chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain in extremity, Rash, Urticaria
Clinical narrative: Nurse from doctor office called and said patient has experienced bilateral hives/rash & pain in arm and bruises in scalp.
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 7/23/12 AM Pt awoke with "tennis ball" size erythema and induration accompanied by tenderness at (L) delt. 7/24/12 AM area improving.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Induration, Skin warm, Swelling
Clinical narrative: Area hot and hard x 2 days. No treatment.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Heart rate increased, Oropharyngeal pain, Throat irritation
Clinical narrative: 5 mins after administration pt complained increased heart rate and scratchy throat. Pt breathing normal BP 105/83 pulse 72, Pt ask sit a little longer. Rechecked 10 mins pt complained headache, throat sore. Rechecked 5 mins. Pt stated feeling dizzy, throat tighter. EPI-PEN administered and 911 called.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Throat tightness
Clinical narrative: 5 mins after administration pt complained increased heart rate and scratchy throat. Pt breathing normal BP 105/83 pulse 72, Pt ask sit a little longer. Rechecked 10 mins pt complained headache, throat sore. Rechecked 5 mins. Pt stated feeling dizzy, throat tighter. EPI-PEN administered and 911 called.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site discomfort, Injection site inflammation, Injection site irritation
Clinical narrative: Inflammation and irritation at injection site with slight discomfort.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Pt healthy & tolerated well for 3 hrs after vaccination, then became very fussy, swelling, redness & tenderness at injection site of PREVNAR.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Pain
Clinical narrative: Large swollen area that is painful.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Muscle rigidity, Musculoskeletal stiffness, Unresponsive to stimuli
Clinical narrative: Patient was very anxious to receive vaccines, Hep A, MENACTRA, HPV, given. Several minutes after injection patient was sitting up on bed became unresponsive. Placed in supine position. O2 given. Became rigid & stiff. After becoming responsive he con't to breath rapidly. EMS was activated. Patient was transported to hospital.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Body temperature increased, Chills, Headache, Influenza like illness, Pain
Clinical narrative: Chills, headache, achy, loopy. Temp 100. Flu like symptoms for 2 days. Resolved.
Age: 17.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Contusion, Erythema, Pain, Tenderness
Clinical narrative: Per Dad and phone report, sore the next day, by evening of 18th, red and sore, from shoulder to just above elbow. Painful to touch and to move though was able to move it and do daily functional activities. No fever. Sore and red, tender for about 5-6 days, then began to resolve, with resulting large bruise that is resolving daily.
Age: 0.37
Sex: M
Vaccine: DTAP
Symptoms: Dermatitis atopic, Eczema, Hypersensitivity
Clinical narrative: He developed severe eczema. Two days after the DTaP vaccine, his face was completely raw and weeping. He was officially diagnosed with atopic dermatitis one week after the vaccine. He had completely normal smooth skin before the shot. Immediately following the vaccine, he developed allergies to everything he came in contact with. Prior to the vaccine he never had one reaction or symptom to anything (for example, soap, cream, food, clothing).
Age: 15.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Body temperature increased, Discomfort
Clinical narrative: Denies redness or pain at injection site.  T 102 oral.  No nausea or vomiting.  Father states he gave child Ibuprofen for elevated temperature. Recommended that child be seen by PCP if no improvement in next 48 hours.  Encouraged to continue with Tylenol or Ibuprofen for discomfort and to maintain good fluid intake.
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: Body temperature increased, Headache, Influenza like illness, Mobility decreased, Muscular weakness
Clinical narrative: Elevated temperature, flu-like symptoms, nausea, headache.  Received a total of four rabies vaccines on 6/19, 6/22, 6/26 and 7/3/2012 as well as rabies immune globulin on 6/19/2012.  Received all four vaccines in left deltoid, per patient request.  On 7/31/2012, called to report left arm weakness and difficult raising arm.
