chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: HPV2
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported by a consumer and described the occurrence of miscarriage in a 24-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) while pregnant.  A physician or other health care professional has not verified this report. Concurrent medications included Multivitamins. On 10 August 2010 at 11:00 the subject received 1st dose of CERVARIX in the left arm. The subject discovered she was pregnant one week later on 18 August 2010. The subject experienced vaccine exposure during pregnancy. The date of last menstrual period was not provided and her estimated date of delivery was 20 May 2011. On 7 November 2010, 89 days after vaccination with CERVARIX, the subject experienced a miscarriage. This case was assessed as medically serious by agency. No additional details were provided.
Age: 64.0
Sex: F
Vaccine: RV1
Symptoms: Abdominal pain upper, Accidental exposure, Eye irritation, Nausea, Ocular hyperaemia
Clinical narrative: This case was reported by a healthcare professional (also the subject) and described the occurrence of eyes splashed with vaccine in a 64-year-old female subject who was preparing to administer a dose of ROTARIX (GlaxoSmithKline) to a patient. Concurrent medical conditions included depression, giant cell arteritis, high blood pressure, high cholesterol and penicillin allergy. Concurrent medications included PREDNISONE, LIPITOR, DIOVAN, ATENOLOL, Baby ASPIRIN, PRILOSEC, ZOLOFT, ABILIFY and LORAZEPAM. On 19 January 2011 at 17:00 the subject was drawing up the ROTARIX vaccine in a syringe after having mixed up the diluent with powder. She pressed down the transfer adaptor syringe into the top and the vaccine splashed out into the subjects right eye. The subject stated that the splashing may have caused by the pressure she placed onto adaptor while trying to fit it onto the top. Immediately after the exposure of ROTARIX to her right eye, the subject experienced burning and redness of the right eye. It was reported that these symptoms were improved as of the next day. On 20 January 2011, the subject experienced brief nausea and stomach ache which resolved soon after starting. The healthcare professional considered the events were clinically significant (or requiring intervention). The healthcare professional considered the events of redness and burning of the right eye as probably related to vaccination with ROTARIX, while nausea indicated as possibly related. Attribution of stomach ache was not specifically provided.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Fever T 101 degrees taken by ear thermometer 1/11/11 approximately 11 PM. Hives noted 1/12/11 8:30 AM came in for evaluation & rash - urticaria still present 3:20PM 1/12/11.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, swelling size of tennis ball from elbow to shoulder, itching, pain - severe sharp pains at site. Iced site for 2 days. Took ADVIL & BENADRYL & sleeping pills at night. Shoulder numb & weak.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Redness, swelling size of tennis ball from elbow to shoulder, itching, pain - severe sharp pains at site. Iced site for 2 days. Took ADVIL & BENADRYL & sleeping pills at night. Shoulder numb & weak.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Pt received ZOSTAVAX on 1-10-11 then developed suspicious rash (seven) 7 days later (chicken pox like) verified by MD.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash appeared. Still had rash on 1/21/11 when seen by physician.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: C-reactive protein, Decreased appetite, Differential white blood cell count, Fatigue, Full blood count
Clinical narrative: Patient received 1st GARDASIL imm. on Jan. 5, 2011. On Jan. 11 developed a rash on both arms & chest. Took BENADRYL to alleviate itching. Jan. 13, noticed spots had appeared in rash area. Other symptoms Jan. 11-14 included shaky hands, hands were achy, fatigue, loss of appetite & nausea. Rash disappeared Jan. 15 but fatigue & nausea continue. Patient had used tanning bed during the time rash appeared.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain, Pruritus, Rash, Red blood cell sedimentation rate
Clinical narrative: Patient received 1st GARDASIL imm. on Jan. 5, 2011. On Jan. 11 developed a rash on both arms & chest. Took BENADRYL to alleviate itching. Jan. 13, noticed spots had appeared in rash area. Other symptoms Jan. 11-14 included shaky hands, hands were achy, fatigue, loss of appetite & nausea. Rash disappeared Jan. 15 but fatigue & nausea continue. Patient had used tanning bed during the time rash appeared.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Tanning, Tremor
Clinical narrative: Patient received 1st GARDASIL imm. on Jan. 5, 2011. On Jan. 11 developed a rash on both arms & chest. Took BENADRYL to alleviate itching. Jan. 13, noticed spots had appeared in rash area. Other symptoms Jan. 11-14 included shaky hands, hands were achy, fatigue, loss of appetite & nausea. Rash disappeared Jan. 15 but fatigue & nausea continue. Patient had used tanning bed during the time rash appeared.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Herpes zoster, Injection site rash, Injection site vesicles, Varicella virus test positive
Clinical narrative: Developed a vesicular rash on right thigh 6 months after varicella vaccine times 4 days. Skin culture positive for varicella zoster virus. Given 5 day course of oral Acyclovir to treat, recovered without difficulty.
Age: 1.22
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Pyrexia
Clinical narrative: Developed fever on the day of vaccination; followed by seizure (febrile seizure) next day (01/11/2011). Child was evaluated and treated in E/R and discharged home.
