chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: HIBV, PNC, VARCEL
Symptoms: Abscess
Clinical narrative: Sterile abscess at site of either Hib or Varicella vaccine. Appears to resolve spontaneously.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: Developed seizure 24 hours after 4 month immunizations (DTaP, IPV, PCV, Hib). Developed seizure 24 hours after 6 month shot - only DT given that day.
Age: 49.0
Sex: M
Vaccine: FLU3, HEPAB, MMR
Symptoms: Diarrhoea, Lymphadenopathy, Rash maculo-papular
Clinical narrative: Swollen glands - posterior cervical. Diffuse macular papular rash. Diarrhea x2 days.
Age: 1.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Shots on 10/10/03, broke out with rash on 10/19/03.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Had chicken pox vaccine on 9/22/03. On 9/30/03 developed fever of 100.4 with no other symptoms. Was seen by MD, who wrote a note saying she did not have a communicable disease. On 10/13/03 had mild temp (100.2) and rash under one arm. She was seen by MD who said the rash was not chicken pox.
Age: 2.08
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Mom reports at 1 PM today noticed swelling and red area on left thigh. Shot given about 3:15 PM 7/21/03. Child healthy on exam yesterday. He had 1 1/2cm post occipital node with 2 tiny insect bites in both q neck. Today left thigh 5 x 9 raised hot swollen area, nontender perfusin normal pulse 2+. No treatment just cold compresses and return tomorrow.
Age: 2.0
Sex: M
Vaccine: HBHEPB
Symptoms: Heart rate irregular, Pyrexia, Wheezing
Clinical narrative: Seen in clinic 12:30pm-immunized. Seen again at 7:30pm in clinic. Presented with c/o irregular hearbeat, fever, retractions with wheeze. Exam per Dr pending-WNL. No tx given. "Will observe and call."
Age: 66.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Erythema, Feeling hot, Oedema, Pruritus
Clinical narrative: Itching, swelling, red, hot, burning, placed ice bag on swelling and took Benadryl.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Oedema peripheral
Clinical narrative: At time of 2 mo shots, IPV, prevnar given in one thigh (R)-marked limb swelling, lasting a few hours with complete resolution.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Feeling hot
Clinical narrative: 18cm x 13cm red circular area-warm to touch.
Age: 4.9
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site rash, Rash macular
Clinical narrative: Localized edema, pink 7cm x 7cm macular rash no itching.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal discomfort, Dizziness, Hyperhidrosis
Clinical narrative: Pt presented to the ER with dizziness, sweatiness, abdominal discomfort. Pt states he thinks these side effects are due to the hepatitis vaccine.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt noted to have reddened warm local reaction about 6 inches in area on upper right arm. Daughter reports that pt got pneumonia vaccine previous day in physician's office in this arm. Please follow up for lot # and ? with physician's office. Treated with cold compresses for comfort.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Abscess, Headache, Injection site erythema, Injection site infection, Injection site oedema
Clinical narrative: 5/1/03 L very swollen with redness down the entire bicep-cannot stand anything touching it. "H/O baby shot got infected and had to be lanced" states has scar on elbow area. Deltoid area (not biceps) and was swollen down arm to elbow; now localized 4x6cm erythematous swelling with pustules at site of Td 8d ago and less swollen than 2d ago but pustules are now. No fever/chills. Dr saw also we agree on plan. ? forming abscess without L axillary adenopathy. Alcohol cleanse; open pustule with sterile needle, swabbed pus with culturette. Probable sterile abscess rxn to Td shot. Diclox 250 qid #30. Tx'd culturette for bacterial G stain, CBS, surgeon for IRD. 5/6/03, pt is a very pleasant 60 year old pt of Dr who had a tetanus injection in her left deltoid about 10 days ago. A couple of days ago she saw Dr. It was obviously developing an infection in this area. She was started on some antibiotics yesterday. A culture of a pustula was taken yesterday. He saw her today and requested an urgent surgical consultation. She comes in today to be seen and evaluated. She is on Verapamil, Wellbutrin and Imitrex prn for headaches. Add Duricef 500mg po bid for Dr's treatment and give her Darvocet N 100, 15 of those for pain.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: 5/1/03 L very swollen with redness down the entire bicep-cannot stand anything touching it. "H/O baby shot got infected and had to be lanced" states has scar on elbow area. Deltoid area (not biceps) and was swollen down arm to elbow; now localized 4x6cm erythematous swelling with pustules at site of Td 8d ago and less swollen than 2d ago but pustules are now. No fever/chills. Dr saw also we agree on plan. ? forming abscess without L axillary adenopathy. Alcohol cleanse; open pustule with sterile needle, swabbed pus with culturette. Probable sterile abscess rxn to Td shot. Diclox 250 qid #30. Tx'd culturette for bacterial G stain, CBS, surgeon for IRD. 5/6/03, pt is a very pleasant 60 year old pt of Dr who had a tetanus injection in her left deltoid about 10 days ago. A couple of days ago she saw Dr. It was obviously developing an infection in this area. She was started on some antibiotics yesterday. A culture of a pustula was taken yesterday. He saw her today and requested an urgent surgical consultation. She comes in today to be seen and evaluated. She is on Verapamil, Wellbutrin and Imitrex prn for headaches. Add Duricef 500mg po bid for Dr's treatment and give her Darvocet N 100, 15 of those for pain.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Injection site rash
Clinical narrative: Developed clustered pox lesions at injection site L anterior thigh-symptom therapy only recommended (PO Benadryl, topical Calamine, tepid soaks) with appropriate isolation measures.
