chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.85
Sex: F
Vaccine: YF
Symptoms: Lethargy, Nasal congestion, Pyrexia
Clinical narrative: Mother reports child became febrile at about 5 pm on 7/30/14. Forehead scan temp 101 degrees F/Rectal 99 degrees F/axillary not reported. Child appeared lethargic "not crawling much" Nasal congestion noted. Continues to breastfeed WNL. Mother reports pediatrician made aware with Childrens TYLENOL tx continuing.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a certified midwife nurse regarding a patient of unknown age and gender. In 2010, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot number were not provided). In March 2014, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not provided). In July 2014, the patient was vaccinated with the third dose of GARDASIL (dose, route and lot number were not provided). No adverse effects reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: This spontaneous report as received from a other health professional refers to approximately 18 year old female patient of unknown age. The pertinent medical history included urinary tract infection. The patient's concurrent conditions included hearing loss and ADHD. The patient received dose one and two of GARDASIL in June and August of 2011. On 17-JUL-2014 the patient received GARDASIL. No other concomitant therapies reported. The reporter stated that the patient received a confirmation of pregnancy via a urine test on 21-JUL-2014 and patient indicated that she must have been about 4.5 weeks pregnant when she received the third dose of the GARDASIL. The LMP was calculated as June 2014. There was no intervention required to prevent serious criteria. There was no significant disability or incapacity. No hospitalization required. The event was not life-threatening. The outcome of the event was reported as not recovered/not resolved. No PQC involved. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a male patient of unknown age who on 28-JUL-2014, was vaccinated with a dose of improperly stored M-M-R II (lot# not reported). No adverse effects reported. No further details provided. Additional information is not expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a currently 4 year old patient of unknown gender. On an unknown date, the vaccine PROQUAD (Merck) was improperly stored. On an unknown date, the patient was vaccinated with PROQUAD (Merck) (dose, route and lot # were not reported). No adverse effects reported. At the time of the report the action taken was not reported. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This spontaneous report was received from a company representative via a registered pharmacist refers to a 66 year old female patient. On 25-JUN-2014, the patient was vaccinated with ZOSTAVAX lot# J014566, .65 ml, subcutaneous in the triceps on her left arm. On 26-JUN-2014, "within 24 hours", the patient experienced that the injection site was warm to touch with no pain. No treatment given. The patient told the pharmacist that the event "resolved on fourth day post vaccination". No information regarding the patient's medical history or concomitant medications was provided. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Decreased appetite, Fluid intake reduced, Pyrexia, Rash
Clinical narrative: Started with small rash, awoke during night with fever. Decreased appetite, decreased fluid intake. Rash started on arms and legs has since spread. Temp 101.6.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Right arm swelling, redness, itching (1 inch x 2 inches) at injection site. No need for emergency room, no visit to MD. No problems breathing.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased, Muscular weakness
Clinical narrative: Pt was unable to lift arm to dress, noted weakness.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Periarthritis
Clinical narrative: Pt was being treated for frozen shoulder, 2 weeks after pt began to have abduction problems again.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles, Rash vesicular, Viral test
Clinical narrative: Vesicular rash near site of injection, surrounding erythema.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Golf-ball sized rash at site of injection.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blood pressure decreased, Chest discomfort, Dyspnoea, Feeling abnormal
Clinical narrative: Patient said she felt funny. Her stomach was upset & her head felt "funny". I talked to the patient & she became pale & I checked her blood pressure it was 71/33. Her breathing was labored & when I asked if she had tightness in her chest she shook her head yes. Epi Pen administered then after 5 minutes rechecked bp 95/73. EMS was alerted before the administration of the Epi Pen. The patient was then taken to the ER to be evaluated.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pallor
Clinical narrative: Patient said she felt funny. Her stomach was upset & her head felt "funny". I talked to the patient & she became pale & I checked her blood pressure it was 71/33. Her breathing was labored & when I asked if she had tightness in her chest she shook her head yes. Epi Pen administered then after 5 minutes rechecked bp 95/73. EMS was alerted before the administration of the Epi Pen. The patient was then taken to the ER to be evaluated.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Eye penetration, Fall, Immediate post-injection reaction, Presyncope
Clinical narrative: Pt came into clinic for 11yo shots, patient received Boostrix and Menveo in left arm. Patient vasovagal immediately, unable to catch her, she received laceration above right eye.
