chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Cardiac stress test, Chest pain, Echocardiogram, Herpes zoster
Clinical narrative: This spontaneous report as received from a 77 years old female consumer reporting on herself with atrial fibrillation, restless legs, penicillin allergy and allergic reaction to clindamycin and BIAXIN. The patient was vaccinated with ZOSTAVAX (dose, route, site of administration and lot # not reported) on 11-NOV-2006. No other co-suspects were reported. Concomitant medications included clonazepam, atorvastatin, diltiazem, warfarin, omeprazole, ZETIA, sertraline hydrochloride and ALIGN probiotic. The consumer reported that she was diagnosed with shingles on 06-JUL-2012. She developed left sided chest pain on 05-JUL-2012, she was evaluated at an unspecified urgent care facility and was told that the pain was "structural". The next day on 06-JUL-2012, the consumer returned to the unspecified urgent care facility due to increased chest pain. From that facility, the patient was taken by ambulance to the emergency room. The patient was admitted and diagnosed with shingles. Treatment included morphine, VALTREX and OXYCONTIN. Unspecified blood tests, cardiac stress test and echocardiogram were performed (results not provided). The outcome of shingles was reported as not recovered. The relatedness for shingles in unknown for ZOSTAVAX. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: TYP
Symptoms: Hypersensitivity, Swollen tongue
Clinical narrative: Prior to this never had an allergic reaction. Took 1st dose pill at 4 pm ate dinner around 5:00 pm feeling ok. When to bed at midnight woke up at 4 am with swelling tongue. When to hospital emergency room. Treated with IVP - SOLU MEDROL 125 mg, PEPCID IVP 40 mg , BENADRYL IVPB - 50 mg at hospital. They gave me prescription for prednisone 20 mg & PEPCID 20 mg for 5 & 10 day after.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Vomiting
Clinical narrative: Vomiting & diarrhea. Dehydration. Admitted to hospital.
Age: 32.0
Sex: M
Vaccine: SMALL
Symptoms: Rash pustular, Skin lesion
Clinical narrative: Small pox given, 12 days later 16 lesions developed over on (L) & (R) shoulder, (R) side, (L) & (R) forearm 24-36 hours. No itching at site. No fever.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test negative, Vomiting
Clinical narrative: This spontaneous report as received from a physician refers to a 62 days old female patient with none drug allergies. The patient was vaccinated with first dose of 2 ml ROTATEQ (lot # was unspecified) on 09-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 10-JUL-2012 the patient experienced vomiting and diarrhea, the patient was seen in the office on 12-JUL-2012 and a Rotazyme test on stool specimen was negative. On 09-MAY-2012 the patient was born and a preterm at 34 weeks gestation. The physician added that the patient's mother, who was breastfeeding, developed a sore throat recently. Treatment with hydration therapy. The outcome of vomiting and diarrhea was reported as recovering/resolving. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Antibody test, Asthenia, Blood pressure abnormal, Blood thyroid stimulating hormone, Cytomegalovirus test
Clinical narrative: 7/11/12: Syncopal episode after immunizations. LOC about 30 secs placed supine, BP/color back to baseline about 25 minutes. 7/18/12: Sinus headache, fever - sinusitis by history/exam, started AUGMENTIN. 7/25/12: headache, decreased energy, pale, nauseated, feeling faint, decreased HR.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Differential white blood cell count, Dizziness, Epstein-Barr virus antibody, Full blood count, Headache
Clinical narrative: 7/11/12: Syncopal episode after immunizations. LOC about 30 secs placed supine, BP/color back to baseline about 25 minutes. 7/18/12: Sinus headache, fever - sinusitis by history/exam, started AUGMENTIN. 7/25/12: headache, decreased energy, pale, nauseated, feeling faint, decreased HR.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Heart rate decreased, Loss of consciousness, Metabolic function test, Nausea, Pallor
Clinical narrative: 7/11/12: Syncopal episode after immunizations. LOC about 30 secs placed supine, BP/color back to baseline about 25 minutes. 7/18/12: Sinus headache, fever - sinusitis by history/exam, started AUGMENTIN. 7/25/12: headache, decreased energy, pale, nauseated, feeling faint, decreased HR.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Platelet count, Pyrexia, Sinus headache, Syncope, Urine analysis
Clinical narrative: 7/11/12: Syncopal episode after immunizations. LOC about 30 secs placed supine, BP/color back to baseline about 25 minutes. 7/18/12: Sinus headache, fever - sinusitis by history/exam, started AUGMENTIN. 7/25/12: headache, decreased energy, pale, nauseated, feeling faint, decreased HR.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Vaccination complication
