chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Injected limb mobility decreased, Musculoskeletal stiffness, Oedema peripheral
Clinical narrative: Severe stiffness in entire arm starting about an hour after vaccine. Swollen nearly all around entire arm and up into the shoulder. Red, hot, and itchy.  Hive like area on the edge. Cold packs for 7 hours. During the night woke with chills. Swelling decreasing as today progresses and mobility increasing.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Skin warm, Urticaria
Clinical narrative: Severe stiffness in entire arm starting about an hour after vaccine. Swollen nearly all around entire arm and up into the shoulder. Red, hot, and itchy.  Hive like area on the edge. Cold packs for 7 hours. During the night woke with chills. Swelling decreasing as today progresses and mobility increasing.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Activated partial thromboplastin time normal, Back pain, Blood amylase normal, Blood creatine phosphokinase
Clinical narrative: About 15 minutes after vaccine administration patient experienced chest tightness and midback and epigastric pain.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray normal, Chest discomfort, Electrocardiogram normal, Fibrin D dimer normal, Full blood count normal
Clinical narrative: About 15 minutes after vaccine administration patient experienced chest tightness and midback and epigastric pain.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Laboratory test normal, Lipase normal, Liver function test normal, Pregnancy test negative, Prothrombin level normal
Clinical narrative: About 15 minutes after vaccine administration patient experienced chest tightness and midback and epigastric pain.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Troponin, Urine analysis normal
Clinical narrative: About 15 minutes after vaccine administration patient experienced chest tightness and midback and epigastric pain.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Large local reaction around injection site with 8x8 cm area of erythema, swelling and TTP 1 week after administration.  Area swelling and redness did not extend beyond shoulder or elbow.  Pt was restricted from some duties becuase of arm pain.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Pain in extremity
Clinical narrative: Large local reaction around injection site with 8x8 cm area of erythema, swelling and TTP 1 week after administration.  Area swelling and redness did not extend beyond shoulder or elbow.  Pt was restricted from some duties becuase of arm pain.
Age: 13.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Injection site pain, Pain in extremity, Syncope, Vaccine positive rechallenge
Clinical narrative: Patient received Pneumovax on the right arm without incident.   She was then given the HPV vaccine on the left arm.  This time she had pain and proceeded to faint.  This was her third HPV vaccine.  Apparently, she fainted with the first HPV vaccine.  The second was given while she was lying down and only experienced pain at the site of injection.
Age: 26.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Arthralgia, Cytomegalovirus test, Full blood count normal, Liver function test normal, Mononucleosis heterophile test negative
Clinical narrative: Received MMR 2/20/08 developed rash, arthralgias, 2/28/08. Lab on 3/5/08 showed mildly low platelets.
Age: 26.0
Sex: F
Vaccine: HEP, HEPA, MMR
Symptoms: Platelet count decreased, Rash, Streptococcal identification test negative, Urine analysis normal
Clinical narrative: Received MMR 2/20/08 developed rash, arthralgias, 2/28/08. Lab on 3/5/08 showed mildly low platelets.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Syncope and collapse day after. Flu symptoms.
Age: 43.0
Sex: F
Vaccine: MMR, TD
Symptoms: Eyelid oedema, Rash pruritic, Sinus operation, Throat tightness, Urticaria
Clinical narrative: MMR given on 2/20/08. On 2/26/08, Pt reports that she starting experiencing sinus drainage, sore throat, swollen eyelids, and an itchy rash that spread all over her trunk, arms, and thighs starting evening of 2/25/08. She states that she took Benadryl 50mg PO for tightness in throat. Denies fever. She stated that her airway was "fine." Informed Pt that she needed to emergency treatment if problems with airway developed. Pt states that she will see her private physician. On 2/26/08 she provides documentation from her medical provider that states that she "has hives" and is "not contagious." The doctor prescribes Allegra 180mg/day and Prednisone 60mg x3 days, 40mg x3 days, then 20mg/day until gone.
