chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.55
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Injection site atrophy, Injection site reaction, Skin discolouration
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 6 month old male patient who experienced an area of atrophy at the right thigh injection site and discoloration at injection site. At 6 months of age, the patient received the third dose on 1/17/2005. The patient also received the third dose of Act Hib haemophilus B conjugate vaccine tetanus and the third dose of Daptacel diphtheria and tetanus toxoids and acellular pertussis absorbed and Flovent (fluticasone Propionate). The patient experienced discoloration (injection site discoloration) and an area of atrophy at the right thigh injection site in Jan 2005. The patients parents reported that they initially noticed an area of discoloration a few days post injection and then a depression formed in this area (injection site atrophy). The area appeared as if everything under his skin dissolved and he had a dent under his skin. There was no lasting discomfort in this area. The site of administration for both the Prevnar and the Act Hib was the right thigh. Outcome was unknown. No additional information was available at the time of this report.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site infection, Injection site oedema, Injection site pain, Skin irritation
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding his 24 month old daughter who experienced an injection site infection, tenderness at the injection site, swelling at the injection site, redness at injection site and irritation at the injection site. At 24 months of age, the patient received the fourth dose on 7/13/2005. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 7/13/2005. Dose regimen was 1 dose 1 time per day (intramuscular). the patient was not receiving concomitant therapy. On 7/13/2005, the child developed tenderness (injection site pain), swelling (injection site swelling), redness injection site erythema and irritation at the injection site injection site irritation. Two days later the reporter stated that the symptoms were severe and the patient was seen in an ER. She was diagnosed with an injection site infection and was treated with Amoxil. As of 7/26/2005 the tenderness had not resolved.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Tenderness
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding his 24 month old daughter who experienced an injection site infection, tenderness at the injection site, swelling at the injection site, redness at injection site and irritation at the injection site. At 24 months of age, the patient received the fourth dose on 7/13/2005. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 7/13/2005. Dose regimen was 1 dose 1 time per day (intramuscular). the patient was not receiving concomitant therapy. On 7/13/2005, the child developed tenderness (injection site pain), swelling (injection site swelling), redness injection site erythema and irritation at the injection site injection site irritation. Two days later the reporter stated that the symptoms were severe and the patient was seen in an ER. She was diagnosed with an injection site infection and was treated with Amoxil. As of 7/26/2005 the tenderness had not resolved.
Age: 0.33
Sex: M
Vaccine: HIBV, PNC
Symptoms: Injection site reaction
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3 month old male patient who experienced extreme flushing in the limb where the vaccine was administered. At 3 months of age, the patient received the second dose on 6/21/2005 Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 6/21/2005. Dose regimen was 1 dose intramuscular. Concomitant therapy included Hib titer vaccine (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate) injection). On 6/21/2005, five minutes after the administration of the Prevnar vaccine, the patient experienced extreme flushing of the limb. This event occurred in the same limb as where the Prevnar was administered. The child was taken to the ER. Outcome was unknown. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a patient who received improperly stored vaccine. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was unspecified. Concomitant medications were not reported. The patient received Prevnar that was improperly stored (medication error). The temperature of the refrigerator was noted to be at least 20 degrees F. No additional information was available at the time of this report.
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection)was received from a healthcare professional regarding a 24 month old female patient who experienced warmness, redness and swelling at the injection site. At 24 months of age, the patient received a dose on 3/16/2005. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 3/16/2005. Dose regimen was 1 dose. Patient was not taking concomitant therapy. The patient experienced redness (injection site erythema), swelling, and warmness at the injection site right thigh in Mar 2005. The patient was considered recovered 2005. No additional information was available at the time of this report. The reporter also stated that another patient also received this same lot number and developed the same reaction (see case HQWYE632401APR05).
Age: 2.0
Sex: F
Vaccine: PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received a healthcare professional regarding a 24 month old female patient who experienced warmness, redness and swelling at the injection site, At 24 months of age the patient received a dose on 3/16/2005. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 3/16/2005. Dose regimen was 1 dose. Patient was not taking concomitant therapy. The patient experienced redness (injection site erythema), swelling (injection site swelling) and warmness (injection site warmth) at the injection site (right thigh) in Mar 2005. The patient recovered 2005. No additional information was available at the time of this report. The reporter also stated that another patient also received this same lot number and developed the same reaction (see case HQWYE632101APR05).
