chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.31
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Cough, Crying, Decreased appetite, Diet refusal, Haematochezia
Clinical narrative: Patient became unusually fussy and could not be consoled easily. Wasn't nursing well. Fell asleep around 10pm and woke up around 1am with 101-102 fever. Treated with infant ibuprofen. Fever went down to 99-100. Fever/treatment continued for next day. That evening (12/29) noticed three areas of red blood in stool. Called PCP and was told it was likely an anal tear. Patient is breastfed so no straining to have movement, and movements had been normal. Continued fussy for next day. On 1/1 developed dry cough and some chest congestion. Eating normally, and having regular wet/soiled diapers. Was not ill prior to shots (Prevnar 13 and Hib), does not attend daycare and has not been exposed to sick people.
Age: 0.31
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Irritability, Pyrexia, Rectal fissure, Respiratory tract congestion
Clinical narrative: Patient became unusually fussy and could not be consoled easily. Wasn't nursing well. Fell asleep around 10pm and woke up around 1am with 101-102 fever. Treated with infant ibuprofen. Fever went down to 99-100. Fever/treatment continued for next day. That evening (12/29) noticed three areas of red blood in stool. Called PCP and was told it was likely an anal tear. Patient is breastfed so no straining to have movement, and movements had been normal. Continued fussy for next day. On 1/1 developed dry cough and some chest congestion. Eating normally, and having regular wet/soiled diapers. Was not ill prior to shots (Prevnar 13 and Hib), does not attend daycare and has not been exposed to sick people.
Age: 22.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Anxiety, Panic attack, Syncope
Clinical narrative: Fainting after injection and have been suffering severe anxiety and panic attacks ever since.
Age: 22.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Anxiety, Blood test, Nervous system disorder, Panic attack, Social phobia
Clinical narrative: Fainting after injection and have been suffering severe anxiety and panic attacks ever since.
Age: 22.0
Sex: F
Vaccine: HPVX, HPV4
Symptoms: Syncope
Clinical narrative: Fainting after injection and have been suffering severe anxiety and panic attacks ever since.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Pain in arm at vaccination site has never gone away. Still painful, especially at night.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Eye swelling, Injection site erythema, Injection site induration
Clinical narrative: Redness at injection site which grew darker red and hard over a week; circular rash spread to saucer shape on entire upper left arm, even under arm; became ill, fever of 102 deg, stayed in bed two days, felt sick for 3 wks but had to return to work, had throat, upper respiratory illness, swollen and red eyes, dizzy, felt faint and weak; when rash was going away the hardness of the area softened into lumps under my skin and nurse practicioner told me to report reaction.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site mass, Injection site rash, Malaise, Ocular hyperaemia, Pyrexia
Clinical narrative: Redness at injection site which grew darker red and hard over a week; circular rash spread to saucer shape on entire upper left arm, even under arm; became ill, fever of 102 deg, stayed in bed two days, felt sick for 3 wks but had to return to work, had throat, upper respiratory illness, swollen and red eyes, dizzy, felt faint and weak; when rash was going away the hardness of the area softened into lumps under my skin and nurse practicioner told me to report reaction.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Upper respiratory tract infection
Clinical narrative: Redness at injection site which grew darker red and hard over a week; circular rash spread to saucer shape on entire upper left arm, even under arm; became ill, fever of 102 deg, stayed in bed two days, felt sick for 3 wks but had to return to work, had throat, upper respiratory illness, swollen and red eyes, dizzy, felt faint and weak; when rash was going away the hardness of the area softened into lumps under my skin and nurse practicioner told me to report reaction.
Age: 95.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain, Decreased appetite, Full blood count normal, Haemoglobin decreased, International normalised ratio decreased
Clinical narrative: May of 2010, CBC plt were normal. Dec of 2010, WBC count of 2.5 - hemoglobin = 7.0 - plt = 14 - no schistocystes or RBC fragments to suggest consumptive coagulopathy, no teardrop cells, plts appear nl, INR = 1.29. Patient complaining of melanic stools, abdominal pain, nauseam decreased appetite, for since December 20, 2010.
Age: 95.0
Sex: F
Vaccine: FLUX
Symptoms: Melaena, Nausea, Platelet count decreased, White blood cell count decreased
Clinical narrative: May of 2010, CBC plt were normal. Dec of 2010, WBC count of 2.5 - hemoglobin = 7.0 - plt = 14 - no schistocystes or RBC fragments to suggest consumptive coagulopathy, no teardrop cells, plts appear nl, INR = 1.29. Patient complaining of melanic stools, abdominal pain, nauseam decreased appetite, for since December 20, 2010.
