chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Patient received vaccinations on 6/28/13. He reported to the Urgent Care department on 6/30/13 at 0847 with complaints of fever, bodyaches, fatigue, redness, and swelling around the injection site. He was subsequently transferred to the Emergency Department and given ibuprofen 800mg po, morphine 4mg IV, ondansetron 4mg IV, normal saline infusion x 1 L, and 1gm of ceftriaxone.
Age: 21.0
Sex: M
Vaccine: MNQ, PPV
Symptoms: White blood cell count increased
Clinical narrative: Patient received vaccinations on 6/28/13. He reported to the Urgent Care department on 6/30/13 at 0847 with complaints of fever, bodyaches, fatigue, redness, and swelling around the injection site. He was subsequently transferred to the Emergency Department and given ibuprofen 800mg po, morphine 4mg IV, ondansetron 4mg IV, normal saline infusion x 1 L, and 1gm of ceftriaxone.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Abnormal behaviour, Decreased appetite, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: Extreme swelling, increasing throughout weekend, fever and leg painful and hot to touch. Patient would not eat or play, just wanted to lay around. Felt bad.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Skin warm, Swelling
Clinical narrative: Extreme swelling, increasing throughout weekend, fever and leg painful and hot to touch. Patient would not eat or play, just wanted to lay around. Felt bad.
Age: 3.0
Sex: M
Vaccine: DTAPIPV, MMRV, DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme swelling, increasing throughout weekend, fever and leg painful and hot to touch. Patient would not eat or play, just wanted to lay around. Felt bad.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash, Rash erythematous, Rash generalised
Clinical narrative: Pt developed a red rash on his face on 6/27/13 and by 6/28/13 they had spead all over his body.
Age: 1.32
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash, Varicella post vaccine
Clinical narrative: Developed rash that looked like breakthrough chicken pox.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: M.A. gave an adult dose of Hep A instead of a pediatric dose.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Nausea
Clinical narrative: This spontaneous report as received from a pharmacist refers to 71 year old female patient. On 11-JUN-2013 the patient was subcutaneously vaccinated in left arm with dose of ZOSTAVAX (0.65 ml, lot # J000445, exp. 11-JUN-2014). On 16-JUN-2013 9 (reported as yesterday), the patient called pharmacy to report reaction. The patient had nauseous and had pain throughout her joints. The outcome of pain throughout her joints and nauseous was reported as not recovered/not resolved. The relatedness between pain throughout her joints and nauseous and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin irritation
Clinical narrative: This spontaneous report as received from a female patient of unknown age, regarding herself. On May 2013 (reported as last week) the patient was vaccinated with a dose of ZOSTAVAX, (route, dose, site of administration, lot number and expiration date were not reported). In May 2013 (reported as last week), the patient skin irritation after taking ZOSTAVAX and the rash went from her upper arm to her elbow. She went to the local ER (Emergency Room). The doctor's there didn't provide her with any information. The patient asked to know why she developed the rash. The outcome of rash and skin irritation was not reported. The relatedness between rash went from her upper arm to her elbow and skin irritation was not reported. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, itching, pain from injection site to elbow. KEFLEX 500 mg x 5 days.
Age: 0.4
Sex: F
Vaccine: HIBV, IPV, PNC, RV5
Symptoms: Frequent bowel movements, Haematochezia, Mucous stools
Clinical narrative: This spontaneous report as received from a physician refers to a 4 month old female patient, with no known drug allergies and no pertinent medical history. On 07-JUN-2013 (on Friday) the patient was vaccinated with the second dose of ROTATEQ, orally (dose, was not reported) and a dose of Hepatitis B (Recombinant) (manufacturer unknown) (lot number, dose not provided). Other vaccines administered on 07-JUN-2013 included: IPV, PREVNAR and HIB (unspecified carrier). On 07-JUN-2013 the patient experienced two bloody stools with mucus since receiving ROTATEQ, as well as frequent bowel movements. There were no other side effects and no signs of intussusception. The patient sought medical attention. The patient was seen in the physician office on 10-JUN-2013 in the morning and a stool sample was obtained to verify that the bloody stools are not related to a bacterial infection. The lab diagnostics resulted: unspecified stool culture. The patient's formula was also changed to an unspecified formula to verify there was not lactose intolerance. The outcome of two bloody stools with mucus and frequent bowel movements was reported as not recovered/not resolved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Minor swelling rt. deltoid. Mild tenderness, using arm normally.