Sex: U
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a patient who inadvertently received improperly stored vaccine. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. The patient inadvertently received improperly stored vaccine (medication error) on an unspecified date. The reporter noted that the refrigerator range was between 30 and 34 degrees F on many days between 1/3/2005 and 3/29/2005. The reporter indicated that some children received improperly stored vaccine (medication error) between 1/3/2005 and 3/29/2005 however, the reporter was unable to provide information on the specific patients. Additional reports will be generated when identifying information is provided. No additional information was available at the time of this report.
Sex: U
Vaccine: PNC
Symptoms: Medication error
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a consumer regarding a patient who received all 4 doses of Prevnar before the age of 12 months. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was immunization. Product was administered on an unspecified date. Dose regimen was 1 drop. Concomitant medications were not reported. It was reported that the patient received all 4 doses of Prevnar before the age of 12 months inappropriate schedule of drug administration. The outcome is unknown. It has been determined that HQWYE704728SEP05 is a duplicate report of HQWYE703328SEP05. Therefore, the reports are being consolidated into HQWYE703328SEP05, which will remain the official case of record. No additional information was available at the time of this report.
Age: 50.0
Sex: F
Vaccine: PNC
Symptoms: Eye disorder, Hyperaemia, Medication error, Ocular hyperaemia
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a nurse regarding herself, a 49 year old female who inadvertently splashed Prevnar into her left eye on 2/1/2006. On 2/2/2006, the reporter developed red shot marks in the left eye. The patients concurrent illness included hypertension. Indication for Prevnar was not provided. Product was administered on 2/1/2006. Dose regimen was unknown dose ophthalmic. Concomitant therapy included Lopressor)metoprolol Tartrate). On 2/1/2006, when the nurse attempted to administer Prevnar, the needle dislodged and Prevnar splashed into the left eye (accidental exposure). On 2/2/2006 the reporter developed red shot marks in left eye ocular hyperemia. The nurse reported that her vision had not been affected. As of 2/3/2006, it was unknown if the reporter had recovered from the events. It has been determined that HQWYE708608FEB06, is a duplicate report of HQWYE708608FEB06. Therefore, the reports are being consolidated into HQWYE708608FEB06, which will remain the official case of record. No additional information was available at the time of this report.
Sex: F
Vaccine: PNC
Symptoms: Contusion, Injection site hypersensitivity, Injection site oedema
Clinical narrative: Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 4 year old female patient who experienced injection site swelling, injection site redness and injection site bruising. The patient received a dose in Sept 2005. Relevant medical history was not provided. Indication for Prevenar was immunisation. Product was administered in Sept 2005. Dose regimen was 1 dose 1 time per day intramuscular. Additional suspect medication included DTP vaccine (diphtheria and tetanus toxoids and pertussis). Concomitant medications were not reported. The patient experienced injection site swelling, injection site redness, and injection site bruising (injection site Hemorrhage) in Sep 2005, No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Dyspnoea, Hypersensitivity, Rash maculo-papular
Clinical narrative: Immunizations given and within 20 minutes, turned "red and splotchy all over", and per grandma, was having difficulty breathing. To ER-good respiratory status but pulse ox 90-92% in room. Received Orapred and Racemic aerosol tx-pulse ox 96%. Still with hives/rash and admitted overnight for observation and did well. Presumed allergic reaction 4/28/2006-Discharge summary reviewed-final diagnosis was presumed allergic reaction to immunizations.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Eczema, Eosinophilia, Laboratory test abnormal, Lymphocytosis, Pruritus
Clinical narrative: About 2 weeks after receipt of influenza vaccine in Dec 05, 8 YO male developed mildly pruritic Eczematoid lesions on extremities and trunk similar to reaction in 2004, looking back mother noted that previous reaction was about 3/4 weeks following his last flu vaccine, and lasted about 1 year. See comments for description of previous reaction.
