chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pyrexia, Swelling, Tenderness
Clinical narrative: Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00771, 2012-00772, 2012-00774, 2012-00775 and 2012-00776. A 41-year-old female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, route and site of administration unknown) on 04 October 2011. Following vaccination the patient reported right shoulder pain, right axilla tenderness and swelling which persisted from 04 October 2011 to 23 November 2011. The patient also had a low grade fever off and on until November. It was unknown if the patient had any illness at the time of vaccination, had any pre-existing medical conditions, took any concomitant medications or had any other vaccinations within 4 weeks of FLUZONE. The patient had previous "arm issues" due to prior reaction to anesthesia. No further information was available at the time of the report. The patient's outcome was unknown. Documents held by sender: none.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, RV5
Symptoms: Faecal volume increased, Haematochezia, Occult blood positive, Pyrexia
Clinical narrative: Since immunizations: Fever 102 yesterday, 100.5 this AM (no meds this AM). Increase in stool output. Blood in stool - flecks on day of vaccines, approximately 1 tsp today. Stool Guiac (+) in office. Feeding well, acting well. Nl PE (no s/s intussusception).
Age: 0.8
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Muscle twitching, Myoclonus, Pyrexia
Clinical narrative: Fever (101 - 102 degrees) duration 6 hrs. Twitching of right extremity (duration 6 hrs). No treatment (physical examination at doctor's office). Dx: (Myoclonus).
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Approx 1 wk after immunizations were given pt broke out in a rash/whelps. Mom brought the pt in for a follow up appt and noticed the whelps.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Robust take following exposure to vaccinia virus, Skin lesion, Vaccination complication, Wound secretion
Clinical narrative: Pt presented with tegaderm and gauze covered lesion, dressing had not been removed since placement and was showing large amount of drainage.  Robust take was seen with several sattelite lesions after the dressing was removed.  Lesion was covered with band aids and instruction of care was given.  Pt has pregnant wife and 1 yr old son in the home.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Robust take following exposure to vaccinia virus, Secretion discharge, Skin lesion, Vaccination complication
Clinical narrative: Pt presented with tegaderm and gauze covered lesion, dressing had not been removed since placement and was showing large amount of drainage.  Robust take was seen with several sattelite lesions after the dressing was removed.  Lesion was covered with band aids and instruction of care was given.  Pt has pregnant wife and 1 yr old son in the home.
Age: 1.27
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Abnormal behaviour, Crying, Middle insomnia, Pyrexia, Skin warm
Clinical narrative: Woke in the night crying, hot/feverish, vomited.  Was soothed and returned to sleep. Still feverish/clingy next morning.
Age: 1.27
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Vomiting
Clinical narrative: Woke in the night crying, hot/feverish, vomited.  Was soothed and returned to sleep. Still feverish/clingy next morning.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13, RV1
Symptoms: Convulsion, Pyrexia
Clinical narrative: High fever of 105 degrees Fahrenheit with "convulsions". Cold towels and alternating Tylenol and Motrin until morning. Went to see pediatrician in am.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Blood test, Catheterisation cardiac, Computerised tomogram
Clinical narrative: I believe the am or pm are accurate, but not a hundred percent sure. Anyway the adverse events were sudden BP elevation which lead to admission. One week later recurred and admitted again.  Secondary hypertension workup negative. Labile blood pressure elevation and hypotenstion over one month with neurological symptoms, including but not limited to numbness, "electrical sensations" burning skin, weakness. Peaked around 4 weaks then continued quite severely, but less dramatic. Developed irregular heart beat and admitted again. As of this date, weakness symptoms are much improved. Sensory symptoms better, but still present with various other, neurological and cardiac symptoms still present.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Diagnostic procedure, Heart rate irregular, Hypoaesthesia, Hypotension, Neurological symptom
Clinical narrative: I believe the am or pm are accurate, but not a hundred percent sure. Anyway the adverse events were sudden BP elevation which lead to admission. One week later recurred and admitted again.  Secondary hypertension workup negative. Labile blood pressure elevation and hypotenstion over one month with neurological symptoms, including but not limited to numbness, "electrical sensations" burning skin, weakness. Peaked around 4 weaks then continued quite severely, but less dramatic. Developed irregular heart beat and admitted again. As of this date, weakness symptoms are much improved. Sensory symptoms better, but still present with various other, neurological and cardiac symptoms still present.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Paraesthesia, Sensory disturbance, Skin burning sensation, Urine analysis
Clinical narrative: I believe the am or pm are accurate, but not a hundred percent sure. Anyway the adverse events were sudden BP elevation which lead to admission. One week later recurred and admitted again.  Secondary hypertension workup negative. Labile blood pressure elevation and hypotenstion over one month with neurological symptoms, including but not limited to numbness, "electrical sensations" burning skin, weakness. Peaked around 4 weaks then continued quite severely, but less dramatic. Developed irregular heart beat and admitted again. As of this date, weakness symptoms are much improved. Sensory symptoms better, but still present with various other, neurological and cardiac symptoms still present.
