chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PPV, VARCEL
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Pain in left leg, complaints when walking, unexplained: Fevers, symptoms associated with cough (unknown skin irritants), back and neck aches!  No treatments issued at clinic, no records made or recorded!2/2/09-records received-3/14/03-received 2 month series of shots at 4 months during well baby visit with C/O dry skin. Routine visits parent has concerns related to multiple infections. History or viral and bacterial infections.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Biopsy lymph gland abnormal, Candidiasis, Liver induration, Sarcoidosis
Clinical narrative: I had my 1st Hep B injection on 10-2-1990, my liver became hard to the touch - I mentioned this to the nurse when I had my 2nd on 11-1-1990. Last one given on 4-15-1991.  10/1/08 Reviewed neurologist medical records of 5/22/2000-5/8/2007. FINAL DX: neurosarcoidosis Records reveal patient experienced numbness over lateral left hip & thigh approx 4/2000 which spread to left anterior lower ribs, abnormal taste, radicular pain of cervical & thoracic region, multiple joint pain, difficulty swallowing.  Tx w/high dose steroids both oral & IV, plaquenil, methotrexate, neurontin & multiple pain meds.  Initially improved w/multiple relapses/flairs, multiple drug changes & drug complications.  Developed osteoporosis secondary to long term steroid use.  Became unable to work due to her worsening condition.  Diagnosed by other phycisians w/fibromyalgia & chronic myofascial pain.
Age: 66.0
Sex: M
Vaccine: HEPAB, TD
Symptoms: Cerebrovascular accident, Chest pain, Hyperhidrosis, Pain in extremity, Pallor
Clinical narrative: During 40 minute drive home client started sweating, having some left arm pain. Client's wife described him as pale, chest pain starting. Client life-flighted, dx with CVA. Surgery 8/12 and 8/14 for stents.  10/10/08 Reviewed hospital medical records of 8/12-8/15/2008. FINAL DX: coronary artery disease w/acute inferior myocardial infarction; HTN; hyperlipidemia Records reveal patient experienced exertional chest pain x several mo & developed severe chest pain on 8/12/08.  Transferred from outlying ER for higher level of care.  Tx w/PTCA, progressed well & d/c to home.
Age: 66.0
Sex: M
Vaccine: HEPAB, TD
Symptoms: Stent placement, Surgery
Clinical narrative: During 40 minute drive home client started sweating, having some left arm pain. Client's wife described him as pale, chest pain starting. Client life-flighted, dx with CVA. Surgery 8/12 and 8/14 for stents.  10/10/08 Reviewed hospital medical records of 8/12-8/15/2008. FINAL DX: coronary artery disease w/acute inferior myocardial infarction; HTN; hyperlipidemia Records reveal patient experienced exertional chest pain x several mo & developed severe chest pain on 8/12/08.  Transferred from outlying ER for higher level of care.  Tx w/PTCA, progressed well & d/c to home.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: Rash-red, raised above skin itching
Age: 42.0
Sex: M
Vaccine: SMALL
Symptoms: Rash
Clinical narrative: Patient complained of rash on left leg and right hip after 5 days of vaccination.  Patient treated with Loratidine and monitor for several days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: After receiving the vaccine ZOSTAVAX, I had redness, itching, and warmth at the injection sight for approximately 1 week.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: Patient developed a large, painful nodule in his left upper arm (65 x 80mm) within a few days on Anthrax vaccination.  Typhoid vaccine also given in L UE.  This was patient's 4th Anthrax shot - previous 3 were in Feb-March 2000.
Age: 1.4
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: None - incorrect vaccine given, no adverse reaction.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Rash macular, Rash pruritic
Clinical narrative: The following evening (almost 24 hours after vaccination of Varicella #2 dose) patient's right forearm and upper arm developed small circular raised rash on inner and outer aspects, but not hand.  Rash duration was 1 1/2 to 2 hours and was pruritic.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Immediately after immunizations, patient stated she was dizzy and light headed.  Had patient lay down and monitor vital signs - stable.  Observed in office for 15 minutes by LPN and physician.  Patient left office with no further complications.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Patient was given GARDASIL; kept in exam room for observation, approximately 1 1/2 minutes after vaccine was given.  Patient was found laying down on exam table, stating she thought she fainted.  Vital signs were monitored - stable.  Observed in office by MA and physician; was not allowed to drive home from office.
Age: 15.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and erythema at vaccine site x 1 day.  Advised anibulizers.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Atrial fibrillation, Echocardiogram normal, Stress echocardiogram, Syncope
Clinical narrative: Syncope and atrial fibrillation 3-4 hours after administration.
