chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Fatigue, Feeling abnormal, Headache, Impaired work ability, Incoherent
Clinical narrative: Dizziness, chronic flu like symptoms, progressive fatigue, joint & muscle pain-severe pain throughout body- headaches & throbbing, brain fog, body throbbing. Disorientation, memory loss-unable to formulate words or think coherently, "brain fog"- heart palpitations, nausea, inability to perform job, insomnia-inability to function-many days would remain in bed, feeling like I had been hit or run over by a truck- constant feeling that I was going to cry & frequent weeping, social isolation, severe anxiety & depression.  8/27/09 PCP medical records received 8/7/03 to 10/03/05. Assessment: musculoskeletal pain. Patient presents with post traumatic stress, hypoglycemia, insomnia, menopause and diffuse musculoskeletal pain. Low energy, feels like crying. achy. Acupuncture treatment.  Melanoma dx'd on back - surgery.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Influenza like illness, Insomnia, Myalgia, Nausea, Pain
Clinical narrative: Dizziness, chronic flu like symptoms, progressive fatigue, joint & muscle pain-severe pain throughout body- headaches & throbbing, brain fog, body throbbing. Disorientation, memory loss-unable to formulate words or think coherently, "brain fog"- heart palpitations, nausea, inability to perform job, insomnia-inability to function-many days would remain in bed, feeling like I had been hit or run over by a truck- constant feeling that I was going to cry & frequent weeping, social isolation, severe anxiety & depression.  8/27/09 PCP medical records received 8/7/03 to 10/03/05. Assessment: musculoskeletal pain. Patient presents with post traumatic stress, hypoglycemia, insomnia, menopause and diffuse musculoskeletal pain. Low energy, feels like crying. achy. Acupuncture treatment.  Melanoma dx'd on back - surgery.
Age: 45.0
Sex: F
Vaccine: LYME
Symptoms: Palpitations, Social avoidant behaviour, Speech disorder
Clinical narrative: Dizziness, chronic flu like symptoms, progressive fatigue, joint & muscle pain-severe pain throughout body- headaches & throbbing, brain fog, body throbbing. Disorientation, memory loss-unable to formulate words or think coherently, "brain fog"- heart palpitations, nausea, inability to perform job, insomnia-inability to function-many days would remain in bed, feeling like I had been hit or run over by a truck- constant feeling that I was going to cry & frequent weeping, social isolation, severe anxiety & depression.  8/27/09 PCP medical records received 8/7/03 to 10/03/05. Assessment: musculoskeletal pain. Patient presents with post traumatic stress, hypoglycemia, insomnia, menopause and diffuse musculoskeletal pain. Low energy, feels like crying. achy. Acupuncture treatment.  Melanoma dx'd on back - surgery.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray abnormal, Chills, Cough, Pyrexia, Rales
Clinical narrative: Pt. presented to clinic Aug. 04/09 - Symptoms had started 2 days prior - fever, chills, cough. PE - (+) Left lower lobe rales - treated with BIAXIN XL, Albuterol.
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: White blood cell count normal
Clinical narrative: Pt. presented to clinic Aug. 04/09 - Symptoms had started 2 days prior - fever, chills, cough. PE - (+) Left lower lobe rales - treated with BIAXIN XL, Albuterol.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Foaming at mouth, Loss of consciousness, Pallor, Posturing, Tremor
Clinical narrative: After receiving Tdap, VZV, MENACTRA (in this order), client immed. lost consciousness, color very pale, had posturing of upper extremities followed by shaking of arms and legs and foaming @ the mouth lasting < 5 seconds. No incontinence of urine or stool. Had not eaten before vaccines.
Age: 0.4
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Body temperature increased, Injection site mass, Irritability
Clinical narrative: Quarter size lump R. leg sm Lump on L Leg. Temp. 101.8 very cranky.
Age: 0.11
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Influenza like illness, Pyrexia, Similar reaction on previous exposure to drug
Clinical narrative: Pt received TDAP 8/4/09 @ 3:50 PM.  On 8/6/09 flu like symptoms (dizzy, fever 101).  Symptoms cleared same day.  Similar reaction in past (per mom) to TD.
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Dizziness, Dyspnoea, Ear discomfort, Headache, Heart rate increased
Clinical narrative: Started feeling dizzy, ears felt plugged, then started with headache, + started having breathing difficulty.  EPIPEN given 0.3 ml @ 1:44 PM vitals P-100, B/D 120/60 R 22,
Age: 17.0
Sex: F
Vaccine: HEP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Respiratory rate increased, Vital capacity
Clinical narrative: Started feeling dizzy, ears felt plugged, then started with headache, + started having breathing difficulty.  EPIPEN given 0.3 ml @ 1:44 PM vitals P-100, B/D 120/60 R 22,
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Erythema, Induration, Oedema peripheral, Skin warm
Clinical narrative: Mom and daughter back today. Patient (R) arm red, swollen, hot, hard to touch. Mother states patient has allergies to NEOSPORIN down latex? 100m x 120m - reaction site Started 8/4/09 around 1000 mm mother gave TYLENOL 500 mg this AM referred to PCP or ER for follow - up.
