chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Fall, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: Information has been received from a Licensed Visiting Nurse (LVN), concerning a 60 year old female with rhinitis allergic, postnasal drip and recurrent respiratory tract infections and with drug reactions/allergies to AUGMENTIN, ZITHROMAX, DURICEF, erythromycin, iodine and AVELOX who on 22-FEB-2010 was vaccinated with PNEUMOVAX 23 (Lot # 664653/1337Y) 0.5 mL IM into the left deltoid. Concomitant therapy included BONIVA, OMNARIS, PATANASE and temazepam. The nurse reported that the patient experienced sore arm after administration of with PNEUMOVAX 23. Eighteen hours later she woke up in the middle of the night and felt nauseated. She got up to go to the bathroom and passed out when returning from the bathroom. She fell against the wall. Her husband took her to a 24 hour emergency care center. She was then transported to the hospital where she was admitted for observation for two days (23-FEB-2010 to 25-FEB-2010). It was reported that the patient recovered from the events. This is one of three reports concerning the same source. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HIBV
Symptoms: Hallucination, auditory, Hallucination, visual, Schizophrenia
Clinical narrative: I already filled this out. Pt. experienced hypnotic effects, with hallucinations both audio & visual. These side effects started again in 2007, pt diagnosed with chronic schizophrenia 2009.
Age: 72.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Large area (about 12 cm) erythema/warmth at (L) arm at site of injection. Started about 24 hours after injection.
Age: 1.51
Sex: F
Vaccine: HEPA, IPV
Symptoms: Livedo reticularis
Clinical narrative: Reported by patient's mother on 5/5/10. Mom reports mottling on palms of hands and feet. States she noticed it approx. 1 hour after shots were given. She is unsure if the mottling was there before vaccination. Clinic where vaccines administered is not their Primary Care Provider. Instructed mom to contact PCP to let them know what happened.
Age: 24.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Health Dept went off-site to jail to provide H1N1 to employees and in-mates. Patient were asked prior to vaccination if they had received H1N1 vaccination previously. All answered no. Vaccination provided to patient. As clerks keyed dates into system realized patient had received H1N1 vaccination previously 12-09. patient had no problems from vaccination, just received 2 doses.
Age: 46.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Health Dept went off-site to jail to provide H1N1 to employees and in-mates. Patient were asked prior to vaccination if they had received H1N1 vaccination previously. All answered no. Vaccination was provided to patient. As clerks keyed dates into system realized patient had received H1N1 vaccination previously in 12-09. Patient had no problems from vaccination, just received 2 doses.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Asthenia, Dizziness, Syncope
Clinical narrative: Felt weak, dizzy -> syncope episode less than 1 min, pt alert responsive after. Had pt rest supine 5-15 min. BP S to SLP. Felt fine within 5 min, orthostatic RPS normal. Pt discharged no other of s/sx of reaction.
Age: 41.0
Sex: M
Vaccine: MEN, TYP, YF
Symptoms: Pyrexia
Clinical narrative: Fever ~101 F
Sex: F
Vaccine: HPV4, MEN
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who, on an unspecified date, was vaccinated with a dose of GARDASIL (dose and lot number not reported). Concomitant therapy included meningococcal vaccine (unspecified). The nurse reported that "the patient was administered a dose of the vaccine, which dose was unspecified". It was reported that right after receiving the vaccination "about a month ago" the patient was lying down in the office and when she went to get a glass of water she passed out. The patient was also showing "seizure-like" activity". The patient sought for unspecified medical attention. Upon internal review, seizure-like activity was determined to be an other important medical event. Additional information has been requested.
Sex: F
Vaccine: PER
Symptoms: Convulsion
Clinical narrative: Initial report was received 23 April 2010 from a consumer (the reporter's status as a health care professional could not be confirmed). The reporter stated that they had a two month old patient, and the patient's mother (age not reported) may have experienced a seizure an unspecified amount of time after she had received a pertussis vaccine (manufacturer and lot number not reported) when she was a child. Outcome was not reported. No adverse event was reported for the two month old patient. The reporter declined to provide any additional information. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no drug reactions or allergies who on 29-APR-2010 was vaccinated intramuscularly with a first dose of GARDASIL. On 29-APR-2010 the patient developed itching all over her body after receiving her first dose and only dose of GARDASIL. The patient sought unspecified medical attention and was given BENADRYL via intramuscular injection. No laboratory diagnostic studies were performed. On 29-APR-2010, the patient had fully recovered from this event. "The patient was given BENADRYL via intramuscular injection" was considered to be an other important medical event by the physician. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Confusional state, Convulsion, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a medical assistant concerning a 13 year old female with a history of attention deficit non-hyperactivity disorder and no drug allergies, who on 09-SEP-2009 was vaccinated with the first dose of GARDASIL (lot # 659054/0315Y, IM, 0.5ml), on 11-NOV-2009 with the second dose (lot # 663453/0249Y, IM, 0.5ml) and the third dose on 06-APR-2010 (lot # 659054/0315Y, IM, 0.5ml). Concomitant therapy included METADATE CD. On 06-APR-2010 the patient experienced a seizure less than 5 minutes after her third dose. The patient immediately regained consciousness with smelling salts. She was confused for less than 30 seconds. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. On 06-APR-2010, the patient recovered. Follow up information has been received from the medical assistant indicating that the patient had no previous history of seizures and no problems after the first and second doses of GARDASIL. No other vaccine was given on 06-APR-2010. No treatment was required and no referrals were made. Upon internal review, the events were considered to be other important medical events. No further information is available.