Age: 27.0
Sex: F
Vaccine: TTOX
Symptoms: Dizziness, Dysarthria, Hyperhidrosis, Nausea, Pain
Clinical narrative: AWOKE WITH SEVERE GENERALIZED BODY PAIN, DIZZINESS, NAUSEA, TREMORS AND SLURRED SPEECH, SWOLLEN FACE, DIAPHORESIS.
Age: 27.0
Sex: F
Vaccine: TTOX
Symptoms: Swelling face, Tremor
Clinical narrative: AWOKE WITH SEVERE GENERALIZED BODY PAIN, DIZZINESS, NAUSEA, TREMORS AND SLURRED SPEECH, SWOLLEN FACE, DIAPHORESIS.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Amnesia, Confusional state, Somnolence
Clinical narrative: Confusion, somnolence, amnesia when waking up at 6:30 AM. Employer called her asking why she was 30 minutes late for work.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Erythema, pain, and swelling of left upper arm extending from shoulder to elbow.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on face around eyes.
Age: 3.0
Sex: F
Vaccine: FLU3, HEPA, HIBV, VARCEL
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Rec'd phone call on 2.2.12 at 10 am from pediatrician from Medical Center.  States pt brought to Medical Center at 11 pm on 2.1.12 with c/o temp of >104 and febrile seizures.  Dr. treated pt.  Pt had ID consult with another Dr.  Dr. notified our clinic physician.  Dr. stated she will refer pt for neuro consult.  Pt recovered and is doing well.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 20 January 2012. A 46-year-old female patient had received an injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C3971 (sanofi pasteur Inc. lot number U4103AA) on 03 November 2011 and following vaccination developed pain in the left arm and shoulder which still persisted at the time of the report. Illness at the time of vaccination was reported as none. The patient had allergies to sulfa and mannitol. The patient had a medical history of high cholesterol. It was unknown if the patient took any concomitant medications. No other vaccinations were given within four weeks of ADACEL. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 43.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Immediate post-injection reaction, Neurological symptom
Clinical narrative: Initial report was received from a health care professional on 20 January 2012. A 43-year-old female patient (reported as 44-years-old) had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C4063 (sanofi pasteur Inc. lot number U4308AA) and an intramuscular injection in the right deltoid of FLUZONE, sanofi pasteur Inc., lot number U4122CA on 20 January 2012 at 13:25. Immediately after the vaccinations, the patient experienced a nerve reaction down the underside of the left arm to the fingers and a warmth turning into a numbness. The patient had no weakness in the arm and had a good grip. Red streaking appeared at the left wrist to the thumb area and the numbness was beginning to affect the whole arm. illness at the time of vaccination and pre-existing medical conditions were reported as none. It was unknown if the patient took any concomitant medications or had any adverse events following prior vaccinations. No further information was available at the time of the vaccination. The patient's outcome was reported as not recovered. Documents held by sender: none.
Sex: U
Vaccine: TYP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site warmth
Clinical narrative: Initial report received on 05 May 2011 from a consumer. Two unidentified patients each received a left arm injection of TYPHIM Vi (lot number E1288-1) on 04 or 05 May 2011. Immediately afterwards, each patient developed injection site redness which extended toward the elbow and the area was warm to touch. No other information was provided.
