chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Computerised tomogram head, Cytomegalovirus test, Double stranded DNA antibody, Dyskinesia, Encephalopathy
Clinical narrative: 7/30/12 ED: "Feeling out of it", "feeling like she was outside of her body", altered mental status, occasional episodes when she thought it she heard family voices in her head. 7/21/12 ED: Repeating things, repetitious motion, "out of it," --> admitted AMS, no seizures, neuro consulted for 3 episodes of unresponsiveness, lasting 20-40 mins. Jerkiness involving RLE, LUE, encephalopathy, fatigue, temperature increased.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Epstein-Barr virus test, Fatigue, Feeling abnormal, Flow cytometry, Hallucination, auditory
Clinical narrative: 7/30/12 ED: "Feeling out of it", "feeling like she was outside of her body", altered mental status, occasional episodes when she thought it she heard family voices in her head. 7/21/12 ED: Repeating things, repetitious motion, "out of it," --> admitted AMS, no seizures, neuro consulted for 3 episodes of unresponsiveness, lasting 20-40 mins. Jerkiness involving RLE, LUE, encephalopathy, fatigue, temperature increased.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Herpes simplex serology, Laboratory test, Lumbar puncture, Mental status changes, Nuclear magnetic resonance imaging brain
Clinical narrative: 7/30/12 ED: "Feeling out of it", "feeling like she was outside of her body", altered mental status, occasional episodes when she thought it she heard family voices in her head. 7/21/12 ED: Repeating things, repetitious motion, "out of it," --> admitted AMS, no seizures, neuro consulted for 3 episodes of unresponsiveness, lasting 20-40 mins. Jerkiness involving RLE, LUE, encephalopathy, fatigue, temperature increased.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Repetitive speech, Rubella antibody test, Stereotypy, Thyroid stimulating immunoglobulin, Unresponsive to stimuli
Clinical narrative: 7/30/12 ED: "Feeling out of it", "feeling like she was outside of her body", altered mental status, occasional episodes when she thought it she heard family voices in her head. 7/21/12 ED: Repeating things, repetitious motion, "out of it," --> admitted AMS, no seizures, neuro consulted for 3 episodes of unresponsiveness, lasting 20-40 mins. Jerkiness involving RLE, LUE, encephalopathy, fatigue, temperature increased.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Varicella virus test, Viral test
Clinical narrative: 7/30/12 ED: "Feeling out of it", "feeling like she was outside of her body", altered mental status, occasional episodes when she thought it she heard family voices in her head. 7/21/12 ED: Repeating things, repetitious motion, "out of it," --> admitted AMS, no seizures, neuro consulted for 3 episodes of unresponsiveness, lasting 20-40 mins. Jerkiness involving RLE, LUE, encephalopathy, fatigue, temperature increased.
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Unevaluable event
Clinical narrative: 7/30/12 ED: "Feeling out of it", "feeling like she was outside of her body", altered mental status, occasional episodes when she thought it she heard family voices in her head. 7/21/12 ED: Repeating things, repetitious motion, "out of it," --> admitted AMS, no seizures, neuro consulted for 3 episodes of unresponsiveness, lasting 20-40 mins. Jerkiness involving RLE, LUE, encephalopathy, fatigue, temperature increased.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Dermatitis atopic, Rash generalised
Clinical narrative: This spontaneous report as received from a physician refers to a 52 years old female patient with asthma and morphine allergy; the patient was known to be "atopic". The patient was vaccinated with a dose of ZOSTAVAX (Lot number, dose and route not reported) on 08-MAY-2012. No other co-suspects were reported. There was no concomitant medication. Physician reported that on 18-MAY-2012, then days after receiving ZOSTAVAX, the patient developed a rash all over her body. "A part of the rash was biopsied and it came back as atopic dermatitis. The patient was treated with systemic and topical steroids and anti-histamines. At the time of the report, the outcome of atopic dermatitis was reported as not recovered/not resolved. The patient contacted the physician. Atopic dermatitis was considered to be disabling for short period of time by the reporter physician. The relatedness for atopic dermatitis was unknown for ZOSTAVAX. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, TD
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient was given wrong vaccine: given Td > 7 yrs instead of DTaP required for school ages 4-6.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Headache, Hypersensitivity, Malaise
Clinical narrative: Notice on next day.  Had bodyaches, general malaise with headache. Arm with redness, swelling, painful and warm to touch. No hives or vesicle, no discharges. Examined by Dr, diagnosed with Cellulitis, allergic reaction and prescribed with Keflex.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Oedema peripheral, Pain, Pain in extremity, Skin warm
Clinical narrative: Notice on next day.  Had bodyaches, general malaise with headache. Arm with redness, swelling, painful and warm to touch. No hives or vesicle, no discharges. Examined by Dr, diagnosed with Cellulitis, allergic reaction and prescribed with Keflex.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Dyskinesia, Gaze palsy, Pallor
Clinical narrative: Verbatim per incident report: "Administered Menveo and Hep A #1 in left deltoid and HPV #1 in right deltoid. Assisted client from exam table to chair. While observing sibling receiving immunizations, patient's head leaned back against the wall, eyes rolled back, face went pale, upper and lower extremities with movement lasting 5 seconds. Awoke unaware of what had happened. Laid (patient) down on table with cold rag on forehead, knees bent. He did not eat breakfast this morning. Gave cereal bar and sunny delight. Color returned to face, lips pink. Bp 90/60, Pulse 72, Resp 24. Reccomended to follow up w/ pediatrician. Dr. contacted and notified, ok to finish vaccine series. Schedule well child visit and can discuss further with them (parents). Mom aware.