Age: 20.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Facial palsy
Clinical narrative: Patient called health department relating he had received H1N1 in Nov. In February, he could not whistle and right side of face was paralyzed. He saw his family physician and was diagnosed with Bell's Palsy. States symptoms (facial paralysis) lasted about 2 months.
Age: 36.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None Reported.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Fatigue, Headache, Local reaction, Malaise
Clinical narrative: Developed presyncope immediately after receiving vaccine and continued to have episodes x 3 ds. Also developed fever to 101.5 and sinus congestion, headache, myalgia and malaise x 5-6 ds that necessitated bedrest. Developed large local reaction even though injection given IM in the deltoid 12 x 12 cm. Symptoms: Fever (780.6), dizziness and giddiness (780.4), malaise and fatigue NEC(780.79), headache(784.0), swelling/mass/lump, localized superficial(782.2).
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Myalgia, Presyncope, Pyrexia, Sinus congestion, Swelling
Clinical narrative: Developed presyncope immediately after receiving vaccine and continued to have episodes x 3 ds. Also developed fever to 101.5 and sinus congestion, headache, myalgia and malaise x 5-6 ds that necessitated bedrest. Developed large local reaction even though injection given IM in the deltoid 12 x 12 cm. Symptoms: Fever (780.6), dizziness and giddiness (780.4), malaise and fatigue NEC(780.79), headache(784.0), swelling/mass/lump, localized superficial(782.2).
Age: 3.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Left thigh 8cm x 7cm red, indurated no fluctuance. Same leg as DTaP.
Age: 13.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 5 inch by 3 inch pink/red area of slightly swollen skin surrounding the injection site of VARIVAX he received 48 hours ago; there is a central area of induration approx 1.5 inches in diameter that is extremely painful.
Age: 64.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Disorientation, Inflammation, Injected limb mobility decreased, Injection site erythema, Injection site warmth
Clinical narrative: Pt states that he received vaccination on 1 Mar 2010 to left deltoid IM and left tricep S.C. Pt report that 2 Mar 10 he had increased muscle weakness, inflammation, disorientation. Right arm 15.5 cm, left 17 cm, area of deltoid to mid arm erythematous. No evidence, drainage or discharge. Area is warm to touch, L ROM unable to lift over head. Denies numbness or tingling with good CMS to fingers. Good recall, short and long term.
Age: 64.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Muscular weakness, Skin warm
Clinical narrative: Pt states that he received vaccination on 1 Mar 2010 to left deltoid IM and left tricep S.C. Pt report that 2 Mar 10 he had increased muscle weakness, inflammation, disorientation. Right arm 15.5 cm, left 17 cm, area of deltoid to mid arm erythematous. No evidence, drainage or discharge. Area is warm to touch, L ROM unable to lift over head. Denies numbness or tingling with good CMS to fingers. Good recall, short and long term.
Age: 13.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema, Pain
Clinical narrative: At 4:30 PM pt c/o stinging, redness, and edema on left arm.  Mother contacted facility and pt was assessed by staff at 4:50.  BP 100/60, HR 98, RR 16, noted 15 x 15 cm redness and denied c/o shortness of breath.  Applied ice pack to left arm. Dr. in to assess pt. Orders given to take OTC Benadryl prn and to call 911 with shortness of breath.  Per mother s/s were gone by the afternoon on 5/4/10.
Age: 1.54
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Injection site movement impairment, Injection site swelling
Clinical narrative: Mom called office and stated that on 5/1/2010 1 day after patient received vaccine of DTaP, Hep B and HiB on right thigh, leg became swollen and patient was unable to bend his leg. The swelling lasted 1 day.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death
Clinical narrative: At birth at Hospital patient began with Infamil formula and when perinatal insurance cut me off I was forced to use Similac Advanced, my son took ill with gastrointestinal diarrhea immediately. Health professional & Doctor were fully aware of this. Health professional threatened me she was fully aware of my C.P.S. history & would report me if patient wasn't brought in by 2-18-09 for his shots.