Age: 46.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swollen, redness, warm, mainly on underside, but on outer aspect as well - elbow to shoulder; somewhat hardened to touch - compared to other arm.  No skin eruptions - smooth.  0 fever, 0 diff breathing or increased HR.  SXs still present.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site scab
Clinical narrative: Painful 4.5 cm X 4.5 cm Red Raised area Right arm deltoid area noted 8/11/09 12:30 PM - Ibuprofen as needed for pain - Cool compresses as needed - Continue to monitor - Return child to office if worse
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC
Symptoms: Contusion, Erythema, Mass, Pyrexia
Clinical narrative: 4 x 3 cm Reddened with lump under skin. Bruise in center. Fever of 100.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site scab
Clinical narrative: Red, scabbed dots upper R arm.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Received vaccine 2/1/8 but developed shingles 7/8/9 anyway.
Age: 41.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Influenza serology negative, Oropharyngeal blistering, Pyrexia, Streptococcal identification test negative
Clinical narrative: 6/12 by history hives like rash, fever, watery blisters mostly above waist & watery blisters down throat.  Seen in ER 6/12/09 flu & strep negative.
Age: 41.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: 6/12 by history hives like rash, fever, watery blisters mostly above waist & watery blisters down throat.  Seen in ER 6/12/09 flu & strep negative.
Age: 1.3
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Gait disturbance, Irritability, Pain in extremity
Clinical narrative: Irritable leg pain, limping, unsteady gait - refusing to walk.
Age: 10.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Skin warm, Swelling
Clinical narrative: Swelling, warm.  TX:  KEFLEX, BENADRYL, cool compress.
Age: 1.3
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Convulsion, Pyrexia
Clinical narrative: Pt. ran fever 6 hours after vaccines of over 105 degrees & was seizing.  Parents took child to E.R. where fever & seizures were controlled & child was released.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Feeling hot, Oedema peripheral, Pain
Clinical narrative: Presents to clinic today, 8/3/09, c/o (L) upper arm swelling and heat. Upon assessment, (L) upper arm swollen, hot to touch, and client c/o pain only when touched. Denies pain any other time. Parent states giving MOTRIN Q6H. Advised to continue and use warm compresses.
Age: 13.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Client reports left arm started swelling and turning red 1 day (7/21/09) after MCV4 and VARICELLA administered.  Reports slight pain to left arm.  Came into clinic today (7/23/09) for guidance on how to treat.  Left arm obviously swollen, hot to touch, no redness noted.  Client denies pain at this time.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Blister, Rash papular, Scab, Skin lesion, Urticaria
Clinical narrative: Lesions noted 2 days prior to visit - described as different crops of lesions at one time from papular and urticaria - like to vesicles, some popped out and crusting.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Blister, Oropharyngeal pain, Rash, Rash papular, Rhinorrhoea
Clinical narrative: 3 days ago developed rashes with different lesions at the same time from papular, to vesicle to crusts it pock lesions. runny nose & sore throat also noted.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Skin lesion
Clinical narrative: 3 days ago developed rashes with different lesions at the same time from papular, to vesicle to crusts it pock lesions. runny nose & sore throat also noted.
Age: 1.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Blister, Rash papular, Urticaria
Clinical narrative: Vesicular lesions together w/crusted over and new papular and some urticaria-like lesions all over trunk, few on neck, and all over leg X 6 days now.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Dizziness, Headache, Nausea, Oropharyngeal pain, Streptococcal identification test negative
Clinical narrative: Pt vaccinated 8-5-09.  Onset 8-6-09 with headaches sore throat, nausea and congestion.  On 8-11-09 seen at local walk-n clinic now complaining of dizzyness, and other symptoms described.  No fever, Negative Step.  Encouraged ACETAMINOPHEN and fluids.
Age: 15.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Upper respiratory tract congestion
Clinical narrative: Pt vaccinated 8-5-09.  Onset 8-6-09 with headaches sore throat, nausea and congestion.  On 8-11-09 seen at local walk-n clinic now complaining of dizzyness, and other symptoms described.  No fever, Negative Step.  Encouraged ACETAMINOPHEN and fluids.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cough, Dysphagia, Dyspnoea, Nasoendoscopy, Pyrexia
Clinical narrative: 19th July, Fever, unable to swallow or breathe for a minute or two. 28th July, Unable to swallow/breathe for a minute or two after lying down. Coughing constantly. Rash started 30th July on trunk, arms and thighs - still active daily as of 13th August.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: 19th July, Fever, unable to swallow or breathe for a minute or two. 28th July, Unable to swallow/breathe for a minute or two after lying down. Coughing constantly. Rash started 30th July on trunk, arms and thighs - still active daily as of 13th August.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Cough, Dysphagia, Dyspnoea, Pyrexia
Clinical narrative: 19th July, Fever, unable to swallow or breathe for a minute or two. 28th July, Unable to swallow/breathe for a minute or two after lying down. Coughing constantly. Rash started 30th July on trunk, arms and thighs - still active daily as of 13th August.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Abdominal discomfort, Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: 26 hrs. later I got the chills (6pm) by 8pm I had a fever.  About 3 AM came the upset stomach- The fever lasted until 8:30 AM of the 1st of August.  Arm turned red where shot was given + very painfull to the touch.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness, great deal of swelling (right arm looked as if a had a huge tumor hanging off it!!), (lasted approx. 4 days). I took a BENADRYL 1 tablet each night at bed time.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Joint swelling, Local swelling, Lymphadenopathy
Clinical narrative: Pt reported swelling in same side upper body to include neck shoulder with enlarged glands within 24 hrs after IZ, worse at 48 hours after IZ. Seen 72 hours after IZ with soft tissue (R) neck swelling and (+) supra clavicular, (+) ant cervical nodes, (-) erythema, (-) Fever, Pt has F/U appt for repeat clinical exam.
