACTRA.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU3, HIBV, MNQ
Symptoms: Medication error
Clinical narrative: Menactra given Pt should have been given Prevnar. No adverse reaction reported. No treatment needed.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient received influenza vaccine at approximately 1:00pm 09/26/2005. She called the clinic 24 hrs later to report a rash on the trunk of her body, under breast and on belly. Rash does not itch. No other symptoms reported. Called 09/29/2005 rash gone.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hypersensitivity
Clinical narrative: 2 x 2" redness at left upper arm occurring 48 hours post immunization, treated with cold compress, Motrin.
Age: 76.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site mass, Pruritus, Skin discolouration
Clinical narrative: !st noticed a lump under her skin at TD injection site (left gluteus) on Saturday morning Oct 1/05. Began itching on Sunday Oct 2, ON examination of site red area 10 cm x 3 cm noted with dark purplish area in center about 1cm in diameter. Non tender to touch but itchy. Induration of 2 cm. Also noted. No other complaint (systemic). Also examined by Dr. Warm compresses at 15 - 20 min intervals. Benadryl PRN itching.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema
Clinical narrative: Localized injection site redness, swelling after immunization left upper arm approx 10cm x 9cm.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Hypersensitivity
Clinical narrative: Redness and warmth of entire deltoid ice and antihistamine started about 4 hrs after injection. First seen 3pm next day.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, PNC
Symptoms: Feeling hot, Hypersensitivity, Injection site induration
Clinical narrative: Red, Warm, mild induration right thigh.
Age: 33.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal distension, Malaise, Muscle spasms, Nausea
Clinical narrative: I had severe camping, with bloating and nausea. I was pretty miserable for several days, but 09/09 abd 09/10 were the worst. Over the counter medications.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Hypersensitivity, Injection site induration, Oedema, Pyrexia
Clinical narrative: Vaccine given approx 11:30am 10/01/2005 mother called Monday to report redness, swelling, induration. Tuesday child developed low grade fever, brought child for visit, Area was 5 1/4 x 7 1/2" erythema, central induration. Rx Augmentin, BID x 10D, Zyrtec 10mg 5days.
Age: 1.52
Sex: M
Vaccine: DTAP, DTP, PNC
Symptoms: Otitis media
Clinical narrative: Had never received the Prevnar vaccination before. He also had never had any ear infections ever. Within the week after receiving the PV shot he developed an ear infection. He had an ear infection for about 3 months straight. Since he had that reaction he has not received this vaccination again, neither has any of my other children. I don't know the lot number of the vacinations. He recieved a DTap/DTP shot on the same day. He had already received the Dtap/DTP 3 previous times with no reactions. Both were shots and both were in his legs/thighs.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Urticaria
Clinical narrative: Evening after shot and day after shot developed hives where pneumonia shot was given and all down arm to elbow.  Also tremendous soreness in arm and feeling like I had a virus.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site abscess, Injection site erythema, Injection site infection, Injection site vesicles, Lymphadenopathy
Clinical narrative: Vaccinated on Thursday 9/29 with IPV in left upper thigh and DTaP in right upper thigh.  By Friday afternoon, 3.5" diameter red bulls eye appeared on top of large welt at DTaP vac. site. The center was blistered and weeping. Covering Ped. MD. had us proceed to Emergency Room, where my son was prescribed Keflex 250mg 4x daily.  Sent home only to return a few hours later because infection had grown to 8" in diameter and leg was severely swollen.  Three red streaks appeared on top left part of welt and were traveling up the leg.  Lymph nodes in groin area were found to be swollen.  My son was hospitalized for 48 hours on IV antibiotics.  He needs to continue antibiotics for 6 more days and is doing much better.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Vaccinated on Thursday 9/29 with IPV in left upper thigh and DTaP in right upper thigh.  By Friday afternoon, 3.5" diameter red bulls eye appeared on top of large welt at DTaP vac. site. The center was blistered and weeping. Covering Ped. MD. had us proceed to Emergency Room, where my son was prescribed Keflex 250mg 4x daily.  Sent home only to return a few hours later because infection had grown to 8" in diameter and leg was severely swollen.  Three red streaks appeared on top left part of welt and were traveling up the leg.  Lymph nodes in groin area were found to be swollen.  My son was hospitalized for 48 hours on IV antibiotics.  He needs to continue antibiotics for 6 more days and is doing much better.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Erythema, Headache, Pain, Pyrexia, Rash pustular
Clinical narrative: Presented on 10/4/05 with reports of red raised lesions to the body. Lesions noted to the R hand, neck, head, and L foot and L knee. Reported elevated temp of 103 2 days ago with headache which he was seen in the local ER for. Reports that pustules are painful. States that small blisters presented last week and that they began rupturing 1-2 days after they developed. Lesions were scraped for culturing. Smallpox vaccination site is 10cm in diameter. There is localized swelling and redness encompassing the vast majority of his upper left arm and down to the elbow area. Placed on quarters til lesions scab over and culture results are in.
Age: 32.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Skin ulcer, Swelling
Clinical narrative: Presented on 10/4/05 with reports of red raised lesions to the body. Lesions noted to the R hand, neck, head, and L foot and L knee. Reported elevated temp of 103 2 days ago with headache which he was seen in the local ER for. Reports that pustules are painful. States that small blisters presented last week and that they began rupturing 1-2 days after they developed. Lesions were scraped for culturing. Smallpox vaccination site is 10cm in diameter. There is localized swelling and redness encompassing the vast majority of his upper left arm and down to the elbow area. Placed on quarters til lesions scab over and culture results are in.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Urticaria
Clinical narrative: Generalized urticaria approximately 6 hours after administration.  no respiratory difficulties.
Age: 1.01
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Irritability, Lethargy, Pyrexia, Vomiting
Clinical narrative: August 17, 2005 Vaccinations given. @ 3:30 pm August 22, 2005 102.5 fever - crabby August 23, 2005 103.0 fever - crabby September 3, 2005 102.0 fever September 4, 103.5 fever, vomiting, very lethargic and distraught. September 5, 2005 104.5 fever, very lethargic and withdrawn September 6, 105.2 fever.  Took her into the doctor and he said it's a reaction to the vaccines, more specifically the MMR.  Her ears where perfect, lungs = perfect, glands = perfect.  Said to wait another day or two and see if the fever goes away, if it DOES, it's the vaccines.  If not, we'll test for a UTI.  The fevers went away the next day.  She returned to her happy, playful self.  * Treatment for fevers: Ibuprofen and Tylenol alternating and that didn't even bring the fever down.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Abnormal sleep-related event, Apnoea, Asphyxia, Cardio-respiratory arrest, Cyanosis
Clinical narrative: Mother put pt to bed the noc of 09/30/05 - went to wake up next morning - baby was blue and no breathing. Records rec'd 11/7/05 - additional term Status Asthmaaticus. ER records received which revealed patient arrived in full arrest & was unable to be resuscitated. Autopsy report received which revealed COD as asphyxia, smothering in face down position on mattress.  Patient was cosleeping w/2 adults & male adult was lying directly on back of patient's head.