Sex: F
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Iz admin, both on R and L thigh 20 min after Iz's both legs redden and slightly swollen. Ice pack applied to areas.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Hypoventilation, Lethargy, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: After receiving injection c/o feeling dizzy "going to pass out, unconscious, extremities became rigid, blue, nonresponsive, respiration shallow, unconscious approx 15-20 sec, regained conscious speech slow, color improved to pink, lost conscious x 2, lethargic, sleepy used ammonia inhalant 1st response-O2 per mask.
Age: 28.0
Sex: M
Vaccine: HEP
Symptoms: Pallor
Clinical narrative: After receiving injection c/o feeling dizzy "going to pass out, unconscious, extremities became rigid, blue, nonresponsive, respiration shallow, unconscious approx 15-20 sec, regained conscious speech slow, color improved to pink, lost conscious x 2, lethargic, sleepy used ammonia inhalant 1st response-O2 per mask.
Age: 1.0
Sex: M
Vaccine: HEP, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Bump on abd and back.
Age: 1.25
Sex: F
Vaccine: HIBV, MMR
Symptoms: Febrile convulsion
Clinical narrative: MMR, Hib vaccines administered October 6. Febrile seizure requi9ring intubation and stabilization-10/13.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Flushing, Oedema peripheral, Pruritus, Throat tightness
Clinical narrative: Pt reported possible adverse event at 1500 on 10/22/03. "Facial flushing, sensation of throat closing, intense redness from below L ear to L shoulder to L mid-forearm, some swelling and terrible itching." Self medicated with Benadryl.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site induration, Rash erythematous
Clinical narrative: Erythematous rash R lateral thigh 2x3cm, hard.
Age: 3.6
Sex: F
Vaccine: HEPA, MMR
Symptoms: Irritability, Pyrexia
Clinical narrative: Received Hep A and 2nd week on 10/18/03-was sl. fussy pm of 10/18 and call of 10/19-10/20/03 woke up with fever. Temp at office visit 104.5. 10/24/03 attempted to call home # for status check-number was disconnected.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Face oedema, Urticaria
Clinical narrative: Hives and swelling of upper lip occurring 5-10 mins after varicella vaccine. Responded well to one Benadryl.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Injection site erythema, Injection site inflammation, Pyrexia
Clinical narrative: C/O red, inflamed arm at site of Hib inject. from deltoid to elbow high temp.
Age: 5.5
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site induration, Injection site inflammation
Clinical narrative: The left upper arm had considerable area of inflammation and erythema and even induration towards the superior aspect of the reddened area.  It extends from just immediately below the shoulder to immediately above the elbow on the left side.
Age: 3.0
Sex: M
Vaccine: HEP, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: On left anterior thigh, area of erythema and swelling at vaccine site about 4 cm by 4.5 cm (+) hot to touch (+) induration.
Age: 57.0
Sex: F
Vaccine: MMR, TD
Symptoms: Asthenia, Chest pain, Dizziness, Hearing impaired, Heart rate increased
Clinical narrative: Dizziness, vomiting, swelling, left chest pain, weakness, loss of hearing, fast hear-beat.
Age: 57.0
Sex: F
Vaccine: MMR, TD
Symptoms: Oedema, Vomiting
Clinical narrative: Dizziness, vomiting, swelling, left chest pain, weakness, loss of hearing, fast hear-beat.
Age: 68.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chest pain, Hypertension, Pruritus, Rash, Urticaria
Clinical narrative: Moderate hives on sole of foot,(with severe itching) palm of hand, underarms.  Never experienced any allergic reactions from previous (20 years) flu vacines.
Age: 68.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Moderate hives on sole of foot,(with severe itching) palm of hand, underarms.  Never experienced any allergic reactions from previous (20 years) flu vacines.
Age: 17.0
Sex: F
Vaccine: TTOX
Symptoms: Injection site mass, Nausea, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Right arm swelled to 3x's normal size and knot at injection site getting bigger & bigger. Nausea, feet edematous, hives, itching. Started swelling on 10-18-03 and by 10-19-03 all the above signs were present. To ER at AMC on 10-19-03 gave Benadryal an steriod injection.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness, Lightheaded, generalized weakness
Age: 44.0
Sex: M
Vaccine: ANTH
Symptoms: Cough, Dyspnoea, Emphysema, Hyperlipidaemia
Clinical narrative: This is 45 year old who had been in his usual health until the first weeks of June 2003 when developed a persistent dry, non-productive cough. He received above vaccinations between 02/11/03 and 03/28/03. He had a normal course of recovery from all these vaccinations. He was deployed on 04/27/03. While overseas he developed cough, which he attributed to the frequent sand storms. He returned home on 08/08/03 on emergency leave. During his leave he experienced an episode of severe unretractable coughing that resulted in him passing on 09/03/03. Prior to this episode he was seen by a civilian physician who ordered a CT of the chest and chest xray (CXR). The client states that he was told that the CXR demonstrated mild emphysema, the CT scan showed no pericardial fluid and normal mediastinal width. He was started on Albuterol MDI 2 puffs TID. He also was found on laboratory results to have hyperlipidemia (Cholesterol 218) and was started on LesCol. He returned on 09/08/03 and was seen by Dr. on 09/15 or 9/16 for same complaint. Had pulmonary function tests (PFT) completed which revealed normal study. He also had a repeat CXR which was repeatedly normal. He was subsequently started on Serevent Discus 1 puff BID. On 10/15/03 he returned to see Dr. in follow-up. He was started on Aciphex 20mg BID for GERD. He discontinued the respiratory meds. Client now states that his coughing has gotten progressively worse, with no improvement in breathing capacity. He reports that he has never had heartburn, except one isolated incident after eating very hot, spicy food about 10 years ago. He relates that when he tries to take in a breath it feels like the airways are restricted and can't get the air into his lungs. He has to alter his activity on a daily basis secondary to his difficulty breathing. Climbing stairs requires extra effort and a reduced speed to accomplish. He relates that he can't run more than 100 yards without difficulty, when his usual activity is to run 5-6 miles 2-3 times a week. Client coughed throughout interview. He is currently profiled for 60 days.