Age: 51.0
Sex: F
Vaccine: HEPAB, TYP, YF
Symptoms: Gait disturbance, Myalgia
Clinical narrative: Severe muscle pain inside of gluteus maximus, difficulty walking & lying down did not alleviate the pain.
Age: 28.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Burning sensation, Erythema, Pain, Skin warm
Clinical narrative: Redness, medium to large area about the size of a small baseball, warm to the touch, burning feeling, very sore. Advised to take Motrin and use ice packs.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dermatitis allergic, Rash erythematous, Rash generalised
Clinical narrative: Patient received a Tdap 0.5ml, Hepatitis A 0.5ml in the left deltoid IM and Gardasil 0.5ml, Menactra 0.5ml in the right deltoid on 7/8/14. An all over raised, reddened rash "Allergic rash, as pts. physician claims" appeared 5 days later after vaccination. Pt. was seen by her physician on 7/25 and prescriped Predinsone oral X5days and hydrocortisone cream. Mother of pt. states pt. is now doing well and rash has cleared up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site urticaria
Clinical narrative: Erythema and pruritis with one hive at site of injection.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Lymphadenopathy
Clinical narrative: Noticed visibly distended lymph nodes in right side of his neck.  A little bigger than a pea.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Lymphadenopathy
Clinical narrative: Visibly swollen lymph nodes on right side of neck. I felt two.  Took him to Dr. and the Dr. felt multiple.  Said it was unrelated to MMR shot.  Very unlikely that is the case.  My son had not been sick at all.  This was the only change.  Lymph nodes may have been swollen earlier but were noticed on 4/20/14.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pain, itching at sight noticed upon wakening 7/30/14. Redness and swelling in a 3.5 inch diameter around site injection and a red ring on outer edge noticed 7/31/2013 upon wakening. Gave Benadryl and topical cortisone - which relieved itchiness only.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Dizziness, Dyspnoea, Full blood count normal, Headache
Clinical narrative: On 7/28/14 in the evening, client c/o of joint aches. On 7/29 c/o nausea, itching all over body, difficulty breathing, and muscle twitching. 7/30 body aches worsening, lethargic, headache, dizziness. Called MD and was told to go to ER. CBC and Liver profile drawn and all normal.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Lethargy, Liver function test normal, Muscle twitching, Nausea, Pruritus generalised
Clinical narrative: On 7/28/14 in the evening, client c/o of joint aches. On 7/29 c/o nausea, itching all over body, difficulty breathing, and muscle twitching. 7/30 body aches worsening, lethargic, headache, dizziness. Called MD and was told to go to ER. CBC and Liver profile drawn and all normal.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Area of injection red, swollen, and hot. On second day, 7/31/14, area of redness spread, still swollen and very hot. Went to doctor 7/31/14 and he diagnosed cellulitis and prescribed antibiotics. Doctor said could have damaged my lungs and heart if not treated.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Hyperglycaemia, Myocardial infarction, Troponin increased
Clinical narrative: Hyperglycemia and eventual myocardial infarction.
Age: 1.04
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: High fever for 3 days  Followed by severe measles type rash
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Feeling abnormal, Intussusception, Vomiting
Clinical narrative: Recurrent vomiting and fussiness.
Age: 8.0
Sex: M
Vaccine: TYP
Symptoms: Dyskinesia, Head titubation
Clinical narrative: 36 hrs after 1st dose of pills head flicking side to side every few mins. Then slowly progressed to nodding up and down and flicking sometimes every thirty seconds but usually every 5 to 10 seconds. No other symptoms or adverse reaction. Doesn't do it while sleeping.
