chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: 12 yo female here for 2nd HPV. Administered to patient by IM M (L) thigh, pt lying on bed. Pt was instructed to lie for 15-30 min, sipping juice. 12 min called about pt passed out on BR floor. Mom took her to BR 8-10 min later needed to go badly. Mom stayed with pt as she stood up from toilet, turned pale, shuddered, blacked out, mom supported her through the fall. LOC was momentary. Pt was pale & diaphoretic 5 min later walked to bed.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Upper arm/shoulder pain over 1 month.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right deltoid, warm to touch, red swollen, painful.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Complex partial seizures, Condition aggravated, Loss of consciousness
Clinical narrative: Aug 10th- mild seizure. Aug 12th, 13th multiple seizures each day (partial complex seizure)- some loss of consciousness 30 seconds.
Age: 7.0
Sex: M
Vaccine: FLUN3
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: Seizures-generalized 2 days after immuniz.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Patient received FLUVIRIN 2011-2012 instead of FLUVIRIN 2012-2013.
Age: 7.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Pt received DTAP vaccine on 8/6/12 AM and gradually developed area of erythema and induration measuring 4.6 inches x 6 inches on Left upper arm 8/9/12. Area is warm, itchy and tender to touch.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Nausea, Pruritus, Rash
Clinical narrative: C/O itching and rash on chest with c/o nausea.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Infection, Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling of upper right arm at injection site per parent.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Thirst
Clinical narrative: Pt stated thirsty after climbing stairs even though drank two glasses of water after.  Also had moderate headache.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis (L) upper arm.. injection site (L) deltoid onset of redness, swelling warmth within 1 day of injection.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: 1 hour after vaccine started having severe headache took Ibuprofen and ALTRAM 2 hours later headache went away. Approx 14 hours after immunization skin rash over site of injection and a few inches around. Warm to touch swelling at site of injection. Today she noticed small area of rash on both forearms. No itching.
Age: 31.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Condition aggravated, Dysphagia, Gastrooesophageal reflux disease, Nausea
Clinical narrative: After two days post vaccination, patient had an increase in symptoms related to his Myasthenia Gravis. These include weakness, difficulty swallowing, acid reflux, and nausea. Two days rest and doses of MESTINON needed following doctor visit.
Age: 11.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Convulsion, Syncope
Clinical narrative: Received 2 immunizations in clinic - walked with parent thru building and out to parking lot before collapsing in parking lot with seizure activity. Evaluated by clinic staff and EMS summoned - transported to ER per EMS. Discharged from ER with instructions to make appt with neurologist.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site reaction, Pallor
Clinical narrative: Rush on (L) ant thigh at site of injection diffuse erythematous blanching approx. 2-3 cm diameter no papules, vesicles, or pustules x 6 days appeared few days after vaccine administration. Tx: KEFLEX x 10 days. Resolved 3 days, staring PO ABX. No complications.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Blood pressure decreased, Heart rate decreased, Hyperhidrosis, Pallor, Syncope
Clinical narrative: 1 minute after administration Pt had fainting episode with profuse sweating and decreased BP decreased pulse, paleness, resolved over next 10 minutes, gradually.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: At injection site, itchy, red, warm to touch, 3 1/2" x 2" patch. Not resolving after 3 days - counseled to take TYLENOL/MOTRIN and ice. If gets worse, seek medical attention.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Feeling hot, Loss of consciousness, Nausea, Pallor
Clinical narrative: Pt received the vaccine, was fine and went to check out with her mom and passed out at the check out desk. Pt was pale and hot. We took off her sweatshirt and put a cold compression her neck. Then we gave her a juice box to sip on, and she refused crackers. She felt sick to her stomach, no emesis, we took her B/P-normal. She laid down in a room for awhile, then felt better to leave. 11:10am to about 12:00pm.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chest discomfort, Heart rate increased, Hypersomnia, Pallor
Clinical narrative: Hep B #2 - 1-2 hours later experienced, heavy chest (not SOB) weak, fast heart beat, pale, slept 14-16 hours - did not take anything for symptoms. Rest of household was experiencing GI issues - client did not experience these as the other household members.