Age: 6.0
Sex: M
Vaccine: FLUX
Symptoms: Skin ulcer, Vaccine positive rechallenge, Volume blood increased
Clinical narrative: About 2 weeks after receipt of influenza vaccine in Dec 05, 8 YO male developed mildly pruritic Eczematoid lesions on extremities and trunk similar to reaction in 2004, looking back mother noted that previous reaction was about 3/4 weeks following his last flu vaccine, and lasted about 1 year. See comments for description of previous reaction.
Age: 35.0
Sex: M
Vaccine: FLU3, SMALL
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis around injection
Age: 28.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Injection site hypersensitivity, Injection site reaction
Clinical narrative: <5mm papule red, umbilicated on both hands. Small pox vaccine auto inoculation no bacterial infection at this point.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Ecchymosis, Epistaxis, Leukocytosis, Melaena, Otitis media
Clinical narrative: Thrombocytopenia presumed DX ITP onset of petechial rash within 24 hours of vaccine admin. Medical records state epistaxis, otitis, melena, ecchymosis, raised skin lesions.msv.  60 day Follow-up Information 06-JUL-2006: Thrombocytopenia resolved after Rx with IVIG.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenia
Clinical narrative: Thrombocytopenia presumed DX ITP onset of petechial rash within 24 hours of vaccine admin. Medical records state epistaxis, otitis, melena, ecchymosis, raised skin lesions.msv.  60 day Follow-up Information 06-JUL-2006: Thrombocytopenia resolved after Rx with IVIG.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Left upper arm pain, swelling, redness. Pain radiating to distal arm, head, fingers. Ice and ibuprofen helped relieve discomfort. Swelling and redness resolved at office visit 4/19 9AM. Still left upper arm soreness but improving.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Laboratory test abnormal, Pyrexia, Rash, Viral infection
Clinical narrative: High fever 106, febrile seizure 9 days after MMR vaccine and Varivax. Rash 4 days after seizure. 4/28/06 Received medical records from hospital where both twins were admitted.  Admit dx: febrile convulsions & r/o sepsis.  Final dx: viral syndrome.  Temp max 105.  Remained afebrile for 24 hrs & was d/c home.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Myalgia
Clinical narrative: C/o arm being swollen, red, achy, warm to touch. Tx: ice, Tylenol prn. Zyrtec 10mg 1 daily x 5 days.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Feeling hot, Injection site erythema, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Pt given immunizations on 4/18/06. Returned to primary care provider with red, raised lump approx 5cm, warm to touch, pt with c/o pain only when touched. Wound was on pt left thigh at site of Pediarix injection.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Pt given immunizations on 4/18/06. Returned to primary care provider with red, raised lump approx 5cm, warm to touch, pt with c/o pain only when touched. Wound was on pt left thigh at site of Pediarix injection.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: Erythema, induration, warmth, non tender, right deltoid area 7x6cm.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness, swelling of left arm.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hyperaemia, Injection site erythema, Injection site oedema
Clinical narrative: Localized erythema, edema, Hyperemia
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular, Skin ulcer
Clinical narrative: Multiple vesicular lesions, some scabbed some fluid filled. Also erythematous papules on trunk, legs and arms.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site hypersensitivity, Rash
Clinical narrative: Rash on abdomen, redness at injection site.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: 5yr old male received 3 vaccines DTaP, IPV, MMR on 4/18/06. Mom noted redness, swelling of left mid thigh to knee that evening. Child seen by Dr on 4/19/06 with DX of local reaction vs cellulitis RX Keflex x 10 days. No fever, minimal tenderness, warmth to touch.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth, Pyrexia
Clinical narrative: Arm red, hot, swollen, fever
Age: 7.0
Sex: F
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site hypersensitivity, Injection site reaction, Injection site warmth
Clinical narrative: Red, Hot 8in in circumference area noted on RAT after vaccination with MMR.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Injection site warmth, Tenderness
Clinical narrative: Pt had large, erythematous area swollen, tender and warm at site of Pediarix injection given 4/18/06. Was given Keflex 4/21/06
Age: 34.0
Sex: F
Vaccine: DTAP
Symptoms: Headache
Clinical narrative: Severe unilateral headache. Necesated ER visit with CT Scan & Spinal Tap.
Age: 3.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, swelling and redness, 2 days after injection. Day 3, 8cm X 7cm area of patchy erythema with minimal swelling on 4/13/06.