Age: 27.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abortion induced, Foetal disorder, Maternal exposure during pregnancy
Clinical narrative: I was 8 weeks pregnant at a time, baby was diagnosed later with kidney issues and heart defect, had to terminate pregnancy. Vaccine was H1N1.
Age: 0.39
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Started off as bump at site of injection. Progressively got worse as the week went on and now is hot, red, with a 6 inch diameter and a bruise raised skin in the middle.  Father has had similar reactions to vaccines yet we are required to get these to go to school.  She is on a catch up plan as we chose not to vaccinate the first 4 years.  This could be an accumulation allergic reaction.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Discomfort, Erythema, Pruritus
Clinical narrative: Large reddened areas appeared on the trunk of the body, mostly on the front side.  Extremely itchy and uncomfortable.  Some of the reddened areas were fluid filled, these fluid filled areas grew in size over the course of the next few days.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site pain
Clinical narrative: Pts arm is red, itching, and painful at vaccination site.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Left arm deltoid area 3.25in x 3.50 in; approx 0.5 cm depth swollen area; warm to the touch. Mildly tender; raised lesion; mild erythema; mild rash; itching. Patient denies pain.  Benadryl 25 mg po given & Rx for Benadryl prescribed.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth, Skin lesion
Clinical narrative: Left arm deltoid area 3.25in x 3.50 in; approx 0.5 cm depth swollen area; warm to the touch. Mildly tender; raised lesion; mild erythema; mild rash; itching. Patient denies pain.  Benadryl 25 mg po given & Rx for Benadryl prescribed.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb discomfort, Pain in extremity, Skin induration, Skin mass, Skin warm
Clinical narrative: Patient felt discomfort and pain in arm. Arm was red and she felt like their was a grapefruit sized lump under her skin that felt as hard as a rock. Patient stated that the area was very warm where the lump was.
Age: 52.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site reaction, Pain in extremity
Clinical narrative: Patient felt discomfort and pain in arm. Arm was red and she felt like their was a grapefruit sized lump under her skin that felt as hard as a rock. Patient stated that the area was very warm where the lump was.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling/redness to left deltoid measuring 13x8cm, warm to touch after receiving HPV vaccine.
Age: 18.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Blood culture, C-reactive protein, Cellulitis, Erythema, Full blood count abnormal
Clinical narrative: Swelling to both feet with pain (10/10) and erythema.  Increasing symptoms through 7/29 when he was seen in ED with initial dx cellulitis.  Dx changed to lymphedema commonly seen with trainees and unrelated to timing of immunizations which were rescheduled and edema occurred on the same day following arrival at the base.  He likely recovered, but was seen on 8/1 when he was better, but still in pain and difficulty walking.
Age: 18.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Gait disturbance, Haematocrit normal, Haemoglobin normal, Lymphoedema, Oedema
Clinical narrative: Swelling to both feet with pain (10/10) and erythema.  Increasing symptoms through 7/29 when he was seen in ED with initial dx cellulitis.  Dx changed to lymphedema commonly seen with trainees and unrelated to timing of immunizations which were rescheduled and edema occurred on the same day following arrival at the base.  He likely recovered, but was seen on 8/1 when he was better, but still in pain and difficulty walking.
Age: 18.0
Sex: M
Vaccine: IPV, MNQ, TDAP
Symptoms: Oedema peripheral, Pain in extremity, Red blood cell sedimentation rate normal, White blood cell count increased
Clinical narrative: Swelling to both feet with pain (10/10) and erythema.  Increasing symptoms through 7/29 when he was seen in ED with initial dx cellulitis.  Dx changed to lymphedema commonly seen with trainees and unrelated to timing of immunizations which were rescheduled and edema occurred on the same day following arrival at the base.  He likely recovered, but was seen on 8/1 when he was better, but still in pain and difficulty walking.