Age: 26.0
Sex: M
Vaccine: DTP, HEP, HEPA, JEVX, RAB
Symptoms: Asthenia, Electroencephalogram normal, Gait disturbance, Laboratory test normal, Lethargy
Clinical narrative: Initial information retrieved via the scientific literature on 20 December 2010. Adverse event reports following encephalitis vaccination, Vaccine Vol. 29 10 December 2010, 58-64. A 26-year-old male had received a third dose of JE VAX; a dose of DTP; Hepatitis A and B vaccine; and a Rabies vaccine on an unspecified date. The lot numbers were not reported for any of the vaccines. The trade names and manufacturer names for all vaccines except for the JE VAX vaccine were not reported. Eighteen hours after receiving the vaccines the patient developed generalized weakness with progressive gait disturbance, lethargy, and a syncopal episode. The patient had no significant medical history or acute illnesses prior to vaccination. All diagnostic test, including brain magnetic resonance imaging, electroencephalogram, and serum chemistries were within normal limits. The patient was treated with methylprednisolone, clonazepam, pantoprazole, and azithromycin. The patient was hospitalized for 3 days and discharged following substantial improvement with no further complications. The reporter for this case is the same as for cases 2005-00286, U1999-00204, 2010-07083, -07085, -07086, -07087. Documents held by sender: None.
Age: 26.0
Sex: M
Vaccine: DTP, HEP, HEPA, JEVX, RAB
Symptoms: Nuclear magnetic resonance imaging brain normal, Syncope
Clinical narrative: Initial information retrieved via the scientific literature on 20 December 2010. Adverse event reports following encephalitis vaccination, Vaccine Vol. 29 10 December 2010, 58-64. A 26-year-old male had received a third dose of JE VAX; a dose of DTP; Hepatitis A and B vaccine; and a Rabies vaccine on an unspecified date. The lot numbers were not reported for any of the vaccines. The trade names and manufacturer names for all vaccines except for the JE VAX vaccine were not reported. Eighteen hours after receiving the vaccines the patient developed generalized weakness with progressive gait disturbance, lethargy, and a syncopal episode. The patient had no significant medical history or acute illnesses prior to vaccination. All diagnostic test, including brain magnetic resonance imaging, electroencephalogram, and serum chemistries were within normal limits. The patient was treated with methylprednisolone, clonazepam, pantoprazole, and azithromycin. The patient was hospitalized for 3 days and discharged following substantial improvement with no further complications. The reporter for this case is the same as for cases 2005-00286, U1999-00204, 2010-07083, -07085, -07086, -07087. Documents held by sender: None.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site reaction, Ligament rupture, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: 2 Hours After injection given, the site was sore and feel like my muscle is weak. 01/03/2011 Update Client states she has ongoing problems with her injection arm and that she had an MRI that showed a torn ligament in the shoulder. States the vaccine was given "high up" States she sees an orthopedic Dr. 1/2011.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong technique in drug usage process
Clinical narrative: 2 Hours After injection given, the site was sore and feel like my muscle is weak. 01/03/2011 Update Client states she has ongoing problems with her injection arm and that she had an MRI that showed a torn ligament in the shoulder. States the vaccine was given "high up" States she sees an orthopedic Dr. 1/2011.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Autoimmune disorder, Bacterial test negative, CSF protein increased, CSF white blood cell count increased
Clinical narrative: Increased fatigue and weakness beginning on 10/28.  Symptoms became increasingly severe.  Pt taken to ER morning of 10/31 with numbness in right hand and right foot; blurred vision; clumsiness; MRI and CT scan ordered for stroke screening - results were negative; condition deteriorated rapidly through 11/2; Pt intubated, became non-responsive; transferred to ICU evening of 11/2; remained in ICU for 3.5 weeks in a non-responsive state.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Clumsiness, Computerised tomogram normal, Electromyogram abnormal, Endotracheal intubation, Fatigue
Clinical narrative: Increased fatigue and weakness beginning on 10/28.  Symptoms became increasingly severe.  Pt taken to ER morning of 10/31 with numbness in right hand and right foot; blurred vision; clumsiness; MRI and CT scan ordered for stroke screening - results were negative; condition deteriorated rapidly through 11/2; Pt intubated, became non-responsive; transferred to ICU evening of 11/2; remained in ICU for 3.5 weeks in a non-responsive state.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: General physical health deterioration, Hypoaesthesia, Intensive care, Nuclear magnetic resonance imaging normal, Ultrasound scan normal
Clinical narrative: Increased fatigue and weakness beginning on 10/28.  Symptoms became increasingly severe.  Pt taken to ER morning of 10/31 with numbness in right hand and right foot; blurred vision; clumsiness; MRI and CT scan ordered for stroke screening - results were negative; condition deteriorated rapidly through 11/2; Pt intubated, became non-responsive; transferred to ICU evening of 11/2; remained in ICU for 3.5 weeks in a non-responsive state.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Unresponsive to stimuli, Viral test negative, Vision blurred
Clinical narrative: Increased fatigue and weakness beginning on 10/28.  Symptoms became increasingly severe.  Pt taken to ER morning of 10/31 with numbness in right hand and right foot; blurred vision; clumsiness; MRI and CT scan ordered for stroke screening - results were negative; condition deteriorated rapidly through 11/2; Pt intubated, became non-responsive; transferred to ICU evening of 11/2; remained in ICU for 3.5 weeks in a non-responsive state.
Age: 50.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Abdominal discomfort, Acne, Asthenia, Back pain, Bacterial test
Clinical narrative: My skin rash itching, hot feeling, red pimples that burn and sting. The feeling of burning hot itching feeling. Along with weakness, dizziness and sick to my stomach, nausea discomfort & headache constipation with black stool & back pain.
