chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old male subject who was vaccinated with KINRIX. There were no concomitant medications. Concurrent medical conditions included penicillin allergy. On 13 April 2009 at 16:30 the subject received 1st dose of KINRIX (0.5 ml, intramuscular, left arm). On 15 April 2009, 2 days after vaccination with KINRIX, the subject experienced "palm-sized" injection site redness and injection site pruritus. At the time of reporting the outcome of the events was unspecified. Follow-up received from the events was unspecified . Follow-up received from the healthcare professional 04 May 2009: Previous vaccination included 4 doses of DTAP (unknown manufacturer) administered on unspecified dates. The subject had not experienced adverse events following previous vaccinations. There were no concomitant vaccinations. The onset date of the events was change to 14 April 2009, 1 day after vaccination with KINRIX. The diagnosis was reported as localized reaction to immunization with associated signs/symptoms of injection site redness and injection site pruritus. The subject was seen in the reporters office on 15 April 2009 with "swelling / redness resolving but still evident." The healthcare professional considered it "possible but doubtful" that the events could have been associated with suspected transmission of an infectious agent via a medicinal product, and that the events were not associated with medical history, concurrent illness or erroneous administration. This case was assessed as medically serious by GSK. The subject was treated with Benadryl. On 20 April 2009, the events were resolved. The healthcare professional considered the events possibly related to vaccination with KINRIX. The healthcare professional had reported this case to the Regulatory Agency (reference number not specified).
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Intussusception, Nausea, Pyrexia
Clinical narrative: Child received oral Rotavirus vaccine Jan 30 2009. Had some nausea, vomiting, fever for 24 Hrs then resolved but 5 1/2 wk later developed intussusception requiring surgery on 03-05-09.  6/2/09 additional hospital records, including operative report, received DOS 3/8/09 to 3/13/09. FINAL DIAGNOSIS: Intussusception not reduced with air enema. Post vaccination presents with several day history of vomiting and no stool output. Lethargic. Distended abdomen with palpable mass in the RLQ. Lethargic. Ileocolic intussusception surgically reduced. ICD-9 Codes: 560.0 Intussusception of Intestine, 27651 Dehydration, 46.82 Intra-abdominal manipulation of large intestine, 47.19 Incidental Appendectomy NEC.  5/21/09 Received ER medical records of 3/7 & 3/8/2009. FINAL DX: voomiting w/dehydration Records reveal patient had vomiting, decreased oral intake, decreased urine output, decreased activity, listless, sleepiness, nasal discharge/congestion x 1 day when seen 3/7.  Tx w/IVF & antiemetic.  Improved & d/c to home.  Vomiting continued, developed projectile vomiting, lethargy & returned to ER on 3/8 FINAL DX: vomiting w/mod dehydration & volume depletion Tx w/antiemetic & IVF.  Improved but transferred to higher level of care.  5/26/09 Received hospital d/c summary of 3/8-3/13/2009. FINAL DX: exp laparotomy for reduction of intussusception; dehydration, resolved. Records reveal patient experienced lethargy, RLQ mass, constipation.  Surgery consult done & taken to OR on 3/9.  Progressed well & d/c to home.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Full blood count, Metabolic function test, Pyrexia, Skin exfoliation
Clinical narrative: Prolonged fever 3/14/09 - 3/18/09 with rash head to toe - rash eventually peeled. Hospitalized after 2 ER visits - had a/c for Kawasaki with cardiology consult.  5/14/09 PCP records received from 3/4/09-5/8/09. Pt did receive Rotavirus vax x 3 doses in 2008. Seen for WCC 3/4/09. Impression: Healthy. LOM. Pus noted behind L TM, otherwise normal exam. Tx with abx. RTO 3/16/09 with c/o rash. Confluent wheal and flare all over. Fussy. Referred to hospital. Cardiology consult 3/19/09 for eval of rash and fever. Dx:  Innocent murmur.  Still's murmur.  Clinical presentation does not appear c/w Kawasaki disease. 5/18/09 MR received for DOS 3/19/09 with D/C DX:  Suspected vaccine reaction.  Possible drug reaction.  Generalized exanthum. Pt admitted for eval of generalized erythematous rash with some dry areas and dry, cracked lips. Not felt to be Kawasaki. D/C for out pt f/u./pc ICD9 782.1 Non-specific skin eruption NEC.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Rash, redness pain, swelling at and around injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Oedema peripheral
Clinical narrative: Small red circle around shot. Now white circle, swollen arm, 6 inches across red circle.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt had localized erythema/ induration on left shoulder after vaccines placed
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Anorexia, Blood test, Computerised tomogram, Dizziness, Laboratory test
Clinical narrative: Shaky No appetite Tremors Loss of mobility Dizzy Weight loss.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging, Tremor, Weight decreased, X-ray
Clinical narrative: Shaky No appetite Tremors Loss of mobility Dizzy Weight loss.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Nausea, Pain
Clinical narrative: Pt was given shots on 5-1-09.  45 mins after shots started fever, body aches, nausea, on sat started reaction around shot area red, very itchy hot to touch still vomiting and body aches, on 5-5-09 still has body aches, very itchy at site of shots.