Age: 13.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: REDNESS SWELLING AND PAIN ON INJECTION SITE
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, DTAP, HPV4, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: LEFT UPPER ARM PRESENTS WITH REDNESS, SWELLING AND TENDERNESS. REDNESS AND SWELLING RADIATES APPROXIMATELY 1 INCH ABOVE ELBOW. PATIENT COMPLAINS OF PAIN ONLY WHEN ARM IS BENT. PATIENT PRESENTS WITH MOTHER AT HIS SIDE AND SHE WANTED PATIENT EVALUATED.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, DTAP, HPV4, MNQ
Symptoms: Discomfort, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: LEFT UPPER ARM PRESENTS WITH REDNESS, SWELLING AND TENDERNESS. REDNESS AND SWELLING RADIATES APPROXIMATELY 1 INCH ABOVE ELBOW. PATIENT COMPLAINS OF PAIN ONLY WHEN ARM IS BENT. PATIENT PRESENTS WITH MOTHER AT HIS SIDE AND SHE WANTED PATIENT EVALUATED.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Malaise, Measles, Myalgia, Rash generalised
Clinical narrative: Following MMR injection on 5-31, pt developed viral prodrome with URI sx on 6-08, then a Measles rash (whole body) 2 days later with persistent myalgias, arthralgias, off/on rash, malaise that is present to date 8-02.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Upper respiratory tract infection, Viral infection
Clinical narrative: Following MMR injection on 5-31, pt developed viral prodrome with URI sx on 6-08, then a Measles rash (whole body) 2 days later with persistent myalgias, arthralgias, off/on rash, malaise that is present to date 8-02.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left arm, near varicella injection site became red and swollen.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Injection site mass, Injection site pain, Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: Patient complained of swollen upper arm.  5x7 firm, nonmobile lesion/mass on left upper arm 7 days after first Gardasil. No redness, edema, rash. Positive tenderness with palpation. Watch reevaluate in one week. Ibuprofen for tenderness.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site. Denies fever.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Computerised tomogram, Ear pain, Ear, nose and throat examination, Headache
Clinical narrative: Acute pain on right side of body radiating from lower back neck up side of head to hairline, jaw area and mouth and ear.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphatic disorder, Neck pain, Oral pain, Pain in jaw
Clinical narrative: Acute pain on right side of body radiating from lower back neck up side of head to hairline, jaw area and mouth and ear.
Age: 1.27
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Body temperature increased, Convulsion, Differential white blood cell count, Full blood count, Urine analysis
Clinical narrative: CHILD WAS OBSERVED BY PARENT HAVING A SEIZURE TEMP OF 104.5 REPORTED BY PARENT AND TOOK TO ER TO BE CHECKED OUT CHILD DID HAVE PREVIOUS FEBRILE SEIZURE PRIOR TO IMMUNIZATIONS
Age: 0.36
Sex: M
Vaccine: DTAPIPVHIB, RV5
Symptoms: Rotavirus infection, Rotavirus test positive
Clinical narrative: Contracted Rotavirus.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Syncope, Vomiting
Clinical narrative: Fainting and vomiting after GARDASIL immunization. Dizziness and nausea lasted 1/4 hour.
Age: 19.0
Sex: F
Vaccine: ANTH, SMALL, TYP
Symptoms: Dermatitis contact, Rash generalised, Rash pustular
Clinical narrative: Generalized rash 24 hrs prior to Typhoid, Smallpox, Anthrax and PPD screening/vaccination - saw PCM. Given steroid tx for poss. reaction to vaccination. Seen at SRP. Call Vaccine Center. Pics sent. Dx "nonviral pustulosis vs poison ivy". Continue meds. 48 hr quarters. Return to SRP 8/06.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Acute disseminated encephalomyelitis, Dizziness, Visual impairment
Clinical narrative: Wed 29 Feb 12 - Received Flu shot. Mon 19 March 12 - Received Tdap vaccine. About Thurs 22 March 12 - Dizzy & visual disturbance. Mon 9 April 12 - To ED & admit. Tues 10 April 12 - Transfer to another hospital by ambulance. DX: Acute Disseminated Encephalomyelitis. W or Th 18 or 19 April - back home.
Age: 36.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: Is it possible that as a result of giving me multiple vaccinations all at one time - that this could have created an "opportunity" for something like shingles to surface? I had also received an SI joint injection (corticosteroid) on Aug. 25th, 2011 (same hospital).