Age: 21.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: stating adverse event to influenza vaccination. Right Deltoid area at injection site, red, warm, swollen and painful to the touch (5/10) and while at rest (2/10). Patient concerned that this is an adverse reaction to influenza vaccination. He has had 3 previous vaccinations with influenza without adverse event.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Eye irritation, Face oedema, Hypoaesthesia, Tachycardia
Clinical narrative: numbness of tongue, lip swelling, itching around eyes, chest heaviness, tacchycardia c rrr@100bpm
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Eye pain, Feeling hot, Hypersensitivity, Ocular hyperaemia, Photophobia
Clinical narrative: BEGINNING THE DAY AFTER THE IMMUNIZATION, CHILD HAD RED EYES, SENSITIVITY TO LIGHT, PAIN, ALSO RED RASH OVER BODY AND SKIN HOT TO TOUCH BUT NO GENERAL FEVER (ATOPIC DERMATITIS ACC TO PRI PROVIDER).  THIS OCCURS EVERY 1-2 WEEKS AND LASTS 4 TO 7 DAYS.  TX HAS BEEN SYMPTOMATIC AND CHILD HAS SEEN ALLERGIST PEDIATRICIAN AND EYE SPEC.  HAS HAD ALLERGY TESTING & SKIN BX. PARENT CALLED CLINIC TODAY TO REPORT SITUATION.  SAY ALLERGIST THINKS CHILD IS ALLERGIC TO THIMEROSAL.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Rash
Clinical narrative: BEGINNING THE DAY AFTER THE IMMUNIZATION, CHILD HAD RED EYES, SENSITIVITY TO LIGHT, PAIN, ALSO RED RASH OVER BODY AND SKIN HOT TO TOUCH BUT NO GENERAL FEVER (ATOPIC DERMATITIS ACC TO PRI PROVIDER).  THIS OCCURS EVERY 1-2 WEEKS AND LASTS 4 TO 7 DAYS.  TX HAS BEEN SYMPTOMATIC AND CHILD HAS SEEN ALLERGIST PEDIATRICIAN AND EYE SPEC.  HAS HAD ALLERGY TESTING & SKIN BX. PARENT CALLED CLINIC TODAY TO REPORT SITUATION.  SAY ALLERGIST THINKS CHILD IS ALLERGIC TO THIMEROSAL.
Age: 9.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Injection site erythema, Myalgia, Pyrexia
Clinical narrative: REDNESS AT SITE, FEVER OF 101 NEXT DAY.  MUSCLE ACHES. Follow up on 11/17/2003: "Both vaccinations given in same arm; unable to determine which caused reaction."
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Facial palsy, Headache, Hypoaesthesia
Clinical narrative: Patient experienced severe headache along with facial numbness on her left side
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Difficulty in walking, Pain, Pyrexia, Tremor
Clinical narrative: Had a temperature of about 103, shaking, very achey and hard to walk and my arm hurt where I received the shot.  Took one dose of Vicks cold/flu tablets (2) and took Tylenol (1 - 650 mg.) the next day.  Recovered in about a day and a half.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Rash
Clinical narrative: Small rash developed on left arm two days after receiving vaccine.  The next day the rash was 5 inches in diameter and hot to the touch.  Patient saw doctor and was prescribed cephalexin 500mg BID for ten days.  Rash cleared by end of treatment.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure decreased, Dizziness
Clinical narrative: Influenza vaccine given at 0900, employee reported history of anxiety with shots.  Sat for 2 minutes after shot, reported feeling fine.  After walking back to the unit, employee reported feeling dizzy, weak and lightheaded for about one and a half hours.  BP was 70/? when checked. Employee does not remember diastolic.  Employee reports symptoms resolved spontaneously and at 12:30pm when speaking with employee to f/u no symptoms noted at all.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Feeling hot, Flushing, Injection site pain, Pain
Clinical narrative: Within 10 minutes of vaccination, pt. experienced facial flushing and swelling that was observed by self and others. Right arm tender, very swollen, bruised.  Friday night face felt hot, swollen.Did not sleep well that night; felt hot, aching all over. Symptoms of feeling hot, swollen continued all weekend. States she thought she must be runny a fever but upon checking found it to be 98.2.Made appt to see MD on Monday 10/27 and was told she had hives over face, chest, back, most likely due to influenza shot. MD recommended benadryl 25 mg STAT and then q 4-6 hrs. until rash resolves. Pt has had numerous flu shots in the past without problem.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Urticaria
Clinical narrative: Within 10 minutes of vaccination, pt. experienced facial flushing and swelling that was observed by self and others. Right arm tender, very swollen, bruised.  Friday night face felt hot, swollen.Did not sleep well that night; felt hot, aching all over. Symptoms of feeling hot, swollen continued all weekend. States she thought she must be runny a fever but upon checking found it to be 98.2.Made appt to see MD on Monday 10/27 and was told she had hives over face, chest, back, most likely due to influenza shot. MD recommended benadryl 25 mg STAT and then q 4-6 hrs. until rash resolves. Pt has had numerous flu shots in the past without problem.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site warmth
Clinical narrative: Redness extending from shoulder to elbow and 4-5 inches across which was hot to touch
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Coma, Depressed level of consciousness, Listless, Somnolence
Clinical narrative: listnessness. Sleepiness. Fell asleep 2 hours after injection, could not be awaken for 20 hours.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Unevaluable event
Clinical narrative: 09/12/03- scheduled to receive anthrax #3 and PPD-vaccinator mistakenly injected anthrax into the patient's left upper forearm- left forearm immediately began to swell, reddened and became "very painful"- following day, above sxs worsened- by next day, all of the above sxs dissipated. Patient's clinical summary sent to VAERS via FedEx on 10/28/03.