Age: 13.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Burning sensation, Pruritus, Rash generalised, Skin discolouration
Clinical narrative: Three days after the shots were given, patient and I started noticing small bumps appearing on her arms.  A few days later, her entire body was covered, from her neck down to her feet.  Patient complains a lot about the burning, itching and discoloration of her skin.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Face oedema
Clinical narrative: 9-9-08 HPV given in right arm and facial edema started 9-10-08
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Biopsy muscle, Biopsy skin, Blood test, Dermatomyositis
Clinical narrative: Autoimmune muscle disease. Dermatomyositis. Muscle weakness, fatigue, purple patches on skin. 9/23/08-records received-office visit 04/27/07-seen for contraception follow up received 1st HPV vaccine. 6/20/07-second HPV vaccine. 10/23/07-3rd HPV vaccine. No office visits documented between vaccinations. 3/14/08-C/O stomach pain after dairy. Continues to use Loestrin 24 BCP. 7/15/08-C/O autoimmune disorder. Muscle pain and weakness. Dermatomyositis. 8/20/08-has been using Yaz BCP now having difficulty with increased bleeding and period lasting longer. 9/11/08-DX dermatomyositis.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Electromyogram, Fatigue, Muscular weakness, Skin discolouration
Clinical narrative: Autoimmune muscle disease. Dermatomyositis. Muscle weakness, fatigue, purple patches on skin. 9/23/08-records received-office visit 04/27/07-seen for contraception follow up received 1st HPV vaccine. 6/20/07-second HPV vaccine. 10/23/07-3rd HPV vaccine. No office visits documented between vaccinations. 3/14/08-C/O stomach pain after dairy. Continues to use Loestrin 24 BCP. 7/15/08-C/O autoimmune disorder. Muscle pain and weakness. Dermatomyositis. 8/20/08-has been using Yaz BCP now having difficulty with increased bleeding and period lasting longer. 9/11/08-DX dermatomyositis.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Patient's arm was swollen by phone message. Patient was not seen. Left arm  got swollen.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Mass, Pruritus
Clinical narrative: 1 inch lump on deltoid with redness; No fever. Cool to touch, complained of "itchiness"
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Computerised tomogram normal, Pyrexia
Clinical narrative: Prolonged low grade fever.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Heart rate decreased, Syncope
Clinical narrative: Patient fainted after receiving vaccines. Was on exam table at time of incident it was assisted to supine it immediately regained consciousness vs: HR at 1225 54; HR at 1238 - 80
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chills, Dizziness, Headache, Pyrexia, Tremor
Clinical narrative: Developed a fever 101 on 9/9 increased 102 feeling dizzy and c/o headache, shaking and chills with fever
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea and vomiting one day after injection.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: After receiving vaccine, client fell to floor. Initially pale and unresponsive. Became responsive after a few seconds. Stated unable to feel (L) arm and knees initially. By 1:00 pm, able to move all extremities. Monitored until 2:00 pm before allowed to leave with an adult.
Age: 0.63
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Did not verify age of patient before giving injections, unable to reach mother, unknown reaction to vaccines.
Age: 0.82
Sex: F
Vaccine: HIBV
Symptoms: Febrile convulsion
Clinical narrative: Febrile, convulsion x 2 requiring ER visits
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC
Symptoms: Ataxia, Headache, Listless, Pyrexia
Clinical narrative: Listlessness and fever to 102.  Then developed ataxia and h/a.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Cellulitis, Computerised tomogram normal, Convulsion, Injection site erythema
Clinical narrative: (R) thigh 24 hours after vaccines given noticed 2 inch round red area at site of vaccines, continued to enlarge. Seen at MD office 8/13, given IM dose ROCEPHIN, started on AUGMENTIN. Called office in AM 8/29 with increasing enlargement of cellulitis. Seen in office and decision made to admit for inpatient therapy (IV antibiotics). Had seizure in hospital, neg CT scan. Home on PO abtx.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: (L) arm pain, reddened area warm and hard to touch, lump - 15x15 mm
Age: 55.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Feverish, sweaty, (L) arm- warm, red, swollen - 11 x 11 cm, site itchy
Age: 55.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pyrexia
Clinical narrative: Feverish, sweaty, (L) arm- warm, red, swollen - 11 x 11 cm, site itchy
Age: 1.3
Sex: F
Vaccine: DTAPH
Symptoms: Oedema peripheral, Skin warm, Vomiting
Clinical narrative: Vomiting x 1d, leg warm and swollen
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Right thigh - 14.5 x 10.5cm area red, hot, itching, painful
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 18 year old male presented for 2nd injection of HEP A series, I was thinking injection was due in 2 months (like Hep B Series).  I authorized MA to give injection and found out later it was given 2 months early.  MA did not catch the error either before injection was given.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult HEP A given to pediatric patients. A new public health nurse and back-up RN pulled from a wrong bin.