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Immediate post-injection reaction, Local swelling, Pain, Pharyngeal oedema
Clinical narrative: Case number PHEH2014US014770 is an initial spontaneous report received from a consumer on 22 Jul 2014. This report refers to a female patient of unknown age. Her medical history and concomitant medications were not reported. On 11 Oct 2012, she was vaccinated with FLUVIRIN (batch number: 120581, expiry date: 01 Jun 2014). It was reported that immediately after the vaccination, she had a reaction in her arms. She stated that they swelled up to the "size of a football" with a severe burning pain and then she started having shortness of breath due to throat swelling. Following the events, she was hospitalized on an unspecified date. She reported that she had been hospitalized multiple times through the years, for the same symptoms her doctor stated that the events were due to flu shot. The outcome was reported as condition unchanged.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report was received from a pharmacist refers to an unspecified number of patients of unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date, an unspecified number of patients were administered improperly stored doses of RECOMBIVAX HB (strength, dose, dose number, route and lot number were unspecified). Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports from the same reporter where other patients were administered improperly stored PNEUMOVAX23 (MARRS# 1407USA03820) and VAQTA (MARRS# 1407USA014449). Additional information is not expected because reporter refused additional contact.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and unknown gender. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date, an unspecified number of patients were administered improperly stored doses of PNEUMOVAX 23 (strength, dose, dose number, route and lot number were unspecified). Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were addministered improperly stored RECOMBIVAX HB (MARRS # 1407USA014448) and VAQTA (MARRS # 1407USA014449). Additional information is not expected because reporter refused additional contact.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unkown age and gender. Drug reactions or allergies and pertinent medical history were unspecified. On an unknown date, an unspecified number of patients were administered improperly stored doses of VAQTA (strength, dose, dose number, route and lot number were unspecified). Concomitant therapies were unspecified. The outcome of received improperly stored vaccine was unknown. This is one of several reports received from the same reporter where other patients were administered improperly stored PNEUMOVAX 23 (MARRS # 1407USA013820) and RECOMBIVAX HB (MARRS # 1407USA014448). Additional information is not expected because reproter refused additional contact.
Age: 1.55
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 22 year old patient of unknown gender. On 15-MAY-1992 the patient was vaccinated with dose 1 of RECOMBIVAX HB thimerosal status unknown (route, dosage and lot no. unknown). On 10-JUL-1992 the patient received dose 2 of RECOMBIVAX HB thimerosal status unkonwn (route, dosage and lot no. unknown). ON 04-FEB-1993 the patient received dose 3 of RECOMBIVAX HB thimerosal status unknown (route, dosage and lot no. unknown). It was reported that on a titer drawn on 11-JUL-2014 the patient failed to seroconvert. The outcome of the event was reported as not recovered. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Immediately after administering Hepatitis A noted rash around both of the patient's eyes. Vital signs were checked and stable. Steroids and BENADRYL was administered P.O.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pregnancy test urine negative, Vomiting
Clinical narrative: Nausea and vomiting x12 hrs.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Hives to arm, legs, face.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Swelling, Swelling face
Clinical narrative: Swelling of face and mouth. Occurred one week after vaccine.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Blepharospasm, Fall, Head injury, Lip injury, Seizure like phenomena
Clinical narrative: Patient received vaccines HPV - MENVEO. Sat for 1-2 minutes. Felt fine. Then stood up and fell face first on floor. Fell against sister's knee on way down. Hit (R) side of top of head. Bit (R) lower lip - inner and outer aspects. Ice bag. Eyelids twitched. Slight seizure like movements. BP - 129/78, P - 52.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Slight fever, malaise; painful, sore, swollen red arms (both).
