chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Cyanosis, Dyspnoea
Clinical narrative: Information has been received from a healthcare worker concerning a 10 year old female who on  10/9/04 was vaccinated with MMR (lot # 647648/0318P). Subsequently, the patient had difficulty breathing and turned blue. The physician administered nebulization and epinephrine. The patient was taken to the hospital by ambulance and was shortly released. The patient was reportedly doing well. It was reported that the office manager said that this must be a bad batch of MMR and should be removed. Upon internal review, difficulty breathing and turned blue were considered to be other medical events (OMIC). It was also reported that another patient had an adverse event (WAES0410USA02277). Additional information has been requested.
Age: 0.63
Sex: F
Vaccine: DTAP, FLU3, HEP, IPV, PNC
Symptoms: Intussusception
Clinical narrative: From initial information received on 10/18/04 from a healthcare facility regarding an adverse event occurring in the USA, it was reported that a 7 month old female patient received FLUZONE SV 2004-2005, lot number U1407AA, on 10/12/04. The route and site of administration were not reported. An unspecified amount of time later, the patient was seen by a surgeon at a hospital and was diagnosed with intussusception of the bowel. It is unknown if the patient was actually admitted, however, the reporter stated that she believed she was. No other details were provided. The reporter stated that she believes the patient recovered from this event.  Follow up on 11/12/04 states: "From additional information received on 11/04/04 from a health care professional, the vaccine was administered in the pt's left leg on 10/12/04 at 12:00 in the afternoon. Four days later on 10/16/04 at 3:00AM, the pt developed intussusception of the bowel. No other medical information was provided at this time."
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Dyspnoea, Gastrooesophageal reflux disease, Hyponatraemia
Clinical narrative: 4 hours after immunizations, delayed breathing. EMS called and hospitalized for 2 days for obstruction.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Acidosis, Atelectasis, Atrial fibrillation, Cardiac failure, Dyspnoea
Clinical narrative: Septic shock syndrome, Acute renal failure, acute tubular necrosis. Non-Q myocardial infarction. Discharge Summary received on 12/07/2004 states hyperglycemia, acidosis, atrial fibrillation, lung dis, atelectasois, and CHF. Medical Records received on 12/07/2004 states rash, fever, SOB, lethargy and itching.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Hyperglycaemia, Laboratory test abnormal, Lethargy, Lung disorder, Myocardial infarction
Clinical narrative: Septic shock syndrome, Acute renal failure, acute tubular necrosis. Non-Q myocardial infarction. Discharge Summary received on 12/07/2004 states hyperglycemia, acidosis, atrial fibrillation, lung dis, atelectasois, and CHF. Medical Records received on 12/07/2004 states rash, fever, SOB, lethargy and itching.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Pyrexia, Rash, Renal failure, Renal tubular necrosis
Clinical narrative: Septic shock syndrome, Acute renal failure, acute tubular necrosis. Non-Q myocardial infarction. Discharge Summary received on 12/07/2004 states hyperglycemia, acidosis, atrial fibrillation, lung dis, atelectasois, and CHF. Medical Records received on 12/07/2004 states rash, fever, SOB, lethargy and itching.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Sepsis, Shock, White blood cell count increased
Clinical narrative: Septic shock syndrome, Acute renal failure, acute tubular necrosis. Non-Q myocardial infarction. Discharge Summary received on 12/07/2004 states hyperglycemia, acidosis, atrial fibrillation, lung dis, atelectasois, and CHF. Medical Records received on 12/07/2004 states rash, fever, SOB, lethargy and itching.
Age: 21.0
Sex: M
Vaccine: HEP, TD
Symptoms: Cerebral haemorrhage, Injury, Loss of consciousness
Clinical narrative: 3-8 minutes after receiving Td and Hepatitis B shots, client left clinic room to lobby to pay bill (20-30 feet). He passed out with warning and fell straight backwards, suffering a severe blow to the back of his head. He was taken per ambulance to hospital where diagnosis was concussion with cerebral bleed.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Tenderness
Clinical narrative: Red erythematous area 3 1/2 diameter around injection site. Tender, no fever. Cool compresses, observe.
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Injection site pain, Tenderness
Clinical narrative: redness and edema to left upper thigh, front area approx 4x3" warm and tender to touch pt c/o pain/discomfort.