Age: 1.9
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Febrile convulsion, Laboratory test
Clinical narrative: Patient had a 2 minute febrile seizure 24 hours after a Flu-zone flu shot and was brought to Hospital. Lot UT35678A, Exp June 2011
Age: 1.9
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood culture negative, Chest X-ray normal, Convulsion, Culture throat negative, Pyrexia
Clinical narrative: Patient had a 2 minute febrile seizure 24 hours after a Flu-zone flu shot and was brought to Hospital. Lot UT35678A, Exp June 2011
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Swelling, Tenderness
Clinical narrative: Fever (low grade at time of EC visit), erythema with well-defined border, tenderness & swelling.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Eczema, Screaming
Clinical narrative: High pitched screaming for more than 5 hours after vaccines were given. Also, my son developed eczema within 2 weeks after he received first Vaccination.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt leg at site of injection was indurated, swollen, with erythema, no pain on palpation, but mild limping
Age: 31.0
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous, Rash pruritic, Upper respiratory tract infection
Clinical narrative: Upper respiratory infection symptoms 24 hours after vaccine. Fine red raised rash with itching noted on upper chest initially, then legs, arms, and buttocks 48 hours after vaccine. Topical hydrocortisone cream and Benadryl 50mg. orally (both OTC) taken
Age: 1.38
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever of 101.3
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Oedema peripheral, Vomiting
Clinical narrative: Swelling in legs, crying, vomiting
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Injection site induration, Injection site mass, Injection site pruritus, Pain in extremity
Clinical narrative: Dad brought patient to office today stating patient complained that leg hurt yesterday.  Dad felt hard lump over injection site.  Denies fever.  Dad gave child Motrin for pain relief.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Electromyogram abnormal, Immediate post-injection reaction, Myalgia, Neuritis
Clinical narrative: Immediate onset of pain, myalgia.  Went to Dr. on 10/26/2010 for extreme pain.  Had MRI (negative), Saw Orthopedist who did EMG (showed slight neuritis), numerous blood work showed only elevated Sed Rate.  Currently complaining of increasing discomfort.  Currently taking Steroids.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging normal, Pain, Red blood cell sedimentation rate increased
Clinical narrative: Immediate onset of pain, myalgia.  Went to Dr. on 10/26/2010 for extreme pain.  Had MRI (negative), Saw Orthopedist who did EMG (showed slight neuritis), numerous blood work showed only elevated Sed Rate.  Currently complaining of increasing discomfort.  Currently taking Steroids.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella post vaccine
Clinical narrative: POX, LIKE CHICKEN POX.  A FEW ON THE LEGS AT FIRST, THEN MORE APPEARED MOSTLY ON THE ARMS AND LEGS.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Rash began on shoulders than new crop each day and itchy.
Age: 3.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Erythema and swelling of the left thigh.  Patient treated with IV antibiotics for presumed cellulitis.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: High fever (105 rectal)
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Productive cough, Pyrexia
Clinical narrative: Our son had fever mild fever on evening of injection and next day following injection. Cough and increase in fever late afternoon of 1/14/2011 - Administered Tylenol at 4:45 and 11:30pm and Xopenex at 9:15PM. Administered Xopenex inhaler at 4:45AM on 1/15 for coughing. He cried out at 7:30 AM and with high Fever of 106.4 degrees and coughing up clear mucus. Placed him in warm tub and administered Motrin and Xopenex. Took to pediatrician and continued alternating Tylenol and Motrin every 3 hours - and Xopenex nebulizer every 4 hours. Fever continued between 102 and 105 until AM of 1/16.
Age: 1.51
Sex: M
Vaccine: FLU3
Symptoms: Decreased activity, Discomfort, Febrile convulsion, Hypotonia, Lethargy
Clinical narrative: The evening of the vaccine patient, after the late afternoon nap (~4:30 PM), he had a fever, was very lethargic, and showed discomfort. I gave him Tylenol. He slept normally that night, but still had a fever in the morning. Administered Tylenol during the day, and he was active, though not quite at normal levels for him. After a late afternoon nap he showed signs of greater discomfort, and his fever seemed to be on the rise. I gave more Tylenol at about 5 pm. The fever continued to climb. At 6 pm I took his temp again and it had not decreased, and I was shocked to see it had spiked up to 103. He was on my lap, and was obviously not comfortable. I was considering going to the ER, when he had two very short (< 1 sec) spasms which after the fact I realized were a precursor to a Febrile seizure. I was about the pick up the phone to inquire of my friend about what ER she would recommend when he had what later turned out to be a Febrile seizure. It lasted about 30 seconds, and he essentially began to shake and went limp and unresponsive. I immediately dialed 911 and an ambulance took us to the Medical Center, where the condition was diagnosed, and treated with Tylenol and Ibuprofen. We left the ER about 3 hours later and patient went to sleep normally. During the next day his fever gradually returned to normal. No other symptoms of illness were present before, during, or after. (ie no coughing, runny nose, etc). His twin brother also had the vaccine at the same time, and showed no fever or other symptoms.