Sex: F
Vaccine: FLUX
Symptoms: Polyneuropathy chronic
Clinical narrative: Initial report was received from another manufacturer on 23 January 2012 (Services Request Number 1-4810764278). A female patient (age not reported) had received an influenza vaccine (manufacturer, lot number, date site and route of administration not reported) 20 years ago and an unspecified amount of time later developed chronic inflammatory polyneuropathy. Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Type III immune complex mediated reaction
Clinical narrative: This is a non-serious cluster of 2 patients who experienced adverse events following administration of FLUZONE Intradermal (lot number not reported). Initial report was received on 31 October 2011 from a health care provider. Two patients (age and date of birth not reported) had received FLUZONE Intradermal, (lot number, route and site of administration were not reported). One of the patients an employee at a dental clinic experienced a bad reaction to the intradermal injection. The second patient ended up in the emergency room (ER) with swelling down to the elbow. No further informational was available at the time of the report. The patient's outcome was not reported. Follow-up information received from a health care professional on 20 January 2012. It was clarified by the reported that a cluster of 4 patients (previously reported as 2 patients) had received FLUZONE Intradermal (lot number UT4163AA) on different days and experienced reactions. This case will now be the case of reference for 1 of the 4 patients who had been identified as a 43 year-old female patient who is discussed below. Due to the follow-up information received on this patient this case now meets seriousness criteria and has been upgraded to serious. Information regarding the other 3 patients (all non-serious cases) are captured in case numbers 2012-00783, 00784, 00785. A 43-year-old female patient who had concurrent illnesses of upper respiratory infection (URI), had received a left arm injection of FLUZONE Intradermal (lot number UT4163AA) on 27 October 2011 at 3 pm, and 2 days later on 29 October 2011 at 3:30 pm reported swelling down to the elbow. The patient presented to the emergency room and was administered steroid injection and antibiotics for arthus reaction. Concomitant medications included B12 injection. The patient recovered on an unspecified date. Documents held by sender: none.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site cellulitis
Clinical narrative: Pt was seen on 1-17-12 two vaccines were administered. Pt came back next day 1-18-12 with cellulitis (R) deltoid. He was treated Amoxicillin 400mg was prescribed a pt  f/u appt was made for 1-25-12 and cellulitis was resolved.
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Facial paresis, Fatigue, Lethargy
Clinical narrative: Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00771, 2012-00772, 2012-00773, 2012-00774, 2012-00775 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, date, route and site of administration not reported) and an unspecified amount of time later experienced "achy-ness, nausea, left sided weakness of mouth, nose and chin, lethargy, tiredness, chills, low grade fever, cough and congestion." Illness at the time of vaccination was reported as none. It was unknown if the patient had any pre-existing medical conditions, took any concomitant medications or had any other vaccinations within 4 weeks of FLUZONE. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00771, 2012-00772, 2012-00773, 2012-00774, 2012-00775 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, date, route and site of administration not reported) and an unspecified amount of time later experienced "achy-ness, nausea, left sided weakness of mouth, nose and chin, lethargy, tiredness, chills, low grade fever, cough and congestion." Illness at the time of vaccination was reported as none. It was unknown if the patient had any pre-existing medical conditions, took any concomitant medications or had any other vaccinations within 4 weeks of FLUZONE. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Eye pruritus, Eyelid oedema, Fatigue, Headache
Clinical narrative: Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00771, 2012-00773, 2012-00774, 2012-00775 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, date, route and site of administration not reported) and an unspecified amount of time later experienced "headache, blood shot eyes, itchy eyes, swollen eyelids, then for next 2 days weak, nausea, fatigue, temperature 99.9, then eyes improved but for 2-3 more days continued to have nausea, fatigue and swollen injection site." It was unknown if the patient had any illness at the time of vaccination, had any pre-existing medical conditions, took any concomitant medications or had any other vaccinations within 4 weeks of FLUZONE. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Nausea, Ocular hyperaemia
Clinical narrative: Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00771, 2012-00773, 2012-00774, 2012-00775 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, date, route and site of administration not reported) and an unspecified amount of time later experienced "headache, blood shot eyes, itchy eyes, swollen eyelids, then for next 2 days weak, nausea, fatigue, temperature 99.9, then eyes improved but for 2-3 more days continued to have nausea, fatigue and swollen injection site." It was unknown if the patient had any illness at the time of vaccination, had any pre-existing medical conditions, took any concomitant medications or had any other vaccinations within 4 weeks of FLUZONE. No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Pain, Pain in extremity
Clinical narrative: Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00772, 2012-00773, 2012-00774, 2012-00775 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, date, route and site of administration not reported) and an unspecified amount of time later experienced "chest feeling heavy, achy for a couple of days and right arm soreness." It was unknown if the patient had any illness at the time of vaccination. The patient had a medical history of asthma and was concomitantly using an unspecified inhaler. The patient had a severe reaction years ago following prior vaccination (vaccine not specified). No further information was available at the time of the report. The patient's outcome was reported as recovered. Documents held by sender: none.
