chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Nervousness, Staring
Clinical narrative: Tightness in chest; Labored breathing; Behavior changes; Insomnia; Dry-hoarse cough; Staring-eye become fixated; Crying; Nervous; Despondent; Incessant talking (repeating herself over & over); Confused; Can't focus/concentrate; Patient never experienced this before.
Age: 20.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Anxiety, Psychotic disorder
Clinical narrative: Tightness in chest; Labored breathing; Behavior changes; Insomnia; Dry-hoarse cough; Staring-eye become fixated; Crying; Nervous; Despondent; Incessant talking (repeating herself over & over); Confused; Can't focus/concentrate; Patient never experienced this before.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Skin rash starting from face downward.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Expanding red area from quarter to palm size, very hot. Was on the way to M.D. We called MD for patient.
Age: 4.0
Sex: F
Vaccine: DT, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was given DT but needed DTaP. No treatment was given at this time. Patient still needs pertussis, not sure if to redose or what to do next.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: (L) arm pain with movement began 4 days after injection above injection site around rotator cuff; no redness, no inflammation at site, no swelling, no fever; referred to neurologist.
Age: 32.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: (L) arm pain with movement began 4 days after injection above injection site around rotator cuff; no redness, no inflammation at site, no swelling, no fever; referred to neurologist.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Rash
Clinical narrative: Rash on leg and abdomen 48-72 hours after vaccine then temp 101.6 10 days following vaccine.
Age: 1.26
Sex: F
Vaccine: PNC13
Symptoms: Expired drug administered, No adverse event
Clinical narrative: None will revaccinate in 6 weeks. PCV 13 was expirated when given. No adverse effects. 3/20/13.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Headache, Malaise, Pruritus, Pyrexia, Rash generalised
Clinical narrative: KINRIX RD and PROQUAD LD were administered to case. Developed body wide rash on arms and legs within 20 min. Complained of itching, general malaise and headache. Went to clinic to see doctor. Could not ascertain any specific vaccination site as worse than the other. Case developed fever of 102 degrees-103 degrees F that night but better the next morning. Mother stated that he is still taking some BENADRYL for itching a week later.
Age: 1.51
Sex: M
Vaccine: HEPA, HIBV
Symptoms: Abdominal discomfort, Diarrhoea, Occult blood negative, Pyrexia, Vomiting
Clinical narrative: Fever to 102.9 day after shots, vomiting and diarrhea - treated with OTC ADVIL and diet changes for stomach symptoms.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Client stated she woke up itching & found hives all over her body. Denies any breathing difficulties. She will see her MD this AM
Age: 2.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Broke out with vesicular rash on trunk morning of the 14th day after vaccination.
Age: 1.19
Sex: M
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Pt. received double dose of varicella, one Proquad, one Varivax.  Pt. did not have any adverse reactions.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Crying, Oral pain, Oropharyngeal pain, Poor quality sleep
Clinical narrative: She started crying while sleeping and for the last three days she is waking up crying at night. She says her mouth and throat hurts.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Blood glucose normal, Dizziness, Dyskinesia, Nausea, Pain
Clinical narrative: NKA. Given Hep A vaccination and she c/o pain followed by nausea and dizziness. She looked pale & jerked twice. Assited by another RN and a Nurse practicioner. Pt. was responsive, Vitals: 87/41, HR up 50-61, O2 sat 100%, resp. 18, still dizzy, assisted to get to bed and given water. Blood sugar was 119, given more to drink orange juice since she said she was on bike race earlier that morning and did not eat. B/P is up to 117/70, HR 64, 100%Sat, resp.16, says she is alright. Assisted to get up and walked without dizziness. Given food to eat. Pt. eventually was sent home stable after treating her for approx 1 hr. Husband was called by patient and updated.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Pallor
Clinical narrative: NKA. Given Hep A vaccination and she c/o pain followed by nausea and dizziness. She looked pale & jerked twice. Assited by another RN and a Nurse practicioner. Pt. was responsive, Vitals: 87/41, HR up 50-61, O2 sat 100%, resp. 18, still dizzy, assisted to get to bed and given water. Blood sugar was 119, given more to drink orange juice since she said she was on bike race earlier that morning and did not eat. B/P is up to 117/70, HR 64, 100%Sat, resp.16, says she is alright. Assisted to get up and walked without dizziness. Given food to eat. Pt. eventually was sent home stable after treating her for approx 1 hr. Husband was called by patient and updated.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Red area approximately 3 inches by 2 inches in size; somewhat warm; itching; slightly swollen; slight pain at injection site; symptoms lasted approximately four days then began to subside slowly.