Age: 31.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash to face.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthma, Biopsy, Bronchitis, Cough, Gastritis
Clinical narrative: 12-18-09 To clinic for acute bronchitis. 1-6-10 Pt with no c/o of illness at time of receiving ZOSTAVAX vaccine. 1-9-10 To clinic for asthma/cough. 1-18-10 MD - bronchitis/cough. 1-25-10 Walk-in clinic - bronchitis/cough (CXR done). 2-19-10 To clinic - asthma/cough. 2-22-10 MD Pulmonologist - asthma. 3-8-10 Hospital - Aspiration pneumonia. 3-17-10 MD cough. 4-1-10 Hospital for aspiration pneumonia, acute tracheitis with herpes virus.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Gastrooesophageal reflux disease, Herpes simplex serology positive, Herpes virus infection, Laboratory test, Pneumonia aspiration
Clinical narrative: 12-18-09 To clinic for acute bronchitis. 1-6-10 Pt with no c/o of illness at time of receiving ZOSTAVAX vaccine. 1-9-10 To clinic for asthma/cough. 1-18-10 MD - bronchitis/cough. 1-25-10 Walk-in clinic - bronchitis/cough (CXR done). 2-19-10 To clinic - asthma/cough. 2-22-10 MD Pulmonologist - asthma. 3-8-10 Hospital - Aspiration pneumonia. 3-17-10 MD cough. 4-1-10 Hospital for aspiration pneumonia, acute tracheitis with herpes virus.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Tracheitis, X-ray
Clinical narrative: 12-18-09 To clinic for acute bronchitis. 1-6-10 Pt with no c/o of illness at time of receiving ZOSTAVAX vaccine. 1-9-10 To clinic for asthma/cough. 1-18-10 MD - bronchitis/cough. 1-25-10 Walk-in clinic - bronchitis/cough (CXR done). 2-19-10 To clinic - asthma/cough. 2-22-10 MD Pulmonologist - asthma. 3-8-10 Hospital - Aspiration pneumonia. 3-17-10 MD cough. 4-1-10 Hospital for aspiration pneumonia, acute tracheitis with herpes virus.
Age: 34.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vertigo, Vestibular neuronitis
Clinical narrative: Vaccine 11/4/09 to right arm. 1 month later had to be seen in ED for "stroke like symptoms". Dx with peripheral vertigo and referred to PCP. PCP Dx=Vestibular Neuritis.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadanopathy-multiple nodes axillary, cervical, inguinal.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Abdominal pain upper, Asthenia, Diarrhoea, Fatigue, Headache
Clinical narrative: Initial report received on 26 March 2009 from a consumer, who is the patient. A 35 year old female patient, whose medical history included allergies to gluten, penicillin, sulfa drugs, dye in pyridium, DEMOROL, FLOMAX and TOPAMAX, received four doses of IMOVAX (lot number not reported) starting on 08 March 2009. Concomitant medications included NEURONTIN, DARVOCET and ULTRACAL. Within 12 hours of receiving each dose of the vaccine, the patient experienced the same reaction which consisted of a stomach ache, diarrhea, fatigue, weakness, cramps in legs, and headaches which lasted several days. According to the patient, the reaction after each rabies vaccine was similar to the reaction she has if she has gluten. The patient's outcome was reported as unknown.
Age: 35.0
Sex: F
Vaccine: RAB
Symptoms: Muscle spasms, Vaccine positive rechallenge
Clinical narrative: Initial report received on 26 March 2009 from a consumer, who is the patient. A 35 year old female patient, whose medical history included allergies to gluten, penicillin, sulfa drugs, dye in pyridium, DEMOROL, FLOMAX and TOPAMAX, received four doses of IMOVAX (lot number not reported) starting on 08 March 2009. Concomitant medications included NEURONTIN, DARVOCET and ULTRACAL. Within 12 hours of receiving each dose of the vaccine, the patient experienced the same reaction which consisted of a stomach ache, diarrhea, fatigue, weakness, cramps in legs, and headaches which lasted several days. According to the patient, the reaction after each rabies vaccine was similar to the reaction she has if she has gluten. The patient's outcome was reported as unknown.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Vaccination complication
Clinical narrative: Mom called office to report patient had adverse reaction to chicken pox vaccine - reports 5cm erythema et edema at injection site. They applied topical steroid et he is fine now. She called 5/5/10.
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Confusional state, Diarrhoea, Headache, Nausea
Clinical narrative: Initial report was received 13 July 2009 from a consumer who is also the patient. A 52-year-old female patient had received an injection of IMOVAX Rabies (also reported as HDCV, lot number not reported) at 16:00 hours on 09 July 2009, and approximately 10 hours later, she developed a fever, generalized achiness, nausea, diarrhea, chills, a severe headache and was confused. The patient contacted a health care professional in her state, as well as the Center for Disease Control and Prevention (CDC) for guidance on completing the final dose of the post-exposure two dose series and it was recommended she complete the second dose with a chick cell culture rabies vaccine. The patient received the second dose on an unspecified date and an unspecified amount of time later, she experienced some achiness, nausea and a headache. The patient had previously received a pre-exposure series of rabies vaccine ten years ago and subsequently received a two dose post-exposure rabies vaccine series due to a "bite situation" four to five years ago. According to the patient, she had not received any other vaccines within the four weeks prior to receiving IMOVAX. At the time of the report, the patient's recovery status was reported as unknown. Follow up information received from the patient on 05 August 2009 who stated that the IMOVAX was administered in the left arm and the Rabies vaccine was administered in the right arm. No other vaccines were received within 4 weeks of 09 July 2009. The patient recovered. Follow-up information received on 24 August 2009 from a consumer. The patient had no concurrent illnesses at the time of the IMOVAX vaccination on 09 July 2009. The patient has pre-existing medical condition of hiatal hernia for which she takes Ranitidine concomitantly. Per the patient, she also experienced symptoms of achiness, nausea and headache two hours after administration of Dose #2 Rabies vaccine (manufacturer unknown) that lasted 10-12 hours. The adverse events did not require physician visit or treatment. The indication for the vaccinations was due to a non-bite, animal saliva in open cut. The animal treated positive. Follow-up information was received from a health care professional on 09 November 2009 which indicated that the patient had not received the vaccines at that facility. The health care provider had no information regarding the event.
