chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Activities of daily living impaired, Asthenia, Decreased appetite, Diarrhoea, Disability
Clinical narrative: Initial case received from a consumer, who is also the patient, on 13 August 2010.  A female patient received an injection of MENACTRA (lot number U2990AA) and ADACEL (lot number C3382AA) on 09 August 2010.  The evening of vaccination she woke up cold and shaking violently, and began having diarrhea attacks.  The following day she reported being completely disabled, was unable to get out of bed, unable to eat, and unable to care for her children.  She reported being dizzy, weak, and nauseous, and had a headache.  She later developed a red ring on her arm at the injection site, which was 4.5 inches in diameter, and she observed spasms at the injection site.  Outcome and treatment were not reported.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Feeling cold, Headache, Injection site erythema, Muscle spasms
Clinical narrative: Initial case received from a consumer, who is also the patient, on 13 August 2010.  A female patient received an injection of MENACTRA (lot number U2990AA) and ADACEL (lot number C3382AA) on 09 August 2010.  The evening of vaccination she woke up cold and shaking violently, and began having diarrhea attacks.  The following day she reported being completely disabled, was unable to get out of bed, unable to eat, and unable to care for her children.  She reported being dizzy, weak, and nauseous, and had a headache.  She later developed a red ring on her arm at the injection site, which was 4.5 inches in diameter, and she observed spasms at the injection site.  Outcome and treatment were not reported.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Nausea, Tremor
Clinical narrative: Initial case received from a consumer, who is also the patient, on 13 August 2010.  A female patient received an injection of MENACTRA (lot number U2990AA) and ADACEL (lot number C3382AA) on 09 August 2010.  The evening of vaccination she woke up cold and shaking violently, and began having diarrhea attacks.  The following day she reported being completely disabled, was unable to get out of bed, unable to eat, and unable to care for her children.  She reported being dizzy, weak, and nauseous, and had a headache.  She later developed a red ring on her arm at the injection site, which was 4.5 inches in diameter, and she observed spasms at the injection site.  Outcome and treatment were not reported.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Dizziness, Headache, Pallor, Pyrexia
Clinical narrative: Initial report received from a health care professional on 13 August 2010.  A 15-year-old male patient, with a history of asthma and an allergy to amoxicillin, received (dose 1) on 06 August 2010 a right deltoid intramuscular injection of MENACTRA, lot number U3478AA.  The patient had no illness at the time of vaccination and received no vaccinations within 4 weeks.  On 07 August 2010, he developed fever (no documented temperature), chills, dizziness, pale and headache.  The physician prescribed Advil.  The patient's mother reported that the symptoms resolved in 24 hours.  No relevant diagnostic testing was performed.  The outcome was reported as recovered.  Documents held by sender: None.
Age: 46.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial case received from a consumer, who is also the patient's husband, on 13 August 2010.  The reporter also reported similar events in himself; that information is captured in case number 2010-04381.  A 46-year-old female patient received an intramuscular left deltoid injection of MENACTRA (lot number not reported) on 11 August 2010 for travel purposes.  The patient denied relevant medical history or illness at time of vaccination, and had no known allergies.  One day post-vaccination, on 12 August 2010, the patient complained of a fever, headache, and fatigue.  She also noted redness, swelling, and warmth at the injection site, and complained that her arm was sore.  She was seen by a physician on 14 August 2010 and treated with steroids and antibiotics.  As of 15 August 2010, she reported feeling "better", although her arm was still sore.  Follow-up information was received 31 August 2010 from a health care professional who provided lot numbers for which identified the events experienced by this patient and her husband (captured in case 2010-04381) are in the context of a cluster.  The MENACTRA lot number was U3434AA.  Outcome remained not recovered.  Documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Initial case received from a consumer, who is also the patient's husband, on 13 August 2010.  The reporter also reported similar events in himself; that information is captured in case number 2010-04381.  A 46-year-old female patient received an intramuscular left deltoid injection of MENACTRA (lot number not reported) on 11 August 2010 for travel purposes.  The patient denied relevant medical history or illness at time of vaccination, and had no known allergies.  One day post-vaccination, on 12 August 2010, the patient complained of a fever, headache, and fatigue.  She also noted redness, swelling, and warmth at the injection site, and complained that her arm was sore.  She was seen by a physician on 14 August 2010 and treated with steroids and antibiotics.  As of 15 August 2010, she reported feeling "better", although her arm was still sore.  Follow-up information was received 31 August 2010 from a health care professional who provided lot numbers for which identified the events experienced by this patient and her husband (captured in case 2010-04381) are in the context of a cluster.  The MENACTRA lot number was U3434AA.  Outcome remained not recovered.  Documents held by sender: none.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Migraine, Pyrexia
Clinical narrative: Initial report received on 27 August 2010 from a health care professional.  A 12-year-old female patient had received a second dose of MENACTRA vaccine on 23 August 2010.  It was reported the patient had received the first dose of MENACTRA vaccine on 07 October 2005.  On 24 August 2010, i.e. the following day after receiving the MENACTRA vaccination, the patient started to experience headache and fever.  Two days later, the headaches were of a migraine type nature.  The patient was evaluated by her physician the following day, but it was not reported whether the patient required any treatment.  No relevant diagnostic tests or laboratory data were performed.  The patient had no concurrent illnesses at the time of the vaccination on 23 August 2010, and had no known allergies.  Per the mother of the patient, the patient had experienced headaches prior to receiving the MENACTRA vaccination on 23 August 2010.  The patient's recovery status was not reported.  Documents held by sender:  None.