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Erythema, Local swelling, Skin warm
Clinical narrative: Pt started chilling 4 hrs after inject. Next morning arm was swollen red/warm had temp go up to 100.5. Pain is better today still sore and red no temp today.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood culture, Body temperature increased, Chest X-ray, Full blood count, Influenza virus test
Clinical narrative: Pt had elevated temp of 103 for 3 days.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Metabolic function test, Red blood cell sedimentation rate, Streptococcus test, Urine analysis
Clinical narrative: Pt had elevated temp of 103 for 3 days.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal pain, Chest discomfort, Chills, Diarrhoea, Dizziness
Clinical narrative: Softball sized swelling, redness, warmth at site of injection which started about 1 hr after vaccine administration. Itching started locally immediately. Also developed abd pain, body aches, nausea, fever, chills, shaking, dizziness, teeth chattering, heaviness in chest, diarrhea with cramps, nightmares. Came to clinic with these symptoms 2 hours after injection.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Softball sized swelling, redness, warmth at site of injection which started about 1 hr after vaccine administration. Itching started locally immediately. Also developed abd pain, body aches, nausea, fever, chills, shaking, dizziness, teeth chattering, heaviness in chest, diarrhea with cramps, nightmares. Came to clinic with these symptoms 2 hours after injection.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Neutrophil count decreased, Nightmare, Pain, Pruritus, Pyrexia
Clinical narrative: Softball sized swelling, redness, warmth at site of injection which started about 1 hr after vaccine administration. Itching started locally immediately. Also developed abd pain, body aches, nausea, fever, chills, shaking, dizziness, teeth chattering, heaviness in chest, diarrhea with cramps, nightmares. Came to clinic with these symptoms 2 hours after injection.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Tremor, White blood cell count decreased
Clinical narrative: Softball sized swelling, redness, warmth at site of injection which started about 1 hr after vaccine administration. Itching started locally immediately. Also developed abd pain, body aches, nausea, fever, chills, shaking, dizziness, teeth chattering, heaviness in chest, diarrhea with cramps, nightmares. Came to clinic with these symptoms 2 hours after injection.
Age: 1.34
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: A DPT administered on 7/30/14 to Rt thigh; By 7/31/14 Rt thigh markedly swollen - this is our second similar reaction in last two months.
Age: 15.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 15 year old male patient. On 28-JUL-2014 the patient was vaccinated with PROQUAD (route, dosage, dose no. and lot no. unknown). It was reported that the patient received PROQUAD instead of VARIVAX. No adverse effect was reported. Additional information has been requested.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a physician refers to a 6 month old male patient. Patient's medical history and drug reactions/allergies were not reported. On and unknown date, the patient was vaccinated with the third dose of ROTATEQ 1 ml, oral (lot# was not reported). On 29-JUL-2014, after receiving the third dose of ROTATEQ the patient had hives surrounding his mouth. The physician reports that the hives resolved on their own within 40 minutes. The physician also reported that the patient had no adverse effects with pervious doses of ROTATEQ. No treatment was given for the adverse event. No lab diagnostics studies were performed. On an unknown date, the patient sought medical attention calling the physician's office. The outcome of hives surrounding his mouth was reported as recovered/resolved 29-JUL-2014. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a unspecified reporter refers to a 4 year old female patient. Medical history and concurrent conditions were not reported. On 16-JUN-2014, the patient was vaccinated with MMR II in the right upper thigh, lot # reported as J009885 (dose and strength were not reported). These vaccines were out of range temperature and the vaccines had been administered to patients. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: This spontaneous report as received from an approximately 52 year old female consumer regarding herself as a patient with Penicillin and sulpher allergy. The patient's medical history included herpes breakout (several years ago). In approximately June 2014 (reported as about a month ago), the patient was vaccinated with ZOSTAVAX (lot, dose, frequency and route not reported). Concomitant therapies included VIIBRYD. In 2014 a couple weeks after she received ZOSTAVAX, the patient experienced a broke had a full break out of genital herpes. The outcome of full break out of genital herpes was unknown. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Heart rate decreased, Hyperhidrosis, Syncope
