chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This literature marketed report as received from a health care professional refers to a 4.7 year old patient. Effectiveness of varicella vaccine (manufacturer unknown) was assessed by reviewing the medical records of closely monitored HIV-infected children, including those receiving highly active antiretroviral therapy (HAART) between 1998 and 2007. The medical records of 164 perinatally HIV-infected children from between 1989 and 2007 were reviewed to determine whether and when they had received varicella vaccine (manufacturer unknown), developed varicella, and/or developed herpes zoster. All perinatally HIV-infected children were included except for those who developed varicella before 1 year of age because varicella vaccine (manufacturer unknown) was not given before then. Immunized children received at least 1 dose of live attenuated varicella vaccine. The effectiveness of the vaccine was calculated as 1 minus the rate ratio. Incidence rates of varicella were calculated for 2 periods: the prevaccine era for HIV-infected children (1989-1998, when none of the children received varicella vaccine) and the vaccine era (1999-2007). Rate ratios for development of herpes zoster among children who had been immunized versus those who had varicella were calculated. It was reported that patient developed breakthrough varicella at 4.7 years after the last immunization. The outcome of the event reported was unknown. The author considered the event as related to varicella vaccine (manufacturer unknown). This case is linked to the case 1405USA004682 via Same Literature Link. 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 a patient of unknown age. The patient received the 1st dose of GARDASIL (dose, route and lot# not reported) on 22-OCT-2013, the 2nd dose of GARDASIL (dose, route and lot # not reported) on 11-MAR-2014 and was in the office today, 02-MAY-2014, attempting to get the 3rd dose of GARDASIL. No adverse effects were reported. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a physician assistant via a representative refers to an approximately 10 year old male patient. In approximately May 2012 (reported as 2 years ago) the currently 12 year old patient was vaccinated with a dose of GARDASIL (lot#, dose and route not reported), fainted post vaccination. The outcome of the event was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Nausea
Clinical narrative: This spontaneous report as received from a nurse refers to a 13 year old female patient. No pertinent medical history was reported. No drug reactions or allergies were reported. On 28-AUG-2013 the patient was vaccinated with a second dose of GARDASIL lot # H021346, expiration date 01-OCT-2015, 0.5ml dose, intramuscular. The nurse stated that the patient received GARDASIL series as follows: first dose on 20-JUN-2013, lot# H021346, expiration date 01-OCT-2015, intramuscular, second dose on 28-AUG-2013, lot# H021346, intramuscular, and third dose on 10-APR-2014, lot# H020901, expiration date 05-JUL-2015, dose 0.5ml, intramuscular (also reported as subcutaneous). Concomitant therapy included HAVRIX (dose and indication not reported) administered on 10-APR-2014 in the opposite arm of the GARDASIL. It was reported that on 28-AUG-2013 (immediately after receiving her second dose), the patient experienced nausea and lightheadedness. It was reported that the patient was observed for 15 minutes at the physician's office and sent home due the patient feeling better (it was also reported that finally the patient recovered from nausea and lightheadedness, but exact date was unspecified). The nurse also reports that the patient was nausea right before (on an approximately 10-APR-2014), receiving her third dose of GARDASIL. She states that due to the patient feeling nausea, the patient received her third dose of GARDASIL in the "reclining position". It was reported that the patient's mother "feels" like the third dose of GARDASIL was administered subcutaneous instead of intramuscular but the nurse reported that the first, second and third dose was administered intramuscular. The patient's blood pressure on 28-AUG-2013 (after receiving her second dose) was 106/66 (units not provided). No other laboratory diagnostics were performed. The patient's outcome of event: nausea right before receiving her third dose of GARDASIL was reported as recovered (date unspecified). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: MNQ, TYP, YF
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: PATIENT HAD PRE DEPLOYMENT HCG DRAWN AND WAS FOUND TO HAVE BEEN PREGNANT.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Cough, Headache, Myalgia, Parotid gland enlargement
Clinical narrative: Tinnitus, headache, joint pain. Initially.  On 05/10/14 cough, parotid area swelling and pain, headache, tooth pain, myalgias.
Age: 40.0
Sex: M
Vaccine: MMR
Symptoms: Salivary gland pain, Tinnitus, Toothache
Clinical narrative: Tinnitus, headache, joint pain. Initially.  On 05/10/14 cough, parotid area swelling and pain, headache, tooth pain, myalgias.