Age: 25.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 09/12/03- scheduled to receive anthrax #3 and PPD-vaccinator mistakenly injected anthrax into the patient's left upper forearm- left forearm immediately began to swell, reddened and became "very painful"- following day, above sxs worsened- by next day, all of the above sxs dissipated. Patient's clinical summary sent to VAERS via FedEx on 10/28/03.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest pain, Cough, Dyspnoea
Clinical narrative: From initial info received on 10/15/2003 from a pharmacist, regarding an adverse event occurring in the USA, it was reported that a 50-year-old male pt received Fluzone SV '2003-'2004 USP, lot number U1268AA (route and site not reported) at 8:44 AM on 10/14/2003. At 2:30 PM, the pt experienced shortness of breath, cough and feeling heaviness in his chest. The pt called the clinic nurse one hour after experiencing these symptoms and he was advised to call 911. The reporting pharmacist spoke with the pt the following day (10/15/2003) and the pt stated that he did not call 911, but took a "hot shower" and used Vicks. The pt stated that he "now feels fine". The pt's recovery status was not reported. The pt had slight wheezing and allergic rhinitis prior to injection. From additional info received on 10/16/2003, from the reporting pharmacist, it was reported that the pt was seen in the clinic on 10/14/2003 for complaints of pain in his right ear, ear infection and a cough. The pt was diagnosed with a sinus infection and possible asthmatic bronchitis. He was prescribed Bacrim DS twice a day, albuterol inhaler two puffs twice a day and Actifed one tablet twice a day. It was recommended that he attend smoking cessation classes as well. At the time of his visit, the pt received the influenza vaccine and there is no documentation that the pt had ever received one in the past. Reportedly, the pt does not have any known food or drug allergies. The pt did not go to the ER after experiencing the reported adverse events and stated that the events resolved after he took a shower and used Vicks. The reporter stated that the pt's recovery status is recovered. 10/17/2003: During internal review of this file, it was noted that the "Required emergency room/doctor visit" box was inadvertently clicked. Per the source documentation for this case, it was noted that the pt was not seen in an ER or by a physician for the adverse events he experienced on 10/14/2003. A new version of this case was created for the purpose of correcting this error.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Myocardial infarction
Clinical narrative: From initial info received on 10/22/03, from a health care professional, regarding a death occurring, it was reported that a 79 year old female pt died of a "heart attack" on 10/19/03, two days after receiving a dose of Fluzone SV '2003-'2004, lot number U1260AA, given IM in the left deltoid on 10/17/03. The reporter stated that the case of death indicated on the death certificate was cardiac arrest. A 15-day follow up report received 11/04/2003 adds: From additional info obtained on 10/27/2003, from a telephone conversation with the reporter, it was stated that the responsible physician is waiting for follow-up documents. The reporter also stated that she was not sure if there will be an autopsy report and that they had not yet received any hospital records or test results. The correct spelling of the responsible physician's last name was also provided. A 15-day follow up report received 11/13/2003 adds: From additional info received on 11/06/2003 from faxed correspondence from the reporter, it was reported that the pt had pre-existing conditions of hypertension, hyperlipidemia, osteoarthritis, spinal stenosis, acromegaly and Parkinson's disease. The pt received the influenza vaccine on 10/17/2003 and expired on 10/19/2003 at 9:31 AM. Per the reporter, the pt's death was not caused by the vaccine. The death certificate was also provided and the "immediate cause" of death was listed as cardiac arrest . Both hypertension and hyperlipidemia were listed as "underlying cause". No other info was reported. Case is closed.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Cardiac failure congestive, Renal failure acute