Age: 0.19
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RV5
Symptoms: Convulsion, Nonspecific reaction
Clinical narrative: This case was reported by a healthcare professional and a sales representative and described the occurrence of seizure in a 2-month-old male subject who was vaccinated with Pediairx (GlaxoSmithKline). Concurrent vaccination included Hib (Pasteur); pneumococcal vaccine (unspecified manufacturer) and Rotateq (unspecified manufacturer) all given on 18 February 2008. There were no concurrent medications. On 18 February 2008 at 13:00 the subject received 1st dose of Pediarix at 0.5 ml in the right hip. On 20 February 2008, 2 days after vaccination with Pediarix, the subject experienced a seizure. The reporting sales representative stated that the subject experienced a pertussis reaction. The subject was hospitalised overnight. At the time of reporting seizure was resolved. No specific outcome was provided for the pertussis reaction. The healthcare professional considered the event seizure was probably related to vaccination with Pediarix.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Aspiration bone marrow, Blood product transfusion, Immunoglobulins, Petechiae, Platelet count decreased
Clinical narrative: developed petechiae (1/19) with platelet count down to 4,000 on admission (1/21) given IVIG, later received oral dexamethasone for  platelet count <20,000 but still being followed up as platelet count may still drop  3/14/08 Reviewed hospital medical records of 1/21-1/23/2008. FINAL DX:Idiopathic thrombocytopenic purpura, bilateral otitis media & RSV bronchiolitis. Records reveal patient experienced fever, nasal congestion, wheezing x 1 week.  Seen at urgent care & dx w/croup.  Tx but no improvement & then petechiae/bruising, poor appetite, continued fever.  Seen by PCP, dx w/otitis media & labs done which revealed plts 4000.  Tx w/IVIG, IV antibiotics
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Abnormal behaviour, Anger, Headache, Nasopharyngitis, Pyrexia
Clinical narrative: Gave me frequent headaches. My wife diagnosed me with a different attitude after the shots. I get mad most of the time with no apparent reason. I suddenly have frequent colds and fever from 100.4 to 101.5.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Axillary pain, Erythema, Oedema peripheral
Clinical narrative: Axillary swelling with pain and erythema starting the evening of the day of injection and continuing through to next day when seen in office. reaction (R) axillary region.
Age: 0.6
Sex: F
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No adverse event #2 Fluzone was given 13 days early
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: None Fluzone 0.5cc was administered- should have been .25cc
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect dose administered, Overdose
Clinical narrative: None 2 doses Fluzone administered when only 1 needed due to age.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient received 2nd HPV vaccine 2-27-08, and woke with hives on her neck and face 2-28-08. Slight itching.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site cellulitis, Injection site urticaria
Clinical narrative: Urticaria at injection site; (+) cellulitis at injection site
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Erythema, Skin warm
Clinical narrative: Small area to left arm where Varicella vaccine was given that has slight erythema, warm to touch. No heat radiating from site.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: No adverse event - .25cc dose was given instead of .5cc.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: Pt developed shingles of her ophthalmic branch on the right side on 3/3/08.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin lesion, Skin warm
Clinical narrative: Red, warm lesion 8.5 x 7.5cm - 1 cc borders marked with ink - antibiotics if increased in size.
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Administered.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Borrelia burgdorferi serology negative, Facial palsy, Urine analysis normal
Clinical narrative: Bells Palsy 11/17/07.  Treatment Prednisone, Doxycycline, Valacyclovir.  Lyme titre negative.  4/8/08 Reviewed PCP medical records of 10/12/07-3/25/08 which include consultant's evaluations. FINAL DX: acute left Bell's palsy, slowly improving. Records reveal patient experienced usual state of good health on day of vax.  Seen in ER 11/7.  Initially upon awakening noted right side bell's palsy which resolved then developed left side bell's palsy within short time.  Tx w/steroids, antiviral & antibiotic.  Facial droop, paralysis, numbess & fatigue increased.   Unable to close left eye, unable to smile, unable to drink liquids w/o dribbling.  Referred for MRI & consults to neuro & ophtho.  Ophtho 1/15/08 revealed Bell's palsy & mild corneal drying.  Neuro consult 2/8/08 revealed flat left nasolabial fold, unable to whistle, unable to completely close left eye, unable to raise eyebrow or furrow forehead on left.
Age: 1.1
Sex: F
Vaccine: DTAP, PNC, RV5
Symptoms: Wrong drug administered
Clinical narrative: Patient was given wrong vaccines.  Was given DTaP, Prevenar, Rotavirus.  Had received DTaP, Prevenar on 2-1-08.  MA had given her wrong set of shots.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, IPV, MMRV, PNC
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: 5 yr old male received #5 DTaP, #4 IPV, #2 MMRV, #1 PV7, and #1 HIB and #1 Hep A. Mother reports she took child to clinic on 4/27/07 with an allergic reaction. The child had wheals (hives) on his entire body. He was dx with allergic urticaria at clinic. She reported she gave Benadryl for a month after this reaction. He had another allergic reaction 9/47/07 to cough medication.
Age: 5.0
Sex: M
Vaccine: HEPA, IPV, MMRV
Symptoms: Local reaction, Swelling
Clinical narrative: Reaction to left thigh up to the knee.  Warm compresses to area for swelling and observe.
Age: 1.4
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site swelling, Injection site urticaria, Urticaria
Clinical narrative: Immediate large urticaria and swelling at vaccine site after MMR given.
Age: 0.18
Sex: M
Vaccine: IPV, PNC
Symptoms: Oedema peripheral
Clinical narrative: Slightly swollen left leg.
