chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Injection site swelling
Clinical narrative: Initial report received from a health care professional in the USA on 23 April 2008. A 5 year old, female patient (with a history of allergy to peanuts and eczema) complained of swelling of the left deltoid, 2 days after she received a fifth dose of DAPTACEL (lot number C2933AB) intramuscularly in the left deltoid, a fifth dose of IPOL (lot number A0298) intramuscularly in the left deltoid and a first dose of TUBERSOL (lot number C2678AA) intradermally in the left forearm on 25 March 2008.(Needle length - 5/8" 25 gauge). The swelling of the left deltoid was described as 8 x 12 cm around the injection site. The arm was described as red, hot to touch. No complaints of range of movement change. She did not have any illness prior to the vaccinations and was on topical creams. She was treated with MOTRIN and cold compress for the adverse events. She did not have any diagnostic or laboratory tests done. The symptoms resolved and the patient recovered.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTAPHEPBIP, MMR, VARCEL
Symptoms: Convulsion, Fall, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: MOTHER STTES PT WALKED INTO KITCHEN AND ELL BACKWARDS AND THEN HAD SEIZURE WHICH LASTED LESS THEN 1 MINUTE. STATE PT STATES HE FELL OUT OF BED JUST PRIOR TO THIS EIPSODE. ON 8/5/08 PM (NIGHT SHOT GIVEN) HE HAD FEVER OF 102 AND WAS FEBRILE THE NEXT DAY (8/6). MOM GAVE IBURPOPHEN FOR FEVER. PEDIATRICIAN ORDERED MRI WHICH WAS WNL. NO FURTHER PROBLEMS
Age: 29.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site swelling, Injection site warmth
Clinical narrative: 3-4 days after MMR, arm began hurting.  5-6 days after MMR, red streak appeared near injection site, 7 days after MMR, injection site became very swollen, red, painful, and hot.  Pt thinks he may have run a fever last night.  None this am.
Age: 29.0
Sex: M
Vaccine: MMR
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: 3-4 days after MMR, arm began hurting.  5-6 days after MMR, red streak appeared near injection site, 7 days after MMR, injection site became very swollen, red, painful, and hot.  Pt thinks he may have run a fever last night.  None this am.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Chills, Feeling hot, Vomiting
Clinical narrative: Client reported that 12 noon on 08/25/2008 she started having abdominal pain, vomiting, feeling feverish, having chills.  Advised to seen medical follow up.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Poor quality sleep
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female with drug reactions/allergies to aspirin, nonsteroidal anti-inflammatory drug (unspecified) and CELEBREX who on 13-AUG-2008 was vaccinated intramuscularly in the left arm with a 0.5 mL dose of PNEUMOVAX 23 (either Lot# 659150/1384U or 658673/0990U). The nurse reported that the patient developed injection site arm pain the same night of the vaccination. The pain kept the patient up the whole night and was described as extreme. There was no redness, no warmth, and no swelling reported at the injection site. The patient's experiences were considered to be disabling. The nurse requested lot checks for both of the reported lots. Additional information has been requested.
Age: 0.1
Sex: M
Vaccine: HEP
Clinical narrative: Unexplained death at age 6 weeks about 24 hrs after Hepatitis B #2 dose. Autopsy pending. 9/22/08-records receivd for DOS 8/15-/16/08-transferred after cardiopulmonary arrest and severe hypoxic-ischemic encephalopathy. Found unreponsive and pulseless on couch following nap. Received unresponsive with fixed and dilated pupils, hypothermic core temperature 32.6 rectally.  Coarse bilateral breath sounds. Intubated, mechanical ventilation. 1/12/09-Autopsy report received-COD Asphyxia. Undetermined cause.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female patient with no medical history reported, who on 21-JUL-2008 was vaccinated intramuscularly into the arm with a dose of PNEUMOVAX 23 (Lot 658673/099U or 659150/1384U). On 21-JUL-2008 the patient reported severe arm pain at the injection site, minor swelling, and unbearable pain, with no warmth and no redness. The patient was seen in the office on 22-JUL-2008. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. The nurse requested lot checks for both of the reported lots. The reporter considered severe arm pain, minor swelling and unbearable pain to be disabling. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Ecchymosis, Full blood count, Petechiae, Platelet count decreased, Purpura
Clinical narrative: Petechiae, purpura, and ecchymosis were observed over arms and legs bilaterally starting 8/6/08 and thrombocytopenia was found on 8/7/08 at hospital. Pt was transferred to another hospital and was treated for ITP - given WinRho (pt 0+).  10/3/08 Reviewed hospital medical records of 8/7-8/9/2008. FINAL DX: idiopathic thrombocytopenic purpura Records reveal patient experienced rash & bruising x 1 day.  Had been transferred from outlying ER.  Exam revealed petechiae, ecchymosis, pus on right peritonsillar area.  Heme/onc consult done.  Tx w/WinRho.  Improved & d/c to home w/heme/onc clinic & serial labs f/u  10/21/08 Reviewed ER medical records of 8/7/08. FINAL DX: rash; thrombocytopenia; possible drug rash; possible ITP Records reveal patient experienced petechial rash on right arm, purpuric rash left shoulder, left forearm, LLE approx 1 week s/p vaccine.  Transferred to higher level of care.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 8/22/08 - am - Noted redness and swelling of L posterior deltoid where varicella vaccine given 8/21/08 (5 cm x 7 cm - mild erythema 3 x 4 cm - mod erythema and edema - centrally).