Age: 15.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Fall, Loss of consciousness
Clinical narrative: Several minutes after vaccine administration, pt arose from chair & reported feeling lightheaded. Slumped to the floor & was unconscious for approximately 45 seconds fully recovered within minutes.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Pruritus, Rash
Clinical narrative: Noticed rash & extreme redness on top of both feet developed into burning & itching - severe burning more at night (not too bad during day). Only redness was on top of feet. Few spots on upper thighs but no where else, gradually got better over next week, Dr gave Rx for mupirocin, very small pimple like spots which dried up but never scabbed over condition continues to improve at this time.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Local reaction, Oedema
Clinical narrative: Primarily a local reaction with erythema & edema & mild fatigue afebrile.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches, headaches, chills and fever.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Acne, Rash, Skin ulcer
Clinical narrative: Rash next day after receiving vaccine, started in bikini area and spread to thighs. Looked like little pimples and they exploded, became sores after.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Injection site movement impairment, Injection site pain, Injection site swelling
Clinical narrative: I received a Tdap booster on 7/10/12 up high on my right arm/almost at the shoulder joint. The site was sore if bumped or I laid on it until 7/21/12 when I woke up and couldn't move/use the right shoulder. The injection site was warm and slightly swollen. Any motion or touch to the site or shoulder caused extreme pain, nausea, tears. Used ice, aspirin and Soma during the day.  After midnight 7/22/12 I finally went to the emergency room.  Treated with antibiotics and pain pills, a sling.  Follow up w/pcp 7/23/12, she ordered a shoulder xray, no work for 2 weeks, continue antibiotics, pain meds.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Lacrimation increased, Nausea, X-ray limb
Clinical narrative: I received a Tdap booster on 7/10/12 up high on my right arm/almost at the shoulder joint. The site was sore if bumped or I laid on it until 7/21/12 when I woke up and couldn't move/use the right shoulder. The injection site was warm and slightly swollen. Any motion or touch to the site or shoulder caused extreme pain, nausea, tears. Used ice, aspirin and Soma during the day.  After midnight 7/22/12 I finally went to the emergency room.  Treated with antibiotics and pain pills, a sling.  Follow up w/pcp 7/23/12, she ordered a shoulder xray, no work for 2 weeks, continue antibiotics, pain meds.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt received injection Thursday and came back to clinic Friday afternoon with moderate size swelling and soreness at injection site of varicella redden and swollen the size of golf ball around raised 4-5 mm and warm.  By next Tuesday (8/7/12) swelling down and left arm normal.  Patient took ibuprofen and used cold packs cold packs on swollen arm.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized redness, itching and swelling in an area approximately 10 cm around injection site on right arm (site of Tdap immunization).  Parent applied cold packs and monitored for other symptoms; reported on 8/10/12 that no other symptoms had occurred and local symptoms were improving.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Biopsy lip, Dry mouth, Sjogren's syndrome
Clinical narrative: Came down with severe dry mouth - later diagnosed as Sjogren's Syndrome.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, redness, swelling and small blister at injection site.  This was followed by generalized symptoms of stomach ache, mild fever, headache, sore throat and tingling in leg.  Symptoms continued to worsenand on advice of PMD went to ER where she received Benadryl and other medication on 8/13/12.  As advised by ER, reported to us on 8/14/12.  Patients states she is "ok" following treatment.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site vesicles, Oropharyngeal pain, Paraesthesia, Pyrexia
Clinical narrative: Pain, redness, swelling and small blister at injection site.  This was followed by generalized symptoms of stomach ache, mild fever, headache, sore throat and tingling in leg.  Symptoms continued to worsenand on advice of PMD went to ER where she received Benadryl and other medication on 8/13/12.  As advised by ER, reported to us on 8/14/12.  Patients states she is "ok" following treatment.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Swelling to softball diameter within 8 hours of the administration of the vaccine.  By 36 hours later, the entire thigh/front half of the upper leg is red, hot, and swollen.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Muscular weakness
Clinical narrative: Weakness lower extremities. Guillain Barre Syndrome.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: (R) upper arm with large, red, indurated area at injection site, warm, tender to touch, swelling, rash.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: (R) upper arm with large, red, indurated area at injection site, warm, tender to touch, swelling, rash.