Age: 1.29
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Balance disorder, Convulsion
Clinical narrative: Per mom started having balance problems and then had a seizure. Event started approximately in the afternoon.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Dysphagia, Pharyngeal disorder, Pharyngeal hypoaesthesia
Clinical narrative: Difficulty swallowing, took 25 mg Benadryl, had mom call the doctor's office, appt. made after talking to the doctor.  No respiratory problems.  Got to office stated her throat felt like it has in the past after having a cavity filled, kind of numb.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: Pt passes out after vaccine administration, fell out of chair, and hit her head on the chair.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Loss of consciousness, Pyrexia
Clinical narrative: Sudden high fever and ten minute loss of consciousness.
Age: 65.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema
Clinical narrative: At the site of injection, patient experienced red flare ups at the upper right arm all the way down to the elbow lasting 3 days.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 77 year old female patient. On 16-APR-2013 the patient was vaccinated with ZOSTAVAX (lot# unspecified), subcutaneous. On 01-MAY-2013, the patient developed shingles approximately two weeks after receipt of ZOSTAVAX. VZVID packed was sent. The outcome of shingles was reported as not recovered. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a registered nurse refers to an 18 month old patient. The nurse stated new patient to their office, 8 month old child, has a vaccination record from another health care provider, that shows that ZOSTAVAX (dose, route and lot # not specified) was administered. Nurse stated she thought it might just be a paper documentation error. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On an unknown date in 2007 the patient was vaccinated with ZOSTAVAX (lot# was not reported, dose route was not reported). On an unknown date the patient experienced varicella like rash. The patient visited to physician's office to seek medical attention. Unspecified treatment was given for the adverse event. The outcome of varicella like rash was reported as recovering/resolving. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to an 84 year old female patient. On 25-APR-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided) subcutaneously. The patient developed shingles approximately two weeks after receipt ZOSTAVAX, on 09-MAY-2013 (also reported about two weeks ago, approximately on 25-APR-2013, also reported the therapy was continued). The outcome of adverse event was reported as not recovered. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age, unknown gender. On 08-APR-2013 the patient was vaccinated subcutaneously with an expired dose of MMR II (lot # 670210/0447AA, expiry date 28-MAR-2013). It was unknown if this was the first or second dose of MMR II the patient had been administered. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 73 year old female patient. Approximately one year ago in May 2012, the patient was vaccinated with ZOSTAVAX (dose, route, lot and frequency not reported). Approximately 1 year ago in May 2012, the patient developed an acute case of shingles, after receiving in ZOSTAVAX vaccine through an unspecified pharmacy. The patient sought medical attention. The outcome of the event was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a Registered Nurse who stated that she heard from an unspecified person that "a bunch of patients at an unspecified nursing home were administered ZOSTAVAX (dose, route and lot # were unknown) on unspecified dates and developed shingles about 10-15 days after ZOSTAVAX administration". The outcome of event unknown. The action taken of ZOSTAVAX and relationship between event were unknown. Attempts are being made to verify the existence of the patients and to obtain patients identifier. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Malaise, Pain in extremity
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The consumer reported that on 03-APR-2013 the patient was vaccinated with a standard dose (0.5 mL) of PNEUMOVAX 23 (lot # H014561, expiration date 21-MAR-2014) (route unspecified). The consumer reported that approximately on 03-APR-2013, the patient experienced arm pain, and redness immediately following vaccination. At the time of the report the outcome of arm pain, malaise and redness was unknown. This is one of two cases from the same reporter (MARRS # 1305USA001147). Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test normal, Neuralgia
Clinical narrative: This spontaneous report as received from a 76 year old female patient with chronic back pain and diabetic and she was allergic to "Norontin, Lyrica, Cymbalta". She said she received a dose of ZOSTAVAX injection 1 "in the left arm" for prevention of shingles in 2009 and broke out with shingles 12-JUN-2010 and was still experiencing nerve pain. She had sought medical attention and was given antiviral pills for treatment. Regular lab work and basically everything was pretty normal. She had a bunch of concomitant therapies for the shingles and she had a salve that she used that helped morphine. The outcome was unknown at the time of report. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: TTOX
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Edema, pain, erythema 5" x 3".