Age: 26.0
Sex: M
Vaccine: UNK
Symptoms: Back pain, Body temperature increased, Lymphadenopathy, Muscle spasms, Neck pain
Clinical narrative: Lymphadenopathy, (axillary), low grade temps, upsilateral upper back and neck px, Muscle spasm developed 5-6 days after injection- tx NSAIDS Do, aceta
Sex: U
Vaccine: DTAP
Symptoms: Exophthalmos, Hypersensitivity
Clinical narrative: Initial report was received on 13 August 2008 from another manufacturer.  The initial reporter to this manufacturer had been a health care professional.  An unidentified patient received an injection of DTaP (manufacturer and lot number not reported).  The patient developed an allergic reaction like "protosis" after receiving the injection.  The patient's recovery status was not reported.  No additional information was provided.
Age: 34.0
Sex: F
Vaccine: IPV, MNQ, YF
Symptoms: Incorrect dose administered
Clinical narrative: Aug 26, 2008 5pm Pediatric dose  Hep A was given instead of Adult dose Hep A.   )Patient had no problems after receiving dose or other vaccine give at same time.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Haematuria, Heart rate increased, Oxygen saturation decreased, Pneumonia
Clinical narrative: Temperature 99.4 degrees, pulse 128, resp. 48 in clinic 8/13/08.  Pt stated short of breath and felt like "throat was closing up" around 1800 on 8/12/08.  Pt. admitted to hospital 8/13/08.  SpO2 93% on RA.  9/15/2008 MR received for DOS 8/14-15/2008 with D/C DX:  Bilateral bibasilar pneumonia most likely causing dyspnea and hypoxia. Hematuria. Pt presented with shortness of breath, fatigue and feeling like his trhroat was closing up since the prior evening.  Found to be tachypneic, tachycardic and with O2 sat of 93%. Temp 99.4. Dry cough. Temp increased to 101 o/n.  Tx with abx, solumedrol and benadryl with some improvement noted.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Respiratory rate increased, Throat tightness
Clinical narrative: Temperature 99.4 degrees, pulse 128, resp. 48 in clinic 8/13/08.  Pt stated short of breath and felt like "throat was closing up" around 1800 on 8/12/08.  Pt. admitted to hospital 8/13/08.  SpO2 93% on RA.  9/15/2008 MR received for DOS 8/14-15/2008 with D/C DX:  Bilateral bibasilar pneumonia most likely causing dyspnea and hypoxia. Hematuria. Pt presented with shortness of breath, fatigue and feeling like his trhroat was closing up since the prior evening.  Found to be tachypneic, tachycardic and with O2 sat of 93%. Temp 99.4. Dry cough. Temp increased to 101 o/n.  Tx with abx, solumedrol and benadryl with some improvement noted.
Age: 29.0
Sex: M
Vaccine: FLUX
Symptoms: Acoustic stimulation tests, Hearing aid user
Clinical narrative: Missing date of 1997 vaccination.  Reported acute hearing loss 6 hours after vaccinated now (2008) requiring hearing aide.  Symptoms: Hearing loss.  10/14/08 Reviewed medical records of 8/26/08. FINAL DX: sensorineural hearing loss left ear  Records reveal patient experienced complete hearing loss of left ear 6 hrs s/p 1997 influenza vaccine.
Age: 32.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Burning sensation, Headache, Hypoaesthesia, Muscle spasms, Paraesthesia
Clinical narrative: Symptoms-burning sensation, acute muscle spasms, numbness of hands, paresthesias, headache, severe localized back pain.  Treatment-IV SOLUMEDROL, cyclobenzaprine, DILAUDID, DECADRON, ibuprofen.  8/29/08 Reviewed PCP medical records & vax records of 8/7/08. FINAL DX: allergic reaction to menactra, acute muscle spasm & back pain. Records reveal patient experienced back pain w/redness, burning all over, spasms of back, tingling of arms, radiating all over.  Symptoms began 5 min after received vaccine in left deltoid.  Exam revealed tender paraspinous muscles, flushed skin, diaphoresis.  O2 sats WNL.  Tx w/epi, steroids, pain med & IVF.  Sent to ER for eval.  9/5/08 Reviewed hospital medical records of 8/7-8/8/2008. FINAL DX: allergic reaction to vaccine Records reveal patient experienced severe low back pain almost immediately after vaccination w/paresthesias, muscle spasm & swelling of injection site.  Also had migraine headaches x 4-5 days.  Seen in PCP office & received steroids & antiinflammatory meds. Neuro consult done & dx w/muscle spasm reaction to injection w/no further neuro deficits.  Tx w/IV steroids x 3 doses.  D/C to home.
Age: 32.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Back pain, Burning sensation, Headache, Hypoaesthesia, Muscle spasms
Clinical narrative: Symptoms-burning sensation, acute muscle spasms, numbness of hands, paresthesias, headache, severe localized back pain.  Treatment-IV SOLUMEDROL, cyclobenzaprine, DILAUDID, DECADRON, ibuprofen.  8/29/08 Reviewed PCP medical records & vax records of 8/7/08. FINAL DX: allergic reaction to menactra, acute muscle spasm & back pain. Records reveal patient experienced back pain w/redness, burning all over, spasms of back, tingling of arms, radiating all over.  Symptoms began 5 min after received vaccine in left deltoid.  Exam revealed tender paraspinous muscles, flushed skin, diaphoresis.  O2 sats WNL.  Tx w/epi, steroids, pain med & IVF.  Sent to ER for eval.  9/5/08 Reviewed hospital medical records of 8/7-8/8/2008. FINAL DX: allergic reaction to vaccine Records reveal patient experienced severe low back pain almost immediately after vaccination w/paresthesias, muscle spasm & swelling of injection site.  Also had migraine headaches x 4-5 days.  Seen in PCP office & received steroids & antiinflammatory meds. Neuro consult done & dx w/muscle spasm reaction to injection w/no further neuro deficits.  Tx w/IV steroids x 3 doses.  D/C to home.