Sex: U
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Localized redness, swelling & central area of induration, occurred within 6-8 hrs of the receipt of the injection.
Age: 1.25
Sex: F
Vaccine: DTAP, MMR, PNC
Symptoms: Rash morbilliform
Clinical narrative: Measles-like rash. No other signs or symptoms. No treatment.
Age: 11.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Dizziness, Facial palsy
Clinical narrative: Mother states around 6pm 4/26/06 daughter complained of face looking different.  Right side of face "won't move".  Right eye will not close, right side of lips won't move and she felt dizzy.  To ED 4/26/06 Diagnosis of Bell's Palsy per Mother.  Given prednisone in ED and RX to continued taking as well as Acylovir X 7days per Mom.
Age: 11.0
Sex: F
Vaccine: TDAP, TD
Symptoms: Facial palsy
Clinical narrative: Mother states around 6pm 4/26/06 daughter complained of face looking different.  Right side of face "won't move".  Right eye will not close, right side of lips won't move and she felt dizzy.  To ED 4/26/06 Diagnosis of Bell's Palsy per Mother.  Given prednisone in ED and RX to continued taking as well as Acylovir X 7days per Mom.
Age: 45.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt reported symptoms of pain,tenderness and swelling in left upper arm at injection site.  Pt rated pain at 8/10.  She complained of feeling ill-after resting felt better.  During follow up visit with doctor, her temperature was 97.1 F.  Doctor's impression was that she was having a severe local reaction.  Doctor wrote a prescription for Lortab for pain if needed.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Drug ineffective, Rash
Clinical narrative: Received MMR for a negative Rubella titre on 4/14/06. Reported rash on body on 4/27/06.
Age: 94.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Back pain, Hypokinesia, Nausea, Neck pain, Pain
Clinical narrative: Pt stated she was unable to raise left arm when taking her shirt off and had instant pain over the left anterior portion of her shoulder.  She had immediate nausea and did vomit.  Small movements produced pain at time of follow up visit.  She stated the pain seem to be traveling up her neck and down through her back at times.  She was advised by NP to take Aleve one tab twice daily.  She was also given Darvocet N 100.  Also advised to use Tylenol 2 tabs for breakthrough pain as she needs to.
Age: 94.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Vomiting
Clinical narrative: Pt stated she was unable to raise left arm when taking her shirt off and had instant pain over the left anterior portion of her shoulder.  She had immediate nausea and did vomit.  Small movements produced pain at time of follow up visit.  She stated the pain seem to be traveling up her neck and down through her back at times.  She was advised by NP to take Aleve one tab twice daily.  She was also given Darvocet N 100.  Also advised to use Tylenol 2 tabs for breakthrough pain as she needs to.
Age: 94.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain
Clinical narrative: Pt stated she was unable to raise left arm when taking her shirt off and had instant pain over the left anterior portion of her shoulder.  She had immediate nausea and did vomit.  Small movements produced pain at time of follow up visit.  She stated the pain seem to be traveling up her neck and down through her back at times.  She was advised by NP to take Aleve one tab twice daily.  She was also given Darvocet N 100.  Also advised to use Tylenol 2 tabs for breakthrough pain as she needs to.
Age: 41.0
Sex: F
Vaccine: MMR
Symptoms: Pain, Pain in extremity
Clinical narrative: Vaccinated at 12:50 PM and went home.  Felt pulling at top of right foot.  At approximately 1:40 PM foot started to hurt - took off her shoes and pain (cramplike) started.  Couldn't stand on foot and kneecap triggered pain when trying to standed.  Patient feels achy and foot is  hot to touch.  Patient took Advil at 4:45 PM.  Right arm does not hurt.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Chest discomfort, Rash pruritic, Wheezing
Clinical narrative: 11:45 AM:  Developed itchy rash on R chest, which spread to R neck and both cheeks.  Then chest felt tight, used albuterol inhaler.  Wheezing followed, and patient take to ED.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site warmth, Swelling
Clinical narrative: Swollen Left deltoid area.  Warm to touch.  Symptoms began about 24 hours after vaccination.  Parent applied warm compress to area.  Child playful and denies pain.  Moves arm without complaint.  No fever.  Parent states swelling not getting any worse than yesterday.