Clinical narrative: Syncopal episode. HR decreased 45, BP 90/54, SaO2 98% diaphoretic at discharge. HR - 72 - BP 108/64 SaO2 100% back to baseline < 30 min.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Paraesthesia, Pruritus generalised
Clinical narrative: Generalized itching and tingling, started 2 days after GARDASIL vaccine was given. At first diffuse, then over a few days was localized to patches on the back and abdomen.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history, drug reaction or allergies were reported. On 07-JUL-2014 the patient was vaccinated with expired PNEUMOVAX 23 lot # H015780, expiration date 11-JUN-2014, (strength, route, dose and dose number were unspecified). No symptoms reported. No concomitant therapies were reported. The outcome of vaccinated with expired PNEUMOVAX 23 was unknown. Additional information is not expected because reporter refused additional contact.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Skin warm, Tenderness
Clinical narrative: Patient received PNEUMOVAX in (L) arm as noted (10) around 1500 that afternoon, patient's arm became tender, red, and warm to touch. Today 7/31/14, arm is swollen, red, and tender touch. Patient given BENADRYL and encouraged to elevate arm and ice as needed for comfort.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Swelling, redness, hot to touch. Dx: Cellulitis. Rx: KEFLEX 500mg TID x1 wk.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to unspecified patients of unknown age and gender. No information received regarding medical history and concurrent conditions. The nurse reported that since 01-JUL-2014, unspecified patients might have been administered with ROTATEQ (dose, frequency and lot# not reported) orally, that were not stored property. No adverse effects reported. This is one of the several reports received from the same reporter. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender, who on an unknown date was vaccinated with ZOSTAVAX (dose, lot # and route not provided). The pharmacist reported that an unspecified patient received an expired dose of ZOSTAVAX a couple of months ago. No adverse effects reported. Outcome of expired drug administered was unknown. No further information was provided. Additional information is not expected, because can't contact the pharmacist.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Her physician told her that she is prone to pneumococcal infection. No drug reactions or allergies were reported. On 30-JUL-2014 the patient was vaccinated with expired PNEUMOVAX 23 0.5 ml, lot # J004747, expiration date 20-JUL-2014, intramuscular (strength and dose number were unspecified). No adverse effects reported. No concomitant therapies were reported. The outcome of received an expired dose of PNEUMOVAX 23 was unknown. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV2
Symptoms: Erythema multiforme, Pruritus, Rash, Rash macular
Clinical narrative: Erythema multiforme like lesions. Macular erythematous in the extremities, abdomen and chest started 4 hrs after shot with itching.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to unspecified number of patients. On an unknown date the patients were vaccinated with doses of ZOSTAVAX (lot#, strength, dosage, route unknown). On 14-MAR-2014 the reporter reported a temperature excursion. Since the excursion that was reported, some of these doses of ZOSTAVAX had been administered to patients. The healthcare worker did not report an adverse experience. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Computerised tomogram head normal, Dizziness, Head discomfort, Headache, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. On 24-JUL-2014, the patient was vaccinated with the first dose of GARDASIL injection, 0.5 ml intramuscular for vaccination (lot #, expiration date and strength not reported). On 31-MAR-2014, the patient was vaccinated with the second dose of GARDASIL (lot # J006236, expiration date 25-FEB-2016), injection, 0.5 ml, intramuscular. Other suspect therapies included VARIVAX (lot#, expiration date, dose, route and strength not reported) was administered during same appointment when the second dose of GARDASIL was administered (on 31-MAR-2014). The registered nurse reported that while the patient was still in the office he fainted. The patient was given water and carbohydrates (unspecified), electrolytes (unspecified) GATORADE and the patient recovered "a few minutes later" while in the office. The patient had a Computerized tomogram (CT) scan of his head and results were "negative" at unspecified time. The reporter also stated that the patient had not eaten any food that day prior to coming to the office. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Computerised tomogram head normal, Syncope