Age: 32.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Myelitis transverse, Paraesthesia
Clinical narrative: Symptoms-burning sensation, acute muscle spasms, numbness of hands, paresthesias, headache, severe localized back pain.  Treatment-IV SOLUMEDROL, cyclobenzaprine, DILAUDID, DECADRON, ibuprofen.  8/29/08 Reviewed PCP medical records & vax records of 8/7/08. FINAL DX: allergic reaction to menactra, acute muscle spasm & back pain. Records reveal patient experienced back pain w/redness, burning all over, spasms of back, tingling of arms, radiating all over.  Symptoms began 5 min after received vaccine in left deltoid.  Exam revealed tender paraspinous muscles, flushed skin, diaphoresis.  O2 sats WNL.  Tx w/epi, steroids, pain med & IVF.  Sent to ER for eval.  9/5/08 Reviewed hospital medical records of 8/7-8/8/2008. FINAL DX: allergic reaction to vaccine Records reveal patient experienced severe low back pain almost immediately after vaccination w/paresthesias, muscle spasm & swelling of injection site.  Also had migraine headaches x 4-5 days.  Seen in PCP office & received steroids & antiinflammatory meds. Neuro consult done & dx w/muscle spasm reaction to injection w/no further neuro deficits.  Tx w/IV steroids x 3 doses.  D/C to home.
Age: 0.5
Sex: M
Vaccine: HIBV, PNC, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Patient given Tdap instead of DTaP #3. No treatment per CDC.
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Pt complains that 31/2 wks after receiving 3rd GARDASIL injection - came down with shingles. (Pt just wanted to notify us with information
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4
Symptoms: Abasia, Arthralgia
Clinical narrative: GARDASIL vaccine and within a 2 week time frame from receiving each dose of the vaccine "patient" suffered extreme hi pain. The pain was so severe she couldn't walk. Still has hip pain - constant but not as severe. Follow-up Information 30-SEP-2008: I cannot give exact date or time. Events started within a week or 2 weeks after all 3 Gardasil shots.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, HPV4
Symptoms: Abasia, Arthralgia, Nuclear magnetic resonance imaging normal, Vaccine positive rechallenge
Clinical narrative: GARDASIL vaccine and within a 2 week time frame from receiving each dose of the vaccine "patient" suffered extreme hi pain. The pain was so severe she couldn't walk. Still has hip pain - constant but not as severe. Follow-up Information 30-SEP-2008: I cannot give exact date or time. Events started within a week or 2 weeks after all 3 Gardasil shots.
Age: 15.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed hives about 5 hours after vaccines administered.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Full blood count, Hot flush, Hyperhidrosis, Thyroid function test
Clinical narrative: 2 days to 1 week after receiving HPV, started with "hot flashes," face gets red and has increased perspiration. This happened with all three doses of HPV vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vaccine positive rechallenge, Vanillyl mandelic acid urine
Clinical narrative: 2 days to 1 week after receiving HPV, started with "hot flashes," face gets red and has increased perspiration. This happened with all three doses of HPV vaccine.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood pressure, Dizziness, Malaise
Clinical narrative: Patient was given 3 vaccines she described feeling sick after Tdap and MENACTRA had been given and then dizzy after GARDASIL was given BP was 70/50 at that time
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Blood culture, Chest X-ray, Full blood count, Irritability, Laboratory test
Clinical narrative: Irritability x 5 days since vaccines administered. Ordered CXR and Bld cx, CBC, Chem 7
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Fatigue, Headache, Pyrexia
Clinical narrative: fatigue, headache, weakness & fever onset 1 week after vaccine
Age: 5.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: erythema, heat, swelling in shoulder and joint above site of deltoid injection
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: 1O:35AM CHILD GIVEN VACCINES; IPOL,HEPA,DTAP. 10:40AM COUGH AND SOB,10:45 GIVEN CLARITEN 10mg, SX PROGRESSED TO WHEEZING 10:50 NEB TREATMENT WITH XOPONEX 0.63AND PULMICORT 0.5mg. IMPROVED WITH TREATMENT. OBSERVED UNTIL 11:30 WHEN CLEARED TO LEAVE FOR HOME WITH RX P=ORAPRED 30mg DAILY FOR THREE DAYS AND NEB TREATMENTS PRN.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Received three immunizations in the arms on 8/18/08 on Wed. the 20th he developed a high fever of 103f and severe pain all the way down both legs starting at the waist and down both legs. Legs were very painful to touch. By Thurs. the 21st the fever and leg pains were gone and just had mild soreness at injection sites on arms.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: PT RECEIVED TDAP, MMR, VARM AND IPV ON 8-18-08 NOTED REDNESS, PAINFUL, WARM TO TOUCH AND EDEMA TO RIGHT ARM; LOCATION OF TDAP. PT WAS TAKEN TO URGRET CARE ON 8-19-08.  PT WAS REASSESSED IN OFFICE ON 8-20-08 AND TREATMENT ORDERED.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Cellulitis, Chest X-ray normal, Cough, Dyspnoea