Age: 50.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Blood test abnormal, Burning sensation, Constipation, Discomfort, Dizziness
Clinical narrative: My skin rash itching, hot feeling, red pimples that burn and sting. The feeling of burning hot itching feeling. Along with weakness, dizziness and sick to my stomach, nausea discomfort & headache constipation with black stool & back pain.
Age: 50.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Faeces discoloured, Feeling hot, Headache, Laboratory test abnormal
Clinical narrative: My skin rash itching, hot feeling, red pimples that burn and sting. The feeling of burning hot itching feeling. Along with weakness, dizziness and sick to my stomach, nausea discomfort & headache constipation with black stool & back pain.
Age: 50.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pruritus, Rash
Clinical narrative: My skin rash itching, hot feeling, red pimples that burn and sting. The feeling of burning hot itching feeling. Along with weakness, dizziness and sick to my stomach, nausea discomfort & headache constipation with black stool & back pain.
Age: 0.52
Sex: F
Vaccine: DTAP, DTOX, DTP, FLUX, HBHEPB, IPV, PPV, RVX
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Lumbar puncture normal
Clinical narrative: Seizures 3 within 24 hours of flu vaccine lasting 2-11 minutes each time patient is now on KEPPRA 2x a day until follow-up EEG
Age: 0.52
Sex: F
Vaccine: DTAP, DTOX, DTP, FLUX, HBHEPB, IPV, PPV, RVX
Symptoms: Nuclear magnetic resonance imaging normal, Stool analysis normal, Urine analysis normal
Clinical narrative: Seizures 3 within 24 hours of flu vaccine lasting 2-11 minutes each time patient is now on KEPPRA 2x a day until follow-up EEG
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Folliculitis, Rash
Clinical narrative: Pt was seen in ED for a rash on his body that occurred about 15 days after he received the smallpox vaccine while abroad.  Pt's case was discussed with multiple public health entities who determined after looking at photos I sent to them that this was likely a folliculitis post smallpox vaccine (benign condition).
Age: 8.0
Sex: F
Vaccine: JEV, RAB
Symptoms: Abdominal pain, Chills, Headache, Pyrexia
Clinical narrative: Developed abdominal pain 5-6 hrs after received Rabies vaccine and JE-VAX in the morning. Headache with fever & chills at night. Went to ER at local hosp. Given TYLENOL for fever & observed. Fever was down in the next morning and no other illness.
Age: 58.0
Sex: U
Vaccine: FLUX
Symptoms: Abdominal distension, Colonoscopy normal, Dizziness, Full blood count normal, Gastrointestinal pain
Clinical narrative: Chronic lightheadedness, bloating, bowel spasms, shakiness.
Age: 58.0
Sex: U
Vaccine: FLUX
Symptoms: Tremor
Clinical narrative: Chronic lightheadedness, bloating, bowel spasms, shakiness.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Nausea, Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Bright erythema 6 inches long 3/4 around arm. Hot, swollen, painful (like a hive) area on arm of injection. Nauseous & faint 2 days after. Rash appeared less than 24 hours after injection. Right deltoid IM 1" needle.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Syncope, Urticaria
Clinical narrative: Bright erythema 6 inches long 3/4 around arm. Hot, swollen, painful (like a hive) area on arm of injection. Nauseous & faint 2 days after. Rash appeared less than 24 hours after injection. Right deltoid IM 1" needle.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: None - no reaction reported patient received 2 flu vaccinations: 1) 10-28-2010 FLUVIRIN (.5ml) 2) 11-5-2010 FLUVIRIN (.5ml).
Age: 2.0
Sex: F
Vaccine: FLUN3, HEPA
Symptoms: Eyelid oedema, Ocular hyperaemia, Pyrexia, Somnolence, Vomiting
Clinical narrative: Fever to 101, red puffy eyes, increased sleepiness emesis x 1.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Cyst, Injection site anaesthesia, Pain in extremity
Clinical narrative: 3-4 hours after injection, patient experienced numbing on (R) upper arm, where injection was given. Pain spread down arm to lower extremities. Emergency room doctor - did not think shot was cause, they found a cyst in her abdomen.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received pneumococcal vaccine on 12/25/10 by morning 12/27/10 arm was swollen, reddened and tender for approx 8 inches around injection site ((L) arm).
Age: 0.74
Sex: F
Vaccine: DTAPIPVHIB, FLU3, PNC
Symptoms: Body temperature increased, Febrile convulsion
Clinical narrative: Temp 103.9 febrile seizure around 11:00 pm.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration
Clinical narrative: Patient noticed red, hard spot at injection site a few days following vaccination. Upper arm mobility is effected. He came to pharmacy of administration on 12/26/10 to report it.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Approx 2 wks extreme pain at injection site & around. Over several days pain traveled down to mid arm.. making - movement & use difficult!
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Blood urine present, Confusional state, Dyskinesia, Haematuria, Pyrexia
Clinical narrative: High fever 103.2. Lasted two days than 10 days prior, low grade fever for full 10 days of 100.8. A rash all over body. Dry red bumps. Jerking in sleep 10 days. Confused. Was hospitalized. Hematuria.