Age: 35.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt was given shots on 5-1-09.  45 mins after shots started fever, body aches, nausea, on sat started reaction around shot area red, very itchy hot to touch still vomiting and body aches, on 5-5-09 still has body aches, very itchy at site of shots.
Age: 1.6
Sex: M
Vaccine: HEPA
Symptoms: Blister, Erythema
Clinical narrative: See accompanying note.
Age: 0.6
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Crying uncontrollably for 5 days after shots given.
Age: 5.0
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella vaccine breakthrough diagnosed by Dr in our office on 5-1-09. Had VARIVAX X 2. Sibling also has varicella.
Age: 9.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella Vaccine Breakthrough. Diagnosed in office by Dr. on 5-1-09. Had 30 lesions. VARIVAX X 2.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Abnormal behaviour, Decreased appetite, Irritability, Somnolence
Clinical narrative: Behavior change.  Sleepy day after vaccines.  A few days later, more resistant behavior in this easy going toddler- irritable, clingy, decrease appetite, finicky - no fever or rash.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mother states pt has red, swollen, itchy area where shot was given. Left arm, 1/2 dollar size.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash pruritic
Clinical narrative: 12 mo received immunizations (Preona #4 Hep A + VARIVAX) then developed raised red itchy rash 5/7/09. No fever, illness or fussiness.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Lethargy, Moaning, Pyrexia
Clinical narrative: Patient was lethargic moaned and maintain a fever in excess of 103 degrees for six hours.  Unable to fully wake up.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy to vaccine, Dyspnoea, Pruritus, Urticaria, X-ray with contrast upper gastrointestinal tract
Clinical narrative: We gave him a shot by annual check up.  And he had UGI.  90 minutes later after shot he start having hives, itchy, slight dyspnea.  We brought him back to our office.  Start O2 2l and call 911 to send him ER.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local, allergic reaction, rt arm redness, & swelling
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Swelling face, Urticaria
Clinical narrative: Hives with sig. facial swelling Benadryl + Epinephrine given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: L deltoid redness and hardness pt. denied any pain except when someone touches with hand. Mom noticed 48 hours after immunizations treatment - cold compress, Motrin + Benadryl.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Breath sounds abnormal, Grunting, Irritability, Pyrexia
Clinical narrative: Client received vaccinations @ approximately 2 PM 5/7/09 fussy @ 5 PM 8-9 Developed fever 104.0 F even with TYLENOL every  4 hrs @ 1 am fa got Ibuprofen & gave had front fan & cool wet towels under arm pits.  Child was fussy but no high pitch persistent cry.  Grunty noise this am has rattley respiration child has reactive airway disease referred to local physician low grade temp 5/8/09 Also seen by local physician who felt it was a normal reaction.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Both thighs red, swollen, hot to touch, tender.  Rt thigh 2 hrs 6 x 10cm, Lt thigh 8 x 12 cm.  Started with redness + swelling -> dramatically worsening in 48 hrs period, double in size on 5/6/09.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: c/o dizziness-instructed to lay down waited for 15 min and sat up slowly.  No further problems.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Heart rate increased
Clinical narrative: swollen lymph nodes @ neck, rapid heart rate dizziness, weakness, headache, shake, nervious feeling feeling, nausea, rash, body aches, tiredness.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Nausea, Nervousness, Pain, Rash
Clinical narrative: swollen lymph nodes @ neck, rapid heart rate dizziness, weakness, headache, shake, nervious feeling feeling, nausea, rash, body aches, tiredness.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Tremor
Clinical narrative: swollen lymph nodes @ neck, rapid heart rate dizziness, weakness, headache, shake, nervious feeling feeling, nausea, rash, body aches, tiredness.
Age: 2.0
Sex: F
Vaccine: MMR
Symptoms: Irritability, Rash generalised, Urticaria
Clinical narrative: 48 hours after receiving MMR she broke into a rash all over body with hives.  She was extremely fussy and miserable for the next 48 hrs No treatment
Age: 1.1
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever started 6 days after vaccines - lasted 3 days; Temp 104.8 degrees no other symptoms but of above from mother
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Irritability, Pyrexia, Rash, Rash erythematous, Rash macular
Clinical narrative: 4/28/09 fever 102 degrees - 103 degrees axillary, cranky saw Dr (PMD)  5/01/09 Rash face, neck, chest, underarms, abdomen & back - progressed thru day red & blotchy.  On 5/2/09 face swollen.  Called PMD advised BENADRYL.  Rash remains on back & abdomen but has improved.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Swelling face
Clinical narrative: 4/28/09 fever 102 degrees - 103 degrees axillary, cranky saw Dr (PMD)  5/01/09 Rash face, neck, chest, underarms, abdomen & back - progressed thru day red & blotchy.  On 5/2/09 face swollen.  Called PMD advised BENADRYL.  Rash remains on back & abdomen but has improved.