Age: 0.58
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Alopecia
Clinical narrative: Alopecia.
Age: 1.5
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Patient had left thigh swelling and redness 24 hours after his DTaP was given there.
Sex: M
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Cognitive disorder, Diabetes mellitus, Dizziness
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. On an unspecified date after vaccination with Lymerix, the subject experienced pain and swelling in his joints. fatigue, thyroid problems, high blood pressure, hyperlipidemia, diabetes, gastrointestinal problems, dizziness memory loss, sleep disturbance, sinus problems, rashes, headache, ear ringing, cognitive problems, neuropathy, tingling, numbness, neurological injuries, autoimmune disease, and decreased activities of life. In addition, the subject suffers from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reported to be caused by vaccination with Lymerix. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Hyperlipidaemia, Hypertension
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. On an unspecified date after vaccination with Lymerix, the subject experienced pain and swelling in his joints. fatigue, thyroid problems, high blood pressure, hyperlipidemia, diabetes, gastrointestinal problems, dizziness memory loss, sleep disturbance, sinus problems, rashes, headache, ear ringing, cognitive problems, neuropathy, tingling, numbness, neurological injuries, autoimmune disease, and decreased activities of life. In addition, the subject suffers from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reported to be caused by vaccination with Lymerix. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Hypoaesthesia, Immune system disorder, Joint swelling, Nervous system disorder, Neuropathy
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. On an unspecified date after vaccination with Lymerix, the subject experienced pain and swelling in his joints. fatigue, thyroid problems, high blood pressure, hyperlipidemia, diabetes, gastrointestinal problems, dizziness memory loss, sleep disturbance, sinus problems, rashes, headache, ear ringing, cognitive problems, neuropathy, tingling, numbness, neurological injuries, autoimmune disease, and decreased activities of life. In addition, the subject suffers from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reported to be caused by vaccination with Lymerix. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Paraesthesia, Rash, Rheumatoid arthritis, Sinusitis, Sleep disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. On an unspecified date after vaccination with Lymerix, the subject experienced pain and swelling in his joints. fatigue, thyroid problems, high blood pressure, hyperlipidemia, diabetes, gastrointestinal problems, dizziness memory loss, sleep disturbance, sinus problems, rashes, headache, ear ringing, cognitive problems, neuropathy, tingling, numbness, neurological injuries, autoimmune disease, and decreased activities of life. In addition, the subject suffers from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reported to be caused by vaccination with Lymerix. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: M
Vaccine: LYME
Symptoms: Thyroid disorder, Tinnitus
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in an adult male subject who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. On an unspecified date after vaccination with Lymerix, the subject experienced pain and swelling in his joints. fatigue, thyroid problems, high blood pressure, hyperlipidemia, diabetes, gastrointestinal problems, dizziness memory loss, sleep disturbance, sinus problems, rashes, headache, ear ringing, cognitive problems, neuropathy, tingling, numbness, neurological injuries, autoimmune disease, and decreased activities of life. In addition, the subject suffers from rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reported to be caused by vaccination with Lymerix. This case was assessed as medically serious by manufacturer (OMIC). At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Amnesia, Arthralgia, Back pain, Balance disorder, Cognitive disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of Bell's palsy in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, Bells palsy, jaw pain, gastrointestinal problems, eye problems, headaches, myalgias, tinnitus, twitching, numbness and tingling, poor balance, night sweats, memory loss ,sinus problems, loss of concentration, rashes, dizziness, shortness of breath, back pain, and rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the out come of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Eye disorder, Facial palsy
Clinical narrative: This case was reported by a lawyer and described the occurrence of Bell's palsy in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, Bells palsy, jaw pain, gastrointestinal problems, eye problems, headaches, myalgias, tinnitus, twitching, numbness and tingling, poor balance, night sweats, memory loss ,sinus problems, loss of concentration, rashes, dizziness, shortness of breath, back pain, and rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the out come of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Hypoaesthesia, Immune system disorder
