chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Injection site rash, Irritability, Pyrexia, Rash
Clinical narrative: Patient had 1 year vaccines of Fri 4/27/12. Mother states rash appeared on Sat. Patient was fussy, started running a fever of 101 degrees on Sunday - Mon noticed rash on injection site - Rt leg. When patient was brought into office on Mon 5/1/12 it had spread to his left foot, groin, and face. Had decreased appetite, and decreased wet diapers. Dx with Varicella was given nystatin for rash in groin and to F/U in 1-2 weeks.
Age: 1.02
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urine output decreased, Varicella post vaccine
Clinical narrative: Patient had 1 year vaccines of Fri 4/27/12. Mother states rash appeared on Sat. Patient was fussy, started running a fever of 101 degrees on Sunday - Mon noticed rash on injection site - Rt leg. When patient was brought into office on Mon 5/1/12 it had spread to his left foot, groin, and face. Had decreased appetite, and decreased wet diapers. Dx with Varicella was given nystatin for rash in groin and to F/U in 1-2 weeks.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Myalgia, Pyrexia, Rash, Vaccine positive rechallenge
Clinical narrative: After each of 2 MMR booster, (2-27-12) and (4-13-12) - 7 days later had fever of 102 degrees, weakness, muscle aches, rash for several days.
Age: 0.15
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Crying, Lethargy, Somnolence
Clinical narrative: Baby 1 month 23 days old came in to our clinic for well looking check up & exam. Baby has no prior illness, eating well, voids out normal. Baby received the oral RV vac, then the injectable required vaccine, after the PCV vac, baby cried a little then became quiet, sleepy like lethargic. No change in color, normal color. Normal breathing, HR, pulse ox no abn. body movement, cries nl moro reflex but sleepiness lethargic later. Hence we cal the paramedic and brought baby to ER. Observe these for 2 hrs. Then release & sent home. Baby was ok.
Age: 10.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: C-reactive protein increased, Full blood count normal, Headache, Metabolic function test normal, Musculoskeletal stiffness
Clinical narrative: 6 days after vaccines onset of occipital headache with neck stiffness without fever/cough or rhinorrhea.
Age: 1.09
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Blister, Excoriation, Irritability, Papule, Pyrexia
Clinical narrative: Rash & fever started 4-18-12. TYLENOL & ibuprofen administered at home. Fussiness & fever prompted visit to clinic. Note states skin is pruritic with tiny bumps. Vesicles grouped; multiple papules & excoriation on trunk --> seen on 5-1-12.
Age: 1.09
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash & fever started 4-18-12. TYLENOL & ibuprofen administered at home. Fussiness & fever prompted visit to clinic. Note states skin is pruritic with tiny bumps. Vesicles grouped; multiple papules & excoriation on trunk --> seen on 5-1-12.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL, HEPA, HPV4, TDAP, VARCEL
Symptoms: Convulsion, Hyperhidrosis, Hypotonia, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: After administration of vaccine #4, client became limp and lost consciousness. Client immediately began having an upper body seizure, lasting 5-7 seconds, client then became alert for approximately 5 seconds, then had another seizure lasting 5-7 seconds. Client was then alert, but pale and diaphoretic. 911 was called and client was transported to the hospital via ambulance.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV4, TDAP, VARCEL, HEPA, HPV4, TDAP, VARCEL
Symptoms: Pallor
Clinical narrative: After administration of vaccine #4, client became limp and lost consciousness. Client immediately began having an upper body seizure, lasting 5-7 seconds, client then became alert for approximately 5 seconds, then had another seizure lasting 5-7 seconds. Client was then alert, but pale and diaphoretic. 911 was called and client was transported to the hospital via ambulance.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Allergy test, Anaphylactic reaction, Choking, Food allergy, Food intolerance
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 19 year old female patient with a history of with food allergy, hives, pharynx itchy sensation of, throat constriction, respiratory tract congestion, discomfort, ache, weakness, fatigue, anaphylactic reaction and nickel sensitivity, was vaccinated on 22-JUL-2011 with the third dose of GARDASIL, (lot # 667930/1561Z), (site and route not reported). No concomitant medications were reported. On 23-JUL-2011, the patient presented with achiness, congestion, which got progressively worse to become food intolerance, hives, itchy throat and choking, anaphylactic reactions to food which increased with time. Laboratory test performed: The patient underwent extensive allergy testing, lab testing under close doctor supervision and still was not better. The following information was obtained through follow-up and/or provided by the government. 05-JAN-2012 lab/diagnostic records received for date of service (DOS) 26-SEP-2011. Allergy and spirometry test results were unremarkable. This report was considered serious and immediately life threatening and cause of permanent disability. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 446717. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Laboratory test, Pain, Respiratory tract congestion, Throat irritation, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 19 year old female patient with a history of with food allergy, hives, pharynx itchy sensation of, throat constriction, respiratory tract congestion, discomfort, ache, weakness, fatigue, anaphylactic reaction and nickel sensitivity, was vaccinated on 22-JUL-2011 with the third dose of GARDASIL, (lot # 667930/1561Z), (site and route not reported). No concomitant medications were reported. On 23-JUL-2011, the patient presented with achiness, congestion, which got progressively worse to become food intolerance, hives, itchy throat and choking, anaphylactic reactions to food which increased with time. Laboratory test performed: The patient underwent extensive allergy testing, lab testing under close doctor supervision and still was not better. The following information was obtained through follow-up and/or provided by the government. 05-JAN-2012 lab/diagnostic records received for date of service (DOS) 26-SEP-2011. Allergy and spirometry test results were unremarkable. This report was considered serious and immediately life threatening and cause of permanent disability. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 446717. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Allergy test negative, Anaphylactic reaction, Choking, Food intolerance, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 19 year old female patient with a history of with food allergy, hives, pharynx itchy sensation of, throat constriction, respiratory tract congestion, discomfort, ache, weakness, fatigue, anaphylactic reaction and nickel sensitivity, was vaccinated on 22-JUL-2011 with the third dose of GARDASIL, (lot # 667930/1561Z), (site and route not reported). No concomitant medications were reported. On 23-JUL-2011, the patient presented with achiness, congestion, which got progressively worse to become food intolerance, hives, itchy throat and choking, anaphylactic reactions to food which increased with time. Laboratory test performed: The patient underwent extensive allergy testing, lab testing under close doctor supervision and still was not better. The following information was obtained through follow-up and/or provided by the government. 05-JAN-2012 lab/diagnostic records received for date of service (DOS) 26-SEP-2011. Allergy and spirometry test results were unremarkable. This report was considered serious and immediately life threatening and cause of permanent disability. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 446717. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 19.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Respiratory tract congestion, Throat irritation, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 19 year old female patient with a history of with food allergy, hives, pharynx itchy sensation of, throat constriction, respiratory tract congestion, discomfort, ache, weakness, fatigue, anaphylactic reaction and nickel sensitivity, was vaccinated on 22-JUL-2011 with the third dose of GARDASIL, (lot # 667930/1561Z), (site and route not reported). No concomitant medications were reported. On 23-JUL-2011, the patient presented with achiness, congestion, which got progressively worse to become food intolerance, hives, itchy throat and choking, anaphylactic reactions to food which increased with time. Laboratory test performed: The patient underwent extensive allergy testing, lab testing under close doctor supervision and still was not better. The following information was obtained through follow-up and/or provided by the government. 05-JAN-2012 lab/diagnostic records received for date of service (DOS) 26-SEP-2011. Allergy and spirometry test results were unremarkable. This report was considered serious and immediately life threatening and cause of permanent disability. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 446717. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Death
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 12 year old female patient with no medical history, was vaccinated on 23-FEB-2012 with the third dose of GARDASIL, (lot # 672232/1495AA), I.M, in the left arm and with the second dose of VAQTA, (lot #672226/1441AA), I.M. in the left arm. The patient died on 26-FEB-2012. This report was considered serious due to death. The original reporting source was not provided. A lot check has been initiated. The VAERS ID # is 450655. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (672232/1495AA for GARDASIL) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. A standard lot check investigation has been finalized. All in-process quality checks for the lot number (672226/1441AA for VAQTA) in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Decreased activity, Fatigue, Malaise, Muscle spasms, Myalgia
Clinical narrative: Patient called (5/16/12) and stated that around three or four days after received ZOSTAVAX began feeling malaise and body aches. She has continued to feel very tired and wake up with leg spasms. She is seeing Dr. and possibly a specialist for further treatment - spoke with her again on 5/23/12.