Age: 42.0
Sex: F
Vaccine: HEPA, IPV, MMR, YF
Symptoms: Discomfort, Erythema, Paraesthesia
Clinical narrative: This case was received from a physician on 06 August 2009.  It was reported as part of a cluster of two patients; information for the other patient is captured in case number 2009-03593.  A 42-year-old female patient, with no past medical history, received the following vaccines on 04 August 2009: IPOL (lot number B0475); a left deltoid, subcutaneous dose of YF VAX (lot number UF645AA); HAVRIX vaccine (GSK, lot number AHAVB302BA); and MMR (Merck, lot number 3055Y).  The patient had previously received oral polio vaccine and MMR as a child.  One day post-vaccination, she experienced diffuse erythema, with generalized discomfort and tingling over her entire body surface.  No additional information was reported.  Documents held by sender:  None.
Age: 40.0
Sex: F
Vaccine: HEPA, IPV, MMR, YF
Symptoms: Discomfort, Erythema, Paraesthesia
Clinical narrative: This case was received from a physician on 06 August 2009. It was reported as part of a cluster of two patients; information for the other patient  is captured in case number 2009-03592. A 40-year-old female patient, with no past medical history, received the following vaccines on 04 August 2009: IPOL (lot number B0475); a left deltoid, subcutaneous dose of YF VAX (lot number UF645AA); Hepatitis A vaccine (GSK, lot number AHAVB302BA); and MMR II (MSD, lot number 3055Y). The patient had previously received oral polio vaccine and MMR as a child. One day post-vaccination, she experienced diffuse erythema, with generalized discomfort and tingling over her entire body surface. No additional information was reported. Documents held by sender: None.
Age: 42.0
Sex: F
Vaccine: IPV
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pruritus, Medication error, Tuberculin test negative
Clinical narrative: Initial case received on 18 January 2010 from a health care professional. A 42 year old female patient received a left forearm intradermal injection of IPOL (lot number D0304-2) on 12 January 2010 instead of TUBERSOL for PPD skin testing. On 13 January the patient experienced "arm itching." She was advised to use a cold compress. The patient was seen in the physician's office two days after administration of IPOL intradermally and continued to experience itching of left forearm and redness of site. No further reactions were reported. The patient's history included hypertension and an allergy to VICODIN. Concomitant medications included Amlodipine Besylate. Follow up information was received on 09 February 2010 from a health care professional. On 01 February 2010 the patient received a dose of PPD in the right forearm (manufacturer and lot not reported). At this time, the patient was seen for follow up and did not have any problems. The results for the PPD test were negative. The patient was reported as recovered. Follow-up information was received on 19 March 2010 from a health care professional. No treatment was required for this patient. The PPD received on 01 February 2010 was TUBERSOL, Lot # C3266AA to the right forearm intradermally. The results read on 04 February 2010 were negative. The patient did not have any symptoms or problems associated. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Adverse event
Clinical narrative: Initial report on 19 March 2010 from a healthcare professional. The report involves a cluster of 2 patients who both received the same vaccine with the same lot number and experienced similar adverse events. The other linked case is 2010-01699.
Age: 29.0
Sex: F
Vaccine: IPV, YF
Symptoms: Back pain, Chest pain, Feeling hot, Headache
Clinical narrative: Initial report was received on 16 April 2010 followed by additional information received on 19 April 2010 from a health care professional. A 29-year-old female patient had received an injection of YF VAX and IPOL (lot numbers, routes and sites of administration not reported) on 02 April 2010 and approximately two weeks later, she complained of lower back pain which radiated to the chest and a severe headache. She also "felt warm to hot at night". According to the reporter, a temperature reading was not obtained. The patient had no concurrent illness at the time of vaccination and her past medical history and usage of concomitant medications were unknown. According to the reporter, the patient called their physician's office to report the symptoms which had just begun, but the patient had not been evaluated by the physician. Recovery status was reported as unknown. Follow-up information was received 21 April 2010 from a health care professional. The lot number for YF VAX was UF629AA and the lot number for IPOL was D0304-2. According to the reporter, the patient's symptoms had subsided. Documents held by sender: None.