Age: 0.95
Sex: U
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a 11 month old patient(gender unknown). On 28-APR-2000, the patient was vaccinated with a dose of M-M-R II(lot#, expiry not reported). No adverse event reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot, Induration, Injection site erythema, Injection site swelling
Clinical narrative: Received shot on 6/25, called office on 6/28 stating redness and swelling at tetanus site, has been getting bigger. No problems breathing OV 6/28 some induration 10 x 9 cm warmth, redness, swelling given abx 6/28 ?cellulitis.
Age: 67.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling
Clinical narrative: Received shot on 6/25, called office on 6/28 stating redness and swelling at tetanus site, has been getting bigger. No problems breathing OV 6/28 some induration 10 x 9 cm warmth, redness, swelling given abx 6/28 ?cellulitis.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist via a physician refers to a 70 year old male patient. No medical history provided. In 2013, ("several weeks ago") the patient was vaccinated with ZOSTAVAX (subcutaneous, arm, indication: vaccination, dosing unknown). No concomitant medication provided. Following the vaccination the patient developed muscle aches in the injection site ar,. The outcome of persistent muscle aches in the injection site arm was reported as not recovered. The patient sought medical attention by contacting the physician. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored M-M-R II(lot#, expiry not reported). No adverse effects reported. The nurse stated that the vaccine was exposed to warmer temperatures. However, she had to research to determine if the vaccines were administered. This is 1 of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse events.
Sex: M
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of pharmacy concerning a male patient of unknown age. On 20-JUN-2013, the patient was vaccinated with an expired dose of M-M-R II (lot number and expiry date reported as 0851AA and 03-JUN-2013 respectively), subcutaneously. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Intervertebral disc degeneration, Lordosis, Muscle spasms
Clinical narrative: Patient reports acute onset of right sided upper back pain radiating down right arm the day after vaccination. She was seen at clinic and was diagnosed with shingles and started on VALTREX she never had a rash, so no cultures could be done. She has been treated with anti-inflammatories, corticosteroids, muscle relaxers, NEURONTIN, massage and chiropractic therapies. She is currently recieving Sarapin injections to the muscle from a naturopathic physician. She is better but not back to her pre-immunization status.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Spinal X-ray abnormal
Clinical narrative: Patient reports acute onset of right sided upper back pain radiating down right arm the day after vaccination. She was seen at clinic and was diagnosed with shingles and started on VALTREX she never had a rash, so no cultures could be done. She has been treated with anti-inflammatories, corticosteroids, muscle relaxers, NEURONTIN, massage and chiropractic therapies. She is currently recieving Sarapin injections to the muscle from a naturopathic physician. She is better but not back to her pre-immunization status.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Local swelling, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Patient report red rash on extremities and trunk that comes and goes since administration on 6/5/13. Rash is blotchy and itchy. Immediately after injection (L) arm became swollen; treated w/antihistamine 6/24/13. Patient seen at health center treated w/prednisone.
Age: 5.0
Sex: M
Vaccine: DTAP, HIBV, HPV4, MMR, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Inflammation, Injection site inflammation, Myositis, Oedema peripheral, Pain in extremity
Clinical narrative: Pt developed pain and swelling 1 day after vaccine in that arm which remains inflamed and may require I and D procedure.
Age: 38.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ultrasound scan abnormal
Clinical narrative: Pt developed pain and swelling 1 day after vaccine in that arm which remains inflamed and may require I and D procedure.
Age: 1.22
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Child had fine red rash on trunk prior to vaccine being given. Rash present all over body next day.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site, injection 6/19/14, patient recommended to use BENADRYL, ice, ibuprofen by physician. Scheduled Dr. visit for 7/1/13 same day pharmacy notified.
Age: 50.0
Sex: F
Vaccine: HEPAB, MMR, TYP, YF
Symptoms: Injection site erythema
Clinical narrative: Client noticed she developed an area of redness approximately 2" long x 1 in wide at site of YF vaccination. Did not feel bad after vaccinations received. Pointed out to nurse on 6/25/13 visit when here with sons.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Pain, Skin warm
Clinical narrative: Redness and pain/warm to touch. 9 x 10 cm induration.