Age: 35.0
Sex: M
Vaccine: RAB
Symptoms: Nausea
Clinical narrative: Elevated temperature, flu-like symptoms, nausea, headache.  Received a total of four rabies vaccines on 6/19, 6/22, 6/26 and 7/3/2012 as well as rabies immune globulin on 6/19/2012.  Received all four vaccines in left deltoid, per patient request.  On 7/31/2012, called to report left arm weakness and difficult raising arm.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Computerised tomogram head normal, Diarrhoea, Headache, Injection site pain, Injection site swelling
Clinical narrative: C/O injection site soreness, swelling and increasing pain that was worse on Saturday (7-28).  Then diarrhea on Sunday with headache on Sunday night.  Went to local ER 2 AM Mon morning with c/o "throbbing" headache.  ER staff noted photophobia, PERL, neck supple.  Pt was given IVF and IV MS, with relief of headache.  CT of head showed no acute process.  Pt discharged to home with Rx for lortabs, instructions to stay off work for 2-3 days, and apply ice packs to injection site.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Photophobia
Clinical narrative: C/O injection site soreness, swelling and increasing pain that was worse on Saturday (7-28).  Then diarrhea on Sunday with headache on Sunday night.  Went to local ER 2 AM Mon morning with c/o "throbbing" headache.  ER staff noted photophobia, PERL, neck supple.  Pt was given IVF and IV MS, with relief of headache.  CT of head showed no acute process.  Pt discharged to home with Rx for lortabs, instructions to stay off work for 2-3 days, and apply ice packs to injection site.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Incorrect dose administered, Musculoskeletal pain
Clinical narrative: Pneumovax booster administered 2/29/2012 and accidentally revaccinated with Pneumovax on July 12, 2012. Patient c/o of increased shoulder and joint pain (hx rheumatoid arthritis. Treatment = Use pain meds prn and continue prednisone. Monitor for fever. Any SOB, rash go directly to ED.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash, Pyrexia
Clinical narrative: LOW FEVER 100.0F ALL WEEK FEVER INCREASED TO 102.0F FOR 24-36 HRS ON 7/29/2012 LEFT ARM INCREASED REDDNESS 1" X 1" ACROSS ARM. SCATTERING OF PINK SPOTS. FEVER GONE THE NEXT DAY AND FEELS FINE.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Client fainted helped to the floor elevated legs cool wash cloth to forehead. Client came to within couple of seconds, water provided. Client helped to waiting room, mother present 5-10 minutes mother and client feel comfortable to leave. Client walks out per self, accompanied by mother and sister.
Age: 72.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Chills, fever of 100.4 (normal for me is 97.6). Continued off and on for 3 days. Site of injection still tender.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pain, Rash
Clinical narrative: BURNING AND STINGING RASH WITH BLISTERS ON UPPER ABDOMEN. SPREAD OVER NEXT FEW DAYS WHEN I CONTACTED MY PHYSICIAN BY PHONE AND RECEIVED A PRESCRIPTION FOR A 7 DAY COURSE OF VALACYCLOVIR.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Red on/around site of injection, immediate swelling.
Age: 22.0
Sex: M
Vaccine: IPV, TYP
Symptoms: Rash generalised
Clinical narrative: Rash all over body.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Rash erythematous
Clinical narrative: Patient broke out in red rash - on stomach, back and arms.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Urticaria
Clinical narrative: Patient broke out in welps and hives for 3 days - covered patients face, back, stomach, legs, and arms. Treated with Benadryl.
Age: 15.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, PER, TDAP, VARCEL
Symptoms: Nausea, Paraesthesia, Tinnitus, Visual impairment
Clinical narrative: SYMPTOMS: vision difficulty, ears ringing, tingly feeling all over, nausea.  TIME: symptoms started 10 minutes after immunization and continued for 30 minutes.  TREATMENT: layed down to rest in cool room, applied ice to injection site.
Age: 2.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Diffuse urticarial reaction. No SOB no cough.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Dizziness, Headache, Pyrexia, Tachycardia
Clinical narrative: Vaccine was given at 11:30 am on 7/27. That evening he developed chills, fever and dizziness. Also headache tachycardia on 7/29/12.
Age: 20.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Antibody test, Injection site erythema, Injection site pain, Injection site swelling, Mumps antibody test
Clinical narrative: Had Varicella vaccine on 7-10-12. The next day, he felt soreness when touching the injection site, removed his sweatshirt, & noticed swelling & redness in his right upper arm. Area of redness is approximately 70 x 85 mm on 7/13/12.