Age: 64.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Fatigue, Malaise, Muscle spasms, Pain
Clinical narrative: Patient called (5/16/12) and stated that around three or four days after received ZOSTAVAX began feeling malaise and body aches. She has continued to feel very tired and wake up with leg spasms. She is seeing Dr. and possibly a specialist for further treatment - spoke with her again on 5/23/12.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Activities of daily living impaired, Conjunctivitis, Convulsion, Electroencephalogram normal, Epilepsy
Clinical narrative: First conjunctivitis then 2 days later high fever of 104 and 1 week after can't even move joints in every part of body to the point he couldn't get out of bed. Sed rate level was elevated and the week after that he has 3 seizures within 24 hours. Now he is diagnosed with epilepsy and is on heavy meds for it.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging normal, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: First conjunctivitis then 2 days later high fever of 104 and 1 week after can't even move joints in every part of body to the point he couldn't get out of bed. Sed rate level was elevated and the week after that he has 3 seizures within 24 hours. Now he is diagnosed with epilepsy and is on heavy meds for it.
Age: 14.0
Sex: F
Vaccine: HEPA, HPVX, VARCEL
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Noticed upon waking hives starting on upper left arm (same area as HPV injection) which spread to both arms and legs.  As of May 22nd, noticing new hives still showing up and no sign of going away. Now hives on ears, feet and hands too. They are not that itchy, however.
Age: 30.0
Sex: M
Vaccine: HEPA, TDAP, TYP
Symptoms: Asthenia, Injection site pain, Muscular weakness
Clinical narrative: Symptoms noticed while working out at a fitness gym.  Noticed left arm had been severely weakened compared to right arm during lifting session.  Lost over half its strength comparitvely. Mild soreness in area of vaccine.  Condition has not improved at all since vaccine.
Age: 55.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Pain, Pyrexia, Rash, Rubella antibody negative
Clinical narrative: Nursing student Rubella antibody IgG = <.90 needed MMR to began clinicals. On 5-11-12 Pt c/o swollen neck glands, pain, fever, rash on hands & elbows, still broke out with rash on 5-22-12 on hands & elbows.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ
Symptoms: Headache, Pain
Clinical narrative: Aches, soreness, HA - sx. started less than 24 hours after receiving GARDASIL vaccine (this was 2nd GARD injection - 1st was rec'd on 03/13/12) Felt to be possible serum sickness secondary to GARDASIL injection.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swelling, redness (L) upper arm.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a physician concerning an infant who on an unknown date, was vaccinated with a dose of ROTATEQ, oral (dose, lot number not reported). On an unknown date, the patient had a bloody stool and was hospitalized. Therapy with ROTATEQ was discontinued. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Dizziness, Dysphonia, Headache, Injection site erythema
Clinical narrative: Shot sight swollen (4" area) injection sight hard red, hot (3") area. fever 103 degrees, nausea, headache dizzy, loss of appetite, "raspy" throat all symptoms lasted 24 hrs. Except shot sight stayed swollen & itched for 4 add'l days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Shot sight swollen (4" area) injection sight hard red, hot (3") area. fever 103 degrees, nausea, headache dizzy, loss of appetite, "raspy" throat all symptoms lasted 24 hrs. Except shot sight stayed swollen & itched for 4 add'l days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shot sight swollen (4" area) injection sight hard red, hot (3") area. fever 103 degrees, nausea, headache dizzy, loss of appetite, "raspy" throat all symptoms lasted 24 hrs. Except shot sight stayed swollen & itched for 4 add'l days.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Arthralgia, Decreased appetite, Full blood count, Mental impairment, Metabolic function test
Clinical narrative: Vaccines 5/2/12 & on 5/4/12 started with muscle fatigue at night (PM) & on 5/5/12 - Fever around 100 - & joint achiness - cloudy thought process & decrease in appetite - see in office on 5/7/12 - still had fever 5/9/12 so lab work done - & fever was gone on 5/14/12 per mom treating now.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Muscle fatigue, Pyrexia, Red blood cell sedimentation rate, Rheumatoid factor, Urine analysis
Clinical narrative: Vaccines 5/2/12 & on 5/4/12 started with muscle fatigue at night (PM) & on 5/5/12 - Fever around 100 - & joint achiness - cloudy thought process & decrease in appetite - see in office on 5/7/12 - still had fever 5/9/12 so lab work done - & fever was gone on 5/14/12 per mom treating now.