Clinical narrative: ZOSTAVAX given 7-16-12 - PT came in on 7-19 with extensive redness from shoulder to elbow at site of injection - PT to see primary MD - PT returned later in day & said MD diagnosed as reaction to vaccine & prescribed antibiotics.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Barium enema abnormal, Enema administration, Intussusception
Clinical narrative: Intussusception.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Abnormal behaviour, Activities of daily living impaired, Euphoric mood, Inappropriate affect
Clinical narrative: Pt states that for 45 min - 1 hr after receiving GARDASIL he felt "he was on drugs, like really high like marijuana". Pt stated he was laughing at everything. Mom was with pt stating he was acting obnoxious and she could not take him to school due to behavior.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Left arm swelling and red, sore 2 day after shot. Worsened over 5 days Pt was treated w/ KEFLEX.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Raised, red patch (size of a quarter) noticed when she awoke the morning after the immunization. At the DTaP injection site. This was itchy & enlarged to a 5-6cm circle - with an outer red ring & central round red, patch. (Looked like a Lyme rash.) Prescribed ATARAX and was almost resolved by 7/24/2012.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling of upper R arm consistent with cellulitis. Started on Keflex.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: High fever, body aches, worsening over 2 days, took Advil PM with relief a couple hours later.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt left arm at site of vaccine administration red swollen and warm to touch, pt instructed to seek medical attention, pt seen at ER and treated with antibiotic for cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Body temperature increased, Diet refusal, Restlessness, Vaccination site induration, Vaccination site swelling
Clinical narrative: Mom reported that child's left arm (vaccination site) got swollen, hard and hot, child had temperature of 103.9F at 1:30pm; Tylenol was administered and 4 hours later temp was 101F and Mom gave child Tylenol again;  child had a bottle of milk since yesterday morning, refused to eat, and was restless; on 7/26/12 at 7:20am, arm swelling got worse and child's temp is 102F.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Vaccination site warmth
Clinical narrative: Mom reported that child's left arm (vaccination site) got swollen, hard and hot, child had temperature of 103.9F at 1:30pm; Tylenol was administered and 4 hours later temp was 101F and Mom gave child Tylenol again;  child had a bottle of milk since yesterday morning, refused to eat, and was restless; on 7/26/12 at 7:20am, arm swelling got worse and child's temp is 102F.
Age: 49.0
Sex: F
Vaccine: TDAP
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Severe soreness at injection site, redness, warmth at injection site. C/O pain that was all the way down her arm rated 9/10 and bringing her to tears.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, PNC13, VARCEL
Symptoms: Vomiting
Clinical narrative: Vomiting x3.
Age: 15.0
Sex: M
Vaccine: HEP, MMR, TD
Symptoms: Dizziness
Clinical narrative: Pt. felt faint, BP taken 60/40, pt. given water, pt. had not eaten since late am, pt. given granola bar, re: check pt. BP after eating & drinking water 80/60. Pt. reported feeling better after resting and eating/drinking.
Age: 9.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Parent reports coffee cup sized red painful raised rash at site of varicella injection. Parent took child to urgent care where she was given a steroid injection and oral medication. Parent unsure of name of medication. Pain and rash decreased some after injection. Treated 7/20/12.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: W/in 24 hours of getting the ZOSTAVAX injection pt noticed a small red area which expanded to an area of 2" x 5" which stayed raised & red for approx 15 days. Was somewhat itchy but not enough to warrant using any treatment. Patients doctor wanted the event reported.
Age: 14.0
Sex: M
Vaccine: TDAP
Symptoms: Bordetella test positive, Polymerase chain reaction
Clinical narrative: Initial report was received from a health care professional on 19 July 2012. A 15-year-old male patient had received an intramuscular injection of ADACEL, Sanofi Pasteur Ltd., lot number C3838BA in August of 2011 (site of administration unknown). The patient was seen in the physician's office on 11 July 2012 and tested PCR positive for pertussis. It was unknown if the patient had childhood DtaP series. The patient was being treated with ZITHROMAX and family members were being tested. The patient had a past medical history of asthma and it was unknown if the patient had any illness at the time of vaccination. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Fainted - no injury noted around 210pm - had not eaten reviewed VIS with mom & daughter (client).
