chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Encephalitis post immunisation
Clinical narrative: This study case was received from the investigator in a trial on 16 July 2013. A 20-year-old male subject with a no past medical history was found to have encephalitis following immunization procedures 10 days after the subject had received the following vaccinations on 25 May 2010: an injection of ACAM2000 (lot number, route and site of administration not reported), an injection of Anthrax (manufacturer, lot number, route and site of administration not reported) and an injection of TYPHIM VI (lot number, route and site of administration not reported). Troponin I, ECG, echocardiogram, lumbar puncture and MRI of the brain, spinal cord and heart were not performed. Treatments were not reported. 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: HPV4
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with the second dose of GARDASIL (dose, lot # and route not reported). The physician reported that during an office visit where the patient was scheduled to receive VARIVAX (Merck) the patient was inadvertently administered the second shot of the GARDASIL vaccine, two and a half weeks after she receiving the first dose of GARDASIL vaccine. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. On 22-JUL-2013 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # reported as 1064AA, exp. 05-JUL-2013) (dose and route not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated with GARDASIL injection 120 Y(dose,route and lot#unknown) on 08-JUL-2013 and 24-JUL-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. There was no PQC. It was unknown if the patient had sought medical attention. The outcome and action taken were not provided. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Incorrect dose administered, Mumps antibody test negative
Clinical narrative: This spontaneous report was received from an office manager refers to a female patient of unknown age. Medical history was reported as none. The Office manager reported that the patient received a first dose of MMR II at about 18 months of age and a second dose at around 4 years of age. On 18-JUN-2013, the patient received a dose 3 of MMR II (lot # expiry not reported) because a recent titer was low for mump. The outcome and causality of recent titer was low for mumps was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female consumer of unknown age reporting on herself. In 2009 reported 4 years ago, the patient was vaccinated with ZOSTAVAX, injection in arm, (route, lot number and exp.date not reported). The patient could not spell what other medicines she was taking concomitantly. In March 2013 the patient came down with shingles after having had the vaccine. There was unspecified treatment given for the adverse event. The outcome of event was unknown. 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 student refers to a patient of unknown age and gender (no demographic information was provided). No information regarding the patient's medical history was provided. On 18-JUL-2013 the patient was vaccinated with dose 2 of GARDASIL, valid lot # 0298AA, which had been expired on 21-JUN-2013. The first dose was received on 15-MAY-2013. No concomitant medications was reported. No adverse symptoms were reported. No outcome was reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a 67 year old female patient. On 07-JUL-2009, the patient was vaccinated with a dose of ZOSTAVAX (lot# expiry not reported). On 07-JUN-2013, the patient developed shingles after receiving ZOSTAVAX. This patient had received the vaccine on 07-JUL-2009 and then developed a dermatone rash around her waist on 07-JUN-2013. Patient sought medical attention. The patient called her physician, was seen and examined in the office on an unspecified date and the physician then prescribed VALTREX and LYRICA to the patient to manage her symptoms. The patient recovered shingles on an unknown date in approximately 2013. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 25 year old female patient. On 16-JUL-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular in the right arm. Lot number H019992, expiry date 09-DEC-2013. On 16-JUL-2013, the patient experienced redness, swelling and pain at the injection site of her right arm. The patient called the clinic on 17-JUL-2013 to report the reactions. The patient was instructed to apply some ice to her injection site and use Ibuprofen to reduce the swelling and pain. The patient was seen by the medical staff at the clinic on 18-JUL-2013. After she was seen in the clinic the patient was prescribed Cephalexin. The outcome of the events was reported as recovering/resolving. Causality assessment was not provided. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 24-JUL-2013, the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot number and expiry date reported as 671126/1062AA and 05-JUL-2013 respectively, dose and route unspecified. No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a patient of unknown age. On 11-JUN-2013, the patient was vaccinated with a dose of M-M-R II, (lot # H010135, expiry date 17-MAY-2014, route was not reported) which may have been improperly stored at 8.5 degrees Celsius and 9.1 degrees Celsius for 720 hours. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: This spontaneous report was received from the consumer, a male patient of unknown age. No information regarding the patient's medical history was provided. On 18-JUL-2013 the patient was vaccinated with ZOSTAVAX vial 19400PFU, 0.65 ml, subcutaneously, at a "Rite Aid Pharmacy" at an unspecified location. No concomitant medication was reported. On 22-JUL-2013 the patient experienced small blistering on his foot. He did not seek for medical attention. The outcome of small blistering on foot was reported as recovering/resolving. No causality assessment was provided. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Chest X-ray, Computerised tomogram, Musculoskeletal pain, Neck pain