Clinical narrative: This is a 83 year old male who died on August 21, 2003 while enrolled in RSV S and I study with RSV vaccine. The subject received RSV vaccine or Placebo and Influenza vaccine on 10/21/02. The subject died 304 days post immunization while in hospice care. The event was reported by the investigator as not related to the study vaccine. A 15-day follow up report received 10/31/2003 adds: The subject died 305 (corrected) days post immunization while in hospice care. Additional info received 10/24/2003: Date of death is 08/22/2003, changed from 08/21/2003. Diagnosis: Pt died at hospice on 08/22/2003 from CHF and ESRD.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Haematoma, Hypokinesia, Injection site haemorrhage, Injection site mass
Clinical narrative: Information has been received from a pharmacist and a RN concerning a 68 year old male with no known allergies who during a vaccination clinic at a pharmacy on 10/5/03 between 1400 and 1500 was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (644219/1079M). On 10/8/03 the pt was also vaccinated in the left arm with a dose of influenza virus split virion 3v vaccine inactivated (Fluzone). Concomitant therapy included Flovent and Serevent. The pt's wife reported to the pharmacist that on 10/8/03, about 6 hrs after administration, the pt developed a lump at the site of injection in the right arm. It continued to get worse and worse. On the morning of 10/9/03 the pt went to the ER because the arm had become so swollen and painful and he was unable to move it. A venous ultrasound revealed a hematoma at the injection site. The pt was diagnosed with cellulitis and treated with Rocephin and Keflex. On the afternoon of 10/9/03 the pt was seen by his primary care physician and started on Keflex, Vicodin, and ibuprofen. As of 10/10/03, the pt was doing better. It was also reported that the wife had indicated that her husband developed a 'bad reaction" in the arm to the pneumococcal 23v polysaccharide vaccine because the product was "contaminated." On 10/10/03 the pt's wife called the pharmacist to obtain the lot number for the pneumococcal 23v polysaccharide vaccine and that the pt was going for a second visit to his PCP. On 10/11/03 the pt was again seen in the physician's office and was considered to be much improved. It was also reported that this pt lives about an hour away from the pharmacy and is not a regular customer of this pharmacy. A product quality complaint is involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards and was released. Upon internal review, cellulitis and hematoma at the injection site were determined to be other important medical event (OMIC). Additional info has been requested.  Follow up on 11/26/2003: "No futher information is expected."
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain
Clinical narrative: Information has been received from a pharmacist and a RN concerning a 68 year old male with no known allergies who during a vaccination clinic at a pharmacy on 10/5/03 between 1400 and 1500 was vaccinated IM in the right arm with a dose of pneumococcal 23v polysaccharide vaccine (644219/1079M). On 10/8/03 the pt was also vaccinated in the left arm with a dose of influenza virus split virion 3v vaccine inactivated (Fluzone). Concomitant therapy included Flovent and Serevent. The pt's wife reported to the pharmacist that on 10/8/03, about 6 hrs after administration, the pt developed a lump at the site of injection in the right arm. It continued to get worse and worse. On the morning of 10/9/03 the pt went to the ER because the arm had become so swollen and painful and he was unable to move it. A venous ultrasound revealed a hematoma at the injection site. The pt was diagnosed with cellulitis and treated with Rocephin and Keflex. On the afternoon of 10/9/03 the pt was seen by his primary care physician and started on Keflex, Vicodin, and ibuprofen. As of 10/10/03, the pt was doing better. It was also reported that the wife had indicated that her husband developed a 'bad reaction" in the arm to the pneumococcal 23v polysaccharide vaccine because the product was "contaminated." On 10/10/03 the pt's wife called the pharmacist to obtain the lot number for the pneumococcal 23v polysaccharide vaccine and that the pt was going for a second visit to his PCP. On 10/11/03 the pt was again seen in the physician's office and was considered to be much improved. It was also reported that this pt lives about an hour away from the pharmacy and is not a regular customer of this pharmacy. A product quality complaint is involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards and was released. Upon internal review, cellulitis and hematoma at the injection site were determined to be other important medical event (OMIC). Additional info has been requested.  Follow up on 11/26/2003: "No futher information is expected."
