chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, White blood cell count increased
Clinical narrative: This spontaneous report as received from a other health professional (physician assistant) who was mother of patient via company representative refers to a female patient of unknown age. In April 2007 the patient was vaccinated with GARDASIL dose 1. Approximately in 2007 the patient experienced seizure (medically significant) sometime after the first vaccination. Unspecified Laboratory test was done on an unknown date with result of elevated white blood cell count after the vaccination. The outcome of seizure and elevated white blood cell count was unknown. The relation between the event and the vaccine was unknown. It was reported that the series of vaccination has been completed. Upon internal review event seizure was considered medically significant. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Parapsoriasis
Clinical narrative: Case number PHEH2014US001958, is an initial spontaneous report from a consumer received on 24 Jan 2014. This report refers to a male patient of unknown age. Past medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: 1309601) intramuscularly on 05 Jan 2014. Around 07 Jan 2014, 48 to 72 hours after vaccination, he was diagnosed with pityriasis lichenoides chronica (PLC). The outcome of the event was condition unchanged at the time of reporting. The seriousness and causality were not reported.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Neck pain, Pain
Clinical narrative: Rt deltoid area swollen since vaccine was given on 1/26/14, bright red rashes, very hard around and at vaccine site, painful to movements of Rt arm pain radiates to my right neck. Heat application only. On Sunday, January 26, 2014, I went to clinic to have a PPD and a TDAP vaccination, a requirement of my school for my upcoming advanced nursing clinical. I received the two vaccines, the PPD in my left forearm and the TDAP my right deltoid. The next morning I felt pain, soreness and swelling in my right arm, at and around the vaccination site. I am aware that these symptoms are usually indicated after most vaccines but my arm had a rash started at and around the vaccine area, it became hard and swollen, pain continues and radiates to my neck. I applied heat compress and applied some BENADRYL cream but it did not feel any better. I went back to the clinic on Wednesday to have my PPD read and spoke with the CRNP that was there; I showed her the vaccine site, she had no explanation for the reaction. Today, the date of this letter is six days, my arm is still as previously indicated, except the rashes are less visible but the redness remains. I have never had the TDAP vaccine before but it 2007, I had the DT booster which was also required by my school for clinical. Following that vaccine, I had soreness, mild pain with red rashes that looked more like red bumps (similar to pox). The CRNP who administered the vaccine let me speak with the physician from (infectious disease). His response was "This is a normal reaction, apply heat and some BENADRYL and in a few days it should be fine". In about four days, the pain, soreness, swelling and red rashes/bumps subsided and I was ok. Unfortunately, the experience with the TDAP is prolonged now to six days with all the above mentioned symptoms and the heat and BENADRYL is not effective in this case. I would like to know, what is the component in this vaccine that causes this reaction. I was given this form to report this problem and will appreciate your feedback as soon as possible.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous
Clinical narrative: Rt deltoid area swollen since vaccine was given on 1/26/14, bright red rashes, very hard around and at vaccine site, painful to movements of Rt arm pain radiates to my right neck. Heat application only. On Sunday, January 26, 2014, I went to clinic to have a PPD and a TDAP vaccination, a requirement of my school for my upcoming advanced nursing clinical. I received the two vaccines, the PPD in my left forearm and the TDAP my right deltoid. The next morning I felt pain, soreness and swelling in my right arm, at and around the vaccination site. I am aware that these symptoms are usually indicated after most vaccines but my arm had a rash started at and around the vaccine area, it became hard and swollen, pain continues and radiates to my neck. I applied heat compress and applied some BENADRYL cream but it did not feel any better. I went back to the clinic on Wednesday to have my PPD read and spoke with the CRNP that was there; I showed her the vaccine site, she had no explanation for the reaction. Today, the date of this letter is six days, my arm is still as previously indicated, except the rashes are less visible but the redness remains. I have never had the TDAP vaccine before but it 2007, I had the DT booster which was also required by my school for clinical. Following that vaccine, I had soreness, mild pain with red rashes that looked more like red bumps (similar to pox). The CRNP who administered the vaccine let me speak with the physician from (infectious disease). His response was "This is a normal reaction, apply heat and some BENADRYL and in a few days it should be fine". In about four days, the pain, soreness, swelling and red rashes/bumps subsided and I was ok. Unfortunately, the experience with the TDAP is prolonged now to six days with all the above mentioned symptoms and the heat and BENADRYL is not effective in this case. I would like to know, what is the component in this vaccine that causes this reaction. I was given this form to report this problem and will appreciate your feedback as soon as possible.