Age: 66.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Hard core at middle of vaccine site with red streak coming down. Told pt to check with MD on red streak. Still waiting to hear back from pt.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site infection, Injection site mass
Clinical narrative: Infection at injection site - red had a lump given antibiotic resolved.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site pustule, Injection site rash
Clinical narrative: 1.5 cm rash (R) thigh at injection site with one pustule approximately 1 mm.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Scar
Clinical narrative: I broke out with 6 blisters on my face about a week - 10 days after I received the shot. They lasted a little more than 2 weeks. There was no pain. I have minor scars.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Local swelling, Skin irritation, Vaccination complication
Clinical narrative: Pt developed redness at site of inj 2 days after inj. Then day 3 redness larger warm to touch.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: 2 days after ZOSTAVAX -swollen pustules in mouth. Rx for viscous  lidocaine 4 days later.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Mass, Myalgia, Neck pain
Clinical narrative: Client called 6/25/13 at 1630 to report onset of pain and achiness to arm where injection received, area red at injection site this started on 6/22/13 redness improved still is present although better, 6/24/13 reported a lump on (Lt) side collarbone arm remains achy along with muscles under arm. C/O pain from lump up neck.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Client called 6/25/13 at 1630 to report onset of pain and achiness to arm where injection received, area red at injection site this started on 6/22/13 redness improved still is present although better, 6/24/13 reported a lump on (Lt) side collarbone arm remains achy along with muscles under arm. C/O pain from lump up neck.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Vaccination site oedema, Vaccination site pain
Clinical narrative: Redness, edema and pain at site of vaccines administration bilaterally arms. Pt mother states she was tx with ATB and BENADRYL.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Approximately 5 weeks after receiving vaccine, a blister-like rash appeared at injection site measuring 3 inches in diameter.
Age: 5.0
Sex: F
Vaccine: DTAP, MMRV
Symptoms: Oedema, Pyrexia, Urticaria, Wheezing
Clinical narrative: Vaccines given 6-17-13. Fever that night and hives starting the next day. Increased hives and edema sent patient to ER - improvement on DECADRON. Hives increased and wheezing today 6-21-13 --> responding well to therapy.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Acne, Arthralgia, Back pain, Barium swallow, Blood test
Clinical narrative: Memory problems, joint pain, rib and chest pain, ulcers on fingers, bad circulation, Raynaud's, back and leg pain, extreme tiredness, loss of appetite, weight loss, strands of grey hair, panic attack, depression - more symptoms continued to pop-up - nothing has been cured.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiovascular disorder, Chest pain, Computerised tomogram, Decreased appetite, Depression
Clinical narrative: Memory problems, joint pain, rib and chest pain, ulcers on fingers, bad circulation, Raynaud's, back and leg pain, extreme tiredness, loss of appetite, weight loss, strands of grey hair, panic attack, depression - more symptoms continued to pop-up - nothing has been cured.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Endoscopy upper gastrointestinal tract, Fatigue, Hair colour changes, Melanocytic naevus, Memory impairment
Clinical narrative: Memory problems, joint pain, rib and chest pain, ulcers on fingers, bad circulation, Raynaud's, back and leg pain, extreme tiredness, loss of appetite, weight loss, strands of grey hair, panic attack, depression - more symptoms continued to pop-up - nothing has been cured.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal chest pain, Pain in extremity, Panic attack, Raynaud's phenomenon, Skin ulcer
Clinical narrative: Memory problems, joint pain, rib and chest pain, ulcers on fingers, bad circulation, Raynaud's, back and leg pain, extreme tiredness, loss of appetite, weight loss, strands of grey hair, panic attack, depression - more symptoms continued to pop-up - nothing has been cured.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Stomach scan, Weight decreased, X-ray, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Memory problems, joint pain, rib and chest pain, ulcers on fingers, bad circulation, Raynaud's, back and leg pain, extreme tiredness, loss of appetite, weight loss, strands of grey hair, panic attack, depression - more symptoms continued to pop-up - nothing has been cured.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Confusional state, Dehydration, Pyrexia, Renal failure
Clinical narrative: FEVER AND CHILLS, ADMITTED TO HOSPITAL ON 19 JUNE 2013 WITH FEVER OF 104.8.
Age: 52.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Injection site swelling, Pyrexia
Clinical narrative: Extreme swelling at site, fever that evening 101.3 highest temp.  Fatigue.
Age: 18.0
Sex: F
Vaccine: DTAP, HEP, MNQ
Symptoms: Breath sounds abnormal, Dysphagia, Dyspnoea, Erythema, Flushing
Clinical narrative: Itching, flushed, diminished lung sounds, difficulty breathing, difficuty swallowing, rash, erythema.