Age: 0.41
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker (medical assistant) refers to a 4 month old patient (gender unspecified). On 02-MAY-2014, the patient was vaccinated with second dose of ROTATEQ, 2 ml once, oral, (lot number J011344, expiry date 20-MAY-2015). Healthcare worker stated ROTATEQ had been improperly stored at 1C for an unspecified number of hours. No adverse effects reported. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Arthritis
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with (Oka/Merck) (VARIVAX) (strength, dose, route unknown). On an unknown date the patient developed arthritis after receiving (Oka/Merck) (VARIVAX) and the patient contacted the pharmacist but no intervention to prevent serious criteria. No PQC was involved. The action taken and outcome of the event was unknown. The causality of arthritis and VARIVAX was unknown. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Formication, Rash erythematous, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: This spontaneous report as received from a 67 year old male patient referred to himself. The patient was allergy to anything with a "zone" in it, included prednizone and cortisone. The patient could take cremes but nothing that went inside. The patient's medical history included asthma attack. The patient's concurrent condition included blood pressure issue that was caused by the asthma. On an unknown date in approximately August 2013 (6 to 8 months ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route and lot# not reported). Second suspect therapies included LISINOPRIL for blood pressure issue was given at the end of February 2014. On an unknown date in February 2014 (at the end of February 2014), less than a year after receiving the vaccine the patient came down with undiagnosed red itchy patches on multiple areas of his body immediately after taking lisinopril for the blood pressure issue that was caused by the asthma he had. Lisinopril was known to cause hives. The patient stated that he thinks he had shingles currently but that his doctor said he didn't think it was shingles but rather hives. The patient said that when he touched the bumps it "activated them to be itchy", it's not on the skin, but under the skin, like you had ants waking on you". He said that he had it in 5 spots on his body, "legs. belly, head, back of the neck and the tops of his arms" up to his elbow and "they took turns itching. One area would stop itching and another area would pick up." The patient sought medical attention and the doctor issued him a special body wash and a creme to ease the symptoms of the shingles/hives. No lab diagnostics studies were performed. At the time of reporting, the patients outcome was unknown. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 22 year old female patient. Eight years ago, in 2008 the patient was vaccinated with the series of GARDASIL. The patient experienced nausea and fever after the third dose of GARDASIL. The patient reported the adverse effects with the third dose, but no adverse effects after the first and second dose of GARDASIL. The treatment for the patient was unspecified because the patient was not at their practice at the reporting time. On unspecified date, the patient recovered from nausea and fever. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to her 6 month old daughter. On 05-MAY-2014 the patient was vaccinated with first dose of GARDASIL, injection (dose and lot# not reported. The patient was supposed to receive an unspecified dose of an unspecified hepatitis b vaccine (recombinant) (manufacturer unknown). The patient was not feeling any adverse reactions. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No medical history, allergies and drug reactions provided by the reporter. On 28-APR-2014 the patient was vaccinated with RECOMBIVAX HB (1 ml, intramuscular, second dose, anatomical location and lot number not reported). The first dose of RECOMBIVAX HB (1 ml, intramuscular, anatomical location and lot number not reported) was administered in September 2012. No concomitant medications were reported. Lab diagnostics studies not reported. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 17 year old female patient with Crohn's disease. On 28-JAN-2014, the patient was vaccinated with the first dose of RECOMBIVAX HB. Dose 2 of RECOMBIVAX HB was administered at the end of February 2014, and the third dose on 30-APR-2014. The patient did not receive any other vaccines at the same time as RECOMBIVAX HB. The physician reported that the third dos of RECOMBIVAX HB was administered too soon (on 30-APR-2014). There were no serious side effects. An outcome was not reported. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Underdose
Clinical narrative: This spontaneous report as received from a other registered nurse refers to a 20 year old female patient. The patient's pertinent medical history included asthma and irritable bowel syndrome (IBS). No drug reactions/allergies. On 27-DEC-1993 the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown)) dose 1, 5 MCG/0.5 ml, intramuscular. On 28-JAN-1994 and on 23-MAY-1994 the patient received respectively dose 2 and dose 3 (5MCG/0.5 ml intramuscular). The lot number provided for all 3 of those doses is 1301W. Concomitant therapies included ALBUTEROL. Recently the patient was found to have negative antibody titers for hepatitis B. The outcome and the causal relationship were not provided. Furthermore it was reported that the patient on 28-APR-2014 received a pediatric dose of RECOMBIVAX HB (captured in MARRS 1405USA00093). Additional information has been requested.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Varicella post vaccine
Clinical narrative: Pt given VZV vaccine in Lt arm - 4 day later rash on arm c/w chicken pox. Mom knew that rash was possible side effect of vaccine.