Age: 4.0
Sex: U
Vaccine: DTAP, MMR, VARCEL
Symptoms: Cellulitis, Cold compress therapy, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: On 8/21 pt had MMR II, DPT and Varicella vaccinations. DPT and Varicella were given in the right arm and MMR II in the left arm (per the nurses memory; not documented).On 8/22/08 the mother noted the right arm was swollen, red, hot and hard from the shoulder to the elbow. She took the pt to the ER. The hospital child was prescribed BENADRYL. On 8/23/08 the redness and swelling were past the elbow so the mother took the child to the pediatrician. The child was prescribed erythromycin for a possible cellulitis. Additionally the mother started applying cold compresses. Around noon on 8/24 the symptoms started to improve. At 1600 8/25/08 the pt was 90% better. Mother instructed to stop antibiotics. Symptoms completely resolved without further treatment. Symptoms: Erythema, Swelling, Pain.
Age: 4.0
Sex: U
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: On 8/21 pt had MMR II, DPT and Varicella vaccinations. DPT and Varicella were given in the right arm and MMR II in the left arm (per the nurses memory; not documented).On 8/22/08 the mother noted the right arm was swollen, red, hot and hard from the shoulder to the elbow. She took the pt to the ER. The hospital child was prescribed BENADRYL. On 8/23/08 the redness and swelling were past the elbow so the mother took the child to the pediatrician. The child was prescribed erythromycin for a possible cellulitis. Additionally the mother started applying cold compresses. Around noon on 8/24 the symptoms started to improve. At 1600 8/25/08 the pt was 90% better. Mother instructed to stop antibiotics. Symptoms completely resolved without further treatment. Symptoms: Erythema, Swelling, Pain.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site cellulitis
Clinical narrative: Leg of injection "size of 4 softbays" per mom. Per ER-cellulitis- Rx: KEFLEX. Much better within 36 hrs.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Local reaction, Skin warm, Swelling
Clinical narrative: Severe local reaction - swelling red, hot to touch.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Cough, Dermatitis diaper, Diarrhoea, Oedema peripheral, Rash macular
Clinical narrative: Patient presented to office 24 hours after receiving MMR and Varivax with swollen hands and feet and macular, lacy rash on face, arms and legs.  Sibling reacted "violently" to Benadryl.  No other treatment.  Also seen 5 days later with viral pharyngitis and viral rash, diarrhea and cough.  Treated with Nystatin cream to diaper rash.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Viral pharyngitis, Viral skin infection
Clinical narrative: Patient presented to office 24 hours after receiving MMR and Varivax with swollen hands and feet and macular, lacy rash on face, arms and legs.  Sibling reacted "violently" to Benadryl.  No other treatment.  Also seen 5 days later with viral pharyngitis and viral rash, diarrhea and cough.  Treated with Nystatin cream to diaper rash.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None - incorrect vaccine given for age.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient received 1st dose of Hep B at birth. I misread report thinking patient was getting 1st dose Hep B today in office visit. I administered vaccine per doctor order. Therefore patient received 2 doses in 5 days.
Age: 49.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Heart rate normal
Clinical narrative: After finishing an uncomplicated plasma donation, donor received a rabies vaccination.  While being injected, began to complain of dizziness, lightheadedness, VS 94/53, P 69.  Was sitting in chair and placed head on MSA's exam table.  Starting feeling better: drank 3 oz water.  VS, 2 minutes later 96/70, P 83 and stated, "I feel fine now."
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Child received his 2nd varicella on 9/9/08 in right deltoid. He had a small rash on 9/10/08 which enlarged to a 4cm x 2.5cm indurated and erythematous - Non tender
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: (L) deltoid area, red (+) warm 3.5x4cm induration. (+) 5x6 cm redness. Warm compress and observe.
Age: 1.1
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Patient received MMR vaccine SQ in left arm.  Within five minutes, hive appeared.  Only 1 hive in 30 minutes appeared.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: Mom called at 1545 and said pt had varicella vaccine at 1330 and when got home pt was itchy and broke out in hives. Told mom to do 2 tsp of Benadryl Q 6 h prn and 10 mg Claritin daily for 1 wk. Call for worsen symptoms.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None - incorrect vaccine given for age.  No adverse reaction.
Age: 1.2
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash is still there. Rash started the night after shot was given. Rash was on her stomach.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase normal, Blood bilirubin normal, Chills
Clinical narrative: Patient developed diarrhea, vomiting one day after vaccine (varicella) was given. Diarrhea watery. Also c/o of subjective fever, chills, and dizziness. No rash reported.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Dizziness, Full blood count, Laboratory test, Pyrexia
Clinical narrative: Patient developed diarrhea, vomiting one day after vaccine (varicella) was given. Diarrhea watery. Also c/o of subjective fever, chills, and dizziness. No rash reported.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Patient developed diarrhea, vomiting one day after vaccine (varicella) was given. Diarrhea watery. Also c/o of subjective fever, chills, and dizziness. No rash reported.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Lethargy, Pyrexia, Vomiting
Clinical narrative: Vaccines administered 9:45am.  Mother reported fever in child at 12:30 - 1 am lasting 4 hours and child lethargic in AM with fever of 101 - she gave Tylenol 4, within 20 hours fever at 100.  Today, vomiting abated.  "Reaction" began approximately 14 hours after vaccine.  Child had similar reaction on #2 DTAP but tolerated #3 without problems.  F/U call 9/10 - vomiting began between 1 - 1:30 am.  Today she has a 99 temperature, feeling better.