Age: 42.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Lymphadenopathy, Mammogram normal, Vaccination site pain, White blood cell count normal
Clinical narrative: On 1/20/14 patient called to say she had noted swollen node (L) axilla - she saw the provider 1/17/2014 - she said that node had become smaller by 1/20/14 - she was being scheduled for a mammogram. She denied any illness except some tenderness at vaccine inj. site which had improved and reduced in tenderness. 1/30/14 phone call. She states her mammogram was normal - WBC was normal - her provider said it may be due to her Tdap vaccination or maybe a sebaceous cyst. A breast or axilla U/S is planned if she wants to proceed.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Haemarthrosis, Local swelling, Pain in extremity, Vascular injury
Clinical narrative: Pt had swelling and pain in arm. Tennis ball sized swelling near elbow. Went to ER. Dr determined a blood vessel was punctured resulting in blood pooling in elbow. Patient treated with pain medication and antibiotic and told to follow up with PCP.
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Abdominal distension, Diarrhoea, Discomfort
Clinical narrative: Received flu shot approximately 1030am. Started with GI bloating and slight discomfort approximately 7pm. Woke up around 11pm with severe GI upset and diarrhea off and on through the night. Symptoms resolved approximately 8am following day. No changes were made to my typical diet and no other possible source of illness I could identify.
Age: 0.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Injection site swelling
Clinical narrative: Mom called states increased swelling from hip to ankle greater on (R). Inconsolable crying x 4 hrs, high-pitched. Not reported till 11/20. Contacted Mom 11/21/13. States leg was twice the normal size.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Pyrexia
Clinical narrative: Fever - 101 degrees F. Headache. Chills. Joint aches. Decreased appetite.
Age: 35.0
Sex: F
Vaccine: HEPA, IPV, TYP
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: (R) arm itchy. (-) SOB. Erythema 5 cm (R) arm. Swelling 10 cm (R) arm.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Eye swelling, Swelling face
Clinical narrative: Patient called 7 days later saying he began suffering over weekend with swollen eyes and now face is swelling - advised to consult MD. He insisted was caused by his flu shot, I informed him we would report it.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: I have always had soreness at the injection site of flu shots, but this time it has not gone away after a couple days. It is now almost 2 months since the injection soreness is not felt when arm is at my side, is felt when arm is over head (backstroke - swimming), holding hair dryer, combing hair, etc.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Pt called and states has rash on chest and itching.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Developmental delay, Irritability, Speech disorder developmental
Clinical narrative: Fussy, stopped talking and sitting up.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diet refusal, Vomiting projectile
Clinical narrative: Patient began to have projectile vomiting at approx. 2 AM after vaccination, refusal to drink bottle; no diarrhea; on 1/29/14 mother states that pt. began to eat again and was able to keep formula down. Pt. was prescribed ondansetron HCl solution in clinic on 1/28/14.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Spinal pain, X-ray
Clinical narrative: Severe back pain in spine - the ordeal of 2 surgeries recently I have walked in the hills of mountains and here - 1.0 hour without any pain. The following morning since the flu shot I have been in serious pain - hardly able to walk at all!
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Developed large red, swollen area approximately 4" diam distal of injection site on arm.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Received Menactra approximately 10 AM on 1/28/14. Noted hives on legs later that evening. Gave Benadryl - hives improved. Hives became progressively worse over next 24-48 hrs.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Blood test, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Within minutes of receiving flu shot, soreness/pain at injection site. Within 20 min, pain extended to elbow. < 2hrs, entire arm in a lot of pain. Pain continued, although easing. Started losing mobility. 3 1/2 months later, arm still painful, mostly around injection site, and loss of mobility. Treatments: Dr. visits, X-ray (negative), physical therapy (stopped per Dr orders), blood test. Has impacted everyday life (dressing, washing, reaching, etc).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Within minutes of receiving flu shot, soreness/pain at injection site. Within 20 min, pain extended to elbow. < 2hrs, entire arm in a lot of pain. Pain continued, although easing. Started losing mobility. 3 1/2 months later, arm still painful, mostly around injection site, and loss of mobility. Treatments: Dr. visits, X-ray (negative), physical therapy (stopped per Dr orders), blood test. Has impacted everyday life (dressing, washing, reaching, etc).