Age: 1.29
Sex: F
Vaccine: HEPA, MMR, PNC, TDAP, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: No known adverse reaction.  Tdap administered along with MMR, Varicella, Hep A,  PCV7, to soon for vaccines.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Skin warm, Vision blurred
Clinical narrative: 12 minutes after injection patient  got warm, vision blurred, then nausea.  Pt was laid down with cool wash cloth + given juice.  Pt was slowly sat up at different levels until sitting straight over a 10 minute time frame.  Pt warm 15 more minutes then left with self. since she had no more side effects.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Anorexia, Diarrhoea, Weight decreased
Clinical narrative: Excessive diarrhea - watery. X 2/ 8-10. X 3 + 8-11. Anorexic.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 8/7/09. c/o redness. Swelling and sore are left lower arm 8/8/09. Area on left lower arm red and raised 3 inches in length and 1 1/2 inches wide. Called family physician and instructed to give TYLENOL and contact HCHD. 8/9/09, Area remains the same. TYLENOL continued. 8/10/09, Redness and swelling resolving still c/o soreness. Health department contacted.
Age: 11.0
Sex: U
Vaccine: TDAP, VARCEL
Symptoms: Chills, Decreased appetite, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Varicella vaccine administered 8/7/09. That evening had fever/chills - slight redness at site. Over next 48-72 hours redness at site increased, swelling and tenderness increased. Mother explained pt had decrease pain - was itchy at site. Fever 102 8/8 and 8/9, decrease appetite - exam in office 8/10/09. non-toxic, erythematous - no vesicles - large 15 x 16 cm irregular erythematous area - RUE very tender.
Age: 11.0
Sex: U
Vaccine: TDAP, VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Varicella vaccine administered 8/7/09. That evening had fever/chills - slight redness at site. Over next 48-72 hours redness at site increased, swelling and tenderness increased. Mother explained pt had decrease pain - was itchy at site. Fever 102 8/8 and 8/9, decrease appetite - exam in office 8/10/09. non-toxic, erythematous - no vesicles - large 15 x 16 cm irregular erythematous area - RUE very tender.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Cough, Dysphonia, Headache, Injection site papule, Pyrexia
Clinical narrative: COUGH(WHOOPING COUGH LIKE SYMPTOMS),HEADACHE,HOARSENESS FOR HALF A DAY,COUGHING MORE,LITTLE SMALL BUMPS AROUND INJECTION SITE ON RIGHT LEG(NOT LIKE A RASH)MAJORITY OF BUMPS WENT AWAY,HEAD ACHE WENT AWAY,BUT STILL HAVE A MILD FEVER,STILL COUGHING
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Rash papular
Clinical narrative: COUGH(WHOOPING COUGH LIKE SYMPTOMS),HEADACHE,HOARSENESS FOR HALF A DAY,COUGHING MORE,LITTLE SMALL BUMPS AROUND INJECTION SITE ON RIGHT LEG(NOT LIKE A RASH)MAJORITY OF BUMPS WENT AWAY,HEAD ACHE WENT AWAY,BUT STILL HAVE A MILD FEVER,STILL COUGHING
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Blood sodium decreased, C-reactive protein increased, Platelet count decreased, Pyrexia, Rash erythematous
Clinical narrative: Difused rash, erythemaos, macular, papular,raised,urticarialand fever 101.3F. Onset occurred acutely 08/12/2009.  9/14/09 ICD-9 Codes: 782.1 Rash and nonspecific skin eruption, 780.60 Fever unspecified.  10/2/09 Received ER medical records of 8/16/09. FINAL DX: rach, febrile illness w/o source Records reveal patient experienced diffuse erythematous maculopapular urticarial rash x 4 days w/fever.  Improved w/tx & d/c to home.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Rash maculo-papular, Urticaria
Clinical narrative: Difused rash, erythemaos, macular, papular,raised,urticarialand fever 101.3F. Onset occurred acutely 08/12/2009.  9/14/09 ICD-9 Codes: 782.1 Rash and nonspecific skin eruption, 780.60 Fever unspecified.  10/2/09 Received ER medical records of 8/16/09. FINAL DX: rach, febrile illness w/o source Records reveal patient experienced diffuse erythematous maculopapular urticarial rash x 4 days w/fever.  Improved w/tx & d/c to home.