Clinical narrative: ON 8-14-08 PT RECEIVED VAR, TDAP AND MCV4. ON 8-15-08 AT 430 PT AWOKE WITH C/O NAUSEA, RT ARM PAIN, LIMITED ROM, FEVER, WEAKENSS, COUGHING, HEART POUNDING, SOB, PT WAS TAKEN TO CMC-LINCOLN ER.  WHILE IN THE ER PT DX. WITH TDAP INJECTION REACTION. ON 8-16-08 PT REMAINS WITH WEAKNESS, FEVER RESOLVED, IN AFTERNOON MOTHER NOTED FEVER,NECK PAIN, SEVERE REDNESS AND EDEMA FROM INJECTION SITE TO ELBOW.  ALSO NOTED AREA TO BE WARM TO TOUCH, PAINFUL AT TDAP INJECTION SITE.  MOTHER CALLED MD ON CALL AND INFORMED TO TAKE PT TO ER. ON 8-16-08 PT RETURNED AGIAN TO CMC-LINCOLN ER - PT DX WITH CELLULITIS RT. ARM DUE TO TDAP INJECTION.  PT RETURNED TO OFFICE ON 8-18-08 AND S/S HAD IMPROVED.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Full blood count normal, Injected limb mobility decreased, Injection site cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: ON 8-14-08 PT RECEIVED VAR, TDAP AND MCV4. ON 8-15-08 AT 430 PT AWOKE WITH C/O NAUSEA, RT ARM PAIN, LIMITED ROM, FEVER, WEAKENSS, COUGHING, HEART POUNDING, SOB, PT WAS TAKEN TO CMC-LINCOLN ER.  WHILE IN THE ER PT DX. WITH TDAP INJECTION REACTION. ON 8-16-08 PT REMAINS WITH WEAKNESS, FEVER RESOLVED, IN AFTERNOON MOTHER NOTED FEVER,NECK PAIN, SEVERE REDNESS AND EDEMA FROM INJECTION SITE TO ELBOW.  ALSO NOTED AREA TO BE WARM TO TOUCH, PAINFUL AT TDAP INJECTION SITE.  MOTHER CALLED MD ON CALL AND INFORMED TO TAKE PT TO ER. ON 8-16-08 PT RETURNED AGIAN TO CMC-LINCOLN ER - PT DX WITH CELLULITIS RT. ARM DUE TO TDAP INJECTION.  PT RETURNED TO OFFICE ON 8-18-08 AND S/S HAD IMPROVED.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Injection site warmth, Nausea, Neck pain, Pain in extremity
Clinical narrative: ON 8-14-08 PT RECEIVED VAR, TDAP AND MCV4. ON 8-15-08 AT 430 PT AWOKE WITH C/O NAUSEA, RT ARM PAIN, LIMITED ROM, FEVER, WEAKENSS, COUGHING, HEART POUNDING, SOB, PT WAS TAKEN TO CMC-LINCOLN ER.  WHILE IN THE ER PT DX. WITH TDAP INJECTION REACTION. ON 8-16-08 PT REMAINS WITH WEAKNESS, FEVER RESOLVED, IN AFTERNOON MOTHER NOTED FEVER,NECK PAIN, SEVERE REDNESS AND EDEMA FROM INJECTION SITE TO ELBOW.  ALSO NOTED AREA TO BE WARM TO TOUCH, PAINFUL AT TDAP INJECTION SITE.  MOTHER CALLED MD ON CALL AND INFORMED TO TAKE PT TO ER. ON 8-16-08 PT RETURNED AGIAN TO CMC-LINCOLN ER - PT DX WITH CELLULITIS RT. ARM DUE TO TDAP INJECTION.  PT RETURNED TO OFFICE ON 8-18-08 AND S/S HAD IMPROVED.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Palpitations, Pyrexia, Urine analysis normal, Vaccination complication
Clinical narrative: ON 8-14-08 PT RECEIVED VAR, TDAP AND MCV4. ON 8-15-08 AT 430 PT AWOKE WITH C/O NAUSEA, RT ARM PAIN, LIMITED ROM, FEVER, WEAKENSS, COUGHING, HEART POUNDING, SOB, PT WAS TAKEN TO CMC-LINCOLN ER.  WHILE IN THE ER PT DX. WITH TDAP INJECTION REACTION. ON 8-16-08 PT REMAINS WITH WEAKNESS, FEVER RESOLVED, IN AFTERNOON MOTHER NOTED FEVER,NECK PAIN, SEVERE REDNESS AND EDEMA FROM INJECTION SITE TO ELBOW.  ALSO NOTED AREA TO BE WARM TO TOUCH, PAINFUL AT TDAP INJECTION SITE.  MOTHER CALLED MD ON CALL AND INFORMED TO TAKE PT TO ER. ON 8-16-08 PT RETURNED AGIAN TO CMC-LINCOLN ER - PT DX WITH CELLULITIS RT. ARM DUE TO TDAP INJECTION.  PT RETURNED TO OFFICE ON 8-18-08 AND S/S HAD IMPROVED.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Accidental overdose, Inappropriate schedule of drug administration
Clinical narrative: Client presented at immunization clinic at 0928am for a meningococcal vaccine required for college. Client stated that she had never received the vaccine previously. Client was given the Menactra vaccine at 0945am. After administration and while entering vaccine information into the county record system (M&M) and the NCIR it was noted that the client had received the Menactra vaccine previously on 06/27/2007. Client and parent was immediately informed of error and CDC was notified -call reference # 1-62191992 at 0954am. Client left clinic having no symtpoms of adverse reaction and phone number was taken to follow up with client with CDC recommendations. CDC recommendations were relayed to client at 1009am via telephone call. Client was informed to contact PMD or EMS for adverse reactions and then to please report to VAERS and to health center. Client verbalized understanding.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme Minor occuring 8 days after administration of MMR and Chicken Pox vaccines at 12 month well child visit.  No other triggers could be identified (patient had no medication, infections, illnesses, or foods that could have caused reaction).  Required doctor's office visit.  Erythema Multiforme minor has not yet resolved in patient, but continuing treatment with Zyrtec in hopes that it will resolve soon.