Age: 3.0
Sex: M
Vaccine: DT, IPV
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site erythema, Injection site swelling, No reaction on previous exposure to drug
Clinical narrative: Initial report was received on 16 June 2010 from a health care professional. This report involved one patient out of a cluster of two patients who experienced an adverse event after receiving DT ADS PED USP. The adverse event experienced by the second patient has been captured in case number 2010-03424. A 3-year-old male patient had received a third dose intramuscular injection of DT ADS PED USP (site not reported), lot number U2630AA and a dose of IPOL, lot number D0122-2 (route, site and dose number not reported) on 09 June 2010 and immediately after vaccination, the patient developed extensive redness, swelling and discomfort in his entire thigh down to the knee. A few days later, the patient developed a rash on the groin and torso and under his arms. The patient was evaluated by their physician (date and results not reported). The patient had no history of adverse events following prior vaccinations. Outcome was entered as unknown on the VAERS form; however, the reporter stated the symptoms of extensive redness, swelling and discomfort in the entire thigh down to the knee persisted at the time of the report. Documents held by sender: None
Age: 3.0
Sex: M
Vaccine: DT, IPV
Symptoms: Rash
Clinical narrative: Initial report was received on 16 June 2010 from a health care professional. This report involved one patient out of a cluster of two patients who experienced an adverse event after receiving DT ADS PED USP. The adverse event experienced by the second patient has been captured in case number 2010-03424. A 3-year-old male patient had received a third dose intramuscular injection of DT ADS PED USP (site not reported), lot number U2630AA and a dose of IPOL, lot number D0122-2 (route, site and dose number not reported) on 09 June 2010 and immediately after vaccination, the patient developed extensive redness, swelling and discomfort in his entire thigh down to the knee. A few days later, the patient developed a rash on the groin and torso and under his arms. The patient was evaluated by their physician (date and results not reported). The patient had no history of adverse events following prior vaccinations. Outcome was entered as unknown on the VAERS form; however, the reporter stated the symptoms of extensive redness, swelling and discomfort in the entire thigh down to the knee persisted at the time of the report. Documents held by sender: None
Age: 13.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Autopsy, Bacterial infection, Death, Joint sprain, Lumbar puncture abnormal
Clinical narrative: Headache, nausea/vomiting began evening of 2/12/2010. Patient found dead morning of 2/13/2010. Autopsy performed 2/14/2010 - meningococcal disease determined to be COD. Gram negative diplococci observed on brain stem area, petechial rash observed by pathologist.
Age: 13.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Meningitis meningococcal, Meningococcal infection, Polymerase chain reaction
Clinical narrative: Headache, nausea/vomiting began evening of 2/12/2010. Patient found dead morning of 2/13/2010. Autopsy performed 2/14/2010 - meningococcal disease determined to be COD. Gram negative diplococci observed on brain stem area, petechial rash observed by pathologist.
Age: 13.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Autopsy, Death, Headache, Meningococcal infection, Nausea
Clinical narrative: Headache, nausea/vomiting began evening of 2/12/2010. Patient found dead morning of 2/13/2010. Autopsy performed 2/14/2010 - meningococcal disease determined to be COD. Gram negative diplococci observed on brain stem area, petechial rash observed by pathologist.
Age: 13.0
Sex: F
Vaccine: MNQ, HPV4, MNQ
Symptoms: Neisseria test positive, Petechiae, Polymerase chain reaction, Vomiting
Clinical narrative: Headache, nausea/vomiting began evening of 2/12/2010. Patient found dead morning of 2/13/2010. Autopsy performed 2/14/2010 - meningococcal disease determined to be COD. Gram negative diplococci observed on brain stem area, petechial rash observed by pathologist.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1), FLUN3
Symptoms: CSF test abnormal, Cataplexy, HLA marker study positive, Hypersomnia, Immunoglobulin therapy
Clinical narrative: Narcolepsy and cataplexy. Excessive sleepiness and weight gain. Sleeps 18 hours per day. Hospitalized and treated with IVIG. Now on Ritalin. Hospitalized 3/20/10 to 3/25/10.