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Angioedema, Contusion, Erythema multiforme, Hypersensitivity, Influenza
Clinical narrative: A report from a Health Professional concerns a 6 year old male. No information regarding relevant medical history, concomitant medication was provided. The patient received FLUMIST (intranasal) on 27-Nov-2013. The health professional reported that the patient received FLUMIST QUAD nine days ago on 27-Nov-2013 and developed hives seven days ago, and was tested positive for the flu with fever and congestion which started on 04-Dec-2013. He was seen at the doctor's office on 04-Dec-13 and prescribed ORAPRED 49 ML for three days. The patient was taking a dose of 8.2 ML of ORAPRED three times a day. He came back to the physician's office on 06-Dec-2013 as his condition worsened and was prescribed ORAPRED of 50 ML again for three days for his symptoms. Patient had erythema multiforme, possible virus infection, bruising, joint swelling, angioedema, and possible hypersensitivity reaction. Patient was treated with prednisone, BENADRYL and ZYRTEC. The outcome of erythema multiforme, angioedema, tested positive for flu, fever, congestion, bruising and joint swelling was unknown, the patient recovered from the hypersensitivity reaction or viral infection on an unspecified date, and at the time of reporting, the hives were ongoing. The reporter assessed the events of tested positive for flu, hypersensitivity reaction vs viral infection, fever, congestion, and hives to be non-serious. The company physician identified erythema multiforme from the source document and added it as a serious adverse event (seriousness criterion of important medical event) while bruising, angioedema, and joint swelling were judged non-serious. Follow-up information received by AstraZeneca/MedImmune on 21-Jan-2014 from a health professional upgraded this case to globally expedited: Serious event of erythema multiforme was added. Non-serious events of hypersensitivity reaction vs. viral infection, joint swelling, angioedema, and bruising were added. Lab details added.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza virus test positive, Joint swelling, Pyrexia, Respiratory tract congestion, Urticaria
Clinical narrative: A report from a Health Professional concerns a 6 year old male. No information regarding relevant medical history, concomitant medication was provided. The patient received FLUMIST (intranasal) on 27-Nov-2013. The health professional reported that the patient received FLUMIST QUAD nine days ago on 27-Nov-2013 and developed hives seven days ago, and was tested positive for the flu with fever and congestion which started on 04-Dec-2013. He was seen at the doctor's office on 04-Dec-13 and prescribed ORAPRED 49 ML for three days. The patient was taking a dose of 8.2 ML of ORAPRED three times a day. He came back to the physician's office on 06-Dec-2013 as his condition worsened and was prescribed ORAPRED of 50 ML again for three days for his symptoms. Patient had erythema multiforme, possible virus infection, bruising, joint swelling, angioedema, and possible hypersensitivity reaction. Patient was treated with prednisone, BENADRYL and ZYRTEC. The outcome of erythema multiforme, angioedema, tested positive for flu, fever, congestion, bruising and joint swelling was unknown, the patient recovered from the hypersensitivity reaction or viral infection on an unspecified date, and at the time of reporting, the hives were ongoing. The reporter assessed the events of tested positive for flu, hypersensitivity reaction vs viral infection, fever, congestion, and hives to be non-serious. The company physician identified erythema multiforme from the source document and added it as a serious adverse event (seriousness criterion of important medical event) while bruising, angioedema, and joint swelling were judged non-serious. Follow-up information received by AstraZeneca/MedImmune on 21-Jan-2014 from a health professional upgraded this case to globally expedited: Serious event of erythema multiforme was added. Non-serious events of hypersensitivity reaction vs. viral infection, joint swelling, angioedema, and bruising were added. Lab details added.