Age: 83.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: TD vaccine ordered and TDAP give in errorl
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Nausea, Pulse pressure decreased, Shock, Vomiting
Clinical narrative: Patient became light headed, dizzy w/ nausea & vomiting.  Shock-like reactionl.  Light pulse w/ blood pressure 98/66.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pain, Pyrexia
Clinical narrative: Fever of 102. Body aches. Both starting around midnight. Treatment - alternating Tylenol and Advil every 2 hours until fever resolves.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Convulsion, Gaze palsy, Musculoskeletal stiffness
Clinical narrative: After completion of vaccinations patient slumped on exam table, and then began to convulse with eyes rolling in the back of his head.  His arms raised by his side and tightened.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 3x5 inch area in SQ tissue on back of upper arm from below deltoid to elbow, firm, raised, red and very warm to touvh. Also tender to touch.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: 3x5 inch area in SQ tissue on back of upper arm from below deltoid to elbow, firm, raised, red and very warm to touvh. Also tender to touch.
Age: 2.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Wrong technique in drug usage process
Clinical narrative: HIB dilute with wrong solution. No adverse reaction. DOB was listed on hardcopy form as 07/10/1980 for a child with a patient age of 2 years.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth, Pain
Clinical narrative: At approximately 2100, Pt complained of pain to his left arm where he stated he received a Pneumonia Vaccination during the previous shift.  His nurse examined his arm and found edema, erythema, warmth, and induration at his L Deltoid. The sitting Charge Nurse was notified, and patient's physician was notified. Md ordered Ibuprofen 600mg, and Codeine 1 tab together with a cold compress to affected area.
Age: 0.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ataxia, Febrile convulsion, Polymerase chain reaction, Pyrexia
Clinical narrative: Child developed fever with 24 hours of vaccine.  Two days after vaccine developed ataxia.  Was admitted to hospital for ataxia and had multiple febrile seizures there.  supportive care in hospital (IV fluids, cooling blanket).  Had PCR for HHV6 positive during hospital stay believed to be source for fever and ataxia.  8/24/09 Received hospital medical records for 7/20-24/2009. FINAL DX: ataxia, febrile seizure, roseola d/t hhv-6 Records reveal patient experienced fever, ataxia 4 days s/p vaccination.  Admitted for observation & rehydration.  Had self-resolving seizure lasting 1-2 min w/cyanosis.  Developed lacy erythematous rash on trunk c/w roseola.  Neuro consult done.  Slowly improved & referred to outpatient PT
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Significant skin reaction at site of injection. Started 24 to 36 hours after receiving injection. 3 inch circumference site with raised hardened red skin. Appears to be self limiting and resolving when reported to pharmacy on 08/15/2009.
Age: 16.0
Sex: F
Vaccine: HPVX
Symptoms: Cardiac murmur, Chest pain, Condition aggravated, Costochondritis, Echocardiogram
Clinical narrative: Ongoing chest pain intermittently since the vaccine administration consistent with costochodritis, patient has a mvp that appears to have worsened with a louder murmur, will obtain echocardiogram
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Localized - Red, swelling, warmth to touch, 3" diameter R thigh, 1" L thigh - Treatment 12.5 mg Benedryl
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient has a reddened area at injection site that is slightly itchy.
Age: 31.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Patien developed rash approximately two inches in are on right deltoid one day after receiving the Anthrax immunization. Patient stated that are was warm and itchy. Pateient was prescribed benadryl, topical steriod cream and placed on nquarters for 24hrs.
Age: 49.0
Sex: F
Vaccine: DT
Symptoms: Diarrhoea, Fatigue, Head discomfort, Headache, Nausea
Clinical narrative: Patient states that she suffered from posterior headaches describes as heaviness, nausea, diarrhea, and fatigue. Thinks she may have had a low grade fever. The nausea and diarrhea resolved within a couple days. Headache ongoing, but improving.
Age: 49.0
Sex: F
Vaccine: DT
Symptoms: Pyrexia
Clinical narrative: Patient states that she suffered from posterior headaches describes as heaviness, nausea, diarrhea, and fatigue. Thinks she may have had a low grade fever. The nausea and diarrhea resolved within a couple days. Headache ongoing, but improving.
Age: 15.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Amnesia, Blood pressure decreased, Convulsion, Gaze palsy, Hyperhidrosis
Clinical narrative: After receiving 2nd injection (MMR) the client slumped over in the chair, his eyes rolled in the back of his head, he started to shake similar to a seizure.  Mom requested that I call 911, so I did.  His BP was 68/50, very pale and diaphoretic.  No hx of fainting after imm., no history of seizure.  Client stated that his vision was impaired and does not remember what happened after the injection.  Ambulance came and he was transported to hospital per mom's request.  Client's color was returning and he was in good spirits as he left.