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Varicella vaccine break through. Diagnosed in office by Dr with varicella on 4-28-09. Had 7 lesions. No fever. Had VARIVAX x 2.
Age: 0.8
Sex: F
Vaccine: HEP, IPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme- started 5/2/09. Thought to be hives- nuclear by E multiforme on 5/4/09. BENADRYL tried w/o relief.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever 103
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Anorexia, Blood test normal, Culture throat negative, Flushing, Headache
Clinical narrative: Initial report received on 02 April 2009 from a physician.  A 16 year old female patient, with no medical history, received the following vaccines in the left deltoid on 06 March 2009;  an intramuscular injection of MENACTRA (lot number U2730AA), a subcutaneous injection of VARIVAX (Merck, lot number 1143X), and an intramuscular injection of BOOSTRIX (GSK, lot number AC52B030AA).  The patient had received no other vaccines within the four weeks prior.  On 08 March 2009, two days after vaccination, the patient developed a fever (101.3 oral), body aches, a severe headache, malaise, anorexia, and a rash on the upper extremities.  The rash was lacy in appearance and her face was flushed.  The patient was seen in the ER and received a prescription for AMOXICILLIN.  She was seen again in the ER, on an unspecified date; AMOXICILLIN was stopped and ZITHROMAX was prescribed.  On unspecified dates, the patient had the following tests:  viral and throat cultures, which were negative and blood work-up which was within normal limits.  The patient was reported to have recovered on an unspecified date.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Malaise, Pain, Pyrexia, Rash, Viral test negative
Clinical narrative: Initial report received on 02 April 2009 from a physician.  A 16 year old female patient, with no medical history, received the following vaccines in the left deltoid on 06 March 2009;  an intramuscular injection of MENACTRA (lot number U2730AA), a subcutaneous injection of VARIVAX (Merck, lot number 1143X), and an intramuscular injection of BOOSTRIX (GSK, lot number AC52B030AA).  The patient had received no other vaccines within the four weeks prior.  On 08 March 2009, two days after vaccination, the patient developed a fever (101.3 oral), body aches, a severe headache, malaise, anorexia, and a rash on the upper extremities.  The rash was lacy in appearance and her face was flushed.  The patient was seen in the ER and received a prescription for AMOXICILLIN.  She was seen again in the ER, on an unspecified date; AMOXICILLIN was stopped and ZITHROMAX was prescribed.  On unspecified dates, the patient had the following tests:  viral and throat cultures, which were negative and blood work-up which was within normal limits.  The patient was reported to have recovered on an unspecified date.
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Headache, Injection site pain
Clinical narrative: Woke up with Very sore arm (painful to touch in shot area), a general headache (which I normally do not get), and achiness all over. I had received the shot less than 24-hours before.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Febrile convulsion, Otitis media
Clinical narrative: Febrile Seizure lasted 60 seconds self-resolved,seen in ED dxed with Bilateral Otitis Media treated with Amoxicillin
Age: 47.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Activities of daily living impaired, Arthralgia, Depressive symptom, Gait disturbance, General physical health deterioration
Clinical narrative: I'm currently serving my 4th deployment since 2003.  I received 6 doses of the Anthrax vaccination between December 2003 and April 1st, 2009.  I never really had serious side effects from these vaccines until I received my 6th dose, last month, approximately 40 days ago.  I was very active, working out 2 1/2 hours a day, mixing 1 1/2 hours of cardio with 1 hour of weight lifting 6 days a week.  I am 48 years old and was bench pressing 350 lbs in March, 2009 and could do sets of 225 lbs for 15-20 reps.  After this last Anthrax dose on April 1st, 2009, I have severe joint pain in my shoulders and hips.  My condition is getting worse and I have been ordered to stop working out for 2 weeks now.  My doctor ordered blood tests to check for abnormalities.  My 1st ESR test, Sedimentation Rate, was (47), <22 is normal, 2 weeks later I was tested again, without working out for a week and my ESR Sed Rate hit 68, 3 times the normal range.  My condition seems to be steadily degenerating and I am being routinely medevac'd next week for tests.  My blood tests results are indicating possible Rheumatoid Arthritis.  2 years ago I ran the Marathon, I could regularly log 10-12 mile runs and I won several bench press competitions.  Right now, I would have trouble running 100 yards and 95 pounds on the bench sends nerve pains shooting through my body.  My hip joints stiffen significantly after sitting for any amount of time, especially while driving and I have to limp, with a crazy gait, for about a minute before my hips loosen up.  I have a physically demanding job as a Protective Services Officer and frequently carry 100 lbs. of protective gear, weapons and ammo on missions.  I have to rely on Motrin or Naproxen to make it through flights, convoys and VIP patrols.  I can't say for sure if my symptoms were caused by my 6th Anthrax shot but I truly believe this last vaccine I received on April 1st, 2009 has contributed to disabling me.  At night, I can't roll over on my shoulders, tucking in my tee shirt in the back is impossible and raising my arms over my head makes me grimace.  I have always been very active and it is depressing to all of a sudden have debilitating sore joints.  I'll be tested next week, so maybe some light will be shed on what's going on.  I have 20 years of military service under my belt and just reenlisted, last week for 2 more years.  It kills me to not be able to do my job affectively.