Age: 20.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella virus test
Clinical narrative: Had Varicella vaccine on 7-10-12. The next day, he felt soreness when touching the injection site, removed his sweatshirt, & noticed swelling & redness in his right upper arm. Area of redness is approximately 70 x 85 mm on 7/13/12.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site rash, Injection site vesicles
Clinical narrative: On 7-1-2012, the morning after the vaccination, the injection site area (about 8" round) was red, warm, inflamed. A blistery rash covered it. It was a hard tissue area. Urgent care physician prescribed Valcyclovir 1 gram TID for 5 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: On 7-1-2012, the morning after the vaccination, the injection site area (about 8" round) was red, warm, inflamed. A blistery rash covered it. It was a hard tissue area. Urgent care physician prescribed Valcyclovir 1 gram TID for 5 days.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Borrelia test positive, Facial paresis, VIIth nerve paralysis
Clinical narrative: (R) sided Bells Palsy - Lyme (-) tx eye drops. Pt seen 9 am - 7/13/12 eve same day family noted (R) side facial weakness.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Swelling
Clinical narrative: Pain in upper arm. Redness and some swelling. Lasted for two days.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Feeling abnormal, Mental status changes
Clinical narrative: Mom reports today (7-24-12) that pt. had "altered mental status" after receiving GARDASIL on 8-5-2011. She describes pt being "dizzy, not knowing where he was spacey". Mom reports patient was totally recovered next day.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Erythema, Induration, Injection site erythema, Injection site urticaria, Irritability
Clinical narrative: Morning after immunizations pt. developed red welts on (L) leg where vaccine given. Pt. was a little fussy - area reddened - induration 1" diameter - apply ice.
Age: 28.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Oedema, Swelling
Clinical narrative: Four days post vaccination; swelling w/ edema & erythema to left axillary region. No lesion present at time of visit.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthma, Cough, Dysphonia
Clinical narrative: GARDASIL given 7-26-12 patient started coughing/asthma exacerbation a couple of hours after injection. Similar event after 1st HPV - was horse yesterday.
Age: 14.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Asthma, Condition aggravated, Cough
Clinical narrative: GARDASIL given 7-26-12 patient started coughing/asthma exacerbation a couple of hours after injection. Similar event after 1st HPV - was horse yesterday.
Age: 1.11
Sex: M
Vaccine: HIBV, PNC
Symptoms: Culture throat negative, Irritability, Pharyngeal erythema, Pyrexia
Clinical narrative: Patient was getting his second PREVNAR and second HIB on 7-16-12 and developed fever and fuzziness the same evening. Fever 4 to 5 days. Patient had a fever after his 1st PREVNAR on 5-25-12 he had been restless prior to vaccination & developed red throat with the fever.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness/swelling 30.5cm x 40cm at injection site. (7-20 12 - pt was given script for KEFLEX 500).
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Vision blurred
Clinical narrative: Dizziness, blurry vision within 10 mins of administration of vaccine. Monitored VS. No treatment; was given ice, cold water.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Head injury, Loss of consciousness, Syncope
Clinical narrative: About 2 minutes after HPV vaccine given, pt. fainted in her chair and hit head on countertop. Regained consciousness after about 4-5 seconds. Put her head between her knees to recover. Did not want to lie down. Given ice pack and juice.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Local reaction
Clinical narrative: Mild cellulitis (L) leg v.s. localized reaction to vaccine given. Saw patient in weekend clinic 7/28/12. Treated with TYLENOL, Amoxicillin and cold compresses.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling presented on 7-26-12. 1.5in (width) 1 in (height).
Sex: F
Vaccine: TDAP
Symptoms: Muscular weakness, Sensation of heaviness
Clinical narrative: About a couple of days later starting to feel weakness in left arm. Feels heavy. Worsening. No redness or bruising or swelling. No systemic illness.
Age: 1.33
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Contusion, Induration, Irritability, Pyrexia
Clinical narrative: Fussy. Mild fever - lasted only 1 day after vaccine administration. Bruising to body, head/scalp; neck, R/L forearm legs. Back & some to tummy. Some have induration. Onset 7/29/12.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chills, Injection site swelling, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph nodes, fever, chills, overall weakness, swollen arm at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Auricular swelling, Eye swelling, Lip swelling, Swelling face, Urticaria
Clinical narrative: Pt. developed generalized hives, swelling of face, eyes, lips & ears. Vitals stable afebrile. Rec'd Dexamethasone & BENADRYL.