Age: 18.0
Sex: F
Vaccine: DTAP, HEP, MNQ
Symptoms: Pruritus, Rash
Clinical narrative: Itching, flushed, diminished lung sounds, difficulty breathing, difficuty swallowing, rash, erythema.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, bruising, hot to the touch.
Age: 45.0
Sex: F
Vaccine: TDAP, UNK
Symptoms: Injection site pain, Oedema peripheral
Clinical narrative: Swelling into underarm and soreness at site.
Age: 55.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blister, Pigmentation disorder, Pyrexia, Rash pustular, Robust take following exposure to vaccinia virus
Clinical narrative: 55 year old male with history rash following Smallpox vaccination and concern for adverse vaccine reaction presents for initial consultation. On 5 March of this year patient received Meningococcal conjugate and Typhoid killed injected vaccines. On 6 March he received Anthrax (dose #5) and ACAM2000 (re-vaccination; dose #2). Approximately 48 hours later he developed scattered vesicles (3-4) and pustules (2-3) over his forehead, chest, hip and back. Mild subjective fever. Denies arthralgias/myalgias and headache. Five days later he presented to Immunizations clinic where he was noted to have a major take at the vaccination site. His symptoms resolved over the course of the next 10-14 days without treatment; he feels that he has had continued recurrence of the lesions but admits that he has a history of chronic acneiform rash over his back. Denies residual scarring but notes some skin pigment changes at affected sites. He notes a linear "blister" over the right side of his waist that developed this weekend.
Age: 55.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Skin lesion
Clinical narrative: 55 year old male with history rash following Smallpox vaccination and concern for adverse vaccine reaction presents for initial consultation. On 5 March of this year patient received Meningococcal conjugate and Typhoid killed injected vaccines. On 6 March he received Anthrax (dose #5) and ACAM2000 (re-vaccination; dose #2). Approximately 48 hours later he developed scattered vesicles (3-4) and pustules (2-3) over his forehead, chest, hip and back. Mild subjective fever. Denies arthralgias/myalgias and headache. Five days later he presented to Immunizations clinic where he was noted to have a major take at the vaccination site. His symptoms resolved over the course of the next 10-14 days without treatment; he feels that he has had continued recurrence of the lesions but admits that he has a history of chronic acneiform rash over his back. Denies residual scarring but notes some skin pigment changes at affected sites. He notes a linear "blister" over the right side of his waist that developed this weekend.
Age: 14.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Local swelling, Oedema peripheral, Rash
Clinical narrative: Began to get rash 2 hrs. after vaccine. By the next afternoon, the back of the arm was covered with the rash and it was swollen, hard, lumpy(3x4 inch area). By the third day the area of rash was larger, but had softened and was still hot, red. Now on day 5, just red.
Age: 14.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Skin warm
Clinical narrative: Began to get rash 2 hrs. after vaccine. By the next afternoon, the back of the arm was covered with the rash and it was swollen, hard, lumpy(3x4 inch area). By the third day the area of rash was larger, but had softened and was still hot, red. Now on day 5, just red.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Foster mother brought infant to office for well child check and immunizations. Patient was MCIRed, need immunizations given. After immunizations given foster mother gave staff immunization record to record immunization on and was noted that patient received Pediarix, ActHIB, and Prevnar 13 on 06/22/2013. Foster mother was informed of med error and instructed to contact office or take to ER if any adverse signs or symptoms presented.