Age: 1.51
Sex: M
Vaccine: FLU3
Symptoms: Muscle spasms, Pyrexia, Tremor, Unresponsive to stimuli
Clinical narrative: The evening of the vaccine patient, after the late afternoon nap (~4:30 PM), he had a fever, was very lethargic, and showed discomfort. I gave him Tylenol. He slept normally that night, but still had a fever in the morning. Administered Tylenol during the day, and he was active, though not quite at normal levels for him. After a late afternoon nap he showed signs of greater discomfort, and his fever seemed to be on the rise. I gave more Tylenol at about 5 pm. The fever continued to climb. At 6 pm I took his temp again and it had not decreased, and I was shocked to see it had spiked up to 103. He was on my lap, and was obviously not comfortable. I was considering going to the ER, when he had two very short (< 1 sec) spasms which after the fact I realized were a precursor to a Febrile seizure. I was about the pick up the phone to inquire of my friend about what ER she would recommend when he had what later turned out to be a Febrile seizure. It lasted about 30 seconds, and he essentially began to shake and went limp and unresponsive. I immediately dialed 911 and an ambulance took us to the Medical Center, where the condition was diagnosed, and treated with Tylenol and Ibuprofen. We left the ER about 3 hours later and patient went to sleep normally. During the next day his fever gradually returned to normal. No other symptoms of illness were present before, during, or after. (ie no coughing, runny nose, etc). His twin brother also had the vaccine at the same time, and showed no fever or other symptoms.
Age: 70.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blood test abnormal, Polymyalgia rheumatica, Urine analysis abnormal, X-ray abnormal
Clinical narrative: Polymyalgia Rheumatica
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Patient was given first dose of vaccine for influenza. Patient was instructed to wait in waiting room to monitor for adverse reactions. approx 10 minutes after immunization was given Patient mom told front desk personnel that her daughter had developed a rash and was constantly itching. Patient was brought back to exam room and seen by provider immediately. Patient was given 2.5ml Benadryl per Provider verbal order. Patient remained in exam room for 30 minutes for further observation. Seen again by provider and was allowed to leave with instructions from provider.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Started as a red circle around the injection site.  On 1/24/2011, redness is raised, itchy, a little warm, and 3-4" X 1" in size. Patient reports no fever.
Age: 15.0
Sex: F
Vaccine: FLUN3
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: SWOLLEN LIPS, HIVES, ITCHY SKIN.
Age: 4.0
Sex: F
Vaccine: FLUN3
Symptoms: Cyanosis, Electroencephalogram abnormal, Grand mal convulsion, Resuscitation
Clinical narrative: 2 mins generalized tonic-clonic seizure with cyanosis requiring CPR
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia
Clinical narrative: Fever of 101.8 for 2 days; when given Tylenol fever would reduce and then creep back up to 101.8 after 4 hours.
Age: 1.02
Sex: F
Vaccine: FLUX, HEPA, MMR, PPV, VARCEL
Symptoms: Body temperature increased, Cyanosis, Dyskinesia, Febrile convulsion, Gaze palsy
Clinical narrative: Febrile seizure including shaking and jerking of limbs, stiffness, blue lips, eyes rolling back, loss of consciousness (2 minutes or less). Temp of 103.6.
Age: 1.02
Sex: F
Vaccine: FLUX, HEPA, MMR, PPV, VARCEL
Symptoms: Loss of consciousness, Musculoskeletal stiffness, Tremor
Clinical narrative: Febrile seizure including shaking and jerking of limbs, stiffness, blue lips, eyes rolling back, loss of consciousness (2 minutes or less). Temp of 103.6.
Age: 33.0
Sex: F
Vaccine: FLUX, MNQ
Symptoms: Headache, Injection site erythema, Injection site swelling, Meningism, Neck pain
Clinical narrative: Initial report received from a health care professional via Health Authority (HA reference: 132167) on 13 Jan 2011: This patient was vaccinated with MENVEO (batch number M10094) intramuscularly and INTANZA (other manufacturer, batch number G9732-1) intramuscularly on 14 Dec 2010 at 13:05 and 13:00 hours respectively. On the same day she developed cervico-cephalgic meningeal inflammation with pain at motion of the head. She also developed reddening and swelling at the injection site. Outcome of the events was not reported. The events were assessed as non-serious by the reporter.
Age: 33.0
Sex: F
Vaccine: FLUX, MNQ
Symptoms: Pain
Clinical narrative: Initial report received from a health care professional via Health Authority (HA reference: 132167) on 13 Jan 2011: This patient was vaccinated with MENVEO (batch number M10094) intramuscularly and INTANZA (other manufacturer, batch number G9732-1) intramuscularly on 14 Dec 2010 at 13:05 and 13:00 hours respectively. On the same day she developed cervico-cephalgic meningeal inflammation with pain at motion of the head. She also developed reddening and swelling at the injection site. Outcome of the events was not reported. The events were assessed as non-serious by the reporter.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Incorrect route of drug administration, Musculoskeletal pain, Pain in extremity
Clinical narrative: Two days following the vaccine I had severe pain in my upper arm and shoulder. It was extremely painful to dress or perform activities of daily living. I took ALEVE which did help slightly. On January 21, I finally went to my physician for treatment. It (the vaccine) was administered above the deltoid muscle.