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Anorexia, Chills, Cough, Headache, Laboratory test abnormal
Clinical narrative: Pt apparently had his first shot for influenza at Dr's office on 10/14/03 in the morning at 11 am up to 12 noon. That evening of 10/14/03 had sore throat. Became more ill upon awakening on 10/15/03 Wednesday. Sore throat, cough and fever, ached all over, not eating, intense headache. Did attempt to go to work but felt worse and went home at 3:30pm. Shaky, uncontrolled chills, and his temp was 103. Cough somewhat productive, not colored. He tried taking ibuprofen and Day Quil but his fever progressed up to 105. Admitted to hospital on 10/16/03-indication: chills, fever, pneumonia, cough and congestion, headache, muscular aches and pains. X-ray indicated no radiographic evidence of acute cardiopulmonary disease. Pt was hospitalized until 10/19/03. Discharge 10/19/03 with instructions to follow up with his physician in 7-10 days. Wellbutrin 150mg take twice a day. Continue any other home meds.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Lung disorder, Myalgia, Nasal congestion, Pain, Pharyngolaryngeal pain
Clinical narrative: Pt apparently had his first shot for influenza at Dr's office on 10/14/03 in the morning at 11 am up to 12 noon. That evening of 10/14/03 had sore throat. Became more ill upon awakening on 10/15/03 Wednesday. Sore throat, cough and fever, ached all over, not eating, intense headache. Did attempt to go to work but felt worse and went home at 3:30pm. Shaky, uncontrolled chills, and his temp was 103. Cough somewhat productive, not colored. He tried taking ibuprofen and Day Quil but his fever progressed up to 105. Admitted to hospital on 10/16/03-indication: chills, fever, pneumonia, cough and congestion, headache, muscular aches and pains. X-ray indicated no radiographic evidence of acute cardiopulmonary disease. Pt was hospitalized until 10/19/03. Discharge 10/19/03 with instructions to follow up with his physician in 7-10 days. Wellbutrin 150mg take twice a day. Continue any other home meds.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Pneumonia, Pyrexia
Clinical narrative: Pt apparently had his first shot for influenza at Dr's office on 10/14/03 in the morning at 11 am up to 12 noon. That evening of 10/14/03 had sore throat. Became more ill upon awakening on 10/15/03 Wednesday. Sore throat, cough and fever, ached all over, not eating, intense headache. Did attempt to go to work but felt worse and went home at 3:30pm. Shaky, uncontrolled chills, and his temp was 103. Cough somewhat productive, not colored. He tried taking ibuprofen and Day Quil but his fever progressed up to 105. Admitted to hospital on 10/16/03-indication: chills, fever, pneumonia, cough and congestion, headache, muscular aches and pains. X-ray indicated no radiographic evidence of acute cardiopulmonary disease. Pt was hospitalized until 10/19/03. Discharge 10/19/03 with instructions to follow up with his physician in 7-10 days. Wellbutrin 150mg take twice a day. Continue any other home meds.
Sex: U
Vaccine: HEP, PNC
Symptoms: Erythema, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Had a fever of 104 since 08/31.  Kept a fever.  Patient had for 1 week per mother.  Had a rash on 09/04/2003.  Seen in my office 09/05/2003.  Tiny red spotches all over body.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Pain, Urticaria
Clinical narrative: 10/25/2003 @ 20:00: Chills, body aches; 10/26/2003 @ 11:00: Hives (palms of hands, torso, thighs)
Sex: M
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Blazing case of hives.  Treated with cortisone and antihistamines.
Age: 46.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Hypoxia, Injection site oedema, Injection site pain
Clinical narrative: Client developed pain and swelling five hours after receiving Pneumonia vaccine in the left shoulder and arm.  Shoulder is warm to touch.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Headache, Hot flush, Nausea
Clinical narrative: Twenty minutes after flu shot given patient returned complaining of severe headache, sick to her stomach, hot and clammy.  Patient taken to ER.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Localized urticaria noted right upper arm. The follow up received on 11/17/03 states onset redness.
Age: 75.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site oedema
Clinical narrative: Right arm swelling at site reported to be pneumovax.
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Chest pain, Hypertension, Pruritus, Rash, Urticaria
Clinical narrative: Rash/hives on palms and soles, intensive itching peaked 3-4 days after vaccination, high blood pressure (155/90) for 4 days and chest pain (never had before).
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pruritus, Urticaria
Clinical narrative: Rash/hives on palms and soles, intensive itching peaked 3-4 days after vaccination, high blood pressure (155/90) for 4 days and chest pain (never had before).
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Erythema, Feeling hot, Headache, Urticaria
Clinical narrative: Headache, erythema, wheal 6cm x 4.5 cm.  Warm to touch, patient applied hand to region.  Patient went to ER and was given antibiotics for the cellulitis.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Malaise, Nausea
Clinical narrative: She felt light headed, general sense of being "unwell", nausea.  We had her rest about 20-25 minutes.
Age: 47.0
Sex: F
Vaccine: TTOX
Symptoms: Chills, Injection site pain, Pain, Rash erythematous
Clinical narrative: Redness, swelling at injection site-patient noticed today soreness at site since injection.  Chills Tuesday night/Wednesday morning.  Complained of soreness/achiness in legs since Tuesday-reddened area on arm (5 inches by 2 inches).  Received tetanus injection Monday at around 17:00.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Feeling hot, Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: 1) Raised, red, warm to the touch, inflammation at injection site (about 3 inches in diameter) 12 hours after injection. 2) Severe joint pain with about 6 hours after injection.  Treatment: Benadryl about 36 hours after injection.  All symptoms resolved within 48 hours of injection.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dizziness, Nausea
Clinical narrative: Dizziness, nausea, chills started within 1 hour of vaccine.  Dizziness and chills subsided after 3 hours, nausea persisted for approximately 24 hours.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Oedema, Pruritus
Clinical narrative: Swelling, redness and itching.  After a week it still has a little pain at sight.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia, Headache, Hyperhidrosis, Nausea
Clinical narrative: Nausea, irratio heart beat, headache, sweating lasting 2 days.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nausea, Oedema
Clinical narrative: Nausea, red, swollen