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Convulsion, Laboratory test, Pallor, Syncope
Clinical narrative: She fainted, ghostly white. Then she went into seizure. BP 100/60.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Electroencephalogram, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: (1)Large (golf ball size) lump at injection site. Hot, sore, itchy. Lasted 3 weeks before starting to shrink very slowly. (2)Week 2, right arm began to seize several times per hour (opposite arm of injection), couldn't write or type. Continued for 3 more weeks. (3)Week 4, right leg began to seize numerous times per hour. That all continued to May 10, 2013 when I suffered a focal seizure on right side (head to toe). I've never had a seizure before. The emergency room doctor put me on Keppra until I could meet with a neurologist. Five more focal seizures on right side (head to toe) occurred over the next five days. Neurologist added Tegretol and the seizures stopped as did the inability to write. I am still suffering with strange tingles and pains on my right side and also my left side. It took two months for the lump at the injection site to disappear. In addition, I will add that my menstrual cycle became unpredictable. I cycle every 28 days every month without fail for my entire adult life. (Not on birth control) I was due my period on April 1, four days after the Dtap shot, it was 12 days late. I got a full period again 10 days later, and the next cycle was late.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Menstruation irregular, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: (1)Large (golf ball size) lump at injection site. Hot, sore, itchy. Lasted 3 weeks before starting to shrink very slowly. (2)Week 2, right arm began to seize several times per hour (opposite arm of injection), couldn't write or type. Continued for 3 more weeks. (3)Week 4, right leg began to seize numerous times per hour. That all continued to May 10, 2013 when I suffered a focal seizure on right side (head to toe). I've never had a seizure before. The emergency room doctor put me on Keppra until I could meet with a neurologist. Five more focal seizures on right side (head to toe) occurred over the next five days. Neurologist added Tegretol and the seizures stopped as did the inability to write. I am still suffering with strange tingles and pains on my right side and also my left side. It took two months for the lump at the injection site to disappear. In addition, I will add that my menstrual cycle became unpredictable. I cycle every 28 days every month without fail for my entire adult life. (Not on birth control) I was due my period on April 1, four days after the Dtap shot, it was 12 days late. I got a full period again 10 days later, and the next cycle was late.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Partial seizures
Clinical narrative: (1)Large (golf ball size) lump at injection site. Hot, sore, itchy. Lasted 3 weeks before starting to shrink very slowly. (2)Week 2, right arm began to seize several times per hour (opposite arm of injection), couldn't write or type. Continued for 3 more weeks. (3)Week 4, right leg began to seize numerous times per hour. That all continued to May 10, 2013 when I suffered a focal seizure on right side (head to toe). I've never had a seizure before. The emergency room doctor put me on Keppra until I could meet with a neurologist. Five more focal seizures on right side (head to toe) occurred over the next five days. Neurologist added Tegretol and the seizures stopped as did the inability to write. I am still suffering with strange tingles and pains on my right side and also my left side. It took two months for the lump at the injection site to disappear. In addition, I will add that my menstrual cycle became unpredictable. I cycle every 28 days every month without fail for my entire adult life. (Not on birth control) I was due my period on April 1, four days after the Dtap shot, it was 12 days late. I got a full period again 10 days later, and the next cycle was late.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Fall, Hyperhidrosis, Laceration, Loss of consciousness, Pallor
Clinical narrative: After receiving varicella vaccine in right arm SQ, pt reported feeling fine. He left office and when he got in elevator, Mom reported he fainted & fell to knees which caused a laceration.  He passed out for 2-3 seconds and shook during this time period per Mom.  After this he was alert and returned to office with Mom and sister. He was taken to exam room. He was pale and diaphoretic. BP: 92/58, Temp: 96.4.  Dr examined and juice was given. Blood sugar was 108. Patient reported exercising for 1 and 1/2 hrs prior to coming to office and was visibly worried prior to getting the vaccine. After several reevaluations, pt left the office at 12:00pm.  Patient was called on 6/24/13 and Mom reported that he was doing fine.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Syncope
Clinical narrative: After receiving varicella vaccine in right arm SQ, pt reported feeling fine. He left office and when he got in elevator, Mom reported he fainted & fell to knees which caused a laceration.  He passed out for 2-3 seconds and shook during this time period per Mom.  After this he was alert and returned to office with Mom and sister. He was taken to exam room. He was pale and diaphoretic. BP: 92/58, Temp: 96.4.  Dr examined and juice was given. Blood sugar was 108. Patient reported exercising for 1 and 1/2 hrs prior to coming to office and was visibly worried prior to getting the vaccine. After several reevaluations, pt left the office at 12:00pm.  Patient was called on 6/24/13 and Mom reported that he was doing fine.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: + inches wide at site of shingles vaccination. Extremely swollen, sore to the touch and itchy.  Area under the affected skin is very hard.  As of 7/1 8:12 PM the adverse event is still on going but swelling is reduced.  Treated with Cortisone 10 cream without much success.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Oedema peripheral
Clinical narrative: Initially sore upper arm, some swelling and tenderness. Increased swelling and tenderness by nightfall - 10:00pm. Even more swelling and actual pain all day 6/19/2013 accompanied by nausea and loss of appetite, chills, fatigue, and slight fever (2 degrees above normal). Noticed that upper arm had swollen to twice normal size by early morning of 6/20/2013 and upper arm had developed red blotches extending from mid-upper-arm to elbow joint.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Rash macular, Swelling, Tenderness
Clinical narrative: Initially sore upper arm, some swelling and tenderness. Increased swelling and tenderness by nightfall - 10:00pm. Even more swelling and actual pain all day 6/19/2013 accompanied by nausea and loss of appetite, chills, fatigue, and slight fever (2 degrees above normal). Noticed that upper arm had swollen to twice normal size by early morning of 6/20/2013 and upper arm had developed red blotches extending from mid-upper-arm to elbow joint.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, HEP, PPV, RVX
Symptoms: Brain injury, Developmental delay, Failure to thrive, Hypotonia
Clinical narrative: Patient development rapidly declined after every vaccine. Her weight and head circumference moved below the charts, she stopped thriving, becamse severely hypotonic and showed significant brain damage.