Age: 43.0
Sex: F
Vaccine: HEPAB, IPV, TYP, YF
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt came to clinic for numerous travel vax's. The only one given in (R) arm was IPOL on 5/7/14. Returns to clinic on 5/13/14 with approximately 7cm red raised area warm to touch on (R) UQ. Some pain, c/o H/A.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness and swelling at injection site 9 AM 5/10/14. Dizziness, headache, fever 5 PM 5/10/14 until 6 PM on 5/11/14. Redness and swelling on upper arm still evident 5/13/14 some itching. Swelling area was approx 2 x 5 inches.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness and swelling at injection site 9 AM 5/10/14. Dizziness, headache, fever 5 PM 5/10/14 until 6 PM on 5/11/14. Redness and swelling on upper arm still evident 5/13/14 some itching. Swelling area was approx 2 x 5 inches.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Burning sensation, Erythema, Inflammation, Pruritus, Rash
Clinical narrative: Inflamed, red, circular area on right arm, area burns and itches at times. No pain event reported to me 5-7-14 at 12:00 pm. I told patient to have her doctor look at rash.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient has 4-4.5 inch in diameter red swelling around injection site, left upper arm. It is also hot to the touch. Instructed her to go to ER /and or walk-in clinic to evaluate further.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Coagulation test, Haemorrhage intracranial, Nuclear magnetic resonance imaging brain, Retinal haemorrhage, Seizure like phenomena
Clinical narrative: Seizure-like activity. Child was diagnosed with intranial and bilateral retinal hermorrhages.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Skeletal survey, Ultrasound skull
Clinical narrative: Seizure-like activity. Child was diagnosed with intranial and bilateral retinal hermorrhages.
Age: 48.0
Sex: M
Vaccine: HEPA, JEV1
Symptoms: Condition aggravated, Paraesthesia
Clinical narrative: Persistent paresthesia from JE vaccine administration on 4-17-14 (#1); this was an aggravation of a pre-existing paresthesia (unk etiology).
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Local swelling, Skin warm
Clinical narrative: Patient received vaccine on 4/30/14. On 5/6/14 patient noticed her arm to be red, warm and swollen. Patient went to the ER on 5/6/14 and was diagnosed with cellulitis. The ER couldn't confirm it was from injection.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Induration, Local swelling, Pain in extremity
Clinical narrative: (R) arm red and painful. Pain decreased over 24 hours. Swell with red indurated area covering 1/2 upper arm (viewed 5/1/14).
Age: 0.24
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Dehydration, Pyrexia, Urine output decreased, Vomiting
Clinical narrative: See attached office and infusion notes - 2 days worth d/t dehydration/vomiting. The patient presents with a chief complaint stated by mother that patient received her 2 mo vaccines yesterday. Last night patient started vomiting at 10 pm. Patient also started running a fever up to 101 early this morning. Also has only had about 3 wet diapers since yesterday evening. Mother states that patient is not keeping anything down. The patient is a 12 week old female who presents with a complaint of vomiting. The patient is here for an initial visit. The onset of the vomiting has been sudden and has been occurring in an intermittent pattern for 12 hours. The course has been constant. The vomiting is characterized as containing undigested food and bilous. The vomiting occurs immediately after meals. The symptoms are aggravated by eating. The symptoms have no relieving factors. The symptoms have been associated with fever, while the symptoms have not been associated with constipation or diarrhea. There has been no previous evaluation.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Injection site pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Persistent pain in upper left arm at site of injection. Pain radiating to wrist and shoulder. Stiffness and pain of arm requiring daily ibuprofen. Inability to sleep on left side w/out pain.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site rash, Rash
Clinical narrative: Had WCC and vaccinations. Prevnar 13, Rotateq, Pentacel, mother states no fever, cried some and had a rash on both arms and one leg. Everything was fine and rash resolved pretty quickly and mother unsure if it were heat related.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Influenza like illness, Musculoskeletal disorder, Neck pain, Pain in extremity
Clinical narrative: From time of shot severe pain in arm running up the neck and down arm, severely tired with flu like sysmptoms. Twenty days lter still have severe pain in arm, very hard to use!!!