Age: 0.67
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Rota given after indicated time frame of 32 weeks. Patient is 34 weeks of age. Patient took rota well with no reaction. Patient observed in office. 15 min. after rota.
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Cough, Diarrhoea, Enteritis infectious, Rhinorrhoea, Upper respiratory tract infection
Clinical narrative: Developed runny nose, cough, vomiting & diarrhea within 48 hours of administration. Pt evaluated by MD on 5/18. Dx: URI, Intestinal infection, enteritis - viral. Directed to push fluids. Call if symptoms worsen.
Age: 1.51
Sex: F
Vaccine: HEPA
Symptoms: Viral infection, Vomiting
Clinical narrative: Developed runny nose, cough, vomiting & diarrhea within 48 hours of administration. Pt evaluated by MD on 5/18. Dx: URI, Intestinal infection, enteritis - viral. Directed to push fluids. Call if symptoms worsen.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Dizziness, Pallor, Tremor
Clinical narrative: A few minutes after GARDASIL patient felt faint became pale & shaky - gave cake & layed patient down - vitals remained good - episode pasted in about 10 minutes.
Age: 11.0
Sex: U
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Diagnostic procedure, Dizziness, Laboratory test normal, Pallor, Tremor
Clinical narrative: A few minutes after GARDASIL patient felt faint became pale & shaky - gave cake & layed patient down - vitals remained good - episode pasted in about 10 minutes.
Age: 52.0
Sex: M
Vaccine: HEPA, IPV, TDAP, YF
Symptoms: Rash macular
Clinical narrative: Clt called & c/o "splotches" on his neck & head. No c/o SOB, or other complaints (per secretary). Advised to go to nearest E.R. (since client does not have a private physician). Also advised to take BENADRYL (per MFGTR directions).
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site inflammation
Clinical narrative: Inflammation at injection site. Topical & oral BENADRYL.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Muscular weakness, Pain in extremity
Clinical narrative: Arm with aching within one hour of injection followed by 2 days of debilitating fatigue and muscle weakness.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Red raised lump. MOTRIN, ice packs.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash on both thighs, child scratching area where shot was given.
Age: 1.07
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Coordination abnormal, Fall, Gait disturbance, Haematocrit normal, Haemoglobin normal
Clinical narrative: Approximately 1 hour after receiving vaccines, mom noted that she started walking funny and "appeared drunk." Her hand-eye coordination was off for about 2 days. Trouble walking and falling down lasted about 5 days. No fussiness. No fevers. No vomiting. Good PO.
Age: 1.07
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Platelet count normal, White blood cell count normal
Clinical narrative: Approximately 1 hour after receiving vaccines, mom noted that she started walking funny and "appeared drunk." Her hand-eye coordination was off for about 2 days. Trouble walking and falling down lasted about 5 days. No fussiness. No fevers. No vomiting. Good PO.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Abnormal behaviour, Autism, Childhood disintegrative disorder, Decreased eye contact, Decreased interest
Clinical narrative: Cranky, very quiet, stopped babbling and talking, loss of interest in parents, limited eye contact.
Age: 2.0
Sex: M
Vaccine: HIBV
Symptoms: Irritability, Regressive behaviour, Self injurious behaviour, Speech disorder, Speech disorder developmental
Clinical narrative: Cranky, very quiet, stopped babbling and talking, loss of interest in parents, limited eye contact.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Convulsion, Dizziness, Fall, Head injury, Syncope
Clinical narrative: Pt received Menveo vaccine in RD and Tb skin test in left forearm, approximately 7 minutes after receiving vaccine pt became light headed and fainted, fell to floor began having seizure like activity for approximately 1-3 minutes, pt had hit head in the process of falling, pt came to was Alert and oriented, after laying on floor for approximately 10 minutes moved pt to exam room table and pt then again began feeling faint and went into seizure like activity again for approximately 30 secs then came to. EMS was called and sent to hospital where pt was evaluated.  Never had a hx of fainting with vaccines but has had hx of fainting with sight of blood.