Sex: M
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 01-MAY-2013, the patient was vaccinated with a dose of GARDASIL (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot#, expiry not reported). No adverse effects reported. The nurse stated that the vaccine was exposed to warmer temperatures. However, she had to research to determine if the vaccines were administered. This is 1 of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX23(lot#, expiry not reported). No adverse effects reported. The nurse stated that the vaccine was exposed to warmer temperatures. However, she had to research to determine if the vaccines were administered. This is 1 of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Presyncope, Syncope
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 18-JUN-2013 the patient was vaccinated with first dose of GARDASIL lot # H021861 in the right deltoid for prophylaxis (lot # H021861, expiration date 09-OCT-2015). on 18-JUN-2013 ,four minutes after receiving the dose the patient experienced vasovagal episode and syncope. The patient recovered shortly, after sitting in the office for 20 minutes. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 04-MAY-2013, the patient was vaccinated with a dose of GARDASIL (lot # H020002, expiry date 08-AUG-2015), with the same lot of improperly stored GARDASIL. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 0.18
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: "Red, induration at site of upper injection on right thigh" - small area of induration "dime size" over injection site.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site papule
Clinical narrative: Left arm (injection site) painful, swollen, erythematous and itchy. Small raised papule at site also. Had headache and fatigue.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Left arm (injection site) painful, swollen, erythematous and itchy. Small raised papule at site also. Had headache and fatigue.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Within hours of admin., injection site started to swell. Swelling continued over next several days -> to elbow. No rash. No fever. Area pink. Rec. to tx with ibuprofen and cool compress. CB if no improve or worsens.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: Itchy rash developed soon after vaccine administered at site of IPV shot (30 hrs later) no treatment as he was not at clinic when happened.
Age: 11.0
Sex: M
Vaccine: HEP, HPV4, MNQ
Symptoms: Rash generalised, Urticaria
Clinical narrative: Rash all over body after HPV, MCV injection within 24hrs. Seen in ED unclear if hives were secondary to IZ.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Less than 10 spots on body a couple on face for 3 days, low grade temp.
Age: 2.0
Sex: M
Vaccine: DTAP, HEP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Erythema, warmth of entire lateral/posterior upper (R) leg.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath. Diphenhydramine 50 mg once.
Age: 1.0
Sex: F
Vaccine: HIBV, PNC13, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Parents brought her 7-1-13 for check of site of varicella. 2d ago they noted a red bump at presumed site - never blistered, no itch, non-tender, larger. Today 2cm horizontally with 1cm diameter vertically. Not hot. No bruising. Red. Deep mass. No fever. Diarrhea x10 since MN. I do not feel this is related.
Age: 84.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood pressure increased, Dizziness, Vision blurred
Clinical narrative: Increased blood pressure from 150/70 to 174/80 then back to "normal" after 20 minutes. Dizziness, blurred vision; this happened approx. 1/2 hour after shingles vaccine. No treatment was required, nor given.
Age: 0.61
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPIPVHIB, HEP, PNC13
Symptoms: Apnoea, Cyanosis
Clinical narrative: 7 month old female who presented with apnea - baby stopped breathing: lips turned blue, lasted >15 seconds. Recovered and looked and acted fine during exam at clinic.