Age: 75.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Tenderness
Clinical narrative: Redness, swelling, warmth, tenderness of right upper extremity above and below vaccine site. Covers entire tricep region.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Rec'd influenza vaccine 10/18/04 developed redness, swelling (5cm) on right upper deltoid.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Parkinsonism
Clinical narrative: 3 hours after shot, large knot on side of neck appeared.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction
Clinical narrative: Administered Pneumonia shot in left arm at about 2:30PM 10/22/04. Pt noticed around Friday evening left arm from shoulder down turned red and some swelling. Pneumococcal vaccine polyvalent Pneumovax 23 Lot 0513P ex 03/09/06.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Cellulitis, Erythema, Injection site mass, Joint range of motion decreased, Oedema
Clinical narrative: Right upper arm swollen, indurated, painful, erythematous within 24 hours of immunizations. No fever, limited ROM, swelling, redness and erythema, extended from antesubterol to above shoulder joint. Treated with Augmentin for a presumed cellulitis and Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR
Symptoms: Pain
Clinical narrative: Right upper arm swollen, indurated, painful, erythematous within 24 hours of immunizations. No fever, limited ROM, swelling, redness and erythema, extended from antesubterol to above shoulder joint. Treated with Augmentin for a presumed cellulitis and Benadryl.
Age: 1.35
Sex: M
Vaccine: FLU3
Symptoms: Convulsion, Irritability, Pyrexia
Clinical narrative: On 10/18/04 pt received Influenza vaccine. He became irritable and febrile. On 10/20/04, he had a generalized seizure with fever (105F)
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Left arm numbness from shoulder to fingertips, painful.
Age: 2.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Erythema, Flushing, Hypoxia, Pruritus, Urticaria
Clinical narrative: 30-45 min post influenza admin (pt's 3rd dose) pt experienced pruritus, interior flushing, redness of face, hives, wheezing.
Age: 2.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Wheezing
Clinical narrative: 30-45 min post influenza admin (pt's 3rd dose) pt experienced pruritus, interior flushing, redness of face, hives, wheezing.
Age: 1.11
Sex: M
Vaccine: FLU3
Symptoms: Face oedema, Rash, Scrotal oedema
Clinical narrative: Facial edema, scrotal edema, body rash at creases, gave 0.1mg Epinephrine SQ x1 and sent to ER.  Nurse follow up on 11/12/04 states: "no new information."
Age: 0.58
Sex: M
Vaccine: DTAP, FLU3, HEP, IPV
Symptoms: Apnoea, Convulsion, Cyanosis, Gaze palsy, Lethargy
Clinical narrative: x2 seizures lasting 15 minutes at home. Body shaking with starring, some apnea, duskiness, lethargic afterwards. Paramedics called both times. No treatment. (01:30 and 08:00 10/22/04).
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Asthenia, Balance disorder, CSF test abnormal, Cognitive disorder
Clinical narrative: 6 year old female with meningoencephalitis (cause unknown) who has been recovering over last 2.5 months. She received the vaccine and developed more encephalopathic symptoms about 8 hours after receiving the vaccine. She is 11 days out from vaccine and still has slurred speech, word-finding difficulty, gait difficulties, etc. Discharge Summary received on 12/07/2004 states abdominal pain, leg pain, fever, headache, stiff neck, unresponsive, irritable, sleepy, decreased stregnth, decreased po intake, urinary retention, and bladder spasm. Medical Records received on 12/07/2004 states vomiting. Follow up 03/04/05: Patient has almost completely recovered. She still has some fine motor and cognative deficits. We did give her a prolonged course of steroids after her MRI was consistent with "Acute Demyelinating Encephalomyelitis". She has improved neurologic function. Per annual follow report 1/26/2006 She still has subtel cognitive/processing problems, she has balance issues.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Coma, Condition aggravated, Dehydration, Dysarthria, Electroencephalogram abnormal
Clinical narrative: 6 year old female with meningoencephalitis (cause unknown) who has been recovering over last 2.5 months. She received the vaccine and developed more encephalopathic symptoms about 8 hours after receiving the vaccine. She is 11 days out from vaccine and still has slurred speech, word-finding difficulty, gait difficulties, etc. Discharge Summary received on 12/07/2004 states abdominal pain, leg pain, fever, headache, stiff neck, unresponsive, irritable, sleepy, decreased stregnth, decreased po intake, urinary retention, and bladder spasm. Medical Records received on 12/07/2004 states vomiting. Follow up 03/04/05: Patient has almost completely recovered. She still has some fine motor and cognative deficits. We did give her a prolonged course of steroids after her MRI was consistent with "Acute Demyelinating Encephalomyelitis". She has improved neurologic function. Per annual follow report 1/26/2006 She still has subtel cognitive/processing problems, she has balance issues.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Encephalitis, Gait disturbance, Headache, Irritability, Musculoskeletal stiffness