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration, Neuralgia
Clinical narrative: This spontaneous report as received from a female consumer reporting on herself with history of herpes zoster/shingles. On an unknown date "several years ago" the patient was vaccinated with ZOSTAVAX, subcutaneous for previous shingles reaction. (dose unspecified) (lot# and exp date unspecified). The reporter inquired as to appropriateness of reintroduction of ZOSTAVAX, since her physician recommended that ZOSTAVAX, be re-administered. Caller stated that she previously experienced an adverse reaction with ZOSTAVAX, to prevent herpes zoster (neuralgia). The outcome of herpes zoster neuralgia was unknown. The patient sought unspecified medical attention. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: Patient mother called pcp last night to inform that he developed a high fever 105F less than 1 hr. after LD shot.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a consumer refers to a 50 year old male patient with sulfonamides allergy. On 03-MAY-2013 the patient was vaccinated with ZOSTAVAX (Lot # not reported) subcutaneous (dose not reported) for prevention of shingles. Concomitant therapies included VYTORIN and PRINIVIL. The patient reported that on 05-MAY-2013, the patient experienced large histamine base reaction that is 6 inches by 6 inches around the injection site on his left arm after receiving ZOSTAVAX. The patient sought medical attention at urgent care visit. Treatment was given with BENADRYL. The outcome of the patient experienced large histamine base reaction that is 6 inches by 6 inches was reported as recovering/resolving. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Rt upper arm presented large 1-1/2" hard, erythematous tender area.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a unspecified number of patients. On an unknown date the patients were vaccinated with ZOSTAVAX (Lot # not reported) (dose and route not reported) for shingles vaccines. No other co suspects were reported. No concomitant therapy was reported. On an unknown date the patients developed redness, swelling and tenderness at injection site. The outcome of the patients had developed redness, swelling at injection site and tenderness at injection site was unknown. Additional information is not expected.
Sex: U
Vaccine: MMR
Symptoms: Mumps antibody test negative
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with MMR II (Lot # not provided) (dose, route not provided). No other co-suspects were reported. No concomitant therapy was reported. The nurse practitioner reported that a serologic testing was performed and determined a negative titer for mumps. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a Bachelor Science in Nursing refers to an unspecified patients. On an unknown date unspecified patients were vaccinated with GARDASIL (dose, via, lot number and expiration date not reported). There was no concomitant medication reported. Reporter stated that GARDASIL, not stored within proper temperatures ranges and therefore unsupported on an unspecified dates, was administered to unspecified patients on unspecified dates. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from the Healthcare worker refers to a patient of unknown age and gender. On 07-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # unspecified, expiration date March 2013) (dose, route and anatomical location unspecified). The Healthcare worker reported that was administered an expired dose of ZOSTAVAX. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender, who was admitted to an unspecified hospital, on an unspecified date for an unspecified reason. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (route of administration and lot number were not reported). No other concomitant medications were reported. Pharmacist noted that patient was administered PNEUMOVAX 23 twice in a short period of time. While in the hospital the patient was administered PNEUMOVAX 23 and then admitted to an unspecified nursing home on an unspecified date where PNEUMOVAX was administered again on an unspecified date. No adverse effect noted. The outcome of the patient at the moment of the report was unknown. The relationship between therapy with PNEUMOVAX 23 and the events was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Chlamydia test, Exposure during pregnancy, Inappropriate schedule of drug administration, Laboratory test, Potassium hydroxide preparation positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 20 year old pregnant female patient. The patient had no pertinent medical history or drug reactions/allergies. On 2009 the patient received the first dose of GARDASIL (lot no. not reported). On 10-MAR-2013 the patient went to the reporter's office for second dose of GARDASIL (lot no. h015555 exp 13-APR-2013, dose 2, 0.5 ml, intramuscular). The patient was given a pregnancy test, which was positive, but the positive pregnancy test results were not given to Nurse practitioner until after GARDASIL was administered. Nurse practitioner also performed a "wet prep" test and diagnosed bacterial vaginosis, for which she was prescribed metronidazole (manufacturer unspecified). The patient became pregnant with LMP of 10-MAR-2013 and EDD of 15-DEC-2013. It was reported that the child had a gestation of 7 weeks and 5 days. The outcome of bacterial vaginosis was unknown. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pregnancy test positive, Vaginitis bacterial