Age: 24.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: C/O redness at injection site along with swelling, itchy and warm.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Child received ROTATEQ and was 14 week old.
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: erythema and swelling of affected arm. Tx for cellulitis with KEFLEX x 1 wk. Mimimal resolution after 1 day no F/S/C. Continue also BENADRYL, pm
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Pruritus, Skin warm
Clinical narrative: 9-5-08, arm has long red area size of softball which is hot to the touch, et, itchy.  Seen in ER at clinic.  Treated for cellulitis.  Prescribed Clindamyacin 300mg PO Q 8 hours x 7 days.
Age: 4.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Eye rolling, Staring
Clinical narrative: Rolled eyes for about 60 sec. Stared x 2 at preschool two hours after receiving influenza vaccine and Hep A ped.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, HEPA, MMR
Symptoms: Arthralgia, Nasopharyngitis, Pain in extremity
Clinical narrative: Cold symptoms started 9-7-08. On 9-9-08 started with generalized pain in arms, legs, buttocks. Pain especially severe in hips and legs. Pain was so severe on 9-9-08 that parent took child to E.R.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Rt arm swollen red, warm. Tx Keflex, Benadryl, cool compress.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: PATIENT RECEIVED THE VACCINE AND APPROXIMATELY ONE MINUTE LATER SHE FELL TO THE FLOOR FROM THE EXAM TABLE.  PATIENT STATES SHE BEGAN TO FEEL DIZZY AND EVERYTHING WENT BLACK.  NEXT THING SHE REMEMBERS IS WAKING UP ON THE FLOOR.
Age: 39.0
Sex: F
Vaccine: DTAP, FLUN3
Symptoms: Erythema, Pain, Tenderness, Wrong drug administered
Clinical narrative: Pt has area of 9.5X4 cm on  left deltoid that is reddened and tender to the touch. Pain extends toward left subclavicular area. No numbness or radiation down affected arm reported. Symptoms started within 3 hours of vaccination.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Received Tdap from Employee Health. Developed itching 4 hours after drug given progressed to hives and treated in ER with decadron, benadryl and pepcid
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Fontanelle bulging, Foster care, Ultrasound skull normal
Clinical narrative: Pediarix, ActHib and PCV were administered in the afternoon of 9/8/2008. About 4 am the next morning the foster mom noticed the child's fontanel was protruding about 1/2 inch above her head. The foster mom called the baby's doctor, but couldn't get in right away. She then took the baby to the Emergency Room. By this time, the fontanel had reduced in size by about 1/2. The ER doctor did not run any test and sent them home. The next day, Wednesday, the foster mom was still concerned so she took the baby to her doctor. At that time, the foster mom's doctor, had an ultrasound done on the baby's head. Everything was reported to be normal. No other findings have been reported.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: per CDC recommendations no f/u required with patient and family.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: very high fever
Age: 18.0
Sex: F
Vaccine: HPV4, MMR, MNQ
Symptoms: Antinuclear antibody, Arthralgia, Blood albumin decreased, Blood alkaline phosphatase normal, Blood calcium normal
Clinical narrative: joint pains
Age: 18.0
Sex: F
Vaccine: HPV4, MMR, MNQ
Symptoms: Carbon dioxide decreased, Protein total increased, Red blood cell sedimentation rate increased, Red cell distribution width increased, Rheumatoid factor
Clinical narrative: joint pains
Age: 1.5
Sex: F
Vaccine: MMR
Symptoms: Insomnia, Irritability, Pyrexia, Rash erythematous
Clinical narrative: Patient received the vaccine at 8:30am on July 29. In the evening on August 7 she began displaying signs of illness, including fussiness, fever and sleeplessness. She awoke in the middle of the night with high fever and tossed and turned the rest of the night. I did not notice till morning (and the lights were turned on) the red dots on her body. We gave her tylenol and administered cool washcloths to lower her body temperature which ranged between 103-101 for a few days.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Heart rate increased, Pruritus, Urticaria
Clinical narrative: Staff member of medical care facility given #2 of Hep B. series. Had rapid heart rate and hives(red, raised, itchy areas) around neck shortly after vaccine injection. Reported incident one hour after vaccination.  Sent to the local clinic where they administered 2 shots and sent her home.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Patient refers the appearance of blister like lesions all around the body. The doctor diagnosed it as varicella.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Received Dtap to left arm on 9/13/08. Noticed an area of redness 5cm x 4cm with tenderness and warmth to the touch.  Reaction started one day later. No fever. Symptomatic treatment advised.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: Received Dtap to left arm on 9/11/08. Noticed an area of redness 5cm x 5cm with tenderness and warmth to the touch. Reaction started one day later. No fever. Syptomatic treatment advised.
