chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dehydration, Hyponatraemia, Laboratory test abnormal, Oral intake reduced
Clinical narrative: This subject is an 83 year old female, who was admitted to hospital due to acute renal failure while enrolled in RSV11 study. The subject received RSV Vaccine or Placebo and Influenza Vaccine on 10/22/02. The subject developed generalized weakness, low grade fevers, low intake and decreased urinary output for 24 hours and was brought to the emergency room by the family on 7/25/03, and was admitted to hospital on 7/25/03, 276 days post immunization. She was diagnosed with renal failure which was thought to be superimposed on an underlying chronic renal failure. Treatment included IV fluid with infusion of normal saline and put on oral fluid restriction to one liter per day and Lasix was hold. The subject's hyponatremia recovered and dehydration was resolve with IV infusion. During her admission it was suspected that she had Parkinsonism. She was started on a low dose Sinemet to be followed up by the primary care physician. Discharge diagnosis: Hyponatremia recovering, Suspicion of Parkinsonism, History of coronary artery disease, stable, Acute renal failure secondary to dehydration superimposed on chronic renal failure, Dehydration, resolved, Diabetes Mellitus, on insulin, Hypertension controlled, Mild chronic anemia of chronic disease. After subject was stable she was discharged home for hospice home care visits. While at home she got a severe upper respiratory infection. Subject and family only wanted good comfort interventions. The subject expired on 9/28/03 at home. The event was reported by the Investigator as unrelated to the study vaccine. Additional information received and available in the source file: History and Physical for admission 7/25/03, Discharge Summary for 7/25 to 7/27/03, Summary of Lab tests from 5/31/02 to 7/27/03, Chest X-ray 7/25/03, Hospital Discharge Notification, Hospice Plan of Care 9/1/03, Hospice Physician Admission Orders 9/1/03. A 15-day follow up report received 10/22/2003 adds no new info. A 15-day follow up report received 10/23/2003 adds: Additional info received 10/07/2003. Subject was a hospice pt. No autopsy was done. Confiemed that pt wasn't hospitalized on 09/08/2003. 10/17/2003: No further info is anticipated, case is closed.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Renal failure, Urine output decreased
Clinical narrative: This subject is an 83 year old female, who was admitted to hospital due to acute renal failure while enrolled in RSV11 study. The subject received RSV Vaccine or Placebo and Influenza Vaccine on 10/22/02. The subject developed generalized weakness, low grade fevers, low intake and decreased urinary output for 24 hours and was brought to the emergency room by the family on 7/25/03, and was admitted to hospital on 7/25/03, 276 days post immunization. She was diagnosed with renal failure which was thought to be superimposed on an underlying chronic renal failure. Treatment included IV fluid with infusion of normal saline and put on oral fluid restriction to one liter per day and Lasix was hold. The subject's hyponatremia recovered and dehydration was resolve with IV infusion. During her admission it was suspected that she had Parkinsonism. She was started on a low dose Sinemet to be followed up by the primary care physician. Discharge diagnosis: Hyponatremia recovering, Suspicion of Parkinsonism, History of coronary artery disease, stable, Acute renal failure secondary to dehydration superimposed on chronic renal failure, Dehydration, resolved, Diabetes Mellitus, on insulin, Hypertension controlled, Mild chronic anemia of chronic disease. After subject was stable she was discharged home for hospice home care visits. While at home she got a severe upper respiratory infection. Subject and family only wanted good comfort interventions. The subject expired on 9/28/03 at home. The event was reported by the Investigator as unrelated to the study vaccine. Additional information received and available in the source file: History and Physical for admission 7/25/03, Discharge Summary for 7/25 to 7/27/03, Summary of Lab tests from 5/31/02 to 7/27/03, Chest X-ray 7/25/03, Hospital Discharge Notification, Hospice Plan of Care 9/1/03, Hospice Physician Admission Orders 9/1/03. A 15-day follow up report received 10/22/2003 adds no new info. A 15-day follow up report received 10/23/2003 adds: Additional info received 10/07/2003. Subject was a hospice pt. No autopsy was done. Confiemed that pt wasn't hospitalized on 09/08/2003. 10/17/2003: No further info is anticipated, case is closed.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Back pain, Headache, Myalgia, Nausea, Neuralgia
Clinical narrative: We received the follow information from a foreign regulatory agency: A 20 year old female patient received a second injection of Rabipur (lot # 320011) on 7/22/03 for prophylactic vaccination. The first vaccination occurred on 7/15/03. On the second vaccination day she developed headache, nausea, muscle pain, high fever, neuralgia, back pain and restlessness and was hospitalized. She recovered and was discharged on 7/25/03.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Pyrexia, Restlessness
Clinical narrative: We received the follow information from a foreign regulatory agency: A 20 year old female patient received a second injection of Rabipur (lot # 320011) on 7/22/03 for prophylactic vaccination. The first vaccination occurred on 7/15/03. On the second vaccination day she developed headache, nausea, muscle pain, high fever, neuralgia, back pain and restlessness and was hospitalized. She recovered and was discharged on 7/25/03.