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Computerised tomogram, Convulsion
Clinical narrative: This spontaneous report as received from a consumer refers to her 16 years old son with no pertinent medical history or drug reactions or allergies. The patient was vaccinated intramuscularly with dose 1, 0.5 ml of GARDASIL (lot number not reported) on 25-JUL-2012. The patient's mother reported that on 25-JUL-2012 the patient received the dose by the medical assistant who was the nurse practitioner in the doctors office. The mother was upset that she did not receive more information on GARDASIL. The mother stated that she and her son were told they could leave the office right after the injection was given. The mother left with her son and later on her son had a seizure (medically significant). The mother took her son to the hospital. The patient was given a CAT SCAN (result not provided) but was not admitted to the emergency room at one hospital. The ER doctor recommended the patient schedule an EEG. The mother also stated she did not think she would take the patient back to get the remaining schedule doses of GARDASIL. The outcome of seizure was reported as recovered. The relatedness for seizure was not provided for GARDASIL. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Hypophagia, Pyrexia, Urine analysis normal
Clinical narrative: Fever - started 4 hours after receiving vaccine. Temp: 104 (tympanic) in office today. Decreased PO/, still febrile now (28 hours after receiving vaccine).
Age: 1.57
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Whelp on (R) thigh at site on injection. No spread. No wheezing or generalized urticaria.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Diarrhoea, Headache, Injection site reaction, Local reaction, Nausea
Clinical narrative: Headache, nausea, diarrhea, local reaction at injection site next day after injection no tx except KENALOG 80 mg I (L) buttock.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: PT c/o nausea/"light headed" and tired after vaccines today. T - 101.7 advised TYLENOL, fluids, call if sx do not improve/worsen.
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood pressure increased, Cold sweat, Dizziness, Feeling cold, Hyperhidrosis
Clinical narrative: Received vaccines HPV and Tdap at 1400. 1405 pt. felt like she was going to pass out. Became pale, diaphoretic, clammy and cold. BP 68/40, HR 49. C/O blurred vision. With monitoring after 10 minutes BP increased 74/52 then 94/62, O2 Sat remained at 99%. Pt. could se without difficulty. Ambulated without difficulty and stated felt "fine".
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Pallor, Vision blurred
Clinical narrative: Received vaccines HPV and Tdap at 1400. 1405 pt. felt like she was going to pass out. Became pale, diaphoretic, clammy and cold. BP 68/40, HR 49. C/O blurred vision. With monitoring after 10 minutes BP increased 74/52 then 94/62, O2 Sat remained at 99%. Pt. could se without difficulty. Ambulated without difficulty and stated felt "fine".
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Nausea
Clinical narrative: 7/24/12 2200 noticed single vesicular papular on chin 7/25/12 developed sore throat, headache worked 8 hours shift during evening increased symptoms including nausea, fatigue, malaise and vaginal lesion pain on urination. 7/26/12 fever 101.1 nausea, headache increased, 2nd lesion chin, many les. (vaginal) took day off - 7/27/12. Fever res. decreased symp. Ref. to E.R.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Pyrexia, Rash papular, Simplex virus test positive, Vaginal lesion
Clinical narrative: 7/24/12 2200 noticed single vesicular papular on chin 7/25/12 developed sore throat, headache worked 8 hours shift during evening increased symptoms including nausea, fatigue, malaise and vaginal lesion pain on urination. 7/26/12 fever 101.1 nausea, headache increased, 2nd lesion chin, many les. (vaginal) took day off - 7/27/12. Fever res. decreased symp. Ref. to E.R.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella virus test negative, Viral test positive
Clinical narrative: 7/24/12 2200 noticed single vesicular papular on chin 7/25/12 developed sore throat, headache worked 8 hours shift during evening increased symptoms including nausea, fatigue, malaise and vaginal lesion pain on urination. 7/26/12 fever 101.1 nausea, headache increased, 2nd lesion chin, many les. (vaginal) took day off - 7/27/12. Fever res. decreased symp. Ref. to E.R.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: 7/19/12 - cramps on side of neck going down towards trapezoid muscle. Pt. didn't consult with MD & started feeling better. Approximately 2 days when follow up made on 7/20/12.
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Cellulitis, Erythema
Clinical narrative: Pt given TDAP, Heat 8-2-12 for wound check. (L) arm appears red. N.P. Rx KEFLEX. Dx with cellulitis.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: 16x8 cm erythema (R) ant thigh.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: 10-15 papular vesicular arms, legs with torso.