Age: 52.0
Sex: F
Vaccine: RAB
Symptoms: Pain, Pyrexia
Clinical narrative: Initial report was received 13 July 2009 from a consumer who is also the patient. A 52-year-old female patient had received an injection of IMOVAX Rabies (also reported as HDCV, lot number not reported) at 16:00 hours on 09 July 2009, and approximately 10 hours later, she developed a fever, generalized achiness, nausea, diarrhea, chills, a severe headache and was confused. The patient contacted a health care professional in her state, as well as the Center for Disease Control and Prevention (CDC) for guidance on completing the final dose of the post-exposure two dose series and it was recommended she complete the second dose with a chick cell culture rabies vaccine. The patient received the second dose on an unspecified date and an unspecified amount of time later, she experienced some achiness, nausea and a headache. The patient had previously received a pre-exposure series of rabies vaccine ten years ago and subsequently received a two dose post-exposure rabies vaccine series due to a "bite situation" four to five years ago. According to the patient, she had not received any other vaccines within the four weeks prior to receiving IMOVAX. At the time of the report, the patient's recovery status was reported as unknown. Follow up information received from the patient on 05 August 2009 who stated that the IMOVAX was administered in the left arm and the Rabies vaccine was administered in the right arm. No other vaccines were received within 4 weeks of 09 July 2009. The patient recovered. Follow-up information received on 24 August 2009 from a consumer. The patient had no concurrent illnesses at the time of the IMOVAX vaccination on 09 July 2009. The patient has pre-existing medical condition of hiatal hernia for which she takes Ranitidine concomitantly. Per the patient, she also experienced symptoms of achiness, nausea and headache two hours after administration of Dose #2 Rabies vaccine (manufacturer unknown) that lasted 10-12 hours. The adverse events did not require physician visit or treatment. The indication for the vaccinations was due to a non-bite, animal saliva in open cut. The animal treated positive. Follow-up information was received from a health care professional on 09 November 2009 which indicated that the patient had not received the vaccines at that facility. The health care provider had no information regarding the event.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis to left arm. Keflex 250/5 1.5 tsp BID x10 days.
Age: 23.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Initial report was received 27 May 2009 from a consumer. A 23-year-old male patient had received an injection of IMOVAX RABIES VACCINE, lot number B0359-2 on 14 May 2009 and "since last week", has experienced a headache, nausea, dizziness and a fever. The patient reported they had been bitten by a bat and had received two doses of rabies vaccine (manufacturer and lot number not reported) while overseas during March 2009. He returned and received two additional doses of rabies vaccine (lot number and dates of administration not reported, manufacturer unknown) and two additional doses of RABAVERT (lot number and dates of administration not reported, manufacturer NOVARTIS) prior to receiving IMOVAX RABIES vaccine on 14 May 2009. The patient declined to provide their health care professionals contact information and no additional information was provided at the time of the report. The recovery status was reported as unknown on the VAERS form; however the reporter stated they had experienced their symptoms "since last week" at the time of the report. Follow-up information was received from the patient on 12 June 2009, and included contact information. The patient stated that he had been bitten by a bat on the left index finger, and the wound had been washed and cleansed at that time. In addition to the doses rabies vaccine noted previously, the patient stated he also received Rabies Immune Globulin (manufacturer and lot number not reported) in and around the wound site and in the deltoid. The bat had not been captured, and was not available for testing. At the time of the report, the fever, nausea, and dizziness had resolved; headache was ongoing. Documents held by sender: None.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Developed reddened, swollen and warm skin around site where 2 vaccines were given on (L) ant. thigh measuring 6x7cm.
Age: 59.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Laboratory test abnormal, Pruritus
Clinical narrative: Initial information received on 16 July 2009 from a consumer. A 59 year old female with a history of liver failure, Lyme's disease, sulfa and penicillin allergies received IMOVAX (lot number not known) on 12 July after being bit by a bat on 29 June 2009. On 15 July 2009 the patient experienced itching and weakness. In 1999 the patient received 5 doses of IMOVAX, 2 doses of IMOVAX in 2001, 2 doses of IMOVAX in 2003, and 2 doses of IMOVAX in 2006. The patient stated that she had titers drawn which were high. Recovery status was unknown. List of Documents held by Sender: none.
Sex: M
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Hives
Age: 1.52
Sex: M
Vaccine: DTAP
Symptoms: Blood calcium normal, Blood chloride normal, Blood electrolytes normal, Blood glucose normal, Blood phosphorus normal
Clinical narrative: Tonic clonic seizures on April 15, had 3 possibly 4 tonic clonic seizures lasting less than 5 minutes each, resulting in ER visit and hospitalization. Loaded with DILANTIN, KEPPRA, and ATIVAN which stopped seizures. Possible short duration seizures since April 16, but largely controlled on KEPPRA.