Age: 5.0
Sex: M
Vaccine: FLUN4
Symptoms: Viral infection
Clinical narrative: A report from a Health Professional concerns a 6 year old male. No information regarding relevant medical history, concomitant medication was provided. The patient received FLUMIST (intranasal) on 27-Nov-2013. The health professional reported that the patient received FLUMIST QUAD nine days ago on 27-Nov-2013 and developed hives seven days ago, and was tested positive for the flu with fever and congestion which started on 04-Dec-2013. He was seen at the doctor's office on 04-Dec-13 and prescribed ORAPRED 49 ML for three days. The patient was taking a dose of 8.2 ML of ORAPRED three times a day. He came back to the physician's office on 06-Dec-2013 as his condition worsened and was prescribed ORAPRED of 50 ML again for three days for his symptoms. Patient had erythema multiforme, possible virus infection, bruising, joint swelling, angioedema, and possible hypersensitivity reaction. Patient was treated with prednisone, BENADRYL and ZYRTEC. The outcome of erythema multiforme, angioedema, tested positive for flu, fever, congestion, bruising and joint swelling was unknown, the patient recovered from the hypersensitivity reaction or viral infection on an unspecified date, and at the time of reporting, the hives were ongoing. The reporter assessed the events of tested positive for flu, hypersensitivity reaction vs viral infection, fever, congestion, and hives to be non-serious. The company physician identified erythema multiforme from the source document and added it as a serious adverse event (seriousness criterion of important medical event) while bruising, angioedema, and joint swelling were judged non-serious. Follow-up information received by AstraZeneca/MedImmune on 21-Jan-2014 from a health professional upgraded this case to globally expedited: Serious event of erythema multiforme was added. Non-serious events of hypersensitivity reaction vs. viral infection, joint swelling, angioedema, and bruising were added. Lab details added.
Age: 1.04
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives all over body. BENADRYL here in office at f/u visit.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Petechiae, Platelet count decreased, Pyrexia, Thrombocytopenia
Clinical narrative: Petechia 12/20, thrombocytopenia 12/21/ (Platelets 7 K). Fever 12/20 and 12/21. Platelets 12K on 12/23; back to normal on 12/27 (314K).
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Ultrasound scan normal
Clinical narrative: Pt was administered PNEUMOVAX 23 injection on 1/16/14. Pt called back to our office saying that the site was red and swollen, staff spoke with pt and advised pt to take BENADRYL and ice site as it was likely a local reaction. 1/17/14 staff called pt to report labs. Pt states that his arm was swollen from shoulder to elbow, tender, and red. I advised pt to come in today for Dr. to look at.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP, ANTH, SMALL, TYP
Symptoms: Rash generalised
Clinical narrative: Rash throughout body (wrists, stomach, waistline, face, legs). Rash developed 15 days after vaccine.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Extremely warm (hot) at vaccination site. Red, itchy, extreme soreness, swelling. Returned 1-17-14 - given antibiotic - Cephalexin (KEFLEX) 500 mg and Cetirizine (ZYRTEC).
Age: 32.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema, Pain in extremity, Rash macular
Clinical narrative: (R) arm pain, mild edema, blotchy erythema. The incident occurred 2 days ago. Incident location: after PNEUMOVAX shot. Injury mechanism: vaccine. The pain is present in the right shoulder. The quality of the pain is described as aching. The pain does not radiate. The pain is severe. The pain has been constant since the incident. Pertinent negatives include no chest pain, muscle weakness, numbness or tingling. She has tried NSAIDs for the symptoms. The treatment provided mild relief. Pt had a hard time with her day care yesterday as was having problems lifting kids.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Increased redness and swelling - see ER report attached.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report was received from a female consumer of an unknown age, via company representative referring on herself. The patient reported that last week, on 13-JAN-2014 approximately, she was vaccinated with a dose of ZOSTAVAX (series, route of administration and lot # not reported). The patient told to the company representative that last week, on 13-JAN-2014, approximately, that she didn't feel any worse for wear except she had an egg at the injection site that continues to be very tender and itchy. The outcome of I have an egg at the injection site that continues to be very tender and itchy was unknown. The reporter considered I have an egg at the injection site that continues to be very tender and itchy to be related to ZOSTAVAX. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Rash at injection site, both arms, abdomen; legs.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Faecal incontinence, Hypoaesthesia, Muscular weakness, Nuclear magnetic resonance imaging
Clinical narrative: Horrible left arm pain, weakness, left arm, pain to bend of arm, numbness, loss of bowels spontaneous.
Age: 52.0
Sex: F
Vaccine: UNK
Symptoms: Nuclear magnetic resonance imaging brain, Pain in extremity
Clinical narrative: Horrible left arm pain, weakness, left arm, pain to bend of arm, numbness, loss of bowels spontaneous.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Dysgeusia, Hypogeusia
Clinical narrative: Immediate bitter taste in mouth after injection followed by hypogeusia.