Age: 19.0
Sex: F
Vaccine: RAB
Symptoms: Full blood count normal, Lymphadenopathy, Mononucleosis heterophile test negative, Pyrexia
Clinical narrative: Initial case was received on 07 May 2010 from a healthcare professional. A 19 year old female patient vaccines received included: a left deltoid intramuscular injection of IPOL (lot number B0475-2) on 21 April 2010; a left deltoid intramuscular injection of TYPHIM VI (lot number E-0214-1) and a left deltoid intramuscular injection of IMOVAX (lot number D0792-1) on 22 April 2010; a left deltoid intramuscular injection of IMOVAX (lot number D0869-1) on 29 April 2010. She had received a left deltoid intramuscular injection of  "IXARIO" (Novartis lot number JEV08E10B) on 14 April 2010. The patient's concomitant medications included CELEXA, ATIVAN and BCP-TRINESSA. She had allergies to red dye and sulfa. She had no illness at the time of the vaccinations. On 15 April 2010 the patient experienced a cough and sore throat until 21 April 2010. The cough and sore throat were treated with a Z PAK. On 05 May 2010 the patient experienced a fever of 105 F with mildly enlarged glands in the neck, which as of this report were getting better, but not resolved. On an unspecified date a CBC and monospot tests were normal. Follow-up information was received on 01 June 2010 from a healthcare professional. The IMOVAX injections were given for pre-exposure. The third dose of IMOVAX (lot number D0792-1) was completed on 13 May 2010. The patient completed "JE IXARIO" (lot number JEV08F12B) on 12 May 2010. The fever and mildly enlarged lymph glands resolved spontaneously by 10 May 2010 and no further treatment was needed. Documents held by sender: None.
Age: 22.0
Sex: M
Vaccine: FLU(H1N1), SMALL, TYP
Symptoms: Blister, Erythema, Pruritus, Purulence, Rash vesicular
Clinical narrative: Vesicular rash, pruritis, erythema, purulence, skin lesion, blister.
Age: 22.0
Sex: M
Vaccine: FLU(H1N1), SMALL, TYP
Symptoms: Skin lesion
Clinical narrative: Vesicular rash, pruritis, erythema, purulence, skin lesion, blister.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Fever, erythema (5cm), pain at injection site 100.9 degrees chills, nausea.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1), FLUN3, SMALL, TYP
Symptoms: Lymph node pain
Clinical narrative: Lymph node pain.
Age: 1.54
Sex: M
Vaccine: FLU3
Symptoms: Crying, Insomnia, Irritability, Pyrexia, Rash
Clinical narrative: Papular rash over arms, legs and trunk very itchy. Fever with T max 100.4, irritability. Inconsolable crying, Insomnia.
Age: 1.54
Sex: M
Vaccine: FLU3
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Papular rash over arms, legs and trunk very itchy. Fever with T max 100.4, irritability. Inconsolable crying, Insomnia.
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMR, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives about 1 hr after the following vaccines: MMR, VZV, IPV, DTAP, Flu 1/19/11 was seen by RN given BENADRYL - hives subsided. Developed fever to 102 degrees F same night.
Age: 1.36
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Antibiotic resistant Staphylococcus test positive, Injection site abscess, Injection site abscess sterile, Injection site nodule, Injection site pain
Clinical narrative: Pt. received 4 immunization on 1/12/11. Mom detected swelling and a knot under the skin at the immunization site on (L)AT. Area was tender. Mom took child to ED on 1/19/11. Culture was not done. Diagnosed at ED sterile abscess secondary vaccines. No medications given. Mom states warm compress advised. 1/21/11 Mom called ED would like reevaluation. Seen 1/21/11 Dx abscess (L) thigh. Cultured, result MRSA on 1/24/11. Appt for 1/25/11 to reevaluate.
Age: 1.36
Sex: F
Vaccine: DTAP, MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Staphylococcal infection
Clinical narrative: Pt. received 4 immunization on 1/12/11. Mom detected swelling and a knot under the skin at the immunization site on (L)AT. Area was tender. Mom took child to ED on 1/19/11. Culture was not done. Diagnosed at ED sterile abscess secondary vaccines. No medications given. Mom states warm compress advised. 1/21/11 Mom called ED would like reevaluation. Seen 1/21/11 Dx abscess (L) thigh. Cultured, result MRSA on 1/24/11. Appt for 1/25/11 to reevaluate.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Cold sweat, Confusional state, Disorientation, Pallor, Syncope
Clinical narrative: After administering vaccines, patient experienced syncope episode less than 5 seconds, pale complexion with clammy skin. Alert but disoriented to place with slight confusion. Water given and rested for 30 minutes while monitoring. Discharged 45 minutes later.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Full blood count, Induration, Red blood cell sedimentation rate, Urticaria
Clinical narrative: 8x8 cm area erythema, central area firm & red. Pt reports generalized hives 1-23-11 - Took BENADRYL was given Rx ALLEGRA 180 mg today.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: LAT swelling & mild burning.