Age: 1.52
Sex: M
Vaccine: DTAP
Symptoms: Blood potassium normal, Blood sodium normal, Carbon dioxide decreased, Electroencephalogram abnormal, Full blood count normal
Clinical narrative: Tonic clonic seizures on April 15, had 3 possibly 4 tonic clonic seizures lasting less than 5 minutes each, resulting in ER visit and hospitalization. Loaded with DILANTIN, KEPPRA, and ATIVAN which stopped seizures. Possible short duration seizures since April 16, but largely controlled on KEPPRA.
Age: 1.52
Sex: M
Vaccine: DTAP
Symptoms: Grand mal convulsion, Nuclear magnetic resonance imaging normal
Clinical narrative: Tonic clonic seizures on April 15, had 3 possibly 4 tonic clonic seizures lasting less than 5 minutes each, resulting in ER visit and hospitalization. Loaded with DILANTIN, KEPPRA, and ATIVAN which stopped seizures. Possible short duration seizures since April 16, but largely controlled on KEPPRA.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: He didn't have any side effects.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper vastus lateralis with slightly raised quarter sized red area at injection site.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to office approximately 24 hrs later with localized redness, swelling, tenderness to site of injection of VARIVAX booster.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Oedema, Oedema peripheral, Skin warm
Clinical narrative: Redness, swelling to right arm which started yesterday. Erythema, edema, warmth noted to right arm. Proximal lower (R) arm and distal upper (R) arm on posterior and anterior medial surfaces.
Age: 23.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Erythema, Oedema
Clinical narrative: Redness, swelling to right arm which started yesterday. Erythema, edema, warmth noted to right arm. Proximal lower (R) arm and distal upper (R) arm on posterior and anterior medial surfaces.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Inj given in pre-deployment line on Sat 1 May 10.  Site red, hot and hard after 24 hrs.  Spread to 4" X 7" by 3 May 10.  Placed on KEFLEX (500 mg, 2 X day for 10 days).  Extremely sore, red, hot & itchy.
Age: 51.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site warmth
Clinical narrative: Inj given in pre-deployment line on Sat 1 May 10.  Site red, hot and hard after 24 hrs.  Spread to 4" X 7" by 3 May 10.  Placed on KEFLEX (500 mg, 2 X day for 10 days).  Extremely sore, red, hot & itchy.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Autopsy, Culture positive, Death, Influenza, Influenza like illness
Clinical narrative: Apparently had flu-like symptoms starting about 2 OCT 09. He had lab work & flu shot at the Health Clinic, on 6 OCT 09. He had a respiratory arrest at home on 9 OCT 09. H1N1 influenza from lung cultures & Nl Swab at autopsy.
Age: 52.0
Sex: M
Vaccine: FLUX
Symptoms: Laboratory test, Polymerase chain reaction, Respiratory arrest
Clinical narrative: Apparently had flu-like symptoms starting about 2 OCT 09. He had lab work & flu shot at the Health Clinic, on 6 OCT 09. He had a respiratory arrest at home on 9 OCT 09. H1N1 influenza from lung cultures & Nl Swab at autopsy.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1), HEP, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles left C2, 3, 4 dermatomes. VALTREX, MEDROL Dose Pak.
Age: 71.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None. This was given during a clinic for people working in flood waters. Full charts weren't available. No adverse event occurred - out of licensed age range.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles rash outbreak on torso below right armpit.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None *Note - This was given in a clinic for people working in flood water.  Full charts were not available.  No adverse event occurred.  Out of licensed age range.
Age: 70.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None. This occurred in an immunization clinic for flood emergency workers - Full records were not used. No adverse event occurred, out of licensed age range.
Age: 0.21
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Crying, Irritability
Clinical narrative: Developed inconsolable crying for greater than 4 hrs. following 2 month immunizations. Was fussy for >24 hours. No fever. Received two doses TYLENOL following.
Age: 17.0
Sex: F
Vaccine: HPV4, IPV, MMR, MNQ
Symptoms: Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Erythema and edema at injection site 8 hours after administration. Fever of 103 degrees F. Hydrocortisone 1% cream bid prn.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness 4.5 cm diameter at site - localized & firm to the touch.  Pt is to return to clinic if worsening symptoms.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Large raised/swollen area at VARIVAX vaccine site - 12 days post vaccine. No fever, no redness. Resolved w/in.
Age: 0.16
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Culture stool positive, Dehydration, Diarrhoea, Gastroenteritis rotavirus, Vomiting
Clinical narrative: Dx: Intestinal infection enteritis due Rotavirus, vomiting and diarrhea and dehydration - that required four days of hospitalization - Child was positive for Rotavirus.  Follow up from admission for rotavirus Viral GE with vomiting and diarrhea.  Sx. have resolved s/p admission.  Pt. doing much better now.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: 10 cm by 6 cm localized reaction with raised border occurring 1 wk post injection.