Age: 75.0
Sex: U
Vaccine: PNC
Symptoms: Blood cholesterol increased, Death, Myocardial infarction
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, died on 7/10/2008 in home due to myocardial infarction and high cholesterol. Vaccination took place on 4/9/07. According to the physician, the relationship to treatment is 'None". We would be happy to forward the Study's SAE Report Form upon request.
Age: 66.0
Sex: F
Vaccine: IPV, MNQ
Symptoms: Incorrect dose administered
Clinical narrative: Aug 26,2008 Pediatric dose of Hep A was given instead  of Adult dose Hep A. Patient had no problems after receiving dose or other vaccines given at same time.  No treatment
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Mass, Pain, Skin warm
Clinical narrative: Entire deltoid red and feverish.  Hard knot under the skin about 2 1/2 inches in diameter.  Very painful. Not relieved with tylenol or ibuprofen.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Diarrhoea, Fatigue, Fibromyalgia, Influenza like illness
Clinical narrative: Started as flu like symptoms (diarrhea, original weight loss of 11 pounds, achy/sore muscles and joints, exhaustion.  The diarrhea eventually went away and she regained the lost weight; however, the achy/sore muscles/joints, chronic pain and exhaustion have never gone away. Patient was eventually diagnosed with fibromyalgia, although we have no family history of fibromyalgia, nor had she ever had any related symptoms prior to the Gardasil vaccination. 8/29/08-records received for DOS 4/9/08-initial clinic visit, Fibromyalgia by history.  Travel out of country August 2007 and developed GI upset and nausea. Developed diffuse joint pain. Presently on Lyrica. Office visit 5/13/08-for follow-up. Assessment chronic insomnia improved. New diagnosis by psychologist dysthymia and may have ADD as well. Office visit 7/30/08-C/O decline in mood state and diffuse body pain over past 2 weeks. Irritable not sleeping well. 1/26/2010 Her health condition has not improved since the report I filed without your agency, infact it has continued to deteriorate. After seeing numerous doctors/specialist, she was finally diagnosed with fibromyalgia. Sine that diagnosis in December 2007, she has consistently been on numberous medications in an attempt to manage her symptoms, which include chronic pain, fatigue, leg and body cramps, achy muscles, joint pain, and reoccuring diarrhea. Regardless of the medications she ahs seen very little improvemtn and continues to live her life in pain. In addition to the medication, she has attended physical therapy and regulary sees a therapist regarding depression and dealing with chronic pain.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Laboratory test, Myalgia, Weight decreased
Clinical narrative: Started as flu like symptoms (diarrhea, original weight loss of 11 pounds, achy/sore muscles and joints, exhaustion.  The diarrhea eventually went away and she regained the lost weight; however, the achy/sore muscles/joints, chronic pain and exhaustion have never gone away. Patient was eventually diagnosed with fibromyalgia, although we have no family history of fibromyalgia, nor had she ever had any related symptoms prior to the Gardasil vaccination. 8/29/08-records received for DOS 4/9/08-initial clinic visit, Fibromyalgia by history.  Travel out of country August 2007 and developed GI upset and nausea. Developed diffuse joint pain. Presently on Lyrica. Office visit 5/13/08-for follow-up. Assessment chronic insomnia improved. New diagnosis by psychologist dysthymia and may have ADD as well. Office visit 7/30/08-C/O decline in mood state and diffuse body pain over past 2 weeks. Irritable not sleeping well. 1/26/2010 Her health condition has not improved since the report I filed without your agency, infact it has continued to deteriorate. After seeing numerous doctors/specialist, she was finally diagnosed with fibromyalgia. Sine that diagnosis in December 2007, she has consistently been on numberous medications in an attempt to manage her symptoms, which include chronic pain, fatigue, leg and body cramps, achy muscles, joint pain, and reoccuring diarrhea. Regardless of the medications she ahs seen very little improvemtn and continues to live her life in pain. In addition to the medication, she has attended physical therapy and regulary sees a therapist regarding depression and dealing with chronic pain.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: GARDASIL, MANACTRA, TDAP GIVEN. PATIENT C/O GETTING DIZZY AND THEN FAINTED.  USED AMMONIA INHALENT AND SHE RECOVERED WITHIN 1-2 MINUTES
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: redness and swelling at site of administration
Age: 22.0
Sex: F
Vaccine: DPP
Symptoms: Lymphadenopathy, Vaccination complication
Clinical narrative: Recieved vaccination on 8/13/08.  Presented on 8/18/08 with concern about palpable lymph node on left side of neck.  Sent to HEENT who felt it was related to the vacccine and treated with antibiotic and steriod.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dysarthria, Hypoaesthesia, Paraesthesia
Clinical narrative: 1st inj on 6/17/2008;2nd inj 8/19/2008; on 8/26/2008 pt presented to office with dizzines, tingling in hands to numbness and then slurred speech that happened while at school; when she presented to the office within 1 hour of onset, she had completely recovered from s/s; due to these s/s family defers further vaccination8/28/08-records received for DOS 8/26/08-Chief complaint-dizzy spells/tingling in hands and not able to speak well. C/O dizziness while getting up from sitting position. Neurologic exam, no focal deficit, normal cranial nerves-II-XII sensory and motor WNL. DTR 2 plus, gait normal, no cerebellar signs, no focal signs, normal strength, tone and reflexes, sensory test normal. Assessment: Near-syncope. Suspect orthostatic hypotonia trigger with possible hyperventilation as secondary. Follow-up as needed.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Hypoaesthesia, Pyrexia
Clinical narrative: fever numbness
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Asthenia, Chills, Dizziness, Hyperhidrosis, Hypoaesthesia facial
Clinical narrative: Within hours after tetanus booster vaccine, all-over muscle pain/body aches, chills, sweating that lasted 3 days, weakness, blurred vision and numbness across face on day 4,  weakness and lightheadedness on day 5, then s/s resolved.