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and warmth at site, increased redness in left upper arm over the next week.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Adminstered expired meningococcal vaccine.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Abdominal pain upper, Abnormal behaviour, Activities of daily living impaired, Asthenia, Confusional state
Clinical narrative: Prolonged fatigue, stomach ache, headache, confusion, vertigo, disoriented, dizzines,s fainting every day. Weakness all the time. She is staying in bed all day and can not stand up without these problems. She sleeps all day. She is not herself and can not function.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Disorientation, Dizziness, Dysstasia, Electrocardiogram, Fatigue
Clinical narrative: Prolonged fatigue, stomach ache, headache, confusion, vertigo, disoriented, dizzines,s fainting every day. Weakness all the time. She is staying in bed all day and can not stand up without these problems. She sleeps all day. She is not herself and can not function.
Age: 14.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Headache, Hypersomnia, Neurological examination, Syncope, Vertigo
Clinical narrative: Prolonged fatigue, stomach ache, headache, confusion, vertigo, disoriented, dizzines,s fainting every day. Weakness all the time. She is staying in bed all day and can not stand up without these problems. She sleeps all day. She is not herself and can not function.
Age: 1.01
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Round quarter size pink spot on her left thigh, a little warm, itchy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain in extremity
Clinical narrative: Left leg pain that continued for 10 days with eventual formation of vesicles on leg consistent with VZV infection.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling at site of injection from shoulder to elbow, redness with slight fever to area, tender to touch and movement, severe headache and stiff neck.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal stiffness, Pain
Clinical narrative: Swelling at site of injection from shoulder to elbow, redness with slight fever to area, tender to touch and movement, severe headache and stiff neck.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea, vomiting and symptoms recurred 6 days after shot.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain, Paraesthesia, Rash, Skin discolouration
Clinical narrative: States had a rash on feet the next morning. We saw her Employee Health 2 days following vaccines, Influenza and Tdap. She had 6cm dark spot with rash on L foot R foot was darkened with rash on shin. Has tingling and pain. States was seen by a physician.
Age: 0.01
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No reaction noted.
Age: 7.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Swelling face
Clinical narrative: Has a rash on face and back. Face is swollen.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Haematoma, Injection site mass, Injection site warmth
Clinical narrative: Warm, egg shaped lump at injection site 5/5/14. Dr said "Hematoma, bruise" Follow up 5/7/14 - Not hurting now, Dr - rx'd "TYLENOL and warm compresses".
Age: 4.0
Sex: M
Vaccine: IPV, MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: CMA administered expired polio vaccine to patient. Child had no reactions.
Age: 30.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: VARIVAX vaccine given in (R) subcutaneous tissue on 5/5/14 and employee reported redness, pain, swelling at site on 5/6/14. She followed up on 5/7/14 with PA at office and was given BENADRYL PO, ibuprofen, and steroid cream (topical). T-98.6 orally. Measures 70x40 mm.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Cold sweat, Dizziness, Feeling abnormal, Thirst
Clinical narrative: Sx for 2-3 days after vaccine; dizzy, not feeling right; clammy; increased thirst.
Age: 58.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Bradycardia, Electrocardiogram abnormal, Fatigue, Feeling abnormal, Gaze palsy
Clinical narrative: Patient lst consciousness approx 1 min. Helped into wheel chair, once in exam room, she lost consciousness again, with a tremor noted, eyes rolled back and unresponsive for approx 30- 40 seconds. Heart rate dropped, diaphoretic, PCP present. Assisted x 2 to exam table. O2 via n/c at 3 liters with juice given. EKG per PCP showed bradycardia otherwise normal. Patient able to return home after approx 30 min. Patient called by staff and reported no other events, she did state however that she felt drained and not like herself.