Age: 33.0
Sex: M
Vaccine: LYME
Symptoms: Asthenia, Back pain, Hypoaesthesia, Laboratory test abnormal, Musculoskeletal stiffness
Clinical narrative: Stiffness in neck and shoulders, loss of strength in hands and forearms. Numbness in hands. pain in lower back and hips.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Fatigue, Injection site abscess, Malaise, Rash
Clinical narrative: Smallpox vaccine 09/19/03.  On 09/26/03, erythematous rash with excessive drainage from SP site.  Primary response, malaise, fatigue, axillary and groin lymph. Prescribed Tequin for 5 days, developed mutiple erythematous pustular lesion back, chest.  Re-evaluated 10/06/03, pustular lesions scabbed, erythematous lesions.
Age: 34.0
Sex: M
Vaccine: SMALL
Symptoms: Skin ulcer
Clinical narrative: Smallpox vaccine 09/19/03.  On 09/26/03, erythematous rash with excessive drainage from SP site.  Primary response, malaise, fatigue, axillary and groin lymph. Prescribed Tequin for 5 days, developed mutiple erythematous pustular lesion back, chest.  Re-evaluated 10/06/03, pustular lesions scabbed, erythematous lesions.
Sex: U
Vaccine: FLU3
Symptoms: Rash pruritic
Clinical narrative: Rash, itching 1 day post treatment.  Patient went to MD-received prescription for cyproheptadine 4 mg 2 times daily.
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot
Clinical narrative: Area on leg warm, red, no temperature.  Given Amox 250 mg/sec 1 tsp a day for 7 days.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site mass
Clinical narrative: Complained of knot in right thigh for 12 days.  No steady state of infection, no heat or redness noticed.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Blister, Injection site pain, Oedema, Pruritus
Clinical narrative: Patient reports that after receiving vaccine, later in the day the right side of her face started itching and she developed a fever blister.  By the end of the day the inside of her jaw and tongue felt swollen.  Vaccine site was slightly sore.  Patient called her MD on the 3 rd day but did not see anyone for medical treatment.  Took benadryl.  Had loss of appetite.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Apnoea, Bradycardia
Clinical narrative: Patient received IPV, HIB, DTAP and Hep B.  Within 5 minutes of shots, became apneic, bradycardic and required 3L 100% of O2 with prolonged vigorous stimulation.  This occurrec 3 times again in a 30 minute time period before the patient returned to baseline with a needed increase in O2 requirement.
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Breath holding, Crying, Cyanosis, Drooling, Hypotonia
Clinical narrative: 07/24/2003:  Received 2 month shot.  2 hours later pale/limp.  Down breathing.  Cyanosis (+) drooling, (+) crying for 20 minutes.  Dad gave CPR for few seconds but dad states not stopped breathing.  MD:"Immunization reaction / ?breathholding spell".  Discharged home.  GENERAL DISCHARGE INSTRUCTIONS:  Your baby most likely had an immunization reaction with continuous crying and screaming and with a transient episode of slow breathing or breath holding.  Give your baby has just received a dose of acetaminophen which should help with the pain of the reaction.  Follow up on 11/20/2003: "This information is not at our office."
Age: 0.4
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Pallor, Respiratory rate decreased
Clinical narrative: 07/24/2003:  Received 2 month shot.  2 hours later pale/limp.  Down breathing.  Cyanosis (+) drooling, (+) crying for 20 minutes.  Dad gave CPR for few seconds but dad states not stopped breathing.  MD:"Immunization reaction / ?breathholding spell".  Discharged home.  GENERAL DISCHARGE INSTRUCTIONS:  Your baby most likely had an immunization reaction with continuous crying and screaming and with a transient episode of slow breathing or breath holding.  Give your baby has just received a dose of acetaminophen which should help with the pain of the reaction.  Follow up on 11/20/2003: "This information is not at our office."
Age: 1.8
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Feeling hot, Rash pruritic, Rhinorrhoea
Clinical narrative: Itchy rash starting in groin area, spreading rapidly onto legs/torso/face/arms.  Runny nose for 3-4 days.  Subject warmth, some scratching.
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Right deltoid area red, swollen and warm to touch.
Age: 0.1
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying
Clinical narrative: Uncontrollable crying.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Pruritus
Clinical narrative: Red swollen knot the size of a golf ball at injection site.  Itches and hurts.  No fever.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Feeling hot, Oedema, Pain
Clinical narrative: At 16:00 on 10/06/2003, patient noticed soreness in left arm.  About 20:00 she noticed left arm was warm to touch and swollen.  Unable to sleep off discomfort of arm.  Today 10/07/2003, evident edema from just above anticubital space extending to about 6 inches below left shoulder.  Generalized redness and warmth.  No lumps, knots, or bruises noted.  Able to use left hand.  No numbness or tingling noted.
Sex: M
Vaccine: DTAP
Symptoms: Muscle twitching, Pyrexia, Vomiting
Clinical narrative: High fever (104), vomiting entire night. Twitching (unsure if seizure) while temperature was high.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Muscle spasms
Clinical narrative: Patient states: I woke up at 03:00 with a charlie horse in my right leg and it got worse and now it is in my right arm.  difficulty moving.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash papular, Rash vesicular
Clinical narrative: Low grade fever for 2 days.  Red, papular and vesicular rash on torso.  Mild.  Appeared consistent with mild varicella.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Baby developed fever to 103 (axillary) at 05:00.  Checked by me at 16:30, rectal temp 101.6.  Baby with no other symptoms.  Appeared well.