Age: 26.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain, Pyrexia
Clinical narrative: Pain, redness, inflammation on area of injection (left arm). Fever - 39 degrees. Dx. Cellulitis Tx DURICEF 500mg bid x 7 d.
Age: 26.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: White blood cell count increased
Clinical narrative: Pain, redness, inflammation on area of injection (left arm). Fever - 39 degrees. Dx. Cellulitis Tx DURICEF 500mg bid x 7 d.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: 8/11/12: Red, bumpy rash to left thigh. No tenderness or itchiness noted per mom.
Age: 64.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash generalised
Clinical narrative: Patient had bumps all over body. One bump on leg he scratched & was open. Hard blisters all over body along with rash. Temp. 98.6.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Screaming
Clinical narrative: Parent states patient cried a high pitched scream for three to four hours.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Left thigh has large 4.5 x 7.5' erythematous swelling on anterior thigh, mild induration at center, no inguinal adenopathy; patient is ambulative, well.
Age: 28.0
Sex: F
Vaccine: HEP, PNC
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral, Pain
Clinical narrative: Right upper arm with redness/pain/swelling over majority of arm 1st day after injection. 2nd day swelling down to 6-7 cm, pain/tender. 3rd day swelling mild, local, not red, still tender mildly.
Age: 28.0
Sex: F
Vaccine: HEP, PNC
Symptoms: Tenderness
Clinical narrative: Right upper arm with redness/pain/swelling over majority of arm 1st day after injection. 2nd day swelling down to 6-7 cm, pain/tender. 3rd day swelling mild, local, not red, still tender mildly.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Myalgia, Pruritus, Skin infection, Swelling
Clinical narrative: Muscle pain in affected arm itching, swelling, redness welt (not growing) patient saw physician assistant, who diagnosed her with a Type II skin infection and prescribed an antibiotic.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Muscle pain in affected arm itching, swelling, redness welt (not growing) patient saw physician assistant, who diagnosed her with a Type II skin infection and prescribed an antibiotic.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Viral infection
Clinical narrative: 8-3-12 Mother reports pt has a fine, raised, red rash over entire body which started on 8/1. Reports pt seen 2 days prior, for viral infection et high temp. by doctor. Didn't know if rash was from shots or viral infection. Denies itching or difficulty breathing. Referred to doctor.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pruritus generalised
Clinical narrative: Pain at injection site. Itching whole body. Injection site size of golf ball. Warm at injection site. Told patient to take BENADRYL, apply cold compress and go to Dr. or call ASAP.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site pain, Macule
Clinical narrative: Mom noted redness in (L) thigh, with induration. Minimal pain. Noted the following morning after injection. See in clinic today 2 x 2.5 cm macule with 1 cm induration. Rec: observation and reassurance.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen/painful lymph nodes in axillary on side of body that vaccine was administered. Patient noticed symptoms approximately 9 hours after administration.
Age: 18.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Red itchy painful swelling at site of VARIVAX & Hep A vaccine 2 1/4 x 1 1/2" oval red area at deltoid.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Swelling and redness at site of injection and pain and soreness in entire arm.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Pain, Pruritus, Vaccination site warmth
Clinical narrative: Pt c/o pain, itches, feels warm on vaccine site.
Age: 11.0
Sex: F
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Swelling, hard, painful at site of administration starting day after administration.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apparent life threatening event, Cyanosis, Erythema, Hypotonia, Pyrexia
Clinical narrative: Taken to ER by ambulance after episode of facial cyanosis, turning limp, and not breathing for about 30sec. When tilted up had emesis and turned pink. When arrived at ER was found to have fever 38.9 degrees C.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Respiratory arrest, Vomiting
Clinical narrative: Taken to ER by ambulance after episode of facial cyanosis, turning limp, and not breathing for about 30sec. When tilted up had emesis and turned pink. When arrived at ER was found to have fever 38.9 degrees C.