Age: 58.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Heart rate decreased, Hyperhidrosis, Loss of consciousness, Tremor, Unresponsive to stimuli
Clinical narrative: Patient lst consciousness approx 1 min. Helped into wheel chair, once in exam room, she lost consciousness again, with a tremor noted, eyes rolled back and unresponsive for approx 30- 40 seconds. Heart rate dropped, diaphoretic, PCP present. Assisted x 2 to exam table. O2 via n/c at 3 liters with juice given. EKG per PCP showed bradycardia otherwise normal. Patient able to return home after approx 30 min. Patient called by staff and reported no other events, she did state however that she felt drained and not like herself.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Rash erythematous
Clinical narrative: Pain lower to upper left side of back, red rash middle/left side of back.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Back pain, Rash
Clinical narrative: Pain lower to upper left side of back, red rash middle/left side of back.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pain lower to upper left side of back, red rash middle/left side of back.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: PATIENT IS HAVING DIARRHEA TO LOOSE STOOLS WITH BLOOD. NOT INTUSSUSCEPTION.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Pain in extremity
Clinical narrative: Received Menactra in right arm and Tdap in left about 1 pm at school. Mom reports later that evening that student complains of sore arm- was given ibuprofen. Next day, patient came home from school early complaining of a very sore arm. Mom found right arm to warm to touch, solid red from just above elbow to just below shoulder (approx. 6 to 7 inches in width and length). On his left arm where he received the Tdap, patient also had redness, edema, and warm to touch at the site. However, the diameter was approx. ~3 inches. Mom had brought patient into Public Health to be evaluated. It was recommended to be seen at clinic. Patient was seen that very afternoon of May 7, 2014 with his personal MD. Dr. prescribed a 5 day course of prednisone. Mom noticed improvement in the next 24 to 36 hours of edema, redness, and soreness. When contacted on May 13, 2014, patient had completely recovered.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal discomfort, Headache, Hypoaesthesia, Malaise, Paraesthesia
Clinical narrative: Child started to have numbness and tingling in arm where vaccine was administered in, as well as both legs bilaterally. Later in afternoon child had upset stomach and headache. The headache and tingling/numbness sensation continued through next day. Headache resolved on day 3. On day 2 post vaccination the child had generalized malaise. Child continued to have numbness and tingling sensation in legs bilaterally and right arm through day 3 post vaccination administration, but symptoms sensation were becoming less. Today, 1 week post vaccination client continues to have tingling sensation in right hand and both feet.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal discomfort, Flatulence, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: Fever of 101, stomach upset, gas, lack of sleep, sore arm.  Duration of approximately 2 days.  Treated with Tylenol and rest.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Aphasia, Autism
Clinical narrative: By the end of the month patient went from speaking 50-75 words to becoming completely silent for half a year and has yet to regain any words a year and a half later.  he was since been diagnosed with autism.  He was an happy intelligent normal little boy before this vaccine and that was quickly changed after the vaccine.
Age: 1.54
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Local swelling, Urticaria
Clinical narrative: Redness/swelling of left arm at onset- then pt developed diffuse urticarial rash 04/26/14 which has continued to persist through today's date 05/13/14. Tx: Benadryl, prednisolone.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. It was reported that the healthcare worker called for additional information as patient was in office to potentially obtain second dose of GARDASIL two weeks early. The date of initial injection of GARDASIL was not known. No adverse effect reported. No additional information was reported. Additional information has been requested.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Fussiness, redness and swelling at sites.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report has been received from a registered pharmacist refers to unspecified patients of an unknown age. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot No: J013137; expiration date: 17-Jan-2015 (dose and route were not provided). The registered pharmacist stated that on an unknown date, the doses of ZOSTAVAX were previously exposed to 31.5F for a cumulative time of 71 hours, were not exposed to the more recent temperature excursions. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Erythema, Injection site erythema, Injection site urticaria, Irritability, Swelling face
Clinical narrative: Approx 5 min after vaccines given, pt developed 3-4 erythematous urticaria on lower legs and one on left forearm. BENADRYL cream applied. Urticaria completely resolved within 5 min. Developed facial swelling irritability at home that night and went to ER. Evaluated and monitored. Not treated. Symptoms resolved spontaneously.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Urticaria
Clinical narrative: Approx 5 min after vaccines given, pt developed 3-4 erythematous urticaria on lower legs and one on left forearm. BENADRYL cream applied. Urticaria completely resolved within 5 min. Developed facial swelling irritability at home that night and went to ER. Evaluated and monitored. Not treated. Symptoms resolved spontaneously.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Redness swelling and warm to the touch. ER - gave rx of prednisone. - Agency - No rx given.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Blister, Injection site erythema, Injection site reaction, Injection site scar, Injection site swelling
Clinical narrative: Per mom pt had swelling and redness with multiple blister/bullae (has picture taken) on (R) upper arm at vaccination site the day after vaccination. ++ fever. Seen by MD at another facility and Rx PO KEFLEX, BENADRYL and prednisolone. Today pt doing well, has scar on (R) arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site vesicles, Pyrexia
Clinical narrative: Per mom pt had swelling and redness with multiple blister/bullae (has picture taken) on (R) upper arm at vaccination site the day after vaccination. ++ fever. Seen by MD at another facility and Rx PO KEFLEX, BENADRYL and prednisolone. Today pt doing well, has scar on (R) arm.