Age: 29.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Injection site pruritus, Pain, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Patient complained of itching at injection site the day following vaccination (Sunday).  On Monday she discovered a red bump, warm to the touch with constant itching and "sore" like pain 3/10.
Age: 29.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Injection site pruritus, Pain, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Day following vaccination pt had itching at vaccination site. 2 days post vaccination pt develops raised red bump, warm to touch, constant itching, with sore like pain 3/10.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: C-reactive protein normal, Complement factor C3, Complement factor C4, Full blood count normal, Henoch-Schonlein purpura
Clinical narrative: Initially had large local reaction at site of injection; developed purpuric rash 3 days later. DDx concerning for HSP. Diagnosed with hypersensitivity vasculitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Leukocytoclastic vasculitis, Local reaction, Metabolic function test normal, Purpura
Clinical narrative: Initially had large local reaction at site of injection; developed purpuric rash 3 days later. DDx concerning for HSP. Diagnosed with hypersensitivity vasculitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: Initially had large local reaction at site of injection; developed purpuric rash 3 days later. DDx concerning for HSP. Diagnosed with hypersensitivity vasculitis.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Employee reported that on 1/6/14 she still had pain at injection site and couldn't raise her right arm.
Age: 71.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Eye swelling, Headache, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat, headache, body aches, fever & swelling of face, chin & eyes.
Age: 71.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Swelling face
Clinical narrative: Sore throat, headache, body aches, fever & swelling of face, chin & eyes.
Age: 71.0
Sex: F
Vaccine: VARZOS, FLUX, VARZOS
Symptoms: Headache, Pain, Pharyngeal oedema, Pyrexia, Swelling face
Clinical narrative: Sore throat, headache, body aches, fever & swelling of face, chin & eyes.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral, Rash
Clinical narrative: Pt had rash develop on arm that was vaccinated. Pt also c/o tingling lips.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Biliary dilatation, Hepatitis A, Hepatitis A antibody positive, Ultrasound liver abnormal
Clinical narrative: This case was reported by a physician and described the occurrence of dilated common bile duct in a currently 53-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 4 January 2014 the subject received 1st dose of HAVRIX (unknown details). On 17 January 2014, 13 days after vaccination with HAVRIX, the subject experienced hepatitis a infection (described as "mild case of clinical hepatitis A") and hepatitis a virus igm antibody positive. On an unknown date in January 2014, the subject experienced dilated common bile duct. Per the physician, the immunization series was not delayed. Medical attention was received at the doctor's office. The physician was "unsure" if the events were "an adverse reaction, coincidental, or if there was another cause." The physician was not sure "if this dilated common bile duct was present before the HAVRIX vaccine because it was never investigated." This case was assessed as medically serious by GSK. Relevant test results included: On January 17 2014, the subject had a positive hepatitis A IgM result. The subject received an ultrasound examination in January 2014 with results showing a "dilated common bile duct that is 10 millimeters and, per the physician, "that is a bit long." At the time of reporting the outcome of the event of dilated common bile duct was unknown. The event of hepatitis A infection and hepatitis A virus IgM antibody positive was noted by the physician as improved.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Injected limb mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: Approximately 3 hours after receiving vaccine patient's (L) arm became extremely sore. She was unable to lift (L) arm w/out supporting it w/ her (R) arm. She felt feverish but didn't take temperature. Pain and weakness lasted for 4 days but lessened each day.