Age: 0.61
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, DTAPIPVHIB, HEP, PNC13
Symptoms: Breath holding, Cyanosis
Clinical narrative: 7 month old female who presented with apnea - baby stopped breathing: lips turned blue, lasted >15 seconds. Recovered and looked and acted fine during exam at clinic.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site warmth, Local reaction
Clinical narrative: Patient received ZOSTAVAX vaccine; area reported to be red, itchy, warm and bruised. Her daughter is a nurse said infected, I told her localized reaction
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pt came to clinic 6/28/13 and c/o (L) upper arm soreness and (L) side of neck soreness x4 days which started 1 week post Hep B #2.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Lymphadenitis, Nasopharyngitis, Nausea
Clinical narrative: Employee reports presenting nausea, dizziness, mild cold symptoms and head ache one day after vaccine. Took TYLENOL but didn't help. Patient saw PMD for PE two days after vaccination who noticed swelling "in underarm region" while performing breast exam. Swelling lasted 2 days. Nausea, dizziness, cold symptoms and HA lasted 1 day.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report has been received from a consumer (patient's mother), for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female patient. The patient's medical history and concurrent conditions were not provided. The reporter indicated that the patient was currently pregnant and was vaccinated with two doses of GARDASIL. Therapy dates, dose, route and lot number were not provided. Concomitant therapies included CERVARIX. The patient's Last Menstrual Period (LMP) and Estimated Delivery Date (EDD) were not known. the pregnancy outcome was pending (patient was still pregnant at time of report). The reporter indicated the patient had not experienced any side effects. There was no indication as to why the patient was administered CERVARIX and GARDASIL concomitantly. No further information was available. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling
Clinical narrative: This spontaneous report as received from an unknown pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). On an unknown date, the patient experienced swelling of the right side of the arm six weeks after receiving ZOSTAVAX. Treatment was not rendered for the event. The patient sought medical attention for the event (saw the doctor). It was unspecified whether lab diagnostic studies were performed. Outcome of the event was unknown. Causality was not reported. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 85 year old female patient with heart disease. The patient had no drug allergy. On 22-JUN-2013 the patient was vaccinated with ZOSTAVAX lot # J000430, exp. date 10-APR-2014, subcutaneous in the right arm. Concomitant therapies included indomethacin, hydralazine and potassium (manufacturer unknown). On 23-JUN-2013, patient experienced extremely itchy very, red rash which was 2 to 3 inches in diameter on her right arm a the injection site. At reporting time, the patient was recovering from the events. The patient did not seek medical attention. Pharmacist declined the VZVIP packet. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Erythema, Pain, Pruritus, Swelling
Clinical narrative: Case number PHHY2012US038069 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 447435) website on 07 May 2012, with a follow-up received from the Quality Assurance Department (reference number: 230211) on 28 Jun 2013. This case refers to a 15-year-old female patient. Her preexisting conditions included of attention deficit hyperactivity disorder (ADHD) and allergy to sulfa drugs. She was vaccinated with MENVEO vaccine (batch number: M10058) intramuscularly into her right arm on 06 Jan 2012. On an unspecified date after vaccination she developed redness, swelling, severe itching, pain and cellulitis in an unspecified site. She was treated with BENADRYL 50mg every six hours. She had recovered completely on an unspecified date. Based on the batch review report, the quality assurance department concluded that the concerned MENVEO (batch number: M10058) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No other information was available. Non-significant follow up received from the Quality Assurance Department (reference number: 230211) on 22 May 2013: Updated QA reference number only. Follow-up received from the Quality assurance department on 28 Jun 2013: Updated batch review report.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Blood test, Chest X-ray, Muscle twitching, Oedema peripheral, Urine analysis
Clinical narrative: Case number PHHY2013US056708, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488813) website on 05 Jun 2013, and with a follow up report received from QA department on 28 Jun 2013. This is also a quality complaint report (233523). This report refers to a 24-year-old female patient. Her medical history included allergy to amoxicillin and hospitalization for removal of wisdom teeth in 2006. Her concomitant medications included PPD (purified protein derivative). She was vaccinated with FLUVIRIN (batch number: 122201A) in the left arm and BOOSTRIX (batch number: AC52B103BA) in the right arm on 01 Mar 2013. On 18 Mar 2013, she experienced bilateral edema of the legs from the knee down. The patient also gained 10lb weight. She was still in the process of weight loss. During that period the patient experienced muscle twitching. Laboratory tests such as blood and urine testing were performed along with chest x-ray (results were not reported). The patient had not yet recovered at the time of reporting. The seriousness and causality were not reported. Based on the batch review performed, the quality assurance department concluded that FLUVIRIN (batch number: 122201A) was manufactured in accordance with the approved internal procedures and is compliance with cGMP requirements. Follow up report received from QA department on 28 Jun 2013. Updated QA investigational report.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Weight increased