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Headache, Pain, Pruritus, Rash
Clinical narrative: Broke out in a rash on entire neck & collar bone (upper part) itched, burning, stinging for about 2 wks, better now, rash seems to have cleared up. Had headaches, also better.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Fever 100, swollen left arm, right arm mildly swollen, treated with KEFLEX.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Injection site became reddened, hard, painful to touch. It continued to worsen over the course of a week & my entire upper arm area was reddened & swollen.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site rash, Rash, Varicella post vaccine
Clinical narrative: Received VARIVAX 7/9/12, seen on 7/14/12. Rash x 2 more spots everyday. Initially trunk, now on feet. One spot near injection site (Left arm, SQ). Afebrile. No lesions in mouth. Modified chickenpox x secondary vaccine. CALAMINE lotion - BENADRYL.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema, Injection site rash, Skin warm
Clinical narrative: Pt came to the pharmacy on 7/14/12 with her upper arm red, bruise and warm to the touch. Pt reported that the injection site started out with a small rash the slowly spread to the size of a tennis ball. No trouble breathing or SOB. Pt was instructed to tk BENADRYL and follow up with MD.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Haematochezia, Irritability, Occult blood positive, Pyrexia
Clinical narrative: Infant got diarrhea the day after his immunization along with being fuzzy & running fever - last fever on 7/14, but mom noticed blood in the stool 7/14 into 7/15. Fussiness has improved, but blood in stool persists.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Rash generalised
Clinical narrative: Generalized body rash.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Feeling hot, Loss of consciousness, Nausea, Vomiting
Clinical narrative: Patient felt dizzy, then passed out for <1 min, pt c/o feeling very hot, nauseated/vomiting.
Age: 65.0
Sex: F
Vaccine: HEPAB
Symptoms: Incorrect dose administered
Clinical narrative: Patient presented for Twinrix dose #2 with a friend also present in room to receive Twinrix dose #2. Patient given in each arm both doses of Twinrix prepared.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Chest X-ray, Chest discomfort, Cough, Headache, Lymphadenopathy
Clinical narrative: Rash, burning of skin, headache, swollen glands, prickling of skin, cough, heaviness in chest.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Rash, Skin burning sensation
Clinical narrative: Rash, burning of skin, headache, swollen glands, prickling of skin, cough, heaviness in chest.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain, Injection site swelling, Malaise, Pain
Clinical narrative: Swelling, tenderness and painful skin at injection site.  Site is discolored and Pt. complains of malaise and achiness.
Age: 47.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Headache, Injection site vesicles, Malaise, Nausea, Pyrexia
Clinical narrative: Headache, fever of 100.5, Blisters at site, blurred vision, nausea, malaise.
Age: 47.0
Sex: F
Vaccine: TDAP, TYP, YF
Symptoms: Vision blurred
Clinical narrative: Headache, fever of 100.5, Blisters at site, blurred vision, nausea, malaise.
Age: 1.26
Sex: M
Vaccine: HIBV, PPV
Symptoms: Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever to maximum of 102.8 rectally, irritability, decreased appetite.
Age: 0.34
Sex: F
Vaccine: DTAP, RV5
Symptoms: Crying, Rash erythematous
Clinical narrative: Not sure of the exact time of symptom onset.  She was crying more than usual during the day, and we noticed a red rash from her shoulders along her back down to upper buttock area around 4pm.  Visited the doctor the next morning, but he was not concerned.  The rash gradually faded, but was visible for more than 24 hours.  She had received Dtap in her left thigh, and oral rotavirus vaccines.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dizziness, Fatigue, Feeling abnormal, Hyperhidrosis, Lethargy
Clinical narrative: Dizziness, nausea, sweating, fatigue.  No actual loss of consciousness but became very lethargic. Administered ammonia inhalant. Patient immediately responded and began talking to us. Still felt quite ill, checked BP 90/60, laid on floor with feet elevated for next 20 minutes, slowly began feeling increasingly better. Slowly moved to upright chair, then walked to waiting room, then released once patient stated she felt "normal" again. Total time spent with patient was one hour.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ
Symptoms: Nausea
Clinical narrative: Dizziness, nausea, sweating, fatigue.  No actual loss of consciousness but became very lethargic. Administered ammonia inhalant. Patient immediately responded and began talking to us. Still felt quite ill, checked BP 90/60, laid on floor with feet elevated for next 20 minutes, slowly began feeling increasingly better. Slowly moved to upright chair, then walked to waiting room, then released once patient stated she felt "normal" again. Total time spent with patient was one hour.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash
Clinical narrative: Rash on the back of left calf below the knee.  Small bumps, general redness of area.   Area affected 2" by 4".  No tx.
Age: 19.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: (L) arm swollen with a half a dollar red surface. To put warm compresses and take MOTRIN.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pharyngeal oedema, Pruritus, Rash
Clinical narrative: Pt. called pharmacy to report itching, rash on opposite arm of administration 7/14/12, Pt. told to take BENADRYL and call her MD. 7/15/12 pt. called to report she's under MD. care - paged MD & her throat feels swollen & is painful.
Age: 29.0
Sex: F
Vaccine: DTAP
Symptoms: Axillary pain, Injection site oedema, Injection site pain, Malaise, Pyrexia
Clinical narrative: (L) deltoid injection site edema. Pain at (L) deltoid injection site. Pain radiating to (L) axilla. Malaise. Low grade fever (99.8).