Age: 0.67
Sex: M
Vaccine: PNC
Symptoms: Urticaria
Clinical narrative: Urticaria-like rash on face, arms, legs 1-2 days after 3rd dose Prevnar
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Hyperexplexia, Staring
Clinical narrative: Mom describes 7-(?) episodes lasting 10 seconds each of eyes becoming wide open and staring, body stiffens similar to a startle reflex.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Laboratory test abnormal, Urticaria
Clinical narrative: 26 yo Air force active duty female with hx of delayed hives following AVA #2 and #3. Hives cleared. Allergy w/u included positive skin testing in April and Oct 2003.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Late Tuesday afternoon, patient started having pain at injection site of pneumonia vaccine. Patient has swelling, reddness, and heat to affected site. Swelling in the inner aspect of left upper arm.  Patient is unable to abduct left arm. Appointment scheduled for patient with her PCP today at 11:30 a.m.
Age: 0.3
Sex: M
Vaccine: DT, HEP, IPV, MMR
Symptoms: Rash, Urticaria
Clinical narrative: 4 year old recieved 4 immunizations.  While ina a waiting area of the hopsital developed rapid onset of hives/rash requiring urgent visit to the emergency room. Given epinephrine, & benedryl 25mg with relief of symptoms.  No respiratory distress noted during this episode. Patient discharged from the ER with parent.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered on 10/3/03. Patient presents in office on 10/6/03 c/o arm "puffy and red and warm to touch" near sight of injection.  Patient reports symptoms started one day after immunizations.  Doctor describes 11cm by 8cm are distal to injection site.  Pale - Pinkish red. No raised area, slight warmth,no tenderness.  Injection site in deltoid shows no sign of irritation.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On the afternoon of immunization, patient experienced pain at the site of pneumococcal vaccine which progressed to swelling and reddness with heat.  Swelling, reddness, and heat extends from axillary to wrist of left inner arm. Client notified MD day of onset and was instructed to take benadryl.  Client called today and instructed to come in for assessment.  Inner aspect of left arm with reddness from elbow to wrist, noted hot to touch and swelling. Client is post polio patient with residuals in this arm. Appointment made with MD to be seen today.  Per MD office will call client with appoint time.  Client instructed to call this nurse after visit with MD.  Will follow up with client on Monday.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient had Dtap to Right thigh 10/06/2003.  Now on 10/08/2003 redden warm area 3x3 in. Non tender, ithcy neg. fluid, local reaction.  Gave Benedryl.
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Oedema, Shoulder pain
Clinical narrative: Left arm/shoulder-pain, mild erythema and edema- (Military personel-not much info avalable)
Age: 0.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Lymphadenopathy
Clinical narrative: uticaria near site of immunization, inflammed axillary lymph node.
Age: 45.0
Sex: F
Vaccine: SMALL
Symptoms: Fatigue, Lymphadenopathy, Mouth ulceration, Pharyngolaryngeal pain
Clinical narrative: Vaccine #166 Please see sympton diary.   Approx days 6,7,8, *9 ..began with generalized lymphadenopathy..more at neck (esp L side), and axillary, but also groin.  Generalized fatigue, sore throat, occassioanal internal mouthsores..precede dermal, scalp breakouts.  Appears somewhat cyclic.  Vaccine given 18 December 2002...continues to present with ocassional breakouts and lymph swelling.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Photosensitivity reaction, Pyrexia
Clinical narrative: Less than 24 hours after vaccine administration of 10/7/03, client describes severe headache "like no other before". Pulse 68, B/P 144/94, Temp 97.7, c/o photosensitivity. Referred to Emergency Room, CT head negative,tx with pain medications, scheduled for MRI 10/10/03
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Heart rate increased, Hypersensitivity, Injection site erythema, Injection site hypersensitivity
Clinical narrative: A VAERS report received concerning a 26 year old female who was administered an influenza vaccine (manufacturer and lot number not reported) on 11/7/02. It was reported, 10 minutes after the flu shot patient complained of warmth in her total body. Patient became dizzy and felt like her hands were swelling. Patient became nauseated and then vomited. She then felt like her airway was closing. RN evaluation found the patient vomiting, face flush, heart rate 144, and respiration rate 22. Benadryl 50mg PO given per standing orders. 911 called due to patient's describing the feeling her throat were swelling. No acute respiratory distress evident. Vital signs recheck P 92, R 20, BP 132/100. Paramedics arrived and transported patient to hospital ED for evaluation. Patient evaluated and released on 11/8 with diagnosis of allergic reaction. Patient was recovered on 11/10 at 5 PM. She is doing fine. Last vaccine was 8 weeks ago. No other vaccines in the last 4 weeks. She is allergic to chicken feathers. From additional information received on 10/3/03, it was confirmed by the initial reporter that the patient received FLUZONE SV 2002-2003 USP, lot number U0920AA, administered IM in the left deltoid. The reporter also stated that the patient was sent to ER and had an acute allergic reaction to the flu shot, and this could be related to feathers. The reporter also stated that there is a history of allergies to various medications, but she did not have a listing of them. A fax number and contact person was provided for the medical records department. A release of information was requested from medical records. From additional information received on 10/6/03, the time of onset was clarified. It was also noted that the patient got a very red, itchy arm at the site of vaccination. Medical history and allergy information was provided. A copy of the emergency department record was also provided. At the time of the patient's admission to the emergency department the patient was awake and alert, normal mentation. Vitals were stable. Patient was afebrile. Room air sat of 91%. There was no redness around the injection site and no other hives or rash. There was no angioedema. Oropharynx examination was normal. Lungs were clear, work of breathing normal. Heart rhythm was regular, no murmur or rub. (OMIC)