Age: 7.0
Sex: F
Vaccine: TYP, YF
Symptoms: Body temperature, Cold sweat, Decreased appetite, Feeling cold, Lethargy
Clinical narrative: Initial reported received from a health care professional on 18 June 2010. A 7-year-old female patient, with no medical history and no illness at the time of vaccination, received a left arm subcutaneous injection of YF VAX, lot number UF716AA, and a intramuscular right deltoid injection of TYPHIM VI, lot number D0412-1, on the 15 June 2010 and developed a temperature the night of and the day after the vaccination. As of the 18 June 2010 the patient was pale, lethargic, not eating, cold, clammy, but afebrile. The outcome was reported as not recovered. Documents held by sender: None.
Age: 7.0
Sex: F
Vaccine: TYP, YF
Symptoms: Pallor
Clinical narrative: Initial reported received from a health care professional on 18 June 2010. A 7-year-old female patient, with no medical history and no illness at the time of vaccination, received a left arm subcutaneous injection of YF VAX, lot number UF716AA, and a intramuscular right deltoid injection of TYPHIM VI, lot number D0412-1, on the 15 June 2010 and developed a temperature the night of and the day after the vaccination. As of the 18 June 2010 the patient was pale, lethargic, not eating, cold, clammy, but afebrile. The outcome was reported as not recovered. Documents held by sender: None.
Age: 14.0
Sex: F
Vaccine: TYP
Symptoms: Anxiety, Tremor
Clinical narrative: Initial report received by a health care professional on 25 June 2010. A 14-year-old female patient, with no medical history and no illness at the time of vaccination, received on 22 June 2010 a left deltoid intramuscular injection of TYPHIM VI, lot number E0213-1 and developed "night tremors" after the vaccine during the night. The outcome was reported as unknown. Follow-up information received from a health care professional on 23 July 2010. The patient was not seen by a physician and did not require treatment and "according to her Mother, she is absolutely fine". The patient's mother suspected this was an anxiety reaction due to the patient never having been out of the country and what she had heard about her destination". No further information was provided and no additional information is requested. Documents held by sender: None.
Age: 40.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Dysgeusia, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Initial report received from a nurse practitioner on 23 July 2010. A 41-year-old female patient, who has no known drug allergies, asthma, and COPD (chronic obstructive pulmonary disease) had received an intramuscular left deltoid injection of TYPHIM Vi (lot number E0214-1), and a left deltoid dose of HAVRIX (manufacturer GlaxoSmithKline, lot number AHAVB387AA) on 04 May 2010. Immediately post-vaccination the patient experienced a 5 second metallic taste in her mouth and a sore arm that lasted 2 days. The patient required medical attention; however it was not reported whether the patient received any treatments. At the time of this report, the patient had recovered. Follow-up information received from a health care professional on 16 August 2010 clarified that the patient did not have COPD. The patient's medical history confirmed she had asthma and also included Crohn's disease. The patient used the concomitant medications of fluticasone and ADVAIR and VENTOLIN inhalers as needed (PRN). The patient did not received medical attention and none was given. The outcome for the event remained recovered. Documents held by sender: None.
Age: 38.0
Sex: F
Vaccine: HEPAB, TDAP, TYP
Symptoms: Discomfort, Injection site pain, Muscular weakness, Myalgia, Pain
Clinical narrative: Initial report received from a health care professional on 13 August 2010. A 38-year-old female patient received the following injections on 24 July 2010: a left deltoid intramuscular injection of ADACEL (sanofi pasteur Inc. lot number U3052BA and sanofi pasteur Ltd. lot number C3311), a right deltoid injection (route not reported) of TYPHIM VI (lot number not reported) and a right deltoid injection of TWINRIX (lot number not reported). Since 24 July 2010, she complained of muscle pain and weakness in the left deltoid. She also stated that the left arm was sore 3 inches around injection site. The patient has been seen by a physician who reported the reaction started soon after the injection (same day) and pain and discomfort continued for three weeks. She did not have a history of Ttox-containing vaccination within the past 10 years so Arthus reaction could probably be ruled out. Treatment was not reported. The outcome was reported as not recovered. Further information was declined. Follow-up information was received on 15 September 2010 from a healthcare professional. The patient had no concomitant medication. No treatment has been given. Per reporter, no additional information was available. Documents held by sender: None.