Age: 52.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Extreme pain from injection site radiating down arm.
Age: 17.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Syncope
Clinical narrative: Gave patient varicella shot and she fainted.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Red area around arm 2 inches in diameter.
Age: 16.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Dyspnoea, Hearing impaired, Pallor, Visual impairment
Clinical narrative: 1:20 PM administered Tdap. Pt. reported feeling dizzy, then hearing/visual difficulties within 4 minutes. Turned pale with breathing difficulty. Placed Pt. on floor, administered EPI-PEN. 1:35 PM EMT's arrived and and administered emergency care. Pt was conscious when taken to hospital ER 1:45 PM.
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient had itching and redness at site of shot.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Oedema peripheral
Clinical narrative: Left arm is red, swollen & hard to touch no fever noted.
Age: 0.59
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 7 months old male patient with a history of being a premature baby who on 26-JUL-2012, was vaccinated with the first dose of ROTATEQ (dose and lot number not reported). The physician stated that since child was born preemie at 31 weeks, the usual childhood vaccinations, unspecified, were given, today on 26-JUL-2012. No adverse effects were reported. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4, MEN, TTOX
Symptoms: Hypoacusis, Loss of consciousness, Pallor, Tremor
Clinical narrative: This spontaneous report as received from a physician refers to an 11 years old female patient. On an unknown date, the patient was vaccinated with GARDASIL (lot# not reported). No other co-suspects were reported.  Concomitant medications included tetanus toxoid (manufacturer unknown) and meningococcal vaccine (manufacturer unknown). Then the patient experienced a brief period of shaking, lost consciousness and could not hear. The patient also became very pale in color but all the reactions subsided shortly after without any treatment. The patient received the GARDASIL injection as well as the tetanus toxoid (manufacturer unknown) and meningococcal vaccine (manufacturer unknown) on the same day.  The patient did not sought medical attention. The outcome was reported as recovered/resolved. Upon internal review, lost consciousness and could not hear were determined to be the medically significant events. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old female patient with no pertinent medication history or drug allergy who on 21-MAY-2012 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck). There was no concomitant medication. On 04-JUN-2012 the patient developed tingling and stinging pain on the arm and back after receiving ZOSTAVAX (Merck). Patient sought medical attention by contacting pharmacist. There was no lab diagnostics performed. At the time of report, the patient was not recovered. Follow-up information has been received from the pharmacist, concerning the 64 year old female patient, with no pre-existing allergies and medical conditions, who on 21-MAY-2012 was vaccinated subcutaneously with the first dose of ZOSTAVAX (lot # 672606/1655AA, Exp. 21-JAN-2013) and experienced stinging back pain, stinging pain on arms and legs. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Information has been received from a physician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who on 30-NOV-2011, was vaccinated IM with the first 0.5 ml dose of GARDASIL (site and lot# not reported). On 02-FEB-2012, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (site and lot# not reported). There was no concomitant medication. It was reported that the patient developed an enlarged supraclavicular lymph node with pain on movement after receiving her first dose of GARDASIL. This developed within 24 hours of receiving the vaccine. The physician reported that the patient developed the enlarged supraclavicular lymph node again after receiving her second dose of GARDASIL. The physician stated that it also developed within 24 hours after receiving the second dose of GARDASIL and the enlarged supraclavicular lymph node was also on the same side that the "second" dose of GARDASIL was administered. The physician reported that the enlarged supraclavicular lymph node had gotten smaller and was the size of a "pea". The patient sought medical attention by office visit. The patient did not have any lab diagnostics studies performed and did not receive any treatment for the event. At the time of the report, the patient was recovering. Follow up information was received from a physician reporting that the 14 year old female with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions, on 30-NOV-2011 at 16:45 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 1497AA, Exp. Date: 26-JUN-2014). On 02-FEB-2012 at 15:45, the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot number 1566AA, in validation) and on 07-JUN-2012 at 15:30 was vaccinated intramuscularly with the third dose of GARDASIL (lot number 672834/0131AE, Exp. Date not reported). The three doses were administered at private doctor's office/hospital with private funds. The physician stated that in December 2011 (previously reported as 01-DEC-2011) the patient developed enlarged supraclavicular (two nodes) shortly after received vaccine #1. Nodes reappeared on 02-FEB-2012 (previously reported as 03-FEB-2012) and the patient developed supraclavicular nodes when the patient received vaccine #2, and again on 09-JUN-2012, two days after vaccine #3 was administered, the patient developed supraclavicular nodes. Nodes resolved spontaneously on 23-JUN-2012. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient who on 01-AUG-2008 was vaccinated with a dose of VARIVAX (Merck) (lot#659606/1905U). The nurse mentioned that on 06-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient status was unknown. A lot check has been initiated. Follow up information has been received from a registered nurse concerning a male child patient with no illness at the time of vaccination and no pre-existing allergies, birth defects or medical conditions who received the first dose of VARIVAX (Merck) subcutaneously on 01-AUG-2008 at 11:30 pm. The patient received the second dose of VARIVAX (Merck) at the age of 4 years (in 2011). The patient went to the clinic on 06-JUN-2012 with a rash described as "vesicular, papular, erythematic non confluent, non symmetrical, with no scaling", diagnosed with varicella. No tests were done. This was one of the several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to patients of unknown age. The reporter reported that doses of M-M-R II (lot # was unknown) that had been exposed to temperatures exceeding 46 Fahrenheit for 9 hours, might have been administered to unspecified patients on 30-Jul-2012 and 31-Jul-2012. The nurse could not certain at the time of the call. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. The patients might have been vaccinated with improperly stored dose of M-M-R II (Lot#, dose and route not reported), date unspecified. It was not known if the patients sought for medical attention. No symptoms 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.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 22 year old female patient with drug allergy to DURICEF, CECLOR, sulfa and VERSED who on 15-MAY-2012 was vaccinated with her first dose of GARDASIL (lot # not reported) at an unspecified obstetrics and gynecology (OB/GYN) physician's office. Concomitant therapy included ranitidine. On 15-MAY-2012 the patient experienced an itchy rash all over her body within minutes following the vaccination. The patient received BENADRYL at the OB/GYN's office and was referred to another physician, who saw the patient on 17-MAY-2012. The patient was still experiencing the rash and received injections of dexamethasone (manufacturer unknown) and DEPO-MEDROL during that visit. The patient called the practice on 18-MAY-2012 and still complaining of itchy rash and the physician prescribed a MEDROL dose pak to the patient. No lab test was done. At the time of this report, the patient was recovering from the event. Follow up information was received from a medical assistant reporting that the 22 year old female patient with asthma an allergy to DURICEF, CECLOR, sulfa and VERSED, on 15-MAY-2012, had hives and rash on back, trunk and extremities. At the time of the report, the patient had recovered (date not reported). The patient did not seek medical attention. It was stated that they did not administer the vaccine at their office. The patient was only treated for the reaction. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site rash
Clinical narrative: This spontaneous report has been received from a 60 years female consumer who was vaccinated SC with the first dose of ZOSTAVAX on 23-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 28-JUL-2012 the patient stated she began to have pain and rash at the injection site. She was advised by her physician that she had shingles. The patient sought unspecified medical attention and VALTREX was given for the treatment. At the time of report, the patient's status was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Neuralgia, Pain in extremity, Urticaria
Clinical narrative: Information has been received from a registered pharmacist concerning a 72 year old female with no known drug reaction or allergies who on 30-MAY-2012 was vaccinated subcutaneously in the left arm with a dose of (Lot# 670754/0621AA, expired date 26-JUL-2012, dose not reported). On 31-MAY-2012 the patient developed "hives/rash that looked like big, round, red welts. These hives appeared on the back, chest and abdomen. There was no swelling or itching. It looked like a ringwarm infection in the middle of the hives". The patient also had headache and also "nerve pain in the right arm". The patient came to the pharmacy for medical attention. The pharmacist told the patient to start BENADRYL and cortisone as treatment. There was no any lab and diagnostic test performed. At the time of this report, the status of the patient was unknown. Follow up information has been received from a pharmacist who reported that the female patient on 31-MAY-2012, experienced red welts all over the body, It was described by the pharmacist that the patient said that red welts all over the body disappeared after about 5 days about 05-JUN-2012, the patient was doing fine. The outcome of the other events was unknown. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 60 years old female patient. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) on 12-APR-2012. On approximately 19-APR-2012 (reported as the week after vaccination) the patient experienced full blown case of shingles. The outcome of full blown case of shingles was reported as recovered. The patient sought medical attention by contacting physician. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report was received from a pharmacist who mentioned that two unspecified patients experienced redness at the site after administration of ZOSTAVAX. No further information was provided. At the time of the report, the patients' outcomes were unknown. No further information is available. This is one of the several reports from the same source.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from a register nurse concerning a 47 year old female patient with a medical history of stem cell transplant and her immune system had been wiped out, who on 07-JUN-2012. was vaccinated with dose 1, 40 Microgram hepatitis b vaccine (manufacturer unknown) (route, lot number and expiration date were not provided). No other co-suspects were reported. Concomitant therapy included unspecified immune suppressive therapy. After the vaccination, at some unknown point after the administration, the patient developed muscle soreness. No treatment information was reported. The outcome of muscle soreness was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age who four years ago, in 2008, was vaccinated with the first two doses of GARDASIL and "today" on 18-JUL-2012, was in the office to get the third dose (Doses, routes and lot numbers not reported), No adverse effects were reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Rash maculo-papular, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning two 4 year old patients, siblings, who in January 2012, were vaccinated with a first dose of VARIVAX (Merck) (lot# not reported). The patients were both recently diagnosed with chicken pox after their first dose of VARIVAX (Merck). The patients visited physician's office. At the time of the report, the patients' outcomes were unknown. 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. Follow up information was received from a other health professional reporting that the 4 years old female with a history of being preemie, no illness at the time of vaccination and no adverse events following prior vaccination, on 31-FEB-2012 (previously reported as January 2012) was vaccinated on the right thigh with the first dose of VARIVAX (merck) (lot number 671029/1065AA, Exp. Date 05-JUL-2013) (dose not reported). No other co-suspects were reported. Concomitant vaccines administered on 03-FEB-2012, included second dose of MMR II (lot number 0152AA), second dose of VAQTA on left thigh (lot number 672221/1586AA) and first dose of KINRIX (lot number AC20B154AA) administered on left thigh. It was stated that on 17-JUN-2012, the patient experienced maculopapular rash on hands with fluid filled lesions clustered in groups, the patient was diagnosed with varicella. No treatment information was reported. The patient recovered with no residual effects after 3 weeks on approximately 08-JUL-2012. The relatedness for patient was diagnosed with varicella was unknown for VARIVAX (Merck). This is one of several reports from the same source. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site haematoma, Injection site reaction, Paraesthesia
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 24 years old female patient with no pertinent medical history and no drug reactions or allergies who on 14-JUL-2012, was vaccinated intramuscularly with 0.5 ml dose of GARDASIL (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The healthcare worker reported that on 15-JUN-2012, the patient developed tingling, bruising and redness at the injection site after GARDASIL was administered. No lab diagnostics studies were performed. No treatment was given for the experience. It was stated that the tingling and bruising were improving, however, the redness had not improved. The patient sought medical attention by contacting the physician. The relatedness for patient developed tingling, redness and bruising at the injection site was unknown for GARDASIL. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning unknown number of patients who on an unknown dates were vaccinated with doses of ROTATEQ (doses, routes and lot number not reported) which were stored at lower than recommended temperatures on multiple occasions. No adverse effect reported. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, dose number, lot number and date of event.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a female pharmacist in her 50's reporting on herself, who on an unknown date was vaccinated subcutaneously with a 0.65 ml standard dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, she experienced a rash after getting ZOSTAVAX. No lab diagnostics studies were performed. Cortisone cream was given as a treatment for the experience (it was mentioned but was not completely sure). At the time of the report, the patient had recovered. The patient did not seek medical attention. The relatedness for patient experienced a rash was unknown for ZOSTAVAX. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain of skin, Rash