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oedema peripheral, Pharyngeal oedema, Pruritus, Vomiting
Clinical narrative: A VAERS report received concerning a 26 year old female who was administered an influenza vaccine (manufacturer and lot number not reported) on 11/7/02. It was reported, 10 minutes after the flu shot patient complained of warmth in her total body. Patient became dizzy and felt like her hands were swelling. Patient became nauseated and then vomited. She then felt like her airway was closing. RN evaluation found the patient vomiting, face flush, heart rate 144, and respiration rate 22. Benadryl 50mg PO given per standing orders. 911 called due to patient's describing the feeling her throat were swelling. No acute respiratory distress evident. Vital signs recheck P 92, R 20, BP 132/100. Paramedics arrived and transported patient to hospital ED for evaluation. Patient evaluated and released on 11/8 with diagnosis of allergic reaction. Patient was recovered on 11/10 at 5 PM. She is doing fine. Last vaccine was 8 weeks ago. No other vaccines in the last 4 weeks. She is allergic to chicken feathers. From additional information received on 10/3/03, it was confirmed by the initial reporter that the patient received FLUZONE SV 2002-2003 USP, lot number U0920AA, administered IM in the left deltoid. The reporter also stated that the patient was sent to ER and had an acute allergic reaction to the flu shot, and this could be related to feathers. The reporter also stated that there is a history of allergies to various medications, but she did not have a listing of them. A fax number and contact person was provided for the medical records department. A release of information was requested from medical records. From additional information received on 10/6/03, the time of onset was clarified. It was also noted that the patient got a very red, itchy arm at the site of vaccination. Medical history and allergy information was provided. A copy of the emergency department record was also provided. At the time of the patient's admission to the emergency department the patient was awake and alert, normal mentation. Vitals were stable. Patient was afebrile. Room air sat of 91%. There was no redness around the injection site and no other hives or rash. There was no angioedema. Oropharynx examination was normal. Lungs were clear, work of breathing normal. Heart rhythm was regular, no murmur or rub. (OMIC)
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Body temperature increased, Cellulitis
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old, adult female pt with a medical history of "allergies to sulfur" and conjugated estrogen (Prempro) and a "couple bouts of pneumonia prior to any of her vaccinations" who on 9/16/03 at 16:00 was vaccinated IM in the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine 2.5ml, "once" (643249/0358M). Prior vaccinations included a first and second dose of pneumococcal 23v polysaccharide vaccine, in 1998 and in 1993, respectively. An illness at the time of the vaccination was "fatigue." On 9/16/03, during the "night," the pt developed a fever, redness at the injection site and the site was "swollen and hard." On 9/17/03, the pt was treated with oral antibiotics Keflex and Motrin for an increased temperature and cellulitis. It was noted that the oral antibiotics did not work. On 9/17/03, the pt was seen in the ER and was treated with IV antibiotics. It was also noted that on 9/18/03, the pt was seen in the ER, treated with IV antibiotics and was admitted to the hospital for 2 days. "Lab work" was performed. On 9/19/03, the pt was discharged from the hospital. Subsequently, the pt recovered. It was also noted that "everyone in the office was very concerned," the reporter expressed concern about the particular lot of vaccine and she commented that she "has never seen a reaction like this in 31 years." The reporter also mentioned two other patients who experienced a similar reaction with pneumococcal 23v polysaccharide vaccine (645255/1212M) (WAES0309USA02773 and WAES0309USA03339). No further info is expected. The medical record received on 2/5/04 states rash and redness.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old, adult female pt with a medical history of "allergies to sulfur" and conjugated estrogen (Prempro) and a "couple bouts of pneumonia prior to any of her vaccinations" who on 9/16/03 at 16:00 was vaccinated IM in the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine 2.5ml, "once" (643249/0358M). Prior vaccinations included a first and second dose of pneumococcal 23v polysaccharide vaccine, in 1998 and in 1993, respectively. An illness at the time of the vaccination was "fatigue." On 9/16/03, during the "night," the pt developed a fever, redness at the injection site and the site was "swollen and hard." On 9/17/03, the pt was treated with oral antibiotics Keflex and Motrin for an increased temperature and cellulitis. It was noted that the oral antibiotics did not work. On 9/17/03, the pt was seen in the ER and was treated with IV antibiotics. It was also noted that on 9/18/03, the pt was seen in the ER, treated with IV antibiotics and was admitted to the hospital for 2 days. "Lab work" was performed. On 9/19/03, the pt was discharged from the hospital. Subsequently, the pt recovered. It was also noted that "everyone in the office was very concerned," the reporter expressed concern about the particular lot of vaccine and she commented that she "has never seen a reaction like this in 31 years." The reporter also mentioned two other patients who experienced a similar reaction with pneumococcal 23v polysaccharide vaccine (645255/1212M) (WAES0309USA02773 and WAES0309USA03339). No further info is expected. The medical record received on 2/5/04 states rash and redness.