Age: 32.0
Sex: F
Vaccine: HEPA, IPV, TDAP, TYP
Symptoms: Dry skin, Injection site reaction, Pruritus, Rash erythematous, Skin exfoliation
Clinical narrative: Case received from a healthcare professional through the MIS on 11 October 2010 under the local reference number 10-0698. A 32-year-old female patient, with no illness at the time of vaccination, no pre-existing physician-diagnosed allergies or medical conditions, no other medications and no adverse event following prior vaccination, had received her intramuscular dose of ADACEL, batch number U3298CA (C3447) in the left deltoid, her intramuscular dose of TYPHIM VI, batch number D1087-1, in the left deltoid, her dose of IPOL (batch number, route and anatomical site of administration not reported) and her dose of hepatitis A vaccine (manufacturer unknown, batch number, route and anatomical site of administration not reported) on 01 October 2010. On 03 October 2010, i.e. 2 days post-vaccination, the patient developed a red raised scaly patch on her left deltoid. Dry patches also erupted on her stomach, back, few patches. They were also itchy. The patient was seen by a physician. She received BENADRYL. The patient reported any areas being less itchy, but no improvement otherwise. Documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Blood test normal, Gait disturbance, Headache, Joint stiffness
Clinical narrative: Patient received TD vaccine at her doctor's office due to jamming her finger with a garage door. Next morning, patient woke up with severe muscular pain and weakness in her arms and legs. Her arm and leg muscles were tight and tense. Patient said that the muscle aches come and go, if she starts walking, her muscles are very achy at the beginning, but do get better with more walking. Patient had to go to ER on 05/19/10, due to difficulty walking, where they did a blood test to determine if her muscles were deteriorating, and a "sodium kidney test". The results of the tests were normal; muscles did not hurt to the touch. During past week, patient started feeling tension in her upper jaw, close to the bottom of her ear. Patient said that she was very healthy prior to this event. Patient's last tetanus shot was over 30 years ago. Patient never received Diphtheria vaccine prior to this vaccination. Patient already reported this event to VAERS and to her doctor. Follow up received on 06/03/10: Patient sometimes experiences joint hip pain. Patient reported having a severe headache on 06/02/10. Patient also added that she has lower arm and wrist stiffness and swelling. Follow up received on 07/07/10: Patient said that she has intermittent symptoms of "tightening" and "tenderness" of the muscles of her legs and arms. She has many days free of symptoms but her symptoms return every "four or five days." Her symptoms are relieved with exercise and stretching and she has not sought additional medical attention. She has not had any further weakness. She mentioned that she was considering a visit to a "toxologist".
Age: 77.0
Sex: F
Vaccine: TD
Symptoms: Joint swelling, Muscle tightness, Muscular weakness, Musculoskeletal stiffness, Myalgia
Clinical narrative: Patient received TD vaccine at her doctor's office due to jamming her finger with a garage door. Next morning, patient woke up with severe muscular pain and weakness in her arms and legs. Her arm and leg muscles were tight and tense. Patient said that the muscle aches come and go, if she starts walking, her muscles are very achy at the beginning, but do get better with more walking. Patient had to go to ER on 05/19/10, due to difficulty walking, where they did a blood test to determine if her muscles were deteriorating, and a "sodium kidney test". The results of the tests were normal; muscles did not hurt to the touch. During past week, patient started feeling tension in her upper jaw, close to the bottom of her ear. Patient said that she was very healthy prior to this event. Patient's last tetanus shot was over 30 years ago. Patient never received Diphtheria vaccine prior to this vaccination. Patient already reported this event to VAERS and to her doctor. Follow up received on 06/03/10: Patient sometimes experiences joint hip pain. Patient reported having a severe headache on 06/02/10. Patient also added that she has lower arm and wrist stiffness and swelling. Follow up received on 07/07/10: Patient said that she has intermittent symptoms of "tightening" and "tenderness" of the muscles of her legs and arms. She has many days free of symptoms but her symptoms return every "four or five days." Her symptoms are relieved with exercise and stretching and she has not sought additional medical attention. She has not had any further weakness. She mentioned that she was considering a visit to a "toxologist".
Age: 77.0
Sex: F
Vaccine: TD
Symptoms: Oedema peripheral, Renal function test normal, Tension
Clinical narrative: Patient received TD vaccine at her doctor's office due to jamming her finger with a garage door. Next morning, patient woke up with severe muscular pain and weakness in her arms and legs. Her arm and leg muscles were tight and tense. Patient said that the muscle aches come and go, if she starts walking, her muscles are very achy at the beginning, but do get better with more walking. Patient had to go to ER on 05/19/10, due to difficulty walking, where they did a blood test to determine if her muscles were deteriorating, and a "sodium kidney test". The results of the tests were normal; muscles did not hurt to the touch. During past week, patient started feeling tension in her upper jaw, close to the bottom of her ear. Patient said that she was very healthy prior to this event. Patient's last tetanus shot was over 30 years ago. Patient never received Diphtheria vaccine prior to this vaccination. Patient already reported this event to VAERS and to her doctor. Follow up received on 06/03/10: Patient sometimes experiences joint hip pain. Patient reported having a severe headache on 06/02/10. Patient also added that she has lower arm and wrist stiffness and swelling. Follow up received on 07/07/10: Patient said that she has intermittent symptoms of "tightening" and "tenderness" of the muscles of her legs and arms. She has many days free of symptoms but her symptoms return every "four or five days." Her symptoms are relieved with exercise and stretching and she has not sought additional medical attention. She has not had any further weakness. She mentioned that she was considering a visit to a "toxologist".
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperacusis, Labyrinthitis, Vertigo
Clinical narrative: I reported vertigo symptom and labyrinthitis diagnosis on Nov. 22, 2010 (E-50096). A few days after 1st report, I found both of my ears sensitive to sound and pain sometime. My family doctor checked my ear canal by eyes and didn't find any problem.