Age: 17.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle tightness, Pleuritic pain, Tetanus
Clinical narrative: This case was reported in a literature article and described the occurrence of tetanus in a 17-year-old male subject who  was vaccinated with Diphtheria tetanus acellular pertussis, manufacturer unspecified). The subject's ethnicity was stated and he was homeschooled at the time of the event. On 26 June 2012 he had stepped on a rusty boat anchor and sustained a puncture wound to his foot while working outdoors for a sailing program. He had cleaned the wound with hydrogen peroxide. He had experienced mild pain but no local erythema, swelling or drainage from the wound. No further information on his medical family history or concurrent medication is available. On an unspecified date, the subject might have received an unspecified dose of Diphtheria tetanus acellular pertussis (administration site and route unknown, batch number not provided) during childhood. However, there was no record of him receiving any vaccination in his school, primary care physician's office or in the state immunisation registry. On 30 June 2012, at an unspecified time after vaccination with Diphtheria tetanus acellular pertussis, the subject experienced tightness of neck muscles and jaw. The symptoms had worsened during the day and he had developed pleuritic chest pain too. The subject was hospitalised for 5 days. No details of any laboratory tests or diagnostic procedures have been provided. Diagnosis was tetanus infection. Initial treatment consisted of wound cleaning and administration of 250 U of human tetanus immune globulin, tetanus toxoid vaccine, and 500 mg of metronidazole. He was then transferred to a tertiary medical centre where he received 2 mg of lorazepam and was admitted to the general paediatric ward. During his hospitalization there, he received 500 mg of metronidazole every 8 hours for 5 days and an additional 6000 U of human tetanus immune globulin. Outcome was complete recovery with discharge from the hospital without sequelae on 4 July 2012. The author's conclusion stated that because immunization rates among homeschooled children are largely unknown, this population might be considered at higher risk for contracting more prevalent communicable vaccine preventable diseases.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Activated partial thromboplastin time normal, Antinuclear antibody negative, Computerised tomogram head normal, Conjunctival haemorrhage, Contusion
Clinical narrative: This case was reported in a literature article and described the occurrence of itp (idiopathic thrombocytopenia purpura) in a 57-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included motor vehicle accident and splenectomy. Concurrent medical conditions included end stage renal disease on hemodialysis. The subject had received the vaccine previously with no documented adverse reaction. No further information on his medical or family history or any concurrent medications at the time of the event is available. On an unspecified date, the subject received unspecified dose of Hepatitis B vaccine (unknown route and injection site; lot number not provided). Less than 2 days after vaccination with Hepatitis B vaccine, the subject experienced bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. At 2 days after vaccination with Hepatitis B vaccine, the subject was transferred from the nursing home due to an abnormally low platelet count (3000/ mm3) found on a blood test. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucoasl bleeding in the mouth. The subject was hospitalised. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology; prothrombin time and active partial thromboplastin time were normal as were assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies. Serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. The subject was initially treated with transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura was made. The subject was treated with SOLUMEDROL, normal immunoglobulin (Intravenous Immunoglobulin) and aminocaproic acid. By the end of the fifth day, subject's platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow-up. At the time of reporting the outcome of  the events was unspecified.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Ecchymosis, HIV test negative, Haematuria, Haemoglobin decreased, Headache
Clinical narrative: This case was reported in a literature article and described the occurrence of itp (idiopathic thrombocytopenia purpura) in a 57-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included motor vehicle accident and splenectomy. Concurrent medical conditions included end stage renal disease on hemodialysis. The subject had received the vaccine previously with no documented adverse reaction. No further information on his medical or family history or any concurrent medications at the time of the event is available. On an unspecified date, the subject received unspecified dose of Hepatitis B vaccine (unknown route and injection site; lot number not provided). Less than 2 days after vaccination with Hepatitis B vaccine, the subject experienced bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. At 2 days after vaccination with Hepatitis B vaccine, the subject was transferred from the nursing home due to an abnormally low platelet count (3000/ mm3) found on a blood test. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucoasl bleeding in the mouth. The subject was hospitalised. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology; prothrombin time and active partial thromboplastin time were normal as were assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies. Serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. The subject was initially treated with transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura was made. The subject was treated with SOLUMEDROL, normal immunoglobulin (Intravenous Immunoglobulin) and aminocaproic acid. By the end of the fifth day, subject's platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow-up. At the time of reporting the outcome of  the events was unspecified.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Heparin-induced thrombocytopenia test, Hepatitis B test negative, Hepatitis C test negative, Idiopathic thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: This case was reported in a literature article and described the occurrence of itp (idiopathic thrombocytopenia purpura) in a 57-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included motor vehicle accident and splenectomy. Concurrent medical conditions included end stage renal disease on hemodialysis. The subject had received the vaccine previously with no documented adverse reaction. No further information on his medical or family history or any concurrent medications at the time of the event is available. On an unspecified date, the subject received unspecified dose of Hepatitis B vaccine (unknown route and injection site; lot number not provided). Less than 2 days after vaccination with Hepatitis B vaccine, the subject experienced bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. At 2 days after vaccination with Hepatitis B vaccine, the subject was transferred from the nursing home due to an abnormally low platelet count (3000/ mm3) found on a blood test. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucoasl bleeding in the mouth. The subject was hospitalised. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology; prothrombin time and active partial thromboplastin time were normal as were assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies. Serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. The subject was initially treated with transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura was made. The subject was treated with SOLUMEDROL, normal immunoglobulin (Intravenous Immunoglobulin) and aminocaproic acid. By the end of the fifth day, subject's platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow-up. At the time of reporting the outcome of  the events was unspecified.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Immunoglobulins normal, Laboratory test normal, Melaena, Mouth haemorrhage, Platelet aggregation normal