Age: 0.43
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Emotional distress
Clinical narrative: Gave infant PEDIARIX, Hib, PCV 13 at approx 10:15 on 8/2/12. Rec'd phone call from mother approx 3pm stating infant inconsolable since receiving shots this a.m.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Disorientation, Gaze palsy, Loss of consciousness, Muscle rigidity
Clinical narrative: Observed pt passed out on bench in doctor's office after having Hep A and HPV vaccines. Pt was rigid, with feet stretched out, eyes rolled back, pt was disoriented. Pt was passed out for about 60 sec. Pt was evaluated by doctor.
Age: 1.26
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Slight redness on (L) thigh.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Patient developed a few bumps on back of neck and face on 7/23 patients indicated bumps itched. MD diagnosed as a mild case of shingles and patient was treated with acyclovir 400mg five times daily x 7 days.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Local swelling, Oedema peripheral, Pain in extremity
Clinical narrative: Pt received MENACTRA in Lt arm on 8-1-12. Parent states that arm was red/swollen/warm to touch & painful this morning. Area of redness & swelling 5"x6" Pt was started on Clindamycin (300 mg) TID x 10 days. Dx: Cellulitis.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Skin warm
Clinical narrative: Pt received MENACTRA in Lt arm on 8-1-12. Parent states that arm was red/swollen/warm to touch & painful this morning. Area of redness & swelling 5"x6" Pt was started on Clindamycin (300 mg) TID x 10 days. Dx: Cellulitis.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Two days after vaccines, pt developed localized erythema, warmth, swelling, tightness in arm. No pain, no tenderness; no fever. No other concern. BENADRYL (12.5/5ml) approximately 15ml PO given once in office. Mom advised to bring him for eval if it worsens. To repeat BENADRYL tonight & tomorrow along with TYLENOL.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Erythema, Headache, Myalgia, Rash
Clinical narrative: Day 2 post vaccine (8/1) reported sore muscle, chills, aches, headache, told normal reaction. On 8/2 a.m. reported with rash on chest & back - red, nonitchy but feels warm to the touch. Improving by 5 pm.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: Day 2 post vaccine (8/1) reported sore muscle, chills, aches, headache, told normal reaction. On 8/2 a.m. reported with rash on chest & back - red, nonitchy but feels warm to the touch. Improving by 5 pm.
Age: 1.34
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Decreased appetite, Pyrexia, Rash erythematous, Scab, Varicella post vaccine
Clinical narrative: Patient came back to clinic 4 weeks after immunizations patient had c/o of decreased appetite, fever, red spots over extremities and diaper area then spreading to back. Started light (red) and small raised bumps, then became bright red, larger and scabbed. Treatment supportive care: fluids, BENADRYL if begins scratching, lukewarm baths w/vinegar or oatmeal.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: (8/1/12) itchy, redness, warm to the touch, oval in presentation in the general area of the administration. (Approx 5 in x 3 in) Pt. went to doctor and doctor gave her AUGMENTIN and BENADRYL (8/2/12).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 years old female patient with no drug reactions/allergies or medical history. The patient was vaccinated with a dose of ZOSTAVAX (Lot# 0364AE, Exp date: 16-MAR-2013) subcutaneously on 20-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-JUL-2012 the patient developed an "outbreak" at the site of ZOSTAVAX injection. The area of outbreak was red, raised and 3 inches in diameter. The pharmacist had not seen the "outbreak" area yet, and did not know if there were any pustules. The patient sought medical attention by calling the pharmacy. TYLENOL was given as treatment. No lab diagnostics studies were performed. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram head, Fall, Gaze palsy, Haematoma, Head injury
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old female patient with no medical history and no preexisting illness was vaccinated IM into left arm with lot # (671463/1359AA) dose 3 GARDASIL on 12-MAR-2012. There was no concomitant medication. 5 minutes after the injection, patient got up to get water. She started twitching, stiff, some rolling of eyes and fainted. Patient fell and hit her head on the floor. No incontinence. Patient came to in a few min. 2" x 3" hematoma was noticed. Patient had headache and vomiting. CT scan of head was performed, result not provided. The patient visited emergency room. The status of the patient was unknown. The report was considered to be non serious. The original reporting source was not provided. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Muscle twitching, Musculoskeletal stiffness, Syncope, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 11 years old female patient with no medical history and no preexisting illness was vaccinated IM into left arm with lot # (671463/1359AA) dose 3 GARDASIL on 12-MAR-2012. There was no concomitant medication. 5 minutes after the injection, patient got up to get water. She started twitching, stiff, some rolling of eyes and fainted. Patient fell and hit her head on the floor. No incontinence. Patient came to in a few min. 2" x 3" hematoma was noticed. Patient had headache and vomiting. CT scan of head was performed, result not provided. The patient visited emergency room. The status of the patient was unknown. The report was considered to be non serious. The original reporting source was not provided. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Biopsy vulva abnormal, Laser therapy, Skin discolouration, Therapeutic procedure, Vulval disorder