Age: 15.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Pallor, Tremor, Visual impairment
Clinical narrative: After receiving 2nd injection (MMR) the client slumped over in the chair, his eyes rolled in the back of his head, he started to shake similar to a seizure.  Mom requested that I call 911, so I did.  His BP was 68/50, very pale and diaphoretic.  No hx of fainting after imm., no history of seizure.  Client stated that his vision was impaired and does not remember what happened after the injection.  Ambulance came and he was transported to hospital per mom's request.  Client's color was returning and he was in good spirits as he left.
Age: 12.0
Sex: F
Vaccine: FLUX, MEN, PPV
Symptoms: Erythema, Induration, Mass, Pain, Pyrexia
Clinical narrative: Redness, painful hard lump with Pneumovax. Fever of 101.8. Vomiting
Age: 12.0
Sex: F
Vaccine: FLUX, MEN, PPV
Symptoms: Vomiting
Clinical narrative: Redness, painful hard lump with Pneumovax. Fever of 101.8. Vomiting
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Blindness, Blood glucose normal, Cold sweat, Feeling cold, Lethargy
Clinical narrative: AFTER RECEIVING 1ST GARDASIL VACCINE, PT AND MOTHER RETURNED TO CHECK-OUT WINDOW AND STATED THE PT "COULDN'T SEE." PT BROUGHT BACK TO TRIAGE ROOM WHERE SHE WAS VERY COOL, CLAMMY, AND LETHARGIC. SHE WAS TAKEN BACK TO EXAM ROOM AND WAS BEING HELPED UP ON TABLE WHEN SHE PASSED OUT. PT DID NOT FALL SINCE NURSE AND MOTHER WERE ASSISTING HER. PHYSICIAN MADE AWARE AND WENT TO EXAMINE PT. SHE SOON AWOKE WHILE HE WAS PERFORMING ASSESSMENT. PT RESTED FOR 15 MINS AND WAS ABLE TO WALK AROUND IN HALLWAY BEFORE LEAVING BUILDING.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: AFTER RECEIVING 1ST GARDASIL VACCINE, PT AND MOTHER RETURNED TO CHECK-OUT WINDOW AND STATED THE PT "COULDN'T SEE." PT BROUGHT BACK TO TRIAGE ROOM WHERE SHE WAS VERY COOL, CLAMMY, AND LETHARGIC. SHE WAS TAKEN BACK TO EXAM ROOM AND WAS BEING HELPED UP ON TABLE WHEN SHE PASSED OUT. PT DID NOT FALL SINCE NURSE AND MOTHER WERE ASSISTING HER. PHYSICIAN MADE AWARE AND WENT TO EXAMINE PT. SHE SOON AWOKE WHILE HE WAS PERFORMING ASSESSMENT. PT RESTED FOR 15 MINS AND WAS ABLE TO WALK AROUND IN HALLWAY BEFORE LEAVING BUILDING.
Age: 5.0
Sex: M
Vaccine: FLUN3, HEPA
Symptoms: Abdominal pain upper, Anorexia, Headache, Lethargy, Pyrexia
Clinical narrative: Patient developed a fever, headache, stomach ache, lethargy and loss of appetite approx. 40 hours after receiving vaccination.  The fever lasted for 3.5 days, spiking at 103.4 degrees F 4.5 days after vaccination.  Headache, stomach ache and loss of appetite lasted 3 days; lethargy lasted 4 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: URTICARIAL LESIONS ON FACE, EXTREMETIES (+)PRURITUS ON SET OF RASH < 24 HOURS WITH VACCINE ADMINISTRATIO. NO HISTORY OF NEW SOAPS, LOTIONS, FOODS, MEDS, DETERGANTS.  TREATED WITH ATARAX 10MG/5ML 5ML TID (+) PREDNISOLONE 5MG/5ML 10 ML BID X 5 DAYS.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Left lateral thigh was swollen, red, firm to touch and painful area 9cm x 7.5cm in size.  Fever up to 102F the evening after injection 8/12/09 and the next day.  Treatment plan Motrin dose for age prn for pain and fever, Benadryl dose for size prn and cold compress to area.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: On 8/15/09 about 6:00pm child developed fever  and was taken to ER where parents were told his fever was 104.5 degrees fahrenheit. Child was tested for pnuemonia, ear infection, and strep throat. ER physician told parents the etiology of child's fever unknown.As of 8/17/09 child continues to run fever parents are alternating giving tylenol and Ibuprofen. Mother doesn't know what the fever was today. Mother to take child to his private physician and notify RN of diagnosis.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: Localized inflammatory reaction of skin.  No systemic manifestations.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: None reported
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: 1 week after receiving Zostavax, onset of erythemic maculopapular lesions and erythemic patches to left neck, bilateral lower chest, right lower abd, and superior medial thighs; no vesicles; no dermatomal pattern of lesions; lesions more consistent with contact dermatitis, but without identifiable trigger; lesions do not resemble varicella or herpes zoster;
Age: 0.3
Sex: M
Vaccine: DTPPHIB, PNC, RV1
Symptoms: Barium enema, Diarrhoea, Full blood count, Haematochezia, Intussusception
Clinical narrative: THE PATIENT PRESENTED WITH DIARRHEA ON AUG 11, 2209. BECAUSE OF PERSITENT DIARRHEA, PATIENT WENT TO ER AT HOSPITAL AND WAS TRANSFERRED TO ANOTHER HOSPITAL. THE PATIENT WAS WORKED UP AND REHYDRATED. ON DAY 3 OF HOSPITALIZATION,THE PATIENT HAD EMESIS AND BLOODY STOOLS. HE WAS DIAGNOSED AS HAVING INTUSSUSCEPTION AND WAS REDUCED WITH Ba ENEMA. THE PATIENT WAS DISCHARGED NEXT DAY.  9/3/09 Hospital records received DOS 8/11/09 to 8/14/2009. Assessment: Dehydration, Gastroenteritis, Intussusception. Patient was seen at outside ED, given bolus of fluids and transfered. Patient presented on the day of admission with a 2 day history of diarrhea and a one day history of vomiting. Increased output of mucosy blood-tinged stools. Decreased PO intake and urine output, not producing tears, pale. Lethargic. Belly distended and tender. Reduction of intussusception with barium enema.  ICD-9 Codes: 276.51 Dehydration, 558.9Y Gastroenteritis, 560.0 Intussusception.