Clinical narrative: This case was reported in a literature article and described the occurrence of itp (idiopathic thrombocytopenia purpura) in a 57-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included motor vehicle accident and splenectomy. Concurrent medical conditions included end stage renal disease on hemodialysis. The subject had received the vaccine previously with no documented adverse reaction. No further information on his medical or family history or any concurrent medications at the time of the event is available. On an unspecified date, the subject received unspecified dose of Hepatitis B vaccine (unknown route and injection site; lot number not provided). Less than 2 days after vaccination with Hepatitis B vaccine, the subject experienced bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. At 2 days after vaccination with Hepatitis B vaccine, the subject was transferred from the nursing home due to an abnormally low platelet count (3000/ mm3) found on a blood test. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucoasl bleeding in the mouth. The subject was hospitalised. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology; prothrombin time and active partial thromboplastin time were normal as were assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies. Serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. The subject was initially treated with transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura was made. The subject was treated with SOLUMEDROL, normal immunoglobulin (Intravenous Immunoglobulin) and aminocaproic acid. By the end of the fifth day, subject's platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow-up. At the time of reporting the outcome of  the events was unspecified.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Platelet count decreased, Platelet morphology normal, Platelet transfusion, Prothrombin time normal, Smear site unspecified normal
Clinical narrative: This case was reported in a literature article and described the occurrence of itp (idiopathic thrombocytopenia purpura) in a 57-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included motor vehicle accident and splenectomy. Concurrent medical conditions included end stage renal disease on hemodialysis. The subject had received the vaccine previously with no documented adverse reaction. No further information on his medical or family history or any concurrent medications at the time of the event is available. On an unspecified date, the subject received unspecified dose of Hepatitis B vaccine (unknown route and injection site; lot number not provided). Less than 2 days after vaccination with Hepatitis B vaccine, the subject experienced bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. At 2 days after vaccination with Hepatitis B vaccine, the subject was transferred from the nursing home due to an abnormally low platelet count (3000/ mm3) found on a blood test. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucoasl bleeding in the mouth. The subject was hospitalised. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology; prothrombin time and active partial thromboplastin time were normal as were assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies. Serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. The subject was initially treated with transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura was made. The subject was treated with SOLUMEDROL, normal immunoglobulin (Intravenous Immunoglobulin) and aminocaproic acid. By the end of the fifth day, subject's platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow-up. At the time of reporting the outcome of  the events was unspecified.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Tongue blistering, White blood cell count increased
Clinical narrative: This case was reported in a literature article and described the occurrence of itp (idiopathic thrombocytopenia purpura) in a 57-year-old male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). The subject's medical history included motor vehicle accident and splenectomy. Concurrent medical conditions included end stage renal disease on hemodialysis. The subject had received the vaccine previously with no documented adverse reaction. No further information on his medical or family history or any concurrent medications at the time of the event is available. On an unspecified date, the subject received unspecified dose of Hepatitis B vaccine (unknown route and injection site; lot number not provided). Less than 2 days after vaccination with Hepatitis B vaccine, the subject experienced bruising around his left eye, hemorrhagic blebs on his tongue, hematuria, tarry stools and diffuse ecchymosis over his extremities. He also reported a mild frontal headache. At 2 days after vaccination with Hepatitis B vaccine, the subject was transferred from the nursing home due to an abnormally low platelet count (3000/ mm3) found on a blood test. Physical examination revealed ecchymosis, conjunctival haemorrhage and mucoasl bleeding in the mouth. The subject was hospitalised. On admission, the results of analytical tests were: white blood count of 11,200/mm3, haemoglobin of 12.8 g/dL, platelet count of 3000/mm3, and peripheral smear showed no schistocytes, clumping and normal platelet morphology; prothrombin time and active partial thromboplastin time were normal as were assays for heparin-induced antibodies, heparin induced platelet aggregation, antinuclear antibodies. Serological assays for hepatitis B virus, hepatitis C virus and Human immunodeficiency virus were negative. The subject was initially treated with transfused single donor platelets with no improvement in the platelet count. A diagnosis of immune thrombocytopenic purpura was made. The subject was treated with SOLUMEDROL, normal immunoglobulin (Intravenous Immunoglobulin) and aminocaproic acid. By the end of the fifth day, subject's platelet count was 102,000/mm3 and was 259,000/mm3 at discharge. He was sent to the nursing home on tapering oral steroids for a month. Platelet counts remained normal on a six month follow-up. At the time of reporting the outcome of  the events was unspecified.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Pain in extremity
Clinical narrative: Arm swelled up and was in severe pain. Went to the ER the next morning the doc told me that a nerve was hit this was about 3 weeks ago and arm still is in some pain.