Age: 8.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Hep B given 7/26/12 expired 6/21/12 no sx reported error found 7/31/12.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The patient had fainted after receiving a dose of GARDASIL (lot number, therapy route and site not reported). Date or information for the male patient that fainted was unspecified. The outcome was unknown. Upon internal review, fainted was considered to be a medically significant event. The nurse also reported a second male patient had had passed out after receiving a dose of GARDASIL on 24-JUL-2012 (MARRS # 1207USA009538). Additional information has been requested.
Sex: U
Vaccine: HPV4
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 GARDASIL (doses, routes and lot numbers not reported) which were stored at lower than recommended temperatures on multiple occasions. No adverse effect reported. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, dates of events, recovery status. All attempts to obtain follow-up information has been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of lot # (665266/1378Y, expiration date reported as 12-JUN-2012) GARDASIL on 25-JUL-2012. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from a healthcare worker, for GARDASIL, a Pregnancy Registry product, concerning an 18 year old female patient with no pertinent medical history and no drug reactions or allergies who on 07OCT-2009 was vaccinated IM with the 0.5 ml of the first dose of GARDASIL (lot#was not reported). On 20-MAY-2011, the patient was vaccinated IM with the 0.5 ml of the second dose of GARDASIL (lot # was not reported). On 25-MAY-2012 the patient was vaccinated IM with the 0.5 ml of the third dose of GARDASIL (lot number 0121AA is an invalid lot number for GARDASIL. There was no concomitant medication. The health care worker reported that the patient became pregnant after receiving GARDASIL. No treatment was given for the adverse event. Ultrasound test was performed (results not provided). It was reported that the patient saw a physician. This spontaneous prospective pregnancy report as received from a registered nurse via Pragnancy Questionnaire, refers to a 18 years old female patient with medical history of lactose intolerance, who on 07-OCT-2009 was vaccinated with the first dose of GARDASIL lot # (659184/0843X), on 20-MAY-2011 the patient received the second dose of GARDASIL (lot # 0298AA) and on 25-MAY-2012 the patient received the third dose of GARDASIL (lot number 0121AE - in verification process). On 12-JUN-2012 ultrasound test was performed to confirm uncertain dates. Results of the test revealed normal fetal anatomy and EDC would be on 09-AUG-2012. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Foetal disorder, Gestational hypertension, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a physician, for GARDASIL, a Pregnancy Registry Product, concerning a 17 year old female patient with no concomitant medication, no pertinent medical history and no drug reactions or allergies, who was vaccinated with the first and second dose of GARDASIL , 0.5ml, IM., (lot number not reported) on 29-SEP-2012 and 13-JAN-2012, respectively and was pregnant. The patient sought medical attention. Pregnancy test was performed, The patient last menstrual period was an approximately on 03-SEP-2011 (also reported as "4 to 5 months"). Estimated delivery date is an approximately on 09-Jun-2012. Follow-up information was received from the physician who stated that the patient's last menstrual period was on 03-SEP-2011 and estimated delivery date was 09-JUN-2012. On an unknown date, the patient developed pregnancy induced hypertension (PIH). The physician reported that on 22-JUN-2012 (reported as 39 weeks from LMP), the patient delivered a female baby, weight 3445g, length 53cm, Apgar score 9/9. It was reported that the infant was normal and also that the baby was diagnosed with bilateral preauricular sinus (date unspecified). At the time of the report, the patient's outcome was unknown. The infant adverse event was captured in MARRS# 1207USA008497. 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 health worker refers to a patient of unknown age. The patient was vaccinated with the first dose GARDASIL (lot number, dose, route and injection site were not known) in June 2011. No other co-suspects were reported. No concomitant medications were reported. On 23-JUL-2012 was in the office and no adverse event reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age who on 10-JUL-2012, was inadvertently vaccinated with a dose of VARIVAX subcutaneously, instead of ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to daughter of unknown age. The patient was vaccinated with dose 1, 0.5 ml GARDASIL IM around February 2012 (lot number not provided). Around April 2012, the patient received dose 2, 0.5 GARDASIL IM (lot number not provided). Around June 2012, the patient received dose 3, 0.5 ml GARDASIL IM (lot number not provided). No other co-suspects were reported. No concomitant medications were reported. The patient's mother was concerned the third dose was give outside the recommended dosing scheduled. No adverse event was reported. Therapy with GARDASIL was reported as discontinued in around June 2012. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated subcutaneously with dose 1, 0.5 (Merck) VARIVAX (Lot # not reported) in 1999, the second 0.5 ml dose of (Merck) VARIVAX (Lot # not reported) SQ in 2009 and inadvertently received a third 0.5 ml dose of (Merck) VARIVAX (Lot # not reported) SQ on 16-JUL-2012. No adverse effect was reported. 