Age: 0.58
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Irritability, Musculoskeletal stiffness, Pyrexia, Staring
Clinical narrative: Mother reports that during late yesterday evening that child developed fever and early this am [4:30]had a febrile seizure, which she described as childs body stiffening up and staring blankly, lasted appox 15 seconds. Has not had any seizure activity since that time. Has been fussy since that time. Mom is unable to give exact temp because her thermometer fell to the floor and broke while attemptint to obtain temperature.
Age: 13.0
Sex: M
Vaccine: FLUN3
Symptoms: Dry eye, Facial palsy, Hot flush, Hypoaesthesia oral, Lacrimation increased
Clinical narrative: 30 mins after receiving FluMist pts. left eye began watering every time he blinked and his lip became numb and started getting hot flashes. Pt. came to the office the following day c/o left eye going from excessively watering to excessively dry.  Left side of face became droopy the morning after he got Flumist.  Pt. diagnosed with Bells Palsy, treated with Acyclovir, DexPak, and Lacrilube.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Irritability, Vomiting, Vomiting projectile
Clinical narrative: Patient received IPV, Pneomovac, Hib and DTaP vaccines on 9/15/08.  that night developed increased fussiness and some vomiting, occassionally projectile.  .  Patient seen on 9/16/08 for evaluation.  No rashes, erythema or skin changes.  Injection sites okay
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site swelling
Clinical narrative: administered varicella vaccine intradermal, like a TB skin test on left forearm with 0.1 ml. Whelp appeared.  After error gave 0.5 ml varicella sub-Q left tricep per Nurse Practitioners verbal order.  Gave TB skin test right forearm.
Age: 51.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: Pt broke out in a rash from the elbow up to shoulder, with welts and swelling of the shoulder
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Erythema, Immunisation reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Administered vaccine (Varicella, MCV4, & Tdap) to her left arm on 9/15/08 in the morning. Pt returned to clinic 9/16/08 in the afternoon c/o moderate reaction from vaccine: left arm painful, red, and swollen. Patient denies fever. Patient afebrile at the time of visit. Instructed patient to apply cold compress to affected area and take tylenol or advil for pain if not contraindicated. patient and mother vervalized understandin.
Age: 25.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Eczema vaccinatum, Erythema, Induration, Rash vesicular
Clinical narrative: Pt had initial erythematous reaction placed in VAERS form E-24559 and treated with Benadryl and proper site care. Pt did well and erythema and induration resolved. However, aprox 5 days later, the patient started having a vesicular reaction that he initially thought was chiggers. Pt presented to clinic 2 days later with a chief complaint of chiggers and was diagnosed with eczema vaccinatum. Pt was treated with high dose steroids that has stopped further vesicular eruptions.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Computerised tomogram, Convulsion, Electroencephalogram, Laboratory test, Lumbar puncture
Clinical narrative: Received Menactra vaccine on 8/12/2008.  The next day had fever (103 degrees F) and generalized body aches for three days.  On 09/07/2008 she had another fever and had two generalized convulsive seizures.  She was taken to the Emergency Room by ambulance.  Fever of unknown etilogy at that time.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Received Menactra vaccine on 8/12/2008.  The next day had fever (103 degrees F) and generalized body aches for three days.  On 09/07/2008 she had another fever and had two generalized convulsive seizures.  She was taken to the Emergency Room by ambulance.  Fever of unknown etilogy at that time.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Rash macular, Scab
Clinical narrative: November 20, 2007: Received Zostavax vaccine from Pharmacy.  Vaccine shot given same date at doctor's office by his nurse. On or about May 25, 2008, noticed red blotches on upper left side of chest and front and back of her neck.  On May 28, 2008 M.D. confirmed diagnosis: Shingles and provided Rx for seven days.  Scabs fell off within next 45 days.  Redness of skin (caused by scabs) now not noticeable.
Age: 0.3
Sex: F
Vaccine: RV5, UNK
Symptoms: Crying, Injection site erythema, Irritability, Oral intake reduced, Pyrexia
Clinical narrative: Patient developed fever 102.4, 12 hours after injection. Became fussy, unconsolable. Given Tylenol. T dropped 100.4 24-36 hrs after injection. Pt still has fever. Decreased PO, decreased UO, site red dime size.
Age: 0.3
Sex: F
Vaccine: RV5, UNK
Symptoms: Urine output decreased
Clinical narrative: Patient developed fever 102.4, 12 hours after injection. Became fussy, unconsolable. Given Tylenol. T dropped 100.4 24-36 hrs after injection. Pt still has fever. Decreased PO, decreased UO, site red dime size.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Blood pressure normal, Dizziness, Loss of consciousness, Syncope
Clinical narrative: Pt had 4 ordered vaccines, then c/o dizziness and then passed out in the exam table. Dr. aware. Pt monitored BP remained stable and was last documented as 130/87 prior to being D/C'd by Dr to go home w/mother. Syncopal episode lasted approximately 5 seconds.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Joint stiffness, Staring
Clinical narrative: Mom says that after shots pt had stiff joints (wouldn't move arms and legs well) and had a vacant stare for 2 weeks. Also she says that she and brother got gastro 2 weeks after rotavirus. At time of shot now 21 weeks
Age: 26.0
Sex: M
Vaccine: SMALL
Symptoms: Blister, Rash papular
Clinical narrative: Developed papules/vesicles on face, trunk and arms, scattered. No treatment.