Age: 0.3
Sex: M
Vaccine: DTPPHIB, PNC, RV1
Symptoms: Metabolic function test, Vomiting
Clinical narrative: THE PATIENT PRESENTED WITH DIARRHEA ON AUG 11, 2209. BECAUSE OF PERSITENT DIARRHEA, PATIENT WENT TO ER AT HOSPITAL AND WAS TRANSFERRED TO ANOTHER HOSPITAL. THE PATIENT WAS WORKED UP AND REHYDRATED. ON DAY 3 OF HOSPITALIZATION,THE PATIENT HAD EMESIS AND BLOODY STOOLS. HE WAS DIAGNOSED AS HAVING INTUSSUSCEPTION AND WAS REDUCED WITH Ba ENEMA. THE PATIENT WAS DISCHARGED NEXT DAY.  9/3/09 Hospital records received DOS 8/11/09 to 8/14/2009. Assessment: Dehydration, Gastroenteritis, Intussusception. Patient was seen at outside ED, given bolus of fluids and transfered. Patient presented on the day of admission with a 2 day history of diarrhea and a one day history of vomiting. Increased output of mucosy blood-tinged stools. Decreased PO intake and urine output, not producing tears, pale. Lethargic. Belly distended and tender. Reduction of intussusception with barium enema.  ICD-9 Codes: 276.51 Dehydration, 558.9Y Gastroenteritis, 560.0 Intussusception.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Oedema peripheral
Clinical narrative: R arm 7.0 x 6.0 cm wider.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Raised red blotchy rash at site of injection.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Swollen and red left arm.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Lymphadenopathy, Nausea, Pain, Vomiting
Clinical narrative: Vaccine on 8-7-09. 8-10-09 elevated temp 104, nausea, vomiting (x1) severe nausea sore. No diarrhea. No local reaction. Swollen glands.  BRAT diet, elevated fluids, Prilosec OTC OD.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Grand mal convulsion, Postictal state
Clinical narrative: 20 m after given GARDASIL, had 20- second ser. tonic - clonic sz with mild postictal phase > 10m after.
Age: 13.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Ocular hyperaemia, Oedema peripheral
Clinical narrative: Pts arm got swollen up and pt had a red spot in the bottom of both eyes.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Headache, Pyrexia
Clinical narrative: Fever of 102 or above and headache x3 days after.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Fall, Unresponsive to stimuli
Clinical narrative: 2-3 min after immunization of HPV given, patient swayed back + then fell to Rt side.  Mother + myself called her name with no response for @ 3 seconds.  Patient came to held in office for an additional 20 minutes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Headache
Clinical narrative: Morning after receiving vaccines awoke with c/o a headache 'in the back of her head' - headache persisted for 2 days, better with TYLENOL/MOTRIN.  No intercurrent illness/injury-trauma.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Unevaluable event
Clinical narrative: Non stated. 8/18/09 spoke w/pt says had swelling under left armpit to include chest, triceps and a red spotty rash across chest, symptoms went away with no treatment.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Feeling hot, Flushing, Muscular weakness
Clinical narrative: Approx. 30 min after administration pt states felt "hot" returned to Hospital at 4:05. Noted face slightly flushed, B/P 104/64. States legs weak. 4:20pm B/P at 82/62, Hr 63, less flushed. Weakness resolved.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Dyskinesia, Electroencephalogram, Immediate post-injection reaction, Injection site pain, Metabolic function test
Clinical narrative: HPV injection given IM in R deltoid.  Immediately after pt c/o pain at site.  2 minutes after injection pt was sitting in chair.  Unresponsive to verbal stimulus.  Head tilted to left.  Both hands began to jerk inward simultaneously and L leg was stretched forward.  Episode lasted approximately 5 seconds and pt responded to verbal/physical stimuli.  Pt's memory of event.  VSS.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal stiffness, Nuclear magnetic resonance imaging brain, Posturing, Unresponsive to stimuli
Clinical narrative: HPV injection given IM in R deltoid.  Immediately after pt c/o pain at site.  2 minutes after injection pt was sitting in chair.  Unresponsive to verbal stimulus.  Head tilted to left.  Both hands began to jerk inward simultaneously and L leg was stretched forward.  Episode lasted approximately 5 seconds and pt responded to verbal/physical stimuli.  Pt's memory of event.  VSS.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Memory impairment, Pallor, Syncope
Clinical narrative: Immediately became pale and fainted - revived in at 15 seconds but couldn't remember what happened.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Inflammation
Clinical narrative: Tdap, red hard tricep, inflamed large area.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 7/31/09, left leg is swollen, red, and warm to touch.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Headache, Nausea, Tremor, Vomiting