Age: 6.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash erythematous, Rash generalised, Urine analysis abnormal
Clinical narrative: High fever 103.2. Lasted two days than 10 days prior, low grade fever for full 10 days of 100.8. A rash all over body. Dry red bumps. Jerking in sleep 10 days. Confused. Was hospitalized. Hematuria.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Injection site erythema, Injection site pruritus, Oedema peripheral, Pruritus
Clinical narrative: Severe burning & itching & dollar size hot-spot, within minutes. Then generalized rash & swelling spreading to armpit & to elbow (Left arm) (Pacemaker implant - two to three inches from rash & swelling) returned to see Dr - 12-17-2010. He had not seen a reaction like mine. He suggested BENADRYL (po) and Topical Cortisone. 12-28-2010 still have dollar size red itching spot at injection site. Time course 3 wks to date.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Severe burning & itching & dollar size hot-spot, within minutes. Then generalized rash & swelling spreading to armpit & to elbow (Left arm) (Pacemaker implant - two to three inches from rash & swelling) returned to see Dr - 12-17-2010. He had not seen a reaction like mine. He suggested BENADRYL (po) and Topical Cortisone. 12-28-2010 still have dollar size red itching spot at injection site. Time course 3 wks to date.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Pt received 2 doses of varicella, 9/8/08 & 1/29/10. Pt is in office now with chicken pox.  Provider concerned vaccines were not strong enough.
Age: 0.42
Sex: F
Vaccine: PPV, RV5
Symptoms: Breast feeding, Crying, Faeces discoloured, Flatulence, Haematemesis
Clinical narrative: ROTATEQ administered 12/2/10. Evening of 12/2 & 12/3 the baby was restless & occasionally cried out during sleep probable gassiness. On 12/4 evening baby vomited (projectile) x 2 with 6 PM & 9 PM feedings (exclusively fed breast milk). On 12/5 baby vomited blood after 10AM feeding and was taken to the ER. Also with darker stools (yellow -> brown) x 2 days afterwards.
Age: 0.42
Sex: F
Vaccine: PPV, RV5
Symptoms: Restlessness, Sleep disorder, Vomiting projectile
Clinical narrative: ROTATEQ administered 12/2/10. Evening of 12/2 & 12/3 the baby was restless & occasionally cried out during sleep probable gassiness. On 12/4 evening baby vomited (projectile) x 2 with 6 PM & 9 PM feedings (exclusively fed breast milk). On 12/5 baby vomited blood after 10AM feeding and was taken to the ER. Also with darker stools (yellow -> brown) x 2 days afterwards.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site mass, Malaise, Nausea
Clinical narrative: Nausea, headache x 3 days. Became ill the night I received vaccine. Received vacc. 12/13/10. Red bump at injection site. Small the size of approx 0.2cm diam.
Age: 61.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Pt given varicella injection by mistake, pt was supposed to be given the ZOSTAVAX injection for shingles.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: Pt. developed area of red, hard area on the underside of the same arm that recieved Flu and Shingles vaccine.  Needed to be treated for cellulitis.  Improved over 3 days of treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Pt. had large reported by pt., 12 inches of red, swollen, itchy and hot area. Pt. is a nurse and was treating herself.
Age: 28.0
Sex: U
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Lightheadedness: onset few minutes post dose gave 25 mg BENADRYL and Gatorade which resolved it in a couple minutes. Followed up.
Age: 70.0
Sex: M
Vaccine: HEP, VARZOS
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE Syndrome Dx 10/2010 by Dr. Tx at hospital.
Age: 0.46
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Pallor, Syncope
Clinical narrative: Approximately 15 minutes after infant received the 2nd dose in the Hepatitis B series. The mother became concerned that child was "fainting" and "pale". Infant appeared tired, but otherwise normal to me. Per mother's request 911 was called and patient taken to hospital ER.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Reaction at Varivax site.  Area is warm & erythematous with swelling & induration.  Erythema measured at 2 3/4 inches and induration measured at 2 inches.  Instructed to give Benadryl for swelling and itch. Also apply cool compresses.  Call if area enlarges.