Clinical narrative: This spontaneous report was received from a 66 year old male consumer reporting on himself with asthma and psoriasis and no drug reactions or allergies. On 11-APR-2013 the patient was vaccinated with PNEUMOVAX23 (lot # and expiration date unspecified) injection (dose, route and anatomical location unspecified). Concomitant medications were not reported. On 18-APR-2013, the patient reported that he had severe arthritis pain in his shoulders, neck, knees since he received the PNEUMOVAX23 shot. Patient sought medical attention by seeing physician and the treatment was prednisone 20 mg/once daily. Laboratory tests performed on unknown dates were: Chest x-ray (results unspecified), Computerised Tomography (CT Scan) (results unspecified), Positron Emission Tomography (PET Scan) (results unspecified). At the time of the report the outcome of severe arthritis pain in his shoulders, neck and knees was reported as not recovered/not resolved. Additional information has been requested,
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Positron emission tomogram
Clinical narrative: This spontaneous report was received from a 66 year old male consumer reporting on himself with asthma and psoriasis and no drug reactions or allergies. On 11-APR-2013 the patient was vaccinated with PNEUMOVAX23 (lot # and expiration date unspecified) injection (dose, route and anatomical location unspecified). Concomitant medications were not reported. On 18-APR-2013, the patient reported that he had severe arthritis pain in his shoulders, neck, knees since he received the PNEUMOVAX23 shot. Patient sought medical attention by seeing physician and the treatment was prednisone 20 mg/once daily. Laboratory tests performed on unknown dates were: Chest x-ray (results unspecified), Computerised Tomography (CT Scan) (results unspecified), Positron Emission Tomography (PET Scan) (results unspecified). At the time of the report the outcome of severe arthritis pain in his shoulders, neck and knees was reported as not recovered/not resolved. Additional information has been requested,
Age: 43.0
Sex: F
Vaccine: MNQ, PPV, TDAP, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Apparently cellulitis at the injection site after VARIVAX administration. No reaction with the other vaccines. Emergency room visit currently with antibiotics.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Chest pain, Dizziness, Heart rate decreased, Pallor
Clinical narrative: He felt as though his heart rate slowed, he developed chest pain and lightheadedness. He was pale. We received the rest.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Head injury, Syncope, Tremor
Clinical narrative: Fainted in chair after receiving a PPD and GARDASIL vaccine. Hit back of head on floor. Father states patient "shake some as he fainted". Oriented to T-P-N. No bleeding or knot on head. Walked to car accompanied by both parents.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever of 104 degrees F.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Musculoskeletal pain, Myalgia, Pain
Clinical narrative: 1 week after GARDASIL, patient woke from a sound sleep w/ severe shooting pains in shoulder and upper arm muscles -> continues w/ certain movements and positions.
Age: 49.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pain, Pruritus, Pyrexia
Clinical narrative: Patient had MENACTRA vaccine on 4/26/13 and 2 days later had fever, local pain, redness ans some itchiness which peaked on 4/28/13.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Injection site mass, Injection site swelling
Clinical narrative: Pt received Dtap and HIB vaccines on Right thigh. Two days later 2 lumps were noticed at the vaccination site. Pt iced affected area swelling went down then took pt to ER and has been seen by primary.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: 2-3" diameter erythema, slight swelling no induration, no pain on palpation.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Abdominal pain upper, Dysstasia, Feeling abnormal, Loss of consciousness, Muscular weakness
Clinical narrative: Severe thigh aches, weakness in legs so severe could hardly stand upright. Bad headache, lightheaded, almost passed out. Extreme nausea and stomach cramps. Overall bad feeling.
Age: 12.0
Sex: F
Vaccine: HPV4, MEN, TDAP
Symptoms: Nausea, Pain in extremity
Clinical narrative: Severe thigh aches, weakness in legs so severe could hardly stand upright. Bad headache, lightheaded, almost passed out. Extreme nausea and stomach cramps. Overall bad feeling.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Numbness on right leg.