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 22 year old female patient with no drug reactions or allergies who on 20-MAR-2007 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included MIRENA. The nurse reported that the patient now had vulvar dysplasia (VIN II). The nurse was unsure when the dysplasia developed, but the patient was first seen in their office in April of 2011. The patient had an area that was raised with dysplasia in April of 2011 and another discolored area noted in January of 2012. The patient had had two biopsies and both indicated moderate vulvar dysplasia (VIN II) one in April of 2011 and the other in January of 2012. No treatment was given for the event. At the time of the report, the patient had not recovered. Follow-up information has been received from a licensed practical nurse refers to a patient who on 23-JAN-2012 was performed a biopsy. The result was discolored lesions, bilateral epithelial changes. The patient had laser ablation in February 2012. The patient had consultation with the physician. On 18-JUL-2012 the patient was treated with chemical ablation with trichloroacetic acid. The reported stated the patient was doing well. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Vulvar dysplasia
Clinical narrative: Information has been received from a licensed practical nurse concerning an approximately 22 year old female patient with no drug reactions or allergies who on 20-MAR-2007 was vaccinated with the first dose of GARDASIL (lot # not reported). Concomitant therapy included MIRENA. The nurse reported that the patient now had vulvar dysplasia (VIN II). The nurse was unsure when the dysplasia developed, but the patient was first seen in their office in April of 2011. The patient had an area that was raised with dysplasia in April of 2011 and another discolored area noted in January of 2012. The patient had had two biopsies and both indicated moderate vulvar dysplasia (VIN II) one in April of 2011 and the other in January of 2012. No treatment was given for the event. At the time of the report, the patient had not recovered. Follow-up information has been received from a licensed practical nurse refers to a patient who on 23-JAN-2012 was performed a biopsy. The result was discolored lesions, bilateral epithelial changes. The patient had laser ablation in February 2012. The patient had consultation with the physician. On 18-JUL-2012 the patient was treated with chemical ablation with trichloroacetic acid. The reported stated the patient was doing well. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Gaze palsy, Musculoskeletal stiffness, Syncope
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 13 years old female patient. On 20-JUL-2012, the patient was vaccinated with the first dose of GARDASIL (lot # 672721/0101AE, expiration date: 10-OCT-2014 00:00). No other co-suspects were reported. No concomitant medications were reported. On the same day the patient had an episode of syncope following the vaccination. The medical assistant reported that about 3 to 5 minutes after receiving the first dose of GARDASIL the patient became dizzy and fainted. The patient was laid dose and about 30 seconds later the patient's eyes rolled back into her head and the patient's body became stiff (The eyes rolling back into the head and body stiffness lasted for about 30 seconds total). The patient sought medical attention at office and was recovering at the office at the time of the call. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unspecified date the patient was vaccinated with a dose of improperly stored GARDASIL (Lot#, dose, route not reported). No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patient sought for medical attention. No adverse event 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 licensed practical nurse refers to an unspecified number of patients of unknown age. The patients missed as unspecified number of doses of GARDASIL (Lot # not reported) and received an unspecified number of doses of GARDASIL (Lot # not reported) outside of the recommended 0-2-6 month schedule. No adverse symptoms were reported. Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a 52 years old female patient who on 16-JUL-2012 was vaccinated SC with 0.65 ml of a dose of ZOSTAVAX into the left arm (lot number reported as 0365AE). No other co-suspects were reported. No concomitant medications were reported. On 18-JUL-2012, the patient presented to pharmacy and had red area around the injection site of the left arm. Also, it was reported that the injection site was warm to the touch and no rash was presented. No treatment was given for the adverse event. The patient sought unspecified medical attention by a pharmacy visit. At the time of the report, the patient had not recovered. The relatedness for red area around the injection site and injection site was warm to the touch is unknown for ZOSTAVAX. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered at inappropriate site, 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 of GARDASIL (Lot # not reported) on 14-JUN-2011, a second dose of GARDASIL (Lot # not reported) on 16-AUG-2011 and the third dose of GARDASIL (Lot # not reported) on 03-JUL-2012. The patient received the first and third doses on the arm but the second dose was given on the gluteus maximus. No adverse effect was reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site swelling, Pyrexia, Somnolence
Clinical narrative: This spontaneous report as received from a consumer refers to his 15 years old daughter. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # not reported) on 30-JUL-2012 at 10:00. No other co-suspects were reported. No concomitant medications were reported. The consumer reported that on 30-JUL-2012, the patient was experiencing fever of 102 degrees and chills. The patient had injection site swelling, the size of a softball and was sleepy. The patient did not receive treatment for the adverse events. The patient's parents called the health care professional. At the time of the report, the patient had not recovered. The relatedness for fever for 102 degrees, injection site swelling and chills was unknown for PNEUMOVAX 23. Additional information has been requested.