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old, adult female pt with a medical history of "allergies to sulfur" and conjugated estrogen (Prempro) and a "couple bouts of pneumonia prior to any of her vaccinations" who on 9/16/03 at 16:00 was vaccinated IM in the left deltoid with a third dose of pneumococcal 23v polysaccharide vaccine 2.5ml, "once" (643249/0358M). Prior vaccinations included a first and second dose of pneumococcal 23v polysaccharide vaccine, in 1998 and in 1993, respectively. An illness at the time of the vaccination was "fatigue." On 9/16/03, during the "night," the pt developed a fever, redness at the injection site and the site was "swollen and hard." On 9/17/03, the pt was treated with oral antibiotics Keflex and Motrin for an increased temperature and cellulitis. It was noted that the oral antibiotics did not work. On 9/17/03, the pt was seen in the ER and was treated with IV antibiotics. It was also noted that on 9/18/03, the pt was seen in the ER, treated with IV antibiotics and was admitted to the hospital for 2 days. "Lab work" was performed. On 9/19/03, the pt was discharged from the hospital. Subsequently, the pt recovered. It was also noted that "everyone in the office was very concerned," the reporter expressed concern about the particular lot of vaccine and she commented that she "has never seen a reaction like this in 31 years." The reporter also mentioned two other patients who experienced a similar reaction with pneumococcal 23v polysaccharide vaccine (645255/1212M) (WAES0309USA02773 and WAES0309USA03339). No further info is expected. The medical record received on 2/5/04 states rash and redness.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Difficulty in walking, Dizziness, Dyspnoea, Pyrexia
Clinical narrative: From initial information received on 10/6/03 from a pharmacist, regarding a death occurring in the USA, it was reported that a 55 year old male patient died three days after receiving a dose of FLUZONE, lot numberU1093AA (route/site not reported) on 10/2/03. The patient died on 10/5/03. the reporter will fax the completed report at a future date. Follow up on 10/20/2003: "From additional information received on 10/09/2003, through a telephone call from the reporting pharmacist, it was stated that "no VAERS report will be faxed to AvP and any information can be obtained from the FDA.  A completed VAERS report was sent to the FDA and they have been in contact with the FDA by phone."  It was also stated that "preliminary reports show no cause from flu vaccine".  A 15-day follow up report received 10/20/2003 adds no new info. 16Jan04: No further information is anticipated, this case is considered closed. No relevant additional information is provided for the adverse experience; this specific information is not submitted to health authorities.
Age: 56.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Unevaluable event
Clinical narrative: From initial information received on 10/6/03 from a pharmacist, regarding a death occurring in the USA, it was reported that a 55 year old male patient died three days after receiving a dose of FLUZONE, lot numberU1093AA (route/site not reported) on 10/2/03. The patient died on 10/5/03. the reporter will fax the completed report at a future date. Follow up on 10/20/2003: "From additional information received on 10/09/2003, through a telephone call from the reporting pharmacist, it was stated that "no VAERS report will be faxed to AvP and any information can be obtained from the FDA.  A completed VAERS report was sent to the FDA and they have been in contact with the FDA by phone."  It was also stated that "preliminary reports show no cause from flu vaccine".  A 15-day follow up report received 10/20/2003 adds no new info. 16Jan04: No further information is anticipated, this case is considered closed. No relevant additional information is provided for the adverse experience; this specific information is not submitted to health authorities.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Encephalitis, Herpes zoster, Infection, Laboratory test abnormal, Meningitis
Clinical narrative: Information has been received on 9/29/03 from a physician concerning a 4 year old female who was vaccinated with varicella virus vaccine live. Subsequently, the pt developed shingles. It was reported that "on day 10 into her shingles she developed viral meningitis and was hospitalized." A polymerase chain reaction (PCR) test established that varicella was present. However, "they could not distinguish wild type virus or Oka strain." On 9/29/03 it was reported that the child was doing very well and was completing her 7 day course of acyclovir and a full recovery was suspected. It was noted that the pt had no history of chicken pox nor did any of her siblings. Additional info has been requested.  Follow up on 10/22/2003: "On 10/01/2003 the patient was discharged from the hospital after a 7 day stay.  It was noted that the patient had no history of chicken pox nor did any of her siblings.  On 10/03/2003 the reporting physician stated that the patient "continues to do well and full recovery is expected."  A sample from one of the patient's shingles lesions was to be submitted for testing.  It was also noted that "all children in the family" had been vaccinated.  No product quality complaint was involved.  Additional information has been requested.  This report is a consolidation of two reports received from two different sources regarding the same patient.  