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Chills, Diarrhoea, Insomnia, Loss of consciousness
Clinical narrative: Spoke to patient on 10/16/2003.  Patient states having stepped on staple on 10/11/2003 for which she was seen in ED on 10/12/2003 and received Td injection. Patient then saw MD on 10/14/2003, and on that day received pneumococcal and flu vaccines.  Patient states that 2 hours after the injection she developed aching, chills, temperature to 101, joints hurt, shoulder also.  patient had difficulty sleeping and awoke with diaphoresis and nausea/diarrhea.  States she was sitting on commode and "passed out".  Could not estimate timeframe of LOC.  States woke up leaning against wall still on commode.  Patient then noted that she was "very, very, weak" and slowly improved over the course of the day.  Noted in the shower that she had some "sore" nodes under her left armpit (same arm as she got injection).  Patient pushed fluids and ate solids; voiding QS and was continuing to feel better when I spoke with her on the 16th.  Patient denies shortness of breath, chest pain, palpatations.  Patient informed that she had quite the reaction to the vaccines but was unlikely she was allergic to hem and should be able to receive them in the future although she shouldn't require pneumococcal v.  Patient to take it easy and follow up should she not continue to improve.  Will send VAERS to CDC.  Patient stated verbal understanding and had no further questions at this time.   Patient had bad reaction to flu shot.  Patient is fine now, but would like to know if she is allergic and would like to know if she should not get it again.  This was her first flu shot, and also received shots for pneumonia.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Spoke to patient on 10/16/2003.  Patient states having stepped on staple on 10/11/2003 for which she was seen in ED on 10/12/2003 and received Td injection. Patient then saw MD on 10/14/2003, and on that day received pneumococcal and flu vaccines.  Patient states that 2 hours after the injection she developed aching, chills, temperature to 101, joints hurt, shoulder also.  patient had difficulty sleeping and awoke with diaphoresis and nausea/diarrhea.  States she was sitting on commode and "passed out".  Could not estimate timeframe of LOC.  States woke up leaning against wall still on commode.  Patient then noted that she was "very, very, weak" and slowly improved over the course of the day.  Noted in the shower that she had some "sore" nodes under her left armpit (same arm as she got injection).  Patient pushed fluids and ate solids; voiding QS and was continuing to feel better when I spoke with her on the 16th.  Patient denies shortness of breath, chest pain, palpatations.  Patient informed that she had quite the reaction to the vaccines but was unlikely she was allergic to hem and should be able to receive them in the future although she shouldn't require pneumococcal v.  Patient to take it easy and follow up should she not continue to improve.  Will send VAERS to CDC.  Patient stated verbal understanding and had no further questions at this time.   Patient had bad reaction to flu shot.  Patient is fine now, but would like to know if she is allergic and would like to know if she should not get it again.  This was her first flu shot, and also received shots for pneumonia.
Age: 56.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Dysphagia, Face oedema, Nail discolouration, Pruritus, Rash
Clinical narrative: Rash over entire upper trunk except underneath bra. Facial edema. Nail beds cyanotic. Rash appears to be progressing. Oxygen given as well as 50 mg Benadryl IM. Transferred to ER. Was given Phenergan and Steroid IV and Benadryl IM around 2:30 PM. Discharged around 4 PM. Was told not to have vaccinations together anymore, because could not tell which one caused the allergic reaction. 10/15/03: Call to pt. She states had mild difficulty swallowing last PM and some itching today but generally improved. She called her MD and was advised to continue Benadryl until asymptomatic.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Pallor, Syncope vasovagal
Clinical narrative: Symptoms: sweating, dizzy, lightheaded, pale. Pt experienced these symptoms within 1-2 minutes following vaccination. EMTs took pt to hospital. Dr described event as vasovagal reaction (Pt had recently eaten).
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Pneumovax shot given yesterday on left arm; this morning noticed redness around site and also itchiness. At around mid-morning, site still itchy and redness spread approx 2 inches down (in elongated fashion). Pt took 12.5mg of Benadryl and 400mg of Ibuprofen.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness, Tinnitus
Clinical narrative: On 10/22/03 AM had about 3 hours of front sided tinnitus and partial deafness. Took aspirin 325mg, went to bed, woke up completely symptom free.
Age: 2.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema
Clinical narrative: Pt vaccinated on 10/20/03. Received PCV-7 to RL and Fluzone to LL. Pt RTC on 10/22/03 with localized reaction on right thigh. Onset of reaction was 10/21/03. Mom stated it was swollen, red and warm to touch 1 day after PCV-7. Dr made aware of reaction after shot. No recommendation given states parent. 10/22/03 observation: noted 5cm x 2cm reddened area on right thigh. Not warm to touch. Child no c/o pain with examination of area. Advised warm compress to site, seek MD recommendations on Benadryl. Exam performed by RN.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Erythema and edema arm.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Nausea
Clinical narrative: Nausea and stomach cramping
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Influenza like illness, Muscle spasms, Nausea
Clinical narrative: 10/6 evening began to have flu-like lower GI symptoms. 10/7 woke up with severe lower backache and joint pain, cramping and nausea. This continued thru the day with low grade fever. 10/8 same symptoms but less severe. 10/9 no symptoms.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: 10/6 evening began to have flu-like lower GI symptoms. 10/7 woke up with severe lower backache and joint pain, cramping and nausea. This continued thru the day with low grade fever. 10/8 same symptoms but less severe. 10/9 no symptoms.
Age: 24.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting 1 1/2 hours after receiving vaccines. Compazine 10mg stat and tid will follow injection site. Examined abdomen, lungs, heart.
Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Pyrexia, Urticaria
Clinical narrative: Large red welts on arm flu shot given. Temp 101.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Oedema
Clinical narrative: Pt return to clinic c/o swollen reaction possibly due to flu vac. Treatment f/u or 24-48 hours or return (?) if symptoms worsens. The follow up received on 11/18/03 states Rx monitor/ comfort measures has recovered.