Age: 47.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Joint range of motion decreased, Joint stiffness, Musculoskeletal pain, Neuralgia, Red blood cell sedimentation rate increased
Clinical narrative: I'm currently serving my 4th deployment since 2003.  I received 6 doses of the Anthrax vaccination between December 2003 and April 1st, 2009.  I never really had serious side effects from these vaccines until I received my 6th dose, last month, approximately 40 days ago.  I was very active, working out 2 1/2 hours a day, mixing 1 1/2 hours of cardio with 1 hour of weight lifting 6 days a week.  I am 48 years old and was bench pressing 350 lbs in March, 2009 and could do sets of 225 lbs for 15-20 reps.  After this last Anthrax dose on April 1st, 2009, I have severe joint pain in my shoulders and hips.  My condition is getting worse and I have been ordered to stop working out for 2 weeks now.  My doctor ordered blood tests to check for abnormalities.  My 1st ESR test, Sedimentation Rate, was (47), <22 is normal, 2 weeks later I was tested again, without working out for a week and my ESR Sed Rate hit 68, 3 times the normal range.  My condition seems to be steadily degenerating and I am being routinely medevac'd next week for tests.  My blood tests results are indicating possible Rheumatoid Arthritis.  2 years ago I ran the Marathon, I could regularly log 10-12 mile runs and I won several bench press competitions.  Right now, I would have trouble running 100 yards and 95 pounds on the bench sends nerve pains shooting through my body.  My hip joints stiffen significantly after sitting for any amount of time, especially while driving and I have to limp, with a crazy gait, for about a minute before my hips loosen up.  I have a physically demanding job as a Protective Services Officer and frequently carry 100 lbs. of protective gear, weapons and ammo on missions.  I have to rely on Motrin or Naproxen to make it through flights, convoys and VIP patrols.  I can't say for sure if my symptoms were caused by my 6th Anthrax shot but I truly believe this last vaccine I received on April 1st, 2009 has contributed to disabling me.  At night, I can't roll over on my shoulders, tucking in my tee shirt in the back is impossible and raising my arms over my head makes me grimace.  I have always been very active and it is depressing to all of a sudden have debilitating sore joints.  I'll be tested next week, so maybe some light will be shed on what's going on.  I have 20 years of military service under my belt and just reenlisted, last week for 2 more years.  It kills me to not be able to do my job affectively.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Arthralgia, Balance disorder, Diarrhoea, Disturbance in attention, Dizziness
Clinical narrative: Starting the day the first dose rabies vaccine was given symptoms included swolen lymph glands, soreness in left arm, dizziness, exaustion, headache and fever. By the next day i had generalized aching in my joints as well as a low grade fever, dizziness and exhaustion that lasted for five days. On the fifth day diareah and vommiting as well as fever, head ache and dizziness that lasted for 48 hrs. Nine days after the first dose I was starting to feel better and was told I had to take the second dose in the series. By the afternoon of the second dose I was again struck with headache, fever, dizziness, exhaustion and swolen lymph glands. Two days after the second dose I wole up and was extremely jittery, had trouble concentrating on conversations, headache dizziness and an uncontrollable muscle twitch in my forehead as well as nystagnus or uncontrolled wtitching of the eyes. At about 3:30 that afternoon I had the first of two grand mal seizures followed by the second at about 4:15. I was then taken to the emergency room where blood was taken to check my phenobarbital level which came back to be perfectly within theraputic range. My neurologist examined me the following monday morning and checked my blood work. He gave me a clean bill of health but did not want me to take the final shot in the series as he was confident that it was what had caused my breakthrough seizure. My epilepsy has always been very mild and easily controlled by medication, this being the first seizure I've had in many many years. It's been a week and a half since the second dose of the vaccine and I still have a slight bit of dizziness and am a little bit off balance but it seems to be getting beter every day.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Fatigue, Feeling jittery, Grand mal convulsion, Headache, Lymphadenopathy
Clinical narrative: Starting the day the first dose rabies vaccine was given symptoms included swolen lymph glands, soreness in left arm, dizziness, exaustion, headache and fever. By the next day i had generalized aching in my joints as well as a low grade fever, dizziness and exhaustion that lasted for five days. On the fifth day diareah and vommiting as well as fever, head ache and dizziness that lasted for 48 hrs. Nine days after the first dose I was starting to feel better and was told I had to take the second dose in the series. By the afternoon of the second dose I was again struck with headache, fever, dizziness, exhaustion and swolen lymph glands. Two days after the second dose I wole up and was extremely jittery, had trouble concentrating on conversations, headache dizziness and an uncontrollable muscle twitch in my forehead as well as nystagnus or uncontrolled wtitching of the eyes. At about 3:30 that afternoon I had the first of two grand mal seizures followed by the second at about 4:15. I was then taken to the emergency room where blood was taken to check my phenobarbital level which came back to be perfectly within theraputic range. My neurologist examined me the following monday morning and checked my blood work. He gave me a clean bill of health but did not want me to take the final shot in the series as he was confident that it was what had caused my breakthrough seizure. My epilepsy has always been very mild and easily controlled by medication, this being the first seizure I've had in many many years. It's been a week and a half since the second dose of the vaccine and I still have a slight bit of dizziness and am a little bit off balance but it seems to be getting beter every day.