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 healthcare worker refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (lot # not reported) on 20-JAN-2011, dose 2 on 31-MAR-2011. The patient was in the office on 27-JUL-2012 to get the third dose. No adverse effect reported. 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 pharmacist refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (lot # not reported) on 05-AUG-2010. On 13-JUL-2011 the patient was vaccinated with dose 2 GARDASIL (lot # not reported), which was late. No adverse reaction reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash erythematous, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 14 month old patient who on 14-MAR-2012 was vaccinated with a dose of VARIVAX (Merck) (lot # 671427/1217AA). The nurse mentioned that on 31-MAY-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. A lot check has been initiated. Follow-up information has been received from a registered nurse concerning a 14 month old female patient with seborhaeic dermatitis and no illness at time of vaccination who on 14-MAR-2012 at 15:30, was vaccinated with the first dose of VARIVAX (Merck), SC, right leg. The nurse reported that the patient came to clinic on 31-MAY-2012, with a rash described as "1-2 mm area of erythema, some areas have vesicles developing. Most lesions are on the lower legs and upper thighs and buttocks with few lesions on upper extremities". The patient was diagnosed with varicella. There was no laboratory testing done. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. This is one of the several reports from the same source. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Flushing
Clinical narrative: This spontaneous report as received from a doctor of pharmacy concerning a 68 year old male patient with no allergies and a history of pain who on 18-JUL-2012, was vaccinated SQ in the back of left arm with 0.65 ml dose of ZOSTAVAX (lot# 0366AE, exp 23-MAR-2013). Concomitant medication included VOLTAREN GEL. The pharmacist stated that the patient called him on 20-JUL-2012 to state he experienced generalized flushing throughout his body. Post vaccination with ZOSTAVAX, approximately on 18-JUL-2012, the patient noticed some slight flushing after taking his hydrocodone, but when the patient took another dose of hydrocodone last night "approximately on 19-JUL-2012" the flushing was spread throughout his body. The patient did not have any treatment given. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 13.0
Sex: M
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 dose 1 GARDASIL (Lot, number, dose and route not reported) in 2011, a year ago. The patient received dose 2 GARDASIL (Lot number, dose and route not reported) on 11-JUL-2012, which would be late. No other co-suspects were reported. No concomitant medications were reported. No symptoms were reported. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 years old female patient with no pertinent medical history. The patient was vaccinated subcutaneously with a 0.5 ml dose of (Lot # 0414AE; exp date 27-FEB-2014) VARIVAX (Merck) on 03-JUL-2012. No other co-suspects were reported. There was no concomitant medication. On an unknown date the patient experienced an injection site reaction after being administered the vaccine. The patient sought unspecified medical attention. Treatment was provided by observing the patient since the vaccination. The patient does annual check ups. At the time of the report the patient was recovering. The relatedness for injection site reaction is unknown for VARIVAX (Merck). Lot check has been requested by the nurse. This is one of several reports received from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 years old female patient with no pertinent medical history. The patient was vaccinated subcutaneously with a 0.5 ml dose of (Lot # 0414AE; exp date 27-FEB-2014) VARIVAX on 03-JUL-2012. No other co-suspects were reported. There was no concomitant medication. On an unknown date the patient experienced an injection site reaction after being administered the vaccine. The patient sought unspecified medical attention. Treatment was provided by observing the patient since the vaccine. The patient does annual check ups. At the time of the report the patient was recovering. The relatedness for injection site reaction is unknown for VARIVAX. A lot check was requested by the nurse. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 4 year old patient who on 28-AUG-2008 was vaccinated with the first dose of VARIVAX (Merck) (lot # 661444/0529X). On 23-NOV-2011 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot #670796/0781AA). The nurse mentioned that on 11-JUN-2012 the patient had outbreaks of varicella. The patient had contacted the office. At the time of the report, the patient's status was unknown. This was one of the several reports from the same source. Follow-up information was received from a registered nurse who stated that the 4 year old male patient with reactive airway disease, eczema and no illness at time of vaccination on 28-AUG-2008, was vaccinated SQ in the right leg with the first dose of VARIVAX (Merck) lot # 661444/0529Z) at 11:00 am. On 27-NOV-2011, the patient was vaccinated SQ in the left leg with the second dose of VARIVAX (Merck) (lot # 670796/0781AA) at 09:00 am. The nurse reported that the patient went to the clinic on 06-NOV-2012 with a rash described as "erythematous popular and vesicular rash, lesions in various stages and coalescing into patches on arms, leg and buttock, few on face, no lesions on trunk". The patient was diagnosed with varicella. On 20-JUN-2012 the patient recovered. The patient did not have any testing done. A lot check has been initiated. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Injection site pain, Injection site swelling, Mouth ulceration, Nausea