Age: 45.0
Sex: F
Vaccine: TD
Symptoms: Myalgia, Pain, Vision blurred
Clinical narrative: Within hours after tetanus booster vaccine, all-over muscle pain/body aches, chills, sweating that lasted 3 days, weakness, blurred vision and numbness across face on day 4,  weakness and lightheadedness on day 5, then s/s resolved.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Local reaction
Clinical narrative: RED LOCAL REACTION CENTERED AROUND INJECTION SITE
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Local reaction
Clinical narrative: LOCAL REACATION TO ADACEL  6CM X 6 CM
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Body temperature increased, Decreased appetite, Dysphonia, Fatigue
Clinical narrative: 101-102 temperature, extremely tired, hoarse, pale, weak and lack of appetite
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Pallor
Clinical narrative: 101-102 temperature, extremely tired, hoarse, pale, weak and lack of appetite
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Blood culture, Blood thyroid stimulating hormone, C-reactive protein, Epstein-Barr virus antibody, Full blood count
Clinical narrative: HIVE LIKE RASH FEVER ELEVATED LFT
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Laboratory test, Liver function test abnormal, Pyrexia, Rash, Red blood cell sedimentation rate
Clinical narrative: HIVE LIKE RASH FEVER ELEVATED LFT
Age: 11.0
Sex: M
Vaccine: HEPA, TDAP
Symptoms: Urticaria
Clinical narrative: HIVE LIKE RASH FEVER ELEVATED LFT
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Fall, Head injury, Joint injury, Nausea, Neck pain
Clinical narrative: 11 year old male patient was administered 3 immunizations as stated below. His 2 sisters and mother were in the room with him. After his shots were done, the youngest sister (8 y.o) fainted. She had not had any shots. Shortly after his sister fainted the patient said he felt somewhat queasy. We kept him under observation for the next 15-20 minutes, he said he was feeling better. We moved the family into another waiting room and told them to remain seated for another 15-20 minutes. About 10 minutes later the mother called out as the patient fainted. He was seated at the time so his chair ended up tipping to the left and he fell to the ground. He aroused quickly, pulse and respirations were WNL and regular. He was alert and oriented x3 once aroused. He stated that the side of his left temple and his knees hurt and his neck was a little sore from when he fell. It appeared that he may have had small "rug burns" on the side of his left temple and on both knees. We had him stay with us in the office for another 30 minutes under our observation. He ate a granola bar and after a while stated he felt better. We discussed the signs/symptoms of concussion with mother, advised her to follow-up with MD if he exihibits s/s or any other unusual behavior. Escorted family to car w/out incident.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Syncope
Clinical narrative: 11 year old male patient was administered 3 immunizations as stated below. His 2 sisters and mother were in the room with him. After his shots were done, the youngest sister (8 y.o) fainted. She had not had any shots. Shortly after his sister fainted the patient said he felt somewhat queasy. We kept him under observation for the next 15-20 minutes, he said he was feeling better. We moved the family into another waiting room and told them to remain seated for another 15-20 minutes. About 10 minutes later the mother called out as the patient fainted. He was seated at the time so his chair ended up tipping to the left and he fell to the ground. He aroused quickly, pulse and respirations were WNL and regular. He was alert and oriented x3 once aroused. He stated that the side of his left temple and his knees hurt and his neck was a little sore from when he fell. It appeared that he may have had small "rug burns" on the side of his left temple and on both knees. We had him stay with us in the office for another 30 minutes under our observation. He ate a granola bar and after a while stated he felt better. We discussed the signs/symptoms of concussion with mother, advised her to follow-up with MD if he exihibits s/s or any other unusual behavior. Escorted family to car w/out incident.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: PATIENT DIED 10/27/08-autopsy report received-COD undetermined. No injuries or natural causes identified. Toxicology, histology, culture, electrolyte, renal and metabolic screens non-contributory. History of co-sleeping with adult. Evidence of resuscitation attempt. krk
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Varicella
Clinical narrative: On August 25, 2008 patient began having vesicles wich began to spread over the entire body over the next few days. Symptoms are condsistent with the Chickenpox. Supportive treatment was reccomended.
Sex: M
Vaccine: HEP
Symptoms: Cyanosis, Heart rate decreased, Hypotonia, Oral intake reduced, Pallor
Clinical narrative: 8/22/2008: 17:17 Mother brought baby to Urgent Care with complaints of baby not feeding for 5 hours, baby pale and limp. During triage it was noted that baby was limp, dusky blue and non-responsive.  o 1720PM: Oxygen applied - Heart rate 87  o 1721PM: 911 was called o 1723PM: Heart rate deteriorated and CPR was initiated o 1728PM: 911 transport arrived   o 1736PM: Baby transferred to gurney and CPR continued during transfer o 1737PM: Paramedics en route to hospital 12/1/08-autopsy report received-COD Sudden infant death associated with acute gastrointestinal illness of unknown etiology. History of vomiting x 2 days unable to keep feeds down. Abdundant loose stoll within small bowel.