Age: 0.8
Sex: F
Vaccine: PNC
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient presented 2 days later with redness, 9 x 8cm at injection site, swelling, area firm to touch.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: Temp 104.7 3/4/08 - received immunizations 3/3.  Taken to UC - leg swollen, red, hard - given Ceftriaxone.  Improved in 24 hours.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash on underside of arm near armpit and down underside of right arm.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Skin atrophy
Clinical narrative: The vaccine given in my right arm made a large hole in my arm.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Donor c/o hives on 3-1-08 bilateral ankles, antecubitals, wrists, lower back, and bottom feet.
Age: 47.0
Sex: M
Vaccine: TD
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain and decreased ROM in left arm.  Pain began approximately 3 weeks after receiving vaccine and has progressively worsened.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Diverticulum, Erythema, Hypertension, Pain in extremity
Clinical narrative: (L)  arm extremely pain and redness after Pneumovax.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthritis, Computerised tomogram abnormal, Crying, Electromyogram normal, Injected limb mobility decreased
Clinical narrative: (L)  arm extremely pain and redness after Pneumovax.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site pain, Myalgia, Nerve conduction studies normal, Pain in extremity, X-ray limb abnormal
Clinical narrative: (L)  arm extremely pain and redness after Pneumovax.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Erythema, Flushing, Injection site erythema, Skin test positive, Wheezing
Clinical narrative: Patient felt flushed, turned red all over face, chest/torso, etc. and developed wheezing within 5 min of administration of vaccines.  Developed approximately 2.5cm diameter area of redness around site of Varivax injection.  Patient was given Allegra 30mg PO then Benadryl 25mg IM without much improvement, then given epinephrine 1:1000 0.2mg subcutaneous and he felt much better within a few minutes.  Released to home. This is in follow-up to report(s) previously submitted on 5/28/2008. Information has been received from a medical assistant concerning an 8 year old male with seasonal allergies and asthma and a history of pulmonary stenosis requiring surgery at 8 years old, eye surgery at 4 1/2 years old and a previous vaccination adverse reaction (not known) who 03-MAR-2006 was vaccinated IM with his second dose of VAQTA (lot# 658036/0495U). The patient had allergic rhinitis at the time of vaccination. Suspect vaccination administered on that same day included the second SC dose of VARIVAX (lot# 659066/1359U). Other concomitant drug therapy included montelukast sodium (MSD), ZYRTEC and lisinopril. Prior to leaving the office that day, the patient experienced difficulty breathing and developed a rash all over. The patient sought medical attention in the office at the time of reaction. No labs or diagnostic studies were performed. The patient was treated with ALLEGRA and montelukast sodium (MSD). He was then given BENADRYL and epinephrine that resolved his symptoms. The patient was discharged home. The medical assistant mentioned that the patient had a similar reaction with previous vaccination, but the patient's mother could not remember when or what vaccination was given. It was noted that the patient received his first IM dose of VAQTA on 12-NOV-2004 and his first SC dose of VARIVAX on 01-AUG-2000. There was no product quality complaint. Follow-up information from the reporting medical assistant indicated that on 03-MAR-2008 at 13:30 the patient was vaccinated SC with the second dose of VARIVAX (lot# 659066/1359U) in the left arm. Suspect vaccination administered on 03-MAR-2008 at 13:30 included the second IM dose of VAQTA (lot# 658036/0495U) in the right arm. On that same day at 13:35 about 5 minutes after the injections, the patient turned red in the face and torso, felt flushed and developed wheezing. The patient also developed an approximately 2.5 cm diameter area of redness around the site of the VARIVAX (left arm) and not the other injection site (right arm). The patient responded to BENADRYL 25 mg IM and EPI-PEN SC 0.2 mg. On 17-MAR-2008 a skin testing results with a pediatric allergist revealed that the patient was highly reactive to gelatin. It was noted that the reaction was similar to the adverse event(s) prior to the second vaccination with VARIVAX. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Dyspnoea, Rash generalised