Age: 3.0
Sex: F
Vaccine: FLU(H1N1), FLUN3
Symptoms: Narcolepsy, Somnolence, Weight increased
Clinical narrative: Narcolepsy and cataplexy. Excessive sleepiness and weight gain. Sleeps 18 hours per day. Hospitalized and treated with IVIG. Now on Ritalin. Hospitalized 3/20/10 to 3/25/10.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Irritability, Pallor, Vomiting
Clinical narrative: pale color, vomiting and irritability
Age: 24.0
Sex: M
Vaccine: ANTH, SMALL, TDAP, TYP
Symptoms: Rash
Clinical narrative: rash on arms and upper back
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Increase hives, redness, swelling bilateral arms/shoulders radiating down arms.  Sites of Menveo and Adacel.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMR, PNC13, VARCEL, DTAPIPV, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen @ injection site.  Right arm swollen from elbow to injection site.  Both arms hard, red, and hot to the touch.  Child taken to ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMR, PNC13, VARCEL, DTAPIPV, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen @ injection site.  Right arm swollen from elbow to injection site.  Both arms hard, red, and hot to the touch.  Child taken to ER.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMR, PNC13, VARCEL, DTAPIPV, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen @ injection site.  Right arm swollen from elbow to injection site.  Both arms hard, red, and hot to the touch.  Child taken to ER & diagnosed w/Cellulitis.  Given Keflex & Motrin.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HIBV, MMR, PNC13, VARCEL, DTAPIPV, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen @ injection site.  Right arm swollen from elbow to injection site.  Both arms hard, red, and hot to the touch.  Child taken to ER & diagnosed w/Cellulitis.  Given Keflex & Motrin.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Convulsion, Dyspnoea, Exaggerated startle response
Clinical narrative: Pt noted by mother to have seizure activity, difficulty breathing.  Did not seek care for this as pt recovered spontaneously.  Developed exaggerated local response the next day and went to ED.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen and red, warm to touch.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness at the injection site and itchy and soreness.
Age: 1.35
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Expired drug administered
Clinical narrative: MMR Expired Vaccined administrated to patient.  MMR 08/25/2010  MMR #1, MMR II, Merck & Co., Lot #: 1011x, Exp 07/15/2010 Dose: 0.5 ml, Route: SC, Site: Left thigh (anterolateral), Education provided, VIS pub date: 03/13/2008,
Age: 0.23
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Irritability, Ultrasound abdomen abnormal
Clinical narrative: Patient started with extreme irritability after receiving her first DAPT-IPV-HIB, PREVNAR, and rotavirus vaccines. Sx's started the night of the administration and had a current jelly stool  the next day - Ultrasound showed intussusception.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy, Carcinoma in situ, Colposcopy, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: HPV (+) Type 16. (-) pap on 6/17/09. (+) pap on 8/6/10 "carcinoma in situ". 8/17 Colposcopy with biopsies. 9/16 Surgery Scheduled.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: HPV (+) Type 16. (-) pap on 6/17/09. (+) pap on 8/6/10 "carcinoma in situ". 8/17 Colposcopy with biopsies. 9/16 Surgery Scheduled.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Biopsy site unspecified abnormal, Carcinoma in situ, Colposcopy abnormal, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: HPV (+) Type 16. (-) pap on 6/17/09. (+) pap on 8/6/10 "carcinoma in situ". 8/17 Colposcopy with biopsies. 9/16 Surgery Scheduled.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Allergy to vaccine, Cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of swelling injection site in an adult male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 30 July 2010 the subject received a dose of BOOSTRIX (unknown route, unknown deltoid). At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling injection site. At the time of reporting the outcome of the event was unspecified. Follow-up received on 27 August 2010 from the reporting healthcare professional: The subject was 30 years-old. On 06 August 2010 the subject received a dose of BOOSTRIX (0.5 ml, left deltoid). On 08 August 2010, approximately 48 hours after vaccination with BOOSTRIX, the subject experienced cellulitis, allergic reaction to vaccine, injection site redness, injection site pain and injection site induration measuring 100mm x 70mm. The healthcare professional reported the diagnosis as cellulitis vs allergic reaction post TDAP immunization in left deltoid. This case was assessed medically serious by GSK. The subject returned to the clinic on 09 August 2010 due to induration and pain at injection site. He was treated with doxycycline, MOTRIN and BENADRYL. On 15 August 2010, the events were resolved. The subject was instructed not to take Tdap again. The healthcare professional did not consider that the events could have been associated with medical history or concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of swelling injection site in an adult male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 30 July 2010 the subject received a dose of BOOSTRIX (unknown route, unknown deltoid). At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling injection site. At the time of reporting the outcome of the event was unspecified. Follow-up received on 27 August 2010 from the reporting healthcare professional: The subject was 30 years-old. On 06 August 2010 the subject received a dose of BOOSTRIX (0.5 ml, left deltoid). On 08 August 2010, approximately 48 hours after vaccination with BOOSTRIX, the subject experienced cellulitis, allergic reaction to vaccine, injection site redness, injection site pain and injection site induration measuring 100mm x 70mm. The healthcare professional reported the diagnosis as cellulitis vs allergic reaction post TDAP immunization in left deltoid. This case was assessed medically serious by GSK. The subject returned to the clinic on 09 August 2010 due to induration and pain at injection site. He was treated with doxycycline, MOTRIN and BENADRYL. On 15 August 2010, the events were resolved. The subject was instructed not to take Tdap again. The healthcare professional did not consider that the events could have been associated with medical history or concurrent illness, lack of efficacy, erroneous administration or suspected transmission of an infectious agent.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Granuloma, Injection site induration, Injection site pain, Pain, Skin ulcer