Clinical narrative: 6 year old female with meningoencephalitis (cause unknown) who has been recovering over last 2.5 months. She received the vaccine and developed more encephalopathic symptoms about 8 hours after receiving the vaccine. She is 11 days out from vaccine and still has slurred speech, word-finding difficulty, gait difficulties, etc. Discharge Summary received on 12/07/2004 states abdominal pain, leg pain, fever, headache, stiff neck, unresponsive, irritable, sleepy, decreased stregnth, decreased po intake, urinary retention, and bladder spasm. Medical Records received on 12/07/2004 states vomiting. Follow up 03/04/05: Patient has almost completely recovered. She still has some fine motor and cognative deficits. We did give her a prolonged course of steroids after her MRI was consistent with "Acute Demyelinating Encephalomyelitis". She has improved neurologic function. Per annual follow report 1/26/2006 She still has subtel cognitive/processing problems, she has balance issues.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Somnolence, Speech disorder, Urinary retention
Clinical narrative: 6 year old female with meningoencephalitis (cause unknown) who has been recovering over last 2.5 months. She received the vaccine and developed more encephalopathic symptoms about 8 hours after receiving the vaccine. She is 11 days out from vaccine and still has slurred speech, word-finding difficulty, gait difficulties, etc. Discharge Summary received on 12/07/2004 states abdominal pain, leg pain, fever, headache, stiff neck, unresponsive, irritable, sleepy, decreased stregnth, decreased po intake, urinary retention, and bladder spasm. Medical Records received on 12/07/2004 states vomiting. Follow up 03/04/05: Patient has almost completely recovered. She still has some fine motor and cognative deficits. We did give her a prolonged course of steroids after her MRI was consistent with "Acute Demyelinating Encephalomyelitis". She has improved neurologic function. Per annual follow report 1/26/2006 She still has subtel cognitive/processing problems, she has balance issues.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Viral infection, Vomiting
Clinical narrative: 6 year old female with meningoencephalitis (cause unknown) who has been recovering over last 2.5 months. She received the vaccine and developed more encephalopathic symptoms about 8 hours after receiving the vaccine. She is 11 days out from vaccine and still has slurred speech, word-finding difficulty, gait difficulties, etc. Discharge Summary received on 12/07/2004 states abdominal pain, leg pain, fever, headache, stiff neck, unresponsive, irritable, sleepy, decreased stregnth, decreased po intake, urinary retention, and bladder spasm. Medical Records received on 12/07/2004 states vomiting. Follow up 03/04/05: Patient has almost completely recovered. She still has some fine motor and cognative deficits. We did give her a prolonged course of steroids after her MRI was consistent with "Acute Demyelinating Encephalomyelitis". She has improved neurologic function. Per annual follow report 1/26/2006 She still has subtel cognitive/processing problems, she has balance issues.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Pt noticed itching and redness to injection site, bigger than 50 cent, on 10/23/04 at around 8:30AM. Pt called today and advised to take Benadryl 25  ever 5 hours no SOB or any resp distress, no fever. Advised to call all if symptoms worsens. Treatment just started today (10/25/04)
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Pt noticed redness, lump, to injection site about 3 inches wide. No respiratory distress or fever. Pt received injection on 10/22/04 at 3:00PM. Pt noticed reaction the next day 10/23/04 at about 8 AM. Advised to take Benadryl 25m every 6 hrs. Treatment started today. (Benadryl)
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Myocardial infarction
Clinical narrative: Local hospital reported that pt had no prior cardiac history. 10/26/04 Spoke the reporter/provider for this death.  The only information their clinic has on the decedent's prior medical hx is that she did not check off any of the items listed under medical history on the vax permission sheet including those asking about cardiac problems. She did not list any current meds. This woman was the aunt of one of the other health dept. nurses and this nurse has apparently stated that she is unaware of any health problems for her aunt. They are not aware of the name of her PMD. The reporter states that an autopsy was not done. We have requested the hospital records. 10/27/04 Copies of the ER report and the code blue record and death summary are received and sent for scanning. She arrived at the ER at 8:50 AM and expired at 10:48 AM in the CATH lab. The attending physician's summary notes COD most likely an inferior posterior acute myocardial infarction based on ECHO and presenting sxs. Family was apparently advised that she was in cardiogenic shock w/ a small chance for survival without therapy. A temp pacemeaker, intra-aortic balloon pump and possibly salvage angioplasty were planned. In between insertion of the pacemaker and beginning of the angioplasty, she was found to have no pulse by palpation and confirmed on EKG and prolonged code was unsuccessful. Please refer to the scanned records for details.  10/27/04 Call to funeral director to request copy of Death Certificate. This record is received and notes Myocardial Infarction as the COD. Neither the hospital record, the original VAERS reporter nor the hospital attending who signed the Death Certificate know who the PMD was for this woman. I placed a call to the son today. There was no answer and no VM.  Died of a massive MI on Tuesday morning 10/19/04 while in store.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Cerebrovascular accident, Haemorrhage, Haemorrhage intracranial
Clinical narrative: Local hospital reported patient had no prior cardiac history. Patient was found in her bed around noon on Tuesday, 10/19. They believed she had died from a hemorrhagic stroke early Tuesday morning.  Nurse follow up on 10/27/04 states: "intracranial hemorrhage."