Age: 30.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Abdominal pain upper, Incorrect dose administered
Clinical narrative: Initial report received from a health care professional on 10 January 2011. The reporter provided a copy of a VAERS report (temporary VAERS E-report number E-51259) that was submitted by a health care professional. A 30 year-old male patient who had no concurrent illnesses, pre-existing medical conditions, or use of other medications had received a subcutaneous left arm injection of YF VAX, (lot number UF785AA) on 09 January 2011 at 10:22am that was 5 times the recommended adult dose (also reported as patient had received 2.5 ml instead of 0.5 ml). The following day, the patient developed a sore arm (time not reported) and that same day around 12:00pm which was approximately 13 hours post-vaccination the patient complained of upper abdominal pain and was advised to go the emergency room in compliance with poison control. The patient went to the hospital for treatment, however type of treatment received was not reported. It was unknown what relevant diagnostic tests and laboratory data were performed. It was noted the patient had received a yellow fever vaccination 10 years earlier, however it was not reported whether the patient had experienced any adverse events with that vaccination. The patients recovery status for the events of sore arm and abdominal pain were unknown. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Abdominal pain upper, Incorrect dose administered, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 10 January 2011. The reporter provided a copy of a VAERS report (temporary VAERS E-report number E-51259) that was submitted by a health care professional. A 30 year-old male patient who had no concurrent illnesses, pre-existing medical conditions, or use of other medications had received a subcutaneous left arm injection of YF VAX, (lot number UF785AA) on 09 January 2011 at 10:22am that was 5 times the recommended adult dose (also reported as patient had received 2.5 ml instead of 0.5 ml). The following day, the patient developed a sore arm (time not reported) and that same day around 12:00pm which was approximately 13 hours post-vaccination the patient complained of upper abdominal pain and was advised to go the emergency room in compliance with poison control. The patient went to the hospital for treatment, however type of treatment received was not reported. It was unknown what relevant diagnostic tests and laboratory data were performed. It was noted the patient had received a yellow fever vaccination 10 years earlier, however it was not reported whether the patient had experienced any adverse events with that vaccination. The patients recovery status for the events of sore arm and abdominal pain were unknown. Documents held by sender: None.
Age: 30.0
Sex: M
Vaccine: YF, YF, YF
Symptoms: Abdominal pain upper, Incorrect dose administered, Laboratory test normal, Pain in extremity
Clinical narrative: Initial report received from a health care professional on 10 January 2011. The reporter provided a copy of a VAERS report (temporary VAERS E-report number E-51259) that was submitted by a health care professional. A 30 year-old male patient who had no concurrent illnesses, pre-existing medical conditions, or use of other medications had received a subcutaneous left arm injection of YF VAX, (lot number UF785AA) on 09 January 2011 at 10:22am that was 5 times the recommended adult dose (also reported as patient had received 2.5 ml instead of 0.5 ml). The following day, the patient developed a sore arm (time not reported) and that same day around 12:00pm which was approximately 13 hours post-vaccination the patient complained of upper abdominal pain and was advised to go the emergency room in compliance with poison control. The patient went to the hospital for treatment, however type of treatment received was not reported. It was unknown what relevant diagnostic tests and laboratory data were performed. It was noted the patient had received a yellow fever vaccination 10 years earlier, however it was not reported whether the patient had experienced any adverse events with that vaccination. The patients recovery status for the events of sore arm and abdominal pain were unknown. Documents held by sender: None.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood creatine phosphokinase increased, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation, Myopericarditis
Clinical narrative: Individual began experiencing chest pain and shortness of breath. He was taken to the clinic and transferred to the hospital for monitoring. He has been diagnosed with pericarditis. Individual is currently overseas.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Troponin increased
Clinical narrative: Individual began experiencing chest pain and shortness of breath. He was taken to the clinic and transferred to the hospital for monitoring. He has been diagnosed with pericarditis. Individual is currently overseas.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Chest pain, Dyspnoea, Pericarditis
Clinical narrative: Individual began experiencing chest pain and shortness of breath. He was taken to the clinic and transferred to the hospital for monitoring. He has been diagnosed with pericarditis. Individual is currently overseas.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Blood creatine phosphokinase increased, Chest pain, Electrocardiogram ST segment elevation, Electrocardiogram abnormal, Myopericarditis
Clinical narrative: Individual began experiencing chest pain and shortness of breath. He was taken to the clinic and transferred to the hospital for monitoring. He has been diagnosed with pericarditis. Individual is currently overseas.
Age: 24.0
Sex: M
Vaccine: SMALL, SMALL, SMALL
Symptoms: Pericarditis, Troponin increased
Clinical narrative: Individual began experiencing chest pain and shortness of breath. He was taken to the clinic and transferred to the hospital for monitoring. He has been diagnosed with pericarditis. Individual is currently overseas.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC13, RV5
Symptoms: Cough, Irritability, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose started first with 100 degree fever, over next two days developed lots of congestion and coughing and overall fussiness.