Clinical narrative: This case was reported by a lawyer and described the occurrence of Bell's palsy in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, Bells palsy, jaw pain, gastrointestinal problems, eye problems, headaches, myalgias, tinnitus, twitching, numbness and tingling, poor balance, night sweats, memory loss ,sinus problems, loss of concentration, rashes, dizziness, shortness of breath, back pain, and rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the out come of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Muscle twitching, Myalgia, Nervous system disorder, Night sweats, Pain in jaw
Clinical narrative: This case was reported by a lawyer and described the occurrence of Bell's palsy in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, Bells palsy, jaw pain, gastrointestinal problems, eye problems, headaches, myalgias, tinnitus, twitching, numbness and tingling, poor balance, night sweats, memory loss ,sinus problems, loss of concentration, rashes, dizziness, shortness of breath, back pain, and rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the out come of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Paraesthesia, Rash, Rheumatoid factor, Sinusitis, Tinnitus
Clinical narrative: This case was reported by a lawyer and described the occurrence of Bell's palsy in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix (unknown). At an unspecified time after vaccination with Lymerix, the subject experienced arthralgias, fatigue, Bells palsy, jaw pain, gastrointestinal problems, eye problems, headaches, myalgias, tinnitus, twitching, numbness and tingling, poor balance, night sweats, memory loss ,sinus problems, loss of concentration, rashes, dizziness, shortness of breath, back pain, and rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. She also experienced decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the out come of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Ageusia, Alopecia, Amnesia, Anosmia, Arthralgia
Clinical narrative: This case was reported by a lawyer and described the occurrence of paralysis in a female subject of unspecified age who was vaccinated with lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, swelling, flu like symptoms, headache, fatigue, rashes, tingling in extremities, memory loss, hair loss, vision problems, lose of taste and smell, bladder disorders, weight loss, paralysis, decreased activities of daily life, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Cognitive disorder, Fatigue, Headache, Immune system disorder, Influenza like illness
Clinical narrative: This case was reported by a lawyer and described the occurrence of paralysis in a female subject of unspecified age who was vaccinated with lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, swelling, flu like symptoms, headache, fatigue, rashes, tingling in extremities, memory loss, hair loss, vision problems, lose of taste and smell, bladder disorders, weight loss, paralysis, decreased activities of daily life, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Nervous system disorder, Oedema, Paraesthesia, Paralysis, Rash
Clinical narrative: This case was reported by a lawyer and described the occurrence of paralysis in a female subject of unspecified age who was vaccinated with lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, swelling, flu like symptoms, headache, fatigue, rashes, tingling in extremities, memory loss, hair loss, vision problems, lose of taste and smell, bladder disorders, weight loss, paralysis, decreased activities of daily life, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: F
Vaccine: LYME
Symptoms: Rheumatoid arthritis, Visual disturbance, Weight decreased
Clinical narrative: This case was reported by a lawyer and described the occurrence of paralysis in a female subject of unspecified age who was vaccinated with lyme disease vaccine recombinant Lymerix for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix unknown. At an unspecified time after vaccination with Lymerix, the subject experienced joint pain, swelling, flu like symptoms, headache, fatigue, rashes, tingling in extremities, memory loss, hair loss, vision problems, lose of taste and smell, bladder disorders, weight loss, paralysis, decreased activities of daily life, rheumatologic, neurologic and or cognitive impairment of an autoimmune, immune mediated, or other mechanism, all reportedly caused by vaccination with Lymerix. At the time of reporting the outcome of the events was unspecified. This case was assessed as medically serious by manufacturer (OMIC). This information was received via a statement of injuries.
Sex: M
Vaccine: HEPAB
Symptoms: Parosmia
Clinical narrative: This case was reported by a consumer and described the occurrence of sensitivity to the smell of plastics in an adult male subject who was vaccinated with Hep-A inactivated and Hep-B recombinant vaccine (Twinrix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the subject received the first dose of Twinrix and flu vaccine. On an unspecified date in the beginning of 3/05, the subject received the 2nd dose of Twinrix (1 ml). On an unspecified date in 3/06, approx. 2 to 3 weeks after vaccination with the 2nd dose of Twinrix, the subject developed a sensitivity to the smell of plastics that seemed to be getting worse. He worked on a computer, and the smell of the plastic of his computer bothered him. He consulted his physician and there had been "discussion" since he was to receive the 3rd dose of Twinrix in June. The subject considered the events to be disabling. At the time of reporting the event was unresolved.