Age: 0.79
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Hives and rash within 5 minutes of receiving vaccine.
Age: 43.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Swollen, red, hot deltoid, cellulitis.  Follow up on 10/28/04 states: "Problem at pneumovax site."
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site oedema
Clinical narrative: Pt with swelling to right thigh 3"x3". No fever, has immunization 9/29/04 was given Keflex 250/5ml 7.5PO x 10 days has F/U visit 10/4/04.
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Anorexia, Pyrexia, Rash vesicular
Clinical narrative: Fever 10/5, fever no appetite, fever 10/6, no appetite, T98.6 10/7/04 Vesicular eruption >50 lesions, face, neck, trunk, upper extremities.
Age: 0.37
Sex: M
Vaccine: DT, HIBV, IPV, PNC
Symptoms: Abdominal pain, Decreased appetite, Irritability, Oedema, Pyrexia
Clinical narrative: Fever x 2 days, decreased appetite, very fussy, swollen and painful abdomen, ER visit.
Age: 0.37
Sex: M
Vaccine: DT, HIBV, IPV, PNC
Symptoms: Similar reaction on previous exposure to drug
Clinical narrative: Fever x 2 days, decreased appetite, very fussy, swollen and painful abdomen, ER visit.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Hallucination, Similar reaction on previous exposure to drug, Stridor
Clinical narrative: Patient was crying for three hours per mom. Also having hallucinations. Along with stridor in upper airway. However, lungs were clear.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pruritus, Pyrexia
Clinical narrative: Developed itching, rash on forehead 10/17/04. Rash was spread to face, lips, trunk, arms. Also has fever. Was diagnosed with Varicella by PCP 10/20/2004 and placed on acyclovir.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash, Swelling
Clinical narrative: Child developed rash outer right upper arm lower ext. Mostly the thigh as of 10/18/04 like circles of vesicles. Start with lateral swelling of the thigh. Pt received varicella vaccine on the right thigh on 8/30/04. Pt started on acyclovir on 10/20/04.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site vesicles, Pain, Rash
Clinical narrative: 10/15/04 complained of excruciating pain that night in left deltoid and shoulder 10/16 : seen in office: has rash on upper left arm. 10/17: yellow blisters around the injection site (not itchy or infected appearing) 10/21: blisters still there: pain and rash gone. Better.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Convulsion, Hyperhidrosis, Pyrexia
Clinical narrative: Patient had moderate fever and night sweats. But had a bad case of thrashing his body (almost like he's fighting) around in his crib, even when holding him. Stayed up for a straight 6 hours without any sleep . (both doses second and third)
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Patient diagnoses on 9/24/04 with possible varicella. Counseling given re: outbreaks, lenght of outbreak etc. 20 tiny vesicles with red base.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Swelling
Clinical narrative: Pt came in 9/22/04 gave IPV (IM), MMR SQ on right arm, DTaP given LA IM, pt back next day due to reaction, swollen, red, hard right arm, checked by doctor.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Injection site erythema, Injection site induration, Pyrexia, Swelling
Clinical narrative: Received shots 8/22/04. Noticed arm swollen. 9/28 afternoon. Temperature 100 degrees F. Red at injection. Swollen, hard.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site induration, Myalgia, Swelling
Clinical narrative: Generalized myalgia and large red swelling and indurated around site left arm.
Age: 0.15
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying
Clinical narrative: Prolonged crying > 4 hours.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Rash erythematous, Swelling
Clinical narrative: Got DTaP and IPV: Right thigh and developed swelling with erythematous rash 6" x 6" with increase local temp. Treated with Tylenol, Benadryl and ice pack.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Flushing, Rash
Clinical narrative: Eyebrows were red, pt flush, no rash on face. No other signs or symptoms noted.
Age: 1.03
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash macular, Rash maculo-papular, Rash papular, Urticaria
Clinical narrative: Hives rash on legs, trunk and face with red splotches. No erythema. Rash is papular, macular: no fever.
Age: 15.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Myalgia
Clinical narrative: Pt received Td on 9/27/04. On approximately 10/17/204, pt noticed pain in right upper arm. Felt like a bad muscle bruise. Today 10/22/2004. Pt felt like pain lessened. Instructed to see physician.