Age: 36.0
Sex: F
Vaccine: RAB
Symptoms: Muscle twitching, Nystagmus, Pain, Pyrexia
Clinical narrative: Starting the day the first dose rabies vaccine was given symptoms included swolen lymph glands, soreness in left arm, dizziness, exaustion, headache and fever. By the next day i had generalized aching in my joints as well as a low grade fever, dizziness and exhaustion that lasted for five days. On the fifth day diareah and vommiting as well as fever, head ache and dizziness that lasted for 48 hrs. Nine days after the first dose I was starting to feel better and was told I had to take the second dose in the series. By the afternoon of the second dose I was again struck with headache, fever, dizziness, exhaustion and swolen lymph glands. Two days after the second dose I wole up and was extremely jittery, had trouble concentrating on conversations, headache dizziness and an uncontrollable muscle twitch in my forehead as well as nystagnus or uncontrolled wtitching of the eyes. At about 3:30 that afternoon I had the first of two grand mal seizures followed by the second at about 4:15. I was then taken to the emergency room where blood was taken to check my phenobarbital level which came back to be perfectly within theraputic range. My neurologist examined me the following monday morning and checked my blood work. He gave me a clean bill of health but did not want me to take the final shot in the series as he was confident that it was what had caused my breakthrough seizure. My epilepsy has always been very mild and easily controlled by medication, this being the first seizure I've had in many many years. It's been a week and a half since the second dose of the vaccine and I still have a slight bit of dizziness and am a little bit off balance but it seems to be getting beter every day.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, HIBV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: right deltoid with induration, mild erythema, slight itching.
Age: 65.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Influenza like illness, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: My arms swelled up to double its size and was very hot and painful. I couldn't lift my arm for two days. The day after the vaccination I developed flu like symptoms and was sick for two days. Today, four days after the vaccination, my arm is still a bit swolen and sore. I had the same vaccination 5 years ago when I was 60 and did not suffer like this.
Age: 65.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Blood test, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: My arms swelled up to double its size and was very hot and painful. I couldn't lift my arm for two days. The day after the vaccination I developed flu like symptoms and was sick for two days. Today, four days after the vaccination, my arm is still a bit swolen and sore. I had the same vaccination 5 years ago when I was 60 and did not suffer like this.
Age: 65.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: My arms swelled up to double its size and was very hot and painful. I couldn't lift my arm for two days. The day after the vaccination I developed flu like symptoms and was sick for two days. Today, four days after the vaccination, my arm is still a bit swolen and sore. I had the same vaccination 5 years ago when I was 60 and did not suffer like this.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Abdominal X-ray, Enema administration, Intussusception, Irritability, Listless
Clinical narrative: Information has been received from a physician concerning a 6 month old female who with no known allergies on 07-APR-2009 was vaccinated with her third dose of ROTATEQ (lot number 662953/1652X) 2ml oral. On 12-APR-2009 the patient experienced intussusception, vomiting and a runny nose and was hospitalized. Surgery was also performed during hospitalization. Subsequently, the patient recovered from intussusception and a runny nose on an unspecified date. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Ultrasound abdomen abnormal, Vomiting, X-ray abnormal
Clinical narrative: Information has been received from a physician concerning a 6 month old female who with no known allergies on 07-APR-2009 was vaccinated with her third dose of ROTATEQ (lot number 662953/1652X) 2ml oral. On 12-APR-2009 the patient experienced intussusception, vomiting and a runny nose and was hospitalized. Surgery was also performed during hospitalization. Subsequently, the patient recovered from intussusception and a runny nose on an unspecified date. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5, RV5
Symptoms: Intussusception, Rhinorrhoea, Surgery, Vomiting
Clinical narrative: Information has been received from a physician concerning a 6 month old female who with no known allergies on 07-APR-2009 was vaccinated with her third dose of ROTATEQ (lot number 662953/1652X) 2ml oral. On 12-APR-2009 the patient experienced intussusception, vomiting and a runny nose and was hospitalized. Surgery was also performed during hospitalization. Subsequently, the patient recovered from intussusception and a runny nose on an unspecified date. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Computerised tomogram, Convulsion, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who was vaccinated with all three doses of GARDASIL (lot # not provided). On 11-APR-2009 the patient experienced seizures and was hospitalized from 11-APR-2009 to 15-APR-2009. The patient was readmitted from 23-APR-2009 to 25-APR-2009. The patient was readmitted again on 04-MAY-2009 and currently the patient was in ICU. The patient had sought unspecified medical attention. At the time of reporting, the patient's seizures persisted. Upon internal review, the patient's seizures was considered to be other important medical event. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Intensive care, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter who was vaccinated with all three doses of GARDASIL (lot # not provided). On 11-APR-2009 the patient experienced seizures and was hospitalized from 11-APR-2009 to 15-APR-2009. The patient was readmitted from 23-APR-2009 to 25-APR-2009. The patient was readmitted again on 04-MAY-2009 and currently the patient was in ICU. The patient had sought unspecified medical attention. At the time of reporting, the patient's seizures persisted. Upon internal review, the patient's seizures was considered to be other important medical event. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: 6cm x 7cm area of erythema with slight induration, minimally tender.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Convulsion, Diarrhoea, Electroencephalogram, Gastrooesophageal reflux disease
Clinical narrative: Information has been received from a consumer concerning her son who on an unspecified date was vaccinated with the first dose of MMRII (lot not reported). In approximately April 2008, when the patient was 26 months old, the patient was diagnosed with autism. The reporter added that in January 2009, the patient was diagnosed with seizures, and he has been having diarrhea issues and acid reflux too. The patient underwent a 2 day electroencephalography EEG (results not reported). Upon internal review autism and seizures were considered as Other Important Medical event. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Activities of daily living impaired, Bedridden, Chest pain, Decreased activity, Gastric disorder
Clinical narrative: Initial and follow-up information has been received from a consumer concerning a 13 year old female with no pertinent medical history and no drug reactions/allergies who on 13-MAR-2008, 23-MAY-2008 and 26-SEP-2008 was vaccinated with the first, second and third dose of GARDASIL respectively (lot # 659182/1757U, 660391/0063X and 659184/0843X), injection. Concomitant therapy included ibuprofen and AMITRIPTYLIN. In September 2008, the mother stated her daughter experienced chest pain, fever, nausea, muscle stiffness, headaches, stomach problem, and when she was not really feeling well in her pupils became "dilated", while on GARDASIL. She did not go to school and was not active because she could not even get out of bed. The patient had had chest X-rays, EEG'S, CAT Scans, sleep studies, and blood work done which all came back negative. The consumer also reported that the patient was an avid dancer before getting GARDASIL and she could not even get out of bed, "I had taken her to specialist and other physicians and no one can figure out what is wrong". The patient's outcome was not recovered. On unspecified date, the patient sought unspecified medical attention. The nurse stated that the patient's mother consented to come to the office to sign the Consent for the Release of Medical Information concerning the patient, and she would call back when the patient's mother signed the Consent Form about if the patient was able to attend school. Upon internal review she doesn't go to school and isn't active because she can't even get out of bed was considered to be disabling. This is one of several reports concerning the same source. A lot check has been initiated. Additional information has been requested.  5/18/09 Received vaccine & PCP office records of 2/20-3/23/2009. FINAL DX: fatigue syndrome Records reveal patient w/intermittent low grade fever, fatigue, HA, abd pain, chest pain since approx 9/08.  No longer able to participate in dance & missed some days of school.  Referred to Neuro, Cardio & ID.  Seen in ER for passing out.    6/1/09 Neurology consultation records received DOS 4/14/09. FINAL DIAGNOSIS: None provided. Post vaccination: Fevers, injuries, fatigue, headache, migratory aches and pains. Stomach pains, chest pain. Episodes of syncope, fell and hit head on the floor. Dizziness, short of breath, disturbed sleep, snores.  Polysomnogram, 24 hour EEG to be performed. Immunology or infectious disease consult recommended.  7/17/09 Pediatric infectious disease consultant records received DOS 6/25/09. Assessment: Symptoms most likely related to Rheumatological condition. Patient presents with intermittent fever, fatigue, chest pain, abdominal pain, headache and myalgia since Sept. '08 and fainting since March '09. Myalgia of arms and legs. Knee pain. Postural hypotension. Unresponsive during fainting spells. Weight gain.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Headache, Musculoskeletal stiffness, Mydriasis, Nausea, Pyrexia
Clinical narrative: Initial and follow-up information has been received from a consumer concerning a 13 year old female with no pertinent medical history and no drug reactions/allergies who on 13-MAR-2008, 23-MAY-2008 and 26-SEP-2008 was vaccinated with the first, second and third dose of GARDASIL respectively (lot # 659182/1757U, 660391/0063X and 659184/0843X), injection. Concomitant therapy included ibuprofen and AMITRIPTYLIN. In September 2008, the mother stated her daughter experienced chest pain, fever, nausea, muscle stiffness, headaches, stomach problem, and when she was not really feeling well in her pupils became "dilated", while on GARDASIL. She did not go to school and was not active because she could not even get out of bed. The patient had had chest X-rays, EEG'S, CAT Scans, sleep studies, and blood work done which all came back negative. The consumer also reported that the patient was an avid dancer before getting GARDASIL and she could not even get out of bed, "I had taken her to specialist and other physicians and no one can figure out what is wrong". The patient's outcome was not recovered. On unspecified date, the patient sought unspecified medical attention. The nurse stated that the patient's mother consented to come to the office to sign the Consent for the Release of Medical Information concerning the patient, and she would call back when the patient's mother signed the Consent Form about if the patient was able to attend school. Upon internal review she doesn't go to school and isn't active because she can't even get out of bed was considered to be disabling. This is one of several reports concerning the same source. A lot check has been initiated. Additional information has been requested.  