Age: 69.0
Sex: U
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Injection site inflammation, Injection site rash, Pain, Pyrexia
Clinical narrative: 1 hour after receiving vaccination(s) patient experienced chills, fever, body aches, inflammation and rash at injection site to her left arm. This was reported 9-14-2012 patient felt better, however inflammation and rash still present. Patient was advised to take BENADRYL and Ibu.
Sex: F
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a register nurse via company representative, refers to a female patient of unknown age. Co-suspect and concomitant therapies were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, lot number, expiration date, strength and route were not reported). Co-suspect and concomitant therapies were not reported. The patient's mother stated that on an unknown date, the patient experienced warts on the bottom of her feet. At the time of the report the outcome was unknown. The patient seek medical attention with a podiatrist, who stated that the warts were caused by GARDASIL. This case is one (1) of two (2) reports from the same reporter (1405USA004510). Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Parent reports, hot, red, hard swelling from shoulder to injection site on 5-8-14. Seen 5-9-14 area approximately 5 in. in length, skin pink and slightly taut, warm, not hard. No signs of infection. Local reaction at Tdap site.
Sex: M
Vaccine: HPV4
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was from a register nurse via company representative, refers to a male patient of unknown age. Co-suspect and concomitant therapies were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, lot number, expiration date, strength and route were not reported. Co-suspect and concomitant therapies were not reported. The patient's father stated that on an unknown date, the patient experienced warts after receiving GARDASIL. At the time of the report the outcome was unknown. The patient's mother stated that the warts were caused by GARDASIL. This case is one (1) of two (2) reports from the same reporter (1405USA003843). Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site urticaria
Clinical narrative: Quarter size raised welt at injection site several days after vaccine administered. ER visit - dr said cellulitis, gave KEFLEX for several days.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Injection site erythema, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Fever, vomiting, rash all over body, irritable and crying started 5-6 hours after vaccine rash lasted 1 week vomiting x 1 day fever 1 day. The right thigh was swollen and red - groin to knee was red.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Rash generalised, Vomiting
Clinical narrative: Fever, vomiting, rash all over body, irritable and crying started 5-6 hours after vaccine rash lasted 1 week vomiting x 1 day fever 1 day. The right thigh was swollen and red - groin to knee was red.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye movement disorder, Loss of consciousness, Musculoskeletal stiffness, Syncope
Clinical narrative: Approximately 10 min after receiving 4 yr immunization pt had syncope with L.O.C x 30-40s also had upper extremity stiffening and Bil eye deviation.