Age: 0.4
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Irritability, Pain, Swelling
Clinical narrative: Patient developed fussiness and swelling to right thigh three hours after being given immunizations. Went to ER: Painful local reaction to immunizaitons.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Rash papular
Clinical narrative: Papular rash all over the body
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Contusion, Discomfort, Erythema, Pruritus, Swelling
Clinical narrative: DTaP/IPV administered right arm 10/20/2004. 10/21 dad noted bruising. 10/22 noted 4 inch circumference redness and swelling. Itchy. Dad gave Tylenol for discomfort and called office for recommendations. RN recommended some amount 0.1% hydrocortisone to area ID, Benadryl and 1-tsp q 6 hours prn itchying, Tylenol/ Motrin as directed per discomfort.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: Mom walked in to office complaining of reaction to immunization. DTaP RD: measuring 123mm. Immunization given at clinic. Tried to phone mom re: address info. No phone no.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site induration, Pruritus
Clinical narrative: 21OCT04: Pt presents with mild-moderate erythema (7cm x 9.5cm) left upper arm. Mild induration at vaccine site. Non-tender. No taxia rhinitis. Front left arm. Imp: local reaction to vaccine. Ice TID to arm. Tylenol as advised q 4 hours prn. Call if increase at all, if Temp greater than 102 F. Retrun to clinic tomorrow if not notably improved.  22OCT04: parent calle dclinic. Site better. Some itching. Denies need for follow up appointment.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Swelling
Clinical narrative: swelling, redness left deltoid
Age: 1.09
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Drug ineffective, Herpes zoster, Viral infection
Clinical narrative: Patient was vaccinated with the varicella (chickenpox) vaccine when she was a little over one month old and she seemed to be ok. Earlier this month, she developed a bad case of shingles on her right thigh that required a visit to a doctor. I thought that you could only get shingles if you had had chickepox before and my daughter has never had chickenpox ever or even been exposed to it. That is because the virus stays in the body. But, we went to the doctor earlier this month when she broke out with shingles. He said that the vaccine introduces weakened virus into body and that had apparently "awakened" like it would with a natural infection. I really wish that we had been told about this before we allowed our daughter to be vaccinated. Other parents and caregivers as well as the public in general needs to know about this. She is doing a little better now.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Chest pain, Dizziness, Dyspepsia, Fatigue
Clinical narrative: dizzy spells nausea episodic mild to moderate chest pain mild tingling in fingers on left hand fatigue/energy loss Pt c/o chronic substernal chest pain of atypical nature he felt was due to anthrax vax. In Oct04, he was diagnosed with acid reflux at military hospital overseas. He is on antacids and doing well. He was not hospitalized and missed 0 work days due to this AE. Anthrax vax was only vaccine pt rec'd on 7/22/04.
Age: 29.0
Sex: M
Vaccine: ANTH
Symptoms: Nausea, Paraesthesia
Clinical narrative: dizzy spells nausea episodic mild to moderate chest pain mild tingling in fingers on left hand fatigue/energy loss Pt c/o chronic substernal chest pain of atypical nature he felt was due to anthrax vax. In Oct04, he was diagnosed with acid reflux at military hospital overseas. He is on antacids and doing well. He was not hospitalized and missed 0 work days due to this AE. Anthrax vax was only vaccine pt rec'd on 7/22/04.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Cough, Headache, Neck pain, Pyrexia
Clinical narrative: 4-5 days after receiving vaccine, developed intermittent unproductive cough with mucous taste; 8 days after receiving vaccine, developed moderately high fever (101.5 orally) which lasted approximately 12 hours until it was lowered to 99.5 with 2 Advil.  Fever remained at approximately 99.5 - 100 for next 24 hours, then broke.  Back pain developed during fever, still moderately present.  Neck pain developed at end of fever, still quite painful and causing headaches.