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Muscle twitching
Clinical narrative: Day after Menactra injection-twitching at site of injection-would even wake pt from sleep. Lasted 2 weeks-on or off.
Age: 1.02
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: 20 min. after injection of varicella, L arm has 2" raised red area. Child very fussy. No other hives, no resp. distress. Administered 0.2ml (10mg) Benadryl, IM. Observed for another 45 min.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Rt deltoid w/hard, red and edematous area about 6-8cm round, very tender. Tx: w/Benadryl cream.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster infection in child without history of varicella infection. No other known risk factors.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Tenderness
Clinical narrative: Local reaction pink area extending around all 3 injection sites with some swelling, slight tender around deltoid from.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site hypersensitivity, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: Left arm 5in into 6 inches redness, swelling and increase warmth mildly tender clear margins with injection or left deltoid. Start 3/7/06pm A cellulitis reaction to vaccine.
Age: 7.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Blister, Drug ineffective, Viral infection
Clinical narrative: Pt developed varicella disease after vaccination mild case <30 vesicles.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Large local reaction with DTaP site of 5 1/2 x 6 1/2cm of erythema, warmth, induration.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Indurated erythematous patch over right deltoid 8 to 10 cm non tender.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Laboratory test abnormal, Pain, Rash
Clinical narrative: Started feeling achy all over on 4/24/06 until 04/27/06, when rash appeared took Tylenol for aches.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site pain, Injection site warmth, Irritability
Clinical narrative: Fever 101F x 5 days, lt leg swollen, hot, red and very painful. Started after 3rd day of vaccination given from 4/6/06 to 4/11/06. Very fussy. TX Motrin susp 2ml TID.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever 101F x 5 days, lt leg swollen, hot, red and very painful. Started after 3rd day of vaccination given from 4/6/06 to 4/11/06. Very fussy. TX Motrin susp 2ml TID.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: Left thighs warm, erythema, induration 10cm x 8cm. Ibuprofen and Benadryl prescribed.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site mass
Clinical narrative: Left thighs warm, erythema, induration 10cm x 8cm. Ibuprofen and Benadryl prescribed.
Age: 22.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anaemia, Arthralgia, Cardiomegaly, Fatigue, Haemoptysis
Clinical narrative: Severe pain over entire body;Temperature of 102/103; Swelling and numbness of face,lips;Underwent blood exchange transfusion of 8 units of blood;developed pneumonia in right lung; chest tube inserted to remove fluid.  Muscle pain over back and shoulder, general malaise,face numbness and weakness continues to present;unable to resume normal activities. 60 day Follow-up Information 06-JUL-2006: Patient continues to experience pain in her left arm from the shoulder through the length of her arm. She also complains that her chin is still numb. The numbness has improved - originally her face from the jaws down and inclusive of the chin were numb.
Age: 22.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Laboratory test abnormal, Pain, Pleural effusion, Pulmonary infarction, Pyrexia
Clinical narrative: Severe pain over entire body;Temperature of 102/103; Swelling and numbness of face,lips;Underwent blood exchange transfusion of 8 units of blood;developed pneumonia in right lung; chest tube inserted to remove fluid.  Muscle pain over back and shoulder, general malaise,face numbness and weakness continues to present;unable to resume normal activities. 60 day Follow-up Information 06-JUL-2006: Patient continues to experience pain in her left arm from the shoulder through the length of her arm. She also complains that her chin is still numb. The numbness has improved - originally her face from the jaws down and inclusive of the chin were numb.
Age: 22.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Back pain, Back pain, Body temperature decreased, Hypoaesthesia
Clinical narrative: Severe pain over entire body;Temperature of 102/103; Swelling and numbness of face,lips;Underwent blood exchange transfusion of 8 units of blood;developed pneumonia in right lung; chest tube inserted to remove fluid.  Muscle pain over back and shoulder, general malaise,face numbness and weakness continues to present;unable to resume normal activities. 60 day Follow-up Information 06-JUL-2006: Patient continues to experience pain in her left arm from the shoulder through the length of her arm. She also complains that her chin is still numb. The numbness has improved - originally her face from the jaws down and inclusive of the chin were numb.