Age: 55.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Blister, Herpes zoster, Pain, Rash, Scar
Clinical narrative: I developed a really bad rash on my left arm, blisters on my left shoulder blade area, and blisters on my left side of my chest. I still experiencing pain the areas where the blisters appeared.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Abortion spontaneous, Blood human chorionic gonadotropin positive, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a register nurse, for GARDASIL a Pregnancy Registry product, concerning a 14 year old smoker female with depression, who on 12-AUG-2009 was vaccinated with the first dose of GARDASIL (Lot # unknown) and on 11-MAY-2010 with the second dose of GARDASIL (lot # 661531/1311Y). Suspect vaccine therapy included a dose of HEPATITIS A (manufacturer unknown). Other concomitant therapy included "depression medication". The nurse reported that the patient, requested an in-office pregnancy test afterwards which determined she was pregnant. The patient was reported to be 10 weeks pregnant. LMP approximately 28-FEB-2010, EDD approximately 06-DEC-2010). The patient sought unspecified medical attention. Follow-up information has been received from a completed questionnaire, concerning the 14 years old patient with anxiety. Patient's LMP was reported as 20-MAR-2010 and the EDD on 26-DEC-2010 (previously reported as 28-FEB-2010 and 06-DEC-2010 respectively). It was reported that that patient was taken LEXAPRO as concomitant therapy during the pregnancy. On 27-MAY-2010 the patient experienced a spontaneous abortion (<20 weeks). It was unknown if the product of conception was examined or if the fetus was normal. At the time of this report, the patient's outcome was unknown. Upon internal review, spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Drug exposure before pregnancy, Foetal disorder, Twin pregnancy
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 20 year old female patient who on 29-JAN-2009 was vaccinated with the first dose of GARDASIL (No lot number provided). Subsequently the patient became pregnant after receiving GARDASIL. The patient's date of last menstrual period was approximately on 03-AUG-2009 and estimated delivery date is 20-MAY-2010. Series of GARDASIL was discontinued. Unspecified medical attention had been sought. Follow up information has been received from an obstetrical (OB) coordinator who reported that the patient's last GARDASIL was given to this patient on 29-JAN-2009 and her LMP prior to this pregnancy was in July 2009 (previously reported as "approximately on 03-AUG-2009"). This patient delivered twins in May 2010 via a scheduled cesarean section, due to Baby A being in breech position. The OB coordinator didn't know the exact gestational age, but stated the twins were at term, "so at least 38 weeks." She said the mother was doing well, but she could not tell me what the health of the babies was; she did not have any information related to the status of the twins. No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Rash
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 66 year old female patient with no pertinent medical history or drug reactions/allergies, who on 04-NOV-2010 was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (Merck) (lot # 664670/0151Z). There was no concomitant medication. Within a few hours following vaccination, the patient experienced a rash on her torso and at the injection site. On 05-NOV-2010, the patient visited her physician's practice and was diagnosed with shingles. At the time of the report, the patient was recovering. No laboratory diagnostics studies were performed. Follow up information was received from the physician who reported that they were not involved in any way. Follow up information has been received from the physician. It was reported that the patient experienced an outbreak of shingles 4-5 hours after receiving ZOSTAVAX (Merck). The physician reported that it was unlikely to be related. At the time of the report the patient had not recovered. There were no laboratory studies performed. Shingles was considered to be an other important medical event by the physician. Additional information has been requested.
Sex: F
Vaccine: IPV, TTOX
Symptoms: Bedridden, Feeling abnormal, Movement disorder
Clinical narrative: Initial report received from a consumer which was reported from another manufacturer (S2010US32859) on 21 December 2010. A female patient (age not reported) received on an unknown date an injection (route and site not reported) of POLIOMYELITIS VACCINE INACTIVATED, manufacturer and lot number not reported, an injection (route and site not reported) of TETANUS TOXOID, manufacturer and lot number not reported, and a form (route and site not reported) of NOVOCAINE, manufacturer and lot number not reported. On an unknown date, the patient developed the feeling that she was going to die, inability to move and was bedridden. The patient's medical history was not reported. The patient's concomitant medication was ACTONEL. The patient had an adverse event to ACTONEL which included burning, intestinal problems, skin reactions and high blood pressure. No further information was provided. The outcome was not reported. Documents held by sender: None.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Oral disorder, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Initial non-serious report received from a health care professional on 09 November 2010. A 36-year-old male patient, with a history of sleep apnea, obesity, tendonitis and Osgood-Schlatter's Disease, received on 03 November 2010 a left arm intramuscular injection of FLUZONE, lot number U3737AA. The patient had no known allergies (NKA) and had no illness at the time of vaccination. He had not received any previous doses of flu vaccine or H1N1. The patient's concomitant medications included ADVIL and methocarbamol. On 05 November 2010, he developed mouth lesions, rash on body, fever and chills. The outcome was reported as recovered. Follow-up information received from a health care professional on 17 December 2010. From the following information received, this case was upgraded to serious. The patient had not received any other vaccinations within 4 weeks of 03 November 2010. Per the reporter, the patient left their clinic (date not reported) and went to the emergency room where he received Epi injection and prednisone. He returned to their clinic 9 days later with diffuse coalesced areas of hyperpigmentation that were worse on the patient's back and thorax. At that time, the mucosal "lesions" had resolved, and per the reporter, the patient had decreased pruritis. The patient is to have a dermatology consult on 10 January 2011. Per the reporter, the patient has not recovered (previously reported as recovered). Documents held by sender: None.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Skin hyperpigmentation