Age: 34.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient developed rash on skin (not chicken pox) 2 weeks after varicella vaccine dose #1.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Eschar, Impaired healing, Injection site scab
Clinical narrative: Non-healing eschar (2mm) at site of vaccine administration.
Age: 7.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Eye swelling, Respiratory distress, Swelling face, Urticaria, Wheezing
Clinical narrative: Patient had facial swelling - especially eyes, hives, and wheezing/respiratory distress 25 min after shot. Pt had eaten pecans 30 min prior but has no food allergy. Pt had a sat of 92%. BENADRYL, steroids and albuterol were given.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Patient given ADACEL at 8:38 AM on 5/5/2010.  Pt began having headache, lightheadedness, dizziness, nausea, fevers, chills intermittently starting at 7 PM on 5/5/2010.  Had doctors appt on 5/6/2010 at 12:30 PM and was without fever.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Nausea, Pain
Clinical narrative: Left deltoid swollen, red, & itching.  Pt c/o n/v, body ache.
Age: 37.0
Sex: F
Vaccine: HEP, MMR, TDAP
Symptoms: Vomiting
Clinical narrative: Left deltoid swollen, red, & itching.  Pt c/o n/v, body ache.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse reaction occurred.  Accidentally given additional PEDIARIX.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Inappropriate schedule of drug administration, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness, No reaction on previous exposure to drug
Clinical narrative: My wife and son and I all got the seasonal flu shot at a clinic right around Labor Day, not sure of the exact date. All three shots seemed normal and almost painless, and they did not have any reactions. However my injection site, left upper arm, quickly became very sore and stiff. It hurt all the time to varying degrees. I saw my doctor at about 5 weeks but he didn't seem concerned. He did give me the nasal version of the H1N1 vaccination, even though I was a few months over age 50. Around that time I gradually began to get better, but it was 4-5 months before I could sleep on my left side. 8 months after the injection my arm is still not completely pain free or mobile. I have been getting flu shots regularly for about 10 years without any unusual side effects (e.g. 1-2 days of mild soreness). I would like to know 1) if there is any possible treatment, and 2) if there is a nasal version of the seasonal flu vaccination, since I obviously don't plan on getting any more injections.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Sleep disorder
Clinical narrative: My wife and son and I all got the seasonal flu shot at a clinic right around Labor Day, not sure of the exact date. All three shots seemed normal and almost painless, and they did not have any reactions. However my injection site, left upper arm, quickly became very sore and stiff. It hurt all the time to varying degrees. I saw my doctor at about 5 weeks but he didn't seem concerned. He did give me the nasal version of the H1N1 vaccination, even though I was a few months over age 50. Around that time I gradually began to get better, but it was 4-5 months before I could sleep on my left side. 8 months after the injection my arm is still not completely pain free or mobile. I have been getting flu shots regularly for about 10 years without any unusual side effects (e.g. 1-2 days of mild soreness). I would like to know 1) if there is any possible treatment, and 2) if there is a nasal version of the seasonal flu vaccination, since I obviously don't plan on getting any more injections.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Areflexia, Asthenia, CSF protein increased, Lumbar puncture abnormal
Clinical narrative: Patient presented to facility on 3/6/2010 with acute bilater/symmetrical weakness and absent deep tendon reflexes. Symptom onset date documented as 3/2/2010.
Age: 1.44
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Hypophagia, Pyrexia, Tremor
Clinical narrative: Fever 102F the night that child received the 6 vaccines. Tylenol given by mom Q4h. It only worked for 20 minutes. The baby had shaking episode every 2 hours last about 2 minutes. Only consumed yogurt and unable to tolerate baby milk.
Age: 4.0
Sex: M
Vaccine: DTAP, UNK
Symptoms: Gait disturbance, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: 2 shots were given in each leg. His right leg became swollen a short time after getting home. By 9:00 PM he complained about the pain. Around 3:00AM he cried for me to come help him to the bathroom. He couldn't walk. He was trying to crawl to the bathroom but was in too much pain. Today it is 3:20 PM 05/06/2010, the pain is still there, he cannot walk due to the pain. He about screams when you barely touch his leg without applying any pressure. He has a fever.  He has a hard time even adjusting his leg when he's sitting back on the couch. He still has to be carried to the bathroom. The sight of the shot is not red, no pus. It's swollen, normal color.... extremely painful for him. Doctors office said to just ice it, and give Motrin IB for kids.
Age: 62.0
Sex: F
Vaccine: DTOX
Symptoms: Arthralgia, Neck pain, Pain in extremity, Pain in jaw
Clinical narrative: Pain/soreness to left arm going up into neck/jaw; aches in other joints.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV1
Symptoms: Hypotonia, Laboratory test normal, Nervous system disorder, Paralysis, Vaccination complication
Clinical narrative: Paralysis all muscles for 5 months now, severe hypotonia. Hospitalized.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: 1. Injection site reaction-red and raised, approx. 1 inch in diameter. 2. Mild case of hives-head-to-toe, equal to or less than 12 at any given time that came and went-lasted approx. 24hr.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Rt arm (+) warm, tender, erythema at site. T 100.8. Rx with ice, KEFLEX x 10 day.