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 20 year old pregnant female patient. The patient had no pertinent medical history or drug reactions/allergies. On 2009 the patient received the first dose of GARDASIL (lot no. not reported). On 10-MAR-2013 the patient went to the reporter's office for second dose of GARDASIL (lot no. h015555 exp 13-APR-2013, dose 2, 0.5 ml, intramuscular). The patient was given a pregnancy test, which was positive, but the positive pregnancy test results were not given to Nurse practitioner until after GARDASIL was administered. Nurse practitioner also performed a "wet prep" test and diagnosed bacterial vaginosis, for which she was prescribed metronidazole (manufacturer unspecified). The patient became pregnant with LMP of 10-MAR-2013 and EDD of 15-DEC-2013. It was reported that the child had a gestation of 7 weeks and 5 days. The outcome of bacterial vaginosis was unknown. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old patient. On 02-MAY-2013 the patient was vaccinated with PROQUAD (Lot # not provided) 0.5 ml, subcutaneous. No other co suspects were reported. No concomitant therapy was reported. The registered nurse reported that on 02-MAY-2013, the patient was inadvertently vaccinated with PROQUAD. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Healthcare worker refers to a patient of unknown age and gender. On 08-MAY-2013 the patient was vaccinated with third dose of GARDASIL (lot # 668261/1397AA, exp date 09-APR-2013) injection, 0.5 mL, intramuscular. Healthcare worker reported that the first dose of GARDASIL was administered on 07-NOV-2012 and the second dose was administered on 07-JAN-2013. No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a nursing student patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. The patient had received 2 doses of (oka/merck) VARIVAX (lot number, expiration date and dose were not reported). Concomitant medication was not reported. It was reported that the patient's colleague still required titer testing after vaccination and the titer was undetectable. At the time of the report the patient's outcome was unknown. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Redness, swelling in left arm.
Sex: F
Vaccine: HEP
Symptoms: Drug administration error
Clinical narrative: Newborn baby given Hepatitis vaccine and HBIG both in right anterior thigh.
Sex: U
Vaccine: VARZOS
Symptoms: Eyelid ptosis, Lip swelling, Paraesthesia oral, Rash, Swelling
Clinical narrative: Swollen lip. Bumps. Swelling. Tingling to the right of mouth. Skin is sagging above eye.
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Injection site induration, Injection site pain
Clinical narrative: Approximately 12 hrs s/p (L) delt IM admin of MENVEO 0.5cc, pt reported flu-like sx including fevers to 102.2, next night 100.5, chills, sweats, pain to (L) delt with swelling and reported enlarged and tender (L) axillary lymph node "up to size of orange". Sx have mostly resolved. Exam: (L) delt tenderness/firmness, warm site, intact skin; temp 98.4 F.
Age: 34.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site swelling, Injection site warmth, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Approximately 12 hrs s/p (L) delt IM admin of MENVEO 0.5cc, pt reported flu-like sx including fevers to 102.2, next night 100.5, chills, sweats, pain to (L) delt with swelling and reported enlarged and tender (L) axillary lymph node "up to size of orange". Sx have mostly resolved. Exam: (L) delt tenderness/firmness, warm site, intact skin; temp 98.4 F.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Rash macular
Clinical narrative: Patient rec'd immunizations at 2pm and when he woke from nap at 4:30pm he was "blotchy" on stomach, back, cheek and back of head. Not raised or bumpy. Gave BENADRYL, he cleared up, no more problems.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itching, headache, and bruising at the injection site.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Injection site pain
Clinical narrative: Soreness at injection site, aches in joints all over, headache.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash pustular
Clinical narrative: Patient had shingles show up over her back and her belly area with pustules and painful areas. Was prescribed a pain med to take twice a day, for a month (daughter not sure of name).