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Flushing, Headache
Clinical narrative: Grandmother reported child with HA c/o after 1st 24 hours then after 48 hours c/o dizziness, flu like symptoms, nausea, diarrhea, fever, flushed skin, stomache ache. Gave her TYLENOL. No medical attention given just TYLENOL & ginger ale.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: Grandmother reported child with HA c/o after 1st 24 hours then after 48 hours c/o dizziness, flu like symptoms, nausea, diarrhea, fever, flushed skin, stomache ache. Gave her TYLENOL. No medical attention given just TYLENOL & ginger ale.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: ZOSTAVAX given on 7-13-12 on 7-14 Pt said she had a red, area at inj site the size of a dime. On 7-15 it was getting bigger & warm. 7-16-12 area is red, warm et 5cm, which was the same size as pt marked how big it was on 7-15.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abasia, Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling at localized area (left thigh). N/T able to walk.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Pt states entire arm extremely painful since 1st day, after 2 days bacame red and swollen.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia
Clinical narrative: Paresthesias.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: Blisters at injection sight, swelling & red & hot. Patient hurt & ached all over, chills.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Blisters at injection sight, swelling & red & hot. Patient hurt & ached all over, chills.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Condition aggravated, Dyspnoea, Eczema, Injected limb mobility decreased, Injection site discolouration
Clinical narrative: Vaccinated 7-19-12 at 11:00 am. Woke up next day stated arm hurt. Mom looked at arm 7-20-12 at 2:00 a.m. Area from injection site to elbow swollen, purple red itchy hot & painful difficult to move. Has eczema & this ached up in (R) arm elbow also called MD. Take 25 mg BENADRYL & ice to area. Mom states child needed nebulizer tx at home - resp difficulties 7/23/12 resolving somewhat still like red in color, pain & itching.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Vaccinated 7-19-12 at 11:00 am. Woke up next day stated arm hurt. Mom looked at arm 7-20-12 at 2:00 a.m. Area from injection site to elbow swollen, purple red itchy hot & painful difficult to move. Has eczema & this ached up in (R) arm elbow also called MD. Take 25 mg BENADRYL & ice to area. Mom states child needed nebulizer tx at home - resp difficulties 7/23/12 resolving somewhat still like red in color, pain & itching.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pain in extremity
Clinical narrative: Vaccinated 7-19-12 at 11:00 am. Woke up next day stated arm hurt. Mom looked at arm 7-20-12 at 2:00 a.m. Area from injection site to elbow swollen, purple red itchy hot & painful difficult to move. Has eczema & this ached up in (R) arm elbow also called MD. Take 25 mg BENADRYL & ice to area. Mom states child needed nebulizer tx at home - resp difficulties 7/23/12 resolving somewhat still like red in color, pain & itching.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Biopsy skin abnormal, Dermatitis, Drug hypersensitivity, Eczema, Perivascular dermatitis
Clinical narrative: This case was reported by a consumer and described the occurrence of spongiotic dermatitis in a 54-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Historic vaccination included influenza virus vaccine; manufacturer unspecified; unknown; unknown given in 2007. Concurrent medications included SYNTHROID and LEXAPRO. On 16 December 2011 at 10:00 the subject received 2nd dose of ENGERIX B (1 ml, unknown, right arm). On 31 December 2011, 15 days after vaccination with ENGERIX B, the subject experienced spongiotic dermatitis and vascular dermatitis. The subject was trying to determine if she should take the third dose in the series due to the dermatitis she suffered two weeks after taking the 2nd dose in the series. The dermatitis was biopsied and the diagnosis was spongiotic dermatitis with vascular dermatitis. The subject took 29 days of oral steroid treatments to treat the dermatitis. On 28 January 2012, the experienced spongiotic dermatitis with vascular dermatitis were resolved. The subject reported injection site soreness with influenza virus vaccine (manufacturer unspecified) approximately five years ago in 2007; please see case A0977003B. Follow-up information was received on 01 June 2012 via consumer who further clarified her diagnosis was Spongiotic dermatitis with lymphocytic vasculitis consistent with systemic medication hypersensitive reaction. At the time of the report no further information was available. This case was assessed as medically serious by GSK.
Sex: F
Vaccine: HPV4
Symptoms: Gestational hypertension, Maternal exposure during pregnancy, Neonatal disorder, Pregnancy test positive
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a female neonate whose 27 year old mother was vaccinated with the first and the second dose of GARDASIL, 0.5ml, IM., (lot number not reported) on 29-SEP-2012 and 13-JAN-2012, respectively. It was reported that on an unknown date, the patient was diagnosed with bilateral preauricular sinus (congenital anomaly). At the time of the report, the patient's outcome was unknown. On an unspecified date, during pregnancy, the patient's mother experienced pregnancy induced hypertension. (MARRS# 1202USA01011). Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Musculoskeletal stiffness, Pain
Clinical narrative: Left side of body pain & stiffness left hip pain. Improving over time. Advised to take OTC antihistamine and OTC pain reliever.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Myalgia, Myoglobin urine, Pain, Pyrexia
Clinical narrative: 8 d. of moderate - severe body aches & muscle pains, also headaches & fever x 4 days (Tmax 101.9).