Age: 16.0
Sex: M
Vaccine: RAB
Symptoms: Paraesthesia, Peripheral coldness, Skin discolouration
Clinical narrative: Initial report received on 31 March 2009 from a health professional.  A 16 year old male patient, with no medical history, was exposed to the saliva of a cow that died two days later; the cow's head was sent for testing but deemed an invalid specimen.  On 25 March 2009, the patient received a first intramuscular injection of IMOVAX Rabies (lot number A0484) in the left gluteal area and three intramuscular injections (two in the right gluteal area and one in the left gluteal area) of HYPERRAB (manufacturer unknown, lot number 26N97T1).  On 29 March 2009, the patient received a second left deltoid intramuscular injection of IMOVAX Rabies (lot number B0359-2).  On 31 March 2009, the patient's left arm was cold and purple with cold and tingling fingers.  The patient's outcome was reported as unknown.  No other information was reported.  Follow up information was received on 30 April 2009 from a health care professional who stated that the patient spontaneously recovered from the events on 01 April 2009.  The patient received IMOVAX on 01 April 2009, 04 April 2009, 10 April 2009, and 24 April 2009 (lot number B0359-2) in addition to the first two doses.  The patient did not experience further problems following the last four administrations.  The reporter felt that the symptoms were not related to the rabies vaccine.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain, Arthralgia, Confusional state, Headache, Irritability
Clinical narrative: Initial report received from a health care provider on 14 October 2009.  A 42 year-old male patient was vaccinated with a first dose of IMOVAX (Sanofi Pasteur, Lot number unknown) on 16 September 2009 and reported headache, arthralgia (left elbow) and abdominal pain post vaccination.  The patient received the second dose of IMOVAX on 23 September 2009 and reported arthralgia (bilateral knee and left elbow) and abdominal pain post second vaccination.  On 07 October 2009 the patient was examined by a physician and had a "normal exam" as per the physician.  The patient was prescribed NAPROSYN, PROTONIX, LORTAB and Hyoscyamine for pain, which were not effective.  The patient reported no improvement on 14 October 2009 with continued bilateral knee pain, confusion and irritability.  The patient's physician decided not to administer the third dose of the pre-exposure series due to the patient's adverse events.  The outcomes of the events were not reported.  No further information is expected.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Initial report received from a health care provider on 14 October 2009.  A 42 year-old male patient was vaccinated with a first dose of IMOVAX (Sanofi Pasteur, Lot number unknown) on 16 September 2009 and reported headache, arthralgia (left elbow) and abdominal pain post vaccination.  The patient received the second dose of IMOVAX on 23 September 2009 and reported arthralgia (bilateral knee and left elbow) and abdominal pain post second vaccination.  On 07 October 2009 the patient was examined by a physician and had a "normal exam" as per the physician.  The patient was prescribed NAPROSYN, PROTONIX, LORTAB and Hyoscyamine for pain, which were not effective.  The patient reported no improvement on 14 October 2009 with continued bilateral knee pain, confusion and irritability.  The patient's physician decided not to administer the third dose of the pre-exposure series due to the patient's adverse events.  The outcomes of the events were not reported.  No further information is expected.
Age: 48.0
Sex: M
Vaccine: RAB
Symptoms: Antibody test abnormal, Antibody test positive
Clinical narrative: Initial report received on 05 February 2010 from a health professional.  Additional information was received on 08 February 2010.  A 48 year old male patient, who is an animal handler for a veterinarian, had never received rabies vaccination in the past.  He received the three dose series of IMOVAX Rabies (lot number not reported) on 08 June 2009, 15 June 2009 and 30 June 2009 as pre-exposure prophylaxis.  The patient was not immunocompromised.  He had no concomitant medications and no illnesses at the time of vaccination.  He had received no other vaccines on the same day and it was unknown if he had received any other vaccinations within the four previous weeks.  On 20 October 2009, the patient's titer level was less than 1:5, which was considered a sub optimal response.  Therefore the patient received a booster dose of IMOVAX Rabies (lot number not reported) on 30 November 2009.  On 25 January 2010, a repeat serum titer level was less than 0.1.
Age: 45.0
Sex: M
Vaccine: RAB
Symptoms: Malaise, Pyrexia
Clinical narrative: Non-serious case received from a health care professional on 20 October 2009.  A 45-year-old male patient developed malaise and intermittent fevers (as high as 103 degrees Fahrenheit), four days after he had received a third dose of IMOVAX (lot number B0661) on 09 October 2009.  The first two doses of IMOVAX were given on 10 September 2009 and 17 September 2009.  The events required a visit to the doctor's office; treatment was not reported.  At the time of the report, patient outcome was 'not recovered'.  Follow-up information received on 19 November 2009 from a healthcare professional.  The patient had not been exposed to rabies.  The first three doses of IMOVAX Rabies had each been administered intramuscularly in the right deltoid.  The reporter confirmed that the malaise and intermittent fevers started on 13 October 2009.  Corrective treatment was TYLENOL for fever.  No additional information was available at the time of reporting.