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Child seen 4/25/13 with left thigh 2 cm by 4 cm swollen and red and rt thigh 1 cm by 1 cm swollen and red.
Age: 0.18
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Decreased appetite, Irritability, Somnolence
Clinical narrative: 2 mo with fussiness, decreased appetite and increased sleepiness following vaccinations.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Culture stool, Diarrhoea, Diarrhoea haemorrhagic
Clinical narrative: Bloody diarrhea after ROTATEQ 05/14/13 patient came into clinic mom reports no blood in stool but still having diarrhea return or call clinic 05/16/13.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood electrolytes normal, Computerised tomogram normal, Full blood count normal, Grand mal convulsion
Clinical narrative: 12 hrs after Tdap, MCV4, and HPV #2 were given, patient had a generalized tonic clonic seizure at home, lasting less than 5 minutes. Pt. evaluated in ER and found no abnormal labs, normal CT scan of head.
Age: 1.22
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Full blood count, Metabolic function test, Petechiae, Platelet count decreased, Pyrexia
Clinical narrative: Patient went to ER on 5-11-2013 with a fever 104 x 2 days and a rash (petechiae rash), platelet count was low in ER 5. Then follow up at our office 5-13-2013 - no rash and platelets 207.
Age: 1.22
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Urine analysis
Clinical narrative: Patient went to ER on 5-11-2013 with a fever 104 x 2 days and a rash (petechiae rash), platelet count was low in ER 5. Then follow up at our office 5-13-2013 - no rash and platelets 207.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Rash macular
Clinical narrative: Patient given Varicella to left post. upper arm subcutaneously tolerated well. Patients arm immediately started to turn red 5.5 cm x 4 cm area with red blotches as well.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in arm at site of injection and sometimes is very strong pain.
Age: 0.11
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Diet refusal, Flatulence, Occult blood negative
Clinical narrative: Approximately 2.5 hours after vaccines, began crying strongly. Resisted feeding; after 5.5 hours, started to resist feeding (breast and bottle); after 7 hours, stooled with flatus x 4 in about 20 min while in office. No vomiting or spit up.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Injection site urticaria
Clinical narrative: Hive reaction around vaccine site. Administered PO 7.5ml of BENADRYL and 15 min observation.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: She was given the ZOSTAVAX in the back part of her upper R arm. It became swollen, red and very painful. It hurt so bad that she was unable to sleep at night. It is very swollen and hot to the touch, over a large area of her arm, up from her elbow.
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram normal, Myocarditis, Troponin I increased
Clinical narrative: This study case was received from the investigator on 03 May 2013, with follow-up information on 06 May 2013. A 22-year-old male subject, with a past medical history of high blood pressure, elevated cholesterol, dizziness and fainting spells, shortness of breath, eczema, headaches, and numbness or paralysis, developed Non-specific myocarditis, 13 days post vaccination with ACAM2000, SP Biologics Co., (lot number not reported) and concomitantly: ANTHRAX 1, other manufacturer; and TYPHOID - ORAL, other manufacturer, (lot numbers, route, site, side and dose in series not reported) on 05 December 2012. On 18 December 2012, the subject was diagnosed with Non-specific myocarditis. Relevant laboratory data included: Troponin I reported as abnormal, with result of 0.63 ng/mL (also reported as 00.63 (unitless), reported as abnormal on 16 December 2012. On 16 December 2012, an electrocardiogram (ECG) was reported as normal and on 17 December 2012, an echocardiogram was reported as normal. Magnetic resonance imaging (MRI) of brain, spinal cord, and heart were not performed; and lumbar puncture was not performed. No treatments were reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP, ANTH, SMALL, TYP
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, Chest pain, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: This study case was received from the investigator on 03 May 2013, with follow-up information on 06 May 2013. A 19-year-old male subject, with no significant medical history, developed unspecified disease of pericardium, 12 days after receiving an injection of ACAM2000, SP Biologics Co., (lot number not reported) and concomitantly: TYPHIM VI, sanofi pasteur SA; and ANTHRAX 1, other manufacturer, (lot numbers, route, site, side and dose in series not reported) on 16 January 2013. On 28 January 2013, the subject was diagnosed with unspecified disease of pericardium. Relevant laboratory data included: Troponin I was reported as abnormal, with result 0.49ng/mL (also reported as 00.49 (unitless) on 29 January 2013. Also, on 29 January 2013, an electrocardiogram (ECG) was reported as abnormal and an echocardiogram was reported as normal. Magnetic resonance imaging (MRI) of brain, spinal cord, and heart were not performed; and lumbar puncture was not performed. No treatments were reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP, ANTH, SMALL, TYP