Clinical narrative: This spontaneous report as received from a 74 years old male patient with no drug reactions/allergies and history of polio and parathyroid problems, who on 09-MAY-2012 was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously (lot number not reported). No other co-suspects were reported. Concomitant medications included TRICOR, niacin and MIRAPEX. On 16-JUN-2012 the patient experienced another bout of shingles. He had had 2 very bad bouts of shingles before getting the vaccine. This time, he experienced a little rash between his elbow and shoulder in his upper right arm. It hurt to touch his skin there, like the area had been burnt. NO treatment was given for the events. The patient stated that this pain was diminishing and the rash was going away. No laboratory diagnostic studies were performed. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received as part of a business agreement (claim number 30120503005-0001), concerning a patient who on an unknown date, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not reported). Subsequently the patient experienced shingles outbreak. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. This was originally reported by a consumer. Follow up information was received from a patient who was not referred to by a physician and "did this on their own". Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient with no drug reaction/allergies and no pertinent medical history, who on 12-JUL-2012 was vaccinated with a dose of ZOSTAVAX dose not reported) subcutaneously (lot # 671076/1198AA, Exp. 25-OCT-2012). No other co-suspects were reported. No concomitant medications were reported. On 13-JUL-2012 the patient developed soreness and red rash at the injection site. The patient was seen at a local urgent care facility but no treatment was prescribed. On 16-JUL-2012, the pharmacist spoke with the patient and her symptoms had not improved. The patient was planning on consulting with her unspecified physician. No laboratory diagnostic studies were performed. No treatment was given. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with first dose of 0.5 ml GARDASIL (lot # not reported) IM on 31-MAR-2011. It was reported that the patient administered the second dose of GARDASIL (lot # not reported) on 26-MAY-2011, and was in the office to receive the third dose of GARDASIL (lot # not reported) on 07-AUG-2012. No adverse effects reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Diarrhoea, Local reaction, Rash erythematous, Skin warm
Clinical narrative: Information has been received from a female consumer with no pertinent medical history or drug reaction who on 06-JUN-2012 was vaccinated with ZOSTAVAX. There was no concomitant medication. On 07-JUN-2012 the patient noticed a 6 inch hot red spot. On 09-JUN-2012 (Saturday) the patient was in the emergency room with hives. The hcp diagnostics her with a local reaction with a secondary infection of cellulitis. The patient mentioned she was prescribed LEVAQUIN 500 mg and also had a horrible case of diarrhea. The patient mentioned it took about a week to feel better. No lab diagnostics study was performed. The patient sought medical attention. Follow up information as received from a licensed practical nurse refers to a 54 years old female patient with allergy to iodine, BIAXIN and MACRODANTIN. The patient was given ZOSTAVAX on 06-JUN-2012 at pharmacy. Two days later, on 08-JUN-2012, the patient developed cellulitis. She went to clinic and started on antibiotic. Next day, on 09-JUN-2012, she developed welts on upper arm and went to emergency room. The events gradually resolved over next week, in June 2012. The patient's outcome for diarrhea was unknown. The relatedness for secondary infection of cellulitis, horrible case of diarrhea and welts on upper arm is unknown for ZOSTAVAX. Additional information is not expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a female consumer with no pertinent medical history or drug reaction who on 06-JUN-2012 was vaccinated with ZOSTAVAX. There was no concomitant medication. On 07-JUN-2012 the patient noticed a 6 inch hot red spot. On 09-JUN-2012 (Saturday) the patient was in the emergency room with hives. The hcp diagnostics her with a local reaction with a secondary infection of cellulitis. The patient mentioned she was prescribed LEVAQUIN 500 mg and also had a horrible case of diarrhea. The patient mentioned it took about a week to feel better. No lab diagnostics study was performed. The patient sought medical attention. Follow up information as received from a licensed practical nurse refers to a 54 years old female patient with allergy to iodine, BIAXIN and MACRODANTIN. The patient was given ZOSTAVAX on 06-JUN-2012 at pharmacy. Two days later, on 08-JUN-2012, the patient developed cellulitis. She went to clinic and started on antibiotic. Next day, on 09-JUN-2012, she developed welts on upper arm and went to emergency room. The events gradually resolved over next week, in June 2012. The patient's outcome for diarrhea was unknown. The relatedness for secondary infection of cellulitis, horrible case of diarrhea and welts on upper arm is unknown for ZOSTAVAX. Additional information is not expected.