Initial consolidated report received on 09/25/2003 reported encephalitits as the diagnosis. A 15-day follow up report received 12/16/2003 adds: On 10/22/2003, follow-up info was received from a physician who reported that a specimen of spinal fluid with DNA extract, which was VZV +, was submitted for PCR analysis to be done. On 10/30/2003 it was reported that the preliminary results of the PCR on the CSF received were negative. The results of this test were to be verified. Follow-up info reported that the CSF specimen had been collected on 09/25/2003, sent to the laboratory on 10/22/2003, and receifed on 10/23/2003. The CSF sample included 600 ul and also included 70 ul of DNA extracted from the CSF. The B-globin DNA was amplified, there was an adequate specimen, and no VZV was identified (negative). The CSF specimen was tested several times, and the final PCR results indicaated that the CSF was negative for varicella. The reporting physicina reported that she was "somewhat puzzled" by the results since her hospital lab found the CSF to be VZV positive. She also added that while her hospital lab found the CSF to be positive for varicella, they also found it to be negative for enterovirus and herpes simplex virus. It was also reported that the child had recovered completely from the shingles and the aseptic meningitis, and that she was reportedly "doing very well as home." No further info is expected.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Joint stiffness, Urticaria
Clinical narrative: Information has been received from a nurse practitioner at a student health center concerning a 20 year old female student with no known drug allergies who on the afternoon of 9/23/03 was vaccinated IM with a first 10 microgram dose of hepatitis B virus vaccine (lot # 644078/0940M). Concomitant therapy included topiramate, minocycline and fluoxetine HCL. On 9/24/03, the next morning, the patient appeared and had developed hives on her upper and lower extremities and chest tightness. The nurse treated with patient with epinephrine at the student center and then transferred her to the hospital emergency room where she was monitored for several hours and released. It was unknown what, if any, treatment was initiated at the hospital. On 9/25/03, the next day, the nurse practitioner had phone follow up with the patient who told her that she was feeling better and recovered. no product quality complaint was involved. Upon internal review, hives on her upper and lower extremities and chest tightness were determined to be other important medical events (OMIC). Additional information has been requested. A 15-day follow up report received 12/02/2003 adds: Upon internal review, joint stiffness, generalized hives on her upper and lower extremities and chest tightness were determined to be other important medical events. No further info is expected.
Age: 6.0
Sex: F
Vaccine: DTAP
Symptoms: Anaphylactic reaction, Face oedema, Rash
Clinical narrative: Patient was administered DTaP only. Within approximately 5-7 minutes, patient developed rash (face and abdomen) and lips began to swell. Grandmother took patient by car immediately to local pediatrician for treatment. The hospital discharge received on 11/1/03 states anaphylactic reaction.
Age: 1.92
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Sizeable amount of redness and swelling on left arm 24 hours after receipt of vaccines 9/26/03. Moderate amount of swelling and redness still noticeable 9/29/03.
Age: 13.0
Sex: F
Vaccine: HEP, IPV, MMR, TD
Symptoms: Rash, Urticaria
Clinical narrative: All over body rash (hives) starting 5 hours after receipt of vaccines on 9/26/03. Denies difficulty breathing, etc. Still with rash on 9/29/03. Referred to PMD for treatment.
Age: 1.5
Sex: F
Vaccine: PNC
Symptoms: Anorexia, Irritability, Mood swings, Pyrexia
Clinical narrative: Here is my story. I am the father of 18-month-old twins boy and girl. Three days ago, my wife and I took our kids for a wellness visit. The doctor said everything was a OK however he recommended to us to have our kids vaccinated with a drug called Prevnar. Prevnar is predominately given to prevent meningitis. He said it was safe and handed us the marketing brochure printed by the drug company-Wyeth. When the title of the brochure says Is Your Child At Risk and because the brochure talks about risk assessment of course the only my children would be safe is if I keep them in a bubble. We acted to hasty and allowed the vaccines to be given to our kids. So the next day, my son was fine but my daughter (pt) had an adverse reaction, fever, irritability, mood swings, and loss of appetite. It took 3 days for her to recover. I checked the web regarding this drug and now discovered that Prevnar-introduced in 2000-is highly controversial. I am very upset with myself. I should have researched this drug first. I am angry with Wyeth and FDA for marketing this drug for general use. The pamphlet says that only 1,400 cases of meningitis occur each year. Why scare people by saying your child is at risk. Kids survived prior to 2000. The only reason I could see in prescribing this drug is to make money. I do not believe this drug should be recommended to every child.
Age: 48.0
Sex: F
Vaccine: TD
Symptoms: Muscular weakness, Pain
Clinical narrative: Persistent right arm pain and right upper arm weakness.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling to right deltoid the evening the day the injection was given.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Rash
Clinical narrative: 2 days after receiving vaccine had developed a red rash on the left thigh. Redness and swelling also occurred at injection site. All resolved 4 day later.
Age: 57.0
Sex: F
Vaccine: RAB
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Onset of itchy, red palms of hands 9/22/03. 9/23/03 some itching of palms, soles of feet, torso and arms. Some small welts on arms for short period-resolved. 9/24/03 mild itching on arms - resolved same day. No further symptoms.