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Urine analysis
Clinical narrative: 8 d. of moderate - severe body aches & muscle pains, also headaches & fever x 4 days (Tmax 101.9).
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Headache
Clinical narrative: 102 temp starting at 1 pm on 7/25/12 with headache. Mother called physician & is giving TYLENOL. No redness at injection site.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: C/o 1-2 wk hx of numbness/tingling of (L) arm 1 day after receiving HPV#1. No redness/swelling pain. Completely resolved by about 2 wks post-injection.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Malaise, Pain, Skin warm
Clinical narrative: Chills, malaise and general body aches. 7/12: 3.5"x1" red welt on lateral side of arm below deltoid, hot to touch and tender. 7/25: area is light pink but no longer hot or raised.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness, Urticaria
Clinical narrative: Chills, malaise and general body aches. 7/12: 3.5"x1" red welt on lateral side of arm below deltoid, hot to touch and tender. 7/25: area is light pink but no longer hot or raised.
Age: 39.0
Sex: F
Vaccine: DTAP
Symptoms: Hypoaesthesia, Oedema peripheral
Clinical narrative: Swollen arm and numbness on fingertips. No treatment.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Pallor, Vision blurred, Vomiting
Clinical narrative: Pale, vomited, blurred vision, dizzy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Temperature. Aches and pains throughout muscles and joints in legs and arms. Tylenol for fever.
Age: 15.0
Sex: M
Vaccine: HPV4, IPV
Symptoms: Skin exfoliation
Clinical narrative: After vaccine skin started to peel all over body, arm, legs included lasted for more then 2 weeks.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Pallor, Tonic clonic movements
Clinical narrative: About 3-5 minutes after receiving HPV, patient became lightheaded, pale. with clammy hands and had tonic clonic movements for <1 minute.
Age: 14.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pyrexia, Tremor, Urticaria, Vomiting
Clinical narrative: Patient experienced high fever, hives, shakes, vomiting x 2 days. Patient was treated with Tylenol, Motrin and Benadryl.
Age: 12.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Vomiting
Clinical narrative: Pt vomited in his personal car while driving out of County Health Dept. parking lot.  When I arrived at pt's location in lot, he stated he felt "fine" now and denied nausea, vomiting, dizziness, ringing in ears, visual disturbances.  He was able to ambulate independently without difficulty and his skin color was within normal limits. Pt recovered completely before leaving parking lot.
Age: 13.0
Sex: M
Vaccine: MEN, TDAP
Symptoms: Loss of consciousness, Tremor
Clinical narrative: He had termors for day and ever since he has been passing out spontaneously going to see a neurologist this week.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Red circular rash around injection site approximately the size of a silver dollar.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Paraesthesia, Pyrexia, Skin irritation
Clinical narrative: Complaints of fever 100.8 F and tingling sensation in arms began around 2:00 am on 07/26/2012. Tingling of lower extremities began approximately at 12 pm. Tingling of back began at approximately 1:30 pm. Child states skin feels irritated when someone touches him.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Crying, Cyanosis, Dysphonia, Emotional distress, Hyporesponsive to stimuli
Clinical narrative: Pt received Varivax #2 at approximately 4:00pm.  Pt left office and returned ten minutes later.  Pt crying and upset but hoarse voice and mild stridor noted. Attempt to calm pt down and give small drink of water, sat 91-94%. Obs x 5 min, increased facial swelling, esp cheeks, mild peri-oral cyanosis, sat brief drop 88%, pt less responsive and refusing to answer questions. Epi pen 0.15 mg administered, 911 called. Pt with excellent response to Epi pen and within 30 secs, color better, less facial swelling and sat up to 96% without O2. By the time EMS came, 3 min after Epi, sat drifting down to 94% again. Pt to be transported to Hosp via EMS.  Pt given Benadryl and Orapred in ER and observed overnight in hospital for 1 night.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Oxygen saturation decreased, Stridor, Swelling face
Clinical narrative: Pt received Varivax #2 at approximately 4:00pm.  Pt left office and returned ten minutes later.  Pt crying and upset but hoarse voice and mild stridor noted. Attempt to calm pt down and give small drink of water, sat 91-94%. Obs x 5 min, increased facial swelling, esp cheeks, mild peri-oral cyanosis, sat brief drop 88%, pt less responsive and refusing to answer questions. Epi pen 0.15 mg administered, 911 called. Pt with excellent response to Epi pen and within 30 secs, color better, less facial swelling and sat up to 96% without O2. By the time EMS came, 3 min after Epi, sat drifting down to 94% again. Pt to be transported to Hosp via EMS.  Pt given Benadryl and Orapred in ER and observed overnight in hospital for 1 night.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Blood glucose normal, Feeling hot, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: 6:48 pm: Upon entering room pt found unresponsive and diaphoretic sitting in a chair. Patient had been incontinent of urine. RN called for assistance. Dr. responded. Patient moved to the floor where she soon regained consciousness. Placed on oxygen (4L/min). Blood pressure 146/90, pulse thready. 6:51pm: 911 called. Pt denied chest pain and shortness of breath but complained of nausea and feeling hot. 6:55pm = Blood sugar 114 7:00pm = BP 138/74 pulse 64 O2 100% on 4L 07:05 = EMS arrived.