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 16 year old male patient. On 24-JUL-2014, the patient was vaccinated with the first dose of GARDASIL injection, 0.5 ml intramuscular for vaccination (lot #, expiration date and strength not reported). On 31-MAR-2014, the patient was vaccinated with the second dose of GARDASIL (lot # J006236, expiration date 25-FEB-2016), injection, 0.5 ml, intramuscular. Other suspect therapies included VARIVAX (lot#, expiration date, dose, route and strength not reported) was administered during same appointment when the second dose of GARDASIL was administered (on 31-MAR-2014). The registered nurse reported that while the patient was still in the office he fainted. The patient was given water and carbohydrates (unspecified), electrolytes (unspecified) GATORADE and the patient recovered "a few minutes later" while in the office. The patient had a Computerized tomogram (CT) scan of his head and results were "negative" at unspecified time. The reporter also stated that the patient had not eaten any food that day prior to coming to the office. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Congenital hydronephrosis, Foetal exposure during pregnancy, Ultrasound kidney abnormal
Clinical narrative: This report from study was reported via Pregnancy Registry (initial receipt 19-Jul-2014), concerns a neonate patient. The concomitant medications received by the patient from the mother in-utero included prenatal vitamins, folic acid, docosahexanoic acid, ergocalciferol, ascorbic acid, azathioprine, amoxicillin, diphenhydramine, paracetamol and Tdap vaccine. The mother had a medical history of depression, anorexia (resolved in 2013) and Ulcerative Colitis. On 10-Oct-2013, the patient received AFLURIA (batch number not reported) via the mother in-utero, who received the vaccine. On 10-Feb-2014 and 31-May-2014, the patient's mother underwent an ultrasound scan which showed that the patient's kidney was dilated. The patient was born at week 40 of gestation (birth weight: 3632.0 grams, Apgars at 1 min: 9, Apgars at 5 min: 9). On 14-Jul-2014, the patient was diagnosed with grade 2 hydronephrosis. The patient was prescribed prophylactic amoxicillin (1.4 ml of 125 mg/ml solution QD) to prevent urinary tract infection. The Urologist would follow-up with the child in 6 weeks but doesn't think a surgery will be required. Outcome was not reported. Reporter's comments: The reporter assessed the event as serious as it was a congenital anomaly.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Neck injury, Tooth injury
Clinical narrative: This spontaneous report was received from patient's father refers to 13 year old male patient. No current condition was reported. The patient's medical history included SCT disease and Kawasaki disease which patient experienced on an unspecified date when he was younger. Approximately on 28-JUL-2014 (as reported that event occurred after two to three minutes after receiving the vaccine), the patient was vaccinated with GARDASIL dose 3 (as reported last dose) (route- injection, dose strength was not reported). Other suspect therapies included hepatitis A vaccine, inactivated (manufacturer unknown) dose 1, vaccinated on same day on 28-JUL-2014. No concomitant medication was reported. On 28-JUL-2014, after two to three minutes after receiving GARDASIL the patient was passed out (medically significant) and hit the counter as he was falling down, he hit his tooth and also scrape on his neck due to hitting the counter. Patient was passed out for about ten to twenty seconds and when the patient came to he was still dazed. Blood pressure was taken after the reaction and was reported to be normal. There was no treatment given for the events. The outcome of passed out (medically significant) and hit the counter as he was falling down, hit his tooth and scrape on his neck due to hitting the counter and still dazed was reported as resolving. The consumer reported that the patient was still recovering a half hour after receiving the GARDASIL. The event occurred in physician's office. No product quality complaint was reported. The causality between GARDASIL and other suspect therapy hepatitis A vaccine, inactivated (manufacturer unknown) and event was unknown. Upon internal review event passed out was considered medically significant. This case is related to 2 cases via same reporter link. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, HEPA, HPV4
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Neck injury, Tooth injury