Clinical narrative: This case was reported by a healthcare professional (the subject) and described the occurrence of indentation at injection site in a 59-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included high blood pressure. Concurrent medications included blood pressure medication (medication for high blood pressure). On 19 November 2008 at approximately 11:30 the subject received unspecified dose of FLULAVAL (.5 ml, unknown route, left deltoid). In April 2009, 5 months after vaccination with FLULAVAL, the subject experienced indentation at injection site, hardness injection site and pain. The subject's skin was hard an inch and a half around where the vaccine was administered. The pain episodes occur 20 times a day, but resolve before she can take any treatment. She described her pain as 10 plus when looking at a pain scale of 1 to 10. The subject was treated with LIDODERM patch, steroid, KEFLEX and prednisone. The subject visited two different dermatologists. The LIDODERM patches and topical  steroid did not help her symptoms. The KEFLEX and prednisone had helped some. The physician told the subject that this was a chronic condition. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up received on 25 August 2010 from a physician: The physician reported that the subject had developed an indurated, ulcerated area of the skin with underlying granuloma and shooting pain 20x a day. The physician considered the events clinically significant (or requiring intervention). The induration, ulceration, granuloma and pain were worse at the time of reporting. The physician considered the events were possibly related to vaccination with FLULAVAL.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Needle issue
Clinical narrative: The needle bent when retracting causing a lot of pain in her arm.
Age: 20.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Crying, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Pt called 8:15 AM to report arm painful at injection site and "down my arm". Injection site swelled, hot and arm swelled down to elbow. Advised ice packs to site and anti-inflammatory prn. Pt stated, "I have been up all night crying with pain."
Age: 20.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: Pt called 8:15 AM to report arm painful at injection site and "down my arm". Injection site swelled, hot and arm swelled down to elbow. Advised ice packs to site and anti-inflammatory prn. Pt stated, "I have been up all night crying with pain."
Age: 20.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Chills, Headache, Injection site pain, Lethargy, Pain in extremity
Clinical narrative: Chills, lethargy, HA, pain at injection sites: (R) arm pain rated 6/10, (L) arm pain rated 5/10.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema, Pruritus, Urticaria
Clinical narrative: Redness, edema, multiple small hives, pruritis. Ice to site, Benadryl 50 mg IM, observe for 30 minutes. Gave mother of child discharge instructions. PHN contacted pt.'s pediatrician, Dr. and reported occurrence. PHN called pt.'s home and left message to call PHN.
Age: 20.0
Sex: F
Vaccine: SMALL
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Pt received Smallpox inoculation secondary to negative HCG. Pt received Positive HCG 2 wks ago indicating pregnancy during Smallpox inoculation. According to HCG results pt was one mo pregnant.
Age: 1.27
Sex: F
Vaccine: MMR
Symptoms: Rash, Screaming, Urticaria
Clinical narrative: Raised patches of rash/hives sporadically on both of child's legs. No itching. Constant screaming all day. Rash disappeared by end of same day. Rash returned 08/31/2010 for a few hours. Rashed returned 09/01/10 for a few hours.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Blood culture positive, CSF culture positive, Immunodeficiency, Meningitis meningococcal, Meningococcal bacteraemia
Clinical narrative: Culture-confirmed meningococcal infection (serogroup Y), bacteremia and meningitis with probable myocarditis. (Note: Patient received meningococcal conjugate vaccine Menactra 3/28/2007. Patient was diagnosed with complement [C3] deficiency after developing meningococcal disease.)
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Meningococcal infection, Myocarditis, Neisseria test positive
Clinical narrative: Culture-confirmed meningococcal infection (serogroup Y), bacteremia and meningitis with probable myocarditis. (Note: Patient received meningococcal conjugate vaccine Menactra 3/28/2007. Patient was diagnosed with complement [C3] deficiency after developing meningococcal disease.)
Age: 0.79
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia
Clinical narrative: Extremely high fever.   105F.   Has been going on for 48 hours now.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: ITP. Platelet count of 3,000.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Arthralgia, Cough, Headache, Muscle spasms, Pain in extremity
Clinical narrative: Cramp/pain of B/L back of thigh and B/L antecubital fossa, headache & cough. Ambulation ok. No sore throat. No evidence of toxic symptom. No evidence of stiff neck. Fever (T. 100 degrees F) x 2 days, recovered with TYLENOL.