Age: 52.0
Sex: F
Vaccine: HEPAB
Symptoms: Pulse abnormal, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: 6:48 pm: Upon entering room pt found unresponsive and diaphoretic sitting in a chair. Patient had been incontinent of urine. RN called for assistance. Dr. responded. Patient moved to the floor where she soon regained consciousness. Placed on oxygen (4L/min). Blood pressure 146/90, pulse thready. 6:51pm: 911 called. Pt denied chest pain and shortness of breath but complained of nausea and feeling hot. 6:55pm = Blood sugar 114 7:00pm = BP 138/74 pulse 64 O2 100% on 4L 07:05 = EMS arrived.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Anxiety, Condition aggravated, Mycoplasma test positive, Nuclear magnetic resonance imaging brain normal, Obsessive-compulsive disorder
Clinical narrative: Onset anxiety, tics, OCD behavior, worsened with increasing obsessive thoughts for 7 days, then gradually back to baseling by 10 days. No treatment except Zithromax for elevated mycoplasma Ig6. IgM at 7 days out.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Streptococcus test negative, Tic
Clinical narrative: Onset anxiety, tics, OCD behavior, worsened with increasing obsessive thoughts for 7 days, then gradually back to baseling by 10 days. No treatment except Zithromax for elevated mycoplasma Ig6. IgM at 7 days out.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Small intestinal obstruction
Clinical narrative: Child rec'd HPV#1 & MENVEO on 7-16-12 - was fine when left office. On 7-19-12 presented ER - Dx: small bowel obstruction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Rash on abdomen compatible w Herpes Zoster- confirmed by patient's rheumatologist.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Electroencephalogram, Nuclear magnetic resonance imaging
Clinical narrative: Seizure
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Convulsion, Rhinorrhoea
Clinical narrative: Temp 102 F, nasal drainage, seizure.
Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pneumonia, Pyrexia, Rash
Clinical narrative: Seen in ER for 101 F fever, Dx'd with Pneumonia. Rash on 7/18/12.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever.
Age: 0.34
Sex: F
Vaccine: DTAPH, IPV
Symptoms: Injection site rash, Irritability, Pyrexia
Clinical narrative: Fever, fussiness, rash at injection site.
Age: 1.39
Sex: F
Vaccine: MMR
Symptoms: Measles post vaccine, Rash
Clinical narrative: Received MMR 7/6/12. Measles rash 7/16/12.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Arms and left forearm with little bumps. Redness to deltoid after vaccines.
Age: 31.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Immunization given on 7/13/12. Reaction started Saturday PM, with swelling at site. Now has area of induration measuring 1x2 inches, surrounded by redness. Area slightly warm to touch. Seen in clinic 7/16/12.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: 12 hrs later experienced extensive itching, redness, left arm swelling at injection site. Right lower arm has 8" red rash w/extreme itching. Slight erythematous.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash generalised, Urticaria
Clinical narrative: Generalized red rash started on upper body and spread to lower limbs. BENADRYL 25mg 4 times per day for next 2 days. Urticaria resolved over 30 minutes while at office.
Age: 11.0
Sex: M
Vaccine: IPV, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warmth, erythema and swelling to (L) arm at injection site, area measuring 17x16 cm in diameter, 2 days after injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation, Injection site erythema, Injection site swelling
Clinical narrative: Pt RTC 7/18/12, pt states her 1/2 upper (L) arm was red/swollen since 5 pm 7/16/12 after immunization & on exam pt at mid upper arm is red. Deltoid area is clear from redness/swelling. Pt saw a friend MD & rx for KEFLEX. Pt states that inflammation had subsided since spoke with pt 7/19/12 - inflammation subsided even more.
Age: 77.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site discomfort, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Sl. swelling, bruising, warmth and discomfort to (L) deltoid area. Referred to Dr. for evaluation. Tx: Warm compresses to area.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Muscle twitching, Muscular weakness
Clinical narrative: Patient received HPV4 on 8/16/11 & 3/22/12. His father states that since his 2nd HPV4 he has "twitches" in his shoulder muscles. It doesn't bother him to work (muscle weakness) but just when relaxing. He has not seen a dr for these s/s; recommend he see his private provider.