Age: 66.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus
Clinical narrative: erythema, pain at injection site, inflammation, pruritis
Age: 29.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Wrong drug administered
Clinical narrative: Daptacel given instead of Tdap
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Pain, Pyrexia
Clinical narrative: I received the Flu Vaccine yesterday. In the middle of the night I woke up with a fever, chills, shortness of breath, body aches, headache, and uncontrollable shaking. This lasted for one hour. This morning I still have a fever.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: I received the Flu Vaccine yesterday. In the middle of the night I woke up with a fever, chills, shortness of breath, body aches, headache, and uncontrollable shaking. This lasted for one hour. This morning I still have a fever.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Irritability, Screaming
Clinical narrative: crying inconsolably for extended periods of time, extreme crankiness - yelling, screaming, sobbing, whining
Age: 21.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Electrocardiogram normal, Full blood count, Laboratory test abnormal, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Normal VS. PT with reproducable pain over the left anterior chest wall and left arm. Pain is superficial and reproducable.     PT given Naproxen 500mg and Lidoderm 5%
Age: 21.0
Sex: F
Vaccine: TDAP, TYP
Symptoms: Protein urine present, Urine analysis, Urine ketone body, Vaginal haemorrhage
Clinical narrative: Normal VS. PT with reproducable pain over the left anterior chest wall and left arm. Pain is superficial and reproducable.     PT given Naproxen 500mg and Lidoderm 5%
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Meningitis bacterial, Meningococcal infection, Neisseria test positive
Clinical narrative: Initial report received from a lay press reporter on 14 January 2011. A 19-year-old patient (sex not provided) received 3 years ago (date not provided) an injection (route and site not provided) of MENACTRA, lot number not reported. Early in December 2010, the patient was diagnosed with bacterial meningitis. Blood tests revealed the presence of Neisseria meningitidis serotype Y. The patient had received the meningitis vaccine three years before becoming infected. The patient was recovering at home. The outcome was reported as recovering. This case has the same reporter as case 2011-00233. Documents held by sender: None.
Age: 0.16
Sex: M
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Initial report received by another manufacturer on 12 January 2011, who had received the original report from the patient's parent (a consumer). This case is not medically confirmed. A male infant patient had received a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (trade name, manufacturer name, and lot number not reported) on an unspecified day in October 2006. The parent reported that the patient experienced seizures for 5 months after receiving the vaccination in October 2006. Medical attention was sought with "no intervention to prevent serious criteria." The parent did not specify if the patient had any diagnostic tests or laboratory data performed. The adverse event was not life threatening and was specified as not being from overdose, cancer, or congenital anomaly; and was not associated with significant disability or incapacity. The patient was not hospitalized and no treatment was administered. The patient recovered (date unknown). The reporter did not specify if the patient had any medical history, use of concomitant medications, or any drug allergies. No further information was available. The parent requested that the physician not be contacted. Documents held by sender: None.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Auricular swelling, Clostridium test positive, Erythema, Glossodynia, Headache
Clinical narrative: Hard to turn neck, headache back head (gland), ear swollen, jaw swollen, sore red arm, fever, hotness mouth, jaw closure, muscle jaw soreness, blocked salivation glands, tingling in head, numbness tingling in left arm, left side face, left leg, muscle weakness both legs. Muscle pain both legs, weight loss, swollen glands, rapid heart racing, breathing soreness, tongue sore; hard spot. Back tingling: nerves damage.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Hypoaesthesia, Local swelling, Lymphadenopathy, Muscular weakness, Musculoskeletal stiffness
Clinical narrative: Hard to turn neck, headache back head (gland), ear swollen, jaw swollen, sore red arm, fever, hotness mouth, jaw closure, muscle jaw soreness, blocked salivation glands, tingling in head, numbness tingling in left arm, left side face, left leg, muscle weakness both legs. Muscle pain both legs, weight loss, swollen glands, rapid heart racing, breathing soreness, tongue sore; hard spot. Back tingling: nerves damage.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Myalgia, Nerve injury, Oral discomfort, Pain in extremity, Pain in jaw
Clinical narrative: Hard to turn neck, headache back head (gland), ear swollen, jaw swollen, sore red arm, fever, hotness mouth, jaw closure, muscle jaw soreness, blocked salivation glands, tingling in head, numbness tingling in left arm, left side face, left leg, muscle weakness both legs. Muscle pain both legs, weight loss, swollen glands, rapid heart racing, breathing soreness, tongue sore; hard spot. Back tingling: nerves damage.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Palpitations, Paraesthesia, Pyrexia, Salivary gland disorder, Tongue disorder
Clinical narrative: Hard to turn neck, headache back head (gland), ear swollen, jaw swollen, sore red arm, fever, hotness mouth, jaw closure, muscle jaw soreness, blocked salivation glands, tingling in head, numbness tingling in left arm, left side face, left leg, muscle weakness both legs. Muscle pain both legs, weight loss, swollen glands, rapid heart racing, breathing soreness, tongue sore; hard spot. Back tingling: nerves damage.
Age: 37.0
Sex: F
Vaccine: DTAP
Symptoms: Trismus, Weight decreased
Clinical narrative: Hard to turn neck, headache back head (gland), ear swollen, jaw swollen, sore red arm, fever, hotness mouth, jaw closure, muscle jaw soreness, blocked salivation glands, tingling in head, numbness tingling in left arm, left side face, left leg, muscle weakness both legs. Muscle pain both legs, weight loss, swollen glands, rapid heart racing, breathing soreness, tongue sore; hard spot. Back tingling: nerves damage.