Clinical narrative: This spontaneous report was received from a female consumer refers to her 16 years old daughter with none medical history and none drug reaction/s allergies. The patient was vaccinated mistakenly, intramuscularly with a fourth 0.5 ml dose of GARDASIL (Lot# not reported) on 05-JUL-2012, by the office staff, not the treating physician. The consumer explained that the dose was given to the patient mistakenly in lieu of a meningococcal vaccine (unspecified) which had been administered on 12-JUL-2012. There were no concomitant medications. On 12-JUL-2012, the patient experienced nausea, injection site swelling, injection site pain, an ulcer in mouth and headache. It was reported that on an unknown date the patient experienced injection site pain and injection site swelling after previous doses of GARDASIL, (doses, route and Lot numbers not reported). The patient spoken with the physician. There was no treatment given for adverse event. None laboratory test were performed. At the time of the report patient's status was recovering. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a female consumer refers to her 16 years old daughter with none medical history and none drug reaction/s allergies. The patient was vaccinated mistakenly, intramuscularly with a fourth 0.5 ml dose of GARDASIL (Lot# not reported) on 05-JUL-2012, by the office staff, not the treating physician. The consumer explained that the dose was given to the patient mistakenly in lieu of a meningococcal vaccine (unspecified) which had been administered on 12-JUL-2012. There were no concomitant medications. On 12-JUL-2012, the patient experienced nausea, injection site swelling, injection site pain, an ulcer in mouth and headache. It was reported that on an unknown date the patient experienced injection site pain and injection site swelling after previous doses of GARDASIL, (doses, route and Lot numbers not reported). The patient spoken with the physician. There was no treatment given for adverse event. None laboratory test were performed. At the time of the report patient's status was recovering. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old female patient with hypertension and no Drug reactions/Allergies. The patient was vaccinated with 0.65 ml dose of ZOSTAVAX (Lot#0240AE/Exp Date: 15-MAR-2013, subcutaneous on left arm) on 03-JUL-2012. No other co-suspects were reported. Concomitant medications included atenolol and sotalol. On 04-JUL-2012 the patient experienced redness (no swelling, pain or itching) on her left arm at the injection site after receiving ZOSTAVAX, treatment of cold packs to her arm was given for the AE. No lab diagnostics studies performed. The patient sought unspecified medical attention. The outcome was reported as not recovered/not resolved. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacy student concerning a female patient who in 2009 was vaccinated with the first dose of GARDASIL and in 2011 was vaccinated with the second dose of GARDASIL (doses, routes and lot numbers not reported). No adverse events were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropod bite
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 60 years old female patient with none known pertinent medical history and drug allergies to OMNICEF and CELEXA. The patient was vaccinated with ZOSTAVAX (lot # not reported) on an unknown date. No concomitant medications were reported. "Three days later" (exact date unknown) the patient began prednisone therapy ("40 mg daily for four days") for a "mosquito bite or bug bite she experienced while camping." The patient sought for unspecified medical event attention via an office visit. The outcome was reported as not recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Acute stress disorder, Alopecia, Rash generalised
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age with no pertinent medical history. The patient was vaccinated with dose 2 of GARDASIL (Lot # not reported) and dose 3 of GARDASIL (Lot # not reported) on an unspecified dates. No other co-suspects were reported. No concomitant medications were reported. The physician reported that after received the 3 doses of of GARDASIL, the patient's mother claimed that her daughter got a wart like rash all over her body. Also after the third dose, the daughter developed alopecia on the scalp. The patient went to a dermatologist who thought it was a stress like reaction but the mother did some research on the internet and believed that it was the of GARDASIL that caused her daughter's adverse reactions. The physician also reported that when the patient received the second dose of GARDASIL, she got the wart like rash. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a medical assistant with no patient involved. The medical assistant stated the MMR II (lot# not reported) and the sterile water diluent packages look similar which led her to improperly store the MMR II at room temperature with the diluent. "The cartons look so similar that this could lead medication error." The improperly stored MMR II was not administered. Additional information has been requested.