Age: 1.5
Sex: M
Vaccine: DTAP, IPV, PNC
Symptoms: Blister, Erythema, Injection site warmth
Clinical narrative: Blisters; degrees of erythema 2 inch x 2.5 inches.  Redness 3.5 x 4 3/4 in.  Hot to touch.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Infection, Irritability, Malaise, Rash pruritic
Clinical narrative: General malaise noted 10/02/2003 PM.  Increasing irritability, itchy rash noted right arm 10/03/2003 lunchtime.  Spread "all over". Diagnosis: Varicella.
Sex: U
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Patient complained of a "sting" upon injection and red and sore around the site.  Patient called 10/03/2003 at 14:00.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Erythema at site (left arm) warm, non tender.  Treatment: compresses.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 24 hours after immunization left deltoid, red, swollen 11.5 cm x 8 cm.  No fever, uses Aum fine.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Abnormal behaviour, Crying, Irritability, Pyrexia
Clinical narrative: Squeamy cry and fussy for 2 hours (6-8 PM) evening of injection.  Low grade tactile temperature episode of throwing back left arm for several minutes.  Did not seem to regard parents normally.  Seemed normal after Tylenol at 8 PM.
Sex: M
Vaccine: DTAP, IPV, MMR, PPV
Symptoms: Abasia, Anorexia, Injection site oedema, Injection site pain, Rash
Clinical narrative: Rash over 10 cm over DTAP site, very sore, some swelling T 100.7, could hardly walk.  Sent home from school. Had regular Tylenol 3x day of shots and in morning before school.  Loss appetite.  Rash lasted 4 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: Large (10 cm) area of erythema over the injection.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Feeling hot, Injection site induration
Clinical narrative: Area of warmth and induration on left arm 6 cm x 4 cm where vaccine was administered 2 days earlier.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Unconsolable crying for more than 5 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Redness, swelling-cool compress, Tylenol.
Age: 43.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Bursitis, Injection site pain, Tendon disorder
Clinical narrative: L arm site pain with point tenderness at perimeter of deltoid muscle. Onset 24 hrs post injection. A follow up report received 10/23/2003 adds: Diagnosed as deltoid bursitis related to the tetanus vaccination per Dr. Rx with Vioxx, rest, has not lost work.
Age: 1.08
Sex: F
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Spotty, slight rash (pink in color) to belly and lower back.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Feeling hot, Malaise, Pyrexia, Swelling
Clinical narrative: Complained of not feeling well am of 09/25/03 - Had a temp of 101 degrees along with dizziness and slightly swollen left arm.  patient stated left arm was warm to touch - stated symptoms only lasted 24 hours.  Took 2 Extra Strength Tylenol tabs for fever.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Chills, Dizziness, Headache, Myalgia
Clinical narrative: 12:30 AM 10/10/03 patient woke with fever 103 F, shaking chills, and severe myalgia especially of vaccine site but also other major muscle groups.  7:00 AM 10/10/03 patient attempted to stand, developed acute onset pounding headache, dizziness,nausea and tinnitus - unable to walk or stand due to symptoms 7:45 AM 10/10/03 patient obtained glass of water and 600 mg ibuprofen 9:00 AM 10/10/03 fever down to 99.7 F, patient feeling much better. Still sore and dizzy, but able to function.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Tinnitus, Tremor
Clinical narrative: 12:30 AM 10/10/03 patient woke with fever 103 F, shaking chills, and severe myalgia especially of vaccine site but also other major muscle groups.  7:00 AM 10/10/03 patient attempted to stand, developed acute onset pounding headache, dizziness,nausea and tinnitus - unable to walk or stand due to symptoms 7:45 AM 10/10/03 patient obtained glass of water and 600 mg ibuprofen 9:00 AM 10/10/03 fever down to 99.7 F, patient feeling much better. Still sore and dizzy, but able to function.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Asthma, Loss of consciousness, Pulse absent, Syncope
Clinical narrative: Approximately 3 hours after vaccination patient was urinating - arose from the toilet and passed out (was in her daughter's hospital room - elective admission for IVIG).  Had felt well before - no prodromal symptoms.  Found pulseless - required CPR and intubation.  Extubated and well 2 hours later.  Patient had history of multiple ICU admissions for severe asthma, opiate withdrawl and prior syncope attributed to SVT.  NO rash, wheezing, angioedema seen during event.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Folliculitis, Pruritus, Rash erythematous, Rash maculo-papular, Rash pustular
Clinical narrative: Patient received Anthrax #4 on 29 September 03.  On 6 Oct 03, he developed a diffuse pruritic, erythematous,macular/papular lesions with a few pustulers on the lower trunk anterior/posterior, lower abdomen, right forearm and elbow.  Denies recent illnes, fever. Denies food or medication allergies.  Used Hot Tub 3 days prior to onset of rash. Evaluated by PCM; Referred to Vaccine Healthcare Center; Consulted with Dermatology; DX. with Hot Tub Folliculitis
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Skin ulcer