Clinical narrative: Initial non-serious report received from a health care professional on 09 November 2010. A 36-year-old male patient, with a history of sleep apnea, obesity, tendonitis and Osgood-Schlatter's Disease, received on 03 November 2010 a left arm intramuscular injection of FLUZONE, lot number U3737AA. The patient had no known allergies (NKA) and had no illness at the time of vaccination. He had not received any previous doses of flu vaccine or H1N1. The patient's concomitant medications included ADVIL and methocarbamol. On 05 November 2010, he developed mouth lesions, rash on body, fever and chills. The outcome was reported as recovered. Follow-up information received from a health care professional on 17 December 2010. From the following information received, this case was upgraded to serious. The patient had not received any other vaccinations within 4 weeks of 03 November 2010. Per the reporter, the patient left their clinic (date not reported) and went to the emergency room where he received Epi injection and prednisone. He returned to their clinic 9 days later with diffuse coalesced areas of hyperpigmentation that were worse on the patient's back and thorax. At that time, the mucosal "lesions" had resolved, and per the reporter, the patient had decreased pruritis. The patient is to have a dermatology consult on 10 January 2011. Per the reporter, the patient has not recovered (previously reported as recovered). Documents held by sender: None.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Influenza, Influenza A virus test positive, Pain
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza type A in a 29-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included AUGMENTIN and  Antidepressant (unknown). On 30 September 2010 at 15:00 the subject received unspecified dose of FLUARIX at 0.5 ml in the left arm. On 21 December 2010, 82 days after vaccination with FLUARIX, the subject experienced influenza type A (influenza test was positive). Symptoms included, fever (102), cough, body pain and headache. At the time of reporting the outcome of specific symptoms was not reported. Influenza was reported to be unresolved. These events were considered to be the result of vaccination failure according to GSK definition.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of influenza type A in a 29-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included AUGMENTIN and  Antidepressant (unknown). On 30 September 2010 at 15:00 the subject received unspecified dose of FLUARIX at 0.5 ml in the left arm. On 21 December 2010, 82 days after vaccination with FLUARIX, the subject experienced influenza type A (influenza test was positive). Symptoms included, fever (102), cough, body pain and headache. At the time of reporting the outcome of specific symptoms was not reported. Influenza was reported to be unresolved. These events were considered to be the result of vaccination failure according to GSK definition.
Sex: U
Vaccine: FLUX
Symptoms: Arthropathy, Joint injury, Musculoskeletal pain
Clinical narrative: Initial literature report received on 20 Dec 2010: This report consisted of cases retrieved from the Vaccine Injury Compensation Program database. A query of the database was conducted to identify potentially relevant cases based on a claimed injury of shoulder pain, arm pain, shoulder dysfunction, frozen shoulder, adhesive capsulitis, or shoulder bursitis. Brachial neuritis was also included since this injury was frequently claimed when the arm was involved regardless of the actual diagnosis. Case histories of all submitted medical records were reviewed in details to verify vaccination date, symptom onset and clinical course. This patient with no history of shoulder dysfunction, was vaccinated with influenza vaccine (manufacturer unknown, batch number: unknown) on unknown date. It was reported that the vaccine administration led to shoulder injury with significant shoulder pain and dysfunction. The symptoms lasted for more than six months. The outcome was not reported. The authors commented that they believe that this type of phenomenon is not due to a specific vaccine but results from injection of a vaccine antigen to which a person has previously been sensitized as a result of previous naturally occurring infection or past vaccination. This concept is consistent with the vaccines which were given in this case series, namely influenza and tetanus vaccines which are given repeatedly over time. This clinical case series provides additional evidence supporting the report that vaccine administration in the upper third of the deltoid area can have long-lasting consequences unrelated to the specific vaccine administered.
Sex: U
Vaccine: FLUX
Symptoms: Arthropathy, Joint injury, Musculoskeletal pain
Clinical narrative: Initial literature report received on 20 Dec 2010: This report consisted of cases retrieved from the Vaccine Injury Compensation Program database. A query of the database was conducted to identify potentially relevant cases based on a claimed injury of shoulder pain, arm pain, shoulder dysfunction, frozen shoulder, adhesive capsulitis, or shoulder bursitis. Brachial neuritis was also included since this injury was frequently claimed when the arm was involved regardless of the actual diagnosis. Case histories of all submitted medical records were reviewed in detail to verify vaccination date, symptom onset and clinical course. This patient with no history of shoulder dysfunction, was vaccinated with influenza vaccine (manufacturer unknown, batch number: unknown) on unknown date. It was reported that the vaccine administration led to shoulder injury with significant shoulder pain and dysfunction. The symptoms lasted for more than six months. The outcome was not reported. The authors commented that they believe that this type of phenomenon is not due to a specific vaccine but results from injection of a vaccine antigen to which a person has previously been sensitized as a result of previous naturally occurring infection or past vaccination. This concept is consistent with the vaccines which were given in this case series, namely influenza and tetanus vaccines which are given repeatedly over time. This clinical case series provides additional evidence supporting the report that vaccine administration in the upper third of the deltoid area can have long-lasting consequences unrelated to the specific vaccine administered.
Age: 1.17
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Convulsion, Pyrexia, Teething
Clinical narrative: Mom in today states child had seizures 5 days after shots; was airlifted to hospital - states cause of seizures undiagnosed at hospital. Did not report until today child had fever and teething after shots. Unable to contact mother for more information.