Symptoms: Fibrin D dimer normal, Troponin I
Clinical narrative: This study case was received from the investigator on 03 May 2013, with follow-up information on 06 May 2013. A 19-year-old male subject, with no significant medical history, developed unspecified disease of pericardium, 12 days after receiving an injection of ACAM2000, SP Biologics Co., (lot number not reported) and concomitantly: TYPHIM VI, sanofi pasteur SA; and ANTHRAX 1, other manufacturer, (lot numbers, route, site, side and dose in series not reported) on 16 January 2013. On 28 January 2013, the subject was diagnosed with unspecified disease of pericardium. Relevant laboratory data included: Troponin I was reported as abnormal, with result 0.49ng/mL (also reported as 00.49 (unitless) on 29 January 2013. Also, on 29 January 2013, an electrocardiogram (ECG) was reported as abnormal and an echocardiogram was reported as normal. Magnetic resonance imaging (MRI) of brain, spinal cord, and heart were not performed; and lumbar puncture was not performed. No treatments were reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Age: 19.0
Sex: M
Vaccine: ANTH, TYP, ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Troponin I increased
Clinical narrative: This study case was received from the investigator on 03 May 2013, with follow-up information on 06 May 2013. A 19-year-old male subject, with no significant medical history, developed unspecified disease of pericardium, 12 days after receiving an injection of ACAM2000, SP Biologics Co., (lot number not reported) and concomitantly: TYPHIM VI, sanofi pasteur SA; and ANTHRAX 1, other manufacturer, (lot numbers, route, site, side and dose in series not reported) on 16 January 2013. On 28 January 2013, the subject was diagnosed with unspecified disease of pericardium. Relevant laboratory data included: Troponin I was reported as abnormal, with result 0.49ng/mL (also reported as 00.49 (unitless) on 29 January 2013. Also, on 29 January 2013, an electrocardiogram (ECG) was reported as abnormal and an echocardiogram was reported as normal. Magnetic resonance imaging (MRI) of brain, spinal cord, and heart were not performed; and lumbar puncture was not performed. No treatments were reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 08-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot number not provided). The patient experienced a swollen warm red area about the size of an egg described as 2 inches by 3 inches and raised 1/8 to 1/4 inches at the administration site. The outcome of adverse events was not recovered. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 09-MAY-2013 the patient was vaccinated with MMR II (lot number 0599A expiry date 26-APR-2013) dose 1, intramuscular. On 09-MAY-2013, 1 day after onset of therapy the patient was administered an expired dose of MMR II. The physician also noted this dose of MMR II may have been administered intramuscularly. No adverse event was reported. The outcome of patient was administered an expired dose of MMR II, no adverse event and MMR II may have been administered intramuscularly is unknown. Action taken with MMR II was not provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Epstein-Barr virus test positive, Fatigue, Malaise
Clinical narrative: This spontaneous report as received from a physician (M.D.) refers to a 24 year old female patient with mild mitral valve prolapse and no drug reactions/allergies. On 05-APR-2013 the patient was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot# not reported). There was no concomitant therapy. Sometime this month (May 2013, date unspecified) patient had a positive test of Epstein Barr virus with an unspecified lab test. The patient had an office visit. The physician did not make the diagnosis of Epstein Barr, and therefore did not have additional information about diagnostic testing. The patient had symptoms of malaise and fatigue (onset date unknown). The patient was not currently receiving treatment. The outcome of the events was unknown. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: This spontaneous report as received from a physician refers to an 81 year old male patient. Within in the last six months, approximately in November 2012 the patient was vaccinated with ZOSTAVAX (lot number not provided). Within two weeks, approximately on 26-APR-2013 the patient experienced shingles. The patient also developed and was still experienced post herpetic neuralgia(PHN). The outcome of adverse events was reported as not recovered. The patient had sought medical attention via office visit. Additional information is not expected.