Age: 16.0
Sex: F
Vaccine: FLUN3, HPV4
Symptoms: Chest discomfort, Hypoaesthesia facial, Pain, Throat tightness, Wheezing
Clinical narrative: 1 hr after receiving FLUMIST/ pt developed facial numbness, chest and throat tightness with pain and wheezing
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 5/08 Given ZOSTAVAX -> 9/08 Had shingles abd. mod- severe, self limited.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) upper arm where DTaP admin 9/10/08 developed severe swelling, redness, pain starting 9/11/08 - saw doctor 9/12/08. Dx reaction to tetanus - Benadryl given.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Eyelid oedema, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: small red rashes all over body, face and extremities w/fever, edema of eye lids.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Overdose
Clinical narrative: On 09/15/08 patient received immun: Pediarix, IPV, MMR, varicella. Scheduled immun are Dtap, IPV, MMR. and varicella. Patient received 2 doses of IPV as a result. Patient receive this risk of a serious adverse reaction but increase risk local reaction. Attempted to call parent 2 times and left message. No return call.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Red swollen
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Clinical narrative: Details NA. 12/17/08-records received-Sudden death in a 2 month old child. Undetermined causes.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Arthralgia, Influenza like illness, Joint swelling, Laboratory test
Clinical narrative: Information has been received from a physician and a registered nurse (RN) concerning a 17 year old female who on 31-JAN-2007, 07-APR-2007 and 07-AUG-2007 was vaccinated with a 0.5 ml first, second and third doses of GARDASIL vaccine (yeast) (lot #655617/1447F, 657617/0384U and 658222/0927U), respectively. The RN reported that a week and one half after the second dose, on approximately 17-APR-2007 the patient developed flu like symptoms with body ache. Following the third dose of GGARDASIL vaccine (yeast), the patient developed joint swelling and pain with muscle weakness that started in November of 2007. The symptoms got progressively worse to the joint where the patient could not walk. The patient consulted an infectious disease specialist, various testing were performed but the results were negative. The joint swelling and pain with muscle weakness was continued to present. The patient  presently was "better" as far as the joint pain, but still had mild joint pain and muscle weakness. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Pain
Clinical narrative: Information has been received from a physician and a registered nurse (RN) concerning a 17 year old female who on 31-JAN-2007, 07-APR-2007 and 07-AUG-2007 was vaccinated with a 0.5 ml first, second and third doses of GARDASIL vaccine (yeast) (lot #655617/1447F, 657617/0384U and 658222/0927U), respectively. The RN reported that a week and one half after the second dose, on approximately 17-APR-2007 the patient developed flu like symptoms with body ache. Following the third dose of GGARDASIL vaccine (yeast), the patient developed joint swelling and pain with muscle weakness that started in November of 2007. The symptoms got progressively worse to the joint where the patient could not walk. The patient consulted an infectious disease specialist, various testing were performed but the results were negative. The joint swelling and pain with muscle weakness was continued to present. The patient  presently was "better" as far as the joint pain, but still had mild joint pain and muscle weakness. Additional information has been requested.
Age: 33.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA, IPV, MMR, MNQ, PPV, TTOX, TYP, YF
Symptoms: Activities of daily living impaired, Anxiety, Depression, Electromyogram abnormal, Essential tremor
Clinical narrative: On 9 Jan 2003 he received 11 vaccines while preparing for foreign travel: Patient states that tremors started in right hand the next day on 10 Jan 03 (medical records confirm this). He was experiencing anxiety problems at the time and was sent to another location where the tremor was diagnosed as 'benign idiopathic tremor' (no records available). He was subsequently hospitalized for anxiety and depression for 2 months and release from activity duty. His tremor was then thought to be related to anxiety. The right hand tremor continued and then a new tremor started in left hand and left foot one year later. The tremors have been unchanged since 2004. He states the symptoms wax and wane in intensity and often interfere with work as electronic technician. He has fallen in the past from the leg tremors. His spouse says he does not have tremor during sleep. The tremor worsens with concentrated use of the hand or foot such as when using tools, typing, using a mouse, holding a fork, or when driving and using a clutch or climbing a ladder.  Symptoms: Tremors.