Age: 34.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a health care worker refers to a 34 year old patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (919400 PFU) and was not given for prevention (dose, route, lot number and expiration date were not provided). The health care worker reported that a patient was administered a ZOSTAVAX at younger than recommended age. She also stated that ZOSTAVAX was not given for the prevention but that the patient "had already had something". Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: VAR 2 administered SQ left arm 2 days ago. Youth developed a 1 1/4 inch circular red, raised, itchy area at vaccine site. Ice applied Ibuprofen used PRN.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 13-MAR-2014, the patient was inadvertently vaccinated with a dose of M-M-R II (lot # 0411AE, HSA, dose and route not reported) that had expired on 27-FEB-2014. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles
Clinical narrative: This spontaneous report as received from a registered nurse via field employee refers to unspecified number of patients were exposed to wild-type measles. Then on an unspecified date (in 2014), these patients were given M-M-R II (therapy type, lot#, dose, route and duration were unspecified). Then on an unspecified date (in 2014), these patients developed a measles outbreak. The present status of the patients was unspecified. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fatigue
Clinical narrative: Fatigue set in on 12/27 and persisted through 12/28. Resolved by 12/29.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Coagulopathy, Fatigue, Injection site erythema, Muscle tightness
Clinical narrative: Fatigue set in on 12/27 and persisted thru 12/28. By 12/29, fatigue had resolved but patient exeprienced muscle "tightness" and redness at injection site. Tightness resolved after 24 hours but redness remained x 48 hours. Also reported problem donating blood (clotting) 2 weeks later.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Patient had a full blown outbreak of chicken pox head to toe. Was seen at ER 4/18/14, txment with hydroxyzine/Ibuprofen. On 4/23 the bumps were a little more widespread/advised to follow up with reg Dr. They following a normal progression. By 5/5 the rash and bumps were completely resolved.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Exanthem x 1 day. 9 days following vaccination.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to pharmacy 3 days after vaccination with warm red bump at injection site. There was a large area (6 in x 3 in) erythematous bump surrounding injection site. At 4 days the swelling reduced to the injection site and was improving. The patient required no further treatment.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 2 cm by 2cm red area with mild industries on right thigh, nonfade, not warm.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site induration, Injection site rash
Clinical narrative: Rash to right thigh - indurated. Noted on 5-12-14. Seen by doctor 5/13. Supportive care, TYLENOL/MOTRIN PRN.
Age: 24.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Pruritus, Rash
Clinical narrative: Pt developed rash on forearms and tops of ears. C/O pruritus. All symptoms appeared about 18 hours after vaccination. Still visible on 5/12/2014 when presented to health dept. Rash still present 5/12/2014.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Axillary pain, Confusional state, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: While at work on 05-11-14 experienced flushed feeling confusion, lightheadedness, swollen lymph nodes (R) arm pain in armpit, diaphoresis. Stated took amoxicillin due to swollen lymph node rx from previous illness. Company nurse contacted on 05-13-14 when reaction was reported sent to doctor's office at this time.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Lymphadenopathy
Clinical narrative: While at work on 05-11-14 experienced flushed feeling confusion, lightheadedness, swollen lymph nodes (R) arm pain in armpit, diaphoresis. Stated took amoxicillin due to swollen lymph node rx from previous illness. Company nurse contacted on 05-13-14 when reaction was reported sent to doctor's office at this time.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMR
Symptoms: Fatigue, Pain, Pyrexia, Rash generalised
Clinical narrative: Received 1st MMR on 4/28/14. Mom report broke out with rash from face to groin area on 5/6/14 1 week after receiving vaccine. Fever ranged from 100-101 F. Child felt aching and tired. Mom gave MOTRIN and BENADRYL.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Chest X-ray, Cough, Fatigue, Impaired work ability
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old male patient. On an unknown date in April 2014 the patient was vaccinated with ZOSTAVAX (route, dose, lot number unknown). On an unknown date in 2014 the patient experienced rash on trunk as well as respiratory symptoms such as dry cough and fever. On an unknown date in 2014 Chest x-ray and Cat scan were performed and results were negative. On an unknown date physician prescribed MEDROL (dose, frequency and manufacturer unknown) dose pak and patient symptoms began to resolve. After the tapering of the MEDROL dose pak (as per the Physician orders) the patient began to experience rash, respiratory symptoms and fever. Physician reported that upon second dosing regimen of the MEDROL (dose, frequency and manufacturer unknown) dose pak, patient symptoms reoccurred as patient began to wean off the MEDROL pak. Physician reported that during this time frame patient had laboratory work ordered and the CMP came back showing an increase in liver function test (AST, ALT), the CBC were normal. On an unknown date the patient was prescribed DAPSONE (100 mg, frequency and manufacturer unknown) and two weeks into therapy spiked a fever and DAPSONE was discontinued. Physician reported that although rash has completely healed, patient is currently suffering from a 101 F (reported as 101F) temperature. VZV ID packet not offered as patient's rash is completely healed. Physician considered the events to be serious due to disability. The outcome of rash on trunk was reported as recovered/resolved. The outcome of other events was reported as not recovered/not resolved. It was reported that the patient had sought medical attention. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old male patient. On an unknown date in April 2014 the patient was vaccinated with ZOSTAVAX (route, dose, lot number unknown). On an unknown date in 2014 the patient experienced rash on trunk as well as respiratory symptoms such as dry cough and fever. On an unknown date in 2014 Chest x-ray and Cat scan were performed and results were negative. On an unknown date physician prescribed MEDROL (dose, frequency and manufacturer unknown) dose pak and patient symptoms began to resolve. After the tapering of the MEDROL dose pak (as per the Physician orders) the patient began to experience rash, respiratory symptoms and fever. Physician reported that upon second dosing regimen of the MEDROL (dose, frequency and manufacturer unknown) dose pak, patient symptoms reoccurred as patient began to wean off the MEDROL pak. Physician reported that during this time frame patient had laboratory work ordered and the CMP came back showing an increase in liver function test (AST, ALT), the CBC were normal. On an unknown date the patient was prescribed DAPSONE (100 mg, frequency and manufacturer unknown) and two weeks into therapy spiked a fever and DAPSONE was discontinued. Physician reported that although rash has completely healed, patient is currently suffering from a 101 F (reported as 101F) temperature. VZV ID packet not offered as patient's rash is completely healed. Physician considered the events to be serious due to disability. The outcome of rash on trunk was reported as recovered/resolved. The outcome of other events was reported as not recovered/not resolved. It was reported that the patient had sought medical attention. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthma, Blood test, Body temperature increased, Computerised tomogram, Malaise
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old male patient. On an unknown date in April 2014 the patient was vaccinated with ZOSTAVAX (route, dose, lot number unknown). On an unknown date in 2014 the patient experienced rash on trunk as well as respiratory symptoms such as dry cough and fever. On an unknown date in 2014 Chest x-ray and Cat scan were performed and results were negative. On an unknown date physician prescribed MEDROL (dose, frequency and manufacturer unknown) dose pak and patient symptoms began to resolve. After the tapering of the MEDROL dose pak (as per the Physician orders) the patient began to experience rash, respiratory symptoms and fever. Physician reported that upon second dosing regimen of the MEDROL (dose, frequency and manufacturer unknown) dose pak, patient symptoms reoccurred as patient began to wean off the MEDROL pak. Physician reported that during this time frame patient had laboratory work ordered and the CMP came back showing an increase in liver function test (AST, ALT), the CBC were normal. On an unknown date the patient was prescribed DAPSONE (100 mg, frequency and manufacturer unknown) and two weeks into therapy spiked a fever and DAPSONE was discontinued. Physician reported that although rash has completely healed, patient is currently suffering from a 101 F (reported as 101F) temperature. VZV ID packet not offered as patient's rash is completely healed. Physician considered the events to be serious due to disability. The outcome of rash on trunk was reported as recovered/resolved. The outcome of other events was reported as not recovered/not resolved. It was reported that the patient had sought medical attention. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Obliterative bronchiolitis, Pneumonia, Pulmonary function test, Varicella, X-ray
Clinical narrative: This spontaneous report as received from a physician refers to a 62 year old male patient. On an unknown date in April 2014 the patient was vaccinated with ZOSTAVAX (route, dose, lot number unknown). On an unknown date in 2014 the patient experienced rash on trunk as well as respiratory symptoms such as dry cough and fever. On an unknown date in 2014 Chest x-ray and Cat scan were performed and results were negative. On an unknown date physician prescribed MEDROL (dose, frequency and manufacturer unknown) dose pak and patient symptoms began to resolve. After the tapering of the MEDROL dose pak (as per the Physician orders) the patient began to experience rash, respiratory symptoms and fever. Physician reported that upon second dosing regimen of the MEDROL (dose, frequency and manufacturer unknown) dose pak, patient symptoms reoccurred as patient began to wean off the MEDROL pak. Physician reported that during this time frame patient had laboratory work ordered and the CMP came back showing an increase in liver function test (AST, ALT), the CBC were normal. On an unknown date the patient was prescribed DAPSONE (100 mg, frequency and manufacturer unknown) and two weeks into therapy spiked a fever and DAPSONE was discontinued. Physician reported that although rash has completely healed, patient is currently suffering from a 101 F (reported as 101F) temperature. VZV ID packet not offered as patient's rash is completely healed. Physician considered the events to be serious due to disability. The outcome of rash on trunk was reported as recovered/resolved. The outcome of other events was reported as not recovered/not resolved. It was reported that the patient had sought medical attention. Additional information has been requested.