Clinical narrative: Case number PHHY2013US056708, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488813) website on 05 Jun 2013, and with a follow up report received from QA department on 28 Jun 2013. This is also a quality complaint report (233523). This report refers to a 24-year-old female patient. Her medical history included allergy to amoxicillin and hospitalization for removal of wisdom teeth in 2006. Her concomitant medications included PPD (purified protein derivative). She was vaccinated with FLUVIRIN (batch number: 122201A) in the left arm and BOOSTRIX (batch number: AC52B103BA) in the right arm on 01 Mar 2013. On 18 Mar 2013, she experienced bilateral edema of the legs from the knee down. The patient also gained 10lb weight. She was still in the process of weight loss. During that period the patient experienced muscle twitching. Laboratory tests such as blood and urine testing were performed along with chest x-ray (results were not reported). The patient had not yet recovered at the time of reporting. The seriousness and causality were not reported. Based on the batch review performed, the quality assurance department concluded that FLUVIRIN (batch number: 122201A) was manufactured in accordance with the approved internal procedures and is compliance with cGMP requirements. Follow up report received from QA department on 28 Jun 2013. Updated QA investigational report.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Blood test, Chest X-ray, Muscle twitching, Oedema peripheral, Product quality issue
Clinical narrative: Case number PHHY2013US056708, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488813) website on 05 Jun 2013, and with a follow up report received from QA department on 28 Jun 2013. This is also a quality complaint report (233523). This report refers to a 24-year-old female patient. Her medical history included allergy to amoxicillin and hospitalization for removal of wisdom teeth in 2006. Her concomitant medications included PPD (purified protein derivative). She was vaccinated with FLUVIRIN (batch number: 122201A) in the left arm and BOOSTRIX (batch number: AC52B103BA) in the right arm on 01 Mar 2013. On 18 Mar 2013, she experienced bilateral edema of the legs from the knee down. The patient also gained 10lb weight. She was still in the process of weight loss. During that period the patient experienced muscle twitching. Laboratory tests such as blood and urine testing were performed along with chest x-ray (results were not reported). The patient had not yet recovered at the time of reporting. The seriousness and causality were not reported. Based on the batch review performed, the quality assurance department concluded that FLUVIRIN (batch number: 122201A) was manufactured in accordance with the approved internal procedures and is compliance with cGMP requirements. Follow up report received from QA department on 28 Jun 2013. Updated QA investigational report.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Urine analysis, Weight increased
Clinical narrative: Case number PHHY2013US056708, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488813) website on 05 Jun 2013, and with a follow up report received from QA department on 28 Jun 2013. This is also a quality complaint report (233523). This report refers to a 24-year-old female patient. Her medical history included allergy to amoxicillin and hospitalization for removal of wisdom teeth in 2006. Her concomitant medications included PPD (purified protein derivative). She was vaccinated with FLUVIRIN (batch number: 122201A) in the left arm and BOOSTRIX (batch number: AC52B103BA) in the right arm on 01 Mar 2013. On 18 Mar 2013, she experienced bilateral edema of the legs from the knee down. The patient also gained 10lb weight. She was still in the process of weight loss. During that period the patient experienced muscle twitching. Laboratory tests such as blood and urine testing were performed along with chest x-ray (results were not reported). The patient had not yet recovered at the time of reporting. The seriousness and causality were not reported. Based on the batch review performed, the quality assurance department concluded that FLUVIRIN (batch number: 122201A) was manufactured in accordance with the approved internal procedures and is compliance with cGMP requirements. Follow up report received from QA department on 28 Jun 2013. Updated QA investigational report.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP, FLU3, TDAP, FLU3, TDAP
Symptoms: Weight fluctuation, Weight increased
Clinical narrative: Case number PHHY2013US056708, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 488813) website on 05 Jun 2013, and with a follow up report received from QA department on 28 Jun 2013. This is also a quality complaint report (233523). This report refers to a 24-year-old female patient. Her medical history included allergy to amoxicillin and hospitalization for removal of wisdom teeth in 2006. Her concomitant medications included PPD (purified protein derivative). She was vaccinated with FLUVIRIN (batch number: 122201A) in the left arm and BOOSTRIX (batch number: AC52B103BA) in the right arm on 01 Mar 2013. On 18 Mar 2013, she experienced bilateral edema of the legs from the knee down. The patient also gained 10lb weight. She was still in the process of weight loss. During that period the patient experienced muscle twitching. Laboratory tests such as blood and urine testing were performed along with chest x-ray (results were not reported). The patient had not yet recovered at the time of reporting. The seriousness and causality were not reported. Based on the batch review performed, the quality assurance department concluded that FLUVIRIN (batch number: 122201A) was manufactured in accordance with the approved internal procedures and is compliance with cGMP requirements. Follow up report received from QA department on 28 Jun 2013. Updated QA investigational report.