5/18/09 Received vaccine & PCP office records of 2/20-3/23/2009. FINAL DX: fatigue syndrome Records reveal patient w/intermittent low grade fever, fatigue, HA, abd pain, chest pain since approx 9/08.  No longer able to participate in dance & missed some days of school.  Referred to Neuro, Cardio & ID.  Seen in ER for passing out.    6/1/09 Neurology consultation records received DOS 4/14/09. FINAL DIAGNOSIS: None provided. Post vaccination: Fevers, injuries, fatigue, headache, migratory aches and pains. Stomach pains, chest pain. Episodes of syncope, fell and hit head on the floor. Dizziness, short of breath, disturbed sleep, snores.  Polysomnogram, 24 hour EEG to be performed. Immunology or infectious disease consult recommended.  7/17/09 Pediatric infectious disease consultant records received DOS 6/25/09. Assessment: Symptoms most likely related to Rheumatological condition. Patient presents with intermittent fever, fatigue, chest pain, abdominal pain, headache and myalgia since Sept. '08 and fainting since March '09. Myalgia of arms and legs. Knee pain. Postural hypotension. Unresponsive during fainting spells. Weight gain.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion induced, Amniocentesis abnormal, Diagnostic procedure, Drug exposure during pregnancy, Foetal disorder
Clinical narrative: Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 21 year old female with CECLOR allergy on 02-OCT-2008 and 01-DEC-2008 was vaccinated with her first (lot number 659184/0843X) and second (lot number 661764/0650X) dose of GARDASIL 0.5ml IM (site not reported) respectively. Subsequently the patient was determined to be pregnant and she established her prenatal care with a physician. The patient's last menstrual period was 01-NOV-2008. The patient's estimated date of delivery was 08-Aug-2009. Testing performed at 15 weeks gestation revealed Trisomy 18 and the patient underwent an elective termination in February 2009. The patient subsequently fully recovered. On 30-APR-2009 the patient was vaccinated with her third dose of GARDASIL 0.5ml IM (lot number 661846/1312X; site not reported). Additional information was received from the registered nurse. The nurse reported that the patient had seen different physicians for obstetrics and for the pregnancy. The patient was not on any other medications during the vaccines, "just the pill". The patient stopped the pill after the first dose and became pregnant after the second dose. A no Cul test revealed a 3.1cm which suggested a congenital anomaly. An amniocentesis was performed on 19-FEB-2009 which revealed Trisomy 18. Elective termination was performed at the end of February 2009. The patient fully recovered and came back in after the pregnancy and finished her third vaccination. Elective termination was considered to be an other important medical event and Trisomy 18 was considered to be a congenital anomaly. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Dizziness, Haemorrhage, Headache
Clinical narrative: Information has been received from a physician's wife concerning her daughter, an 15 year old female who was on unspecified dates vaccinated with two 0.5ml doses of GARDASIL (lot number not reported). Subsequently the patient experienced blue color around mouth, dizziness, headache and bleeding problems. The patient had sought unspecified medical attention. At time of reporting, the patient was not recovered. The patient's blue color around mouth, dizziness, headache and bleeding problems were considered to be immediately life-threatening. The patient's sister also experienced blue color around mouth, dizziness, headache and bleeding problems after vaccination with GARDASIL (MSD WAES 0905USA00188). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Cyanosis, Dizziness, Haemorrhage, Headache
Clinical narrative: Information has been received from a physician's wife concerning her daughter, an 11 year old female who was on unspecified dates vaccinated with two 0.5ml doses of GARDASIL (lot number not reported). Subsequently the patient experienced blue color around mouth, dizziness, headache and bleeding problems. The patient had sought unspecified medical attention. At time of reporting, the patient was not recovered. The patient's blue color around mouth, dizziness, headache and bleeding problems were considered to be immediately life-threatening. The patient's sister also experienced blue color around mouth, dizziness, headache and bleeding problems after vaccination with GARDASIL (MSD WAES0905USA00344). Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Ultrasound scan