Age: 29.0
Sex: M
Vaccine: RAB
Symptoms: Abdominal pain
Clinical narrative: Initial case received on 26 January 2010 from a healthcare provider.  A 29 year old male patient received an intramuscular left deltoid injection of IMOVAX Rabies (lot number D0869-1) at approximately 1:30 P.M. on 19 January 2010 (The narrative on the report states this was the first dose, but "Number of previous doses" was marked as 1). The patient also received within the previous four weeks, an intramuscular right deltoid injection of H1N1 (lot number UP001AA), a subcutaneous right arm injection of YF VAX (lot number UF627AA) and an intramuscular left deltoid injection of FLUZONE (lot number U3254EA) on 13 January 2010.  On 20 January 2010 at approximately 2:00 P.M. the patient experienced abdominal pain rated 2 on a scale of 10 and lasted 5 hours.  Follow-up information was received 19 February 2010 from a health care professional.  The reporter confirmed the event occurred after the patient had received their first dose of IMOVAX Rabies vaccine, lot number D0869-1.  The patient completed the IMOVAX Rabies series and did not experience any additional adverse events.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient developed Zoster five days after shingles vaccine.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Formication, Paraesthesia
Clinical narrative: Tingling/crawling sensation in left shoulder/neck/cheek. Sensation only felt when holding still. As time went on, the tingling left the face/neck area but is still in shoulder area..many times daily.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Injection site reaction. 10 cm of erythema & edema tender to palpation. Advised to use OTC BENADRYL & cool compresses.
Age: 0.22
Sex: F
Vaccine: DTAP, RV1, UNK
Symptoms: Crying, Dehydration, Diet refusal, Gastrointestinal disorder, Infantile spitting up
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of intestinal problems in a 2-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included DTAP vaccine (manufacturer unspecified) and unspecified vaccines (standard 2 - 3 month series) (manufacturer unspecified) given on 2 March 2010. There were no concurrent medications. On 2 March 2010 at 16:00 the subject received 1st dose of ROTARIX (oral). About 2 weeks after vaccination with ROTARIX, the subject developed intestinal problems, spitting up,high-pitched crying and refusal to eat. At the time of reporting the events were unresolved. The mother also mentioned that her daughter received a dose of ROTATEQ on 12 April 2010 and developed severe dehydration and gastrointestinal upset, described as severe intestinal issues. The mother did not have details of lot numbers and did not know which other vaccines were administered on the same dates.
Age: 57.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erectile dysfunction, Laboratory test normal
Clinical narrative: Patient reports new, persist. erectile dysfunction since receiving H1N1 vaccine.
Age: 16.0
Sex: F
Vaccine: HEP, HPV4, IPV, MMR, TDAP
Symptoms: Clonus, Dizziness, Feeling abnormal, Vomiting
Clinical narrative: Aft immediately upon completion of administrating vaccines pt stated 'what a bad feeling I have' and was observed by this nurse to have a fainting spell with clonic movements. Regained alertness within 30 seconds. Pt was seated in chair at time of occurrence. Legs were elevated. Juice given. Pt also vomited small amount. Pt was assessed by nurse practitioner. Respirations normal. Pt was monitored.
Age: 50.0
Sex: F
Vaccine: PPV, HIBV, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Call from Pt C/O reaction to Pneumovax immunization given yesterday. Right deltoid was sore, red and a little swollen this morning. Soreness redness continues along with increased swelling thoughout the day. Dr. informed. Pt directed to her local ED for evaluation. Pt agrees to this plan.
Age: 50.0
Sex: F
Vaccine: PPV, HIBV, PPV, TDAP
Symptoms: Erythema, Pain in extremity
Clinical narrative: Call from Pt C/O reaction to Pneumovax immunization given yesterday. Right deltoid was sore, red and a little swollen this morning. Soreness redness continues along with increased swelling thoughout the day. Dr. informed. Pt directed to her local ED for evaluation. Pt agrees to this plan.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chills
Clinical narrative: Slight chills and weakness
Age: 1.17
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood count, Pyrexia, Rash, Rash erythematous, Urticaria
Clinical narrative: Fever of 103.3 (rectally) began on 05/02/2010 and continued fevers between 101-103 until 05/05/2010.  The fever did not react to Tylenol or other fever-reducing attempts.  On 05/06/2010, developed a rash on trunk, arms, legs, face, and neck varying from pinpoint red dots to welts.
Age: 55.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP, YF
Symptoms: Diarrhoea, Rash generalised, Urticaria
Clinical narrative: Pt. completed 4 dose course of TYPHOID oral vaccine appropriately. States 2 days after completion, broke out in "hives, rash all over body." Also had diarrhea. Lasted 4 - 5 days - Resolved with use of BENADRYL and time.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Skin warm, Urticaria
Clinical narrative: Large area erythema, increase warmth, induration area approx 10 cm pale erythema with dark erythema with induration approx 4x7 cm. (+) urticaria.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Large area erythema, increase warmth, induration area approx 10 cm pale erythema with dark erythema with induration approx 4x7 cm. (+) urticaria.