Clinical narrative: Patient felt flushed, turned red all over face, chest/torso, etc. and developed wheezing within 5 min of administration of vaccines.  Developed approximately 2.5cm diameter area of redness around site of Varivax injection.  Patient was given Allegra 30mg PO then Benadryl 25mg IM without much improvement, then given epinephrine 1:1000 0.2mg subcutaneous and he felt much better within a few minutes.  Released to home. This is in follow-up to report(s) previously submitted on 5/28/2008. Information has been received from a medical assistant concerning an 8 year old male with seasonal allergies and asthma and a history of pulmonary stenosis requiring surgery at 8 years old, eye surgery at 4 1/2 years old and a previous vaccination adverse reaction (not known) who 03-MAR-2006 was vaccinated IM with his second dose of VAQTA (lot# 658036/0495U). The patient had allergic rhinitis at the time of vaccination. Suspect vaccination administered on that same day included the second SC dose of VARIVAX (lot# 659066/1359U). Other concomitant drug therapy included montelukast sodium (MSD), ZYRTEC and lisinopril. Prior to leaving the office that day, the patient experienced difficulty breathing and developed a rash all over. The patient sought medical attention in the office at the time of reaction. No labs or diagnostic studies were performed. The patient was treated with ALLEGRA and montelukast sodium (MSD). He was then given BENADRYL and epinephrine that resolved his symptoms. The patient was discharged home. The medical assistant mentioned that the patient had a similar reaction with previous vaccination, but the patient's mother could not remember when or what vaccination was given. It was noted that the patient received his first IM dose of VAQTA on 12-NOV-2004 and his first SC dose of VARIVAX on 01-AUG-2000. There was no product quality complaint. Follow-up information from the reporting medical assistant indicated that on 03-MAR-2008 at 13:30 the patient was vaccinated SC with the second dose of VARIVAX (lot# 659066/1359U) in the left arm. Suspect vaccination administered on 03-MAR-2008 at 13:30 included the second IM dose of VAQTA (lot# 658036/0495U) in the right arm. On that same day at 13:35 about 5 minutes after the injections, the patient turned red in the face and torso, felt flushed and developed wheezing. The patient also developed an approximately 2.5 cm diameter area of redness around the site of the VARIVAX (left arm) and not the other injection site (right arm). The patient responded to BENADRYL 25 mg IM and EPI-PEN SC 0.2 mg. On 17-MAR-2008 a skin testing results with a pediatric allergist revealed that the patient was highly reactive to gelatin. It was noted that the reaction was similar to the adverse event(s) prior to the second vaccination with VARIVAX. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Hyperaesthesia, Oedema peripheral
Clinical narrative: Erythema, swelling (L) upper arm, decreased motion whole (L) arm, tender to light touch, upper arm.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Localised infection, Oedema peripheral, Pain in extremity, Skin warm, White blood cell count increased
Clinical narrative: Within 1st few days, arm was warm, swollen and painful. Didn't subside after a week or two. 3 weeks after shot (a week ago), sx increased - more painful and swollen and decreased activity. Went to doctor 2-13-08 who said she had vaccine reaction with local infection in arm. Rx's Omnicef 300mg bid x 10d plus Medrol pack.
Age: 1.4
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: Slight swelling at injection site (LT).
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: A 23-month-old, male patient (with no medical history) developed hives at the injection site and arms, the next day after he received his fourth dose of Daptacel (lot number C2749BA) in the left arm, his fourth dose of IPOL (lot number Y1031) in the right arm and his second dose of Hepatitis A vaccine (Merck, lot number 1280F) in the left arm on 21 August 2007. At the time of the vaccinations, he had a cough and runny nose, and was not on any medications. At the time of the report, he had not recovered. Follow-up information received on 15 October 2007 from a health care professional. The reporter amended the following information: Daptacel was administered in the left thigh, IPOL was administered in the left thigh, and hepatitis A vaccine, lot number 1280F, was administered in the right thigh. There was no relevant diagnostic testing, and no vaccines were administered within four weeks of the 21 August 2007 vaccination. The patient recovered from the event on 27 August 2007.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Initial report received on 28 August 2007 from a health care professional. A three-year-old female patient had received a third dose, left arm, intramuscular injection of Daptacel, lot number C27498BA, on 24 August 2007. One day later, the patient experienced local redness at the Daptacel injection site (left arm) with warmth, swelling, and itchiness. Relevant diagnostic testing was none. At the time of this report, the patient had recovered. Follow-up received from a health care professional 23 October 2007. In response to a query asking if itching was confined to the injection site, it was reported that the injection site redness with warmth, swelling and itchiness was a local reaction involving most of the upper left arm where the injection was given. The patient received treatment with Tylenol. Duration of event was not reported. No additional information was provided. The reporter in this case is the same as in cases 2007-02932, 2007-02950, 2007-02951, 2007-02952, and 2007-02953.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site erythema, Pruritus