Age: 13.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Electroencephalogram normal, Full blood count normal, Incomplete course of vaccination, Metabolic function test normal, Nuclear magnetic resonance imaging normal
Clinical narrative: Mother states patient developed "staring spells" 1-2 weeks after vaccine (GARDASIL) given. Episodes happened after 1st and 2nd vaccine. Refused 3rd injection.
Age: 13.0
Sex: M
Vaccine: HPV4, TDAP
Symptoms: Staring
Clinical narrative: Mother states patient developed "staring spells" 1-2 weeks after vaccine (GARDASIL) given. Episodes happened after 1st and 2nd vaccine. Refused 3rd injection.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV2, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Redness skin around shot site. Mom placed unknown cream onto area and resolved within hours.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Pt reported low-grade fever to 101, chills, nausea, headache, fatigue, joint pain and urinary frequency beginning the morning following the vaccination date. Resolving after 24 hours.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Pollakiuria, Pyrexia
Clinical narrative: Pt reported low-grade fever to 101, chills, nausea, headache, fatigue, joint pain and urinary frequency beginning the morning following the vaccination date. Resolving after 24 hours.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: (L) arm injection site redness, swelling, pain and induration. Pt seen 3 days after injection. Sxs started after injection worsened per mother.
Age: 1.57
Sex: M
Vaccine: DTAP, HEPA, IPV
Symptoms: Urticaria
Clinical narrative: Hives extensively-face, chest, arms/lip within 1 hr of vaccination. On exam withiin 4 hrs noted  no distress no vomiting.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Nausea, Swelling, Ultrasound scan normal
Clinical narrative: Severe redness and swelling. Nausea still persisting as of 7/26. Other symptoms resolved with BENADRYL and warm compress.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: Infant was given Dtap, Hep B-IPV combo vaccine, PCV 13, rotavirus vaccines and an accidental additional Hep B vaccine instead of Hib vaccine. No adverse effects child doing well.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea
Clinical narrative: Patient states she developed severe shortness of breath after receiving PNEUMOVAX23 inj. on 6/26/13. She saw her physician on 7/3, 7/5 and 7/22/13. She has been treated with ZITHROMAX, albuterol MDI and nebulized prednisone.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Akinesia, Erythema, Induration, Tenderness
Clinical narrative: Received Tdap in (L) upper arm (IM) on 07/18/13 at 11:30 am. Grandmother states several hours after injection she noticed reaction. Gave BENADRYL called our office 7/19/13 afternoon. Was seen/noted to have 8.5 cm x 8 cm area of erythema and induration. Area warm to touch and tender Treated with prednisone dose pack and BENADRYL.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction, Rash macular
Clinical narrative: Rash of (R) deltoid injection site. Onset 7/21 - resolved spontaneously 7/23. Rash described as red, slightly raised, blotchy, slightly itchy.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis, Back pain, Laboratory test
Clinical narrative: Patient called about 1 month after vaccine to state she had developed back pain and/or a flair up of arthritis due to ZOSTAVAX. Dr was running tests.
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Faecal volume increased, Faeces discoloured, Irritability, Liver function test, Occult blood negative
Clinical narrative: Irritability, fussiness, pallor x 36 hrs large black stool (guaiac neg) (no currant jelly").
Age: 0.36
Sex: F
Vaccine: DTAP, HIBV, PNC13, RV5
Symptoms: Pallor
Clinical narrative: Irritability, fussiness, pallor x 36 hrs large black stool (guaiac neg) (no currant jelly").