Age: 1.37
Sex: M
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Rash
Clinical narrative: PATIENT HAD FINE RASH ON TRUNK & LIMBS,  HAD NO FEVER, NO MALAISE, NO LOSS OF APPETITE 2-3-DAYS POST IMMUNIZATIONS
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Headache, Pain, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient (pt) is a 41 year old who received his first and only anthrax immunization on 15 Mar 04. He stated that within 30-40 minutes after the immunization he started to develop a headache, which he noticed between his temples. He stated that he never had pain like this before and described the pain as constant and rated it a number 5-6 on pain scale of 1-10 with 10 being worse. He said he developed the pain while driving with his wife on their way for a mini vacation. He said he became uncomfortable and pulled over so wife can drive while he rested.  Approximately 3 ½ hours later, when he woke up he noticed that he had problems focusing and that his vision was blurred. He reported no relief from Tylenol and that the pain remained a # 4-5. He denied nausea, vomiting, altered sensation and reported that his close vision remained blurred until one day after his headaches ceased. He stated it was difficult to focus on road signs. He stated that the headache lasted a total of 3 days before it subsided on day 4 and his vision returned to normal on day 5. Pt also reported that on the day after his shot he went on a little hike, on the beach and through a wooded area, with his wife and when he returned he noticed a rash on his upper legs, abdomen and chest. He was wearing shorts and a shirt. Rash described as red raised bumps without pus or fluid and with slight itching. The rash lasted 5-6 days and he did not apply any creams or lotions. He denied anything unusual in his routine and that there has been no reoccurrence. He stated that his wife did not develop any skin lesions.   He reported that he did not seek any medical attention. He also noted that even though he went on a little hike that they normally do an extensive hike, which, he was unable to do on this trip because of his headaches and vision changes.  The patient reports no further episodes of headaches, vision changes or skin rash since that first episode following his anthrax vaccination.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Vision blurred
Clinical narrative: Patient (pt) is a 41 year old who received his first and only anthrax immunization on 15 Mar 04. He stated that within 30-40 minutes after the immunization he started to develop a headache, which he noticed between his temples. He stated that he never had pain like this before and described the pain as constant and rated it a number 5-6 on pain scale of 1-10 with 10 being worse. He said he developed the pain while driving with his wife on their way for a mini vacation. He said he became uncomfortable and pulled over so wife can drive while he rested.  Approximately 3 ½ hours later, when he woke up he noticed that he had problems focusing and that his vision was blurred. He reported no relief from Tylenol and that the pain remained a # 4-5. He denied nausea, vomiting, altered sensation and reported that his close vision remained blurred until one day after his headaches ceased. He stated it was difficult to focus on road signs. He stated that the headache lasted a total of 3 days before it subsided on day 4 and his vision returned to normal on day 5. Pt also reported that on the day after his shot he went on a little hike, on the beach and through a wooded area, with his wife and when he returned he noticed a rash on his upper legs, abdomen and chest. He was wearing shorts and a shirt. Rash described as red raised bumps without pus or fluid and with slight itching. The rash lasted 5-6 days and he did not apply any creams or lotions. He denied anything unusual in his routine and that there has been no reoccurrence. He stated that his wife did not develop any skin lesions.   He reported that he did not seek any medical attention. He also noted that even though he went on a little hike that they normally do an extensive hike, which, he was unable to do on this trip because of his headaches and vision changes.  The patient reports no further episodes of headaches, vision changes or skin rash since that first episode following his anthrax vaccination.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site swelling
Clinical narrative: After giving vaccine, injection site enlarged immediately. Appeared bruised.  Patient remained in pharmacy 15 minutes for follow-up.  Patient had flu shots in past history with no adverse reaction.  Injection site appeared to shrink slightly. Told patient to take Benadryl and to put ice on site. Told patient to follow-up with MD if problem persists or worsens.
Age: 1.84
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: PT WAS GIVEN VARICELLA IN THIGH.  HAD A DELAYED REACTION 1 WEEK LATER.  MOTHER CALLED TO NOTIFY OFFICE THAT AREA IS RED, RAISED AND HOT TO TOUCH.  AREA IS ABOUT THE SIZE OF A HALF DOLLAR.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: My son has swelling of his left arm and a rash that started out pink and is now red. The arm is hot to the touch and it is the arm the gave him the DTP shot in.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral, Pruritus, Tenderness
Clinical narrative: Approximately 24 hours after recieving the vaccine the back of my arm swelled from my elbow to my deltoid and to both sides of my arm. The area was itchy, red and tender.
Age: 21.0
Sex: F
Vaccine: ANTH, HEP, HEPA, SMALL, TTOX, TYP
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Pt developed diarrhea 4 days post vaccination, emesis, nausea, slight headache, tenderness in axilla, fatigue, some dizziness/weakness, also with erythema and satellite lesions around smallpox vaccination site,  diminished appetite.
Age: 21.0
Sex: F
Vaccine: ANTH, HEP, HEPA, SMALL, TTOX, TYP
Symptoms: Headache, Injection site erythema, Myalgia, Nausea, Vaccination complication
Clinical narrative: Pt developed diarrhea 4 days post vaccination, emesis, nausea, slight headache, tenderness in axilla, fatigue, some dizziness/weakness, also with erythema and satellite lesions around smallpox vaccination site,  diminished appetite.
Age: 21.0
Sex: F
Vaccine: ANTH, HEP, HEPA, SMALL, TTOX, TYP
Symptoms: Vomiting
Clinical narrative: Pt developed diarrhea 4 days post vaccination, emesis, nausea, slight headache, tenderness in axilla, fatigue, some dizziness/weakness, also with erythema and satellite lesions around smallpox vaccination site,  diminished appetite.
Age: 24.0
Sex: M
Vaccine: ANTH, HEP, HEPA, SMALL
Symptoms: Headache, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: Developed rash on face, chest, arms, back and tongue approx 10 days post small pox vaccination.  Rash is erythematous, maculopapular and nonitchy.  Slight headache also.