Clinical narrative: Initial report received on 29 August 2007 from a health care professional.  A five-year-old male patient had received a fifth dose, left arm, intramuscular injection of DAPTACEL, lot number C2749BA; and a right arm, subcutaneous injection of "MMV," manufacturer Merck, lot number 0285U; on 23 August 2007.  The following day, the patient experienced local redness at the DAPTACEL injection site (left arm) with warmth and itchiness measuring three inches in diameter.  At the time of this report, the patient had recovered.  Follow-up information received on 22 October 2007 from a health care professional.  It was reported that the patient was concomitantly vaccinated with MMR vaccine (manufacturer Merck), not "MMV" as previously reported.  The patient had no illness at the time of injection.  Additional information is not anticipated.  The reporter in this case is the same as in cases 2007-02931, 2007-02932, 2007-02951, 2007-02952, and 2007-02953.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Pruritus
Clinical narrative: A five-year-old male patient had received a fifth dose, left arm, intramuscular injection of DAPTACEL, lot number C2749BA, on 21 August 2007.  On the same day, the patient experienced local redness at the DAPTACEL injection site (left arm) with a lot of itchiness.  At the time of this report, the patient had recovered.  Follow-up information received on 22 October 2007 from a health care professional.  The patient had also developed spots on his cheek 15 minutes following vaccination that spread to his left hand.  He experienced no respiratory distress.  The reporter in this case is the same as in cases 2007-02931, 2007-02932, 2007-02950, 2007-02952, and 2007-02953.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Initial report received on 29 August 2007 from a health care professional. A five-year-old male patient had received a fifth dose, left arm, intramuscular injection of Daptacel, lot number U2749BA, and a second dose, right arm, subcutaneous injection of MMR, manufacturer Merck, lot number 0285U on 23 August 2007. Two days later, the patient experienced local redness at the Daptacel injection site (left arm) with warmth and itchiness measuring two inches in diameter around the site. Relevant diagnostic testing was none. At the time of this report, the patient had recovered. The reporter in this case is the same as in cases 2007-02931, 2007-02932, 2007-02950, 2007-02951, and 2007-02953.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Feeling hot, Injection site erythema, Pruritus, Urticaria
Clinical narrative: A five-year-old male patient had received a fifth dose, left thigh, intramuscular injection of DAPTACEL, lot number C2749BA, and a second dose, right thigh, subcutaneous injection of MMR, manufacturer Merck, lot number 0285U, on 22 August 2007.  Two days later, the patient experienced local redness at the DAPTACEL injection site (left thigh) with warmth and itchiness.  It was reported that the reaction involved a "large area of the thigh."  The patient also developed hives.  Other medications and relevant diagnostic testing were none.  At the time of this report, the patient had recovered.  Follow-up information received on 22 October 2007 from a health care professional.  The reporter confirmed that the injection site itching occurred at the site on the left thigh.  The case was reviewed by the reporter, and there was no additional information available.  The reporter in this case is the same as in cases 2007-02931, 2007-02932, 2007-02950, 2007-02951, and 2007-02952.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PPV, RV5
Symptoms: Flatulence, Irritability, Lethargy, Pyrexia, Wrong drug administered
Clinical narrative: Initial report received from a health care provider on 12 September 2007. A 4-month-old male patient with no reported medical history experienced fever of 103 degrees Fahrenheit, irritability, increased flatus, and was inconsolable after he had received an intramuscular right thigh injection of Daptacel, lot number C2655 (complete lot number not reported), an intramuscular injection of ActHIB, lot number UE826AA, a right thigh injection of IPOL, lot number A0126 (complete lot number and route not reported), an oral dose of Rotavirus, lot number 115F, and a left thigh injection of pneumococcal vaccine, lot number 0688U (route not reported). It was reported that pneumococcal vaccine had been administered instead of Prevnar. The expiration date for the dose of ActHIB, lot number UE826AA, was 01 July 2007, which was 72 days prior to the date of administration. The patient had not received any concomitant medications at the time of vaccination and no information about prior exposure to Daptacel, ActHIB, IPOL, or Rotavirus was provided. On 12 September 2007, one day after he had received the vaccine, the patient was evaluated by their physician. Per the reporter, the patient appeared lethargic after vaccination. Additional information provided (verbatim per the reporter), "Patient was given a pneumococcal vaccine instead of Prevnar. 24 hours fever, temperature max 103 degrees Fahrenheit rectally, irritability, increased flatus, inconsolable. The patient was treated with Advil, reassurance and observation". The exact time of onset for symptoms was not reported. The patient was reported as recovered at the time of the report. No additional information was provided. 20 September 2007: Corrective version created for the purpose of adding two separate medication error events to the adverse event screen for separate MEDdra Coding. This case is linked to case number 2007-03134.