Age: 46.0
Sex: M
Vaccine: TYP, YF
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Pain, Pyrexia
Clinical narrative: Fever 99.7 max fatigue aches; diarrhea started Saturday stomach upset.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Cough, Dyspnoea, Respiratory arrest
Clinical narrative: At time of administration, pt began to cough. Nurse thought that pt may have choked on vaccine, but pt continued to cough then stopped coughing & took remainder of vaccine. Started back coughing and began gasping for air. Mother of pt felt that pt stopped breating for a few seconds, but started back when person holdig her adjusted her position. Pt gasped for air and them appeared fine. The remainder of parenteral vaccines were then given. Pt left office appearing fine. Nurse checked on her via phone call later in the day & her mom reported no problems.
Age: 0.35
Sex: F
Vaccine: RV5
Symptoms: Cough, Respiratory rate increased
Clinical narrative: Similar to reaction # 1 on 02/08/2012. Rotateq was administered, pt was swallowing without problem. Pt began coughing, but not gasping for air as at previous reaction. Nurse stopped administration about halfway through. Lungs were checked and were clear. Pt seemed to be breathing a little faster, but soon calmed down & stopped coughing. Appeared fine. Nurse called to check on her later in afternoon and mom reported no problems and said that she was fine.
Age: 29.0
Sex: M
Vaccine: HEPAB, MMR
Symptoms: Injection site reaction, Muscle spasms
Clinical narrative: Muscle spasm in left shoulder. (IM and SQ vaccine administered in the left arm.) No other systemic or local reactions reported or noted.
Age: 21.0
Sex: F
Vaccine: YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, slightly raised skin at injection site, approximately one and a half inches in diameter.
Age: 13.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Information has been received from a physician concerning a 13 year old male who on 09-MAY-2012 was vaccinated intramuscularly with the first, 0.5ml dose of GARDASIL (Lot# 672721/0101AE, expired in October 2014). Secondary suspect therapy on the same day included the second dose of VARIVAX, SC (Lot# 671861/1907AA). On 09-MAY-2012 during the office visit the patient developed syncope and seizure like movements after receiving his injection of GARDASIL. The patient was advised to lie down and elevate the legs as treatment. On 09-MAY-2012 the patient recovered. The patient's mother did not want him to receive the rest of the series, the action taken was unknown at this time. Upon internal review, seizure like movements was determined to be an other important medical event. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Patient received pneumo vaccine and then had a severe localized reaction with redness and swelling.
Age: 46.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site cellulitis, Pain in extremity
Clinical narrative: Patient received pneumo vaccine and then had a severe localized reaction with redness and swelling.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: At 4pm, patient noted raised spot on arm at injection site. At 6pm, site was itchy and reddened, approximately the size of a quarter. Patient took Benadryl. At 2am, patient experienced an ache down arm and in fingers, with swelling under arm. Saw doctor at 9:30am on 5/23/12- diag. local reaction to vaccine, cellulitis. Prescribed Keflex 500 QID.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Lymphadenopathy, Pain in extremity, Vaccination complication
Clinical narrative: At 4pm, patient noted raised spot on arm at injection site. At 6pm, site was itchy and reddened, approximately the size of a quarter. Patient took Benadryl. At 2am, patient experienced an ache down arm and in fingers, with swelling under arm. Saw doctor at 9:30am on 5/23/12- diag. local reaction to vaccine, cellulitis. Prescribed Keflex 500 QID.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion, Alpha 1 foetoprotein abnormal, Foetal disorder, Maternal exposure before pregnancy, Ultrasound antenatal screen abnormal
Clinical narrative: Information has been received from a physician for GARDASIL, a pregnancy registry product, concerning an 18 year old female patient, with no pertinent medical history and no known drug reactions or allergies, who on approximately 12-OCT-2010, was vaccinated with a dose of GARDASIL (Lot #, dose and route not reported), one month prior to conception. It was reported the patient became pregnant her last menstrual period was on 12-NOV-2010 and estimate delivery date is on 19-AUG-2011. A serum alpha-fetoprotein test (AFP) screening was performed and it was abnormal, and an ultrasound of fetus was performed and showed hypoplastic right heart and open neural tube encephalopathy (see WAES#: 1104USA02227B1). Follow up information has been received from a registered nurse via telephone call indicating that the patient was presently pregnant and not due until December 2012. The nurses also stated that the patient was presently being seen for a current pregnancy that was proceeding without any difficulties. However, she stated that the intake medical history form for their clinic mentioned a history of abnormal fetus (WAES 1104USA02227B2). The nurse reported that the patient probably aborted but could not confirm by record at that time. At the time of the report, the patient's outcome was unknown. Upon internal review, probably aborted was considered to be an other important medical event. This is one of several reports from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: PNC13
Symptoms: Adverse reaction, Death, Pneumonia streptococcal
Clinical narrative: This is a spontaneous report by a non contactable nurse. This nurse reported through Pfizer sales representative for a 12-year-old male patient who was administered a dose of PREVNAR 13 on an unknown date. Relevant medical history and concomitant medication were not reported. The patient experienced streptococcus pneumoniae for which he was hospitalized in 2012. In 2012, he experienced unspecified condition due to which he passed away. At the time of the report it was unknown if the autopsy was performed.