Age: 0.68
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Redness and lump on right vastus lateralis.
Age: 1.04
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Eczema, Erythema, Rash papular, Vomiting
Clinical narrative: Pt vomited x 2 hrs, shots eczema worsened. She got redness under both eye & erythematous papules.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Gaze palsy, Hyperhidrosis, Muscle twitching
Clinical narrative: 3:15 pm -> while examining patient she went from sitting to laying down position, cleared eyes, rolled back, twitched entire body x 2 x 30 sec then recovered with sweating + +, completely awake. BP 110/80 HR 120/m.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Peripheral T-cell lymphoma unspecified
Clinical narrative: Pt. developed Peripheral T-cell Lymphoma Oct. 2011. 2nd HPV given Jan. 2009 (most recent immunization). Father feels they are related. Told him I know of no connection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Musculoskeletal stiffness
Clinical narrative: Rash at injection site, stiff neck, itching at injection site.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching, redness of Rt arm 2 days after taking IM PEDIARIX & S/C MMR in right arm.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt began itching (R) arm where the MENVEO vaccines was administered, shortly after swelling and redness developed. Pt was seen in ER where they advised ibuprofen, ice and BENADRYL. Spoke with mom 7-16-12 and reinforced ER advice.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at site.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Malaise, Myalgia, Pyrexia
Clinical narrative: "Malaise, weak, fever, myalgias, side effects & reaction to Tdap". Not released to work through 8-5-12 with follow up scheduled for 7-31-12.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Malaise, Myalgia, Pyrexia
Clinical narrative: "Malaise, weak, fever, myalgias, side effects & reaction to Tdap". Not released to work through 8-5-12 with follow up scheduled for 7-31-12.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Angioedema, Vomiting
Clinical narrative: A: (1) Angioedema shoulders. (2) Vomiting x 2 post vaccination - none today. P: Cold compress/ bowel rest T & R
Age: 1.11
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Doc. varicella lesions feet, ankle, abd. Fever onset 7/16/12. Tx - monitor sxs - no meds.
Age: 20.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: 48 hours post immunizations, scattered pruritic rash on limbs, not trunk; lesions continue to erupt not clearly vesicular, (+) erythematous, papular no SOB, dysphagia, wheezing; antihistamine/topical steroids.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying
Clinical narrative: Excessive crying, several hours, not relieved by TYLENOL.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Immunization on 7/23/12 at 0900 and woke up next morning red, swollen RT arm to elbow. Itchy, no pain, moves it normally. Called 7/26/12 at 0900 swelling gone, redness resolving.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Computerised tomogram head normal, Computerised tomogram normal, Contusion, Fall, Swelling
Clinical narrative: Within several seconds after receiving the vaccine, pt stood up & suddenly had syncopal episode causing her to fall face down - resulted in her losing two front teeth, chipped another tooth & swollen/bruised nose. Pt went to dentist to bond teeth.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Syncope, Tooth fracture, Tooth loss
Clinical narrative: Within several seconds after receiving the vaccine, pt stood up & suddenly had syncopal episode causing her to fall face down - resulted in her losing two front teeth, chipped another tooth & swollen/bruised nose. Pt went to dentist to bond teeth.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, PPV
Symptoms: Injection site induration, Injection site oedema, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Received stated vaccines AM 7/24/12 - 7/25/12 AM developed fever, soreness & warmth to (R) deltoid, nausea. (R) arm tingling, (R) leg feeling tingling. 7.5 cm induration (R) deltoid, warmth to area, tender x 5 cm & edema.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ, PPV
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Received stated vaccines AM 7/24/12 - 7/25/12 AM developed fever, soreness & warmth to (R) deltoid, nausea. (R) arm tingling, (R) leg feeling tingling. 7.5 cm induration (R) deltoid, warmth to area, tender x 5 cm & edema.
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness & pain in entire upper arm (L) side starting one hour after deltoid injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Left thigh with 2-3 in. erythematous ring with underlying nodule. (1) BENADRYL (2) OMNICEF 250/5 - 3ml BID.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient reported to pharmacy with redness, warm to the touch, and slightly raised area at the site of the vaccination. She denied feeling any other symptoms. She first noticed the rash a day after the vaccine. She was recommended BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Left deltoid (administration site) red 6" x 5", firm & warm to touch.