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Feeling cold, Vomiting
Clinical narrative: Child received vaccine on 7-23-13 around 8:30 am. Later that evening he stated it was hot outside but he was cold as he went to bed. He got up early 7-24-13 went to check fishing lines on river and had emesis x1. When he got home temp was 100.9. He has been resting and sleeping since this morning.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: 14 year old boy presented office for administration of HPV#3. Patient subsequently after given vaccine to right deltoid area about less than a minute fainted, unresponsive, generalized pallor observed. After frequent stimulation about 30 sec regained consciousness, cooperative, pallor resolved. Given water, felt better. No O2 given.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Injection site erythema, Local reaction
Clinical narrative: (R) upper thigh local reaction from PREVNAR and HIB vaccination given 7/25/13.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Nausea, Pallor, Wheezing
Clinical narrative: Wheezy, nausea, pallor just after injection.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Fall, Loss of consciousness, Pallor
Clinical narrative: Pt walked out to waiting room and per mom felt dizzy, she had him sit down and he slumped over and passed out. When I saw pt he was awake, but pale and dizzy. Recovered and walked out of office.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Glassy eyes, Headache, Pallor, Posture abnormal, Syncope
Clinical narrative: 13 yo received HPV #1, then hep A; within 1 minute c/o headache, then head drooped (placed supine) looked glassy-eyed to RN, extended (L) arm x 1. Responsiveness pale but all VSS = Syncopal episode
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown ages and gender. No information regarding the patients medical history was provided. There was a possibility that the patients were administered with improperly stored VARIVAX (Merck) vial dry SD vaccine. Lot number was reported as J000153 (validation pending) with expiry date of 07-JAN-2015. No concomitant medication was reported. No adverse effects were reported. No outcome was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac pacemaker insertion
Clinical narrative: This spontaneous report was received from a registered pharmacist via a company representative concerning a female patient of unknown age with heart problems (unspecified). Around 08-AUG-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. Since an unknown date, the patient was experiencing heart problems (unspecified) prior to receiving ZOSTAVAX. Approximately on 08-SEP-2012 (about a month after ZOSTAVAX was administered), the patient was admitted into an unspecified hospital for an unspecified amount of time and needed to have a pace maker implanted. It was unspecified if any lab tests were performed. On an unknown date, the patient recovered and the patient was doing well at the time of report. The causality was unknown. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Foetal disorder, Ultrasound Doppler normal, Ultrasound scan abnormal
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of intrauterine growth retardation in a 31-week-gestation fetus of unknown gender who was exposed to BOOSTRIX (GlaxoSmithKline) when the mother was being treated during pregnancy. On 3 July 2013 and 26 June 2013, the 26-year-old mother of the subject received 2nd dose and 1st dose of BOOSTRIX (0.5 ml, intramuscular, unknown details). The mother's last menstrual period was not reported and estimated date of delivery was reported to be 25 August 2013. The neonate was exposed to BOOSTRIX (GlaxoSmithKline) at approximately "31 weeks, 3 days" and approximately 32 weeks gestation. An ultrasound examination on 3 July 2013 revealed results which "showed baby with fetal weight in 29th percentile." The subject had another ultrasound on 10 July 2013 which "showed baby with intra-uterine growth retardation." Per the reporter, the subject will now be getting ultrasound examinations every 3 to 5 days. "Dopplers are normal" per the nurse. At the time of reporting, the pregnancy was ongoing. This case was associated to a Mother case. Please see case A1035095A for details regarding the mother case. This case was associated with a suffix case. See case A1035095B for details of the case with the baby.
Age: 0.83
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Grand mal convulsion, Partial seizures, Postictal paralysis, Pyrexia
Clinical narrative: 10mo male with focal left side seizure in setting of fever that progressed to tonic-clonic seizure and prolonged for estimated 30-45min with prolonged post-ictal paralysis. Admitted for fluid hydration, monitoring, and evaluation.
Age: 0.26
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Barium enema, Enema administration, Intestinal perforation, Intussusception, Laboratory test normal
Clinical narrative: Ileocecal Intussusception with perforation during barium enema and open surgery for repair.
Age: 0.26
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Surgery, Ultrasound scan normal
Clinical narrative: Ileocecal Intussusception with perforation during barium enema and open surgery for repair.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Starting on 07-29-13, patient started itching at the injection site. I noticed today, the injection site is very red, hot to the touch, and hard to the touch.
Age: 1.31
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Reddened raised and warm area to right leg.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Rash, Rash macular, Streptococcus test, Streptococcus test negative
Clinical narrative: Reddened raised and warm area to right leg.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: First ever outbreak Herpes Zoster along Left T9 dermatome.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Haemorrhage, Herpes zoster
Clinical narrative: First ever outbreak Herpes Zoster along Left T9 dermatome.
Age: 1.04
Sex: M
Vaccine: HEPA
Symptoms: Syringe issue
Clinical narrative: On the end of the syringe opposite needle the lip of the syringe broke off and glass became imbedded in nurse's thumb. Did not affect patient. Nurse was seen by a provider.