Age: 25.0
Sex: M
Vaccine: FLUN3, TDAP
Symptoms: Autopsy, Endocardial fibroelastosis, Hepatomegaly, Hilar lymphadenopathy, Left ventricular hypertrophy
Clinical narrative: A serious report of idiopathic mitral prolapse resulting in death was received from a nurse concerning a 25-year-old male patient.  The patient's medical history included allergic reaction to amoxicillin in 1990, wherein the patient developed hives.  The patient was not taking any concomitant medications.  The patient received FluMist vaccine for influenza immunization on 17-Oct-2007.  On the same day, the patient also received Adacel, a tetanus, diphtheria and pertussis vaccine.  On 01-Nov-2007, the patient was found dead.  Per the patient's parents, the patient was healthy and had no illness before the death.  The night prior to the death, the patient had dinner and later went to bed.  He was last known to be alive on 31-Oct-2007 at 2300 hours when he was getting ready to go to bed.  He was found dead in his bed by his mother the following morning.  Paramedics were called but the patient was pronounced dead at 0945 hours.  A toxicology test was negative.  The autopsy report showed the following: no trauma, enlarged dilated heart with left ventricular hypertrophy and clean coronaries, parachute deformity with hooding of the anterior mitral cusp and lengthening of the chordae tendineae with mild white thickening of the septal endocardium behind the mitral valve, hyperinflated lungs, pneumomediastinum, enlarged liver and spleen, and an enlarged hepatic portal lymph nodes.  A microscopic report from an agency revealed interventricular septum showing mild fibrous thickening of the left ventricular endocardium, lung showed slight alveolar hemorrhage, and hilar lung with hilar nodes, pulmonary arteries, and bronchus with slight alveolar hemorrhage.  The medical examiner determined that the cause of death was idiopathic mitral prolapse and stated that the condition is a common cause of sudden cardiac death in young adults and is often asymptomatic.  The reporter considered both FluMist and Adacel as suspect vaccines and assessed causality for the events possibly related to either FluMist or Adacel vaccine.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Summary of follow-up information received on 16-Nov-2007 includes: verbal report of the autopsy and toxicology screening from the patient's parents; patient's state of health prior to his death.  Additional information received on 22-Feb-2008 and incorporated into the narrative: results from the autopsy.
Age: 25.0
Sex: M
Vaccine: FLUN3, TDAP
Symptoms: Lung hyperinflation, Lymphadenopathy, Mitral valve prolapse, Parachute mitral valve, Pneumomediastinum
Clinical narrative: A serious report of idiopathic mitral prolapse resulting in death was received from a nurse concerning a 25-year-old male patient.  The patient's medical history included allergic reaction to amoxicillin in 1990, wherein the patient developed hives.  The patient was not taking any concomitant medications.  The patient received FluMist vaccine for influenza immunization on 17-Oct-2007.  On the same day, the patient also received Adacel, a tetanus, diphtheria and pertussis vaccine.  On 01-Nov-2007, the patient was found dead.  Per the patient's parents, the patient was healthy and had no illness before the death.  The night prior to the death, the patient had dinner and later went to bed.  He was last known to be alive on 31-Oct-2007 at 2300 hours when he was getting ready to go to bed.  He was found dead in his bed by his mother the following morning.  Paramedics were called but the patient was pronounced dead at 0945 hours.  A toxicology test was negative.  The autopsy report showed the following: no trauma, enlarged dilated heart with left ventricular hypertrophy and clean coronaries, parachute deformity with hooding of the anterior mitral cusp and lengthening of the chordae tendineae with mild white thickening of the septal endocardium behind the mitral valve, hyperinflated lungs, pneumomediastinum, enlarged liver and spleen, and an enlarged hepatic portal lymph nodes.  A microscopic report from an agency revealed interventricular septum showing mild fibrous thickening of the left ventricular endocardium, lung showed slight alveolar hemorrhage, and hilar lung with hilar nodes, pulmonary arteries, and bronchus with slight alveolar hemorrhage.  The medical examiner determined that the cause of death was idiopathic mitral prolapse and stated that the condition is a common cause of sudden cardiac death in young adults and is often asymptomatic.  The reporter considered both FluMist and Adacel as suspect vaccines and assessed causality for the events possibly related to either FluMist or Adacel vaccine.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Summary of follow-up information received on 16-Nov-2007 includes: verbal report of the autopsy and toxicology screening from the patient's parents; patient's state of health prior to his death.  Additional information received on 22-Feb-2008 and incorporated into the narrative: results from the autopsy.