Sex: U
Vaccine: FLUX
Symptoms: Arthropathy, Joint injury, Musculoskeletal pain
Clinical narrative: Initial literature report received on 20 Dec 2010: This report consisted of cases retrieved from the database. A query of the database was conducted to identify potentially relevant cases based on a claimed injury of shoulder pain, arm pain, shoulder dysfunction, frozen shoulder, adhesive capsulitis, or shoulder bursitis. Brachial neuritis was also included since this injury was frequently claimed when the arm was involved regardless of the actual diagnosis. Case histories of all submitted medical records were reviewed in detail to verify vaccination date, symptom onset and clinical course. This patient with no history of shoulder dysfunction, was vaccinated with INFLUENZA (manufacturer unknown, batch number: unknown) on unknown date. It was reported that the vaccine administration led to shoulder injury with significant shoulder pain and dysfunction. The symptoms lasted for more than six months. The outcome was not reported. The authors commented that they believe that this type of phenomenon is not due to a specific vaccine but results from injection of a vaccine antigen to which a person has previously been sensitized as a result of previous naturally occurring infection or past vaccination. This concept is consistent with the vaccines which were given in this case series, namely INFLUENZA and TETANUS which are given repeatedly over time. This clinical case series provides additional evidence supporting that the vaccine administration in the upper third of the deltoid area can have long-lasting consequences unrelated to the specific vaccine administered.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Bone scan abnormal, Complex regional pain syndrome, Computerised tomogram abnormal, Dysphagia
Clinical narrative: Initial report from pharmacist on 16 Nov 2010: The client drew up PNEUMOVAX (batch no: 0866Z) and FLUVIRIN, (batch no: 111798P1) into the same syringe and administered the vaccine (containing both FLUVIRIN and PNEUMOVAX) to the patient on 16 Nov 2010. No adverse reactions occurred since the administration. Combined follow-up report received on 20 Dec 2010: This patient was vaccinated with FLUVIRIN and PNEUMOVAX 0.5 mL intramuscularly on 16 Nov 2010. Both the vaccine were combined in a single syringe and given as a single dose. The patient was hospitalized (unspecified date and event). No adverse event occurred following this administration.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dyspnoea, Joint effusion, Muscle atrophy, Muscle disorder, Muscular weakness
Clinical narrative: Initial report from pharmacist on 16 Nov 2010: The client drew up PNEUMOVAX (batch no: 0866Z) and FLUVIRIN, (batch no: 111798P1) into the same syringe and administered the vaccine (containing both FLUVIRIN and PNEUMOVAX) to the patient on 16 Nov 2010. No adverse reactions occurred since the administration. Combined follow-up report received on 20 Dec 2010: This patient was vaccinated with FLUVIRIN and PNEUMOVAX 0.5 mL intramuscularly on 16 Nov 2010. Both the vaccine were combined in a single syringe and given as a single dose. The patient was hospitalized (unspecified date and event). No adverse event occurred following this administration.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: No adverse event, Nuclear magnetic resonance imaging abnormal, Pain in extremity, Streptococcal infection, Streptococcus test positive
Clinical narrative: Initial report from pharmacist on 16 Nov 2010: The client drew up PNEUMOVAX (batch no: 0866Z) and FLUVIRIN, (batch no: 111798P1) into the same syringe and administered the vaccine (containing both FLUVIRIN and PNEUMOVAX) to the patient on 16 Nov 2010. No adverse reactions occurred since the administration. Combined follow-up report received on 20 Dec 2010: This patient was vaccinated with FLUVIRIN and PNEUMOVAX 0.5 mL intramuscularly on 16 Nov 2010. Both the vaccine were combined in a single syringe and given as a single dose. The patient was hospitalized (unspecified date and event). No adverse event occurred following this administration.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Walking aid user, White blood cell count increased, Wrong technique in drug usage process
Clinical narrative: Initial report from pharmacist on 16 Nov 2010: The client drew up PNEUMOVAX (batch no: 0866Z) and FLUVIRIN, (batch no: 111798P1) into the same syringe and administered the vaccine (containing both FLUVIRIN and PNEUMOVAX) to the patient on 16 Nov 2010. No adverse reactions occurred since the administration. Combined follow-up report received on 20 Dec 2010: This patient was vaccinated with FLUVIRIN and PNEUMOVAX 0.5 mL intramuscularly on 16 Nov 2010. Both the vaccine were combined in a single syringe and given as a single dose. The patient was hospitalized (unspecified date and event). No adverse event occurred following this administration.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Apparent life threatening event, Chest X-ray normal, Electrocardiogram normal, Electroencephalogram normal, Full blood count normal
Clinical narrative: Apparent life threatening event (ALTE). Parents awoke and heard noises; not breathing right color changed. Secretions in mouth and nose - EMS. Hospitalized; no treatment. ? event GERD related. Rx'ed with ZANTAC.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Increased bronchial secretion, Respiration abnormal, Skin discolouration, Viral test negative
Clinical narrative: Apparent life threatening event (ALTE). Parents awoke and heard noises; not breathing right color changed. Secretions in mouth and nose - EMS. Hospitalized; no treatment. ? event GERD related. Rx'ed with ZANTAC.