Age: 1.02
Sex: M
Vaccine: DTAPHEPBIP, FLU3
Symptoms: Blood culture, Convulsion, Pyrexia
Clinical narrative: Pt. in the evening on 1/29/14 developed a seizure that lasted 15 minutes, but was also febrile at the time. Received ATIVAN x 1 and seizure resolved.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Concussion, Road traffic accident, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 24 year old female patient. Patient's medical history and drug reactions/allergies were not reported. On 03-NOV-1990, the patient was vaccinated with MMR II dose 1 for routine. On 29-NOV-1997, the patient was vaccinated with MMR II dose 2 for routine. On 17-JAN-2014, the patient was in a car accident and sustained mild concussion. On 27-JAN-2014, the patient had titer drawn and the titer results showed that she was immune to measles and mumps but an equivocal rubella titer. No treatment was given for the adverse event. The outcome of equivocal rubella titer and the patient was in a car accident and sustained mild concussion was unknown. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Local swelling, Skin test, Skin test negative, Swelling face
Clinical narrative: 44 y/o Medical Records Manager at Clinic, ref by Occ Hlth to HC for eval of AEFI s/p flu shot on 16NOV05. Facial and hand swelling / wheezing, difficulty breathing 2 hrs after receipt of IIV3.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: 44 y/o Medical Records Manager at Clinic, ref by Occ Hlth to HC for eval of AEFI s/p flu shot on 16NOV05. Facial and hand swelling / wheezing, difficulty breathing 2 hrs after receipt of IIV3.
Age: 1.01
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site vesicles
Clinical narrative: Left upper thigh, 3cm x 2cm erythremic nodule with several small raised vesicles.
Age: 0.53
Sex: M
Vaccine: DTAPIPV, HIBV, PNC13, RV5
Symptoms: Irritability, Wrong drug administered
Clinical narrative: 6 mo patient was supposed to get a PEDIARIX shot but instead got a KINRIX GSK PY3DZ (R) thigh IM vaccine. Mom reported some fussiness later in the day. Gave single dose of TYLENOL. No more treatment needed.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a 60 year old male consumer regarding himself. On 28-JAN-2014 the patient was vaccinated with ZOSTAVAX. On 29-JAN-2014, the patient developed redness, swelling, soreness and warmth at the injection site. The outcome of injection site redness, warmth at the injection site, injection site soreness and injection site swelling was reported as not recovered/not resolved. No treatment was given for the adverse events. No lab diagnostics studies were performed. The patient did not see any medical attention. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Abnormal behaviour, Decreased activity, Skin warm, Somnolence
Clinical narrative: "Not himself" Slept till 8-9 p, on day of shot. Not active. Little warm subjective. As of 2/4/2014 -> still not himself. Still warm.
Age: 1.02
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema/induration at injection site persisting for 13 days. VARIVAX.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a patient of unknown age and gender who on an unknown dates was vaccinated with a three series doses of RECOMBIVAX HB (dose, route and lot # not provided). The physician stated that an unspecified amount of time after the RECOMBIVAX HB series completion, titers were drawn in unspecified lab tests and the patient was negative for hepatitis B immunity. There was no treatment given for the events. The outcome of patient's titers was drawn in unspecified lab tests and the patient was negative for hepatitis B immunity was reported as not recovered. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Swollen arm, redness, tender to touch.