Age: 40.0
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Initial report was received 19 August 2011 which consisted of a cluster of two patients who experienced adverse events after receiving TYPHIM Vi, lot number E0549. This case represents one of the two patients. The other patient has been captured in case number 2011-07269. A 40-year-old male patient who had no concurrent illness and no past medical history had received an intramuscular right deltoid injection of TYPHIM V, lot number E0549 and an intradermal left forearm injection of TUBERSOL 5 TV, lot number C3761AA on 18 August 2011 and later that evening, he complained of a headache, dizziness and fatigue. The patient had not received any other vaccines within four weeks of TYPHIM Vi and TUBERSOL 5 TV. Outcome was not recovered. Documents held by sender: None.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Eye irritation, Eye swelling, Rash, Rash erythematous, Skin exfoliation
Clinical narrative: Initial report was received from a health care professional on 20 January 2012. A 57-year-old female patient had received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc., lot number U4147CA on 28 October 2011. On 29 October 2011, the patient's eyes were swelled and irritated, her face broke out in a red rash and had some minor peeling of the skin. Illness at the time of vaccination was reported as none. The patient had no pre-existing medical conditions. It was unknown if the patient took any concomitant medications, had any other vaccinations within four weeks of FLUZONE or had any adverse events following prior vaccinations. No further information was available at time of the report. The patient's outcome was not reported. Documents held by sender: none.
Age: 68.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Cough, Pyrexia
Clinical narrative: Initial report was received on 20 May 2011 from a health care professional. An "approximately" 68 year-old male had received on 16 May 2011 TYPHIM Vi (lot number, route and site of administration not reported) and hepatitis A (manufacturer, lot number, route and site of administration not reported) and approximately three days later on 19 May 2011, he developed a fever of 103 to 104 degrees and a very mild cough. The patient was evaluated in the emergency room. Treatments were not reported. Illness at the time of vaccination were unknown. No further information was provided at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Age: 36.0
Sex: M
Vaccine: FLU3, HEPAB, TYP, YF
Symptoms: Blood test normal, Chills, Hyperhidrosis, Lymphadenopathy, Pyrexia
Clinical narrative: Initial report was received from a health care professional on 14 November 2011. A 36 year-old male patient had received on 07 November 2011 a first dose subcutaneous left tricep injection of YF VAX, lot number UH101AA; a first dose intramuscular left deltoid injection of TYPHIM Vi, lot number G0481; a first dose intramuscular right deltoid injection of TWINRIX, GSK lot number AHABB223DA and a first dose intramuscular left deltoid injection of AFLURIA, GSK lot number AFLUA609DA. On 10 November 2011, the patient developed cervical, axillary and supraclavicular lymphadenopathy. On 11 and 12 November 2011, the patient developed a fever, chills and sweats. The patient self medicated with ibuprofen 600 mg. He was evaluated by a company physician on 14 November 2011 and was referred to a pvt MD (private MD) and ID (infectious disease) specialist. No further information was available at the time of the report. Outcome was unknown. Follow-up information was received from a health care professional on 25 November 2011. The patient was described to be healthy who was preparing for travel. There were no known contraindications described during the report. According to the reporter, the patient had received all vaccines on 07 November 2011 and approximately four days later on 11 November 2011 (previously reported as 10 November 2011), the patient developed symptoms. The patient was seen by his regular physician who drew blood work that the patient reported to be "all normal". No further information was available at the time of the report. The patient's lymphadenopathy was thought to be resolving. Documents held by sender: none.
Age: 66.0
Sex: M
Vaccine: YF
Symptoms: Chills, Pain, Rash, Rash macular
Clinical narrative: Initial report received from a nurse on 25 August 2011. A 66-year-old male patient had received a subcutaneous left deltoid injection of YF VAX on 17 August 2011 (lot number UH109AA) and 4 days later on 21 August 2011 developed a macular rash on his trunk and back that radiated to the left side. He also complained of chills and body aches. The patient did not require medical evaluation and so no relevant diagnostic tests and/or laboratory data were performed. The patient had no concurrent illnesses, and had not experienced any adverse events with prior vaccinations in the past. He had not received any other vaccinations within 4 weeks prior to 17 August 2011. The reporter did not know if the patient had any pre-existing medical conditions or was using any other medications at time of vaccination. At the time of this report the patient had not recovered. Follow-up information was received 14 October 2011 from a health care professional. The patient had not received any prior doses of YF VAX. The patient had previously received on 03 August 2011, a first dose left deltoid intramuscular injection of TYPHIM VI (lot number E1287) and a first dose intramuscular right deltoid injection of Hepatitis A vaccine (other manufacturer, lot number AHAVB520AA). The patient had a history of high blood pressure and developing a rash with amoxicillin. The patient denied any history of cancer, leukemia, AIDS, seizure, brain or nervous system problems. He had not received any blood transfusions or gamma globulin during the past year. Concomitant medications consisted of Propanolol 10mg BID, DIOVAN 160 1/day, Triamterene HCTH 75/5 1 daily, Diazepam 5mg prn, Simvastatin 80 and Nifedical 30. At the time of vaccination, the patient had no concurrent illness. According to the reporter, the events did not require treatment and the patient recovered (date not reported). Documents held by sender: None.