Age: 33.0
Sex: M
Vaccine: ANTH, FLU3, HEP, HEPA, IPV, MMR, MNQ, PPV, TTOX, TYP, YF
Symptoms: Fall
Clinical narrative: On 9 Jan 2003 he received 11 vaccines while preparing for foreign travel: Patient states that tremors started in right hand the next day on 10 Jan 03 (medical records confirm this). He was experiencing anxiety problems at the time and was sent to another location where the tremor was diagnosed as 'benign idiopathic tremor' (no records available). He was subsequently hospitalized for anxiety and depression for 2 months and release from activity duty. His tremor was then thought to be related to anxiety. The right hand tremor continued and then a new tremor started in left hand and left foot one year later. The tremors have been unchanged since 2004. He states the symptoms wax and wane in intensity and often interfere with work as electronic technician. He has fallen in the past from the leg tremors. His spouse says he does not have tremor during sleep. The tremor worsens with concentrated use of the hand or foot such as when using tools, typing, using a mouse, holding a fork, or when driving and using a clutch or climbing a ladder.  Symptoms: Tremors.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Smear cervix abnormal
Clinical narrative: Information has been received from a physician concerning a female who on 16-FEB-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot No. 655619/1427F and on 19-JUN-2007 was vaccinated with the second dose of GARDASIL vaccine (yeast). On 27-AUG-2007 were received results back from a PAP that was abnormal. It was unclear whether or not the patient had the third dose of GARDASIL vaccine (yeast). The patient sought medical attention. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Pancreatitis, Red blood cell sedimentation rate increased, White blood cell count increased
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 concerning a 16 year old female with low blood who on 23-MAY-2008 completed the series of GARDASIL (lot number 660391/0063X). Concomitant therapy included ORTHO EVRA and ZOMIG. The patient was hospitalized for 5 days, from 02-JUL-2008 to 07-JUL-2008, for severe, first-ever pancreatitis. The diagnosis was Acute pancreatitis possibly secondary to hypertriglyceridaemia. The patient also experienced mild iron deficiency anemia, obesity, protein malnutrition, fevers, elevated inflammatory markers, dyslipidaemia and complained of one day history of severe abdominal pain. On 04-AUG-2008 records received showed the following laboratory test, white blood cell count: 21.1, erythrocyte sedimentation rate: 55, f serum cholesterol test: 223, serum triglyceride test: 260, serum high-density lipoprotein cholesterol test: 62, serum low-density lipoprotein cholesterol test: 109, blood hemoglobin test: 12.5, blood chemistry: normal, hepatic function tests: elevated, serum amylase test: 112, white blood cell count: 20,000, pancreatic abdominal computed axial tomography consistent with pancreatitis. The patients was recovering from elevated inflammatory markers. The patient's older sister had pancreatitis at roughly the same age and was recently diagnosed with pancreatitis and diabetes mellitus. Mild iron deficiency anaemia, acute pancreatitis, severe abdominal pain, dyslipidaemia, hypertriglyceridaemia, elevated inflammatory markers, protein malnutrition, obesity and fever were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 319654-1. A standard lot check investigation was performed. All in-process quality checks for the lot # 660391/0063X 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 and was released. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Abdominal pain, Blood amylase, Blood cholesterol increased, Blood triglycerides increased, Computerised tomogram 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 concerning a 16 year old female with low blood who on 23-MAY-2008 completed the series of GARDASIL (lot number 660391/0063X). Concomitant therapy included ORTHO EVRA and ZOMIG. The patient was hospitalized for 5 days, from 02-JUL-2008 to 07-JUL-2008, for severe, first-ever pancreatitis. The diagnosis was Acute pancreatitis possibly secondary to hypertriglyceridaemia. The patient also experienced mild iron deficiency anemia, obesity, protein malnutrition, fevers, elevated inflammatory markers, dyslipidaemia and complained of one day history of severe abdominal pain. On 04-AUG-2008 records received showed the following laboratory test, white blood cell count: 21.1, erythrocyte sedimentation rate: 55, f serum cholesterol test: 223, serum triglyceride test: 260, serum high-density lipoprotein cholesterol test: 62, serum low-density lipoprotein cholesterol test: 109, blood hemoglobin test: 12.5, blood chemistry: normal, hepatic function tests: elevated, serum amylase test: 112, white blood cell count: 20,000, pancreatic abdominal computed axial tomography consistent with pancreatitis. The patients was recovering from elevated inflammatory markers. The patient's older sister had pancreatitis at roughly the same age and was recently diagnosed with pancreatitis and diabetes mellitus. Mild iron deficiency anaemia, acute pancreatitis, severe abdominal pain, dyslipidaemia, hypertriglyceridaemia, elevated inflammatory markers, protein malnutrition, obesity and fever were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 319654-1. A standard lot check investigation was performed. All in-process quality checks for the lot # 660391/0063X 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 and was released. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Dyslipidaemia, Haemoglobin normal, High density lipoprotein increased, Hypertriglyceridaemia, Inflammation