Sex: F
Vaccine: HBHEPB
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a female patient of unknown age. On 07-MAY-2013 the patient was vaccinated with expired COMVAX, 0.5 ml, intramuscular in the left upper thigh (lot # was reported as 1513AA, expiry date in 06-MAY-2013). No adverse effects reported at this time. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report as received from a consumer's wife refers to her 73 year old husband. The patient did not have any pertinent medical history or drug reactions/allergies. On an unknown date in January 2011 the patient was vaccinated with ZOSTAVAX 1 time vaccine subcutaneously (dose and lot # were unknown). Concomitant medication included Vinastride. On an unknown date in April 2011 the patient was diagnosed with the shingles after receiving ZOSTAVAX. She stated it was on his left side of his face, behind the ear. She also advised he was still experiencing pain in the nerve endings. He had seen his physician and had sought unspecified medical attention. The outcome of events was reported as not recovered/not resolved. No lab diagnosis studies performed. No treatment was given for adverse event, the doctor only diagnosed it. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Antibody test negative, Exposure during pregnancy, Hepatitis B surface antibody negative, Live birth, Seroconversion test negative
Clinical narrative: This spontaneous retrospective pregnancy report as received from a pharmacist refers to a 25 year old female patient. On 14-JUL1989 the patient was vaccinated with one dose of MMR II (lot # and dose not reported). On 10-APR-1990, the patient was vaccinated with one dose of RECOMBIVAX HB (lot # and dose not reported). The patient became pregnant. The LMP and EDD is not known. The patient delivered a infant. The pregnancy outcome was unknown. The pharmacist reported that the patient failed to seroconvert with one dose of each MMR II and RECOMBIVAX HB that she received a child on an unknown date (the LMP and EDD were not known). The pregnancy outcome was unknown. At the time of reporting, the patient was not a pregnant. It was reported that the patient had not recovered from these events. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontnaeous rpeort as received from a pharmacist refers to three patients of unknown age were inadvertently administered ZOSTAVAX single dose (lot # 0364AE, expiry date on 16-MAR-2013). Two patients were administered the expired ZOSTAVAX on 30-APR-2013 and one patient was administered the expired ZOSTAVAX on 07-MAY-2013 (MARRS# 1305USA009049). No adverse effects reported. This is one of several reports received from the same source. 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 three patients of unknown age were inadvertently administered ZOSTAVAX single dose (lot # 0364AE, expiry date on 16-MAR-2013). Two patients were administered the expired ZOSTAVAX on 30-APR-2013 (MARRS# 1305USA0046421) and one patient was administered the expired ZOSTAVAX on 07-MAY-2013. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Psoriasis
Clinical narrative: This spontaneous report as received from a physician refers to a 15 year old male patient. On an unspecified date, the patient began the GARDASIL series. The physician reported that the patient received the second dose of GARDASIL (lot #, route and dose not reported) on 04-OCT-2012 and on 14-FEB-2013 developed psoriasis. The patient received the third dose of GARDASIL (lot #, route and dose not reported) on 26-APR-2013, and the patient still presented with psoriasis. The patient sought medical attention by office visit. The patient was treated with ELIDEL cream, coal tar 20% solution and calcipotriene cream. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Deep vein thrombosis, Injection site erythema, Injection site swelling, Pain in extremity, Swelling
Clinical narrative: Initial report was received from a healthcare professional on 03 May 2013. A 44-year-old female patient had received an intramuscular injection in the right deltoid of ADACEL, lot number C4365AA, on 30 April 2013. The next day, on 01 May 2013, the patient experienced soreness of the arm, swelling of the injection area and under the arm. Two days later, on 03 May 2013, the patient reported very painful arm with redness around the injection site and axilla swelling. The patient was directed to go to the hospital emergency room for evaluation and treatment. A doppler sonogram documented a small deep vein thrombosis (DVT) of right brachial complex. The patient was hospitalized and is being treated with anticoagulant. The patient had no illness at the time of vaccination and allergies to penicillin, clindamycin, tetracycline and NAPROSYN. Outcome was not recovered. Documents held by sender: None.