Age: 29.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 29 years old male inmate without pertinent medical history and drug reactions/allergies. The inmate was vaccinated with PNEUMOVAX23 (0.5ml, SQ right arm, lot# 1947AA, expiration date 20-OCT-2013) for hepatitis C on 25-JUL-2012 and On 26-JUL-2012 in the right upper arm it was red, swollen and painful. No other co-suspects were reported. Concomitant medications included MOTRIN and TYLENOL. Shot of TYLENOL for the treatment of the AE. The outcome of right upper arm red, swollen and painful was reported as recovering/resolving. No lab diagnostics studies performed. The inmate sought medical attention via sick calling to nurse in the prison yard. Report 2 of 3. See SRs 1-5406566483 (MARRS Case # 1208USA001635) and 1-5406566843. Additional information has been requested.
Age: 0.49
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report has been received from a consumer refers her approximately 19 years old son. The patient was vaccinated with the three dose of hepatitis b vaccine (recombinant) (manufacture unknown) on 23-AUG-1993, 08-OCT-1993 and 07-DEC-1994. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient was showing low antibody titers. Reporter said, "My son's physician says he is only 34 to 39% immune to hepatitis B." No treatment information was reported. The patient sought medical attention by office visit. Hepatitis B antibody titers were performed. The patient was not recovered at the time of report. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 14 years old female patient who on 30-JUL-2012 was vaccinated with the a dose of ZOSTAVAX (dose, route and lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The physician reported that on 30-JUL-2012, the patient was vaccinated with ZOSTAVAX instead of VARIVAX (Merck). The patient was supposed to get a second dose of VARIVAX (Merck) but instead received ZOSTAVAX. There was no adverse reaction. No treatment information was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Discomfort, Herpes zoster, Pain, Rash
Clinical narrative: This spontaneous report was received from a 71 years old consumer reporting on herself with asthma, no drug reactions or allergies and a history of irregular heart beat, who on 04-APR-2012, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. Concomitant medications included metoprolol and simvastatin (manufacturer unknown). The consumer reported that on 06-APR-2012. she had small blisters. By Sunday, 08-APR-2012, she had a full blown case of shingles. She had a rash on the side of her heck around to her ear. She was told to use warm compresses and then ice on the area to ease her discomfort, acetaminophen, VICODIN and gabapentin were also given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the patient had not recovered as she was still in pain. The relatedness for patient had a full blown case of shingles/she had the rash on the side of her neck around to her ears was unknown for ZOSTAVAX. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning a 69 year old female patient with no pertinent medical history or drug reactions/allergies who on 17-APR-2012 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). Concomitant medications included amlodipine besylate, CADUET, LANOXIN, aspirin, omega-3 marine triglycerides, metoprolol, TRICOR, magnesium (unspecified) + (glucosamine), ACTONEL, vitamin B (unspecified), ascorbic acid and multivitamin. On 17-APR-2012, the patient developed itchy red bumps scattered all over her body, after receiving a dose of ZOSTAVAX. No treatment was given for the events. The patient sought medical attention, went to the office. No laboratory tests were performed. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Gait disturbance, Head injury, Suture insertion
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 78 years old male patient with seizure disorder. The pharmacist was reporting that the patient was vaccinated with ZOSTAVAX on 17-JUL-2012 SQ (dose and lot# not reported). Concomitant medications included : KEPPRA. The patient fell at home on 18-JUL-2012 (also reported as 18-SEP-2012). The patient was evaluated at a local emergency room, and required 9 sutures to his forehead. The patient relayed to the pharmacist that, prior to the fall, he felt like he was walking too fast and fell when he tried to slow down. The patient received treatment. At the time of the report the patient was recovering from the events. Additional information has been requested.