Age: 67.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: aches, pains, fever, congestion
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: L arm swelling, erythema, pruritis
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Heart rate increased, Rash, Rash macular, Urticaria
Clinical narrative: RED BLOTCHY RASH ON FACE, STARTING ON ARMS AND RAPID HEART RATE. WHEN PATIENT ASSESSED WITHIN 1 HR OF ONSET STABLE VITAL SIGNS, NO RESPIRATORY DISTRESS; URTICARIA ON BOTH CHEEKS; NO SWELLING OF LIPS; NO STRIDOR  ADMINISTERED DIPHENYLHYDRAMINE 12.5MG PO AND OBSERVED OVER NEXT 1 HOUR
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Abdominal discomfort, Delirium, Diarrhoea, Dry mouth, Dysgeusia
Clinical narrative: Felt like I had to puke all the sudden, went to bathroom, I threw up, and unrelenting diarrhea for nearly 12 solid hours, 8:30 PM - 7:30 AM this morning. I Had hot/cold flashes, Muscle pain in, left leg, lower back, stomach. Cotton Mouth, Hallucinations (hearing loud music in my head, Feeling like I'm delirious, and floating, sensitivity to light (everything had a yellow/orange tint). Vivid images when trying to close my eyes between puke/diarrhea. I had a chemical taste in my mouth, and could not hold any liquids. Now, about 24 hours after my shot, I feel physically beat up, tired, headache, and still a little upset stomach.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Feeling abnormal, Feeling of body temperature change, Hallucination, auditory, Hallucination, visual
Clinical narrative: Felt like I had to puke all the sudden, went to bathroom, I threw up, and unrelenting diarrhea for nearly 12 solid hours, 8:30 PM - 7:30 AM this morning. I Had hot/cold flashes, Muscle pain in, left leg, lower back, stomach. Cotton Mouth, Hallucinations (hearing loud music in my head, Feeling like I'm delirious, and floating, sensitivity to light (everything had a yellow/orange tint). Vivid images when trying to close my eyes between puke/diarrhea. I had a chemical taste in my mouth, and could not hold any liquids. Now, about 24 hours after my shot, I feel physically beat up, tired, headache, and still a little upset stomach.
Age: 27.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Myalgia, Nausea, Photophobia, Vomiting
Clinical narrative: Felt like I had to puke all the sudden, went to bathroom, I threw up, and unrelenting diarrhea for nearly 12 solid hours, 8:30 PM - 7:30 AM this morning. I Had hot/cold flashes, Muscle pain in, left leg, lower back, stomach. Cotton Mouth, Hallucinations (hearing loud music in my head, Feeling like I'm delirious, and floating, sensitivity to light (everything had a yellow/orange tint). Vivid images when trying to close my eyes between puke/diarrhea. I had a chemical taste in my mouth, and could not hold any liquids. Now, about 24 hours after my shot, I feel physically beat up, tired, headache, and still a little upset stomach.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Skin warm
Clinical narrative: Rash between fingers, inside arms, behind legs, around arm pit region and around hip bones. Rash hot to touch. Still spreading to other regions as of 1/3/2011.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Urticaria
Clinical narrative: Rash between fingers, inside arms, behind legs, around arm pit region and around hip bones. Rash hot to touch. Still spreading to other regions as of 1/3/2011.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt's mother called and stated pt's arm was swollen, told to bring her in to have it checked.  Pt came in and it had a 60mmx80mm reddened and raised area on right deltoid. Mother notified she can give her Zyrtec and Tylenol or Motrin and apply ice per doctor's instructions.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms, tide chest pain, which makes it difficult to breathe. As of today, 2 month later, I still have a tide chest and the muscles around it on the side and in the back.
Age: 3.0
Sex: F
Vaccine: FLUN3, HIBV, PNC13
Symptoms: Epistaxis
Clinical narrative: nosebleed at time of intranasal flu vaccination
Age: 47.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Gradual onset of symptoms.  Developed soreness, swelling and redness at the site of injection.  Not itchy. Swelling and redness increased; went to ED for evaluation and treatment.  DX:  Cellulitis; Placed on Bactrim DS one every 12 hours for 7 days; Keflex 500mg one capsule every 6 hours for 7 days.  To follow up two days. Sent to Occupational Medicine physician office for follow-up 1/3/2011.  To continue antibiotic and follow-up in 24 hours.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Fever, chills; redness and painful swelling at injection site (R deltoid)
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Blood test, Inflammation, Nuclear magnetic resonance imaging abnormal, Ophthalmological examination abnormal
Clinical narrative: Gradual loss of vision in left eye.  Went to see eye Dr. 10/22/10 and tests showed reduced field of vision.  Following weekend eyesight deteriorated even further.  Went to see eye Dr. again on 10/27/10 because of further loss of eyesight.  Patient estimated 60% of vision loss.  Eye exams showed significant degradation of eyesight in eye vision and field of vision testing.  Dr. ordered MRI for 10/28/10 and MRI came back negative.  Following week had further decrease in eye sight and eye Dr. ordered second MRI and that was done 11/2/10.  This MRI showed inflammation of the optic nerve.  Diagnosis was Optic Neuritis.  Treatment was IV steroids for three days (11/4/10, 11/5/10 and 11/6/10) with follow on oral steroids for 2 weeks.  Eye exam on 12/1/10 patient has seen some improvement in eye sight (from 20/300 to 20/50) and field of vision has shown some improvement.  Patient has not seen any additional improvement since 20/50 eye test on 12/1/10.  Field of vision is still distorted.