Age: 59.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from an office manager refers to a 59 years old patient. The patient was vaccinated with a dose of VARIVAX (Merck) (Lot number, dose and route not reported) on 19-JUL-2012. On the same date, the patient received ZOSTAVAX (Lot number, dose and route not reported) in another arm. No concomitant medications were reported. The patient was supposed to get PNEUMOVAX 23 and not VARIVAX (Merck). The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Vaginal lesion, Vulvovaginal discomfort
Clinical narrative: This spontaneous report as received from a 28 years old female consumer reporting herself with no pertinent medical history and no drug reactions/allergies. The patient was not pregnant at the time of the report. The patient was vaccinated with lot # (0469U); exp. date 28-FEB-2010 GARDASIL (dose and route not reported) on 11-JUN-2008. No other co-suspects were reported. Concomitant medications included CLARINEX and SINGULAIR. Consumer reported that she learned she was diagnosed with HPV (type unspecified) and abnormal cell around 26-JUN-2012. She also stated that on an unspecified date, she experienced mild topical irritation and lesions in the vaginal are. Consumer was no longer seeing the physician who provided the vaccine and plans to see a new physician on 13-JUL-2012. Tests were scheduled for colposcopy. No treatment was given for the events. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. The relatedness for hpv (type unspecified)/abnormal cells, lesions in the vaginal area and mild topical irritation was unknown for GARDASIL. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella virus test negative
Clinical narrative: This spontaneous report as received from physician concerning a 15 year old male patient who on 09-OCT-2007, was vaccinated with the first dose of VARIVAX (Merck) (lot#658294/1103U, exp 13-JUL-2009). On 09-AUG-2008, the patient was vaccinated with the second dose of VARIVAX (Merck) (lot# 0391X, exp 05-MAR-2010) and on 19-SEP-2009, the patient was vaccinated with the third dose of VARIVAX (Merck) (lot# 665103/1001Y, exp 13-JUL-2011). The physician reported that on 20-APR-2012, the patient had a negative titer for varicella (unspecified IgG titer was done). At the time of the report, the patient's outcome was unknown. The patient sought medical attention by physician's office contact. The relatedness for negative titer for varicella is unknown for VARIVAX (Merck). 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 physician refers to a patient of unknown age who four years ago in 2008, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL and on 25-JUL-2012, was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot numbers not reported). No adverse effects were reported. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a 65 years old female patient with back issues; the patient is sensitive to many medications and normally takes pediatric medications. The patient was vaccinated with a dose of ZOSTAVAX (Lot number, dose and route not reported) on 27-MAY-2012. No other co-suspects were reported. Concomitant therapy included ADVIL. On 30-MAY-2012, a few days after the vaccination was given, the patient experienced a deep ache in her left leg down to her foot. The patient explained that the pain was now in the joints of her toes (approximately on 30-MAY-2012). No Lab Diagnostics were performed. No treatment was given for the events. At the time of the report, the events had not improved. The patient sought unspecified medical attention. The relatedness for deep ache in her left leg down to her foot and pain in the joints of her toes was unknown for ZOSTAVAX. 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 physician assistant refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (Lot number, dose and route not reported) in JUN-2011. The patient received dose 2 GARDASIL (Lot number, dose and route not reported) on 11-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. No symptoms were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient with hypertension, anxiety, degenerative arthritis and sulfonamide allergy. Approximately in 2005 ("about 7 years ago"), prior getting PNEUMOVAX 23, the patient had received TD vaccine and experienced an arm rash at the injection site. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot number, route and injection site not reported). Concomitant medications included omeprazole, citalopram, hydrochlorothiazide, naproxen and amlodipine. On an unknown date the patient experienced an arm rash at the injection site. The patient did not receive treatment. On an unspecified date the patient recovered from the arm rash at the injection site. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to an 18 year old female patient who was postpartum. The patient was vaccinated intramuscularly with a first 0.5 ml dose of GARDASIL (Lot #0214AE during verification process, exp. date 13-OCT-2014) on 16-JUL-2012. Concomitant medications included prenatal vitamins (unspecified). On 16-JUL-2012 the patient experienced tonic-clonic movement and syncope after receiving her dose (the syncope and tonic-clonic movement lasted 30 seconds). Patient did not receive any treatment for adverse event. The outcome of syncope and tonic-clonic movement was reported as recovered/resolved in the office (on 16-JUL-2012). Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Hypoaesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 years old male patient was vaccinated with lot # (671994/1537AA) dose 3 GARDASIL on 24-MAY-2012. On the same day, the patient complained of numbness in left leg after the shot given in left arm. The outcome of the event was unknown. The patient did not seek medical attention. The event was considered to be non serious. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who two months ago "approximately on 21-MAR-2012" was vaccinated IM in the right upper arm with the first 0.5 ml dose of GARDASIL (lot # 672233/1561AA).The physician reported that the patient, went to the office for the second dose of GARDASIL and, at that time, reported that she had developed significant redness and swelling at the site of injection the day after receiving her first dose of GARDASIL "approximately on 22-MAR-2012". The patient self-treated with BENADRYL and the injection site reaction resolved without requiring medical treatment. The physician did not administer the second dose of GARDASIL. It had not been determined if the GARDASIL series would be discontinued. At the time of the report, the patient recovered. The patient sought medical attention by visit to the office. Follow up information has been received from a physician refers to a 11 years old female patient with none known pre-existing allergies, birth defects and medical conditions. The patient was vaccinated intramuscularly in right arm with a first 0.5 ml dose of GARDASIL lot # (672233/1561AA) on 15-MAR-2012. No other co-suspects were reported. Concomitant medications included MENACTRA, HAVRIX and BOOSTRIX. It was reported that on 16-MAY-2012, when a second dose of GARDASIL (dose, route and Lot # not reported) was scheduled, mother reported that the patient had redness and swelling on the arm where GARDASIL first dose  was given (onset date was 15-MAR-2012, reported also as a few hours after administration). The mother reported that the patient received BENADRYL for the reaction. On ER mother was instructed to see allergy department in the hospital to further evaluation. At the time of the report the patient's status was recovered (recovery date was not provided). Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Eyelid function disorder, Nausea
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female patient with gastrooesophageal reflux disease and no drug reactions/Allergies who on 03-APR-2012 was vaccinated IM with the first dose of GARDASIL. Concomitant therapy included omeprazole and MICROGESTIN. On 04-APR-2012 the patient found that it was very difficult to open her eyes in the morning. She also had nausea. These problems resolved as the day progressed. The patient recovered on 04-APR-2012 in the evening. The patient sought medical attention by going to the nurse practitioner's office. No treatment was given for the events. No lab diagnostics studies were performed. Follow up information has been received from nurse practitioner refers to 26 year old female patient with no illness at time of vaccination and none pre-existing allergies, birth defects and medical conditions. It was reported that patient presented for second dose of GARDASIL on 05-JUN-2012 (dose, route and Lot # not reported) and reported that on the morning following her first injection of GARDASIL on 03-APR-2012 on 14:19 (dose not reported, IM, right deltoid, Lot#668985/0690AA) it was very difficult to open her eyes. She believes she might have also nauseous. Patient stated she might have experienced similar symptoms in past after GARDASIL "but this was worse". The patient recovered on 04-APR-2012. Additional information is not expected.
Age: 0.42
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 months old female patient. The patient was vaccinated with dose 1, oral, ROTATEQ (lot # not reported) on 30-APR-2012. The patient was receiving dose 2, oral, ROTATEQ (lot # not reported)n 27-JUL-2012. No adverse experience had been observed or reported. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Rash maculovesicular, Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 22 month old patient who on 11-AUG-2011 was vaccinated with a dose of VARIVAX (Merck) (lot # 669918/0112AA). The nurse mentioned that on 04-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. A lot check has been initiated. A follow up information has been received from a registered nurse refers to a 22 months (reported also a 1 year old) male patient. The patient's medical history included cellulitis and colic, patient had none illness at the time of vaccination. The patient was vaccinated subcutaneously in right leg with first dose of VARIVAX (Merck) (dose not reported, lot # 669918/0112AA) on 11-AUG-2011. It was reported that on an unknown date, patient came to clinic with a rash described as "macular, vesicular rash over trunk. No excoriation marks were noted". Diagnosed was chickenpox. At the time of the report the patient's status was unknown. None lab diagnostic tests were performed. This is one of several reports from the same source. Additional information is not expected.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a 90 years old female patient with hypothyroidism, "high blood", and allergy to erythromycin, regarding her own experience. The patient was vaccinated with ZOSTAVAX on 19-JUL-2012 in her upper right arm. Concomitant medications included SYNTHROID and losartan potassium. On 26-JUL-2012, about a week after received her ZOSTAVAX, the patient noticed a big red spot about 3 inches in diameter where the shot was administered. She stated that it itched very badly. The patient applied hydrocortisone cream topically in infected area. She did not sought medical attention. Patient outcome was not reported. Additional information is not expected.