Sex: M
Vaccine: HEP
Symptoms: Resuscitation, Unresponsive to stimuli
Clinical narrative: 8/22/2008: 17:17 Mother brought baby to Urgent Care with complaints of baby not feeding for 5 hours, baby pale and limp. During triage it was noted that baby was limp, dusky blue and non-responsive.  o 1720PM: Oxygen applied - Heart rate 87  o 1721PM: 911 was called o 1723PM: Heart rate deteriorated and CPR was initiated o 1728PM: 911 transport arrived   o 1736PM: Baby transferred to gurney and CPR continued during transfer o 1737PM: Paramedics en route to hospital 12/1/08-autopsy report received-COD Sudden infant death associated with acute gastrointestinal illness of unknown etiology. History of vomiting x 2 days unable to keep feeds down. Abdundant loose stoll within small bowel.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Arthralgia, Joint stiffness, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea, vomiting, fever(100 degrees), muscle & joint aches, stiff joints
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, fever(100 degrees), muscle & joint aches, stiff joints
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash
Clinical narrative: 8/19/2008 - Patient was given the Small Pox Vaccine. 8/25/2008 - Patient comes in for injection site check and site where bandage was placed is red and inflammed.  8/28/2008 - Patient returns to clinic with multiple lesions covering the inflammed area.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema abnormal, Intussusception, Laparoscopy, Lymphadenitis, Ultrasound abdomen abnormal
Clinical narrative: Onset 8/24/08 vomiting 9 PM. Seen at hospital where intussusception dx'ed by abd ultrasound, failed enema reduction. Transferred to another hospital where laparoscopy was done - enlarged mesenteric node was resected. 9/10/08-hospital records received for DOS 8/25-8/27/08-DC DX: Intussusception status post reduction. Dissection of large mesenteric lymph node. Laparoscopic resection of enlarged lymph node. At initial hospital, saline enema failed to reduce intussusception. Vomiting began on evening prior to admission, some blood in stools.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Onset 8/24/08 vomiting 9 PM. Seen at hospital where intussusception dx'ed by abd ultrasound, failed enema reduction. Transferred to another hospital where laparoscopy was done - enlarged mesenteric node was resected. 9/10/08-hospital records received for DOS 8/25-8/27/08-DC DX: Intussusception status post reduction. Dissection of large mesenteric lymph node. Laparoscopic resection of enlarged lymph node. At initial hospital, saline enema failed to reduce intussusception. Vomiting began on evening prior to admission, some blood in stools.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Difficulty breathing - 1800 8/8/08; Dizziness - 1800 8/8/08; Went to ER, given Benadryl IM and observed approx 3 hours.
Age: 23.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Diarrhoea, Dizziness, Nausea
Clinical narrative: Patient called & stated that she begin having symptoms of diarrhea, nausea & dizziness 1 1/2 hours after her injection. No redness or swelling at injection site.
Age: 65.0
Sex: F
Vaccine: FLUX, HEPAB, TDAP
Symptoms: Rash
Clinical narrative: Since March there has been a rash on my back within 3 days of having the injection-Has persisted ever since.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Facial palsy
Clinical narrative: Left BELL'S PALSY-Patient has received a course of oral steroids, but the palsy has not resolved. May not be related to vaccine, but it was a new neurologic finding after vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Mom called and reported child had "welts" elongated on buttocks and abdomen when she woke up the day after receiving vaccines. Slightly red and warm to touch. Told her to see PMD. Saw doctor that day and was given BENADRYL and CLARITIN. Mom reported the welts spread to legs and shoulders the evening of 8-6-08 and resolved 8-7-08. Mom did not check child's temp.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: (1) Hepatitis A #2 given early; 1st dose 7/28/08 - 2nd dose given 8/26/08; (2) GARDASIL #3 given too early; #1 given 6/24/07, #2 given 7/28/08, #3 given 8/27/08
Age: 0.5
Sex: F
Vaccine: HIBV, PNC
Symptoms: Crying, Diarrhoea, Irritability, Mood altered, Pyrexia
Clinical narrative: Mother reports child crying and screaming. Started about 4 hours after shots, had fever of 102. Says child vomited X 1, had diarrhea X 2 this AM. Says child has fever 103, now cries and creams when touched. Mother requested to received 1 shot on 08-21-08. Reported infant now moody, was fussy and cried a lot for 2 hours post first set, came back on 8-26-08 requested Hib & PREVNAR both be given; no problem with vaccine given 8-21/08.
Age: 0.5
Sex: F
Vaccine: HIBV, PNC
Symptoms: Screaming, Vomiting
Clinical narrative: Mother reports child crying and screaming. Started about 4 hours after shots, had fever of 102. Says child vomited X 1, had diarrhea X 2 this AM. Says child has fever 103, now cries and creams when touched. Mother requested to received 1 shot on 08-21-08. Reported infant now moody, was fussy and cried a lot for 2 hours post first set, came back on 8-26-08 requested Hib & PREVNAR both be given; no problem with vaccine given 8-21/08.