Clinical narrative: This spontaneous report was received from patient's father refers to 13 year old male patient. No current condition was reported. The patient's medical history included SCT disease and Kawasaki disease which patient experienced on an unspecified date when he was younger. Approximately on 28-JUL-2014 (as reported that event occurred after two to three minutes after receiving the vaccine), the patient was vaccinated with GARDASIL dose 3 (as reported last dose) (route- injection, dose strength was not reported). Other suspect therapies included hepatitis A vaccine, inactivated (manufacturer unknown) dose 1, vaccinated on same day on 28-JUL-2014. No concomitant medication was reported. On 28-JUL-2014, after two to three minutes after receiving the GARDASIL the patient was passed out (medically significant) and hit the counter as he was falling down, he hit his tooth and also scrape on his neck due to hitting the counter. Patient was passed out for about ten to twenty seconds and when the patient came to he was still dazed. Blood pressure was taken after the reaction and was reported to be normal. There was no treatment given for the events. The outcome of passed out (medically significant) and hit the counter as he was falling down, hit his tooth and scrape on his neck due to hitting the counter and still dazed was reported as resolving. The consumer reported that the patient was still recovering a half hour after receiving the GARDASIL. The event occurred in physician's office. No product quality complaint was reported. The causality between GARDASIL and other suspect therapy hepatitis A vaccine, inactivated (manufacturer unknown) and event was unknown. Upon internal review event passed out was considered medically significant. This case is related to 2 cases via same reporter link. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: Infant vomited once - no fever, no swelling at injection sites - parents believe it was due to vaccinations given
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Computerised tomogram head, Convulsion, Differential white blood cell count, Fall, Full blood count
Clinical narrative: Child received KINRIX and MMRV. Approximately 7 minutes after receiving immunizations, child was not standing in clinic room playing a game on tablet, child began having what appeared to be a seizure, fell straight back hitting head on floor. Seizure activity lasted approximately 30 seconds. Child then opened eyes, would not speak but would respond to name w/stimulation. Transported by ambulance to ER at 12:40 pm.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Head injury, Metabolic function test
Clinical narrative: Child received KINRIX and MMRV. Approximately 7 minutes after receiving immunizations, child was not standing in clinic room playing a game on tablet, child began having what appeared to be a seizure, fell straight back hitting head on floor. Seizure activity lasted approximately 30 seconds. Child then opened eyes, would not speak but would respond to name w/stimulation. Transported by ambulance to ER at 12:40 pm.
Age: 0.32
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site rash, Injection site reaction, Urticaria
Clinical narrative: Patient received shots in office at approx 11:52 on 7/25/14 within 15 min or less patient developed a welt and rash on bil. lower legs (mid calf down). No rash noted anywhere else. Parents deny rash prior to patient receiving shots.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a reporter and refers to a female patient of approximately 4 years old. No information about medical history, concurrent conditions and concomitant medications were reported. On 16-JUN-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (strength not reported) lot#J009885 in the right arm, that was out of temperature. The outcome of event reported is unknown. This is one of the several reports received from the same source. Additional information has been requested.
Age: 1.9
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 22 months old patient of unknown gender. On 04-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Drooling, Eye movement disorder, Pallor, Posture abnormal, Tremor
Clinical narrative: Almost immediately after the final dose was administered patient looked very pale and started to lean over. Her eyes rolled back and there was saliva bubbling from her lips.  The nurse laid her back on the table.  At that point patient's arms tightened against her chest and were shaking.  Within a few seconds her eyes opened and she tried to sit up.  We were trying to get her to lie back down but she was insistent that she had just fallen asleep and was okay to sit up.  We got her to lie back down and with 30 seconds she started to regain her color. Another nurse came in and checked her BP and pulse.  The Doctor then came in and checked her pulse. We had her lay on the table for about 10 minutes.  She was then able to get up without problem.