Age: 41.0
Sex: M
Vaccine: TYP
Symptoms: Mass, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 28 January 2011. A 41-year-old male patient received on 27 January 2011 a left deltoid injection (route not reported) of TYPHIM Vi, lot number E0442-1. The patient received on 21 January 2011 an injection (route and site not reported) of DTAP, lot number and manufacturer not reported, and an injection (route and site not reported) of TWINRIX, manufacturer and lot number not reported. The patient had an allergy to penicillin. He had no medical conditions and took no concomitant medications. The patient had no illness at the time of vaccination and no known adverse event following prior vaccination. On 28 January 2011, the patient noted a lump "bigger than a BB, smaller than a marble on the collar bone." The patient noticed the lump the day after the TYPHIM was given and not noted prior to that time. He also had slight left arm soreness. The outcome was reported as unknown. Follow-up information received from a nurse on 11 March 2011. The patient recovered on an unspecified date. The reporter wrote "Reviewed no additional information at this time."Follow-up information was received on 01 April 2011 from a health care professional. The reporter stated the patient had received the TDAP and TWINRIX at a "other" clinic and was unable to provide additional information on the vaccines. The patient only received the TYPHIM Vi at her facility. No further information was available at the time of the report. The patient outcome remained recovered. Follow-up information was received from a health care professional on 25 April 2011. The patient's "lump" resoled after 10 days. No further information was available 20 May 2011 from a health care professional who provided additional patient contact information. No additional new information was provided at the time of the report. Follow-up information was received on 08 June 2011 from a health care professional. Per the reporter, the facility name and address where the TWINRIX and TDAP were administered is unknown. No new medical information was provided. Documents held by sender: None.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Anaemia, Aplasia pure red cell, Biopsy bone marrow abnormal, Fatigue, Feeling abnormal
Clinical narrative: A serious spontaneous report of exposure during pregnancy and pure red blood cell aplasia has been received from a consumer concerning a 34-year-old female, subsequent to FLUMIST. Medical history included the patient was six weeks pregnant. No obstetrical history or other relevant medical history were provided. Concomitant medications were not reported. The patient received FLUMIST on 28-Oct-2011. On 09-Nov-2011, the patient experienced lethargy, tiredness and feeling her pulse beat in her head. She underwent a bone marrow biopsy and was diagnosed with pure red blood cell aplasia. Per the reporter, the patient's physicians stated that the patient's immune system went into hyper drive and her red blood cells went low with severe anemia. At the time of this report the patient was doing fine and everything was back to normal. The outcome of the events of pregnancy and pure red blood cell aplasia was resolved.
Age: 34.0
Sex: F
Vaccine: FLUN3
Symptoms: Immune system disorder, Lethargy, Maternal exposure during pregnancy, Red blood cell count decreased
Clinical narrative: A serious spontaneous report of exposure during pregnancy and pure red blood cell aplasia has been received from a consumer concerning a 34-year-old female, subsequent to FLUMIST. Medical history included the patient was six weeks pregnant. No obstetrical history or other relevant medical history were provided. Concomitant medications were not reported. The patient received FLUMIST on 28-Oct-2011. On 09-Nov-2011, the patient experienced lethargy, tiredness and feeling her pulse beat in her head. She underwent a bone marrow biopsy and was diagnosed with pure red blood cell aplasia. Per the reporter, the patient's physicians stated that the patient's immune system went into hyper drive and her red blood cells went low with severe anemia. At the time of this report the patient was doing fine and everything was back to normal. The outcome of the events of pregnancy and pure red blood cell aplasia was resolved.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Guttate psoriasis, Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of guttate psoriasis in a currently 34-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). The subject's medical history included psoriasis. On an unspecified date the subject received a dose of FLUARIX (details unknown). Less than a month after vaccination with FLUARIX, the subject experienced urticaria and 4 weeks after vaccination with FLUARIX, the subject experienced guttate psoriasis. The subject's guttate psoriasis may have been triggered by urticaria according to the physician. The physician reported the suspect product as FLULAVAL, but provided a lot number for FLUARIX. No further details were provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
Age: 0.27
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: C-reactive protein increased, Pyrexia
Clinical narrative: CRP was normal at 1.9 on 1/25.  Vaccine given 1/27 and CRP checked on 1/29 due to fever was elevated at 6.97.  Recheck of CRP on 1/30 was still elevated at 7.33.  Fever and elevated CRP ultimately attributed to vaccine, with no other signs of infection present.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Activated partial thromboplastin time, Blood creatine phosphokinase, Blood culture, Blood fibrinogen, Body fluid analysis