Clinical narrative: Patient received Anthrax #4 on 29 September 03.  On 6 Oct 03, he developed a diffuse pruritic, erythematous,macular/papular lesions with a few pustulers on the lower trunk anterior/posterior, lower abdomen, right forearm and elbow.  Denies recent illnes, fever. Denies food or medication allergies.  Used Hot Tub 3 days prior to onset of rash. Evaluated by PCM; Referred to Vaccine Healthcare Center; Consulted with Dermatology; DX. with Hot Tub Folliculitis
Age: 13.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Feeling hot
Clinical narrative: 10/6 mother reported  patient ha a red area l deltoid warm to the touch for 1 wk after vaccination.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Headache, Malaise, Pruritus, Pyrexia
Clinical narrative: Malaise within 5 hours, low fever within 12 hours,high fever (102.5) within 20 hours, headache, joint pain. Itching. Rx-Allegra, chlortremiton, calomine lotion.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue, Injection site erythema, Injection site oedema
Clinical narrative: Client in today to report local reaction from pneumococcal vaccination given 10/03.  Rt forearm today with erythema, redness swelling and warm to the touch.  Patient reported feeling bad and fatiqueed.  Saught tx from PMD
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Rash on face, began Sunday evening. Put birth control patch on Sunday AM does not know name of patch
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Mother states that around noon on Thursday, 10/9/03 her son had red, itchy blotches on his face and torso.  She used some cortisone spray to help relieve the symptoms.  Later in the evening around 9:00 to 9:30 p.m., the itching had gotten worse and she went next door to get some Bendadryl.  By the time she got back, his face appeared very red and blotchy, which appeared to be hives.  She called a minor emergency clinic at 10:00 pm, but the doctor had already left; the nurse told the mother to take her son to the hospital emergency room.  The parents took him to Hospital.  By the time they arrived the benadryl had started working and some of the symptoms had decreased.  Did not have any respiratory symptoms.  They treated him for an allergic reaction.  I spoke with the mother and recommended that she call her son's medical provider to inform her of the reaction.
Age: 32.0
Sex: F
Vaccine: FLU3, TD
Symptoms: Vaginal discharge
Clinical narrative: PT REPORTED VAGINAL "SPOTTING" TODAY. DENIES S/SX OF UTI. MENSTRUAL PERIOD DUE IN ABOUT A WEEK AND A HALF. NOT COMMON FOR PT. TO "SPOT". PT. GIVEN FEMININE NAPKIN
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Coma, Febrile convulsion, Pyrexia, Rash papular
Clinical narrative: 10 days post admin of MMR and Varivax pt developed temp 103.5 had brief unresponsive episode thought to be febrile siezure. Treated and released without sequelae from ER. Developed papular vesicular rash on torso.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphonia
Clinical narrative: Hoarseness
Age: 1.3
Sex: F
Vaccine: HIBV, MMR, HIBV, MMR
Symptoms: Ecchymosis, Petechiae, Thrombocytopenia, Thrombocytopenic purpura
Clinical narrative: 29MAY93 pt presented w/petechiae & burises x 3 days; CBC revealed idiopathic thrombocytopenic purpura; there was no preceeding illness;
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, DTAP, MMR
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: This report was received from manufacturer for Infanrix and was assigned manufacturer report number A0426462A. This report concerns a 5 year old male pt who had no adverse experience following previous immunizations and in July 2003, was vaccinated IM in the right deltoid with a dose of MMR II. Concomitant vaccination in the right deltoid included an IM fifth dose of Infanrix (583A2) packaged in a pre-filled syringe. On 7/30/03, "within a couple of days" post-vaccination, the pt developed redness at the injection site. The pt was seen by a physician, who noted a 3 inch by ? inch area of erythema on the right deltoid. The physician made the diagnosis of injection site cellulitis and prescribed a 10 day course of Omnicef. The event resolved on 8/10/03. It was noted that this was one of six patients from the same facility who developed injection site cellulitis following receipt of four different lots of Infanrix packaged in pre-filled syringes. The reporter considered the event to be serious because it jeopardized the pt or required intervention. Upon internal review, injection site cellulitis was considered to be an other important medical event (OMIC). The reporter considered the event to be possibly related to vaccination with Infanrix. This was originally reported by a licensed visiting nurse. Additional info has been requested.
Age: 1.9
Sex: M
Vaccine: PNC
Symptoms: Drug toxicity, Neurological symptom
Clinical narrative: A legal complaint was received from an attorney alleging that a male child received his first dose of Prevnar vaccine on 5/22/00. Relevant medical history was not provided. A dose of 0.5cc of Prevnar was administered in the left leg on 5/22/00. Additional suspect medications included hep B vaccine (manuf unk), Recombivax-HB (hep B vaccine), Act-Hib, Tripedia, Pedvax-Hib, MMR II, Varivax and Polio vaccine. Vaccination info contained in the legal complaint indicated that the child received Prevnar, Pedvax-Hib, Act-hib, Tripedia, MMR II, Varivax and poliomyelitis vaccines beyond 12 months of age. Concomitant therapy included Tuberculin test. It is alleged that as a result of cumulative exposure to mercury in the thimerosal-containing vaccine (s), the child developed "toxic neurllogical effects of mercury poisoning." This event was considered medically important (OMIC). No additional info was available at the time of this report.