Sex: U
Vaccine: HPV2
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse professional refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (Lot#unspecified) on 02-SEP-2009, dose 2 on 08-NOV-2011 and dose 3 on 24-JAN-2012. No other co-suspects and concomitant medications were reported. No treatment information was reported. No adverse effects were reported. It was unspecified whether the patient had sought medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 23 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with first dose of GARDASIL on 17-JUL-2012 (lot number and route were not reported). On 17-JUL-2012, the patient developed nausea, dizziness, lightheadedness and a cold sweat immediately after receiving GARDASIL. Treatments given for events included juice and cookies. The outcome of cold sweat, lightheadedness, dizziness and nausea was reported as recovered/resolved on 17-JUL-2012. The patient sought medical attention in the office. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a physician refers to a 37 years old female patient. The patient was vaccinated with the first and second dose of 0.5 ml MMR II (lot number not reported) in 1983 and 2000. No other co-suspects were reported. No concomitant medications were reported. On 11-JUL-2012 the patient did a titer test which showed a low titer for mumps. No treatment information was reported. The outcome of a low titer for mumps is unknown. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 23 years old female patient. The patient was vaccinated with dose 1 of GARDASIL (Lot # not reported) on 18-JAN-2008 and received the second dose of GARDASIL (Lot # not reported) on 20-MAR-2008. The patient was receiving her third dose of GARDASIL (Lot # not reported) on 26-JUL-2012. No adverse effect was observed or reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a 70 year old female consumer reporting on herself with a history of four bowel obstructions. The consumer reported that on 29-JUN-2012, was vaccinated with a dose of ZOSTAVAX in her right arm (dose, route and lot number not reported). No other co-suspects were reported. Concomitant medications included ZOLOFT, simvastatin (manufacturer unknown), omeprazole, LIDODERM, fentanyl, IMITREX (sumatriptan), OS-CAL and minerals (unspecified), CENTRUM. It was reported that in the evening of the day that the consumer was vaccinated on 29-JUN-2012, she experienced an area of redness that was between the elbow and the shoulder underneath the top of the right arm after receiving ZOSTAVAX. The redness was about two and one half by one and one half inches in diameter. No lab diagnostics studies were performed. No treatment was given for the experience. The symptoms started to improve on 01-JUL-2012, the consumer was recovering. The consumer did not seek medical attention. The relatedness for area of redness that was between the elbow and the shoulder underneath the top of the right arm after receiving ZOSTAVAX vaccine, the redness was about two and one half by one half inches in diameter was unknown for ZOSTAVAX. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Exposure to communicable disease, Herpes zoster, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a physician concerning an 87 year old male patient with high cholesterol, coronary artery disease (CAD), atrial fibrillation (Afib), peripheral vascular disorder (PVD), vitamin d insufficiency, left eye scleritis, mitral regurgitation(MR), tricuspid regurgitation(TR), pulmonary hypertension, hypertension, chronic kidney disease stage 3(CKD)and impaired fasting glucose who on 17-FEB-2011 was vaccinated with a 0.65 mL dose (reported as standard dose) of ZOSTAVAX (Merck)(lot#: 669533/1382Z) for preventing shingles. Concomitant therapy included COREG, ALTACE, simvastatin (MSD), warfarin, aspirin, vitamin D (unspecified), cyanocobalamin (manufacturer unknown) and DULCOLAX. It was reported that the patient developed shingles a couple of days ago. According to the patient the rash developed on 02-JUL-2012 and he went to the doctor on Monday, 04-JUN-2012, and that's when it was diagnosed. The patient was given a prescription for VALTREX on 04-JUN-2012 and was assumed he started taking it. No lab diagnostics studies performed. At the time of the report, the patient was recovering. Follow up information was received from a health care professional reporting that the 87 year old retired male patient on 17-FEB-2011, was vaccinated in his left deltoid with the first 0.65 dose of ZOSTAVAX (Lot # 669533/1383Z, Expiration date 19-JAN-2012). It was reported that the rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The patient had a history of chickenpox during his childhood and in May-2012, was exposed to chickenpox or herpes zoster. Direct fluorescent antibody was not performed. No specimen was collected for polymerase chain reaction (PCR). It was reported that reddish rash that was somewhat painful and pruritic having stated on 02-JUN-2012, it had not significantly worsened. The patient had not associated fever or chills other areas of rash or new contacts or exposures. The denied any discomfort or itching this morning. He did have a slightly erythematous rash over the right anterior chest surrounding the mid right breast medially. It was reported that patient's daughter was recently diagnosed (May-2012) with varicella zoster. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health care worker refers to 8 patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot #0306AE as reported) anywhere from 29-JUN-2012 till the time of the report instead of ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. No adverse events reported at time of the report. It was unspecified if the patients had sought medical attention. This is one of two reports from the same source (the other report MARRS # 1207USA010810). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age who on 03-JUL-2012, date was vaccinated with a dose of (Merck) VARIVAX (dose, route and lot number not reported) instead of ZOSTAVAX. Medical assistant stated that the physician placed an order for ZOSTAVAX and (Merck) VARIVAX was on the invoice and it was shipped. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Herpes zoster, Herpes zoster oticus, Pain, Rash
Clinical narrative: Information has been received from an approximately 67 year old male consumer with a history of stent in heart 12 years ago with no drug reactions or allergies concerning himself who in approximately 2009 ("about 3 years prior") was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included unspecified pain medication. In October 2011, the patient had some teeth extracted and after that developed a rash on his face that got worse. The patient went to the emergency room where it was diagnosed as dermatitis, but 2 days later it was diagnosed as shingles, although he had had the ZOSTAVAX (Merck) vaccine about 3 years prior. From that he developed Ramsay Hunt Syndrome that was diagnosed by an ear doctor. The patient still had pain. The patient was given ointment and pain medications. Blood test was performed (results not reported). At the time of the report, the patient did not recover. Follow up information was received from a health care professional reporting that the approximately 67 year old male patient "3 to 4 years ago" in approximately 2009 was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). It was reported that the patient developed shingles 3-4 years after getting ZOSTAVAX vaccine. No adverse reactions were reported. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Tooth extraction
Clinical narrative: Information has been received from an approximately 67 year old male consumer with a history of stent in heart 12 years ago with no drug reactions or allergies concerning himself who in approximately 2009 ("about 3 years prior") was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot # not reported). Concomitant therapy included unspecified pain medication. In October 2011, the patient had some teeth extracted and after that developed a rash on his face that got worse. The patient went to the emergency room where it was diagnosed as dermatitis, but 2 days later it was diagnosed as shingles, although he had had the ZOSTAVAX (Merck) vaccine about 3 years prior. From that he developed Ramsay Hunt Syndrome that was diagnosed by an ear doctor. The patient still had pain. The patient was given ointment and pain medications. Blood test was performed (results not reported). At the time of the report, the patient did not recover. Follow up information was received from a health care professional reporting that the approximately 67 year old male patient "3 to 4 years ago" in approximately 2009 was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). It was reported that the patient developed shingles 3-4 years after getting ZOSTAVAX vaccine. No adverse reactions were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a health care worker refers to a patient of unknown age. The patient was vaccinated with VARIVAX (Merck) (Lot#0306AE as reported) instead of ZOSTAVAX  sometime between the dates of 07-JUN-2012 thru 29-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse events reported at time of the report. It was unspecified if the patient had sought medical attention. This is one of two reports from the same source (the other report MARRS # 1207USA010810). Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Skin lesion
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 67 years old male patient with high prostatic specific antigen (PSA), lactose intolerance, hypertension and no allergies. The patient was vaccinated subcutaneously in the left deltoid with lot # (672675/0068AE; expiration date 13-APR-2013), 0.65 ml of ZOSTAVAX on 16-JUL-2012. No other co-suspects were reported. There was no concomitant medications. On 17-JUL-2012, 30 hours post vaccination the patient had rash, looked like lesions, at the injection site of left deltoid. The patient went to the office to be seen on 19-JUL-2012. The reporter confirmed that the patient did not have shingles but the treatment for the injection site rash was ZOVIRARX topical ointment. No lab diagnostics tests were performed. The outcome of rash was reported as not recovered. The relatedness for rash was not provided for ZOSTAVAX. Additional information has been requested.