Age: 1.61
Sex: M
Vaccine: MMR, PPV, VARCEL
Symptoms: Dehydration, Lymphadenopathy, Pyrexia, Viral infection
Clinical narrative: HIGH FEVER. SYSTEM WIDE SWOLLEN LYMPH NODES WITH DEHYDRATION AND VIRAL RESPONSE.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Presyncope
Clinical narrative: Patient felt dizzy at check out, HR 122, had near syncope.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Feeling hot, Headache, Induration
Clinical narrative: Cellulitis with erythema, warmth, induration and pain. Fevers. Total body aches with HA.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Lumbar puncture normal, Pain, Pyrexia
Clinical narrative: Cellulitis with erythema, warmth, induration and pain. Fevers. Total body aches with HA.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness and pruritis to upper left arm.
Age: 7.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever 101-102 x 3d. Red/swelling at site of vaccine - varicella.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Malaise, Myalgia, Neck pain
Clinical narrative: 1 week after Tdap, he developed pain in bilateral hamstrings which then extended up back gradually all way to neck. These symptoms resolved after 7 days but malaise has continued (which also started 7 days after injection).
Age: 33.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Breast pain, Hyperaesthesia, Neck pain, Pain in extremity
Clinical narrative: Severe pain L arm, L breast, L neck with hypersensitivity to skin touch withiing 6 hrs of vaccine. Low grade temp 99.2 within 24 hrs.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV4, HPV4
Symptoms: Dizziness, Gaze palsy, Loss of consciousness, Muscle twitching, Nausea
Clinical narrative: Within first seconds of receiving 1st HPV shot, the patient started feeling nausea, dizzy, became pale white and then had a convulsive syncopal episode with eye rolling, extremity twitching and LOC for 5-6 seconds.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV4, HPV4
Symptoms: Pallor, Syncope
Clinical narrative: Within first seconds of receiving 1st HPV shot, the patient started feeling nausea, dizzy, became pale white and then had a convulsive syncopal episode with eye rolling, extremity twitching and LOC for 5-6 seconds.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV4, HPV4
Symptoms: Dizziness, Fatigue, Loss of consciousness, Muscle twitching, Nausea
Clinical narrative: Within first seconds of receiving 1st HPV shot, the patient started feeling nausea, dizzy, became pale white and then had a convulsive syncopal episode with eye rolling, extremity twitching and LOC for 5-6 seconds.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV4, HPV4
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: Within first seconds of receiving 1st HPV shot, the patient started feeling nausea, dizzy, became pale white and then had a convulsive syncopal episode with eye rolling, extremity twitching and LOC for 5-6 seconds.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Depression, Fatigue, Joint range of motion decreased, Malaise
Clinical narrative: Within about 2 weeks of shot, patient reports that symptoms of aches/pain in shoulders and neck, upper arms, hips, buttocks, thighs, stiffness, limited range of motion, fatigue, malaise, depression, began and steadily worsened. First reported this to us on 7/26/13.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Within about 2 weeks of shot, patient reports that symptoms of aches/pain in shoulders and neck, upper arms, hips, buttocks, thighs, stiffness, limited range of motion, fatigue, malaise, depression, began and steadily worsened. First reported this to us on 7/26/13.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Myalgia, Tenderness
Clinical narrative: Pt describes myalgia, shoulder joint pain, local tenderness-painful when touched.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Pt received vaccine for shingles 6/28/13. Developed shingles disease 7/11/13.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Adverse reaction, Arthralgia, Erythema, Pain in extremity, Rash
Clinical narrative: Pt was given PNEUMOVAX and TDap vaccine on 7/24/13. Pt called office c/o pain in his R arm, rash and redness on 7/30/13. Pt was seen in the office on 7/30/13. Dx:  pain in joint: upper arm and rash. Tx- Prednisone (Medrol Pak) and Hydrocodone were prescribed and will f/u 8/2/13.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Pt had an allergic rxn to ZOSTAVAX inj.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Erythema with minimal swelling at injection site of varicella vaccine (left arm given subcutaneously) no tenderness or warmth on palpation no induration improved with 25 mg of BENADRYL given orally (No systemic symptoms).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Erythema, Local swelling
Clinical narrative: Pt received injection on Friday later that night pt had localized redness and swelling that resolved on Sunday. Pt was given steroid.