Age: 0.36
Sex: F
Vaccine: DTPIHI, HBHEPB
Symptoms: Agitation, Infantile spasms, Irritability
Clinical narrative: After receiving her 4 month shots, patient became extremely irritable and fussy.  After almost 2 weeks we finally took her to the doctor because she didn't seem to be consolable.  We noticed her doing a strange movement, which was later diagnosed as having infantile spasms.  I believe the shots are related since before she had her shots she was extremely happy and very easy going. Per follow up report- Patient is now only three years old. She is still going to a neurologist to monitor her progress. She receives an EEG on a yearly basis as well as a MRI.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: From initial information received on 10/19/04 from another manufacturer regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a 54 year old female patient received a dose of FLUZONE, lot number not reported, as well as a dose of PNEUMOVAX 23, lot number 647359/0740N administered IM on 9/28/04. Both products were administered in the same arm. One day later, on 9/29/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room and was noted to be hospitalized. At the time of this report, the patient had not recovered. The records to testing prior to release of PNEUMOVAX 23, lot number 0740N, have been checked and found to be satisfactory. The lot complied with the standards and was released. The events of lymph node swelling and fever were considered by the other company to be immediately life threatening and disabling. From additional information received on 12Nov04 from a health care professional, it was reported that there are no adverse events to report. In addition, the reporter's telephone number initially reported by another manufacturer is not the correct number. From additional information received on 15Nov04 through email correspondence from another manufacturer, a new telephone number for the initial reporter was provided. No additional information is anticipated, this case is considered closed. The reporter of this case is the same as for cases 2004-03408, 2004-03409, 2004-03410 and 2004-03473.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: From initial information received on 10/19/04 from another manufacturer regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a 67 year old female patient received a dose of FLUZONE, lot number not reported, as well as a dose of PNEUMOVAX 23, lot number 647359/0740N, administered IM on 9/28/04. Both products were administered in the same arm. One day later, on 9/29/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room and was noted to be hospitalized. At the time of this report, the patient had not recovered. The records of testing prior to release of PNEUMOVAX 23, lot number 0740N, have been checked and found to be satisfactory. The lot complied with the standards and was released. The events of lymph node swelling and fever were considered by the other company to be immediately life-threatening and disabling. Fom additional information received on 15NOV2004 form a health care professional, it was reported that there are no adverse events to report. In addition, the reporter's telephone number initially reported by another manufactureris not the correct number. A new telephone number was provided. From additional informaiton received from a telephone communication form the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional informaiton is anticipated, this case is considered closed. The reporter of this case is the same reporter as cases 200403407, 200403408, 200403410 and 200403473.
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: From initial information received on 10/19/04 from another manufacturer regarding an adverse event occurring in the USA, it was initially reproted by a health care professional that a female patient in her late 60's (exact age not reported) received a dose of FLUZONE, lot number not reported, as well as a dose of PNEUMOVAX 23, lot number 647359/0740N administered IM on 9/28/04. Both products were administered in the same arm. One day later, on 9/29/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room and was noted to be hospitalized. At the time of this report, the patient had not recovered. THe records of testing prior to release of PNEUMOVAX 23, lot number 0740N, have been checked and found to be satisfactory. The lot complied with the standards and was released. The events of lymph node swelling and fever were considered by the other company to be immediately life threatening and disabling. From additional information received on 12NOV2004 from a health care professional, it was reported that there are no adverse events to report. In additiion, the reporter's telephone number initially reported by another manufacturer is not the correct number. From additional information received on 15NOV2004 through email correspondence from another manufacturer, a new telephone number for the initial reporter was provided. From additional information receive from a telephone communication from the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional information is anticipated, thiscase is considered closed.
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Medication error, Pyrexia
Clinical narrative: From initial information received on 10/19/04 from another manufacturer regarding an adverse event occurring in the USA, it was initially reproted by a health care professional that a female patient in her late 60's (exact age not reported) received a dose of FLUZONE, lot number not reported, as well as a dose of PNEUMOVAX 23, lot number 647359/0740N administered IM on 9/28/04. Both products were administered in the same arm. One day later, on 9/29/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room and was noted to be hospitalized. At the time of this report, the patient had not recovered. THe records of testing prior to release of PNEUMOVAX 23, lot number 0740N, have been checked and found to be satisfactory. The lot complied with the standards and was released. The events of lymph node swelling and fever were considered by the other company to be immediately life threatening and disabling. From additional information received on 12NOV2004 from a health care professional, it was reported that there are no adverse events to report. In additiion, the reporter's telephone number initially reported by another manufacturer is not the correct number. From additional information received on 15NOV2004 through email correspondence from another manufacturer, a new telephone number for the initial reporter was provided. From additional information receive from a telephone communication from the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional information is anticipated, thiscase is considered closed.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: From initial information received on 10/19/04 from another manufacturer regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a 68 year old female patient received a dose of FLUZONE, lot number not reported, as well as a dose of PNEUMOVAX 23, lot number 647359/0740N administered IM on 9/28/04. Both products were administered in the same arm. One day later, on 9/29/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room and was noted to be hospitalized. At the time of this report, the patient had not recovered. The records of testing prior to release of PNEUMOVAX 23, lot number 0740N, have been checked and found to be satisfactory. The lot complied with the standards and was released. The events of lymph node swelling and fever were considered by the other company to be immediately life threatening and disabling.From additional information received on 12NOV2004 from a health care professional, it was reported that there are no adverse events to report. In additiion, the reporter's telephone number initially reported by another manufacturer is not the correct number. From additional information received on 15NOV2004 through email correspondence from another manufacturer, a new telephone number for the initial reporter was provided. From additional information receive from a telephone communication from the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional information is anticipated, thiscase is considered closed.