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Apnoea, Convulsion, Loss of consciousness, Pulse absent
Clinical narrative: Pt lost consciousness, went into a seizure, stopped breathing, had no pulse. Called 911. Approx 30 seconds went by and pt began breathing on her own. She was checked by EMTs and mom insisted that she go home.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Fatigue, Feeling abnormal, Hyperhidrosis, Pallor
Clinical narrative: 3 minutes after given influenza vaccine, noted to be pale by nurse. C/o lower chest/abdominal discomfort. I was called to room. Child was pale, sweaty, c/o being tired and was saying "I feel funny". HR 40 and irregular, got equipment to get BP and O2 sat, when he vomited a large amount, then improved O2 sat 98%. HR 80-82, BP 88/60, monitored 10-15 minutes. Remained stable and states felt so went home.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 3 minutes after given influenza vaccine, noted to be pale by nurse. C/o lower chest/abdominal discomfort. I was called to room. Child was pale, sweaty, c/o being tired and was saying "I feel funny". HR 40 and irregular, got equipment to get BP and O2 sat, when he vomited a large amount, then improved O2 sat 98%. HR 80-82, BP 88/60, monitored 10-15 minutes. Remained stable and states felt so went home.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash arms, legs, hands, torso, face began 10/21/03. Tx: Rx Steripred DS Dose pack for 12 days, Rx: Benadryl.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Pharyngolaryngeal pain, Pruritus, Pyrexia
Clinical narrative: Vaccine admin around 9:30 AM. NKDA. 1st time to receive vaccine. No food allergies. Pt came to me around 11:30 AM with c/o itching all over. No hives. Noted on body. VS BP 102/76. HR 120 SPO2 98%. Also c/o sore throat, she did not have prior to vaccine. 1 Benadryl 25mg given orally (at 11:35). She started c/o not being able to swallow the Benadryl. Husband notified. At 11:45 pt c/o more difficulties swallowing. 911 notified. .3cc of epinephrine given subq. BP 104/76 99.2 temp, 97%  SPO2 HR 96. Ambulance arrived pt taken to ER.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema
Clinical narrative: Received influenza vaccine on Friday 10/17/03, left upper arm, some redness developed on Saturday but extended down and around anterior reaching 2" width and 3" length. Pt called our office 10/20/03 and was instructed to check with her doctor. He ordered warm packs to area and it's improved 10/21/03.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Erythema, Pruritus, Throat tightness
Clinical narrative: 2100 received injection by 2125 took 50mgs PO Benadryl for throat itchiness and tightening, called to ER. By 2200 Dr on unit referred me to ER for additional Benadryl as was red and itching all over entire body. Seen in ER for additional IV Benadryl, Solu-Medrol 125mg. Discharged to home on 10/16/03 about 0030 on 40mg Prednisone for 5 days, 20 mg Zyrtec qd, 50mg PO Benadryl q 6 hours. F/U by another MD 10/16, add 125mg Solu Medrol IM for continued itching, difficulty breathing.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Headache, Nausea, Pain, Pyrexia, Urticaria
Clinical narrative: Hives below injection site, severe pain in arm and under arm radiating to shoulder blade at 48 hours, couldn't raise arm. Nausea, severe headache, fever for 24 hours, had to stay in bed. Right arm affected.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Pain, Stomach discomfort
Clinical narrative: Joint, bone aching (head, neck, back). Gastric distress. Some chills. Lasted 24-30 hours, reducing over time period.
Age: 3.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Pain, Pyrexia
Clinical narrative: Fever 103-105 degrees for 4 days. Left arm red, swollen, bluish discoloration elbow to shoulder, pain with movement. Resolved 10/4.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Oedema peripheral
Clinical narrative: L arm swollen within 48 hrs after shot given-whole upper arm swollen, skin tight and red.
Age: 57.0
Sex: M
Vaccine: ANTH
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Since I had a shot for anthrax #1 my neck become stiff and aching. He has had 2 subsequent doses in his RA. He complains of ? since that time. Pt on meds for Monopril, Lipipor, Gluphage, Ameryl, and Allopusive.
Age: 17.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Pruritus
Clinical narrative: Pt reported to school after vaccine administration. After lunch pt reported to school RN with extreme itching. No other symptoms reported at this time. Parent picked child from school and brought to PMD>
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: L deltoid injection site swollen, red and warm when touched. Mother did not give any Tylenol or compress to site.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia, Wheezing
Clinical narrative: R thigh with 1/2" hard, red, hot to touch area at inj site. High temp 102.6 A with wheezing audible with naked ear. Reported via phone to pediatrician-Rx for "steroid oint and wheezing medicine." No wheezing today. To recheck 8/29/03.
Age: 1.75
Sex: F
Vaccine: DTAPH
Symptoms: Injection site erythema, Injection site nodule, Injection site oedema
Clinical narrative: Child received DTaP/Hib-combination shot in L thigh on 9/3/03. Mom noted nodule in area after shot which developed reddish/purplish color by next day. Last night leg appeared swollen with redness around site nodule much smaller-child still walking on leg without problem. Told to apply cold compress every 1-2hr x 24 hours.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: 9/25 Thursday: no swelling. 9/26 Friday after 2 PM: small knot. Later parent placed ice on LD, arm swelled more and became red. Saw urgent care physician.