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 concerning a 16 year old female with low blood who on 23-MAY-2008 completed the series of GARDASIL (lot number 660391/0063X). Concomitant therapy included ORTHO EVRA and ZOMIG. The patient was hospitalized for 5 days, from 02-JUL-2008 to 07-JUL-2008, for severe, first-ever pancreatitis. The diagnosis was Acute pancreatitis possibly secondary to hypertriglyceridaemia. The patient also experienced mild iron deficiency anemia, obesity, protein malnutrition, fevers, elevated inflammatory markers, dyslipidaemia and complained of one day history of severe abdominal pain. On 04-AUG-2008 records received showed the following laboratory test, white blood cell count: 21.1, erythrocyte sedimentation rate: 55, f serum cholesterol test: 223, serum triglyceride test: 260, serum high-density lipoprotein cholesterol test: 62, serum low-density lipoprotein cholesterol test: 109, blood hemoglobin test: 12.5, blood chemistry: normal, hepatic function tests: elevated, serum amylase test: 112, white blood cell count: 20,000, pancreatic abdominal computed axial tomography consistent with pancreatitis. The patients was recovering from elevated inflammatory markers. The patient's older sister had pancreatitis at roughly the same age and was recently diagnosed with pancreatitis and diabetes mellitus. Mild iron deficiency anaemia, acute pancreatitis, severe abdominal pain, dyslipidaemia, hypertriglyceridaemia, elevated inflammatory markers, protein malnutrition, obesity and fever were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 319654-1. A standard lot check investigation was performed. All in-process quality checks for the lot # 660391/0063X 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 and was released. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Iron deficiency anaemia, Laboratory test normal, Liver function test abnormal, Low density lipoprotein normal, Malnutrition
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 concerning a 16 year old female with low blood who on 23-MAY-2008 completed the series of GARDASIL (lot number 660391/0063X). Concomitant therapy included ORTHO EVRA and ZOMIG. The patient was hospitalized for 5 days, from 02-JUL-2008 to 07-JUL-2008, for severe, first-ever pancreatitis. The diagnosis was Acute pancreatitis possibly secondary to hypertriglyceridaemia. The patient also experienced mild iron deficiency anemia, obesity, protein malnutrition, fevers, elevated inflammatory markers, dyslipidaemia and complained of one day history of severe abdominal pain. On 04-AUG-2008 records received showed the following laboratory test, white blood cell count: 21.1, erythrocyte sedimentation rate: 55, f serum cholesterol test: 223, serum triglyceride test: 260, serum high-density lipoprotein cholesterol test: 62, serum low-density lipoprotein cholesterol test: 109, blood hemoglobin test: 12.5, blood chemistry: normal, hepatic function tests: elevated, serum amylase test: 112, white blood cell count: 20,000, pancreatic abdominal computed axial tomography consistent with pancreatitis. The patients was recovering from elevated inflammatory markers. The patient's older sister had pancreatitis at roughly the same age and was recently diagnosed with pancreatitis and diabetes mellitus. Mild iron deficiency anaemia, acute pancreatitis, severe abdominal pain, dyslipidaemia, hypertriglyceridaemia, elevated inflammatory markers, protein malnutrition, obesity and fever were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 319654-1. A standard lot check investigation was performed. All in-process quality checks for the lot # 660391/0063X 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 and was released. No further information is available.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Obesity, Pancreatitis acute, Pyrexia, Red blood cell sedimentation rate increased, Total cholesterol/HDL ratio normal
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 concerning a 16 year old female with low blood who on 23-MAY-2008 completed the series of GARDASIL (lot number 660391/0063X). Concomitant therapy included ORTHO EVRA and ZOMIG. The patient was hospitalized for 5 days, from 02-JUL-2008 to 07-JUL-2008, for severe, first-ever pancreatitis. The diagnosis was Acute pancreatitis possibly secondary to hypertriglyceridaemia. The patient also experienced mild iron deficiency anemia, obesity, protein malnutrition, fevers, elevated inflammatory markers, dyslipidaemia and complained of one day history of severe abdominal pain. On 04-AUG-2008 records received showed the following laboratory test, white blood cell count: 21.1, erythrocyte sedimentation rate: 55, f serum cholesterol test: 223, serum triglyceride test: 260, serum high-density lipoprotein cholesterol test: 62, serum low-density lipoprotein cholesterol test: 109, blood hemoglobin test: 12.5, blood chemistry: normal, hepatic function tests: elevated, serum amylase test: 112, white blood cell count: 20,000, pancreatic abdominal computed axial tomography consistent with pancreatitis. The patients was recovering from elevated inflammatory markers. The patient's older sister had pancreatitis at roughly the same age and was recently diagnosed with pancreatitis and diabetes mellitus. Mild iron deficiency anaemia, acute pancreatitis, severe abdominal pain, dyslipidaemia, hypertriglyceridaemia, elevated inflammatory markers, protein malnutrition, obesity and fever were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 319654-1. A standard lot check investigation was performed. All in-process quality checks for the lot # 660391/0063X 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 and was released. No further information is available.