Age: 15.0
Sex: M
Vaccine: FLUN3
Symptoms: Pyrexia
Clinical narrative: Cramp/pain of B/L back of thigh and B/L antecubital fossa, headache & cough. Ambulation ok. No sore throat. No evidence of toxic symptom. No evidence of stiff neck. Fever (T. 100 degrees F) x 2 days, recovered with TYLENOL.
Age: 37.0
Sex: M
Vaccine: HEPAB
Symptoms: Chest discomfort, Palpitations
Clinical narrative: Client states he started having heart racing about 1 1/2 hours after receiving vaccine (Twinrix) and then developed chest pressure (not pain). Recommended ER evaluation.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site inflammation
Clinical narrative: Light headed immediately after injection.  Around 3 hrs after redness and inflammation was noted at the injection site.  Size of area increased from 1/2cm to 3cm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Aggression, Crying, Hypotonia
Clinical narrative: Very aggressive while receiving vaccinations, appeared to get "limp" after while crying. Possible breath holding spell.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: None - Given expired vaccines.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Had PVC13 on 8/27/10. Broke out in hives on 8/27/10.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Febrile convulsion, Pyrexia, Viral infection
Clinical narrative: Febrile seizure 8/17/10, 24 hours after PCV13 given. Fever thought secondary to viral syndrome. Fever lasted 4 days.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Induration, erythema, itching starting one day after injection.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Red swelling past elbow warm to the touch -left arm- where PNEUMOVAX was given.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: Red swelling past elbow warm to the touch -left arm- where PNEUMOVAX was given.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Bacteraemia, Cardiac failure, Culture positive, Neisseria test positive, Renal disorder
Clinical narrative: Primary bacteremia, complications resulted in heart failure. (Note: Patient was on 60 mg prednisone every other day for kidney problems.)
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Bacteraemia, Cardiac failure, Death, Neisseria test positive
Clinical narrative: Primary bacteremia, complications resulted in heart failure. (Note: Patient was on 60 mg prednisone every other day for kidney problems.)
Age: 10.0
Sex: M
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: fever to 102F, giving Tylenol or Motrin
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Encephalomyelitis, Hyporeflexia, Hypotonia, Mobility decreased, Sensory loss
Clinical narrative: mom brought child in the office on 08/09/10 stated that on 8/6/10 she could not use her left side mom took child to Flordia hospital ER per mom they sent her home said she was ok.on 8/9/10 child was incontince of urine and had decreased tone,sensory and reflexes on left lower extremitys.Patient was addmitted to ST JOSEPH  Diagnosed with post polio enccphalomyelitis,post -polio vaccine
Age: 8.0
Sex: F
Vaccine: IPV
Symptoms: Urinary incontinence
Clinical narrative: mom brought child in the office on 08/09/10 stated that on 8/6/10 she could not use her left side mom took child to Flordia hospital ER per mom they sent her home said she was ok.on 8/9/10 child was incontince of urine and had decreased tone,sensory and reflexes on left lower extremitys.Patient was addmitted to ST JOSEPH  Diagnosed with post polio enccphalomyelitis,post -polio vaccine
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Headache, Pyrexia
Clinical narrative: MOTHER STATED PATIENT STARTED RUNNING FEVER OF 103 DEGREES LAST PM AND HAVING HEADACHE.  CAME BY CLINIC TODAY (8/18/10) TO TELL ME HE STILL HAD HEADACHE AND 103 FEVER.  FAMILY DR CLOSED THIS PM.  WAS GOING TO ER.  NEVER CONTACTED CLINIC AGAIN.  PHONE NUMBER WAS NO LONGER WORKING WHEN NURSE CALLED TO FOLLOW-UP.  ASSUMED THAT HE RECOVERED.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain
Clinical narrative: baseball size erythema below injection site, no fever, mild pain
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Conjunctival hyperaemia, Eye swelling, Swelling face, Urticaria
Clinical narrative: Diffuse urticaria; swelling of eyes and face; conjunctival injection.  Patient given oral Benadryl with much improvement in symptoms.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Pyrexia
Clinical narrative: baseball size redness and itching, mild fever
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Myalgia, Oedema peripheral, Pain in extremity
Clinical narrative: Pt woke with extremely sore upper right arm radiating down inside arm to hand some mild swelling no redness, no fever, pt had a hard time moving her right arm abduction and above her head, pt was evaluated next day / Pt applied ice, took Tylenol and Vicodin prn.  Some improvement 8/11 then reoccuring pain 8/12, not as severe as intial pain, pt did rest, ice, Tylenol and physical therapy started for prolonged muscle pain 8/24. Pt is 80% better at this point cont. PT and home exercises, no longer taking Tylenol or Vicodin, is continuing PT 1-2 times a week, no longer pain with most ADLs.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Child received vaccinations and about 1 hour later began breaking out with hives and was taken to the ER. Mom states shild was given Claritin and has been doing okay not. Denies any respiratory problems. Mom states child has many allergies.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: none
Age: 9.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: none
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, PNC13, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness on area of left thigh where in area around where MMR and Prevnar given.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Urticaria.  Pt presented to ED at 2320 on 8/28/10 with swelling, redness, warmth, and itching in arm which received vaccination.  Pt was prescribed Benadryl and discharged.