Clinical narrative: Mom states that a couple hours after she got the vaccine that she complained of pain in her leg and started with a fever.  The next day she had welts on her leg, fever and increased pain.  Mom called after hours nurse who told her to do cool compresses to the sight.  On the second day she said that her leg was hot, red, swollen and she could hardly bend it.  She called the after hours nurse on call and she was instructed to take her child in to be seen.  She took the child to Hospital where she was admitted for 3 days.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: C-reactive protein, Culture, Differential white blood cell count, Erythema, Full blood count
Clinical narrative: Mom states that a couple hours after she got the vaccine that she complained of pain in her leg and started with a fever.  The next day she had welts on her leg, fever and increased pain.  Mom called after hours nurse who told her to do cool compresses to the sight.  On the second day she said that her leg was hot, red, swollen and she could hardly bend it.  She called the after hours nurse on call and she was instructed to take her child in to be seen.  She took the child to Hospital where she was admitted for 3 days.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Gram stain, International normalised ratio, Joint stiffness, Metabolic function test, Oedema peripheral
Clinical narrative: Mom states that a couple hours after she got the vaccine that she complained of pain in her leg and started with a fever.  The next day she had welts on her leg, fever and increased pain.  Mom called after hours nurse who told her to do cool compresses to the sight.  On the second day she said that her leg was hot, red, swollen and she could hardly bend it.  She called the after hours nurse on call and she was instructed to take her child in to be seen.  She took the child to Hospital where she was admitted for 3 days.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Pyrexia, Red blood cell sedimentation rate, Skin warm, Urticaria
Clinical narrative: Mom states that a couple hours after she got the vaccine that she complained of pain in her leg and started with a fever.  The next day she had welts on her leg, fever and increased pain.  Mom called after hours nurse who told her to do cool compresses to the sight.  On the second day she said that her leg was hot, red, swollen and she could hardly bend it.  She called the after hours nurse on call and she was instructed to take her child in to be seen.  She took the child to Hospital where she was admitted for 3 days.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Activated partial thromboplastin time, Aspiration joint, Blood creatine phosphokinase, Blood culture, Blood fibrinogen
Clinical narrative: Mom states that a couple hours after she got the vaccine that she complained of pain in her leg and started with a fever.  The next day she had welts on her leg, fever and increased pain.  Mom called after hours nurse who told her to do cool compresses to the sight.  On the second day she said that her leg was hot, red, swollen and she could hardly bend it.  She called the after hours nurse on call and she was instructed to take her child in to be seen.  She took the child to Hospital where she was admitted for 3 days.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Body fluid analysis, C-reactive protein, Culture, Differential white blood cell count, Erythema
Clinical narrative: Mom states that a couple hours after she got the vaccine that she complained of pain in her leg and started with a fever.  The next day she had welts on her leg, fever and increased pain.  Mom called after hours nurse who told her to do cool compresses to the sight.  On the second day she said that her leg was hot, red, swollen and she could hardly bend it.  She called the after hours nurse on call and she was instructed to take her child in to be seen.  She took the child to Hospital where she was admitted for 3 days.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Full blood count, Gram stain, International normalised ratio, Metabolic function test, Mobility decreased
Clinical narrative: Mom states that a couple hours after she got the vaccine that she complained of pain in her leg and started with a fever.  The next day she had welts on her leg, fever and increased pain.  Mom called after hours nurse who told her to do cool compresses to the sight.  On the second day she said that her leg was hot, red, swollen and she could hardly bend it.  She called the after hours nurse on call and she was instructed to take her child in to be seen.  She took the child to Hospital where she was admitted for 3 days.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Nuclear magnetic resonance imaging, Oedema peripheral, Pain in extremity, Pyrexia, Red blood cell sedimentation rate
Clinical narrative: Mom states that a couple hours after she got the vaccine that she complained of pain in her leg and started with a fever.  The next day she had welts on her leg, fever and increased pain.  Mom called after hours nurse who told her to do cool compresses to the sight.  On the second day she said that her leg was hot, red, swollen and she could hardly bend it.  She called the after hours nurse on call and she was instructed to take her child in to be seen.  She took the child to Hospital where she was admitted for 3 days.