Clinical narrative: 2:30pm  Nausea / emesis shaking headache BP 110/78 sent to ER Home and feeling was hot seen at ER. was taking to long.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Less than 24 hours post imm started with arm pain on R. Nausea, vomiting. Achyness all over and fever 1st to 101 --> TYLENOL --> 103.4 seen in office after 400mg MOTRIN still 103.4 and vomiting.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Reported both cheeks, chin and forehead and under right arm with redness, itching and slight swelling the next day after vaccines were administered. As of 7/27/09 the symptoms were improving. Instructed to call MD if symptoms worsen or continue after treatment with BENADRYL. No c/o SOB or other acute distress noted.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Child received DTAP, VARAIVAX vaccine 8-11-09 (L) deltoid. At scheduled visit 8-13-09 to primary care. Injection site was warm, red and tender. Treated with Keflex 250/5, 1 tsp P.O. q6 hours x 7 days.
Age: 4.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness to R deltoid area.
Age: 59.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash
Clinical narrative: Employee received MMR vaccine 5/18/09. Presented with rash trunk and extremities. Referred for eval and trt positive pruritis. Treated with BENADRY ? other meds?
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Anxiety, Dizziness, Tremor
Clinical narrative: Episode of tremors X approx. 30 sec and c/o light headedness, Immediately subsided when placed in Trendelenburg. Then got up in chair smiling and talking.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Redness and rash.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: LEFT UPPER ARM REDNESS WIHT SLIGHT INCREASED WARMTH.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Pain in extremity, Urticaria
Clinical narrative: Talked to mom 9:00 am- completely recovered per mom- Mom left clinic without having pt scheduled. Pt rec'd Varicella to (R) arm. Immediate wheal with reddened area occurred 80 mm x 65 mm. Dr. examined pt no tingling, c/o arm soreness. Cool pack to arm.
Age: 32.0
Sex: M
Vaccine: HEP, TD
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Burning sensation, Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction from the chicken pox booster.  Hives that were burning hot down my daughter's arm.  This lasted all day and through the night.  She had no difficulty breathing or dizziness.  Benadryl was given along with hydrocortizone cream.  The vaccine was given to her as an infant with no reaction, she then had
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure on evening.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA
Symptoms: Contusion, Erythema, Rash
Clinical narrative: Rash and bruise on leg Rt red
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site nodule, Injection site swelling
Clinical narrative: Local skin reaction large 12cm x 9cm, swollen hard, nodule formed near/around injection site. Pt instructed to use ice, TYLENOL, and BENADRYL if needed.
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Erythema, Rash, Rash papular, Urticaria
Clinical narrative: Coatinous breakouts hives, rashes, red spots.  Small little bumps.  Arms, stomach, back, face, legs.  And where he got his shots.
Age: 20.0
Sex: M
Vaccine: FLUN3
Symptoms: Expired drug administered
Clinical narrative: A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male.  Neither medical history nor concomitant medications were reported.  On 26-Jan-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic.  Additional information was received on 12-May-2009 and incorporated into the narrative:  Product complaint investigation results.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Cold sweat, Colitis, Colitis ischaemic, Colitis ulcerative
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. A 69 year old female with sulfonamide allergy, penicillin allergy, colitis ulcerative, hypertension, diabetes, hyperlipidaemia and gastroesophageal reflux disease and a history of angina pectoris, myocardial infarction, appendicectomy, hysterectomy, endometriosis, ovarian cyst and biopsy breast who on 30-MAY-2007 was vaccinated subcutaneously in the left arm with a first dose of ZOSTAVAX (Merck). Secondary suspect therapy included LEXAPRO. Concomitant therapy included atenolol, omeprazole (manufacturer unknown), furosemide (manufacturer unknown), LIPITOR, aspirin, vitamin D (unspecified) and calcium (unspecified). On 01-JUN-2007 the patient experienced abdominal pain, cold sweat, colitis ischemic, colitis, colitis ulcerative, depression, diarrhoea haemorrhagic, injection site erythema, muscle spasms, nausea, pallor, rectal haemorrhage and vomiting and was hospitalized. At 7 PM of 01-JUN-2007 the patient was threw up, pale, clammy, crampy and reported bloody diarrhea. On 03-JUN-2007 the patient was discharged after given appointment morphine, IV fluids and also began ASACOL. The patient had follow up with gastroenterologist. On 02-JUL-2007 medical record was received for a 2 night admission. During 01-JUN-2007 to 03-JUN-2007 the patient complained of rectal bleeding, abdominal cramping, nausea and vomiting. The patient reported on and off rectal bleeding for 8 months which increased night prior to admission. The patient was treated with bowel rest and ASACOL. Principal diagnosis: colitis, probably secondary to ulcerative colitis vs. ischemic colitis. Secondary diagnosis: hypertension, gastroesophageal reflux disease (GERD), hyperlipidemia, Left arm redness after a ZOSTAVAX (Merck), depression on LEXAPRO. Labs and diagnostics included: whole blood hematocrit 46.5 on admission and colonoscopy showed colitis, possibly ischemic. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 281911. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Colonoscopy abnormal, Condition aggravated, Depression, Diarrhoea haemorrhagic, Gastrooesophageal reflux disease
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. A 69 year old female with sulfonamide allergy, penicillin allergy, colitis ulcerative, hypertension, diabetes, hyperlipidaemia and gastroesophageal reflux disease and a history of angina pectoris, myocardial infarction, appendicectomy, hysterectomy, endometriosis, ovarian cyst and biopsy breast who on 30-MAY-2007 was vaccinated subcutaneously in the left arm with a first dose of ZOSTAVAX (Merck). Secondary suspect therapy included LEXAPRO. Concomitant therapy included atenolol, omeprazole (manufacturer unknown), furosemide (manufacturer unknown), LIPITOR, aspirin, vitamin D (unspecified) and calcium (unspecified). On 01-JUN-2007 the patient experienced abdominal pain, cold sweat, colitis ischemic, colitis, colitis ulcerative, depression, diarrhoea haemorrhagic, injection site erythema, muscle spasms, nausea, pallor, rectal haemorrhage and vomiting and was hospitalized. At 7 PM of 01-JUN-2007 the patient was threw up, pale, clammy, crampy and reported bloody diarrhea. On 03-JUN-2007 the patient was discharged after given appointment morphine, IV fluids and also began ASACOL. The patient had follow up with gastroenterologist. On 02-JUL-2007 medical record was received for a 2 night admission. During 01-JUN-2007 to 03-JUN-2007 the patient complained of rectal bleeding, abdominal cramping, nausea and vomiting. The patient reported on and off rectal bleeding for 8 months which increased night prior to admission. The patient was treated with bowel rest and ASACOL. Principal diagnosis: colitis, probably secondary to ulcerative colitis vs. ischemic colitis. Secondary diagnosis: hypertension, gastroesophageal reflux disease (GERD), hyperlipidemia, Left arm redness after a ZOSTAVAX (Merck), depression on LEXAPRO. Labs and diagnostics included: whole blood hematocrit 46.5 on admission and colonoscopy showed colitis, possibly ischemic. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 281911. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Haematocrit normal, Hyperlipidaemia, Hypertension, Injection site erythema, Muscle spasms
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. A 69 year old female with sulfonamide allergy, penicillin allergy, colitis ulcerative, hypertension, diabetes, hyperlipidaemia and gastroesophageal reflux disease and a history of angina pectoris, myocardial infarction, appendicectomy, hysterectomy, endometriosis, ovarian cyst and biopsy breast who on 30-MAY-2007 was vaccinated subcutaneously in the left arm with a first dose of ZOSTAVAX (Merck). Secondary suspect therapy included LEXAPRO. Concomitant therapy included atenolol, omeprazole (manufacturer unknown), furosemide (manufacturer unknown), LIPITOR, aspirin, vitamin D (unspecified) and calcium (unspecified). On 01-JUN-2007 the patient experienced abdominal pain, cold sweat, colitis ischemic, colitis, colitis ulcerative, depression, diarrhoea haemorrhagic, injection site erythema, muscle spasms, nausea, pallor, rectal haemorrhage and vomiting and was hospitalized. At 7 PM of 01-JUN-2007 the patient was threw up, pale, clammy, crampy and reported bloody diarrhea. On 03-JUN-2007 the patient was discharged after given appointment morphine, IV fluids and also began ASACOL. The patient had follow up with gastroenterologist. On 02-JUL-2007 medical record was received for a 2 night admission. During 01-JUN-2007 to 03-JUN-2007 the patient complained of rectal bleeding, abdominal cramping, nausea and vomiting. The patient reported on and off rectal bleeding for 8 months which increased night prior to admission. The patient was treated with bowel rest and ASACOL. Principal diagnosis: colitis, probably secondary to ulcerative colitis vs. ischemic colitis. Secondary diagnosis: hypertension, gastroesophageal reflux disease (GERD), hyperlipidemia, Left arm redness after a ZOSTAVAX (Merck), depression on LEXAPRO. Labs and diagnostics included: whole blood hematocrit 46.5 on admission and colonoscopy showed colitis, possibly ischemic. The listing indicated that one or more of the events required hospitalization and were considered to be immediately life-threatening. The original reporting source was not provided. The VAERS ID # is 281911. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.