Age: 0.96
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash face and trunk that spread to arms and legs, getting more severe over 36 hours
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia oral, Throat irritation
Clinical narrative: Patient reports that symptoms began around 6:00 pm after eating. States that her tongue and throat feel like they are tingling and feel numb. Does not report having trouble breathing or any noticeable change or swelling to her throat or tongue. Pt is currently being watched by husband and reports taking a Benadryl as recommended by the other pharmacist on duty tonight. Pt instructed to seek medical attention (go to ER) if symptoms worsen or breathing trouble occurs.
Age: 1.26
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Thigh around injection shot became swollen, red, and hot to the touch. Swollen area extended down to the knee. Remained swollen, red, and hot to touch through 9/1/2010.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea, Nausea, Pyrexia, Tremor, Vomiting
Clinical narrative: When I arrived home from work I started running a low-grade fever and had diarrhea, nausea, shakes and vomiting. It continued until late into the night.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, Hot to touch, Red raised circle bigger than the size of a a half dollar
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Started to enter skin when patient stated she did not feel good. I pulled needle out without injecting the FLUZONE. Patient fainted for less than a minute. Called 911 as a precaution. Patient stated afterwards the she did not eat breakfast.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Granuloma annulare, Injection site rash, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Localized rash at injection site "red but no bumps". 5 days later, 8/11/10, rash spread all over body. At this time rash was "raised and very itchy". Sought care from PMD on 8/12/10 and received oral steroids (methylprednisolone) x 6 days plus Fluocinonide (topical x 6 days) then referred to Dermatology and received Clobetasol 0.05 % cream x 7 days. And has f/u appt with Dermatology 09/08/10. Per Dermatologist probable Granuloma Annulare but not diagnosed.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Vaccine received on Aug 30, 2010 and redness (L) deltoid. Aug 31, swelling, hot, itchy, fever - 09/01/2010 - decreased swelling still hot and itchy - loratadine and ADVIL on Aug 31.
Age: 14.0
Sex: F
Vaccine: FLUN3, IPV, VARCEL
Symptoms: Croup infectious
Clinical narrative: ER trip evening after received FLUMIST - Croup - Racemic Epi Decadron.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chest discomfort, Ocular hyperaemia, Pain, Pharyngeal oedema
Clinical narrative: Patient reported she was feeling thick in her throat, indicated it felt funny at 3pm, approx. 4 hrs after receiving flu shot. Also noted slight chest tightness. Both resolved with 50 mg BENADRYL. She developed T, achyness and redness which persisted for 24 hours.
Age: 1.01
Sex: M
Vaccine: PNC13, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Pt. with varicella rash - mild 10 - 12 days after VARIVAX injection.
Age: 60.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Initial non-serious report was received on 02 August 2010 from a health care professional. A 60-year-old female patient had received a first intramuscular left deltoid injection of ADACEL on 21 July 2010. No other vaccinations were received that day, or within 4 weeks prior. On 26-July 2010, i.e. 5 days after receiving the ADACEL vaccine, the patient developed pain in the neck down to the left shoulder and top part of the left arm. At that time, the patient was going to be evaluated by her physician (date not reported). It was unknown if the patient had any concurrent illnesses at the time of vaccination, but did have history of allergy to E-mycin and PCN. The patient was not taking any concomitant medications at the time of vaccination. At the time of this report, the patient had not recovered. Follow-up information was received on 27 August 2010 from a health care professional. Due to the following information received, this non-serious case was upgraded to serious. Per the reporter, the patient had received the ADACEL vaccination on 21 July 2010 at 13:00 pm. Five days after the injection, the patient experienced pain on the left side of her neck that radiated down to the left upper arm; however the patient had no injection site pain. Per the reporter, as of 19 August 2010, the patient had been evaluated by her physician who had diagnosed her with bursitis. The physician did not think the bursitis was associated with the ADACEL injection. The patient recovered; however a recovery date was provided. Documents held by sender: None.