Age: 65.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Erythema, Herpes zoster, Pyrexia, Urticaria, Varicella
Clinical narrative: Statement attached (enclosed). On July 6th 2012, I received a shingles vaccine because  I once had chicken pox as a child. By the second day after I had received the vaccine, I noticed a small area of shingles which appeared for the first time ever in my life and it is located on my left side area between the breast and arm pit. They are bright red and appear like blister size welts, which I still have as I write this letter. In addition to the shingles I also developed a small case of chicken pox to go with it and I believe a low grade temp is normal. Why didn't I take the Blue pill instead of the Red Pill? (A quote from a movie). I hope the FDA wasn't out to lunch on this one while the scientist who made this vaccine cash in as they say......get it out..... and.....sell, sell, sell. I believe this product came out to fast and should of had more research, before profiting off the public and stock. More than 55 years since chickenpox and healthy every day since then and Today I now have shingles and chicken pox. I was doing well until I received the vaccine.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Brachial plexopathy, Electromyogram, Influenza like illness, Mobility decreased
Clinical narrative: Got flu shot on 10-11-11 on duty at the Police Department went to Dr on 10-26-11 with flu like symptom and slight shoulder pain. Turned into deep pain in shoulder and upper pectoral with radiating pain down my arm. Pain became terrible in right shoulder front and back and my 3rd and 4th finger started losing mobility and strength. Cortisone, pain meds.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Myalgia, Nerve conduction studies, Neuralgic amyotrophy, Nuclear magnetic resonance imaging
Clinical narrative: Got flu shot on 10-11-11 on duty at the Police Department went to Dr on 10-26-11 with flu like symptom and slight shoulder pain. Turned into deep pain in shoulder and upper pectoral with radiating pain down my arm. Pain became terrible in right shoulder front and back and my 3rd and 4th finger started losing mobility and strength. Cortisone, pain meds.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Got flu shot on 10-11-11 on duty at the Police Department went to Dr on 10-26-11 with flu like symptom and slight shoulder pain. Turned into deep pain in shoulder and upper pectoral with radiating pain down my arm. Pain became terrible in right shoulder front and back and my 3rd and 4th finger started losing mobility and strength. Cortisone, pain meds.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, Full blood count, Pyrexia
Clinical narrative: Started with fever morning of 7/24/2012 up to 103.2 axillary. Temp max 104.3 at 3 am on 7/25/12.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Swelling, red, itching.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Pt presented with hard, red circle around injection site.
Age: 9.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash erythematous, Swelling
Clinical narrative: At around 4 pm on day patient received vaccinations (07/23/12) she had a tactile fever, felt nausea, bilateral arm soreness. Mom states child felt better Tuesday afternoon (07/24/12) up until Wed. afternoon when she developed another tactile fever and red rash/swelling occurred. Seen by pediatrician 07/26/12 - OX - toxicity from vaccines. Tx TYLENOL prn for fever or discomfort. BENADRYL prn for itching and redness. Return if S & S worsen or rash doesn't resolve in 1-2 weeks.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site discolouration, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Injection site swelling & redness, with "little pimple purple in color at the injection site".
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Syncope
Clinical narrative: Patient fainted.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient came in for 2nd Hepatitis A, 2nd HPV & 2nd Varicella, Hep A, Varicella given left deltoid, HPV given (R) deltoid. Within 15 minutes of vaccination; patient was having systemic hive reaction. Pt given 25 mg 2 ml BENADRYL when pt discharged was much improved.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic, Insomnia, Pain
Clinical narrative: This spontaneous report as received from a physician via a company representative concerning a 70 years old female patient who is also the physician's wife was vaccinated with ZOSTAVAX on 19-JUL-2007 "5 years ago". No other co-suspects were reported. No concomitant medications were reported. The physician stated that on 05-JUL-2012, "two weeks ago" the patient developed ocular shingles had some sleepless nights and pain. No treatment information was reported. The outcome of patient developed ocular shingles, sleepless nights and pain was reported as "she is in the process of recovering". The relatedness for patient developed ocular shingles sleepless and pain was unknown for ZOSTAVAX. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Patient vaccinated on 7/12/12, noticed redness at injection site on 7/20/12. Patient seen at MD on 7/24/12. Treated w/ BACTRIM DS tabs/ Mupirocin topical for possible infection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Pt. received vaccines yesterday around 5 p.m. Today father came in with pt. to check his arm. Pt. had swelling, redness, and blisters around the location where vaccine were administered (left upper arm).
Age: 93.0
Sex: M
Vaccine: TD
Symptoms: Eye swelling, Rash
Clinical narrative: Rash & swollen eyes. Prednisone 30 mg daily x 3 day, Cetirizine 10 mg every day, Hydroxyzine 25 mg prn.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 4 patients of unknown age. The patients were vaccinated with doses of (lot # 0128AE, exp date 10-JAN-2014) MMR II (dose and route not reported) on 02-JUL-2012. No other co-suspects and no concomitant medications were reported. The registered nurse reported that while checking temperature stability of multiple vaccines she noticed that four patients were vaccinated with doses of MMR II that had been exposed to 14.9 degrees Celcius for ten hours. No adverse effect was reported. No other vaccines were administered to patients. No treatment information was reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.