Age: 11.0
Sex: M
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Wrong drug administered
Clinical narrative: PENTACEL given in error on 7/27/2012 error found 3/7/2013 should have been MENACTRA reported to CDC and Sanofi on 3/7/2013.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Feeling abnormal, Oral pruritus
Clinical narrative: This spontaneous report as received from a female registered nurse reporting on herself with no drug reactions or allergies, who a week or two ago in approximately July 2013, she started to feel weird described as uncomfortableness and itchiness on the roof of her mouth. It was stated that these events occurred soon after the administration of ZOSTAVAX (dose and lot number not reported) to the patient in approximately 2013 and lasted a couple of hours. The nurse reported that she had gloves on when she reconstituted and administered ZOSTAVAX to the patient. No treatment was given for the experience. No lab diagnostics studies were performed. The patient did not seek medical attention. The relatedness for uncomfortableness and itchiness on the roof of her mouth and ZOSTAVAX was unknown. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 29 year old female patient. On 16-JUL-2013 the patient was vaccinated with PNEUMOVAX23, 0.5 ml, intramuscular in the right arm. Lot number H019992, expiry date 09-DEC-2013. On 16-JUL-2013, the patient experienced redness, swelling and pain at the injection site of her right arm. The patient called the clinic on 17-JUL-2013 to report the reactions. The patient was instructed to apply some ice to her injection site and use ibuprofen to reduce the swelling and pain. The patient was seen by the medical staff at the clinic on 18-JUL-2013. After she was seen in the clinic the patient was prescribed cephalexin. The outcome of the events was reported as recovering/resolving. Causality assessment was not provided. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Rash vesicular
Clinical narrative: This spontaneous report was received from a consumer regarding her mother, a 65 year old female patient with no pertinent medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX, (0.65 ml, subcutaneous). No other suspect therapies or concomitant medications were reported. 18-JUL-2013 the patient experienced shingles like symptoms of rash, headache and blistering after receiving ZOSTAVAX. It was reported that the above mentioned adverse events had not improved. It was reported that the patient did not seek medical attention. Additional information is not expected.
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.  On 16-JUL-2013 the patient was vaccinated with PNEUMOVAX23 (0595AA, expiration date 30-AUG-2012) intramuscular (dose and anatomical location unspecified). The pharmacist stated that around 90% of this PNEUMOVAX23 dose was from one multi-dose vial of PNEUMOVAX23 which was in date (H010515, expiration date 13-FEB-2014) and that around 10% of this PNEUMOVAX23 dose was from another multi-dose vial of PNEUMOVAX23 which was expired (0595AA, expiration date 30-AUG-2012). No adverse effect was reported. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Serology test
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient between 18 and 19 years old with multiple sclerosis. On 02-JUL-2013, the patient received the first vaccination with the VARIVAX (Merck) and on 27-AUG-2012 the second vaccination. On an unknown date, the result of serologic testing for immune response after administration of VARIVAX (Merck) showed that the patient had no antibodies.  Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. It was reported that the patient received the first and second dose of GARDASIL (Lot # not reported) (dose and route not reported) in 2006 and the third dose was received on 25-JUL-2013. Concomitant therapy was not reported. No symptoms reported. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 5 year old male patient who 26-JUL-2013, was vaccinated with a 0.5 ml dose of GARDASIL intramuscularly (lot # H017698) instead of KINRIX. No adverse effects were reported. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Induration, Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 79 year old female patient with high blood pressure, cholesterol and unspecified type of cancer and with no drug reactions or allergies. On 24-JUL-2013 at 12:00 pm, the patient was vaccinated with 0.5 ml dose of PNEUMOVAX23 (Lot # H014561, expiration date 21-MAR-2014) IM in the right arm. Concomitant therapies included unspecified medications for high blood pressure and cholesterol. The pharmacist reported that on the evening of 24-JUL-2013, the patient developed a fever of 106 F and redness and swelling from the injection site down past her elbow. The patient called the pharmacist on 24-JUL-2013 and the pharmacist advised her to take BENADRYL, ibuprofen and TYLENOL and to place ice on the redness and swelling. The pharmacist reported that the patient did not report any difficulty breathing. The pharmacist reported that the patient followed her instructions for treatment and also went to a physician's office the morning of 25-JUL-2013. At the physician's office, the patient's temperature was recorded to be 99 F and the physician instructed the patient to stop taking any medications to treat a fever. The pharmacist reported that after the patient left the physician's office she went to see the pharmacist and the pharmacist inspected the patient's arm. The pharmacist reported that there was slight bruising at the injection site, however a red, swollen hardened bubble began about 3 inches below the injection site and extended past her elbow. The patient stated that the bubble did not hurt unless you press on about 3 inches below the injection site and extended past her elbow. The patient stated that the bubble did not hurt unless you press on it. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 79 year old female patient with high blood pressure, cholesterol and unspecified type of cancer and with no drug reactions or allergies. On 24-JUL-2013 at 12:00 pm, the patient was vaccinated with 0.5 ml dose of PNEUMOVAX23 (Lot # H014561, expiration date 21-MAR-2014) IM in the right arm. Concomitant therapies included unspecified medications for high blood pressure and cholesterol. The pharmacist reported that on the evening of 24-JUL-2013, the patient developed a fever of 106 F and redness and swelling from the injection site down past her elbow. The patient called the pharmacist on 24-JUL-2013 and the pharmacist advised her to take BENADRYL, ibuprofen and TYLENOL and to place ice on the redness and swelling. The pharmacist reported that the patient did not report any difficulty breathing. The pharmacist reported that the patient followed her instructions for treatment and also went to a physician's office the morning of 25-JUL-2013. At the physician's office, the patient's temperature was recorded to be 99 F and the physician instructed the patient to stop taking any medications to treat a fever. The pharmacist reported that after the patient left the physician's office she went to see the pharmacist and the pharmacist inspected the patient's arm. The pharmacist reported that there was slight bruising at the injection site, however a red, swollen hardened bubble began about 3 inches below the injection site and extended past her elbow. The patient stated that the bubble did not hurt unless you press on about 3 inches below the injection site and extended past her elbow. The patient stated that the bubble did not hurt unless you press on it. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthropod bite, Erythema, Induration, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old male patient with no drug reactions/allergies. On 14-JUN-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # J000436, exp. date 10-APR-2010) (dose and route were not reported). Concomitant therapies included lisinopril (manufacturer unknown), metoprolol, pravastatin sodium and PRILOSEC. Pharmacist reported the patient stated that ever since he received ZOSTAVAX and got bit by a mosquito, the mosquito bites swelled up extremely large and got red, hard and warm to the touch. Pharmacist mentioned this happened where ever the patient got a mosquito bite and was not isolated to any one area on the patient's body. Patient was treated with BENADRYL and hydrocortisone (unspecified). Patient sought the pharmacist. The outcome of the events was reported as not recovered/not resolved. The relationship between the ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a non-healthcare worker refers to a 17 year old patient, gender unspecified. Approximately on an unknown date in July 2006 (reported as 7 years ago), the patient was vaccinated with dose 1, GARDASIL (lot#, expiration date and route not reported). On 26-JUL-2013 the patient was vaccinated dose 2, 0.5 milliliter (ml) with GARDASIL (lot# and expiration date not reported), intramuscularly. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a patient of unknown age. On an unknown date the patient was vaccinated with VARIVAX (Merck) (strength, dose and frequency were not provided) rather than ZOSTAVAX. No adverse event reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: This spontaneous report has been received from a pharmacist who was referring to a 76 year old male patient with diabetes, hypertension, high cholesterol and no drug reaction or allergy. On 12-MAR-2013 the patient was vaccinated with the first dose of ZOSTAVAX (Lot number #H011712 is an invalid lot number for ZOSTAVAX, expiry date reported as 06-MAR-2014) once, 0.65 ml, subcutaneously, after physician recommendation. Concomitant therapies included atorvastatin, metformin, amlodipine, and  hydrochlorothiazide. In May 2013 (reported as sometime in May) the patient experienced spot on his next that was itchy and looked like a welt. The reporting pharmacist stated that she did not believe it was shingles at that time. On an approximately 13-JUN-2013, reported as two weeks ago the patient called the pharmacist and stated that he got chickenpox and shingles after receiving ZOSTAVAX. The patient stated that chickenpox and shingles come and go. On 13-JUN-2013, the patient was seen by dermatologist who diagnosed skin reaction as bug bites and prescribed triamcinolone and valacyclovir. It was reported that the patient's wife was still believe that the patient was experiencing chickenpox and shingles due to information she read on the Internet. The outcome of spot on his neck that was itchy and looked like a welt and skin reaction was reported as not recovered/not resolved. None laboratory test was performed. The reporter did not assessed relatedness between adverse events and therapy with ZOSTAVAX. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pruritus, Skin reaction, Urticaria, Varicella