Age: 1.05
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site papule, Injection site rash, Papule, Pruritus
Clinical narrative: Pt given MMR/Varicella in Left thigh. Pt developed rash on site of vaccine administration one week later. She also has a few papules scattered on her upper extremities and legs. Mom noticed "bump" on thigh developed a cluster of similar papules that were itchy. Redness also developed around the area. Pt had no fever. Pt came to office 8/1/14. Pt given keflex and acyclovir.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients. It was reported that unspecified number of unspecified patients were vaccinated with improperly stored GARDASIL (dose no., lot no. unknown). No concomitant medication was reported. No adverse effects were reported. Product quality complaint was not reported. The outcome of events was unknown. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Bipolar disorder
Clinical narrative: This spontaneous report as received from a physician refers to 10 patients of unknown age. On unknown dates the patients were vaccinated with quadrivalent human papillomavirus (types 6,11, 16,18) recomb. vaccine (manufacturer unknown). The reporter stated that only protect against the four certain strains of HPV vaccine. The reporter got the information from a performance enhancing drug (PED) article in essence magazine in 2011 (it was reported as three years ago). There was side effects involved in the article, which interviewed 10 families who had bipolar affective disorder (BAD) experienced. This is a deterrent against the reporter getting the medication. The outcome of the patients were unknown. The reporter considered the event to be related to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from physician assistant via company representative refers to a patient of unknown age and gender. Patients medical history was unknown. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dose number, dose, frequency, route, lot # and expiry date unknown) injection was administered, patient developed shingles. Patient contacted physician assistant for medical attention and received acyclovir (manufacturer unknown) as treatment. On an unknown date, patient recovered from event. No product quality issue has been filed. Action taken with ZOSTAVAX was unknown. The outcome of shingles was reported as recovered/resolved. The reporter did not provide the causality of ZOSTAVAX to shingles. Additional information is not expected.
Age: 0.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 22 months old patient of unknown gender. On 12-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J015437, expiration date: 09-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health care professional refers to a female patient of age of approximately 14 years old.  No information about medical history, concurrent conditions and concomitant medications were reported. On 22-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot #J006957, expiration date 05-JUN-2015 in the left arm (reported as left deltoid) that was out of temperature. The outcome of event reported is unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.67
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 8 months old patient of unknown gender. On 13-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. There was no pertinent medical history and there were no drug reactions or allergies reported. On unknown dates the patient was vaccinated with dose 1 and 2 of RECOMBIVAX HB 1 ml, intramuscular (lot number reported as J008227 and expiration date unspecified, for dose number 1 and 2 in the series). The patient received the third dose on an unknown date (lot # J008505, expiration date 07-FEB-2016) 1 ml, intramuscular. Thimerosal status of the vaccine was not reported. There were not concomitant medications reported. On an unknown date the patient experienced negative hepatitis B titers. The physician reported that the patient had the titers measured 31 or 32 days after the third dose, and they measured less than 5 which was determined to be negative. No additional symptoms were reported. it was reported that there was no treatment given for the patient. There was no product quality complaint (PQC) involved. The outcome of the event was reported as not recovered. The causality of the event was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to a male patient of unknown age. There was no pertinent medical history and there were no drug reactions or allergies reported. On unknown dates the patient was vaccinated with dose 1 and 2 of  RECOMBIVAX HB 1 ml, intramuscular  (lot number reported as J008227 and expiration date unspecified, for dose numbers 1 and 2 in the series). The patient received the third dose on an unknown date (lot #J008505, expiration date 07-FEB-2016) 1 ml intramuscular. Thimerosal status of the vaccine was not reported. There were no concomitant medications reported. On an unknown date the patient experienced negative hepatitis B titers. The physician reported that the patient had the titers measured 31 or 32 days after the third dose, and they measured less than 5 which was determined to be negative. No additional symptoms were reported. IT was reported that there was no treatment given for the patient. There was no product quality complaint (PQC) involved. The outcome of the event was reported as not recovered. The causality of the event was not provided.  This is one of several reports received from the same reporter. Additional information has been requested.