Clinical narrative: Information has been received from a nurse practitioner through a pregnancy registry for GARDASIL, concerning a 20-year-old female, with prior history of pregnancy and delivery, who on 31-JUL-2008 received a dose of 0.5 ml GARDASIL (lot # 660557/0072X) via intramuscular route in her deltoid area. Concomitant medication included birth control pill YAZ. It was reported that the patient was pregnant now. She had urine pregnancy test; her last menstrual period was on 12-JUL-2008. Estimated delivery date was 18-APR-2009. The patient sought medical attention at the office. At the time of reporting, no adverse symptom was reported. Follow-up information has been received from a completed questionnaire. The patient had positive PPD skin test as concurrent condition and a history of 1 previous pregnancy with full term delivery. There was neither birth defect nor infant complications in the previous pregnancy. Ultrasounds for pregnancy were performed on 02-OCT-2008 and 11-DEC-2008 with results "12 inch /7 w" and 22" inch/ 17 w", respectively. The patient was on iron TID per day and prenatal vitamins once per day during her pregnancy. On 04-APR-2009, 39 weeks (reported as "2 weeks") from LMP, the patient delivered a normal female infant weighing 7 pounds 8 ounces, with 19.5 inch in length and Apgar score 9/9. The infant had sacral dimple. There were no complications, infections or illnesses during her pregnancy, labor/delivery. The infant had no complications or abnormalities. Upon internal review, sacral dimple was considered to be an event of congenital anomalies. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion threatened, Caesarean section, Drug exposure during pregnancy, Placenta praevia, Pregnancy test positive
Clinical narrative: Information has been received from a licensed practical nurse through a Pregnancy registry concerning an 18 year old female who in June 2007 and August 2007 was vaccinated intramuscularly with a 0.5mL first and second dose of GARDASIL.  The nurse reported that the patient was possibly pregnant when she was vaccinated with the second dose of GARDASIL.  On 24-NOV-2007, a pregnancy test was positive.  Follow up information received from a licensed practical nurse revealed that patient received dose one and two of GARDASIL in June 2007 and August 2007.  There was no third dose in their system so the patient never received it at this facility.  She also reported that there was never a pregnancy test done at this facility until 07-APR-2008.  On this date, the patient had a positive test at the office after having two positive tests at home.  Her LMP was 05-MAR-2008.  On 17-APR-2008, she was seen by OB/GYN group.  It was noted at this visit that it was an unplanned pregnancy that occurred on oral contraceptives.  On 28-APR-2008, she was seen for a threatened abortion.  It was noted that at this visit patient was GRAVIDA 1 Para 0 (G1P0).  An ultrasound was done that showed a viable fetus with an EDD of 02-DEC-2008.  On 21-MAY-2008, a placenta previa was noted.  On 12-NOV-2008, an ultrasound was done for growth and weight.  A male baby weighing 6 pounds and 6 ounces was seen.  On 10-DEC-2008, she delivered a healthy boy via C-section.  She said it looked like the patient was induced but she did not have the exact reason for the C-section.  Apgars were 8 and 9 and mom and baby did great.  The licensed practical nurse indicated that , since no pregnancy test was done in their office prior to April 2008 and it was noted that she was G1P0 at the visit in April 2008 then the originally reported "possible" pregnancy must not have been a true pregnancy.  She stated that if there was a pregnancy that had any problems then it would have been in their system.  Upon internal review, threatened abortion and obstetric complication requiring C-Section were considered to be other important medical events.  No further information is available.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound scan
Clinical narrative: Information has been received from a licensed practical nurse through a Pregnancy registry concerning an 18 year old female who in June 2007 and August 2007 was vaccinated intramuscularly with a 0.5mL first and second dose of GARDASIL.  The nurse reported that the patient was possibly pregnant when she was vaccinated with the second dose of GARDASIL.  On 24-NOV-2007, a pregnancy test was positive.  Follow up information received from a licensed practical nurse revealed that patient received dose one and two of GARDASIL in June 2007 and August 2007.  There was no third dose in their system so the patient never received it at this facility.  She also reported that there was never a pregnancy test done at this facility until 07-APR-2008.  On this date, the patient had a positive test at the office after having two positive tests at home.  Her LMP was 05-MAR-2008.  On 17-APR-2008, she was seen by OB/GYN group.  It was noted at this visit that it was an unplanned pregnancy that occurred on oral contraceptives.  On 28-APR-2008, she was seen for a threatened abortion.  It was noted that at this visit patient was GRAVIDA 1 Para 0 (G1P0).  An ultrasound was done that showed a viable fetus with an EDD of 02-DEC-2008.  On 21-MAY-2008, a placenta previa was noted.  On 12-NOV-2008, an ultrasound was done for growth and weight.  A male baby weighing 6 pounds and 6 ounces was seen.  On 10-DEC-2008, she delivered a healthy boy via C-section.  She said it looked like the patient was induced but she did not have the exact reason for the C-section.  Apgars were 8 and 9 and mom and baby did great.  The licensed practical nurse indicated that , since no pregnancy test was done in their office prior to April 2008 and it was noted that she was G1P0 at the visit in April 2008 then the originally reported "possible" pregnancy must not have been a true pregnancy.  She stated that if there was a pregnancy that had any problems then it would have been in their system.  Upon internal review, threatened abortion and obstetric complication requiring C-Section were considered to be other important medical events.  No further information is available.