Age: 7.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Urticaria, Vaccination complication, X-ray
Clinical narrative: Mom states that a couple hours after she got the vaccine that she complained of pain in her leg and started with a fever.  The next day she had welts on her leg, fever and increased pain.  Mom called after hours nurse who told her to do cool compresses to the sight.  On the second day she said that her leg was hot, red, swollen and she could hardly bend it.  She called the after hours nurse on call and she was instructed to take her child in to be seen.  She took the child to Hospital where she was admitted for 3 days.
Age: 46.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. states that the arm where she received the Pneumovax (right arm) started to swell and get warm to touch and is painful. No stridor, no rash all over the body and no resp. distress. No fever or chills.
Age: 1.53
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Rash.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: Sore throat, low grade fever, body aches, runny nose and coughing.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Arm become red swollen and warm to touch. Approximately 4 in. by 2 in.
Age: 0.67
Sex: F
Vaccine: FLUX
Symptoms: Culture positive, Rash, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Staph. Aureus infection first in diaper area and then spread to abdomen. The initial rash and the spreading coincided with the first and second flu shot doses.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Rash
Clinical narrative: Asymptomatic rash on lower legs, pain in right knee for 2 weeks then pain in right ankle.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac stress test, Chest discomfort, Dyspnoea, Erythema, Pain
Clinical narrative: Pt experienced SOB, chest tightness and local pain, itching and redness.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt experienced SOB, chest tightness and local pain, itching and redness.
Age: 0.51
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting with Fever.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Swollen tongue
Clinical narrative: Tongue swelling. Time of onset approximate.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Rash erythematous
Clinical narrative: Pt describes swelling with pain at injection site last night at 5:00 PM, then 2/2/12 at 2:00 PM pt began to develop a red rash on the upper portion of her body.
Age: 23.0
Sex: F
Vaccine: YF
Symptoms: Throat tightness, Urticaria, Wheezing
Clinical narrative: Wheezing, tightness in throat, hives.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Bone pain, Erythema, Skin hypertrophy
Clinical narrative: Pain on a line from spine to breast bone with blistered thickened erythematous skin.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Back disorder, Back pain, Blister, Colonoscopy, Endoscopy upper gastrointestinal tract
Clinical narrative: Pain on a line from spine to breast bone with blistered thickened erythematous skin.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Spinal fusion surgery
Clinical narrative: Pain on a line from spine to breast bone with blistered thickened erythematous skin.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Mobility decreased, Nuclear magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Left arm in severe pain, unable to lift it in any direction or use it to pull or push or lift anything, pain worsens at night, can't sleep, continues to this date with only slight improvement.
Age: 44.0
Sex: F
Vaccine: FLU3, HEPAB, YF
Symptoms: Activities of daily living impaired, Food poisoning, Malaise, Pyrexia, Vomiting
Clinical narrative: 3+ weeks post vaccine "felt like food poisoning" then pt concerned may have been yellow fever vaccine.  Fever, malaise, vomiting. Self limiting in approx. 3 days.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Crying, Dysstasia, Gait disturbance, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Within two minutes of receiving the shot, patient complained that his left hand and arm hurt and his hands and arms began to shake back and forth. The shot went in his left thigh. His crying did not subside. The doctor felt his arms and said his muscles were stiffening. She tried to have him stand and he could not stand or move his arms. His limbs stiffened for about 10 minutes. 10 minutes later, his arms stiffened again and he began to cry again. The symptoms subsided after that. However, he complained of pain in his leg and was tripping and stumbling for 2 days afterward.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity, Tremor
Clinical narrative: Within two minutes of receiving the shot, patient complained that his left hand and arm hurt and his hands and arms began to shake back and forth. The shot went in his left thigh. His crying did not subside. The doctor felt his arms and said his muscles were stiffening. She tried to have him stand and he could not stand or move his arms. His limbs stiffened for about 10 minutes. 10 minutes later, his arms stiffened again and he began to cry again. The symptoms subsided after that. However, he complained of pain in his leg and was tripping and stumbling for 2 days afterward.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Electrocardiogram normal, Electroencephalogram abnormal, Fall, Gaze palsy