Age: 60.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bursitis, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Initial non-serious report was received on 02 August 2010 from a health care professional. A 60-year-old female patient had received a first intramuscular left deltoid injection of ADACEL on 21 July 2010. No other vaccinations were received that day, or within 4 weeks prior. On 26-July 2010, i.e. 5 days after receiving the ADACEL vaccine, the patient developed pain in the neck down to the left shoulder and top part of the left arm. At that time, the patient was going to be evaluated by her physician (date not reported). It was unknown if the patient had any concurrent illnesses at the time of vaccination, but did have history of allergy to E-mycin and PCN. The patient was not taking any concomitant medications at the time of vaccination. At the time of this report, the patient had not recovered. Follow-up information was received on 27 August 2010 from a health care professional. Due to the following information received, this non-serious case was upgraded to serious. Per the reporter, the patient had received the ADACEL vaccination on 21 July 2010 at 13:00 pm. Five days after the injection, the patient experienced pain on the left side of her neck that radiated down to the left upper arm; however the patient had no injection site pain. Per the reporter, as of 19 August 2010, the patient had been evaluated by her physician who had diagnosed her with bursitis. The physician did not think the bursitis was associated with the ADACEL injection. The patient recovered; however a recovery date was provided. Documents held by sender: None.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Bacteraemia, Cardiac failure, Culture positive, Neisseria test positive, Renal disorder
Clinical narrative: Symptoms began 6/6/10 - taken to hospital same day, died 6/6/10. Primary bacteremia with complications COD = heart failure. Patient on 60 mg prednisone every other day for kidney problems.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ, HEPA, MNQ
Symptoms: Bacteraemia, Cardiac failure, Death, Neisseria test positive
Clinical narrative: Symptoms began 6/6/10 - taken to hospital same day, died 6/6/10. Primary bacteremia with complications COD = heart failure. Patient on 60 mg prednisone every other day for kidney problems.
Age: 29.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Major muscle pain in LD, high fever 100.7 degrees - 102.2 degrees, chills, redness, swelling and warm vaccinated area (35 mm).
Age: 29.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Pyrexia
Clinical narrative: Major muscle pain in LD, high fever 100.7 degrees - 102.2 degrees, chills, redness, swelling and warm vaccinated area (35 mm).
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Mobility decreased, Pain
Clinical narrative: Extreme muscle soreness, lasting greater than 2 weeks.  Still present today 09/02/2010.  Limits mobility of arm.  Initially a very sharp sudden pain, depending on movement.  Now more of a dull pain, but still related to certain muscle movements.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Abasia, Abdominal pain, Acute disseminated encephalomyelitis, Aspiration bone marrow, Bacterial test
Clinical narrative: Pt developed fever, vomiting, abdominal pain, increased fatigue 10d (7/3/10) after shots, initially felt to be viral. Then developed increased WBC count to 30K. Admitted to hospital 7/15 due to persistent sx, felt to be infectious, d/c'ed 7/18. Sx persisted, admitted to different hospital with WBC increased to 58K, d/c'ed 7/26 as c. diff colitis. Fatigue worse, re-admitted 7/29 with increased WBC again up to 59K. Patient deteriorated over days, increased fatigue, unable to walk due to fatigue, bowel/bladder control lost. Appears to have encephalopathy, crying constantly, hyper-reflexic with clonus. 8/6/10 Concern re respiratory status with desaturations. 8/8/10 MRI/MRA of brain/spin abnormal bone marrow done. 8/14/10 SOLUMEDROL started at high dose (30 mg/kg) and plan for 2 mo. taper. IVIG also given. 8/18 Patient improving. 8/24 Transferred for rehab. 8/25 Pt began crawling again to get around, a big improvement. By 9/1/10 Pt is walking holding Mom's hand. Still in Rehab as in-patient. Doctor, neuroimmunologist at hospital, describes this as ADEM, "a perfect storm" related to a croup illness in June 2010, followed by vaccines in July 2010.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: CSF white blood cell count increased, Clonus, Clostridium difficile colitis, Clostridium test positive, Crying
Clinical narrative: Pt developed fever, vomiting, abdominal pain, increased fatigue 10d (7/3/10) after shots, initially felt to be viral. Then developed increased WBC count to 30K. Admitted to hospital 7/15 due to persistent sx, felt to be infectious, d/c'ed 7/18. Sx persisted, admitted to different hospital with WBC increased to 58K, d/c'ed 7/26 as c. diff colitis. Fatigue worse, re-admitted 7/29 with increased WBC again up to 59K. Patient deteriorated over days, increased fatigue, unable to walk due to fatigue, bowel/bladder control lost. Appears to have encephalopathy, crying constantly, hyper-reflexic with clonus. 8/6/10 Concern re respiratory status with desaturations. 8/8/10 MRI/MRA of brain/spin abnormal bone marrow done. 8/14/10 SOLUMEDROL started at high dose (30 mg/kg) and plan for 2 mo. taper. IVIG also given. 8/18 Patient improving. 8/24 Transferred for rehab. 8/25 Pt began crawling again to get around, a big improvement. By 9/1/10 Pt is walking holding Mom's hand. Still in Rehab as in-patient. Doctor, neuroimmunologist at hospital, describes this as ADEM, "a perfect storm" related to a croup illness in June 2010, followed by vaccines in July 2010.