Age: 25.0
Sex: M
Vaccine: FLUN3, TDAP
Symptoms: Pulmonary hilar enlargement, Splenomegaly, Sudden cardiac death, Toxicologic test normal
Clinical narrative: A serious report of idiopathic mitral prolapse resulting in death was received from a nurse concerning a 25-year-old male patient.  The patient's medical history included allergic reaction to amoxicillin in 1990, wherein the patient developed hives.  The patient was not taking any concomitant medications.  The patient received FluMist vaccine for influenza immunization on 17-Oct-2007.  On the same day, the patient also received Adacel, a tetanus, diphtheria and pertussis vaccine.  On 01-Nov-2007, the patient was found dead.  Per the patient's parents, the patient was healthy and had no illness before the death.  The night prior to the death, the patient had dinner and later went to bed.  He was last known to be alive on 31-Oct-2007 at 2300 hours when he was getting ready to go to bed.  He was found dead in his bed by his mother the following morning.  Paramedics were called but the patient was pronounced dead at 0945 hours.  A toxicology test was negative.  The autopsy report showed the following: no trauma, enlarged dilated heart with left ventricular hypertrophy and clean coronaries, parachute deformity with hooding of the anterior mitral cusp and lengthening of the chordae tendineae with mild white thickening of the septal endocardium behind the mitral valve, hyperinflated lungs, pneumomediastinum, enlarged liver and spleen, and an enlarged hepatic portal lymph nodes.  A microscopic report from an agency revealed interventricular septum showing mild fibrous thickening of the left ventricular endocardium, lung showed slight alveolar hemorrhage, and hilar lung with hilar nodes, pulmonary arteries, and bronchus with slight alveolar hemorrhage.  The medical examiner determined that the cause of death was idiopathic mitral prolapse and stated that the condition is a common cause of sudden cardiac death in young adults and is often asymptomatic.  The reporter considered both FluMist and Adacel as suspect vaccines and assessed causality for the events possibly related to either FluMist or Adacel vaccine.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Summary of follow-up information received on 16-Nov-2007 includes: verbal report of the autopsy and toxicology screening from the patient's parents; patient's state of health prior to his death.  Additional information received on 22-Feb-2008 and incorporated into the narrative: results from the autopsy.
Age: 9.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Dyspnoea, Pruritus, Wheezing
Clinical narrative: Information has been received from a physician concerning a 9 year old male with a history of agenesis of the right pulmonary artery who on 19-FEB-2008 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot number: /1779U). There was no concomitant medication. On 19-FEB-2008, twenty minutes after the patient received the vaccine, he became very itchy and could not breath. His skin turned red like a sunburn and there was audible wheezing. The patient was kept in the office for several hours and was given an epi-pen Junior, oral BENADRYL, and albuterol with oxygen. He was sent home with BENADRYL for the week. No additional information was provided. Unspecified medical attention was sought in the office. The outcome was reported as recovered. There was no product quality complaint. The reporter felt that the patient's itchiness, not being able to breath, his skin turned red like a sunburn, his audible wheezing were considered to be a significant disability or incapacity and other important medical events. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Dyspnoea, Erythema, Oxygen supplementation, Pruritus, Wheezing
Clinical narrative: Information has been received from a physician concerning a 9 year old male with a history of agenesis of the right pulmonary artery who on 19-FEB-2008 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot number: /1779U). There was no concomitant medication. On 19-FEB-2008, twenty minutes after the patient received the vaccine, he became very itchy and could not breath. His skin turned red like a sunburn and there was audible wheezing. The patient was kept in the office for several hours and was given an epi-pen Junior, oral BENADRYL, and albuterol with oxygen. He was sent home with BENADRYL for the week. No additional information was provided. Unspecified medical attention was sought in the office. The outcome was reported as recovered. There was no product quality complaint. The reporter felt that the patient's itchiness, not being able to breath, his skin turned red like a sunburn, his audible wheezing were considered to be a significant disability or incapacity and other important medical events. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: Information has been received from a physician concerning a 2 month old male with no drug allergies who was vaccinated PO with his first 2.0 ml dose of ROTATEQ (no lot# available). Suspect vaccination administered on the same day included a dose of Hib conj vaccine (OMPC) (manufacturer unknown). Concomitant vaccinations administered the same day included a dose of PEDIARIX and a dose of PREVNAR. Three days after vaccination, the patient died (specific date of death unknown). The cause of death was sudden death syndrome. There was no product quality complaint. Additional information has been requested. 4/18 Spoke w/physician who provided corrected patient name, DOB, DOD, date of vaccination & ME contact #.  States prelim COD is SIDS. 8/5/08 Autopsy states COD as sudden unexpected death by suffocation & manner of death as accident.  Patient found in crib face down w/mouth & nose in full contact w/bedding lying in 'pool' of blood tinged emesis not breathing.  CPR started & EMS responded.  Arrived in ER in full arrest & unable to be resuscitated.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Occult blood positive
Clinical narrative: Information has been received from a physician and a patient's mother (physician) concerning her 32 day old breast-fed son who on 12-FEB-2008 was vaccinated PO with the first dose of Rotateq. On 11-JAN-2008 the patient's mother thought she saw blood in her son's stool. A hemoccult test was performed which was negative. On 14-FEB-2008 the patient experienced strands of blood in his stool and a positive hemoccult test. The patient was not hospitalized. There was no diagnosis at the time. The nurse mentioned that the patient would not be receiving his second dose of Rotateq until the other tests were done. At the time of this report, the patient did not have blood in his stool. There was no product quality complaint. Upon internal review, strands of blood in stool was determined to be an other important medical event. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion
Clinical narrative: Information has been received from an office manager in a physician's office, concerning a 26 year old female patient with unspecified allergies but no drug allergies, and a history of one seizure in childhood, who on 27-FEB-2008 was vaccinated IM, with the first dose, 0.5 ml, of Gardasil (lot #659655/1486U). Concomitant therapy included ALLEGRA-D. On 27-FEB-2008, 5 minutes after the vaccination, the patient experienced a grand mal seizure. She was transported to a local emergency room (ER), but it was unknown if she was admitted to the hospital. No further information was available regarding treatment in the ER. The patient was "seeing a neurologist." Upon internal review, grand mal seizure was considered to be serious as an other important medical event. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion
Clinical narrative: Information has been received from a certified nurse midwife who reported that a patient of his mentioned that her 16 year old female cousin was vaccinated with her third dose of Gardasil. Her cousin subsequently experienced grand mal seizures and was hospitalized. Her cousin did not have any prior history of seizures, and her cousin's twin and older sister received the Gardasil vaccine series and had no adverse effects post vaccination. The nurse stated he did not have any additional information regarding his patient's cousin's experience. At the time of reporting, the patient was still hospitalized. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: HPV4, PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: Information has been received from a physician concerning a 16 year old female student, who on 02-AUG-2007 was vaccinated with a first dose of Gardasil. No reaction was reported after the first dose. On 31-DEC-2007 the patient was vaccinated IM in the left deltoid with a second dose of Gardasil (Lot# 655205/1426F). Concomitant therapy included Pneumovax 23, administered in the left deltoid. It was reported that "each injection site was spread apart from the other." On 01-JAN-2008 the patient experienced pain, swelling, and erythema in the left upper arm and was treated with unspecified antibiotics. On 02-JAN-2008 the patient was seen in the office. The patient recovered after a week and a half on approximately 14-JAN-2008. The physician considered the pain, swelling, and erythema of the left upper arm to be other important medical events. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 year old female, who on 13-JAN-2008 was vaccinated with a second dose of Gardasil. On 13-JAN-2008 the patient experienced seizure. The patient was rushed to the emergency room. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review seizure was considered to be an other important medical event. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdomen scan normal, Anorexia, Dizziness, Electrocardiogram normal, Feeling abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with a history of reflux as a young child and no known drug allergies, who on 20-DEC-2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient felt nauseous and "not quite right." On 20-FEB-2008 the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). On 20-FEB-2008 after the vaccination the patient almost passed out, was nauseous, diaphoretic, and had a severe headache on the way home from the office. The nurse reported that it was not a vagal response. On 21-FEB-2008 the patient felt dizzy and had tachycardia upon arrival to the emergency room. The patient was treated with one liter of saline (previously reported as IV fluids), and a dose of ZOFRAN. The patient felt somewhat better. The client was then given contrast for the abdominal scan, and was nauseous again. An abdominal CT scan was performed and was normal. A pregnancy test was negative. An EKG was performed and was normal. The patient was not hospitalized. It was reported that the patient had lost 5 to 6 pounds and could not eat or drink without feeling nauseous. The patient's mother reported that she did not think the patient's nausea was related to vaccination with Gardasil. The mother believed that the patient "has something like an acid reflux and the Gardasil initiated it." The patient was seen by a gastroenterologist and started the patient on REGLAN and PREVACID. At the time of the report, the patient had not recovered. No product quality complaint was involved. The nurse considered the nausea, dizziness, diaphoresis, weight loss, and not being able to eat or drink to be other important medical events. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Hyperhidrosis, Nausea, Pregnancy test negative, Tachycardia
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female with a history of reflux as a young child and no known drug allergies, who on 20-DEC-2007 was vaccinated with a first dose of Gardasil. Subsequently, the patient felt nauseous and "not quite right." On 20-FEB-2008 the patient was vaccinated with a second dose of Gardasil. Concomitant therapy included meningococcal vaccine (unspecified). On 20-FEB-2008 after the vaccination the patient almost passed out, was nauseous, diaphoretic, and had a severe headache on the way home from the office. The nurse reported that it was not a vagal response. On 21-FEB-2008 the patient felt dizzy and had tachycardia upon arrival to the emergency room. The patient was treated with one liter of saline (previously reported as IV fluids), and a dose of ZOFRAN. The patient felt somewhat better. The client was then given contrast for the abdominal scan, and was nauseous again. An abdominal CT scan was performed and was normal. A pregnancy test was negative. An EKG was performed and was normal. The patient was not hospitalized. It was reported that the patient had lost 5 to 6 pounds and could not eat or drink without feeling nauseous. The patient's mother reported that she did not think the patient's nausea was related to vaccination with Gardasil. The mother believed that the patient "has something like an acid reflux and the Gardasil initiated it." The patient was seen by a gastroenterologist and started the patient on REGLAN and PREVACID. At the time of the report, the patient had not recovered. No product quality complaint was involved. The nurse considered the nausea, dizziness, diaphoresis, weight loss, and not being able to eat or drink to be other important medical events. Additional information has been requested.