Clinical narrative: 7A parents responded to loud sound in pt's room. Found her shaking/trembling with eyes rolled back in head and falling off the bed. Lasted 2-3 min. Taken to ED for eval and testing. Following that episode pt had a number more with similar s/s. Pt dx with seizure disorder and placed on medication. Parents report episodes of syncope b/tw ages 11 & 12 and question absence seizures that began 2 years prior to vaccine administration. Previous doses given 10/12/07 and 12/14/07 in office.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Tremor, Vomiting
Clinical narrative: 7A parents responded to loud sound in pt's room. Found her shaking/trembling with eyes rolled back in head and falling off the bed. Lasted 2-3 min. Taken to ED for eval and testing. Following that episode pt had a number more with similar s/s. Pt dx with seizure disorder and placed on medication. Parents report episodes of syncope b/tw ages 11 & 12 and question absence seizures that began 2 years prior to vaccine administration. Previous doses given 10/12/07 and 12/14/07 in office.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Electrocardiogram abnormal, Fall, Gaze palsy, Malformation venous
Clinical narrative: 7A parents responded to loud sound in pt's room. Found her shaking/trembling with eyes rolled back in head and falling off the bed. Lasted 2-3 min. Taken to ED for eval and testing. Following that episode pt had a number more with similar s/s. Pt dx with seizure disorder and placed on medication. Parents report episodes of syncope b/tw ages 11 & 12 and question absence seizures that began 2 years prior to vaccine administration. Previous doses given 10/12/07 and 12/14/07 in office.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Nuclear magnetic resonance imaging abnormal, Tremor
Clinical narrative: 7A parents responded to loud sound in pt's room. Found her shaking/trembling with eyes rolled back in head and falling off the bed. Lasted 2-3 min. Taken to ED for eval and testing. Following that episode pt had a number more with similar s/s. Pt dx with seizure disorder and placed on medication. Parents report episodes of syncope b/tw ages 11 & 12 and question absence seizures that began 2 years prior to vaccine administration. Previous doses given 10/12/07 and 12/14/07 in office.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: Diagnosed as serum sickness. Day after, redness, soreness. Scar tissue developed, became increasingly red, hot and sore. Few days later, felt flu like symptoms - headache, fever, petechia on feet, arms swollen. Fatigue.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Oedema peripheral, Pain, Petechiae, Pyrexia
Clinical narrative: Diagnosed as serum sickness. Day after, redness, soreness. Scar tissue developed, became increasingly red, hot and sore. Few days later, felt flu like symptoms - headache, fever, petechia on feet, arms swollen. Fatigue.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Scar, Serum sickness
Clinical narrative: Diagnosed as serum sickness. Day after, redness, soreness. Scar tissue developed, became increasingly red, hot and sore. Few days later, felt flu like symptoms - headache, fever, petechia on feet, arms swollen. Fatigue.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Per client report, her left arm has been getting numb since was given the flu shot in December. States just went to ER last Friday night (Jan. 20, 2012). Denies ever having any redness, swelling or drainage. Doctor only gave pain medicine.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: Patient received PNEUMOVAX on 1/31/2012, the following day experienced redness. 2 days later red & swelling of the entire upper arm. Cellulitis-like reaction.
Age: 1.25
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Rash vesicular
Clinical narrative: Localized redness on (R) thigh, 1 x 3 cm with 4 small vesicular lesions.
Age: 1.31
Sex: F
Vaccine: FLU3, MMR, PNC13, VARCEL, FLU3, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: (Rt) upper lateral thigh with 2x2 1/2 inch erythema surrounding injection site with mild warmth & induration.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Per pt. is unable to lift arm beyond shoulder level due to pain. Mobility is mostly available at elbow joint. Pt will visit MD for examination.
Age: 85.0
Sex: U
Vaccine: PPV
Symptoms: Body temperature increased, Confusional state, Rash
Clinical narrative: 2/2/12 Noted with elevated temp and increased confusion & rash. 1/31/12 99.7 at 0425, 99.1 at 0730, 100.5 at 1400, 100.8 at 1915, 98.8 at 2140. 2/1/12 99.1 at 0530, 99.3 at 0815, 100.2 at 1145, 100.4 at 2130, 99.4 at 2230. 2/2/12 102.3 at 1245.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Patient had PNEUMOVAX 1 Feb 2012 at 1300 in immunization hallway by administrator.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Pt complained of possible SOB last night. Has hard hot puff red area around injection site approximately 4 inch in diameter today.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Arm still sore over a week later. Hurts to lift arm above shoulder height. Pt going to contact her Dr.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pain, Pain in extremity, Rash
Clinical narrative: Redness & pain in (R) arm beginning 1/18/12 & increased 1/19/12 & went to ER. C/o rash & severe pain. No fever, no induration, no fluctuance or discharge. Dx - possible acute cellulitis. Rx - Doxycycline 100mg po bid x 7 days.