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Initial report was received from a healthcare professional on 03 May 2013. A 44-year-old female patient had received an intramuscular injection in the right deltoid of ADACEL, lot number C4365AA, on 30 April 2013. The next day, on 01 May 2013, the patient experienced soreness of the arm, swelling of the injection area and under the arm. Two days later, on 03 May 2013, the patient reported very painful arm with redness around the injection site and axilla swelling. The patient was directed to go to the hospital emergency room for evaluation and treatment. A doppler sonogram documented a small deep vein thrombosis (DVT) of right brachial complex. The patient was hospitalized and is being treated with anticoagulant. The patient had no illness at the time of vaccination and allergies to penicillin, clindamycin, tetracycline and NAPROSYN. Outcome was not recovered. Documents held by sender: None.
Age: 0.5
Sex: F
Vaccine: FLU3
Symptoms: Intussusception, Vomiting
Clinical narrative: Initial case was received from a healthcare professional on 08 May 2013. A six-month-old female patient, who had no illness at time of vaccination and no known allergies, received dose one of an injection of FLUZONE, sanofi pasteur Inc., lot number U4547CA, (route, site and side not reported) on Friday, 03 May 2013. The patient started to experience vomiting on the weekend (onset of symptoms reported as 04 May 2013). The infant was hospitalized on Sunday, 05 May 2013 and diagnosed with intussusception. No laboratory, diagnostic tests, or treatments were reported. The patient was discharged on Monday, 06 May 2013. She was seen in the office on Wednesday, 08 May 2013, and is "OK now". The patient's outcome was reported as recovered on 08 May 2013. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Chest X-ray normal, Cough, Laboratory test abnormal, Nasopharyngitis, Pertussis
Clinical narrative: Initial report received on 03 May 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 11 month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject's medical history was not reported. The subject had received three doses of PENTACEL: dose one, lot number C4193AA on 21 June 2012; dose two, lot number C4259AA on 21 August 2012; and dose three, lot number C4299AA, on 22 October 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 11 March 2013, approximately four months after the last dose. On 11 March 2013, the subject developed both a cough and paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included a positive PCR on 25 April 2013. Chest x-ray findings were negative (unspecified date). Corrective treatments consisted of Azithromycin starting on 25 April 2013 for five days. The subject was not hospitalized. At the time of final contact on 26 April 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 46 days. The subject's outcome was not recovered. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 197 cases solicited from the Electronic Disease Surveillance System (EDSS) during the surveillance period from 01 January 2010 to 03 May 2013. These 197 cases represent children who received three or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.51
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Polymerase chain reaction, Post-tussive vomiting, Sleep disorder
Clinical narrative: Initial report received on 03 May 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in an 11 month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject's medical history was not reported. The subject had received three doses of PENTACEL: dose one, lot number C4193AA on 21 June 2012; dose two, lot number C4259AA on 21 August 2012; and dose three, lot number C4299AA, on 22 October 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 11 March 2013, approximately four months after the last dose. On 11 March 2013, the subject developed both a cough and paroxysmal cough without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included a positive PCR on 25 April 2013. Chest x-ray findings were negative (unspecified date). Corrective treatments consisted of Azithromycin starting on 25 April 2013 for five days. The subject was not hospitalized. At the time of final contact on 26 April 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 46 days. The subject's outcome was not recovered. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 197 cases solicited from the Electronic Disease Surveillance System (EDSS) during the surveillance period from 01 January 2010 to 03 May 2013. These 197 cases represent children who received three or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Age: 0.76
Sex: F
Vaccine: HEP
Symptoms: Henoch-Schonlein purpura
Clinical narrative: HSP.