Clinical narrative: This spontaneous report has been received from a pharmacist who was referring to a 76 year old male patient with diabetes, hypertension, high cholesterol and no drug reaction or allergy. On 12-MAR-2013 the patient was vaccinated with the first dose of ZOSTAVAX (Lot number #H011712 is an invalid lot number for ZOSTAVAX, expiry date reported as 06-MAR-2014) once, 0.65 ml, subcutaneously, after physician recommendation. Concomitant therapies included atorvastatin, metformin, amlodipine, and  hydrochlorothiazide. In May 2013 (reported as sometime in May) the patient experienced spot on his next that was itchy and looked like a welt. The reporting pharmacist stated that she did not believe it was shingles at that time. On an approximately 13-JUN-2013, reported as two weeks ago the patient called the pharmacist and stated that he got chickenpox and shingles after receiving ZOSTAVAX. The patient stated that chickenpox and shingles come and go. On 13-JUN-2013, the patient was seen by dermatologist who diagnosed skin reaction as bug bites and prescribed triamcinolone and valacyclovir. It was reported that the patient's wife was still believe that the patient was experiencing chickenpox and shingles due to information she read on the Internet. The outcome of spot on his neck that was itchy and looked like a welt and skin reaction was reported as not recovered/not resolved. None laboratory test was performed. The reporter did not assessed relatedness between adverse events and therapy with ZOSTAVAX. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray, Chest pain, Cough, Ear pain, Neck pain
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 71 year old female patient. On 22-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). On 03-MAY-2013, the patient had contracted shingles. At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source (linked with Case# 1307USA016810). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 71 year old female patient. On 22-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). On 03-MAY-2013, the patient had contracted shingles. At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source (linked with Case# 1307USA016810). Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a field representative refers to a 71 year old female patient. On 22-APR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose and route not reported). On 03-MAY-2013, the patient had contracted shingles. At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source (linked with Case# 1307USA016810). Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Erythema, Injection site warmth, Malaise, Pain, Swelling
Clinical narrative: This spontaneous report as received from a Registered Pharmacist refers to a 60 year old male patient with no known medical history and drug/reactions allergies. On 23-JUL-2013, the patient was vaccinated with ZOSTAVAX (Lot # J002240, exp. date 21-MAY-2014) 0.65 ml dose, subcutaneous in the left arm. Patient also received ADACEL on 23-JUL-2013. The patient developed a red, swollen, "hot to the touch" area 7mm by 5mm on his left arm at the injection site after receiving ZOSTAVAX (on an unknown date in July 2013). The patient also reported that he was feeling "out of sorts" on 24-JUL-2013. On an unknown date, the patient sought medical attention, he came back to the pharmacy. There were no laboratory tests performed. There was not given any treatment for the events. At the time of the report the patient had not recovered from the events. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS, VARZOS
Symptoms: Feeling abnormal, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Registered Pharmacist refers to a 60 year old male patient with no known medical history and drug/reactions allergies. On 23-JUL-2013, the patient was vaccinated with ZOSTAVAX (Lot # J002240, exp. date 21-MAY-2014) 0.65 ml dose, subcutaneous in the left arm. Patient also received ADACEL on 23-JUL-2013. The patient developed a red, swollen, "hot to the touch" area 7mm by 5mm on his left arm at the injection site after receiving ZOSTAVAX (on an unknown date in July 2013). The patient also reported that he was feeling "out of sorts" on 24-JUL-2013. On an unknown date, the patient sought medical attention, he came back to the pharmacy. There were no laboratory tests performed. There was not given any treatment for the events. At the time of the report the patient had not recovered from the events. Additional information has been requested.