Age: 68.0
Sex: F
Vaccine: FLUX, PPV, FLU3, PPV
Symptoms: Lymphadenopathy, Medication error, Pyrexia
Clinical narrative: From initial information received on 10/19/04 from another manufacturer regarding an adverse event occurring in the USA, it was initially reported by a health care professional that a 68 year old female patient received a dose of FLUZONE, lot number not reported, as well as a dose of PNEUMOVAX 23, lot number 647359/0740N administered IM on 9/28/04. Both products were administered in the same arm. One day later, on 9/29/04, the patient developed lymph node swelling and fever. The patient was seen in the emergency room and was noted to be hospitalized. At the time of this report, the patient had not recovered. The records of testing prior to release of PNEUMOVAX 23, lot number 0740N, have been checked and found to be satisfactory. The lot complied with the standards and was released. The events of lymph node swelling and fever were considered by the other company to be immediately life threatening and disabling.From additional information received on 12NOV2004 from a health care professional, it was reported that there are no adverse events to report. In additiion, the reporter's telephone number initially reported by another manufacturer is not the correct number. From additional information received on 15NOV2004 through email correspondence from another manufacturer, a new telephone number for the initial reporter was provided. From additional information receive from a telephone communication from the initial reporter on 17NOV2004, it was reported that the reaction was due to administering both vaccines in the same arm that was an error on their part. All of these patients have recovered. No additional information is anticipated, thiscase is considered closed.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Anorexia, Chest pain, Conversion disorder, Diarrhoea, Dizziness
Clinical narrative: From initial information received on 10/18/04 from a nurse regarding an adverse event occurring in the USA, it was reported that a 46 year old female patient received a FLUZONE vaccination, lot number U1377AA, administered IM at approximately 2:00 PM on 10/8/04. The site of administration was not reported. On 10/9/04, at 6:00 AM, the patient awoke feeling achy and had diarrhea off and on. She took Tylenol and felt somewhat better. Soon after this she felt achy and weak and stated that her legs felt funny. Her legs and elbows felt shaky, as if her blood sugar was low. She then donned a gown and gloves for a procedure and became very hot and she sat down for a few minutes. The patient stated she had to lay down and laid down across a desk and called an outpatient facility for help. She proceeded to have nausea and dry heaves and states she couldn't hold her head up. She tried to get up to go to the bathroom, but said she couldn't stand. After using the bathroom, she said she couldn't pull her pants up. The patient was taken to the emergency department, where she felt numb from her knees down, and from her elbows down. At this point, she stated she was unable to move anything except her head. After a liter of fluids, she felt somewhat better, but was admitted to the ICU overnight, as her physician felt she may have had an acute onset of GBS, which was ruled out. The following day, the patient was able to move and had sensation back. She was moved to a medical/surgical floor and was discharged on Monday, 10/11/04. The patient's medical doctor stated he found nothing and referred her to a psychiatrist who also cleared her. When the patient called the reporter on 10/18/04, she stated that she still felt weak, had frequent headaches, neck pain, and felt woozy the prior evening. Her right hand and both feet felt numb at times. On Friday, 10/15/04, she experienced a lot of rib pain and it hurt to take a deep breath. She reported that a neurologist stated she may have contracted the flu from the flu shot, as her immunity may have been down from a stomach virus earlier the week she had the shot. The patient denies having any fever, sore throat, cough or cold symptoms. She related that while experiencing the paralysis, she was told that she was hyper-reflexive. The patient has not recovered. From additional information received on 01Nov04 from a telephone contact with the initial reporter, it was reported that the pt has fully recovered and has returned to work. She became anxious and she hyperventilated after receiving the vaccine, which caused the other symptoms. She was seen by a neurologist at the hospital and a psychological consult was ordered. The reporter does not have the pt's hospital records, but has provided the name of the person whom to request this information.