Age: 1.1
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Full blood count normal, Lymphadenopathy
Clinical narrative: Swollen glands on back of neck and head.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Autoimmune disorder, Eye pain, Fatigue, Feeling abnormal
Clinical narrative: Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gastrooesophageal reflux disease, Headache, Heart rate increased, Injection site pain, Myalgia
Clinical narrative: Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity, Palpitations, Paraesthesia, Pruritus
Clinical narrative: Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Suicidal ideation, Syncope, Tachycardia, Vision blurred, Vomiting
Clinical narrative: Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Abnormal behaviour, Altered visual depth perception, Anxiety, Computerised tomogram, Confusional state
Clinical narrative: Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Decreased activity, Disturbance in attention, Dizziness, Dry mouth, Dyspepsia
Clinical narrative: Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Eye pain, Faeces discoloured, Feeling abnormal, Gait disturbance
Clinical narrative: Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Gastrointestinal pain, Gastrooesophageal reflux disease, Headache, Insomnia, Mobility decreased
Clinical narrative: Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nausea, Nuclear magnetic resonance imaging, Paraesthesia, Pollakiuria, Pruritus generalised
Clinical narrative: Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 36.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Thirst, Vision blurred, Visual impairment, Vomiting
Clinical narrative: Initial report was received on 15 May 2012 from a consumer, who is also the patient. A 36 year-old male patient with a history of seasonal allergies had received on 20 January 2012, an intramuscular left deltoid injection of FLUZONE (lot number not reported) and an unspecified amount of time later the day of vaccination, the patient began to feel "out of sorts, not himself". Later the same night, the patient experienced extreme itching (with no rash noted), headaches, reflux, blurred vision in both eyes, his body was "sore" and felt like he had been "hit by a truck". The patient vomited, his eyes "hurt" and he had tingling in his hands and feet. The symptoms continued to worsen over the next few weeks. The patient experienced an increased heart rate and was diagnosed with tachycardia. The patient was evaluated in the emergency room (ER) on four occasions for excessive headache, tingling in the arms and legs, racing heart, palpitations, and fainting. The patient was diagnosed with an autoimmune reaction and stated the symptoms were not improving. The patient developed a clear film over his left eye and had been evaluated by an ophthalmologist. The patient also reported pain "similar to a charlie horse" in both arms, but more prominent in the left deltoid. The patient stated he was tired all the time and does not have any energy. The patient reported that he "was so distraught over the change in his health he contemplated suicide". Treatment included TAMIFLU with no improvement. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Chest X-ray normal, Convulsion, Differential white blood cell count normal, Full blood count normal, Postictal state
Clinical narrative: 21 hours post vaccines was playing then collapsed seizing. Lasted 1 min. Stopped on own. EMS took to ER. Post ictal 20-30 min. U/A, CXR, CBC done in ER. All neg. Gave dose ROCEPHIN.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Syncope, Urine analysis normal
Clinical narrative: 21 hours post vaccines was playing then collapsed seizing. Lasted 1 min. Stopped on own. EMS took to ER. Post ictal 20-30 min. U/A, CXR, CBC done in ER. All neg. Gave dose ROCEPHIN.