Age: 1.2
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Injection site erythema, Irritability, Pyrexia
Clinical narrative: Fever - redness at injection, irritable
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Arthralgia, Balanitis, Dysuria, Oedema peripheral, Pain
Clinical narrative: Parents report that Pt began with some symptoms the afternoon after he was vaccinated. He developed some spots that looked like "bug bites" similar to petechiae on his left leg and then his right leg was affected by the end of the evening. He ran a fever of 102.5 and Dad medicated him with Tylenol and his fever responded well. Friday both legs were affected with the dots and some swelling was apparent in both limbs. No fever was present. Saturday he had some continued swelling in both limbs and complained of pain when ambulating-his knees hurt. Monday the previous symptoms were still present. Spots were more like ecchymosis about the size of a dime on his body-trunk not affected, only arms and legs - no fever reported. Tuesday evening he complained to his mother that he had trouble urinating - upon examination she found his penis to be completely swollen, the scrotal area was not affected. Wednesday AM the parents decided to consult with their health care provider. She advised them to visit our public health clinic so we would be aware of Pt's condition and initiate a VAERS report then return to her for follow up care. Our office advised them to seek medical care ASAP and request lab work to determine what was affecting Pt. We discussed the possibility of some underlying condition that would possibly have been triggered by the vaccines. We told them we would be filing a report and would contact them to follow up on his condition. Labs were done, platelet ct <500. White ct WNL. 8/27/08 - Child was referred to pediatric specialist (hematology) at hospital per NP. To be seen there week of Aug 25-29 for consultation. Will report back to local practice regarding this pt. Child is much improved per mother's observation.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Platelet count, Pyrexia, Rash, White blood cell count normal
Clinical narrative: Parents report that Pt began with some symptoms the afternoon after he was vaccinated. He developed some spots that looked like "bug bites" similar to petechiae on his left leg and then his right leg was affected by the end of the evening. He ran a fever of 102.5 and Dad medicated him with Tylenol and his fever responded well. Friday both legs were affected with the dots and some swelling was apparent in both limbs. No fever was present. Saturday he had some continued swelling in both limbs and complained of pain when ambulating-his knees hurt. Monday the previous symptoms were still present. Spots were more like ecchymosis about the size of a dime on his body-trunk not affected, only arms and legs - no fever reported. Tuesday evening he complained to his mother that he had trouble urinating - upon examination she found his penis to be completely swollen, the scrotal area was not affected. Wednesday AM the parents decided to consult with their health care provider. She advised them to visit our public health clinic so we would be aware of Pt's condition and initiate a VAERS report then return to her for follow up care. Our office advised them to seek medical care ASAP and request lab work to determine what was affecting Pt. We discussed the possibility of some underlying condition that would possibly have been triggered by the vaccines. We told them we would be filing a report and would contact them to follow up on his condition. Labs were done, platelet ct <500. White ct WNL. 8/27/08 - Child was referred to pediatric specialist (hematology) at hospital per NP. To be seen there week of Aug 25-29 for consultation. Will report back to local practice regarding this pt. Child is much improved per mother's observation.
Age: 35.0
Sex: M
Vaccine: ANTH, HEP, TYP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site nodule, Injection site swelling, Muscular weakness
Clinical narrative: experiencing a feeling that his arm is asleep since the administration of AVA # 1 on 9 Jul 08. Stated he received AVA # 2 on 28 Jul again in his right arm. Stated numbness radiates down to his hand and at times he has problems with weakness in his arm. Denies any previous or current injuries and other than slight discomfort in his right elbow he denies any other problems. He did report that his right upper arm was swollen and red with a knot after his vaccination but the swelling did not extend below the elbow. Reported that the swelling only lasted a couple of days; Symptoms: Paresthesia, Weakness, Edema at injection site 30-50mm, Erythema.
Age: 39.0
Sex: F
Vaccine: IPV, MMR, VARCEL
Symptoms: Induration, Mass, Pain in extremity, Rash, Red blood cell abnormality
Clinical narrative: The patient developed a hard, red, painful lump on upper right arm and a rash. Patient given 3 shots on same day, 2 in right deltoid, 1 in left deltoid. Patient does not know which vaccines went into her right arm and no notation was made on her immunization record. This form mailed to health department after being faxed to VAERS.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 1 1/2" X 2" area of redness, swelling, warmth, and tenderness at posterior upper left arm. Mom noticed redness and swelling after lunch on 8/26. No action taken at the time. (Instructed to apply ice)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Swelling, Tenderness
Clinical narrative: MMR 0.5cc administered to right arm, Immediate swelling and redness. Tender to palpate. Advised warm compresses to area. Tylenol every 6 hours and Benadryl every 6 hours.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Anxiety, Burning sensation, Dyspnoea, Rash, Stress
Clinical narrative: She felt a burning rash across her chest. Patient started feeling short of breath, feeling very anxious and stressed; a few minutes after receiving the injection. Was advised to take BENADRYL by doctor and to return to clinic if symptoms didn't get better.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, X-ray abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 20-FEB-2008, a 4 month old male with no relevant medical history was vaccinated with his second dose of ROTATEQ (lot number 1394U) by mouth. Concomitant vaccine included HIB conj vaccine (unspecified carrier) (lot number UF238AA, vaccinated IM into the right leg), diphtheria toxoid (+) pertussis while cell vaccine (+) tetanus toxoid (lot number C2933AB, vaccinated IM into the right leg), pneumococcal conj vaccine (unspecified) (lot number C45153, vaccinated IM into the left leg) and poliovirus vaccine inactivated (unspecified) (lot number A0474, vaccinated IM into the left leg). On 31-MAR-2008, the patient experienced abdominal pain, enema administration, gastrointestinal oedema, hematochezia, intussusception and vomiting. Hospital medical records were from 31-MAR-2008 to 01-APR-2008. Records reveal that the patient experienced vomiting, bloody stools one day and overnight apparent abdominal pain upon feeding. The patient was diagnosed by X-ray; abdominal US (+) for IS. was reduced. The repeat US for IS was negative, which revealed mild bowel edema. Subsequently, the symptom were improved and the patient was discharged to home. The listing indicated that one or more of the events required hospitalization, was considered to be immediately life-threatening. No further information is available. A lot check has been requested. The original reporting source was not provided. The VAERS ID # is 309597. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released.